Our Team
- Management Team
- Quality
- Regulatory
- Formulation Development
- Chemistry Development
- Biological Development
- Manufacturing & Supply Chain Management
- Life Science Legal Services
- Analytical Chemistry
- International Sourcing & Business Development
- Strategic Market Research and Intelligence
- Software Development
- Business Development and Business Strategy
- Devices & Diagnostics
Management Team
ANN P. KICH
Ms. Kich has been with Rondaxe Pharma since its inception in 2003 and leads our Finance and HR functions. Ann provides our clients support in the areas of chemical and fermentation manufacturing operations, process engineering, facility evaluations, supply chain development, CoGS projections and supply contract negotiations. Prior to joining Rondaxe, Ms. Kich was an executive at Bristol-Myers Squibb where her 20 year career started as a process development engineer at Bristol-Myers. Through her tenure at BMS, Ann held increasingly responsible positions in manufacturing technical support, environmental, and plant engineering. As an executive at BMS, Ann was the leader of Global Manufacturing Network and Supply Chain Planning organizations incorporating a “cradle to grave” strategy for manufactured products. Ann earned her BSc. in Chemical Engineering at the University of Maine.
KENTON SHULTIS
Mr. Shultis joined Rondaxe in 2008 and is responsible for our Software Development group. 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.
Quality
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.
WILLIAM WINTER, Ph.D.
Dr. Winter became affiliated with Rondaxe in early 2009. Prior to becoming a consultant on quality assurance and systems issues for our clients, Bill was with Bristol-Myers Squibb for a total of 26 years. His most recent position was as Vice President/Senior Director, Analytical Development in New Brunswick, NJ, where he led that organization for seven years. There he established a new Global Analytical Development organization and oversaw the timely and effective completion of approximately 250 analytical transfers to QC labs each year. Prior to that, Bill progressed from Senior Director, Chemical Development, to Vice President, Bulk QA and Worldwide QC. Bill earned his Ph.D. in Organic Chemistry at The Ohio State University, and was a postdoctoral research fellow at Texas Christian University. He received his B.A. in Chemistry with honors from the State University of New York at Potsdam.
PEDRO HERNANDEZ ABAD Ph.D..
Dr. Hernandez Abad became affiliated with Rondaxe in 2011. Pedro is a well-known thought leader in Quality by Design (QbD) and Process Analytical Technology (PAT) with practical, real world experience in the implementation of these important tools to reduce risk and improve efficiency in pharmaceutical manufacturing. Dr. Hernandez’s experience in relations with regulatory bodies, drug substance and drug product manufacture, problem-solving, process chemistry, and medicinal chemistry gives him a unique perspective and valuable set of skills for Rondaxe clients. Most recently, Pedro has held senior development and quality positions at Pfizer, Wyeth and AMRI. Pedro received his BSc, Chemistry from the University of Puerto Rico. He received his PhD from the University of Pennsylvania in Philadelphia and postdoctoral studies at the University of Oxford in the United Kingdom.
ADBELLAH SENTISSI, Ph.D.
Dr. Sentissi joined Rondaxe’s senior advisor team in 2010. Abdellah is a chemist, pharmacist and biologist with 25 years experience in creating and managing quality control laboratories and quality assurance systems for biotechnology companies. Abdellah has worked in a number of senior quality roles in such companies as Massachusetts Biological Laboratories, Endocon, GenVec, Biovest International Inc. and Transmolecular Inc. Additionally he has provided GxP consulting services to Tokai Pharmaceuticals and Anterion, Inc.. Abdellah graduated with Bachelor of Science from University Paul Sabatier in Toulouse, France. He received a Masters from UC-SF in San Francisco, CA and a Ph.D. from Northeastern University in Boston, MA. In addition, Abdellah has nine years experience as a lecturer at Northeastern University School of Pharmacy.
KURT STROBEL PH.D.
