Digital Solutions in Drug Development

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Digital Solutions in Drug Development

R&D is important in the pharmaceutical industry because it promotes innovative production methods, lowers medicine costs and improves product quality. Additionally, research and development may recruit highly-skilled, creative and innovative workers and play a critical role in the innovation process, particularly in the pharmaceutical industry. The research and development process is critical to the pharmaceutical industry’s drug development process. The process begins with identifying a potential candidate drug and is followed by intensive research testing to determine the medicine’s therapeutic suitability.

 

The pharmaceutical industry is concerned with human lives since it creates and manufactures miracle medicines for people. Diseases are becoming more prevalent as a result of pollution and changes in people’s eating habits. Nowadays, nearly everyone is afflicted with at least one disease, whether an infection or a viral illness. Additionally, as a consequence of pollution, people are afflicted with a variety of skin problems. All of these conditions classify people as patients. As a consequence, medicine has become a regular meal for many people.

Research & Development

All companies rely on research and development. In the biopharmaceutical research industry, R&D services generate revenue for the companies participating in the study by saving or improving patients’ lives. Pharmaceutical research and development are important components of many businesses’ success; doctors and scientists from every country have made substantial expenditures in the study and development of this sector. Reliable pharmaceutical research and development services enable businesses to adhere to manufacturing procedures, quality control measures, production scope and technical expertise.

Digital Solutions in Drug Development

From mobile medical apps and fitness trackers to software that aids doctors in their daily clinical decisions, digital technology has sparked a revolution in healthcare. As we adjust to the new normal brought about by the COVID pandemic, the use of digital solutions has grown.

Pharmaceutical Process Development

Process development is the process of creating, implementing, or improving an existing industrial process. It ensures that a product can be manufactured aseptically and consistently to meet requirements before mass production. Furthermore, it creates a minimal industrial strategy by translating methods developed on the bench in a research lab to industrial-scale life-cycle studies that consider needed improvements in a controlled environment, equipment and auxiliary materials.

 

This process also evaluates the manufacturing feasibility of each project and sets quality and testing criteria for production-process controls and released products. We may create new processes, transfer old processes, or enhance existing processes from the start of development. The goal is to reduce the risk of developing a final advanced treatment pharmaceutical product, whether via an end-to-end process or by optimizing certain phases.

Research and Development on the Demand Side | Rondaxe

Research and Development on the Demand Side

Drug prices in a market economy would be determined by supply and demand. Because most of the cost of producing medications is spent on research and development rather than manufacturing pills, the government is mainly concerned with providing patent protection and exclusivity to foster sustainable innovation. The amount of money spent on developing new medicines is contingent upon the capacity to reach this pricing.

Suppose health insurance pays for a significant portion of the cost of medications. In that case, manufacturers may charge higher rates and will almost certainly invest more in the research and development of new therapies. On the other hand, increased price leads to a decrease in the number of units sold of the medicine. As a result of this supply constraint, investment is very sensitive to value; in other words, what a medicine accomplishes medically vs. how much it costs.

 

However, three significant developments in recent years have changed the demand constraint. To begin, more people now have access to prescription medication coverage due to Medicare Part D and the expansion of insurance coverage under the Affordable Care Act. Second, drug insurance has become much more comprehensive due to the introduction of benefit designs that limit the enrollee’s out-of-pocket costs. Third, the cost of many contemporary medications is too high, such as particularly specialized pharmaceuticals used to treat complex, chronic illnesses like cancer, rheumatoid arthritis and multiple sclerosis. This component affects demand as a result of its interactions with various insurance benefit design elements.

Consider the case when a patient is using a $50 medication, and a new, possibly better therapy becomes available for $100. In such cases, insurance benefit designs often allow the patient to take the newer medicine at a higher cost (with the permission of a prescribing physician). While the patient’s cost is less than the difference in the prices of the two medications, only those who believe they will benefit from switching will do so.

 

When annual expenses exceed $100,000 or $200,000, however, everything changes. The majority of patients who are forced to pay a significant portion of the cost of these medications will never get the prescription. On the other hand, out-of-pocket maximums make medications affordable, and as a result, the patient becomes oblivious to price differences. Ultimately, the patient pays the same amount for medications that cost $100,000 or $200,000—their out-of-pocket maximum. This indicates that cost increases at this level do not affect patient demand.

 

Due to current insurance programs and the high cost of medications, rising prices may not result in fewer units. On the contrary, since new medications are anticipated to be profitable, revenues will likely rise, as will investment in their development.

More information on research and development can be found online at rondaxe.com.

Pharmaceutical Technology Transfer Process

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Pharmaceutical Technology Transfer Process | Rondaxe

 

It is vital to impart critical technology and knowledge to ensure the continuous manufacture of high-quality drugs. This procedure is known as technology transfer, and it is the process of bringing a concept from the lab to the market.

 

In the pharmaceutical industry, the term “technology transfer” refers to all of the processes required for successful development, from medicine discovery through product improvement, clinical trials and final commercialization. Additionally, it is sometimes understood how technology inventors make their technology accessible to commercial partners who subsequently utilize it.

The Process of Technology Transfer

Transfer of technology is critical and vital to medication research and development for new pharmaceutical products. Economic factors often influence the choice to transfer such products across manufacturing sites. The procedure is divided into the following phases:

 

  • Data collection
  • Data review
  • Regulatory impact (more emphasis on change approvals)
  • Analytical validation
  • Pilot or total process batch
  • Stability setdown

 

The discovery and development of medications in a typical research-based pharmaceutical company may be split into two phases: research and development.

 

The research phase is primarily concerned with conducting scientific investigations that will develop new services and products that will benefit the public. The process then progresses to the development phase. Additional research is done to evaluate the product’s economic viability and conduct a market study to establish if a consumer need exists. Once research demonstrates economic viability, it is protected by filing for intellectual property protection. Commercialization happens after licensing when the service or product is offered to the market; this is the last step, the stage of production. Additionally, feedback from advertised products is considered.

 

The stages of formulation are:

 

  • Pre-formulation studies
  • Bench-scale- 1/1000th of Y
  • Lab-scale – 1/100th of Y
  • Scale up – 1/10th of Y
  • Commercial – Y

 

Where Y is final commercial scale lot size

Importance of Technology Transfer

Technology transfer reveals critical information for transferring technology from R&D to manufacturing by sifting through data collected during R&D; to explain essential information to facilitate the transfer of technology for products in stock across several manufacturing sites; and to illustrate particular areas of concern and procedures, thus facilitating the smooth transfer of technology.

Ensuring a Successful Technology Transfer | Rondaxe

Certain issues should be discussed to facilitate the transfer of pharmaceutical technology. The following are some examples:

 

  • A safety and health evaluation should be undertaken to guarantee that the products can be handled properly;
  • Validation of cleaning procedures must be conducted. Additionally, batch records and requirements must be recorded correctly;
  • Packaging line trials should be conducted, particularly if the facility is new to the product. By defining stability methods, online transfers against customer-approved processes should be permitted;
  • Operators must be trained, and quality assurance agreements must be in place. Additionally, timelines should be followed, and significant issues and occurrences should be communicated.

 

More information on the technology transfer process is readily available at rondaxe.com.

 

Pharmaceutical Industry Research And Development

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Pharmaceutical-Industry-Research And Development | Rondaxe

Each year, the pharmaceutical industry in the United States develops several new medications with substantial medical benefits. Unfortunately, many of these medications are expensive, leading to rising healthcare costs for the private and public sectors. Policymakers have looked at ways to reduce the cost of medications and government drug expenditure, and such restrictions would very likely reduce the pharmaceutical industry’s incentive to do new research.

 

In one study, the Congressional Budget Office (CBO) analyzes changes in pharmaceutical research and development (R&D) spending as well as the introduction of new medications. Additionally, the CBO examines the following factors that affect how much money pharmaceutical companies spend on research and development:

 

  • Anticipated worldwide profits from a new medication
  • Cost of developing a new drug
  • Government regulations that impact drug demand or supply (or both)

What are the Latest Trends in Pharmaceutical R&D and New Drug Approvals?


In 2019, the pharmaceutical sector invested $83 billion in research and development. These expenses were spent for various purposes including the discovery and testing of novel medications, the creation of incremental enhancements such as product expansions, and clinical testing for safety and marketing purposes. After inflation is considered, the total is about 10 times what the industry spent annually in the 1980s.

Additionally, pharmaceutical companies’ proportion of revenue spent on research and development has increased: Pharmaceutical companies spent almost a quarter of their revenues (net of expenses and buyer rebates) on research and development in 2019, nearly twice as much as they did in 2000. This revenue proportion is much higher than other knowledge-based industries such as semiconductors, specialized hardware and software.

 

Each year, the number of new medications approved has risen during the past decade. For example, from 2010 to 2019, the Food and Drug Administration (FDA) authorized an average of 38 new medicines each year (with a peak of 59 in 2018), a rate 60% greater than the average during the previous decade.

 

Numerous medications approved in the last few years have been categorized as “specialty drugs”. Specialty medications often treat chronic, difficult, or unusual illnesses that need specialized patient care or monitoring. Numerous specialty medications are biologicals (large-molecule pharmaceuticals derived from living cell lines), which are difficult to manufacture, duplicate and are often prohibitively expensive. Until recently, the majority of medications were composed of tiny molecules derived from chemical components. Even though they retained their patent protection, these medications were less costly than more modern specialized drugs. According to data on the kinds of medications now undergoing clinical trials, most of the industry’s creative effort is directed toward specialty pharmaceuticals that may provide new cancer therapies and treatments for nervous system illnesses such as Alzheimer’s and Parkinson’s disease.

What Factors Affect Research and Development Spending?

Three major factors affect pharmaceutical firms’ R&D expenditure decisions: anticipated expenses of developing new medication; global lifetime revenue projections for a new medication; and policies and initiatives affecting the supply and demand for prescription drugs.

 

Numerous variables affect companies’ expectations for a drug’s revenue stream, including the expected pricing in different countries and the estimated worldwide sales volume at those rates (given the potential number of persons who may use the medicine). Additionally, current pharmaceutical prices and sales volumes provide insight into customers’ desires and insurance plans’ readiness to pay for pharmacological treatments. Notably, when pharmaceutical companies set the price of a new medicine, they seek to maximize future revenues after subtracting manufacturing and distribution costs. Thus, a drug’s sunk R&D expenses—that is, the money spent earlier on developing the drug—does not affect its price.

Trends in R&D Spending and New Drug Development

Private investment in pharmaceutical research and development (and approval of new medications) has increased significantly in recent years, continuing a decades-long trend that was halted in 2008 by the availability of generic versions of several top-selling medications, as well as the 2007–2009 recession. Spending on pharmaceutical research and development, for example, increased by almost 50% between 2015 and 2019. Additionally, many medications approved in recent years are costly specialist therapies with a small patient population. On the other hand, the best-selling medications of the 1990s were low-cost pharmaceuticals with large patient populations.

R&D Spending

R&D expenditures in the pharmaceutical industry include a wide variety of activities, including the following:

 

  • The invention or the study and development of pharmaceuticals;
  • Clinical research and development, preparation and submission of FDA approval applications, and design of manufacturing processes for new medicines;
  • Incremental innovations including the development of novel dosage forms and delivery systems for existing medications and evaluating those medications for new purposes;
  • Product differentiation, or the clinical comparison of a novel medication to an existing competitor drug to demonstrate that the new medication is superior; and 
  • Safety monitoring, which the FDA may require to identify adverse effects that were missed during the drug’s development in shorter trials.

 

Private investment in pharmaceutical research and development by Pharmaceutical Research and Manufacturers of America (PhRMA) member firms was about $83 billion in 2019, up from approximately $5 billion in 1980 and $38 billion in 2000. Although those totals omit many smaller pharmaceutical companies that are not PhRMA members, the trend reflects the industry’s R&D expenditures. Additionally, a National Science Foundation (NSF) analysis of all pharmaceutical R&D spending in the United States (including smaller firms) reveals similar trends.

 

While total R&D spending by pharmaceutical firms has increased, small and large enterprises generally focus on distinct R&D activities. For example, small companies that are not members of PhRMA devote a greater part of their research to developing and testing new medications, the majority of which are ultimately acquired by larger corporations. On the other hand, larger pharmaceutical companies (including those in the PhRMA) devote a greater proportion of their R&D budgets to conducting clinical trials, developing incremental “line extension” improvements (new dosages or delivery systems, or new combinations of two or more currently available medications, for example), and conducting post-approval testing for safety monitoring or marketing purposes.

To find out more about research and development, visit Rondaxe online today.

 

 

Pharmaceutical Consulting Firms: Transforming the Pharma Industry

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Pharmaceutical Consulting Firms | Rondaxe

The FDA is beginning to tighten its compliance standards, resulting in a substantial increase in demand for pharmaceutical consulting services. Additionally, a manufacturer may profit from hiring a consulting firm in various ways since the firm will function as a sounding board in times of crisis.

 

Typically, pharmaceutical consulting companies would employ a broad group of specialists with specific knowledge in different facets of the pharmaceutical industry. One of the main objectives of this kind of consulting is to help manufacturers of medical devices and pharmaceutical medications comprehend their compliance responsibilities regarding the manufacturing processes used in their facilities. Additionally, an increasing number of manufacturers are struggling to comply with FDA regulations and therefore seek assistance from consulting companies to assist them.

Is Pharma Consulting the Right Solution for You?

While consulting offers many benefits, deciding if it is the right choice for your particular requirements involves discussing your situation with experts in the field. For instance, if you explain the kind of pharmaceutical goods you produce and your target market, it will be much easier for pharma consulting firms to develop a solution that fits your requirements.

 

Pharmaceutical training seminars are another often-requested resource from consulting companies, due to their high value. They contribute substantially to the knowledge base of workers and management on topics such as good manufacturing practices (GMP) and FDA / GMP audits. Finding the ideal pharmaceutical consulting team should be quite simple. Most manufacturers do online research to determine which consultants are the greatest match for their budget and consultant quality criteria.

