About Rondaxe

Company Overview

Rondaxe is one of the largest and most experienced international CMC consulting groups in the world. We assist both virtual pharma/biotech companies and multi-national pharmaceutical clients from early development through commercial manufacturing. Services include comprehensive CMC solutions, drug development, manufacturing and global regulatory strategies. [Re]source™ is our proprietary pharmaceutical process software to assist clients with data management, cost of goods, productivity analysis and other features.

Client. Partner. Strategic Relationships.

Since our founding in 2001, these are the terms of affiliation Rondaxe has lived by to serve the industry based on mutual respect. Our industry experts and project managers are side-by-side with you from process development, agency interactions and filings, negotiations and contracts with service providers, to commercial supply chain management and final commercial success.

Quality. Compliance. Regulatory.

We understand the regulatory implications of process and development decisions, and we’ll be there for your meetings and filings with FDA and other regulatory bodies. For assured quality and full compliance, let us assist you in the robust evaluation of your current or prospective service providers (vendors), and overall manufacturing processes and strategies.

Science. Experts. Fit-for-Purpose.

Rondaxe is comprised of experts in the fields of chemistry, pharmaceutics, analytical development, route scouting and scale up, GLP/GMP manufacturing, distribution and commercialization of drug product. Our group is experienced and always up-to-date. The Rondaxe Team includes a network of subject matter experts readily available to add expertise to your specific development and manufacturing challenges. We have an extensive list and knowledge of pharmaceutical service providers to ensure the outsourcing partners you select are fit-for-purpose—and at the right price—for your stage of development.
These terms add up to The Rondaxe Way of accelerated and informed decision-making. We eliminate the “white space” between project milestones that force you to wait for analysis or understanding of implications that slow down your progress. These are hidden costs we uncover and eliminate. Collectively, Rondaxe has been through early development to full commercial success dozens of times, not once or twice. Ours is a consultancy of breadth and depth, networked to global subject matter experts for the quickest answers and most up-to-date expertise.

Rondaxe takes our name from a lake in the beautiful Adirondack Mountains in upstate New York. Like our namesake, we’ve been a contributing member of our ecosystem for many years. We bring clients both calm and depth among heightening challenges as compounds progress from discovery to IND, from IND to NDA, and on to successful commercial production and market launch.

Contact us to discuss how we can help you.

Our Team

Management Team

Kenton Shultis

Mr. Shultis joined Rondaxe in 2008 and now serves as our CEO. Ken offers our clients an extensive array of services including product development planning, quality systems design, API and formulation CoGS evaluations, technology transfer support, process and facility engineering and supplier negotiations. He previously was Vice President of Operations and General Manager of Organichem for AMRI after founding American Advanced Organics where he served as President for 2 years. Ken spent 14 years at Bristol-Myers Squibb as Director of Pilot Plant Development where he led several multiple site plant introduction programs. Ken also worked in Process R&D at Merck and in Fermentation Development at Abbott Laboratories. Ken earned his BSc. in Chemical Engineering from the University of Wisconsin and his M.Sc. in Chemical Engineering from the University of Minnesota.

curriculum vitae

Brian James, Ph.D., M.B.A.

Dr. James is a Vice President of Operations and has been with Rondaxe since 2006. Brian oversees project management, API synthesis design and API/Formulation sourcing support to our clients. He manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb for 7 years, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received both his Ph.D. in Chemistry from University of California, his M.B.A. from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University.

curriculum vitae

Joel Lirot

Mr. Lirot joined Rondaxe in 2008 as Vice President of Business Development. Prior to joining Rondaxe Joel spent 13 years in international sourcing, business development, sales and technology transfer management for KNC Laboratories, IRIX Pharma Services and Summit Pharmaceuticals. Over that time he developed an understanding and expertise in pharmaceutical business operations in Asia, particularly Japan where he completed numerous scholastic and professional assignments. Joel received his B.S. degree in Social Sciences from Michigan State University in 1991. Additional Languages: Japanese

curriculum vitae

Formulation Development

Robert Davis, Ph.D.