Dr. Strobel became associated with Rondaxe in 2008. Kurt has strong technical and business qualifications with an impressive track record of more than 32 years of hands-on experience in health care systems manufacturing and quality operations, regulatory systems and supply chain strategies. He has proven leadership, analytical, design and problem solving skills. Kurt career began as Director of Quality Operations and Quality Control at Pfizer responsible for quality of raw materials, intermediates and finished goods produced for the US. He has experience in DMF documentation, cGMP, process validation, systems validation and FDA inspections. He was Qualified Person (QP) responsible for Quality Operations, Quality Assurance Management, implementation of Quality system (ISO 9001, EEC 43/92). He has directed Quality and/or Manufacturing Operations at Dentsply GmbH, Phyton GmbH and Madaus AG where he was responsible for a pharmaceutical operation handling liquid, semi-solid and solid dosage forms. Kurt received his Ph.D. in Organic Chemistry from the Technical University in Darmstadt, Germany.
Regulatory
WILLIAM REGAN
Mr. Regan joined Rondaxe’s senior advisor team in 2009. He has been sharing his unique skills and experiences with the life sciences industry as a consultant since 2006. Prior to that he had worked within the industry for over 20 years, most recently with Bristol-Myers Squibb, where he was Head (VP) of Global Regulatory Affairs, Medical Imaging. During his 15 years there Bill also had responsibility at various times for regulatory due diligence associated with M&A activities, for implementing major synthetic changes, and consolidating CMC regulatory functions for 25+ global facilities after the Bristol-Myers and Squibb merger. Bill received his B.A. in Chemistry from Rutgers University, has a Resource Manager Certification from and is a graduate of Tufts University Program for Pharmaceutical Development.
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.
MICHAEL BURNETT
Mr. Burnett has been affiliated with Rondaxe since 2007. He has extensive CMC Regulatory Sciences experience with US and international government agencies. Mike began his career with Upjohn as an analyst. Since then he has moved through increasingly responsible roles in Quality Assurance and Regulatory Affairs. He was director of Product Registration and Development at Bristol-Myers Pharmaceutical Group in Canada responsible for formulation development, registration systems, new drug submissions, pre-clinical submissions . Mike was Director of CMC Global Regulatory Sciences for BMS based in NJ where he filed, negotiated and obtained approval for new chemical entities in multiple global markets. He submitted over 20 NDAs, clinical trial applications, supplemental NDAs, MAAs and annual reports. He organized and conducted multiple meetings with the FDA and EMEA. He has developed programs and systems to ensure compliance and coordinate global registration efforts. Mike received his B.Sc. in Pharmacy from the University of Toronto.
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.
SANDRA SIMS, PH. D.
Dr. Sims began working with Rondaxe in 2007 as a Sr. Advisor for formulation development and project management. Most recently Sandi was in charge of solid oral dosage form development, supply chain and all CMC activities for multiple IND’s at Meditrina Pharma. Prior to that, she spent 16 years with Pfizer, Inc. in roles of increasing responsibility in formulation development. She led the formulation development for Zyvox IV from discovery, pre-clinical and clinical development through registration and commercial launch. Sandi also held positions as Team Leader and Associate Director for groups responsible for formulation development of sterile, oral solid, ophthalmic and topical products, as well as leading Pfizer’s veterinary products group. Sandi received her B.S. in Pharmacy from West Virginia University and her Ph.D. in Pharmaceutics from the University of Utah.
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.
Chemistry 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.
BRIAN JAMES, Ph.D., M.B.A.
Dr. James joined Rondaxe as Director, CMC Strategic Development, in 2006. Brian provides project management, API synthesis design and API/formulation sourcing support to our clients. He manages 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.
CHRIS WILLIAMSON
Chris Williamson began working with Rondaxe in 2010. Chris has over 35 years of experience in drug discovery, development and sourcing with GlaxoSmithKline. Chris began his career as a research chemist with Glaxo before moving into chemical development roles including commissioning and validation of commercial processes. For over ten years, Chris was the Technical Director responsible for outsourcing, third party contract manufacturing, and technology transfer for the API supply division in GSK while based at the Dartford facility. Chris brings a vast amount of experience in the industry in the area of Technical Development, Technology Transfer, API sourcing, cGMP manufacturing, Due Diligence, Quality, Regulatory Affairs and In-licensing. He is the co-inventor of several patents and has authored papers and lectured internationally. Chris received his BA (Hons) in Chemistry from York University and is an FRSC (Fellow of the Royal Society of Chemistry) in the United Kingdom.
