Choosing the right form and formulation is continuously evolving field. To stay at the cutting edge of this field internally and continuously educate the community externally, Crystal Pharmatech has gathered a panel of distinguished scientists from various disciplines to support our “Crystal Clear Pathways to Select API Form and Formulation”.
The panel serves to educate pharmaceutical companies on the importance of proper selection of API phase and formulation. This panel has combined to assess form and formulation for well over 1,000 development compounds. They’ve seen horror stories of silo’d development mindsets that try to skimp and save on CMC only to get burned very quickly. This panel will initially provide case studies and key learnings that ensure you make informed decisions on form and formulation in a webinar series.
To register for our upcoming Webinar Series (Starting - September 10, 2020), please click here:
Webinar Series on "Selecting the Right API Form and Formulation"
Crystal Clear Pathways to Select API Form and Formulation
Vetting of API forms and formulations for FIH studies is critical to maintain the integrity of downstream processes. Crystal Pharmatech makes best-in-class decisions utilizing a data-driven, multi-disciplinary, institutional knowledge approach based on comparative analysis. We rely on the key, basic, solid-state scientific principles of physical properties, solubility, stability, processability and isolation complexity needed to ensure the API phase and formulation are understood to a level of detail ensuring downstream processes are robust.
Virtual drug development companies often do not have the luxury of this institutionalized knowledge base in diverse, unique disciplines of process development, engineering, and formulation. That knowledge base combined with molecular level solid state understanding is the perfect formula for choosing the optimal form and formulation for FIH studies.
Key Principles of Crystal Standard Package:
Point of observation investigation
Assign confidence levels to phase assignment
Directed/tiered screening
Determine true phase purity
Understand structural anomalies
Decision matrix based on key input from multiple disciplines
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Joe Armstrong
Executive Vice President, Global Head of Research and Development, TCG GreenChem, Inc.
Education B.S., Math and Chemistry, History minor - Pfeiffer University - Ph.D., Synthetic Organic Chemistry - University of Colorado Boulder - Ph.D., Synthetic Organic Chemistry Postdoctoral studies – Total synthesis of monensin spiroketal - University of Virginia
Experience Executive Vice President, Global Head of Research and Development, TCG GreenChem, Inc. (2019 - Present)
Responsible for the development of green processes for the synthesis of raw materials and intermediates and API Lead scientists to invent and develop novel chemistries for drug substance synthetic routes and manufacturing processes
Executive Vice President, AstaTech, Inc., AstaGreen Chem., Inc. (2019) President, Pachamama LLC. (2018 - 2019) Executive Director, Process Chemistry, Merck & Co., Inc. (2011 - 2018)
Project Chemistry and Discovery Process Chemistry for all API deliveries from preclinical to Phase III Supported all transitions of potential small molecules and bio-conjugated molecules from Discovery Chemistry to Preclinical Candidate approvals
Senior Director, Process Chemistry, Merck & Co., Inc. (2007 - 2011)
Preclinical Integration lead for the Schering-Plough/Merck merger Led a cross functional team from Safety Assessment, Pharmaceutical Sciences, Clinical Supplies, Drug Metabolism and Process Chemistry and strategically managed >40 work streams
Director, Pharmaceutical R&D, Merck & Co., Inc. (2005 - 2007)
Led a team of formulators supporting a portfolio of ~10 early, mid and late stage development programs Led a cross-functional (7 distinct departments) international team to simplify the "API to First Patient In" space leading to the decimal potency strategy supporting all Phase I studies and the implementation of on-site formulation
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Sophie-Dorothée Clas
Principal and Consultant, PharmaSolv Consulting, Inc.