 

Pharma consultancy is not a new concept in the pharmaceutical industry. Nonetheless, it is beginning to pay dividends for businesses that have been entangled in a sea of compliance and rules. Consequently, any manufacturer of medical equipment or medications would be prudent to seek the assistance of a respected consulting firm.

Pharma Consulting Uptake on the Increase

Utilizing pharmaceutical consulting companies may significantly enhance a pharmaceutical manufacturer’s compliance record. Given the benefits of using pharmaceutical consulting companies, it’s unsurprising that their use is increasing.

 

Pharma consulting companies are not uncommon in the medical device and supplement industries. Furthermore, the quality of the training programs and the consultants’ expertise has elevated them to an essential resource that businesses seeking to enhance their performance and compliance in the pharmaceutical sector cannot afford to ignore. Pharmaceutical consulting firms can enhance the production processes for medical devices and supplements. It is the responsibility of the professionals in this sector to contribute to the overall safety of the products that reach the market.

Speaking to Consulting Firms about FDA Compliance | Rondeaxe

Speaking to Consulting Firms about FDA Compliance

FDA compliance is undeniably one of the most serious problems plaguing the pharmaceutical business, and it plays a major role in manufacturers’ operations being harmed. As a result, manufacturers would certainly benefit from exploring the services of consulting firms, as their pharmaceutical consultants possess the necessary expertise to help them in resolving any FDA compliance issues that may arise.

 

It is essential to get the most out of consulting companies, including them early in the design and production phases. By doing so, you can help guarantee that they have the opportunity to examine the products you produce and give you any necessary advice about FDA compliance or good manufacturing practice (GMP) problems that may arise.

 

Consulting services will benefit manufacturers of all sizes, regardless of the pharmaceutical products manufactured; their expert analysis and thorough knowledge of how the business operates will allow a pharmaceutical goods manufacturer to thrive.

To find out how your company can benefit from pharmaceutical consulting, give Rondaxe a call at (315) 469-2800 today.

Pharmaceutical Product Development - 1

What You Need to Know About Pharmaceutical Product Development

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The Development of Pharmaceutical Products and the Search for a New Cure

Pharmaceutical product development remains a big mystery for most people, and rightly so since it is a highly complicated process. Everyone benefits, however, from the efforts of pharmaceutical product inventors when they shop at a pharmacy store for anything from antibiotic ointment for a cut to vital prescription medicines for disease. The quest for new medicines and goods to help people stay healthy never ends since even when a cure for sickness is discovered, there are other illnesses like cancer for which a solution is still elusive.

Years of Searching, Years of Testing

Even when a new medication that provides a cure for a condition is found, it may take up to a decade to reach the market where it is required. This is due to the FDA’s requirement that all medicines be carefully evaluated so that the new drug harms no customer.

These tests take so long to complete because all medicines must be examined for long-term and short-term adverse effects. Not all medication passes inspection, and if the side effects are discovered to be worse than the illness itself, the drug and all of the effort that went into it are abandoned.

Pharmaceutical Product Development Costs: Who Pays?

As a result, it is easy to see why prescription medicines may be costly. This is especially true for medicines that treat uncommon illnesses. Suppose only a few people in a society will be buying a drug and using it for a cure. How will a drug company pay for the development costs that efficiently run into millions of dollars?

Should the taxpayer foot part of the bill for this research? Should the expense be passed on to individuals who purchase medicines for more common illnesses, causing them to pay more? These are issues that we must all consider as pharmaceutical product development work progresses into the future.

Pharmaceutical Product Development - 2Product Development for Pharmaceuticals

Pharmaceutical product development encompasses a broad range of operations, from preclinical testing through clinical development, product launch problems, and other pharmaceutical product development-related activities. Many online and offline companies have a worldwide commitment to quality and delivering strategic solutions for compound pharmaceutical products and market development. They have a large-scale infrastructure, committed project teams, cross-functional therapeutic units, and new technologies. These organizations are research institutes that provide pharmaceutical product discovery, development, post-approval services, and various partnership programs. These businesses’ clients and collaborators include pharmaceutical, biotechnology, medical equipment, educational, and government institutions. The team comprises numerous pharmaceutical experts whose primary responsibility is to help clients develop new products and line expansions.

Companies can optimize returns on R&D expenditures and accelerate the delivery of safe and effective medicines to patients using the appropriate methods, new technologies, and therapeutic expertise for pharmaceutical product development. Pharmaceutical R & D activities are often split into two main units: discovery and development. Discovery is aimed towards both novel chemical and biological things. Chemical, biological, pharmaceutical growth, drug security and metabolism, clinical research and development, and medical transactions are all development activities.

Pharmaceutical product development entails using appropriate technical knowledge on various issues concerning the formulation of medicines for immediate or tailored release. The most recent advancement in pharmaceutical product development technology is the ability to produce poorly soluble medicines. Technical transfer problems associated with upgrades and legalization are also part of pharmaceutical product development. Pharmaceutical product development also includes the capacity to design and package medicines to provide the most significant degree of consumer satisfaction.

Companies assist the pharmaceutical product development process by guaranteeing accuracy, quality, and experience and ensuring that projects are executed effectively and professionally. Drug substance manufacturer selection, clinical support valuation, development pre-formulation, formulation development, and development procedures are among the pharmaceutical product development services offered.

Pharmaceutical Manufacturing - 1

Pharmaceutical Manufacturing – Significance and Benefits

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The Benefits of Pharmaceutical Manufacturing

Pharmaceutical manufacturing is the most significant industry in the world of medicine. The advances and technologies that have resulted from it have made many areas of medicine feasible that did not seem to be possible before its introduction. This is a science whose principles are similar to those of chemical engineering.

The creation of components that are required in the pharmaceutical industry is one of the main sectors. It does not end there; it also handles the commercialization of the goods to the more significant pharmaceutical industry. Here are some of the benefits brought about by this area of research.

This area of engineering has been shown to offer a plethora of job possibilities for pharmacy graduates. Graduates are equipped with cross-sectional skills that enable them to operate in a variety of industries. Graduates in this area are in great demand in various technology-related businesses, including biotechnology, nanotechnology, biomedical, food and additive industries, cosmetic industries, and dairy farms, among many others.

Many illnesses emerge daily, and pharmaceutical engineers are responsible for combatting these diseases utilizing cutting-edge medication. To make this a reality for pharmaceutical graduates, they must have solid expertise in this field and a great lot of patience.

Graduates must work hard to stay relevant in this competitive, demanding, and yet rewarding profession. They must understand how to utilize current medications and create new ones in the future so that the world may become a healthier place to live with fewer illnesses.

The truth is that viruses are found regularly, and they all prove to be very harmful to humans. As a result, pharmaceutical engineers must be armed with cutting-edge technology and instruments to rescue humans from potentially fatal medical problems caused by these viruses. The discovery of medications capable of combating spreading illnesses and other health risks is a key component of this area.

Graduates can also create a livable environment in which people can live without worrying about diseases and illnesses. This area of engineering also offers a complex infrastructure for the development of medications. Pharmaceutical engineers go through training sessions to learn about different medicines and managing procedures like manufacturing, packaging, and labelling.

As a result, pharmaceutical manufacturing has a high ability to produce high-quality medicines and sophisticated programs that assist in developing remedies for future health problems. Furthermore, it offers graduates entering the area of medical science a lucrative job. Graduates who are technologically sophisticated and have wide industrial knowledge are qualified to operate in foreign marketplaces where most pharmaceutical firms conduct recruiting campaigns. Graduates work in information systems, product quality systems, manufacturing systems, and supply chain management systems.

Pharmaceutical Manufacturing - 2Pharmaceutical Manufacturing and Its Importance in the Medical World

Pharmaceutical production has achieved significant advances in the medical field. It has produced medications and therapies for both standard and critical illnesses. It has created medications to treat the most lethal illnesses, including infectious diseases, cardiovascular problems, sexually transmitted diseases, and cancer. It has expanded the scope of pharmaceutical engineering. It has also produced critical vaccines and medicines that may protect against hepatitis B, hepatitis C, and polio. It has also made significant contributions to veterinary research. Pharmaceutical manufacturing companies have produced important medicines that can rescue animals from deadly illnesses.

Pharmaceutical production and pharmaceutical engineering have made significant contributions to medical research, which is widely recognized throughout the globe. But they are still striving to make a difference and rid the world of illness. They are conducting an increasing number of research projects and investigations to create efficient and cost-effective medications. They are working hard to enhance the efficacy of current medications and create new ones for future usage.

It covers a broad scope. It includes all processes, from the search for efficient raw materials to delivering medications to the market. It takes years to conduct research and discover a viable treatment for a specific illness. They first discovered a biological and chemical material with the potential to treat illnesses, and then they converted those substances into proper medications. It also commercializes pharmaceuticals for the medications to reach patients on schedule. Pharmaceutical manufacturing is not only concerned with the manufacture and distribution of medicines to the market. They are concentrating their

Consumer's Guide to Pharmaceutical Consulting

A Consumer’s Guide to Pharmaceutical Consulting

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Pharmaceutical Consulting Tips

Although pharmaceutical consulting has only been around for approximately 20 years, it has probably had a greater impact on the landscape of medical care in the United States than virtually any other administrative job. Surprisingly, few customers are aware of the day-to-day choices made on their behalf by businesses. Here’s a behind-the-scenes look into pharmaceutical consultancy.

What it is: Pharmaceutical consulting is a procedure in which specialist firms assist businesses and healthcare providers in lowering the cost of prescription medicine. Methods range considerably, from restricting the kinds of medicines covered by insurance to evaluating administrative procedures and proposing efficiency improvements.

Why consumers should be concerned: Consulting companies may assist in lowering the cost of prescriptions, which may result in cheaper health insurance rates for consumers. However, businesses may offer recommendations that limit customers’ access to certain prescription medicines in certain instances. Occasionally, these companies may engage with physicians, influencing which medicines they prescribe and under what circumstances.

Consumers may be better informed if they: Even if you don’t believe your health-care insurer is restricting your access to certain medicines, it’s a good idea to contact your health-care insurer’s customer service line and ask about their “formulary limitations.” Some insurers, for example, reject all “out-of-formulary” medicines, while others accept them with a fee.

Knowing your insurer’s rules—and how much impact pharmaceutical consulting companies have on them—can help you be a more educated customer. By being more knowledgeable about your prescription benefits, you will be a stronger advocate for yourself if you are ever refused access to a prescribed medicine in the future.

The Advantages of Hiring a Pharmaceutical Consulting Firm

The pharmaceutical business is highly competitive since new medicines are created every week, and each firm wantsHiring a Pharmaceutical Consulting Firm to be the first to market with theirs. A consultant may assist your firm in this area, but there is more to having a successful pharmaceutical company than just putting your goods on the market. Your brands and products need support from physicians, insurers, and community pharmacists to be prescribed at all, which may be difficult to accomplish. How would physicians know to prescribe your goods if they are unaware of them and you fail to advertise them to them adequately? A GP will only prescribe a medication that has been marketed to them, and pharmaceutical consultants may assist you with this.

In truth, pharmaceutical consulting is intended to advise businesses on all aspects of their operations, ensuring their success and keeping them up to speed with the rules and legislation regulating the pharmaceutical sector. Consultants will work with you to ensure that you get the most profit out of the money you spend, from creating a product to making sure it lasts on the market.

Licensing, brand management, business development, clinical research, medical affairs, sales and trade, and product distribution are areas in which pharmaceutical consultants specialize. While you may have expertise in any or all of these areas, the consultants will have specialized in one and provide you with the finest information in the industry. They make it their mission to stay one step ahead of product releases and new laws to advise their customers on the best approach to earn money while complying with the law.

Clinical development is particularly essential in today’s pharmaceutical business since resources are static while the size and complexity of clinical procedures grow. Pharmaceutical experts will evaluate your clinical practices and develop new processes that are more cost-effective and efficient to make the most of what you have. Their goal is to help your company and products reach their maximum potential in all areas of consulting.

A pharmaceutical business cannot keep up with every new product on the market, the laws that go with it, clinical studies, marketing their brand, and selling goods. That is why pharmaceutical consulting is an excellent option—keeping you up to date on industry changes and helping you maximize your company potential.

Lifecycle of a Product

Lifecycle of a Product: The Development of a New Drug

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What is the drug development life cycle?

Developing a new drug (e.g., a new medicine or biologic) is a lengthy, complicated, and costly process that usually takes 10 to 12 years (or more) from product discovery to commercialization. This lifespan typically consists of the following stages:

  • Discovery and research: Identify targeted therapy for illness or condition diagnosis, cure, mitigation, treatment, or prevention.
  • Development: This comprises non-clinical research, clinical investigations, and the creation of chemistry, manufacturing, and controls (CMC) to support clinical trials (e.g., IND, IDE, CTA, IDE) and license applications (e.g., NDA, NDS, MAA).
  • Regulatory review and approval: Data submission for regulatory assessment shows the product’s safety, effectiveness, and quality for the intended indication.
  • Commercialization and marketing: Ongoing regulatory compliance is achieved by filing safety reports and other necessary documents (e.g., product renewal).

New therapeutic product developmentNew therapeutic product development

Non-clinical testing is usually the first step in developing a new therapeutic product, followed by various human clinical trials to support the licensing application. Chemistry, Manufacturing, and Controls (CMC) activities are carried out simultaneously to support these investigations.