DAVID BURDICK PH.D.
David Burdick joined Rondaxe as an advisor in 2011. Dave has an accomplished career in chemical development and leadership. He began his career with Hoffman-La Roche as a development scientist and group leader. Through roles at Roche in the US and Switzerland, Dave had led teams charged with product development, process research, technology transfer and optimization and cost reduction. At AMRI Dave was the section head for generics and chemical development. In this role, he led and implemented projects for over 200 projects, developing innovative solutions, transferring technology including for Schedule II and high potency drugs. He has created IP leading to seven patent claims. David received his B.Sc. in Chemistry from University of Illinois, Champaign-Urbana and his Ph.D. in Organic Chemistry from the University of Michigan in Ann Arbor, MI.
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).
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.
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.
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.
JOAN CONNOLLY
Ms. Connolly began working with Rondaxe in 2011. Joan has an extensive background in Strategy, Sourcing/ Procurement, Process Development & Commercialization and Supply Chain Management roles at ImClone Systems and at Bristol-Myers Squibb. Starting her career as a Process Development Engineer at BMS, Joan has worked as a manager, and then director in the Strategic Sourcing group implementing strategies to align sourcing systems across the organization, managing relationships with suppliers, partnering with development & manufacturing divisions, strengthening intellectual property protection practices for sourcing activities, supporting supply chain optimization re-design initiative and manufacturing network capacity optimization projects. Joan was the launch team leader for ERBITUX, overseeing manufacturing planning and production, PAI readiness, label art approval and delivery, drug product manufacture and distribution to market on approval, achieving product commercialization ahead of the corporate objective. She joined ImClone Systems in 2006 where she worked as a director of contract manufacturing before becoming an associate VP of Strategy & Operations and later of Clinical Supply & Logistics. In her roles at ImClone, Joan managed CMO partner relationships, managed pipeline supply/demand planning, supported Strategic Planning capacity/capability assessments, supported due diligence for M&A activity. She led corporate strategy and priority reviews, co-led corporate integration team on the acquisition by Eli Lilly, managed drug product manufacture, packaging and distribution, worked to build alignment within the organization to deliver demand driven S&OP. She has extensive knowledge in regulatory requirements for GxP manufacturing for small molecules and biologics. Joan graduated with honors from Queen’s University, Kingston, ON with a B.Sc. in Engineering/Chemistry. In 2011, Joan was the Sr. VP and Dinner Chair for the DCAT Association Executive Committee.
Manufacturing & Supply Chain Management
BRENDAN CAREY
Mr. Carey joined Rondaxe in 2008 as Director, Process/Product Development. Brendan provides our clients project management expertise and supports our Software Development group for implementation and training. He has nearly 20 years of pharmaceutical manufacturing experience in Ireland, the UK and the US. His positions with Swords Laboratories, Church and Dwight, and Bristol-Myers Squibb have allowed him to become an expert in all facets of API and formulation manufacturing operations, including process engineering, supply chain management, project management, SAP implementation, contract manufacturing and software development. Brendan is a graduate of University College (B.S., Chemical Engineering) and Trinity College (Post Graduate Diploma, Computer Science), both in Dublin, Ireland.
ROGER CASSIDY
Roger Cassidy began working with Rondaxe in 2011. Roger has an extensive background in Procurement and Supply Chain Management roles at GlaxoSmithKline. Starting as an engineering buyer, Roger has held increasing responsible roles as a Purchasing Executive, Procurement Manager, World Wide Procurement Leader, Sourcing Group Director /Contract Manufacturing and Director of Outsourcing/Production/Procurement. Roger has worked in an international environment with responsibility for managing supply quality and auditing, change management, KPI analysis and reporting, global procurement design, product lifecycle strategy design and implementation, business improvement, supplier relationship management, MRP and SAP implantation projects, commercial negotiation, lead time improvement, contract negotiation, e-sourcing strategy, product transitions, plant shutdowns and outsourcing implementations. He has extensive experience in emerging markets and has strong management skills across all levels of the business. Roger graduated with Honors from the University of London with a B.Sc. in Environmental Sciences. He is a member of the Institute of Purchasing and Supply in the UK.
