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 Garden State PharmaTech in 2014, 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.
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.
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.
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, Indian, 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.