Before joining Rondaxe as a Sr. Advisor in 2005, Dr. Davis spent 36 years in the pharmaceutical industry. He worked with oral solids and liquid manufacturing in ever-increasing positions of responsibility at Bristol-Myers Squibb, concentrating on formulation and process development, scale-up and commercialization. He has led successful tech transfers on over 45 products, both within the same company and between international alliance partners. Bob received both his B.S. in Pharmacy and his Ph.D. in Pharmaceutics from the University of Mississippi.

curriculum vitae

Joseph Bogardus, Ph.D.

Dr. Bogardus began working with Rondaxe as a senior advisor in 2008. Joe specializes in formulation development for small molecules, proteins and peptides. Joe began his career at Bristol-Myers specializing in pharmaceutics development, formulation and stability. He directed the pharmaceutics departments for oral, injectable and topical products and supervised stability groups responsible for reports for regulatory submission. Joe was the executive director of Early Candidate Development and Stability streamlining the development process, reducing timelines and preparing stability reports. Later in Pharmaceutics R&D, Joe was responsible for over 60 scientists conducting formulation, process development and technology transfer of new drug candidates. Joe brings over 30 years of experience in industry and academia. Joe received his B.S. from University of Kentucky. He received his M.S. and Ph.D. in Pharmaceutical Chemistry from University of Kansas, Lawrence, KS.

curriculum vitae

Cynthia Stevenson

Dr. Stevenson has been working with Rondaxe since 2014.  Cynthia has wide expertise in drug formulation, encompassing both large and small molecules, and multiple routes of administration including; injectable, inhaled, oral, implantable pumps, and transdermal.   In addition to her technical expertise, Cynthia has experience in management, strategic planning, and relations with the drug regulatory bodies.  She has held senior positions with On Demand Therapeutics, Ethos Pharmaceuticals, Nektar Therapeutics, and Alza Corporation and started her career at Glaxo.  Cynthia received her B.A. in Chemistry from Colorado College and her M.S. and Ph. D. in Pharmaceutical Chemistry from the University of Kansas.

curriculum vitae

Chemistry Development

Brian James, Ph.D., M.B.A.

Dr. James is a Vice President of Operations and has been with Rondaxe since 2006. Brian oversees project management, API synthesis design and API/Formulation sourcing support to our clients. He manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb for 7 years, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received both his Ph.D. in Chemistry from University of California, his M.B.A. from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University.

curriculum vitae

David Dodds, Ph.D.

Dr. Dodds has been affiliated with Rondaxe since shortly after its inception. After working as a biochemist at Sepracor, where he was responsible for a new biocatalytic process which earned several million dollars in royalties, he joined Schering-Plough’s Research Institute as a Manager of its Biotransformations Group. There he successfully introduced biocatalysis in over a dozen projects, including the approved antifungal posacnazole. David was then Director of Fermentation and Biocatalysis Development at Bristol-Myers Squibb. There he worked on pressing problems associated with enzymatic processes and the development of processes for chiral intermediates for HIV therapeutics. He has served on due-diligence teams, worked with regulatory groups on commercial processes, and supported legal groups defending patents. David received his B.S., M.Sc. and his Ph.D. in Organic Synthesis from the University of Toronto, and his PDF in Molecular Biology from the University of Colorado.

curriculum vitae

Bingidimi I. (JP) Mobele, Ph.D.