Preclinical/non-clinical studies

Before moving on to human research, non-clinical testing (laboratory experimentation and animal study) evaluates the prospective therapeutic benefits of a pharmacological substance and establishes its acceptable safety. Long-term studies (e.g., reproductive and carcinogenicity studies) performed after the clinical trial has begun may also be included. Non-clinical research must be carried out following Good Laboratory Practices (GLP). In this stage of testing, in vitro and in vivo studies may be conducted to investigate metabolism (pharmacodynamics [PD] and pharmacokinetics [PK]), safety, toxicity, dose, and effectiveness. When planning these investigations, be sure to go through any relevant regulatory resources, such as guidance papers from your regulatory agency and safety issues from the International Conference on Harmonization [ICH].

Clinical trials

Clinical trials are intended to evaluate a product’s safety and efficacy in humans. A clinical program is divided into four phases and must follow regional laws and Good Clinical Practices (GCP). Phases I through III are used to collect data on safety and efficacy to support the licensing application. Phase IV occurs after the product has been released (i.e., once the product reaches the market).

Phase I – Human pharmacology

Phase I begins with administering an investigational product to people for the first time (healthy volunteers or patients if for the use of cytotoxic drugs). These investigations often have non-therapeutic goals. A randomized and blinded research design may be used further to ensure the validity of the study’s findings. Clinical trials used in the first stages of drug development may include:

  • An estimate of the initial safety and tolerability, taking into account both single-dose and multiple-dose delivery.
  • A PK study
  • PD studies and studies relating drug blood levels to response (PK/PD studies)
  • Early measures of product activity

Phase II – Therapeutic exploratory

Phase II investigates treatment effectiveness in patients, with designs incorporating concurrent controls and compares to baseline state. Typically, the patient group is chosen based on strict criteria. One important goal is to identify the dose(s) and regimen to support

Phase III trials Other goals may include evaluating possible study endpoints, treatment regimens, and target groups (e.g., moderate vs severe illness) via exploratory analyses, analyzing data subsets, and utilizing multiple endpoints in clinical trials.

Understanding Pharmaceutical Research

Understanding Pharmaceutical Research Studies

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Medical researchers are constantly on the lookout for new or improved methods of treating illness or disease. However, it cannot be widely used until years of careful testing have been completed if they discover something valuable. Medical research studies are what connect medical research to the availability of a drug to physicians and patients. Clinical trials, drug trials, and drug studies are other names for research studies.

What exactly are pharmaceutic research studies?

  • Research studies are designed to test the effect of a medication or treatment on a group of volunteers, assess a drug’s ability to treat a medical condition, monitor the drug’s safety, and look for potential side effects.
  • Research studies are carried out by trained doctors, nurses, and researchers. The study coordinator is in charge of the study’s day-to-day operations. The protocol is carried out under the supervision of the principal investigator (usually a physician).
  • Pharmaceutical companies or other health organizations may fund research studies and design the protocol, a detailed set of guidelines—multi-center research conducted at several locations.

What Are the Various Kinds of Pharmaceutical Research Studies?

  • In conducting research studies, there are three phases or steps. Before a new drug can be approved for public use, complete all three of these steps.
  • Successfully, and all results must be known.
  • Phase I studies are conducted on healthy volunteers who agree to take the study drug to assist doctors in determining the drug’s safety and the presence of any side effects. In addition, studies are conducted to determine how the drug is absorbed, metabolized, and excreted. Phase I studies typically involve a small number of subjects (20-100). Approximately 70% of new drugs will make it through this stage.
  • Phase II studies assess the new drug’s efficacy in patients suffering from the disease or disorder being treated. The primary goal is to determine the new drug’s safety and effectiveness. Hundreds of patients usually take part. These studies are typically “dual-blind, randomized, and controlled.” The effect of the active drug compared to the effect of a placebo (inactive or “sugar” pill) in controlled studies. In a double-blind study, neither the investigator nor the study subjects know who is receiving the active drug and receiving a placebo. One-third of the medicines studied thoroughly in both Phase I and Phase II.
  • Patients with the disorder being treated by the new drug are also used in phase III studies. These studies are carried out to understand better the effectiveness, benefits, and side effects of the study drug. These studies involve many subjects, ranging from hundreds to thousands—seventy to ninety percent of new medicines that enter Phase III studies complete this phase. If the results show a positive effect and safety profile, the company will submit the data and request FDA approval to market the drug.

What Exactly Is Involved in Taking Part in a Research Study?pharmaceutic research studies

  • Participating in a research study is similar to going to a clinic or doctor’s office but with more personal attention. The subject of the study may have been referred by their doctor or may have learned about it elsewhere.
  • Typically, preliminary screening for the study is done over the phone. The study’s actual age, symptoms, and medical history are reviewed, and the study’s details are discussed. If the caller appears to be eligible for the research and is interested in participating, they are invited to come in for the initial, or screening, visit.
  • The screening is performed in a clinic, office, or hospital. The subject and the supervising physician sign the informed consent form after reviewing the information gathered over the phone. The subject receives a copy. May perform a physical examination, blood tests, and other tests. Following this, most studies have a period, usually a few weeks, where baseline information, such as the severity and frequency of symptoms, is collected.
  • The patient returns to the clinic for the randomization visit at the end of the screening period. If the patient’s baseline data indicate that they are eligible for the study, they then randomized (usually by computer) to receive either a placebo or an active drug.
  • During the treatment period, the subjects take the study medication regularly and keep track of their symptoms. Throughout the treatment period, the study coordinator makes regular visits. Medication use and symptoms are reviewed at the end of the treatment period. The study medication’s potential side effects are documented. Many studies include a follow-up period after the treatment period to assess how symptoms and possible side effects have changed. There may be one more visit or phone call to see how the subject is doing since stopping the study drug.

What is a Pharmaceutical Consultation?

Consultation is a formal process for gathering input from our stakeholders. Stakeholders include all individuals and organizations who influence or are influenced by our work, such as:

  • patients, carers, users of pharmacy services and members of the public
  • pharmacists and pharmacy technicians
  • pharmacy owners
  • professional bodies and organizations
  • other regulators
  • governments
  • educators
  • employers

Why do we consult?

We believe people who are impacted by our work must have a say in how we operate. Effective consultation is critical to assist us in improving our work. It informs us and helps us achieve our purpose of protecting, promoting and maintaining the health, safety and wellbeing of patients and public members by upholding standards and public trust in pharmacy.

Pharmaceutical Consulting The Smart Way

Pharmaceutical Consulting The Smart Way

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The Intelligent Approach to Pharmaceutical Consulting

Expenses for research and development, manufacturing, regulatory compliance, marketing, and product distribution continue to rise. Medication and other types of specialist health services continue to increase in price. Furthermore, the number of blockbuster medicines is decreasing, safety concerns are growing, and further government involvement is on the horizon. All of this implies that the value and ROI of pharmaceutical consulting services are rising.

Staying competitive and profitable is becoming more difficult for pharmaceutical businesses, notably smaller enterprises and health care institutions. The challenge then becomes determining which of the many possible solutions will allow businesses to remain competitive and continue in the market. Add to that the tough job of choosing which pharmaceutical consulting business is the greatest match and can offer the finest answers for a particular organization.

Pharmaceutical consulting is a newer kind of consultation. While most consulting companies provide a fairly typical set of services, there is a considerable specialization within the sector. For example, Rondaxe Consulting is one of the world’s biggest and most experienced worldwide CMC consulting firms. Rondaxe works with both virtual pharma/biotech startups and multi-national pharmaceutical customers from concept to commercialization. Comprehensive CMC solutions, medication development, manufacturing, and worldwide regulatory strategies are among the services provided. “Re]sourceTM is a unique pharmaceutical process software designed to help customers with data management, cost of goods, productivity analysis, and other features.

The Benefits of Hiring a Pharmaceutical Consultancy FirmHiring a Pharmaceutical Consultancy Firm

The pharmaceutical business is highly competitive since new medicines are created every week, and each firm wants to be the first to market with theirs. A consultant may assist your firm in this area, but there is more to having a successful pharmaceutical company than just putting your goods on the market. Your brands and products need support from physicians, insurers, and community pharmacists to be prescribed at all, which may be difficult to accomplish. 

How would physicians know to prescribe your goods if they are unaware of them and you fail to advertise them to them adequately? 

A GP will only prescribe a medication that has been marketed to them, and pharmaceutical consultants may assist you with this.

In truth, pharmaceutical consulting is intended to advise businesses on all aspects of their operations, ensuring their success and keeping them up to speed with the rules and legislation regulating the pharmaceutical sector. Consultants will work with you to ensure that you get the most profit out of the money you spend, from creating a product to making sure it lasts on the market.

Licensing, brand management, business development, clinical research, medical affairs, sales and trade, and product distribution are some areas in which pharmaceutical consultants specialize. While you may have expertise in any or all of these areas, the consultants will have specialized in one and will therefore be able to provide you with the finest information in the industry. They make it their mission to stay one step ahead of product releases and new laws to advise their customers on the best approach to earn money while complying with the law.

Clinical development is particularly essential in today’s pharmaceutical business since resources are static while the size and complexity of clinical procedures grow. Pharmaceutical experts will evaluate your clinical practices and develop new, more cost-effective, and efficient processes to make the most of what you have. Their goal is to help your company and products reach their maximum potential in all areas of consulting.

A pharmaceutical business cannot keep up with every new product on the market, the laws that go with it, conducting clinical studies, marketing their brand, and selling goods. That is why pharmaceutical consulting is an excellent option—keeping you up to date on industry changes and helping you maximize your company potential.

Drugs Designed and Developed

How are Drugs Designed and Developed?

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Table of Contents

Producing a new medication is a costly and time-consuming procedure that is heavily regulated.

What is a drug?

  • Drugs are chemical or biological compounds that have an impact on our bodies’ physiological or biochemical functions.
  • They may be single compounds or a combination of several chemicals.
  • Their effects are meant to be helpful. However, some individuals may have negative side effects.
  • All medicines interact with particular ‘targets’ in the body to alter their activity and, in many cases, result in a therapeutic? Impact. As an example, consider pain alleviation.
  • Are drug targets often proteins? However, in other instances, they are tiny segments of DNA or RNA.
  • Drugs either stimulate or inhibit the action of their targets.

How is a Drug Developed? How is a Drug Developed

  • The creation of a novel medicinal medication is a complicated, time-consuming, and costly process.
  • It could take 10-15 years and more than $500 million to develop a medication from an original idea, test its safety and efficacy in humans, and then bring it to the hospital market.
  • 2-4 years of pre-clinical development
  • 3-6 years of clinical development, additional
  • time for dealing with the regulatory authorities.

The first stage in drug discovery.

  • The first stage in the drug development process is drug discovery.
  • In the past, certain medications, such as penicillin, were discovered by mistake.
  • More systematic methods are now utilized, such as:
  • High-throughput screening: a technique that enables scientists to test thousands of possible targets with thousands of different chemical compounds to discover a novel drug-target combination.
  • Developing and synthesizing compounds based on a particular target molecule’s known structure is rational drug design.
  • While high-throughput screening may discover hundreds of possible lead components, many will be discarded during the first round of testing. Compounds are examined in cultured cells or animals during this phase to see how efficient they are and if they are harmful.
  • When compared to high-throughput screening, rational drug design generates fewer molecules. On the other hand, these chemicals are particular to the target and attain this specificity via computer-based modelling.

Stage 2: Preclinical Development

  • Pre-clinical testing is performed to identify how the medication should be developed for its intended purpose.
  • It seeks to determine how medicines are absorbed and distributed in the body and how they are broken down and eliminated.
  • If necessary, promising medicines may be changed to subtly enhance their characteristics, a process known as lead optimization.
  • Pre-clinical testing findings are also used to identify how to best manufacture the medication for its intended clinical usages, such as whether it is more effective as a cream, tablet, injection, or spray.
  • The goal of the pre-clinical trials is to narrow down hundreds of molecules to a few promising potential medicines.
  • These few medicines will then be submitted to the relevant regulatory authorities for approval, and if approved, the compound will be moved forward to clinical development.

Clinical Development Stage 3

  • This is split into four phases: 0 (zero), I, II, III, and IV.
  • Clinical development, often known as clinical trials, tests medication on human volunteers to learn more about its safety and efficacy.
  • Most experimental novel medicines will have been removed before the clinical development phase due to safety and efficacy concerns.
  • A new drug application will only be filed for one or two substances. 
  • After the relevant regulatory authorities authorize a medication, pharmaceutical firms have a limited time to have exclusive rights to sell the drug (exclusivity) before other businesses may market the same drug.
  • This exclusivity term is intended to recoup the enormous expenditure needed to develop and market the new medication.
  • Following complete approval, pharma firms must continue to test their medication and monitor input from healthcare experts to guarantee the drug’s safety and efficacy.
  • Following the release of medication, additional side effects or risk factors that were not previously documented may be discovered. This is Phase IV clinical development, and it is part of the ongoing monitoring of the drug’s efficacy in its target patients adverse.
Drug Development

Drug Development – The Drug Discovery, Clinical Trial, and Post-Marketing Surveillance Process

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Table of Contents

There are many phases involved in the creation of a drug. The procedure may need a significant amount of money and effort. Large pharmaceutical firms often have several medication candidates in development at the same time. Only a handful will make it through regulatory clearance and be marketed to the general public. This is why new drugs are so expensive. The expense is to fund this time-consuming and expensive medication development process.

The drug development process comprises the following steps:

  • Drug Discovery
  • Pre-clinical testing
  • Clinical trials
  • Post-market surveillance
  • Drug Discovery

The process of screening and selecting novel medication candidates is known as drug discovery. Initially, tens of thousands of possible small compounds, natural products, or extracts are tested for desired therapeutic effects. Candidates for protease inhibitors, for example, should bind the protein protease with specific affinity, selectivity, efficacy, and metabolic stability. The candidates to be converted into a tablet that they can take should also address oral stability and bioavailability. Following selecting one or more top candidates, pre-clinical testing is performed to establish safety, toxicity, pharmacokinetics, and metabolism.

