We partner with clients to provide end-to-end CMC program management and functional area coordination to accomplish strategic and tactical milestones. We ensure our clients's success by providing integrated portfolio management delivered by talented experts and specialized laboratories designed around CMC drug development.
Yadan Chen, Founder and CEO, has more than 20 years of experience in New Chemical Entity (NCE) drug development. She is the founder and managing partner of Garden State PharmaTech, a pharmaceutical consultancy company based in New Jersey. Her areas of responsibility included overall scientific, regulatory CMC and quality consulting services, as well as business development & resource management.
Prior to founding Exemplify BioPharma in 2015, Yadan was a principal scientist at Merck and responsible for analytical development and CMC authorization from 1994 to 2014. Her work spanned API process development, analytical development, tech transfer, commercialization and market registration. During her 20-year tenure at Merck, Yadan has led the development and successful NDA/MAA filings of several novel drugs including a small molecule drug conjugate.
Yadan received her B.S. in Chemistry in 1987 from Peking University, Beijing, China and a M.S. in Analytical Chemistry in 1990 from New Jersey Institute of Technology, Newark, New Jersey.
Allen Ritter, Ph.D,
Dr. Allen Ritter, VP of Regulatory CMC, has more than 30 years of international drug development and chemical manufacturing experience. His experience in synthetic organic chemistry, strong problem solving skills and outstanding leadership skills have allowed him the opportunity to lead large and small teams to high levels of productivity and success through many complex challenges.
After receiving his M.S. in Organic Chemistry from Alan Kozikowski at University of Pittsburgh in 1984, Dr. Ritter spent five years in process development at the Upjohn company in Portage, Michigan. He then returned to graduate school to obtain his Ph.D. in Organic Chemistry under Marv Miller at the University of Notre Dame in 1992. He immediately started at Eli Lilly and Company in process development at Lilly’s Tippecanoe Laboratories in Lafayette, Indiana, and held leadership roles in Quality Assurance and Quality Control, in fermentation manufacturing.
In 2004, Dr. Ritter moved to Endocyte, Inc., as Director and then Vice President of CMC and Process and Method Development at Endocyte. He built and lead a team of process and analytical chemists in the definition, validation and outsourcing of the GMP manufacture of multiple APIs and drug products. Challenges in synthesis, characterization, handling, formulation and packaging for commercial sale were all successfully addressed to produce targeted, small molecule drug conjugates. Dr. Ritter's efforts were key to assuring drug supply for fast-track regulatory submissions for Endocyte’s lead compounds.
Paul Johnston, VP Quality Assurance, has over 25 years of QA oversight experience in Pharmaceutical API and Drug Product manufacturing, packaging, testing and distribution. His Audit and Regulatory Inspection experience spans US, Europe, Asia Pacific and Latin America. As Associate Director of R&D Commercialization Quality at Schering-Plough (S-P)/Merck, he was Process Owner for the following R&D audit programs: Internal Audits, Site Inspection Readiness, Hosting Regulatory Inspections, CMC Data traceability and accuracy, Contract Manufacturers and Laboratories qualification, Suppliers qualification, Clinical Depot sites qualification and Pre-Approval Inspections (PAI).
As the Internal Audit and Regulatory Inspection Process Owner, Paul was responsible for the verification of each R&D Quality Management System (21 total) cited under S-P’s Consent Decree. FDA Consent Decree was lifted in 2008. He was the QA Lead for the voluntary EU Health Authority inspection of S-P’s R&D clinical drug product manufacturing, packaging, testing and distribution facilities in New Jersey. EU certification was received in 2009.
Paul was the R&D QA Lead for PAIs, including Peg-Intron, Clarinex, Asmanex, Temodar, Zetia and Dulera. Since June 2011, he has been the Principal Consultant with PTJ Regulatory Compliance Audits LLC providing expertise to the Pharmaceutical industry.
Scott Reynolds, Ph.D.
Dr. Scott Reynolds has more than 30 years of experience in formulation, vaccine and chemical development in the pharmaceutical industry. Scott led groups responsible for a broad swath of the product development life cycle in support of programs ranging from early toxicology support, to all phases of clinical supplies, and through manufacturing plant start-up and inline product support. In his roles as Executive Director of Pharmaceutical R&D, VP Chemical Process Development and Commercialization, VP Pharmaceutical Commercialization Technology, and AVP Formulation Sciences at Merck, Scott directed multi-disciplinary groups of laboratory-based teams, and pilot plant operations staff, located at multiple sites in the US, Europe, and Puerto Rico. Under his direction these teams were responsible for early and late stage API programs, oral dosage formulations, and parenteral products for small molecules, peptides and vaccines.
Scott has extensive experience in API process development, design and development of solid oral and sterile/liquid products, and scale-up and technology transfer.
Scott received his BS in Chemical Engineering from Columbia University, and MS and PhD degrees, also in Chemical Engineering, from the University of Virginia. He is currently the founder and owner of SDR Pharma Consulting LLC providing consulting services to clients in the pharmaceutical and biotechnology industry.
Paul O'Shea, Ph.D.
Dr. Paul O’Shea, Founder and CSO, has more than 25 years of multidisciplinary experience in research and development in the pharmaceutical industry. Paul began his career at generic manufacturer SIFA Fine Chemicals and then joined Merck & Co. Inc. where he has held positions of increasing responsibility through the course of his career. Paul has served in leadership positions in Technical Operations at Merck Sharp & Dohme Ireland, as Director Process Research and Director Discovery Pharmaceutical Sciences at Merck Frosst Canada and as Senior Director Analytical Chemistry and Executive Director Process & Analytical Chemistry at Merck Research Laboratories in Rahway, NJ. Most recently Paul served as president of Shazer Innovative Solutions providing CMC consulting services to a number of clients in the Pharmaceutical and Biotech industries, including due diligences and technical assessments in support of licensing opportunities.