Dr. Mobele became affiliated with Rondaxe as a senior advisor in 2011. JP is an expert process chemist with extensive experience in the development of practical syntheses for a wide range of APIs. He began his industrial career as a Senior Scientist at AMRI, where he was involved in the development of several processes, both as a hands-on bench chemist and as a Group Leader, culminating in the large scale manufacture of multiple drug candidates for toxicological and clinical evaluation (Phase I – III). While at AMRI, JP was instrumental in establishing an integrated solid state business unit specializing in the screening, selection and practical production of developable solid forms of APIs (salts and polymorphs). In 2010, he founded Okapi Chemtech, a chemistry outsourcing management and consulting firm offering custom synthesis, process R&D and manufacturing services to Emerging Pharma and Biotech clients through a network of CROs and CMOs. JP earned a Licentiate (M.Sc.) in chemistry from the University of Kinshasa, a M.Sc. in organic chemistry from Mie University (Japan) and a Ph.D. in organic chemistry from the University of Akron (OH).

curriculum vitae

Shelly James, Ph.D.

Shelly James joined Rondaxe in 2015 as Director of Technical Services. Shelly is involved in multiple projects and handles a diverse array of client needs, including project management, generating technical documents,supplier identification, sourcing and the analysis of cost of goods. Prior to joining Rondaxe, she performed her post-doctoral work at the University of California, San Francisco, where she honed her skills and expertise in non-invasive molecular imaging techniques and synthetic strategies. Shelly received her Ph.D. in Chemistry from Syracuse University, and her B.S. in Chemistry from the University of California, Santa Barbara.

curriculum vitae

Stuart Levy, Ph.D.

Dr. Levy began working with Rondaxe in 2011. Stuart has sixteen years of industrial experience in all aspects of chemical development. He has extensive experience in innovation in the conception of practical synthetic routes to pharmaceuticals, development of chemical processes for the manufacture of APIs and chemical process troubleshooting. He is a hands-on, results-oriented leader of multidisciplinary teams focused on process discovery, process development, scale-up and cGMP kilo lab production. Stuart has extensive expertise in technology transfer of chemistry from the research laboratory to kilo labs, pilot plants and contract research and manufacturing organizations. He has provided leadership and innovation at companies such as PPD Dermatology, Elixir Pharmaceuticals, Epix Pharmaceuticals, Ricera, Sugen and Seres Laboratories. Stuart received both his B.S. in Chemistry and his Ph.D. in Chemistry from University of Illinois, Chicago.

Biological Development

David Dodds, Ph.D.

Dr. Dodds has been affiliated with Rondaxe since shortly after its inception. After working as a biochemist at Sepracor, where he was responsible for a new biocatalytic process which earned several million dollars in royalties, he joined Schering-Plough’s Research Institute as a Manager of its Biotransformations Group. There he successfully introduced biocatalysis in over a dozen projects, including the approved antifungal POSACNAZOLE. David was then Director of Fermentation and Biocatalysis Development at Bristol-Myers Squibb. There he worked on pressing problems associated with enzymatic processes and the development of processes for chiral intermediates for HIV therapeutics. He has served on due-diligence teams, worked with regulatory groups on commercial processes, and supported legal groups defending patents. David received his B.S., M.Sc. and his Ph.D. in Organic Synthesis from the University of Toronto, and his PDF in Molecular Biology from the University of Colorado.

curriculum vitae

Shu-Jen D. Chiang, Ph.D.

Dr. Chiang joined Rondaxe’s senior advisor team in 2009. Prior to affiliating with Rondaxe, he had over 35 years of experience in recombinant DNA technology, genetics and biochemistry, including industrial experience in R&D, fermentation and product purification process development. He was most recently Associate Director with Bristol-Myers Squibb, where he was responsible for API manufacturing technologies, strain engineering and recombinant protein expression for fermentation and biotransformation projects, and external technology transfer. Before that, Shu-Jen was with Abbott Laboratories and SDS Biotech Corporation. Shu-Jen received his B.S. in Biology from Fu-Jen Catholic University, and his M.S. and Ph.D. in Molecular Biology from the University of Texas at Dallas. Shu-Jen is fluent in Mandarin.

curriculum vitae

Leslie E. Walker Ph.D.

