Marcel Schreuder Goedheijt is an expert in Active Pharmaceutical Ingredients and currently works as Independent Consultant (since 2015). Previously, he served as General Manager Cambridge Major Laboratories Europe, a company that provides advanced chemistry services to the worlds leading pharmaceutical and biotechnology companies and specializes in API Manufacturing, Pharmaceutical Development, Process Development, Organic Chemistry (2013-2014). Prior to this, he served as R&D director at DSM. In his role at DSM, he was heading the API business (2011-2013). Before this, he worked as Director Process Chemistry at Merck Sharp&Dohme (2007-2011). In his role at MSD, he was leading the process chemistry department (50 fte's) which is responsible for the early development and timely supply of NCE's (new chemical entities) for pre-clinical activities and clinical phase 1/2a studies and the transfer to late stage development/commercialization including radiolabels for pre-clinical/clinical activities. Prior to this, he was associated with Organon API manufacturing company Diosynth. He holds a PhD degree from the Free University Amsterdam and has expertise in APIs, Organic Chemistry, Research & Development, cGMP, Quality etc.
Dr. Tony Cundell works as an independent consulting microbiologist supporting the pharmaceutical industry, suppliers of microbiological testing equipment and contract testing laboratories. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist, Analytical Sciences - Microbiology in early phase drug development.
In this role he advised product development teams on microbiological issues related to formulation, process development, specification settings and product testing, and consulted on CMC sections, responses to regulatory filings and external inspections. Also he was a Senior Technical Advisor to the Merck Manufacturing Division Microbiology Center for Excellence working on the implementation of state-of-the-art regional microbial identification centers, the validation of alternate microbiological test methods and investigating microbial contamination incidents.
Dr. George Wong, Ph.D.: Former Sr. Research Fellow, Process Chemistry, Schering-Plough/Merck. George has more than 25 years experience in managing drug substance process development and related CMC issues, from early phase through commercialization, technology transfer and process validation. He is experienced in authoring IND, NDA, MAA sections relating to drug substance manufacturing, authoring Registration Starting Material dossier, and responses to questions from Health Authorities.
He also has extensive experience working with Contract Manufacturer Organizations (CMO) based in US, Europe, China and India. He has authored book chapters, publications and patents. He is fluent in Chinese (Cantonese and Mandarin dialects). He has several awards, including the prestigious President's Award (Schering-Plough) in recognition of his contribution towards the commercial launch of Victrelis.
Dr. Pius Tse has over 30 years of professional experience in the pharmaceutical, biomedical device and food ingredients industries. In his most recent role, Pius was the Director of Engineering at Merck with 17+ years of experience in pharmaceutical drug product development and technical services. With hands-on experience, he has provided technical and strategic leadership in overseeing the QbD development, technical transfer, optimization and regulatory filing of numerous pharmaceutical drug products.
Dr. Tse has been responsible for the innovative development, implementation and improvement of drug products and their manufacturing processes from first-in-human to market launch to troubleshooting of commercial manufacturing processes. He has conducted numerous due diligences of various pharmaceutical business opportunities and has extensive experiences in various dosage forms including solid, liquid, parenteral and inhalation products. He has also led efforts in the evaluation and development of PAT and continuous manufacturing.
Dr. Tse received his Ph.D. in Engineering Sciences from University of California, San Diego and his B.A in Applied Physics and Engineering Sciences from Harvard University.
Rainer Newman has an M.S in radiation science with 40 years of experience in sterile medical products manufacturing, engineering, sterilization, aseptic processing and compliance. His professional career included 26 years with Bristol-Myers-Squibb and 10 years with Johnson & Johnson. He also has been a Principal Consultant with PA Consulting Group. Currently he is an independent expert providing aseptic processing and terminal sterilization consulting and training services to pharmaceutical and medical device organizations.
As a Principal Consultant with PA Consulting, he provided both technical and management leadership for sterile product projects. In this role he was active in the conduct of due diligence and technical assessments. Currently Rainer serves on the USP Expert Committee for Microbiology, conducts aseptic processing training for PDA and is active in PDA technical report activities such as PUPSIT and CCIT.
John Curran has spent his entire 33 year career at Merck, starting in an analytical Quality Control/Methods Development laboratory and progressing through the organization the position as Distinguished Scientist in the Pharmaceutical CMC organization. John was an active member of the PhRMA ICH Q11 LDKIT, and represented Merck on the PhRMA API Working Group for three years. He has authored regulatory chapters for the first and second editions of the text, Active Pharmaceutical Ingredients.
Within Merck, John has contributed to strategy and preparation of numerous regulatory submissions covering the full product lifecycle from investigational applications to marketing applications and post approval supplements/variations. He was an active member of the Merck QbD Realization Team and has lead two cross functional development programs.
API Process and Safety
Dr. Guy Gloor has more than 25 years experience in the development and scale-up of fine chemicals and small molecule API. His area of expertise is focused on the interface between laboratory and industrially practicable processes for fine chemical synthesis in a GMP environment.
Dr. Gloor was a member of the design team for Schering-Plough’s Clinical Bulk Supply Facility in Union, NJ, after which led the validation effort and was its first plant manager. He held positions of increasing responsibility in Chemical Development at Schering including Director of Plant Operations and Director of Early Development Engineering and Process Safety. Dr. Gloor is currently a principal of Chesilton LLC as well as an adjunct professor of Chemical Engineering at the New Jersey Institute of Technology.
Regulatory Affair CMC
Paul Johnston 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 (23 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, Dulera. Since June 2011, he has been the Principal Consultant with PTJ Regulatory Compliance Audits LLC providing expertise to the Pharmaceutical industry as an independent Process Owner chartered with implementing the Audits and Inspections and Documentation Control processes cited under a Consent Decree.
QC, QA, Audits and Inspections
Mireille Gerrits is a clinical pharmacology specialist with a strong scientific background in clinical drug development. Before starting her consultancy career in 2015 she was a Director Clinical Pharmacology for Merck in Oss. She joined Merck in 2009 through a merger with Organon/Schering Plough where she worked as Clinical Pharmacology Research Manager since 2005. She worked on different therapeutic areas, amongst others Women’s Health, CNS, pain and immunology and contributed to several regulatory filings. Prior to joining Organon in 2005 Mireille worked for a phase I CRO for almost 12 years, were she held several different positions including study pharmacist, medical writer, study coordinator, project manager and head of the quality management department (responsible for GCP/GLP/GMP).
Mireille’s expertise is focused on designing clinical pharmacology programs which includes clinical programs for new drugs (first in human) as well as studies for new formulations (bioavailability, bio-equivalence) or studies for different populations (ethnic sensitivity). She is also an experienced medical writer and has authored many clinical study documents and regulatory submission documents.
Mireille holds a Master’s degree in Pharmacy and a PharmD from the Utrecht University in the Netherlands and is a certified Clinical Pharmacologist trained at the University of Nijmegen in the Netherlands.
Dr. Allen Ritter Dr. Ritter 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.
Chemistry, fast track regulatory submission and small molecule conjugate