Pre-Clinical Testing

Before testing a novel medication candidate on humans, extensive pre-clinical research in animals is required to guarantee the new medicine’s safety. Pre-clinical testing is also performed to learn about the new drug’s toxicity, metabolic profile, and pharmacokinetics. Pharmacokinetic (PK) studies are performed to understand what occurs to a novel medication in a live creature, from when it enters the body until it is removed via urine and feces. Pre-clinical testing also includes investigating the drug’s biochemical and physiological effects on the body. This is referred to as pharmacodynamics or PD studies. PD research aims to learn about drug action mechanisms and the effects of drug concentration on living organisms. May establish appropriate dosages and dosing regimens for the new medication via PK and PD studies.

Pre-clinical testing also investigates the new drug’s chemical composition. This covers the new drug’s solubility, stability, and formulation in various forms (capsules, tablets, aerosol, injectable, and intravenous). This branch of chemistry is known as Chemistry, Manufacturing, and Control (CMC).

Clinical Trials

Following rigorous preclinical research that yielded encouraging findings for the new medication candidate, the next step is to undertake a human clinical study. In the United States, an application to the FDA known as an Investigational New Drug (IND) application is required before starting a clinical study in humans. The FDA 21 CFR 312, which governs novel drug candidates that need an IND, is linked below.

If the sponsor or drug manufacturer does not receive an objection letter from the FDA within 30 days of submitting an IND application and the IRB authorizes the clinical study, the trial may begin.

Human clinical trials are often conducted in phases:Human clinical trials

  1. Clinical Trial Basics – Drug – Clinical Trial Phases

Phase 0 – Pharmacokinetics (PK) and Pharmacodynamics (PD)

This is the first human study to investigate the pharmacokinetics (PK) and pharmacodynamics (PD). Typically, the number of participants is relatively modest (N = 10 to 15).

  • Pharmacokinetics (PK) studies, similar to those outlined in pre-clinical testing, are conducted to determine what occurs to a novel medication when it enters the human body until it is excreted. PK studies are conducted to understand how the body reacts to a new medication.
  • Pharmacodynamics (PD) investigations are opposed to PK research. The purpose of PD studies is to understand what the new medication does to the body.

Phase I – Safety

Phase I studies are often conducted with a modest number of healthy subjects (N = 20 – 80). This phase aims to learn about the new drug’s safety. Healthy individuals are recruited into this phase to prevent additional complications and symptoms from the underlying illness. Oncology studies, in which real illness patients may be utilized, are an exception to this rule. Phase I studies are often conducted at a specialist facility or clinic where participants may be monitored continuously. These institutions or clinics are often referred to as CPUs (Central Pharmacological Units). In phase I trials, the new drug’s side effects are meticulously documented. Furthermore, phase I studies are often intended to evaluate single (Single Ascending Dose) and multiple (Multiple Ascending Dose) doses and dosing intervals to determine the dosage and dosing interval range where the new medication is safe for humans.

Phase II – Efficacy (Proof of Concept)

Phase II research includes a greater number of participants (N = 100 – 200). This phase’s population consists of patients suffering from the illness that the new medication is intended to cure. The new medication is typically compared to standard care therapy and a placebo group in phase II trials. A placebo is a harmless drug that has no medicinal use (e.g., sugar pill). The purpose of phase II research is to determine the effectiveness of a novel medication. In most cases, additional safety information is also gathered. Phase II studies may be conducted in two stages: Phase IIa to compare dosage and dose regiments and phase IIb to assess effectiveness and safety. Phase I and phase II are sometimes performed concurrently to assess effectiveness and toxicity to save time and money. Because phase II studies assess effectiveness, this stage is often known as “Proof of Concept.” Phase II typically determines the destiny of a novel medication; proceed to phase III if effectiveness is shown, or terminate clinical development if unsuccessful.

Phase III – Pivotal Studies

Phase III trials are intended to acquire a large population to provide statistical proof of the new drug’s effectiveness and safety. Phase III trials are often conducted in large groups of patients with the illness that the new medication is intended to treat (N = 300 – 3000). In phase III trials, novel drugs are compared to standard care therapy and a placebo group, as in phase II studies. Phase III studies are time-intensive and expensive due to the high number of individuals being examined. Phase III studies, like phase II studies, may be conducted in phase IIIa to assess effectiveness and safety and phase IIIb to assess new disease indications or marketing claims. Because of assessing effectiveness and safety in a broad population, phase IIIa is frequently referred to as a “Pivotal Study.” While not always necessary, two successful phase IIIa studies are often required to demonstrate effectiveness and safety to gain regulatory clearance from major regulatory authorities such as the FDA in the United States and the EMA in the European Union. If this phase IIIa studies provide positive findings, the sponsor or drug manufacturer may submit a New Drug Application (NDA) to the FDA or EMA for regulatory clearance.

Phase IV – Post Marketing Surveillance

Phase IV trials are often conducted after regulatory approval of a new medication. Phase IV research aims to gather safety data from a broader population (general population) over a longer period (several years) than in phase I, II, and III trials. Phase IV studies are required to ensure patient safety after regulatory approval of a new medication. As safety data is gathered and submitted to the supervising regulatory authority, the new medication may be limited to certain uses or banned from being marketed entirely if severe adverse effects are discovered.

FAQs about Pharmaceutical Manufacturing

FAQs about Pharmaceutical Manufacturing for Production of Medicines

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Steps in Pharmaceutical Manufacturing for the Production of Medicines

To manufacture effective medications, the pharmaceutical manufacturing unit goes through several processes. Design conception, withdrawal, dispensation, production, modification, liberation, packing, and storage are all stages in the manufacturing process. These elements are critical, and the whole manufacturing process will be complete only when all of these production stages are properly finished. All pharmaceutical manufacturing departments must follow these procedures to create effective medications and various other pharmaceutical products. This article outlines the critical procedures that all pharmaceutical factories must take to produce effective medications.

There are two stages in the pharmaceutical production process. The first unit is the main processing level, while the second is the secondary processing level. The first processing stage is primarily concerned with the enhancement of an effective medication component. This stage also includes some research centers run by pharmaceutical graduates that provide essential pharmaceutical components.

The second portion of this secondary process consists mostly of transforming pharmaceutically active components into effective medications. So, we can say that this is the last stage in drug processing, which is the most essential in creating goods that can be utilized as pharmaceutical products in many healthcare organizations and are used by patients for various health problems.

The finished pharmaceutical goods come in a variety of forms, including liquid, semi-solid, and solid. Capsules, pills, lotions, ointments, and other solid forms are available. Liquid pharmaceutical products include solutions, gels, suspensions, emulsions, and injectables. Several items for external use only, such as inhalers and aerosols, primarily include butane and chlorofluorocarbons. We may conclude that pharmaceutical manufacturing units have contributed significantly to the medical sector and assisted humanity in the battle against various health problems. They are constantly striving to contribute more and more to the medical field.

Pharmaceutical Manufacturing’s Development of Efficient MedicinesPharmaceutical Manufacturing's Development

To create functional medicines, pharmaceutical manufacturing companies go through design conception, manufacture, extraction, dispensation, sanitization, packing, release, and storage of chemical agents. As a result, pharmaceutical production is the foundation of pharmaceutical engineering. The pharmaceutical companies‘ creation of efficient and cost-effective medications is the focus of this essay.

Two main units are engaged in pharmaceutical manufacturing production processes. These are the main processing unit (PPU) and secondary processing unit (SPU) (SPU). The primary function of PPU is to manufacture active pharmaceutical components. It also comprises research efforts carried out by professional and experienced Pharmaceutical engineers. SPU is a set of procedures for converting active pharmaceutical substances into essential medications. As a result, SPU is the second component of the manufacturing process that fully creates essential medications that are very promising and capable of combating many terrible illnesses.

All pharmacological products are primarily offered in three varieties (solid, partially solid, and liquid). Creams, ointments, capsules, and tablets are the most common types of solid and partly solid medicinal medicines. Liquid pharmaceutical products come in various forms, including suspensions, solutions, gels, and emulsions. 

Pharmaceutical manufacturing facilities create finished medications such as synthetic pharmaceuticals, hormones, vaccines, glandular products, antibiotics, vitamins, and pharmaceutical compounds. Some important medicines are derived from plants and are extremely powerful and devoid of any adverse effects. These pharmaceutical companies have created a plethora of essential medications that can combat both common and critical illnesses.

Development Of Pharmaceutical Industry

The Importance Of Research And Development Of Pharmaceutical Industry

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What function does research play in development?

Many organizations rely heavily on research and development (R&D). When properly planned and implemented, it allows a company to create additional money from time to time. The majority of people connect a company’s research and development role with the creation of new goods. While innovations are essential, improving current goods is also crucial since customer tastes are always changing. As a result, we may state that R&D refers to a particular set of operations inside a company. R&D varies from one business to the next based on the operations of that company.

Objective of R&D

R&D is a process that aims to develop new or better technology that may offer a competitive edge at the corporate, industry, or national levels. While the benefits may be enormous, the process of the technical invention is complicated and dangerous. The majority of R&D initiatives do not provide the anticipated financial results, and successful programs may pay for those that are failed or canceled early by management. An R&D project must achieve the following goals:

1 acquire new ideas or information 

2 put it to practical use

3 boost the company’s sales and profits

Types of R&D

The National Science Foundation(NSF) defines three types of R&D:

1 Basic Research

2 Applied Research

3 Development

Rather than a practical application, basic research goals are to gain a deeper knowledge or understanding of the topic under study. Basic research is defined as a study that increases scientific understanding without a particular commercial goal in mind.

Applied research involves acquiring the information or understanding required to determine the methods to fulfill a recognized and particular demand.

It comprises studies to discover new information with particular business goals regarding products, methods, or services.

Research generates information and development designs, as well as prototypes to demonstrate viability.

Engineering then transforms these prototypes into marketable goods or services or processes to create commercial products and services.

Government Promotes Research and Development

The government’s strategy already encourages research and development in a variety of ways. In 1996, the government supported about 32% of gross national spending on R&D. The government also encourages business innovation via direct expenditure on education and training, patent protection, regulation, and competition policy. The government implements various measures that influence companies’ incentives to spend in R&D. Direct financing of government R&D laboratories, universities, or businesses, investment in human capital creation, patent protection legislation, and R&D tax credits are examples of policies that directly target research and development. Other policies that are not directly aimed at R&D but may have a major effect on R&D expenditure include competition policy and regulation.

R&D Tax Credits

The government may stimulate business research and development through tax incentives like

  1. allowance
  2. exemptions
  3. deductions
  4. tax credits

Each of which can be designed with differing criteria for eligibility, allowable expenses, and baselines.

The Advantages of Research And Development Of Pharmaceutical Industry

The pharmaceutical industry includes pharmaceutical production,Promotes Research and Development preparation, and marketing services, and it is heavily reliant on R&D&I for growth.

This industry is continuously pushed to rethink its business models to maximize the revenue from existing patents and optimize the development of new medicines, making R&D&I investments critical to avoid becoming outdated in a highly competitive market.

Investment in innovation in this field enables the development of new medicines, a rise in life expectancy, and the treatment of a wide variety of illnesses, allowing for a substantial improvement in available therapies.

Similarly, investment in R&D in pharmaceutical manufacturing benefits population health. In the long term, other features are identified, such as savings in health expenditure (by decreasing hospitalizations) and lower operational costs in the health sector.

Based on innovation, the pharmaceutical industry has positioned itself at the forefront of the manufacturing model in many nations. It is one of the most significant industrial sectors, with the pharmaceutical industry ranking fourth in sales and employment. From an economic and social standpoint, the contribution of this sector is noteworthy, emphasizing the positive outcomes in employment creation resulting from significant expenditures in R&D&I.

Pharmaceutical Process and Manufacturing Developments

Pharmaceutical Process and Manufacturing Developments: Definition and Advantages

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Table of Contents

Pharmaceutical Manufacturing and Its Industrial Definitions

When producing a single medicine, the process goes through many stages in pharmaceutical manufacturing. Design conception, development, withdrawal, processing, refining, packing, distribution, and storage are the stages. When all of the stages are performed correctly, the whole manufacturing process is finished. To manufacture vital medications and other pharmaceutical goods, pharmaceutical manufacturing facilities must follow this hierarchy of stages.

The whole pharmaceutical manufacturing process may be broken down into two main components. The first is known as the primary processing step, and it is responsible for producing active pharmaceutical components. This phase also involves several research centers run by experienced and talented pharmaceutical engineers to offer efficient pharmaceutical ingredients.

The second unit is known as the secondary processing step, and it is responsible for converting active pharmaceutical components into desired medications. As a result, this phase comprises final medication processing procedures to produce goods that may be utilized as pharmaceutical products in different healthcare facilities to administer to patients suffering from various health problems.

The finished pharmaceutical products come in a variety of forms, including solid, semi-solid, and watery. Capsules, pills, ointments, creams, and other solid forms are prevalent. Gels, solutions, suspensions, emulsions, and injectables are all examples of liquid medicines. 

Vitamins, antibiotics, synthetic hormones and medicines, glandular products, vaccinations, and other pharmaceutical goods are among the most often produced pharmaceuticals. These factories also produce safety and dressing materials and safety equipment to guarantee the total safety of the employees in these plants.

The Advantages of Pharmaceutical Process DevelopmentPharmaceutical Process Development

Pharmaceutical process development encompasses a broad range of tests and processes, all of which are designed to ensure that your pharmaceutical business operates at peak efficiency. As a result, many pharmaceutical manufacturers seek outside assistance from pharmaceutical consulting firms to help their businesses create optimum efficiency at the lowest possible cost per all applicable rules and regulations. Pharmaceutical consulting companies may also assist with the manufacturing, financing, distribution, marketing, and program management of each product or company, providing knowledge that would be difficult to acquire on one’s own.