Dr. Walker joined Rondaxe’s senior advisor team in 2010. He has extensive experience in the planning, implementation and management of Biotech drug development projects.   Les held the position of Director of Drug and Process Development  at Pharmexa until 2008. Les was project director for a Universal Flu Vaccine team, directed vaccine product development including design of immunogenic protein antigens, cleavable multi-epitope peptides and plasmid DNA drug candidates.  He was responsible for formulation development of all drug products and responsible for outsourcing of manufacturing, preclinical toxicology and assay development. Les also had responsibility for regulatory and associated documentation and prepared IND packages and handled FDA responses. In his previous Director of Drug and Process Development role at Cytel, Les managed a team of research molecular biologists and biochemists directing a group responsible for large scale recombinant enzyme production, enzymatic glycosylation cycle scale up and clinical formulation development for carbohydrate, peptide and protein drug candidates. His research has been widely published.  Les received his B.S Biochemistry and Ph.D. from Oklahoma State University with postdoctoral studies at Scripps Clinic and Research Foundation.

curriculum vitae

Dagmar Meissner

Ms. Meissner began working with Rondaxe in 2012.  She has more than 15 years’ experience in downstream processing for mammalian cell and recombinant products, liposomal formulation, and artificial internal organs based on encapsulation of cells for implants. Dagmar started her career at Biogen in process development, working in virtually all areas of downstream purification and isolation.  She went on to work with DepoTech on developing formulations and processes for sustained release formulations.  At Kelco, she lead a team to improve the processes to reliably deliver pharmaceutical grade alginate.  Dagmar then went on to MicroIslet to build and lead a team to use refined alginates to encapsulate cells.  She has extensive experience in process development, equipment qualification, quality risk assessment, and process validation. Dagmar is a Diplomate in Chemical Engineering from the Fachhochschule für Technik Mannheim, Germany and earned a Master’s Degree in Chemical Engineering from Tufts University.

curriculum vitae

Regulatory

Thomas Warden

Tom Warden is an experienced Regulatory Affairs consultant, with over 30 Drug Master Files written and is  Regulatory Affairs Certified (RAC) for ten years. He has extensive experience with FDA inspections, including PAI inspections. He has performed GMP compliance audits-ICH compliance, worked as a GMP compliance consultant for the medical device and pharmaceutical industries. He has experience in sterile and manufacturing process validations, water system design, testing and troubleshooting, documentation control and compliance programs. Tom has worked at COBE Laboratories, Vipont Pharmaceuticals, Hauser Inc. , Natural Pharmaceuticals Inc. in increasingly responsible analytical development, regulatory, quality and operations roles.   At COBE Tom was responsible for a lab of 36 people managing  GMP laboratory testing including chemistry, microbiology, cell culture, particulate counting and identification, biocompatibility testing and animal facilities  He received his Bachelors and Masters degrees in Chemistry and Biochemistry from Colorado State University. He is certified from the Regulatory Affairs Professionals Society.

curriculum vitae

Quality Assurance

Karl Hofmann, JR.

Mr. Hofmann first joined Rondaxe in 2006, and was promoted in 2008 to President, Rondaxe Quality L.L.C. Karl manages all quality system design programs, Pre-Approval Inspection preparations, GMP audits and quality agreement negotiations for our clients. Mr. Hofmann brings to Rondaxe nearly 40 years of both hands-on involvement and managerial oversight of pharmaceutical manufacturing and quality assurance operations. While at Ayerst and Bristol-Myers Squibb, through increasingly more demanding quality and manufacturing assignments, he developed a specialization in GMP and regulatory matters associated with manufacturing small molecule and biologic API’s, sterile manufacturing, plant design, technology transfer and pre-approval inspections by the FDA. Karl received his B.A. in Chemistry from Middlebury College and his M.Sc. in Biochemistry from the State University of New York at Plattsburg.