Education B.S., Chemistry - McGill University Ph.D., Polymer Chemistry - McGill University Postdoctoral fellow – Queen’s University Synthesis, characterization using DSC, Raman, and dynamic mechanical properties studies (DMTA) of homogeneous copolymers of ethylene and 1 alkenes
Postdoctoral fellow – PAPRICAN
Experience Research Associate – McGill University (1986 – 1989)
Synthesized and characterized novel crosslinked bile acid sequestrant polymers Adsorption studies of bile acids on polymer sorbents, graduate student supervision, and budget management
23 years experience in Preformulation and Discovery Pharmaceutics - Merck Frosst Canada, Merck & Co (West Point)
Responsible for contributing to more than 5 marketed drugs (including Singulair®), and Odanacatib which completed Phase III. She also contributed to Doravirine (Pifeltro®) for the treatment of HIV Hershberg Enterprise Award for leading the prodrug initiative which resulted in a prodrug completing safety toxicology studies
Co-authored on 14 patents and 49 referred publications, and has contributed to more than 80 oral and poster presentations, 32 of which as invited speaker Adjunct Professor - University of Montreal, Faculty of Pharmacy (1998 – 2017) Pharmaceutical consultant - PharmaSolv Consulting Inc. (since 2014) Specializes in the selection of the right drug candidate for development, guiding the physico-chemical characterization of drug candidates (preformulation), enhancing bioavailability of poorly soluble drug candidates with enabled preclinical toxicological formulations, and ensuring the developability and formulability of suitable drug candidates for clinical and marketable formulations
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Eric J. Munson
Professor at Purdue University
Education B.A. - Augustana College in Sioux Falls, South Dakota Fulbright Fellowship - Munich, Germany Ph.D. - Texas A&M University Postdoctoral fellow - University of California, Berkeley Experience Chemistry Department at the University of Minnesota (1994 – 2001) Pharmaceutical Chemistry Department at the University of Kansas (2001 – 2010) Pharmaceutical Sciences Department at the University of Kentucky (2010 - 2018) Dane O. Kildsig Chair and Head of the Industrial and Physical Pharmacy Department at Purdue University (2018 – currently) Coinventor on three patents and has published more than 100 research, review, and book chapters
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Chris Senanayake
Chief Executive Officer, TCG GreenChem, Inc.
Education B.S., Chemistry Special - University of Sri Jayewardenepura – M.S., Synthetic Organic Chemistry - Bowling Green State University - Ph.D., Synthetic Organic Chemistry - Wayne State University –
Experience Chief Executive Officer, TCG GreenChem, Inc. (2019 - Present)
Strategic planning and execution, Global financial strategic management, Business development, Technical management, Talent management, Oversee the commercial operation Define and optimize chemical research and development strategies and tactics
Chief Scientific Officer, TCG Lifesciences Pvt Ltd. (2019 - Present) Chief Executive Officer, AstaTech (Chengdu) Biopharmaceutical Corp and AstaGreen Chem, Inc. (2018 - 2019) Vice President, Chemical Development, Boehringer Ingelheim Pharmaceutical (2002 - 2018) Directed chemical process research and development on an international level and provided leadership of US Chemical Development, Global NCE development in a timely and economical manner. Supply required drug substances for pre-clinical, formulation development and clinical studies
Executive Director, Sepracor Inc. (1996 - 2002)
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Paul Luner
Senior Scientific Advisor (Crystal Pharmatech)
Education B.S. Chemisty, Syracuse University M.S. Pharmaceutics, University of Michigan Ph.D. Pharmaceutics, University of Michigan Experience 30 years’ experience spanning drug substance and drug product development. Held group leader positions at Warner Lambert, Pfizer and Boehringer Ingelheim spanning the areas of preformulation, oral formulation development and solid-state sciences, including GMP analysis. Served as Assistant Professor in Pharmaceutics, College of Pharmacy, University of Iowa, 1995-2002; taught graduate level course on solid-state properties and characterization of pharmaceutical materials and led a research program centered on qualitative and quantitative applications of near-infrared spectroscopy for solid form characterization and molecular understanding. Pharmaceutical Development Consult – Triform Sciences, LLC (since 2019)
Provides scientific consulting services to companies and individuals engaged in pharmaceutical development seeking expertise in the CMC related areas of the drug substance/drug product interface. Expertise in Solid State and Pharmaceutical Materials Characterization: polymorphism and solid form selection, Preformulation and Physical Pharmaceutics, Materials Characterization for rapid Oral Solid product development, process induced transformation in API and DP.
Published over 30 refereed articles and 40 poster presentations on pharmaceutically relevant development topics, both fundamental and applied.
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