Process development, validation, and stability testing programs are just a few of the primary services provided by a pharmaceutical consulting company. What they can do is help your pharmaceutical business decrease expenses such as manufacturing costs, distribution costs, and so on, ensuring that your company is operating at peak efficiency. In addition, they can guarantee maximum productivity by assisting you in identifying red flags and mistakes in your process development, which may save you thousands of dollars in time and money.

Pharmaceutical consultants will provide you with clear, flexible guidelines that you can instantly use for your company. A pharmaceutical consulting company may give you pharmaceutical experience in their approaches to product development, research, and operations management by utilizing the appropriate methods and creative techniques. They may aid in delivering safe and effective treatments, improving product quality, and maximizing profits for your company and its shareholders. Why lose thousands of dollars and thousands of hours of productivity because your process development is flawed? No company in the world can afford to do so. That is just a poor business choice.

Pharmaceutical consulting firms may also assist you to stay up to date on new technological developments that might help you enhance your product or increase your manufacturing capacity. By staying current on all of the latest technology systems and advancements, you will be able to take more significant strides toward improving the efficiency of your product. Process development testing encompasses a wide variety of services, including clinical support assessment, business plan assistance, process mapping, competitive analysis, and so on. They will provide a clear picture of what your business is doing incorrectly and what it is doing well to guarantee that your pharmaceutical company is doing everything possible to succeed.

Phases of Drug Development

What are the Phases of Drug Development?

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Stages of Drug Development

To create a safe, effective, and meets all regulatory criteria, every drug development process must go through several phases.

Rondaxe can help you in every step of drug development. Our scientists can assist you in determining your testing requirements, and our professional team can conduct the necessary tests and studies required for FDA approval.

To get you started, we’ve given an in-depth description of several phases in the drug development process, as well as the required research, below.

Discovery

Target identification – selecting a biochemical process implicated in a medical state – is a common starting point for discovery. Drug candidates developed in academic and pharmaceutical/biotech research laboratories are evaluated for interactions with the drug target. For each prospective therapeutic candidate, up to 5,000 to 10,000 molecules are exposed to a rigorous screening procedure that may involve functional genomics and proteomics, as well as other screening techniques. Once scientists have confirmed interaction with the drug target, they usually verify that target by looking for activity against the medical condition for which the medication is being produced. After careful consideration, one or more lead compounds are selected.

Product Characterization

During drug discovery, a promising candidate molecule is identified it can be used in clinical trials. First, the molecule must be described, which includes determining the molecule’s size, shape, strengths, weaknesses, the environment where it functions well, toxicity, bioactivity, and bioavailability. Analytical method development and validation will occur during characterization investigations—early-stage pharmacology research aids in characterizing the compound’s underlying mechanism of action.

Formulation, Delivery, Packaging Development

Medication designers must create a formulation that guarantees appropriate drug delivery parameters. At this stage of the medication development process, it is essential to start thinking about clinical trials. Medication formulation and delivery may be continually improved until, and even beyond, the ultimate approval of the drug. Scientists test the drug’s stability in the formulation and storage and shipping conditions such as heat, light, and time. The formulation must stay potent and sterile, as well as safe (nontoxic). Extractables and leachables research on containers or packaging may also be required.

Pharmacokinetics And Drug Disposition

Pharmacokinetic (PK) and ADME (Absorption/Distribution/Metabolism/Excretion) studies offer valuable information for formulation experts. AUC (area under the curve), Cmax (the highest concentration of the medication in the blood), and Tmax (the time to maximum concentration) (time at which Cmax is reached). Animal PK research will be used in tandem with early-stage clinical trials to see whether animal models predict real-world outcomes.

Preclinical Toxicology Testing and IND Application

Preclinical testing evaluates the developed drug product’s bioactivity, safety, and effectiveness. This testing is crucial to a drug’s ultimate success and is thus examined by several regulatory bodies. Plans for clinical tests and an Investigative New Drug (IND) application are developed throughout the preclinical stage of the research process. Tests conducted during the preclinical phase should be intended to assist subsequent clinical studies.

The main stages of preclinical toxicology testing are:Preclinical Toxicology Testing

  • Acute Studies – Acute tox studies focus on the effects of one or more doses given during 24 hours. The aim is to identify hazardous dosage levels and to look for clinical signs of toxicity. At least two mammalian species are usually examined. Acute toxicity data is used to help establish dosages for repeated dose studies in animals and Phase I human trials.
  • Repeated Dose Studies – Repeated dosage studies may be classified as subacute, sub chronic, or chronic, depending on their length. The exact duration should anticipate the length of the clinical study for the new medication. Once again, two species are usually needed.
  • Genetic Toxicity Studies – These investigations determine if a medication compound is mutagenic or carcinogenic. Genetic alterations may be detected using procedures such as the Ames test (conducted in bacteria). The Mouse Micronucleus Test, which uses mammalian cells to evaluate DNA damage, is one example. In addition, the Chromosomal Aberration Test and related methods identify chromosomal damage.
  • Reproductive Toxicity Studies – The effects of the medication on fertility are investigated in a segment I reproductive tox investigations. Segment II and III research look for impacts on embryonic and postnatal development. In general, reproductive tox studies must be performed before medication may be given to women of childbearing age.
  • Carcinogenicity Studies – Carcinogenicity studies are often required only for medicines used to treat chronic or recurrent diseases. They take time and money and must be prepared for early in the preclinical testing phase.
  • Toxicokinetic Studies – These are usually designed like PK/ADME experiments, except that considerably larger dosage levels are used. They investigate the effects of hazardous medication dosages and aid in estimating the clinical margin of safety. Many FDA and ICH recommendations provide extensive information on the various kinds of preclinical toxicology studies and the proper scheduling for them with IND, NDA, or BLA submissions.

Bioanalytical Testing 

The majority of the other activities in the drug development process are supported by bioanalytical laboratory work and the development of bioanalytical methods. The bioanalytical work is critical for appropriate molecular characterization, assay creation, establishing optimum cell culture or fermentation techniques, calculating process yields, and providing quality assurance and quality control throughout the development process. It is also essential for preclinical toxicology/pharmacology testing and clinical trials.

Clinical Trials

Clinical trials are classified into three kinds of phases based on their objective:

  1. Phase I Clinical Development (Human Pharmacology) – Unless the FDA puts a hold on the research, a biopharmaceutical company may commence a small-scale Phase I clinical trial thirty days after filing an IND. Phase I studies are performed to assess pharmacokinetic parameters and tolerance in healthy individuals. These investigations include initial single-dose trials, dosage escalation, and short-term repeated-dose studies.
  2. Phase II Clinical Development (Therapeutic Exploratory) – Phase II clinical trials are small-scale trials in which 100 to 250 individuals are evaluated for a drug’s preliminary effectiveness and side-effect profile. This category also includes additional safety and clinical pharmacology research.
  3. Phase III Clinical Development (Therapeutic Confirmatory) – Broad-scale clinical trials evaluating safety and effectiveness in large patient groups are known as phase III investigations. While phase III studies are being conducted, preparations are being made to submit the Biologics License Application (BLA) or the New Drug Application (NDA). The FDA’s Center for Biologics Evaluation and Research is presently reviewing BLAs (CBER). In addition, the Center for Drug Evaluation and Research evaluates NDAs (CDER).
Research And Development Of Pharmaceutical Industry

Research And Development Of Pharmaceutical Industry

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Why are research and development essential in the pharmaceutical industry?

R&D plays a vital role in the pharmaceutical industry in enhancing company capability by stimulating innovative production methods, lowering drug costs, and improving product quality. In addition, R&D can encourage highly skilled, creative, and innovative individuals to join the company and plays a vital role in the innovation process, particularly in the pharmaceutical industry. The R&D process is a critical stage in the drug development process in the pharmaceutical industry. The process begins with identifying an initial candidate drug and includes the rigorous research tests that determine the drug’s therapeutic suitability.

The pharmaceutical industry involves human lives because it manufactures and produces medicines that are miracle tablets for humans. Therefore, it is India’s most critical sector.

Diseases are becoming more prevalent these days as a result of pollution and people’s eating habits. Today, everyone has at least one condition, whether it is an infection or a viral infection. Furthermore, due to pollution, people are facing many skin problems also. All these situations drag them to the category of patients. Therefore, medicines are becoming regular meals for many peoples.

This makes the Pharmaceutical industry growing and, most important.

Research Development

In all industries, research and development are critical. And, when it comes to the Biopharmaceutical research industry, R&D services generate revenue for the companies involved in the study lives or improve results frequently in saving lives or improving patients’ lives. The development of many businesses necessitates the perfect Pharmaceutical research and development. Doctors and scientists from all over the world have invested heavily in research and development in this industry. Reliable Pharmaceutical R&D services enable businesses to adhere to manufacturing procedures, quality control measures, production scope, and technical know-how.

Digital Solutions in Drug Development

Digital technology has been driving a revolution in healthcare, from mobile medical apps and fitness trackers to software that supports clinical decisions made by doctors every day. As we adjust to the new normal brought on by the COVID pandemic, the adoption of digital solutions has accelerated.

Process development in the pharmaceutical industry

Process development is the process of establishing, implementing, or improving an existing manufacturing process. It ensures that a product can be routinely made aseptically and meet specifications before mass production. At Akron, we create and optimize processes that create commercially viable products that prioritize quality, affordability, and reproducibility. We develop a minimal industrial strategy by converting methods developed on the bench in a research lab to industrial-scale study lives processes that consider the necessary upgrades in a controlled environment, equipment, and ancillary materials.

In every project, we assess manufacturability and determine the quality and testing required for production-process controls and released products. From the early stages of development, we can create new processes, transfer existing processes, or optimize existing processes. Whether we develop an end-to-end process or optimize specific phases, our goal is to reduce the risk of producing a final advanced therapy medicinal product.

Pharmaceutical Development Company

Demand-side research and development

Drug prices would be determined by supply and demand in a market economy. The government is acting solely to provide patent protection and exclusivity to allow for viable innovation because much of the cost of producing drugs involves research and development instead of manufacturing pills. Can obtain this price influences the amount invested in the development of new medicines. Higher prices, on the other hand, result in fewer units of the drug being sold. Because of this demand constraint, investment is sensitive to value—what a drug accomplishes medically for patients compared to how much it will cost. Manufacturers can charge higher prices and will likely invest more in developing new drugs if health insurance pays for a significant portion of the cost of drugs.

However, three significant developments in recent years have shifted the demand constraint. First, due to the implementation of Medicare Part D and the expansion of insurance coverage under the Affordable Care Act, more people have drug coverage. Second, drug insurance has become significantly more comprehensive due to the proliferation of benefit designs that limit the amount of out-of-pocket spending that the enrollee is required to pay.

Third, some newer drugs, particularly specialty drugs used to treat complex, chronic conditions such as cancer, rheumatoid arthritis, and multiple sclerosis, have incredibly high prices. This factor influences demand via interactions with various elements of insurance benefit design. For example, suppose a patient is taking a $50 drug, and a new, possibly better medication becomes available for $100. In that case, insurance benefit designs usually allow the patient (with the support of a prescribing physician) to use the newer drug at an additional cost. While the difference in cost to the patient is less than the price difference between the drugs, only patients who believe they will benefit from switching will do so.

However, when prices are $100,000 or $200,000 per year, everything changes. Most patients who must pay a significant portion of the cost for these drugs will not afford the medication at all. On the other hand, out-of-pocket maximums make the drugs affordable and, as a result, make the patient insensitive to price differences. As a result, the patient pays the same amount for the $100,000 and $200,000 drugs—their out-of-pocket maximum. This means that raising prices at this level does not result in patient demand restraint.

As a result of the current benefit designs and costly drugs, raising prices even higher may not result in fewer units. On the contrary, because new drugs promise to be profitable, the result will likely be higher revenues and more investment in their development.

Consulting For Pharma

Mitochondrial Uncoupling: If You Want to Live Longer, Look to the Skies

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Over the years an enormous amount of both scientific and pseudo-scientific speculation has been aimed at explaining prevailing trends in the lifespan of animals,and how we might apply those lessons to humans.

Since clear, observable trends exist with respect to various groups of animals and lifespan, if we can understand the underlying processes behind those trends, we might be able to extend and maximize our own lifespans.  The most obvious trend is body size versus lifespan, which is robust and repeatable, yet has some outliers that offer tantalizing grounds for speculation.

Figure 1 shows the trend between size and lifespan.  The trend lines, both of which have significant scatter, clearly show two trends, with the data broken down to illustrate the difference between flying and non-flying species.  The striking difference between species who can and cannot fly will be immediately available to anyone who has ever kept a parrot – some species can reliably outlive their human owners.

sizeA number of theories exist to explain the differences between these groupings – and why bats and birds live so much longer.  The authors of the study behind Figure 1 [1] point to the differences in predation vulnerability and argue that flying reduces predation and vulnerability to food shortages.  In that respect, flight offers some of the same advantages as large body size, resulting in the anomalously longer lifespans enjoyed by bats and birds.  The only problem with this hypothesis is that a Malthusian distribution should ensue, and when these populations explode to the very limits of their ecological carrying capacity, one would expect that these advantages would be nullified.  Yet the differences persist.

An alternative view is that animals adapted for flight have a chemical advantage related to flying.  Their tissues express larger quantities of mitochondrial uncoupling proteins, which allow the “leak” of H+ without producing ATP in the mitochondria.  This means that they can “throw away” excess energy produced when they are at rest, necessary because their cellular machinery is designed to process huge amounts of energy during periods of flight.  Tossing the protons made by oxidative respiration has the side benefit that reactive oxygen species (ROS) are destroyed, preventing cellular damage that accumulates over time and causes aging.  Birds therefore age slowly and maintain their youthful function throughout the vast majority of their years.