GARY NELSON
Mr. Nelson 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.
JOAN CONNOLLY
Ms. Connolly began working with Rondaxe in 2011. Joan has an extensive background in Strategy, Sourcing/ Procurement, Process Development & Commercialization and Supply Chain Management roles at ImClone Systems and at Bristol-Myers Squibb. Starting her career as a Process Development Engineer at BMS, Joan has worked as a manager, and then director in the Strategic Sourcing group implementing strategies to align sourcing systems across the organization, managing relationships with suppliers, partnering with development & manufacturing divisions, strengthening intellectual property protection practices for sourcing activities, supporting supply chain optimization re-design initiative and manufacturing network capacity optimization projects. Joan was the launch team leader for ERBITUX, overseeing manufacturing planning and production, PAI readiness, label art approval and delivery, drug product manufacture and distribution to market on approval, achieving product commercialization ahead of the corporate objective. She joined ImClone Systems in 2006 where she worked as a director of contract manufacturing before becoming an associate VP of Strategy & Operations and later of Clinical Supply & Logistics. In her roles at ImClone, Joan managed CMO partner relationships, managed pipeline supply/demand planning, supported Strategic Planning capacity/capability assessments, supported due diligence for M&A activity. She led corporate strategy and priority reviews, co-led corporate integration team on the acquisition by Eli Lilly, managed drug product manufacture, packaging and distribution, worked to build alignment within the organization to deliver demand driven S&OP. She has extensive knowledge in regulatory requirements for GxP manufacturing for small molecules and biologics. Joan graduated with honors from Queen’s University, Kingston, ON with a B.Sc. in Engineering/Chemistry. In 2011, Joan was the Sr. VP and Dinner Chair for the DCAT Association Executive Committee.
Life Science Legal Services
DAVID REED, J.D.
Mr. Reed became affiliated with Rondaxe in early 2009, after nearly 20 years of providing international legal services to life sciences companies. As in-house counsel for Bayer, ImClone, Osteotech and Bristol-Myers Squibb, Dave advised their international operations on all manner of compliance and contracting issues associated with pharmaceutical and medical device manufacturing. In his career he has been lead counsel for an international audit and procurement
departments; he has also led multi-disciplinary teams focused on licensing, product life cycle and governmental enforcement. While in private practice, Dave’s clients have included Pfizer, J&J and Boehringer-Ingelheim. Dave earned his B.A. at Dartmouth College and received his Juris Doctorate from Syracuse University. He is admitted to practice law in the states of Florida, Massachusetts and New York, as well as in the Northern District of New York
(U.S. Second Circuit) and in the Court of Appeals (U.S. First Circuit).
Analytical Chemistry
DANIEL CARNEY Ph.D.
Dr. Carney has been associated with Rondaxe since 2007. Dan has over thirty years’ experience in industry and academia covering all phases of pharmaceutical research and development, including discovery compound evaluation, drug substance form selection, pre-formulation & formulation development, technology transfer, and formal stability studies for small molecules, peptides and proteins. Dan has held senior roles at Bristol-Myers Squibb Analytical R&D managing analytical teams and overseeing development projects from pre-Phase I through post launch. He brings a wide range of experience collaborating with other development activities such as drug safety, quality control and quality assurance. Dan received his B.S. in Biological Sciences from Northern Illinois University and his Ph.D. in Analytical Chemistry from Southern Illinois University.
