- Management Team
- Quality Assurance
- Formulation Development
- Manufacturing & Supply Chain Management
- Chemistry Development
- Business Development and Business Strategy
- Biological Development
- Strategic Market Research and Intelligence
- Software Development
- International Sourcing & Business Development
- Regulatory
- Device & Diagnostics
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.
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.
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
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.
Roger Brown
Rodger has been working with Rondaxe since 2015. He has been a senior manager of Regulatory Affairs and Quality Assurance in a number of companies, most recently Navidea Biopharmaceuticals where as Vice President of Global Quality Systems and Compliance Policies, he was instrumental in advancing their radiopharmaceutical through the approval process. Rodger is an expert in compliance for devices and parenteral pharmaceuticals and is experienced at establishing robust Quality Systems. Rodger received extensive training in electrical engineering and quality assurance from the University of Oklahoma, the University of Colorado, and the University of Alaska while serving in the U.S. Army.
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.
Kurl 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.
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.
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.
Hass Patel
Dr. Patel has been associated with Rondaxe since 2012. Hass has an extensive background as a Pharmaceutical R&D Director with expertise in chemistry, manufacturing, and controls (CMC) development and regulatory strategies for small molecules including oral solids, liquids and sterile products. His wide experience spans site/tech-transfers, scale-up, clinical and commercial manufacturing, pharmacokinetics, pharmaceutical development, analytical development, and pharmacokinetics. Hass is familiar with ICH, cGMP and FDA guidances. Hass has a Ph.D. in Pharmaceutical Science, University of Bath as well as a Post-doc, Pharmaceutical Chemistry from the University of Kansas. He holds an M.S. in Pharmaceutics & Pharmaceutical Technology in addition to a B.S. in Pharmacy.
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.
Manufacturing & Supply Chain Management
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.
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.
Dix Waever
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 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.
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.
Brian Austad Ph.D.
Dr. Austad has been associated with Rondaxe since 2012. Brian is a senior scientific leader with 14+ years of pharmaceutical research and development experience, specializing in process chemistry with a focus on developing novel medicines for unmet needs. He has extensive experience in natural product synthesis and natural product derivatives; complex chemistry; and optimizing API synthetic routes and manufacturing conditions in support of IND applications, clinical trials, and process validation. Brian was director of Process Chemistry at Infinity Pharmaceuticals where he established and built a highly effective process chemistry group responsible for the API development and manufacture of all Infinity clinical programs. He previously worked at Eisai Research Institute as a scientist and project leader where he was a core contributor the development and manufacture of Halavan®, a fully synthetic derivative of the highly complex marine natural product Halichondrin B. He received his B.S. degree in Chemistry from University of Wisconsin – Eau Claire and his Ph.D. in Synthetic Organic Chemistry from the University of Wisconsin – Madison with Prof. Steven D. Burke.
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.
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.
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.
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.
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.
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 is Director of Software Development. Dan is responsible for the design and implementation of all Rondaxe Software products and head of software operations. He has been involved in the design, development, maintenance and testing of software for over 20 years. He had his own multimedia company doing projects for such companies as Oxygen TV, New Yorker Magazine, TV Guide, and the Sci Fi Channel. Dan spent many years working with the top software producers in the industry, including 4 years spent working for the NYU Media Research Lab on such projects as the development of the FDNY electronic command board management system for Emergency Response. Dan has a B.A. from Bennington College and a Masters in Professional Studies from NYU.
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.
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.
Regulatory
Elizabeth A. Yamashita
Elizabeth Yamashita is an experienced Regulatory Affairs consultant with significant industry experience. Liz started her career in pharmaceutical research with Bristol-Myers Squibb, and went on to join the Worldwide Regulatory Affairs team focusing on initiation of clinical trials and new product registrations. She supported annual updates and development activities for projects in the anti-infective, oncology and biotechnology areas from project initiation through registration approval. Later, she managed a large team of regulatory professionals supporting global regulatory activities, strategies, and submissions. At ImClone Systems (later Eli Lilly), Liz led the regulatory organization for CMC Strategy, Operations and Logistics for monoclonal antibodies. Most recently, she has provided strategic leadership at Savient Pharmaceuticals for CMC and Clinical activities and led all regulatory interactions with Health Authorities. Liz received her B.S. Chemistry from the University of Rochester and received her Regulatory Affairs Certification in 2002.
Roger Brown
Rodger has been working with Rondaxe since 2015. He has been a senior manager of Regulatory Affairs and Quality Assurance in a number of companies, most recently Navidea Biopharmaceuticals where as Vice President of Global Quality Systems and Compliance Policies, he was instrumental in advancing their radiopharmaceutical through the approval process. Rodger is an expert in compliance for devices and parenteral pharmaceuticals and is experienced at establishing robust Quality Systems. Rodger received extensive training in electrical engineering and quality assurance from the University of Oklahoma, the University of Colorado, and the University of Alaska while serving in the U.S. Army.
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.
Sharon Real, Ph.D.
Dr. Real has worked with Rondaxe since 2012. She has more than 20 years’ experience in the pharmaceutical industry. Sharon is a CMC regulatory affairs expert for early stage mammalian cell products. She started her career in pharmaceutical research with Bristol-Myers Squibb, and went on to CMC regulatory affairs with Aguron Pharmaceuticals and later with Pfizer, where she received a Pfizer Achievement Award. Sharon led the manufacturing, sourcing, and CMC regulatory teams at Tracon Pharmaceuticals for both monoclonal antibodies and small molecules. Sharon holds B.S. in Chemistry from Stanford University and a Ph.D. in Chemistry from UCLA.
Devices & Diagnostics
Rodger Brown
Rodger has been working with Rondaxe since 2015. He has been a senior manager of Regulatory Affairs and Quality Assurance in a number of companies, most recently Navidea Biopharmaceuticals where as Vice President of Global Quality Systems and Compliance Policies, he was instrumental in advancing their radiopharmaceutical through the approval process. Rodger is an expert in compliance for devices and parenteral pharmaceuticals and is experienced at establishing robust Quality Systems. Rodger received extensive training in electrical engineering and quality assurance from the University of Oklahoma, the University of Colorado, and the University of Alaska while serving in the U.S. Army.