Other animals, including humans, might be able to benefit from research that targets these proteins.  A growing body of research aimed at treating obesity has a similar goal, and gene therapies that are aimed at stimulating “brown fat” promise to kill two birds with one stone.   Brown fat, a vascular active form of adipose tissue, burns fats rapidly in the presence of oxygen and uncoupling proteins to generate heat.  This is the fat that allows long-lived walruses and cetaceans to keep warm even with wet skin in freezing climates by using fat as nothing more than fuel for the furnace.  Through gene regulation to stimulate brown fat we might be able to reduce obesity and inflammation caused by ROS.

Current research is promising, with the side benefits that gene therapies that increase the activity of the brown fat also cause marked increase in muscle mass and strength, at least in lab mice[2][3].  Scientists at Virginia Tech have recently identified a small mitochondrial uncoupler, named BAM15, that decreases the body fat mass of mice without affecting food intake and muscle mass or increasing body temperature. The research of Santos and colleagues, published in Nature Communications on May 14, 2020, are especially promising for the treatment of obesity and diseases characterized by inflammation.

Although research on mitochondrial decoupling proteins is ongoing, recent progress is promising, and the implications for medicine are sky-high.

[1] Healy, et. al.  2014  Ecology and mode-of-life explain lifespan variation in birds and mammals.  Proc. Royal Soc. B.  DOI: https://doi.org/10.1098/rspb.2014.0298 or visit https://royalsocietypublishing.org/doi/10.1098/rspb.2014.0298.

[2] Weintraub, Arlene.  2020 Gene therapy cuts fat and builds muscle in sedentary mice on unhealthy diets.  Fierce Biotech. May 11. https://www.fiercebiotech.com/research/gene-therapy-cuts-fat-and-builds-muscle-sedentary-mice-unhealthy-diets.

[3] Tang et. al. 2020  Gene therapy for follistatin mitigates systemic metabolic inflammation and post-traumatic arthritis in high-fat diet–induced obesity.   Science Adv. 08 May 2020:Vol. 6, no. 19. DOI: 10.1126/sciadv.aaz7492 or https://advances.sciencemag.org/content/6/19/eaaz7492.

[4]  https://www.sciencedaily.com/releases/2020/06/200608132539.htm?utm_content=131524119&utm_medium=social&utm_source=twitter&hss_channel=tw-463200485

Will Big Pharma Sabotage its’ Own Re-Shoring?

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globe

The need to reshore American products has been recognized on a federal level for many decades, with legislation such as the original Buy American Act, dated to 1933.

The urgency has grown in recent years, with the burgeoning dependence of the United States on foreign medicines and medical equipment now constituting a huge strategic burden.  The issue has recently come to forefront because of  renewed distrust in supply chain stability thanks to Covid-19, however, and current legislation is upping the ante by including Big Pharma among the list of key players that need to be reformed.

The imperative to return American products home is primarily being addressed through legislation offering incentives aimed at making American businesses more competitive, imposing tariffs on foreign goods and offering tax benefits for American manufacturers.  Although 28% of registered worldwide pharmaceutical API manufacturing sites are located within the US, according to government statistics when we consider the sourcing of raw materials, various estimates suggest that the true foreign dependence is even higher.  Indeed, it is surprisingly difficult for consumers to determine the origin of their drugs and medicines, and many pharmaceutical companies are reticent about their suppliers given the proprietary nature of the information.

Figure2-2

President Trump’s proposed “Buy America” Executive Order, spearheaded by White House trade adviser Peter Navarro, was sidelined by the National Security Council before it could be signed last Friday.  Although the exact details of the order are under negotiation, it is clear that the future of the pharmaceutical industry is at a major crossroads: what happens when the order is signed will shape the manufacturing of pharmaceuticals worldwide.

While this situation underscores the necessity for re-shoring American manufacturing of pharmaceuticals, the biggest opposition to the movement is coming from pharmaceutical lobbyists on Capitol Hill.  Perhaps this is unsurprising, given the enormous disruptions that changing the system would cause, and the fact that many of the losers would be large, powerful corporations with pronounced sourcing from overseas.  Nevertheless, the Pharmaceutical Research and Manufacturers of America (PhRMA), which is the largest pharma lobbying group present, has proffered an argument that re-shoring proposals will “… not only overestimate the potential feasibility and underestimate the time and effort it would take to make such changes, but also misunderstand that a diverse pharmaceutical supply chain is precisely what enables the industry to respond quickly and make adjustments in its supply chain sourcing during natural emergencies and global public health crises.”

Some of this rhetoric is true:  the process will definitely be expensive and difficult.  Some of this is false: parallel supply chains increases the robustness of the worldwide supply.  In fact, redundancy is a key element to airplane safety, and by analogy, it’s plain to see that parallel sources are far more secure than relying on a potentially distant source in an emergency.  This resistance is troubling, since the truth is staring us in the face:  global supply chains are not always reliable.  Imports from China for critical medicines and pharmaceuticals are being cut off entirely due to Covid-19.  This dependence has placed lives at risk since 90 percent of the generic medications that Americans use daily are imported.

The reluctance of  Big Pharma to reduce an unhealthy and greedy dependence on cheap labor and materials will have serious consequences for American healthcare as well as national security.  China’s dominance of the pharma supply chain is highly dangerous to the United States.  Pharmaceutical production must be reshored and even expanded in order to develop secure and safe supply chains for medications, vaccines and medical devices. This crossroads brings us to a critical question: will the United States commit its financial might to developing American pharmaceutical manufacturing capabilities, or will pharma itself stand in the way?

Cow Hearts: Beefy Benefits for Humans

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heart2According to the CDC, heart disease is the leading cause of death in the U.S., killing more than 600,000 Americans each year.

  • More than five million Americans are diagnosed with heart valve disease annually.
  • Heart valve disease can occur in any single valve or a combination of the four valves, but diseases of the aortic and mitral valves are the most common.
  • Calcific aortic stenosis is the most common form of aortic stenosis (AS).
  • While up to 1.5 million people in the U.S. suffer from AS, approximately 500,000 within this group of patients suffer from severe AS. An estimated 250,000 patients with severe AS are symptomatic.
  • Without an aortic valve replacement (AVR), as many as 50 percent of patients with severe AS will not survive more than two years after the onset of symptoms.

Aortic valve stenosis — or aortic stenosis — occurs when the heart’s aortic valve narrows. This narrowing prevents the valve from opening fully, which reduces or blocks blood flow from your heart into the aorta and onward to the rest of your body.

heart picRecent advances in the treatments for aortic valve stenosis[1] seem to be tipping doctors and patients increasingly towards xenografts for treatment.  Traditional treatment regimes have involved open heart surgery, focused on the replacement of the damaged aortic valve with a mechanical replacement.  The move away from these highly invasive operations has been prompted largely by a single, increasingly attractive development: Transcatheter Aortic Valve Replacement, or TAVR.

The new method of TAVR was only approved as recently as August 2019 for low-risk patients, as new research began to overturn the idea that mechanical heart valves were superior for patients with significant post-operative life expectancy.  The old thinking went like this: since mechanical heart valves do last longer, these valves could provide patients with a lower risk of failure, complications or repeat surgery.  The problem is that some of these assumptions are no longer true, and in many cases, “biologic valves are better even in the young patient.”[2]

The only true representation of the above claims is the fact that mechanical heart valves last longer.  That’s absolutely true; a valve made from titanium or other high-strength, highly impervious material can last for decades.  Unfortunately, these materials increase the risks of blood-clots since platelets have an affinity for collecting on non-biogenic surfaces.  These blood clots can result in thromboses, heart attacks and strokes.

The current treatment regimen is at best an uneasy compromise, because patients are assigned a life-long regimen of anti-coagulants that must balance the risks of clots against the risks of fatal bleeding, hemorrhagic stroke and other complications from the anti-coagulants.  The mortality and morbidity due to surgical complications and failure of the mechanical valves are complicating factors as well.

TAVR addresses some of these problems with short-term mortality by significantly reducing the risks of open heart surgery.  The minimally-invasive procedure begins by inserting a catheter into the femoral artery (or another blood vessel) and threading it up into the aorta.  Once there, in the increasingly common valve-in-valve (VIV) procedure, a collapsible replacement valve can be delivered right inside the aortic valve and then expanded.  Once it’s inside the valve, the new valve holds everything open during systole, meaning output resistance drops and the heart doesn’t have to work as hard.  The new valve will also close more effectively, so blood doesn’t continually wash back and forth, which further eases stress on the heart.

TAVR heart valves are typically made from cow pericardium[3], which also eliminates the platelet adhesion problems seen with mechanical valves.  Some people can go off of blood thinners, and not have to worry about their potential side effects.  The primary disadvantage of TAVR valves is their limited lifespan of 10 to 12 years.  New refinements are addressing this problem: recent studies have shown the chances of having problems with repeat surgeries and TAVR for failed bio-prosthesis valves are either the same, or slightly better for redo TAVR[4].  In another study of approximately 50 patients who had redo TAVR due to failing bio-prosthetic valves, every patient survived to discharge, with only one serious bleed and one minor, non-disabling stroke[5].  In fact, the lower risk of early- and mid-term morbidity associated with TAVR means that for many people, the procedure offers the best chance to live their best lives – living with the highest quality and lowest risk of disability.

[1] Source for stenosis diagram: Michigan Medicine, Frankel Cardiovascular Center.  https://www.umcvc.org/conditions-treatments/aortic-stenosis.

[2] Expert Analysis. 2015 Surgical Aortic Valve Replacement: Biologic Valves Are Better Even in the Young Patient. American College of Cardiology.

[3] Source for TAVR diagram: TCTMD.com

[4] Maxwell, Y.R. 2018.  Valve-in-Valve TAVR: Mortality, Adverse Events Similar to Redo Surgery at 30 Days. TCTMD/the heart beat.  < https://www.tctmd.com/news/valve-valve-tavr-mortality-adverse-events-similar-redo-surgery-30-days>.

[5] Barbanti, et al. 2016. Circ. Cardiovasc. Interv. (9):e003930.  Outcomes of Redo Transcatheter Aortic Valve Replacement for the Treatment of Postprocedural and Late Occurrence of Paravalvular Regurgitation and Transcatheter Valve Failure.  < https://pubmed.ncbi.nlm.nih.gov/27578840/>. DOI: 10.1161/CIRCINTERVENTIONS.116.003930

Thanks for the Plague, California!

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black_death

Because if hiding dead bodies isn’t a conspiracy, we don’t know what is.The bubonic plague (and its’ siblings, the septicemic and pneumonic plagues) is alive and well in the Western United States.  In fact, in the most plague-stricken region in the United States (Northern New Mexico) several cases pop up every year.  Even with modern antibiotics, nearly 1 in 6 plague patients will die – which is still better than no treatment at all, since some forms are 99% fatal if untreated.

Thanks to horizontal gene transfers and other mechanisms, soon antibiotics may not even help: one recently isolated strain of the plague was found to be resistant to eight antibiotics, including all of the three primary treatments for plague.  Even more disturbing, a Nevada woman who eventually died was treated for a bacterial infection in early 2017 that was resistant to every antibiotic available in the United States.  Yersinia pestis typically hides out in long-term environmental reservoirs, which may provide more opportunities for horizontal gene transfer and makes eradication of the plague almost impossible in the Western U.S. (or other countries).  This makes the average 10 to 20 annual cases in the U.S. largely unavoidable.cycleThe plague is not native to U.S. soil and its’ presence here was neither inevitable nor even especially difficult to avoid.  The plague made landfall in San Francisco’s Chinatown, where deaths started occurring around 1900.  Under the direction of the governor of California, Henry Gage, the bodies of plague victims were hidden for at least two years.  In fact, over 100 deaths were concealed, and newspapers reported that the plague “Did not, nor ever did exist in California.”  The San Francisco Examiner even ran an article :Why San Francisco is Plague-Proof.”

Why hide such a deadly disease from the public?  Greed, pure and simple: Gage and his officials feared the loss of revenue during quarantine, and an even more significant loss of revenue if consumers stopped buying California produce, which was by then a burgeoning $25 million dollar industry.  Despite the attempts by the governor to silence the medical community and corrupt the media, a handful of champions of public health eventually succeeded in ridding the city of the plague.  Two of the city’s most prominent physicians, Wilfred H. Kellogg and Joseph Kinyoun, Chief Bacteriologist and Chief Quarantine Officer,  made valiant efforts to protect the public welfare that did not immediately come to fruition.  After discovering Yersinia pestis in the blood and lymph smears from infected corpses, these doctors made recommendations to contain the outbreak.  The response from California State officials was swift and merciless:  the doctors were fired and massive, devastating smear campaigns were launched against them in the local media.

Still, by 1903 the political tide started to turn against the Governor, and after repeated outbreaks in 1906 and 1908, the plague was eradicated from the city of San Francisco.  The same newspapers that had denied that the Black Death had ever descended on San Francisco now gleefully declared that it had been eradicated.

Unfortunately, while the cleanup-up was a win for San Francisco, lasting damage had been done to the Western United States.  Local populations of mammals, including rats and squirrels had already been infected within the first several years due to the critical delays in treating and containing the outbreak.  Over half of all plague related deaths in the United States now take place in a region that had nothing to do with the introduction of the disease.  Free-ranging animals have spread the disease, until at last, it found its’ greatest permanent reservoir in the United States: The Gunnison and black-tailed prairie dogs of northern Arizona, New Mexico, southern Colorado and Utah.

These regions overlap with the distribution of plague hotspots in the United States, and not just for humans either: over 90% of the inhabitants of an infected prairie dog town will usually die in a single outbreak.  Fleas jump from their dying hosts in favor of dogs (who seem to be plague-resistant) and enter homes where they kill both humans and cats (who seem to be especially vulnerable).  Thus, Henry Gage’s legacy repeats itself, claiming more lives every year, and reminding us that the consequences of inaction during a pandemic are severe, while the consequences of actions taken to deliver misinformation during a pandemic are abominable.