JOHN WOOLEVER
Mr. Woolever is a senior level expert, with over thirty years’ experience in pharmaceutical analytical development and establishing specifications for both small and large molecules. He has focused on for new chemical entities, including preparation and participation in regulatory filings from starting materials, intermediates, APIs, formulations and drug products (DPs). John began his career as a research scientist at FMC Corporation and Bristol-Myers. He grew to lead the Quality Assurance group with responsibility for GMP and GLP analysis, analytical technique development (NMR, Mass Spec.), IND & NDA filing, chromatography, bio-analytics, release of clinical supplies and auditing activities. John led the Separation Sciences group and was chairman of the Specification Committee with responsibility for reviewing, revising, and approving specifications for all raw materials, intermediates, drug substances, and finished products used in clinical trials and FDA filings. John received his MS (Organic Chemistry) from SUNY and a B. S. in Chemistry from Rochester Institute of Technology.
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.
International Sourcing & Business Development
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
WILHELM STAHL, Ph.D.
In 2009 Dr. Stahl became President, Rondaxe Deutschland, OHG, with responsibilities for Sales and Marketing Operations for all Rondaxe entities. Beyond his internal responsibilities, Willie also helps Rondaxe clients with market and product viability assessments, strategic operations evaluations and international supply chain development. Dr. Stahl began his career as a scientist with Hoechst AG in Germany in 1991. Starting in medicinal chemistry, he became a group leader in Natural Product Screening and advanced to the Head of Global Screening after the company became HMR (and finally Aventis). He later joined Bayer AG, where he headed up a Medicinal Chemistry Department and moved on to become Head of Life Sciences at Bayer’s Central Research Units. In his most recent positions Willi was responsible for R&D/Marketing at Lanxess’ Fine Chemicals business unit and subsequently became Head of Saltigo’s Pharma Custom Manufacturing business. Willi earned both his undergraduate and Ph.D. degrees from the Institute for Organic Chemistry and Biochemistry at the University of Bonn, in Germany, and did his post-doctoral work with Prof. K.C. Nicolaou at the Research Institute of Scripps Clinic, Department of Chemistry, La Jolla, CA. Additional Languages: German.
Strategic Market Research and Intelligence
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.
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.
ALLAN SHAW, CPA
Mr. Shaw first became associated with Rondaxe in 2008, working on Rondaxe Licensing and Financing efforts. He has been a member of Navios’ board of directors since 2005 and has over 20 years of financial management experience. Allan is the Founder and Senior Managing Director of Shaw Strategic Capital LLC, an international financial advisory firm currently serving as a strategic advisor to an International bank (in NYC). Prior to that he was the Chief Financial Officer and Executive Management Board Member at Serono International S.A., the then-third largest biotechnology company in the world. Allan has also been CFO and Director for Viatel Inc., an international telecommunications company, and a manager with Deloitte & Touche. He has structured, directed, negotiated and closed over $4 billion in public and private financings. Allan is a CPA and received his BSc. from the State University of New York at Oswego.
Software Development
DANIEL MOSS
Mr. Moss started as Lead Application Developer with Rondaxe in 2008 and was recently promoted to Director of Software Development, based in the Clifton Park, NY office. Dan has been developing software for nearly a decade, focusing on the integration of computer technologies into client projects. His past projects included the development of the FDNY and NYPD electronic command board management system for Emergency Response. Dan has a B.A. from Bennington College and a Masters in Professional Studies from NYU.
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.
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.
DAVID REED, J.D.
Mr. Reed became affiliated with Rondaxe in early 2009, after nearly 20 years of providing international legal services to life sciences companies. As in-house counsel for Bayer, ImClone, Osteotech and Bristol-Myers Squibb, Dave advised their international operations on all manner of compliance and contracting issues associated with pharmaceutical and medical device manufacturing. In his career he has been lead counsel for an international audit and procurement departments; he has also led multi-disciplinary teams focused on licensing, product life cycle and governmental enforcement. While in private practice, Dave’s clients have included Pfizer, J&J and Boehringer-Ingelheim. Dave earned his B.A. at Dartmouth College and received his Juris Doctorate from Syracuse University. He is admitted to practice law in the states of Florida, Massachusetts and New York, as well as in the Northern District of New York (U.S. Second Circuit) and in the Court of Appeals (U.S. First Circuit).