curriculum vitae

Manufacturing & Supply Chain Management

Kenton Shultis

Mr. Shultis joined Rondaxe in 2008 and now serves as our CEO. Ken offers our clients an extensive array of services including product development planning, quality systems design, API and formulation CoGS evaluations, technology transfer support, process and facility engineering and supplier negotiations. He previously was Vice President of Operations and General Manager of Organichem for AMRI after founding American Advanced Organics where he served as President for 2 years. Ken spent 14 years at Bristol-Myers Squibb as Director of Pilot Plant Development where he led several multiple site plant introduction programs. Ken also worked in Process R&D at Merck and in Fermentation Development at Abbott Laboratories. Ken earned his BSc. in Chemical Engineering from the University of Wisconsin and his M.Sc. in Chemical Engineering from the University of Minnesota.

curriculum vitae

Brian James, Ph.D., M.B.A.

Dr. James is a Vice President of Operations and has been with Rondaxe since 2006. Brian oversees project management, API synthesis design and API/Formulation sourcing support to our clients. He manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb for 7 years, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received both his Ph.D. in Chemistry from University of California, his M.B.A. from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University.

curriculum vitae

Jean-Pierre Burion

Mr. Burion began working with Rondaxe in 2013. Jean-Pierre has nearly 30 years’ experience managing the manufacturing side of pharmaceutical supply chains. He served much of his career with Orgamol S.A. and its parent, BASF, where he was Global Product Manager for API’s. He and his group were responsible for directing sales teams and managing client relations and contract negotiations. Later, Jean-Pierre helped OmniChem establish their business development team. He received his training in Lausanne, Switzerland.

curriculum vitae

Gary Nelson

Gary has been associated with Rondaxe since 2008. Gary has an extensive background in Sourcing and Supply Chain. Gary has been a driver in Global Purchasing initiatives evaluating purchasing across divisions of Bristol-Myers negotiating and implementing global contracts having significant positive impact on chemical purchases. As an Associate Director and Director of Global Strategic Sourcing, Gary has managed supplier qualification, supplier change and implementation of global supplier contracts , implemented efforts to reduce supplier base, developed a global purchasing database, led eSourcing team, identification of new suppliers, cost reduction programs, supplier relationship management, Arriba/SAP/AS400 analysis. Most recently Gary was Senior Director of Strategic Sourcing at Medimmune responsible for hiring/training a Sourcing Team, drafting of Procurement Policies and Procedures, SAP eRequisition & SAP SRM implementation. Gary has a B.S. in Chemistry from the University of Southern Indiana, IN.

curriculum vitae

Sota Kurita

Mr. Kurita has been associated with Rondaxe since 2011. Sota has an extensive background in Business Development & Strategy in the US, Japan and Europe, Process Engineering, Regulatory and Market R&D issues. Most recently, Sota has been working as managing director for Allied Laboratories. Previous to this Sota was Manager for Saltigo Business Development with responsibility for Japan and US West Coast Operations. Sota held various positions of increasing responsibility at KNC Laboratories where he was a Board Director and Director of International Business Development. Sota has a B.S. in Chemistry and a M.S. in Organic Chemistry from Konan University in Kobe, Japan.

curriculum vitae

Shelly James, Ph.D.

Shelly James joined Rondaxe in 2015 as Director of Technical Services. Shelly is involved in multiple projects and handles a diverse array of client needs, including project management, generating technical documents,supplier identification, sourcing and the analysis of cost of goods. Prior to joining Rondaxe, she performed her post-doctoral work at the University of California, San Francisco, where she honed her skills and expertise in non-invasive molecular imaging techniques and synthetic strategies. Shelly received her Ph.D. in Chemistry from Syracuse University, and her B.S. in Chemistry from the University of California, Santa Barbara.