[2] Tansy, T. Plague in San Francisco: Rats, Racism and Reform.  2019  Nature. https://www.nature.com/articles/d41586-019-01239-x.

[3] Plague Ecology and Transmission. United States Center for Disease Control (CDC) webpage.  See infographic, vide supra. https://www.cdc.gov/plague/transmission/index.html.

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Anti-Vaxxers a Top Health Threat

By | Blog

A new threat to the health and safety of children has recently begun to take center stage: diseases that were once thought eradicated have reemerged into public consciousness.  These diseases have been aided and abetted by the irresponsible and dangerous behavior of people opposed to vaccines, otherwise known as anti-vaxxers. Read More

Toxoplasma Gondii: The Brain Hitchhiker

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kitty3Toxoplasmosis is a widely known disease that results from infection with the Toxoplasma gondii parasite, one of the world’s most common parasites. Infection usually occurs by eating undercooked contaminated meat, exposure from infected cat feces, or mother-to-child transmission during pregnancy.  Estimates suggest that about 1/3 of the entire human population of the Western world is harboring the parasite in the form of “benign cysts” concentrated mostly in the brain.

The parasite can form cysts anywhere almost: hearts, lungs and eyeballs are common hiding places, but the brain is the preferred hangout for this organism.  If you are a cat lover, chances are high you are already infected, courtesy of your cat.  Cat brains are a natural repository for the adult protists, which reproduce inside our feline friends and spread from cat feces.  This is not to say that won’t infect any warm-blooded animal that they are capable of, but the only hosts truly necessary for their continued survival are felids, according to the CDC website.  Once infected, they usually infect you for your entire lifespan, mostly asymptomatically.toxo

The most interesting thing about the infection, though, is that the cysts hijack our brains, producing subtle but measurable and influences on behavior.  Scientists have suspected that the success of Toxoplasma is due in part to its’ ability to change rats and mice behavior, and causing them to stop fearing cats.

In a now famous study, it was demonstrated that mice, which have a morbid fear of cats and a strong fear reaction to cat odor, tend to lose that fear and unequivocally show a preference for cat odor after being infected with the parasite.

Mice aren’t the only ones whose brains can be hijacked, though: there’s a good chance that the parasite in your head may be at least partly responsible for the shots you call, too.  A growing body of research indicates that the manipulation theory, as it is called in medical and biological journals, extends to human in several ways.  Latent toxoplasmosis in humans has been associated with serious neurological disorders, including schizophrenia, intermittent explosive (rage) disorder and suicide.

In addition, research shows infection by Toxoplasma gondii, directly affects the production of dopamine, a key chemical messenger in the brain.  Dopamine is a natural chemical which relays messages in the brain controlling aspects of movement, cognition and behaviour. It helps control the brain’s reward and pleasure centres and regulates emotional responses such as fear. The presence of a certain kind of dopamine receptor is also associated with sensation-seeking, whereas dopamine deficiency in humans results in Parkinson’s disease.

Infection changes the way that your brain processes information, slowing reaction times (more traffic accidents) and changing your preferences for a great many things, from risk aversion to tidiness to extraversion.  The effects of Toxoplasma infection on an individual depend on genetics, with some genotypes immune to infection and less likely to experience effects, and gender.  To take one example, the effect on personality has been summed up after analyzing multiple studies, each with well over a hundred (and often several hundred) subjects.

According to Effects of Toxoplasma on Human Behavior, significant differences in personality factors were found between Toxoplasma-infected and -uninfected subjects in 9 of 11 studies, and these differences were not the same for men and women. After using the Bonferroni correction for multiple tests, the personality of infected men showed lower rule consciousness and higher vigilance. Thus, the men were more likely to disregard rules and were more expedient, suspicious, jealous, and dogmatic. The personality of infected women, by contrast, showed higher warmth, suggesting that they were more warm hearted, outgoing, conscientious, persistent, and moralistic.

Even sexual characteristics and preferences might be affected.  In one photograph study, men who harbor infections are consistently rated as being more dominant and masculine looking then men who don’t have infections – on the basis of photographs alone.  Toxoplasma increases expression of the genes coding for testosterone in men, and the effect is large enough to be seen by the naked eye and borne out by physical measurements, including a noticeable 3 cm boost in average height.

Although the mechanisms by which this parasite seems to influence its’ hosts are still being elucidated, its’ clear that it touches our lives in ways we never before imagined.  How much of “them” is really “us”?

Anti-Cancer Gut Bacteria

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The human microbiome is the subject of a burgeoning field of research.  The effect of gut microflora, and especially bacteria, has in the last few years been linked to anxiety, depression, gastrointestinal and autoimmune diseases, and numerous other disorders. Read More

New Genetic Test for Antimicrobial Resistance

By | disease, research, antibiotic

how-bacteria-work-360x240You’ve most likely taken an antibiotic at least once in your lifetime. From treatments for painful strep throat or ear infections as a child, to burning urinary tract infections or itchy skin infections, antibiotics are one of the most highly utilized and important medication classes we have.  Soon, your doctor may have a new weapon in their arsenal to diagnose and target treatment:  scientists at American University have developed a rapid, highly sensitive genetic test to determine whether bacteria carry a gene that causes resistance to two common antibiotics. Their research, published in BMC Infectious Diseases, demonstrated that the new test works as accurately as culture-based methods but gives results in minutes, not hours or days.

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Merck Backs Out of Vaccine Commitment to Africa

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Merck’s decision may leave more than 2 million children in West Africa unvaccinated and vulnerable to rotavirus in 2020.

At the same time Merck cut the vaccine supplies to West African countries, they began delivering RotaTeq to China.  Each vaccine will likely cost more than $40 per dose.  When asked if there was a connection between the launch in China and Merck not fulfilling their West African commitment, a Merck spokesperson wrote:

When faced with supply constraints, such as this, we evaluate all options to determine how we can fulfill the agreement we made with UNICEF and GAVI-eligible countries to the best of our ability, while at the same time meet the binding contract demands we have with other countries. The product we have allocated to China is what has been approved for use in that country to fulfill the terms of a binding agreement we signed with a local vaccine company in 2012. As I’m sure you can appreciate, the details of that contract is proprietary to Merck; as such, we cannot confirm the number of doses nor discuss price.

“Kids should not be denied vaccines just because they belong to a poor country.”-Dr. Mathuram Santosham at Johns Hopkins University

Where does that leave the kids in West Africa? UNICEF, which delivers vaccines to poor countries worldwide, says it’s trying to help the West African countries switch to another vaccine.  The World Health Organization prequalified two new rotavirus vaccines manufactured in India earlier this year:  Rotasil and Rotavac.  Both vaccines are available to Gavi at a cost of less than $2 per dose.

Unfortunately, the switch will not be quick-or easy.  Prequalification of a vaccine is the beginning of a long process, including a regulatory actions that must occur.   The process is daunting, with more than a few moving parts that require time and money.  New vaccines may be tested in small pilot programs, health care workers have to be retrained on vaccine administration, clinics need the ability to store and transport the new vaccine.  That will require possibly up to five years for the vaccine to be widely available in West Africa, says Frederick Cassels, at the nonprofit PATH, which helped develop Rotasil and Rotavac.  Even just a delay of a few years would put millions of babies at risk for rotavirus, says Johns Hopkins University’s Santosham. “We all as a community should come together and make sure these kids get this vaccine.”

According to Merck, their third quarter 2018 worldwide sales were $10.8 billion.  Good for Merck-really.  More profits mean more research, and more lives saved overall.  Most reasonable people realize that companies need to make a profit to stay in business, and that includes pharmaceutical companies.  But the pharmaceutical industry is not like other industries that sell tires or pizza.  Due to the nature of the business, pharmaceutical industry profits are made off of illness and disease–this requires a level of sensitivity and responsibility to the community that the local pizza joint does not need to make.

What level of responsibility do pharmaceutical companies owe to the people?  Has Merck denied their responsibility to the community and turned their back on the poor children of Africa?  Can a company be both profitable and ethical, or are those incompatible values?  These are questions that need consideration, since we live in a world with expanding need, and shrinking resources. 

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HIV Controlled by Antibody Therapy

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Today, an estimated 1.1 million people are living with HIV in the United States, and improvements in antiretroviral therapy have turned HIV into a manageable condition.  Thanks to better treatments, people with HIV are now living longer—and with a better quality of life—than ever before.  Yet even the most effective drugs only suppress the virus, which hides in the body, ready to rise to dangerous levels should a patient stop their medication regime. To continue suppression of HIV, patients must adhere to strict daily medication schedules, which can be burdensome and expensive.   Read More

Latest Research Offers Alternative to Addictive Opioids

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The misuse of and addiction to opioids—including prescription pain relieversheroin, and synthetic opioids such as fentanyl—is a growing national crisis affecting public health and creating an enormous burden on the healthcare system.  The Centers for Disease Control and Prevention estimates that the total economic impact of prescription opioid misuse in the United States is $78.5 billion a year, including healthcare, lost productivity, addiction treatment, and criminal justice involvement.

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How Does Talking to Babies Make Them Smarter?

By | social issues, children, education, parenting
Young children who are regularly engaged in conversation by adults may have stronger connections between two developing brain regions critical for language, according to a study of healthy young children that confirms a hypothesis registered with the Open Science Framework. This finding, published in JNeurosci, suggests that talking with children from an early age could promote their language skills. Read More

New TB Study Has Hopeful Results

By | disease, research
Tuberculosis (TB), an infectious disease targeting the lungs, is the second biggest killer, globally.  In 2015, 1.8 million people died from the disease, with 10.4 million falling ill, despite the development of vaccines and effective drug treatment.  At one point, the United Nations predicted that TB would be eliminated worldwide by 2025, but treatment options remain surprisingly sparse.  The only vaccine for TB was developed nearly a century ago, and offers limited protection.  Even worse,  patients are becoming increasingly resistant to available drugs. Read More

Can an Asthma Drug Reverse Dementia?

By | Uncategorised

dementia_istock_000029744938_largeDementia is a term describing a variety of diseases that develop when nerve cells in the brain die or become impaired. The death of neurons causes changes in memory, behavior, physical capabilities and personality. In many of these diseases, such as Alzheimers, the associated changes often prove to be fatal. Read More

Louisiana Hepatitis C Cost Proposal

By | legal, legislation

Biosimilars: Growing Pains in a New Arena

By | Uncategorised

dna_3One of the key strategies for enhancing access to affordable medicines posed by the Trump administration involved establishing the pathway for the development and approval of high-quality biosimilar therapies.  Yet, out of 11 approved products, only three biosimilars are on the market eight years after the enactment of legislation streamlining the process.  If current trends continue, it may be months or years before Americans gain access to these medications.

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New Research on Spinal Cord Injury

By | Uncategorised
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The spinal cord is very sensitive to injury, and unlike other parts of your body, lacks the ability to self repair when damaged, making spinal injuries potentially devastating. A spinal cord injury — damage to any part of the spinal cord or nerves at the end of the spinal canal (cauda equina) — often causes permanent changes in strength, sensation and other body functions below the site of the injury.  An injury can occur when there is damage to the spinal cord from trauma, restriction of blood supply, or compression from a tumor or infection. There are approximately 12,000 new cases of spinal cord injury each year in the United States, most frequently in males. Read More

Preventing CTE & Head Trauma

By | ethics, social issues, legal, sports

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Football is an iconic American sport, but despite the national interest in watching football, professional athletes experience a lack of protection when it comes to brain injuries. It is not uncommon for football players at any level to experience a traumatic head injury at some point during their career. For some, the injuries come in the form of a concussion, which makes up 7.4% of all head injuries sustained from playing football.

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Long Acting Treatment for Schizophrenia May Offer New Hope

By | Uncategorised

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Schizophrenia, Latin for “split mind,” is a chronic, severe and disabling brain disorder, affecting an estimated 2.4 million American adults and their families.  The hallmark of schizophrenia is disorganized thinking, which can manifest as positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal).  Although schizophrenia is not as common as other mental disorders, the symptoms can be very disabling. In the past, there were different classes of schizophrenia, also known as ‘subtypes’. Disorganized schizophrenia, catatonic schizophrenia and schizoaffective disorder have since been absorbed into the larger diagnosis of schizophrenia, but are still used to describe the widely varied ways schizophrenia can manifest from person to person.  Read More

Right To Die

By | ethics

candle-2038736_1920The right to die issue – or death with dignity – as it has been named in the press and by advocacy groups, is a controversial topic. On one side of the argument some people are concerned that passing ‘death with dignity’ statutes and legalizing suicide might expose the most vulnerable groups of people in society. On the other side, some people suffering terminal illness are concerned with exercising their right to bodily autonomy, and deciding when and where that ends.

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Psychopathy as a Disability?

By | mental health

eery-1648250_1920.jpgPsychopathy is a hotly debated topic in the psychiatric community and in society at large. The nature of psychopathy is a frightening one and the root causes of the personality disorder are largely unknown. A person who is diagnosed as being a psychopath may exhibit symptoms such as reckless spending, violence towards animals and arson, ordinarily starting from a very young age. Psychopathy is generally understood by most people to be characterized by diminished capacity for empathy towards other people and living beings.

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Joyce Brown & 5150s

By | ethics, mental health

schizophrenic-2934770_1920Psychiatric care is a difficult field for many patients and providers to navigate. The ethics of psychiatry are constantly changing and are held under great scrutiny. In the eyes of the public, treating mental illness is not as straightforward as treating physical illness.

People with severe mental illness are more likely to be subject to homelessness, violence and unemployment. For many people with psychotic disorders, they’re likely to experience an involuntary psychiatric hold – known as a 5150, which enables them to be held in a psychiatric hospital for evaluation and potentially to be held longer if they’re deemed incapable of checking themselves out or caring for themselves.