Paul has led the transition of a number of programs from late stage lead optimization through to FIH clinical studies, including the development of efficient synthetic strategies for analog synthesis in support of SAR, assessment of physiochemical properties, phase and form selection and the development of formulations to support preclinical in-vivo and toxicology studies.
Paul has expertise in leading drug substance process development from preclinical to commercial scale and has developed synthetic routes for more than 40 NCE’s from gram and kilogram to ton scale production. He has experience working with CRO’s and CMO’s based in US, Europe and Asia and API technology transfer from lab to pilot to manufacturing scale.
Paul earned both a BSc. and Ph.D. in Chemistry from University College Galway, Ireland and has coauthored 43 peer reviewed publications and 19 patents.
Regulatory CMC- EU
Jan-Jaap Scherpbier, VP of Regulatory Affairs, received his Pharm.D. from the University of Groningen in the Netherlands and his Master’s degree in Regulatory Affairs from the University of Wales in Cardiff.
From 1992 to 1999 he had roles with increasing responsibility in analytical and formulation development of generic drugs at Pharmachemie in the Netherlands. As Director of Pharmaceutical Development he was responsible for the development of formulations for tablets, capsules, soft-gel capsules, sterile preparations, the development of analytical methods and the execution of technology transfers.
His regulatory career started with Chiron in Amsterdam. From 2001 until 2003 he led a Regulatory Affairs team for Teva-Pharmachemie with global responsibility for submission and maintenance of generic medicinal product dossiers (including ANDAs). In 2003 he joined Organon (which merged with Schering-plough and Merck) as Director Global CMC Regulatory Affairs. His teams prepared CMC sections of NDAs/MAAs, INDs/IMPDs for the USA, EU and global drug registration and had responsibility for life cycle management of mature products. Regulatory compliance and change management were areas of focus.
Since 2013 he has provided consultancy services in regulatory affairs, drug development and compliance for start-ups and established pharmaceutical companies.
John Dillon, Ph.D
John Dillon is a pharmaceutical process R&D professional with 35 years experience in global leadership roles including a variety of executive positions at Bristol-Myers Squibb, Honeywell, Schering-Plough, Wyeth, Pﬁzer and, most recently, as CEO of Porton USA.
John was the Director of Chemical Development Labs at Bristol Myers Squibb where his team developed processes for several breakthrough therapies such as Taxol® (paclitaxel). At Schering-Plough he was responsible for the transfer of processes to international sites in Singapore and Ireland for both small molecules and biologics. He successfully led an API team under the Consent Decree. This work plan included the revalidation of all API processes at the facility in Puerto Rico.
John served as the Vice President of New Products Process Development at Wyeth Pharmaceuticals where he was responsible for building a global group to develop and commercialize new products from the Wyeth Pipeline based on the principles of Quality by Design (QbD). After the acquisition of Wyeth by Pﬁzer, he served as the Vice President of API Technology responsible for second gen process development including use of chemical, engineering and enzyme technology for API production.
As CEO of Porton USA, John was responsible for developing the global strategy for Porton Pharma Solutions. This included the leadership of M&A activities related to CDMO’S for API, Drug Product Manufacturing and Biologics. After building a Technology Center in Cranbury, NJ, he led the successful acquisition of J-STAR Research, a NJ based CRO handling all aspects of the Due Diligence including Legal and Finance.
John earned a B.S. from Syracuse University, and a Ph.D. in Organic Chemistry from SUNY Binghamton. Additionally, John served as Chairman of the prestigious Organic Reactions and Processes section of the Gordon Research Conference and received numerous awards including three Presidents Awards at Bristol-Myers Squibb. He holds over thirty patents and publications.
Nelu Grinberg, Ph.D.
Dr. Nelu Grinberg has had an eminent career in research chemistry in the pharmaceutical industry. An internationally known expert in analytical chemistry, with an emphasis on chromatography, spectroscopy, and chiral separations, he was a Distinguished Research Fellow in the Chemical Development Department at Boehringer Ingelheim Pharmaceuticals in Ridgefield, CT until January, 2017.
Prior to this, he worked for sixteen years in the Analytical Department at Merck Research Laboratories in Rahway, NJ, where he was a Senior Research Fellow. Dr. Grinberg has authored and co-authored over 140 publications, including articles and book chapters, and has lectured and conducted courses worldwide. He is currently Editor-in-Chief of the Journal of Liquid Chromatography and Related Techniques, Editor of the Chromatographic Science book series, and Co-editor of the Advances in Chromatography series. He is also a member of the Board of the Connecticut Separation Science Council and was a recipient of a Koltoff Fellowship of the Hebrew University of Jerusalem.
Dr. Grinberg obtained his Ph.D. in Chemistry from the Technical University of lasi in Romania. He conducted postdoctoral research with Professor Barry Karger at Northeastern University in Boston, Massachusetts, and with Professor Emanuel Gil-Av at The Weizmann Institute of Science in Rehovot, Israel.
Alexander Korotkov, Ph.D.
Senior Process Chemist
Noam Saper, Ph.D.
Senior Process Chemist
Lars Nordstroem, Ph.D.
Senior Process Chemist
Research Chemist, Analytical Chemistry
Pharm Sci Intern
Sean McCarthy, Ph.D.
Senior Process Chemist
Matt Bauerle, Ph.D.
Group Leader, Analytical Chemistry
Research Chemist, Analytical Chemistry