ALLAN SHAW, CPA
Mr. Shaw first became associated with Rondaxe in 2008, working on Rondaxe Licensing and Financing efforts. He has been a member of Navios’ board of directors since 2005 and has over 20 years of financial management experience. Allan is the Founder and Senior Managing Director of Shaw Strategic Capital LLC, an international financial advisory firm currently serving as a strategic advisor to an International bank (in NYC). Prior to that he was the Chief Financial Officer and Executive Management Board Member at Serono International S.A., the then-third largest biotechnology company in the world. Allan has also been CFO and Director for Viatel Inc., an international telecommunications company, and a manager with Deloitte & Touche. He has structured, directed, negotiated and closed over $4 billion in public and private financings. Allan is a CPA and received his BSc. from the State University of New York at Oswego.
JAMES BERGEY, PH.D.
Mr. Bergey first became associated with Rondaxe in 2009, working on Rondaxe Licensing and Business Development efforts. Jim was an assistant vice president of alliance management and licensing at Wyeth Pharmaceuticals where he was responsible for key alliances such as Elan and Nycomed. Prior to that, he held senior vice president responsibilities at Locus Pharmaceuticals, Neopharm Inc., Inkine Pharm Co. and Bristol-Myers Squibb. Jim holds a Ph.D. in Pharmacology from Temple University School of Medicine after receiving his B.S., Biology and Chemistry, from Temple University College of Education.
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.
Device & Diagnostics
MANA SHIRAZI-KIA.
Mana Shirazi-Kia began working with Rondaxe in 2011 as a Sr. Advisor in the area of devices and diagnostics. Mana has over ten years of experience in quality assurance and process improvement in the biotech industry. She has worked in various engineering roles (validation, manufacturing and development) dealing with all aspects of sampling, inspection, operations, data analysis, quality management and validation. More recently, she has worked at Angiotech Pharmaceuticals working on Quality Systems design implementation and training. At Alpha Technologies, Mana has supported the Quality & CAPA systems and led Internal Audit team. engineer and quality assurance engineer Mana received her Bachelor of Applied Sciences in Mechanical Engineering from the University of British Columbia in Vancouver, Canada.
VIJAYA K. SURAPANENI.
Vijaya Surapaneni joined Rondaxe as an advisor in 2012. Vijay has an accomplished career of leadership experience in Pharmaceutical and Medical Technology Operations. He began his career as a Safety and Environmental Engineer with Parke-Davis/Warner Lambert. Vijay joined Bristol-Myers Squibb in 1989 where he worked as in Safety, Technology Transfer and Continuous Innovation before taking responsibility for Manufacturing Strategy & Planning for the API manufacturing network. In 2003, Vijay was appointed General Manager of a new greenfield $500 M bulk pharmaceutical manufacturing facility in Ireland with responsibility for commissioning, qualification and startup. As Vice-President of Manufacturing at ConvaTec since 2007, Vijay led plants in Australia, Malaysia, Mexico, Dominican Republic and USA responsible for innovative medical technologies. Vijay received his B.Sc. in Chemical Engineering from Manipal Institute of Technology in India and his MS in Chemical Engineering from Michigan State University in E. Lansing, MI.
WILLIAM REGAN
Mr. Regan joined Rondaxe’s senior advisor team in 2009. He has been sharing his unique skills and experiences with the life sciences industry as a consultant since 2006. Prior to that he had worked within the industry for over 20 years, most recently with Bristol-Myers Squibb, where he was Head (VP) of Global Regulatory Affairs, Medical Imaging. During his 15 years there Bill also had responsibility at various times for regulatory due diligence associated with M&A activities, for implementing major synthetic changes, and consolidating CMC regulatory functions for 25+ global facilities after the Bristol-Myers and Squibb merger. Bill received his B.A. in Chemistry from Rutgers University, has a Resource Manager Certification from and is a graduate of Tufts University Program for Pharmaceutical Development.