curriculum vitae

Business Development and Business Strategy

Brian Zorn

Dr. Zorn began working with Rondaxe in 2008 supporting Licensing, Market Intelligence and Business Development projects for our clients. Brian brings a truly unique set of communications, business development and marketing skills and experiences to the team. Brian held a number of senior marketing roles in Parke-Davis division of Warner Lambert working on oncology, anti-infectives, cardiovascular and CNS products. More recently, Brian has held worked with Pharmacia & Pfizer on Bextra® global launch working on product positioning, market plan development and launch implementation. In addition, Brian has worked with Novartis providing agency leadership and strategic marketing direction on their cardiovascular franchise. Since 2005, Brian has led 6 new product launches and provided launch preparation, communication, marketing and business development services to pharmaceutical clients. Brian received both a B.S. in Pharmacy and his Doctor of Pharmacy from the University of Kansas.

curriculum vitae

Katie MacFarlane, Pharm.D.

Dr. MacFarlane began working with Rondaxe in 2008 supporting Licensing and Market Intelligence projects for our clients. Katie brings a truly unique set of skills and experiences to those already available to Rondaxe’s clients. Before entering the world of consulting, Katie had been president and CEO of Xintria Pharmaceutical Corp., a start-up focused on dyslipidemia and Type II diabetes. Before that she was Vice President of Women’s Healthcare and Product Planning for Warner Chilcott, Inc. While there Katie not only managed the sales and marketing teams, she also led the launch of several products and participated in the due diligence and deal negotiations for the acquisition of products from Lilly, BMS and Pfizer. She has also held sales and marketing positions in Pfizer and Warner-Lambert, where she was responsible for the launch of Lipitor®. Katie received both a B.S. in Pharmacy and her Doctor of Pharmacy from Purdue University; she completed her postdoctoral fellowship in Industrial Clinical Pharmacy at Rutgers University.

curriculum vitae

Sota Kurita

Mr. Kurita has been associated with Rondaxe since 2011. Sota has an extensive background in Business Development & Strategy in the US, Japan and Europe, Process Engineering, Regulatory and Market R&D issues. Most recently, Sota has been working as managing director for Allied Laboratories. Previous to this Sota was Manager for Saltigo Business Development with responsibility for Japan and US West Coast Operations. Sota held various positions of increasing responsibility at KNC Laboratories where he was a Board Director and Director of International Business Development. Sota has a B.S. in Chemistry and a M.S. in Organic Chemistry from Konan University in Kobe, Japan.

curriculum vitae

Strategic Market Research and Intelligence

Katie MacFarlane, Pharm.D.

MacFarlane began working with Rondaxe in 2008 supporting Licensing and Market Intelligence projects for our clients. Katie brings a truly unique set of skills and experiences to those already available to Rondaxe’s clients. Before entering the world of consulting, Katie had been president and CEO of Xintria Pharmaceutical Corp., a start-up focused on dyslipidemia and Type II diabetes. Before that she was Vice President of Women’s Healthcare and Product Planning for Warner Chilcott, Inc. While there Katie not only managed the sales and marketing teams, she also led the launch of several products and participated in the due diligence and deal negotiations for the acquisition of products from Lilly, BMS and Pfizer. She has also held sales and marketing positions in Pfizer and Warner-Lambert, where she was responsible for the launch of Lipitor®. Katie received both a B.S. in Pharmacy and her Doctor of Pharmacy from Purdue University; she completed her postdoctoral fellowship in Industrial Clinical Pharmacy at Rutgers University.

curriculum vitae

Brian Zorn

Dr. Zorn began working with Rondaxe in 2008 supporting Licensing, Market Intelligence and Business Development projects for our clients. Brian brings a truly unique set of communications, business development and marketing skills and experiences to the team. Brian held a number of senior marketing roles in Parke-Davis division of Warner Lambert working on oncology, anti-infectives, cardiovascular and CNS products. More recently, Brian has held worked with Pharmacia & Pfizer on Bextra® global launch working on product positioning, market plan development and launch implementation. In addition, Brian has worked with Novartis providing agency leadership and strategic marketing direction on their cardiovascular franchise. Since 2005, Brian has led 6 new product launches and provided launch preparation, communication, marketing and business development services to pharmaceutical clients. Brian received both a B.S. in Pharmacy and his Doctor of Pharmacy from the University of Kansas.