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Insomnia: The Hidden Costs of Poor Sleep

By | Uncategorised
Insomnia is a common problem for people of all ages, with a number of people suffering from an inability to sleep.  Based on estimates derived from population-based studies, approximately 30% of adults worldwide report symptoms of insomnia: difficulty initiating or maintaining sleep, waking up too early or poor quality of sleep.  Common comorbidities associated with insomnia are psychiatric disorders, with an estimated 40% of all insomnia patients experiencing a coexisting psychiatric condition.  Among these psychiatric disorders, depression is the most common, and insomnia is a diagnostic symptom for depressive and anxiety disorders.

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Ketamine and Depression

By | Uncategorised

Depression is one of the most life-threatening mental illnesses in the United States today. Treatment resistant depression, which does not respond readily to talk therapy or medication — the most frequently prescribed treatments for major depression — can lead to self loathing, isolation and thoughts of suicide. Suicide is currently among the leading causes of death in America.  Even medication can have drawbacks, with first line therapies often taking as long as 6 to 8 weeks before being effective.

Faced with the long timeline of drug therapy and unwanted side effects, patients with severe depression sometimes turn to nontraditional treatments such as electroconvulsive therapy and perhaps surprisingly, ketamine therapy — a drug known as ‘Special K’ by recreational drug users. A staggering 70% of patients responded to ketamine therapy for treatment of depression in one study performed.  The study examined the use of intravenous ketamine  for depressed patients at imminent risk of suicide, and with the rapid response shown by patients, makes ketamine a potentially attractive “rescue medication” for depressed patients in need of immediate relief. Read More

Ebola Virus: Finally a Vaccine?

By | medicine, vaccination

 

The Ebola virus, discovered in 1976 near the Ebola River that can cause a severe and often fatal disease called Ebola virus disease (EVD).  Since the first discovery in 1976, there have been sporadic outbreaks of EVD, with the most recent one in 2013-2016 affecting West African countries, mainly Guinea, Sierra Leone and Liberia.  Fruit bats are the most likely reservoir of the Ebola virus.  Ebola is deadly in about 70% of those infected with Ebola; the 2013-2016 Ebola outbreak in West Africa claimed more than 11,000 lives. Read More

High Potency Compounds-Taking on the Challenge

By | Uncategorised

 

As a pharmaceutical or biotech company, if you haven’t had to deal with high potency API (HPAPI) compounds yet, chances are you will eventually.  Approximately 25 percent of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years; the global HPAPI market is expected to reach nearly $26 billion by 2022.

HPAPIs are a rapidly growing segment of the pharmaceutical industry, primarily due to an increased focus on targeted therapeutics, especially in oncology.  A compound is classified as highly potent if it has an occupational exposure limit (OEL) of ≤10μg/m3, a daily therapeutic dose of ≤10mg/day or if a 1 mg/kg/day dose produces serious toxicity in laboratory animals.

25% of drugs currently in development worldwide are highly potent.

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The Days of Clean Sheeting for Cost of Goods are Over.

By | Uncategorised

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We have all been there when we need to determine various costs and where they come from.  We stare at spreadsheets, trying to gather the necessary data, critical and nonessential, and using our calculations to determine how we can lower costs.  This approach is not only time consuming, but inaccurate and inefficient, but what are the alternatives?

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DASH Diet: A Potential Treatment for Depression?

By | mental health, health

Physical health and mental health are definitively linked, and have been for some time. However, the extent that diet and exercise has on mental health remains unknown. There are anecdotes of certain diets lowering blood pressure by seemingly impossible amounts, diabetics claiming to be cured by their lifestyle and even claims of going into cancer remission as a result of a person’s diet.  None of these claims have been seriously substantiated, but recently a diet known as the DASH diet has been linked to lower blood pressure and decreased risk of depression.  Is it possible that something as simple and straightforward as your diet can affect your mental health? Read More

Flu Outbreak Worse This Year

By | healthcare, flu, vaccination

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This year’s flu season has been unprecedentedly aggressive in comparison to recent years, causing levels of panic in the United States on the level of the H1N1 outbreak that occurred in 2009. Also known as swine flu, H1N1 caused rising levels of fear on a global level, with magazine covers publishing headlines about the epidemic and leading the World Health Organization to address the matter publicly, declaring it a pandemic.

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Is Excel Holding You Back?

By | Data Management, Cost Analysis, healthcare

image demonstrating the problem with Excel spreadsheetsIs Excel a dated method of data crunching that is holding back rather than advancing your company? CFOs from Fortune 500 companies are insisting that staff stop using Excel. What does that mean for the pharmaceutical industry, and why is there push back against the popular spreadsheet software? Finance chiefs say the ubiquitous spreadsheet software that revolutionized accounting in the 1980s cannot kept up with the demands of contemporary corporate finance units. After all, just like hair metal bands, the 80s are long gone and pharmaceutical companies need to advance with the times.

Spreadsheets have been a necessary and advantageous tool in a huge number of industries. Excel has revolutionized accounting and driven decision making, but as business becomes more complex and global, Excel cannot bear the expectations and demands of many companies.

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Left Behind: Native American Healthcare

By | healthcare

image depicting native american dreamcatchersFor many Native Americans, receiving healthcare can be a difficult ordeal. Poverty runs rampant on reservations throughout the United States, with one charity named One Spirit putting the number of Lakota families living under the poverty line in South Dakota at a staggering 90%. Even acquiring heating and basic living necessities is difficult for many of these families, reducing healthcare to a secondary concern. Native American people are at high risk for unnecessary death due to an intersection of unique situations such as isolation and poverty levels.

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Autoimmune Disorder Treatment on the Horizon

By | autoimmune disorders, development

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Over 23.5 million Americans are afflicted with autoimmune diseases, including rheumatoid arthritis (RA)an autoimmune disease affecting approximately 1.3 million Americans.  In a case of mistaken identity, the body’s immune system mistakes its own tissues for foreign invaders, such as bacteria or viruses and develops antibodies to destroy the “invaders” in the synovium.  Currently, there is no cure for rheumatoid arthritis and the treatments are often saddled with a variety of side effects, some as severe as the disease.

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Technology & Pharma: An Unexpected Intersection

By | technology

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The pharmaceutical industry is currently in an era of change and in some senses is being upended by these changes, thanks to the development of new technology. Patients are rapidly becoming more empowered to do their own research and make decisions about their healthcare. One of the recent technological developments in the healthcare industry enabling this is the rise of the ‘health app’. Apple products have their own integrated health app that tracks statistics such as weight, heart rate, significant medical dates and other information. 

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Online Drug Shopping Made Easy?

By | ethics

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The names of the top pharmacies in the world will come as no surprise to most:  CVS, Walgreens, Amazon.

Wait, what?  Amazon?

CNBC recently reported that Amazon may be considering the sale of prescription drugs online, a lucrative market of approximately $560 billion annually. Breaking into the U.S. prescription drug market could be the start of huge financial gains for Amazon, but many people are wondering how they would manage the transition from sales of primarily unregulated items, into selling products from one of the most highly regulated industries.

Analysts at Leerink Partners, an investment bank specializing in healthcare, predict Amazon will be involved in prescription drug sales by the year 2019. This idea is not new for Amazon, with a previous attempt at an online site named drugstore.com, which is no longer open. Read More

States in Crisis Sue Opioid Manufacturers

By | lawsuit, opioid crisis, legal, opioids

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Mississippi and Ohio are two states that have been hit hard by the recent opioid crisis affecting the nation, with over 200,000 Ohioans addicted to opioids.  Mike DeWine, the Attorney General, filed a lawsuit in May of 2017 against 5 separate pharmaceutical companies alleging that the companies “helped unleash a health crisis that has had far-reaching financial, social, and deadly consequences in the state of Ohio”.  This makes Ohio the second state to file suit against pharma companies, with Mississippi the first state.  They allege that the manufacturers knowingly marketed opioids while minimizing the risks of addiction, while simultaneously overstating the benefits.

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Do Benzos Cause More Harm Than Good?

By | benzodiazepines, addiction, benzos, harm

worried-girl-413690_1920.jpgBenzodiazepines are a commonly prescribed medication for anxiety, seizures, and a myriad of other medical conditions. However, this medication doesn’t come without its faults, of which there are many serious ones. Benzodiazepines such as Ativan and Xanax are potentially addictive after only a short period of time, and are highly sought after by drug addicts and even patients who aren’t psychologically addicted but are physically dependent on the medication.

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Snake Oil and Social Media

By | social media, regulation, drug promotion

In 2017, advertising and promoting products is a minefield.  The availability of detailed and extensive information on consumer spending habits provides countless ethical pitfalls that are only magnified when the product in question is a drug.  In the past only magazine ads and TV commercials were utilized for drug advertising, now we have an array of choices that don’t always feel like marketing, but more like a conversation with a good friend.

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Not So Nobel Awards

By | humor

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Why do old men have big ears? Can smiling at a crocodile affect your desire to gamble?  And most importantly, can cats act as both a liquid and a solid?

These are the questions that keep us awake at night.  Fortunately, there are scientists working diligently on these puzzles, as well as many other weird and curious questions.  Their efforts have not gone unnoticed, and most recently were celebrated at the 2017 Ig Nobel Awards, a scientific recognition of the strangest and most obscure scientific experiments or studies done in that year.

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Personalized Medicine: The Future of Genetic Testing?

By | genetic sequencing,, drug development

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You’re feeling under the weather, with a cough that just won’t go away, so you decide to visit your doctor.  After a few minutes of one-on-one time, with some poking and prodding, you may be walking out of the office with a prescription in hand and on the way to feeling better.  How much more personal does it get? Perhaps not surprisingly, it can get a lot more personal, and it has nothing to do with your doctor, and everything to do with science.

In our current system of medicine, your treatment plan has very little to do with you specifically; most likely it is the exact same treatment your doctor would give to anyone with the same condition.  Medicine today is based on “standards of care,” the most prudent course of prevention or treatment for the general population.  With medication treatment for depression, for example, those standards may mean treatment with an SSRI (selective serotonin reuptake inhibitor), followed by a second trial if the first one fails. If the second treatment fails, doctors and patients move on to the next one and the next in a trial and error approach.

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AI Innovation in Pharma

By | Uncategorised

 

artificial intelligence compressedArtificial intelligence is more than just a concept for the newest blockbuster movie, it is moving into mainstream science and the pharmaceutical industry as well.  The Korea Pharmaceutical and Bio-pharma Manufacturers Association has recently announced the launch of a team focused on purchasing artificial technology for drug development.  Artificial intelligence computing systems can be used to analyze molecular interactions, and predict drug efficacy and side effects.  The technology can be utilized to guide and optimize clinical trial planning, greatly reducing the timeline for new drug development.

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Exercise Can Prevent Dementia; Why Pharma Companies Should Care

By | Pharma and Politics

 

Alzheimer’s is a progressive, neurodegenerative disease characterized by memory loss and impaired cognition, with as many as 5.4 million Americans living with the disease.  Today Alzheimer’s disease is the sixth leading cause of death in the United States and the 5th leading cause for those 65 and older.  The symptoms of Alzheimer’s slowly creep into our lives and affect loved ones in profound ways.  Throughout the years, research and medications have helped, hindered and or even prevented some of the serious symptoms, but currently, there is no cure.

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Cost versus Quality: Is Manufacturing in India Worth It?

By | Business

image detailing the importance of maintaining high quality in drug manufacturingSix months into an administration’s promise to curb drug prices, the cost of drug development remains high.  As companies scramble to reduce costs, they are moving manufacturing overseas, enticed by lucrative savings.  The question remains: are drug companies really saving money or are reduced costs in production aligned with quality, timeline and regulation issues?

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Social Media and Pharma: The Good, the Bad and the Ugly

By | Business

Over the past decade, there has been a huge shift in the way that businesses and consumers use social media.  Society is undergoing rapid and dramatic change, fueled by an exponential rate of technological innovation.  This has an enormous impact on the pharmaceutical industry which is in a unique position to reap the benefits of increased sales, revenue and power by augmenting their technological capital.  One of the most effective methods to leverage this change is using social media, which leads us to the question:

Can social media be a game changer for pharma? Read More

5 Reasons Why Your Data Management System is Failing You

By | Data Management

 

Pharmaceutical companies are one of the major beneficiaries of emerging technologies.  From innovative ideas for developing new drugs to customer engagement, drug manufacturers are increasingly resorting to cutting edge digital technology to streamline business and improve efficiency.  Nowhere in pharma is the boom in technology more beneficial than in data management, an area where many drug companies struggle to organize and manage massive quantities of information.image illustrting the relationship between pharma and poor data management systems

As the regulatory landscape increases in complexity, the demand for improved 

data management and analytics will increase as well.  With all the new challenges that these trends create, digital data management is an innovation that pharma companies should have in their toolbox.

Below are the top five reasons that your current data management system is failing your company: Read More

Can Higher Drug Prices Lower Healthcare Costs?

By | Pharma Pricing, Pharma and Politics

Of course, if you can get the same medication for less, that is better, but what if switching to a newer more expensive drug actually saved money?  Recently I had the pleasure of moderating a panel at the Outsourced Pharma conference in Boston that was focused on cost and price pressures in the pharma industry. Based on the nodding heads in the audience, I think it is fair to say that our industry has an image problem.  While I cannot and will not try to defend some of the more recent high-profile cases that have garnered media attention, there is certainly a case to be made that not all pricing is gouging patients.Image showing the relationship between healthcare costs and pharma

Last week the Chicago Tribune highlighted a Blue Cross Report that squarely blames pharma companies for high drug prices.  According to the report, member plans spent 73 percent more on prescription drugs in 2016 than in 2010, attributed to “large year-over-year price increases” for new drugs that are protected from competition by patents.  in addition, the report highlighted the increase in consumer spending on drugs noting that consumers have been paying 3 percent more a year, out-of-pocket, for all prescription drugs but 18 percent more a year for patented drugs.”

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