curriculum vitae

International Sourcing & Business Development

Jean-Pierre Burion

Mr. Burion began working with Rondaxe in 2013. Jean-Pierre has nearly 30 years’ experience managing the manufacturing side of pharmaceutical supply chains. He served much of his career with Orgamol S.A. and its parent, BASF, where he was Global Product Manager for API’s. He and his group were responsible for directing sales teams and managing client relations and contract negotiations. Later, Jean-Pierre helped OmniChem establish their business development team. He received his training in Lausanne, Switzerland.

curriculum vitae

Joel Lirot

Mr. Lirot joined Rondaxe in 2008 as Vice President of Business Development. Prior to joining Rondaxe Joel spent 1 3 years in international sourcing, business development, sales and technology transfer management for KNC Laboratories, IRIX Pharma Services and Summit Pharmaceuticals. Over that time he developed an understanding and expertise in pharmaceutical business operations in Asia, particularly Japan where he completed numerous scholastic and professional assignments. Joel received his B.S. degree in Social Sciences from Michigan State University in 1991. Additional Languages: Japanese

curriculum vitae

Devices & Diagnostics

Cynthia Stevenson

Dr. Stevenson has been working with Rondaxe since 2014.  Cynthia has wide expertise in drug formulation, encompassing both large and small molecules, and multiple routes of administration including; injectable, inhaled, oral, implantable pumps, and transdermal.   In addition to her technical expertise, Cynthia has experience in management, strategic planning, and relations with the drug regulatory bodies.  She has held senior positions with On Demand Therapeutics, Ethos Pharmaceuticals, Nektar Therapeutics, and Alza Corporation and started her career at Glaxo.  Cynthia received her B.A. in Chemistry from Colorado College and her M.S. and Ph. D. in Pharmaceutical Chemistry from the University of Kansas.

curriculum vitae

Environmental Toxicology

Packaging

Analytical Chemistry

John D. Orr, Ph.D.

Dr. Orr is a Managing Advisor and has been with Rondaxe since January 2016, assisting clients inthe area ofCMC Analytical and Process Development. Prior to joining Rondaxe, John served as Director of Analytical and Physical Chemistry at Eisai, where he collaborated in the discovery, characterization, development, and CMC regulatory filings of complex natural product based medicines. John is active in several industry groups such as the IQ Consortium and Allotrope Foundation, where he has served as the chair of the Analytical Leadership Groupand as a member of the board of directors. John received his M.S. and Ph.D. degrees in chemistry from The University of Chicago, where he studied bioorganic chemistry, and performed his post-doctoral fellowship at The Samuel Roberts Noble Foundation researching plant molecular biology.

curriculum vitae

Thomas Warden

Tom Warden is an experienced Regulatory Affairs consultant, with over 30 Drug Master Files written and is  Regulatory Affairs Certified (RAC) for ten years. He has extensive experience with FDA inspections, including PAI inspections. He has performed GMP compliance audits-ICH compliance, worked as a GMP compliance consultant for the medical device and pharmaceutical industries. He has experience in sterile and manufacturing process validations, water system design, testing and troubleshooting, documentation control and compliance programs. Tom has worked at COBE Laboratories, Vipont Pharmaceuticals, Hauser Inc. , Natural Pharmaceuticals Inc. in increasingly responsible analytical development, regulatory, quality and operations roles.   At COBE Tom was responsible for a lab of 36 people managing  GMP laboratory testing including chemistry, microbiology, cell culture, particulate counting and identification, biocompatibility testing and animal facilities  He received his Bachelors and Masters degrees in Chemistry and Biochemistry from Colorado State University. He is certified from the Regulatory Affairs Professionals Society.

curriculum vitae