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Anandita |
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Seth |
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Vice President, Process and Analytical Development |
Neurogene Inc. |
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Abizer |
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Harianawala |
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Vice President, CMC & Technical Operations |
Alkeus Pharmaceuticals, Inc. |
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Debasis |
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Patra |
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Vice President, Head of CMC |
OliX Pharmaceuticals |
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Dr. Debasis Patra has doctoral and post-doctoral research experience in novel method development and total synthesis of natural products. He has been working in the pharma/biotech industry for the last 25 years, leading teams of scientists and engineers for the process development and manufacturing of small molecules, peptides, oligonucleotides, etc. Currently he is heading the CMC team at OliX Pharmaceuticals and is responsible for all activities related to drug substance and drug product development and manufacturing to support multiple clinical stage programs (Phase 1/2) in several disease areas, such as ophthalmology, metabolic, dermatology, hair loss, etc. |
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Erin |
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O’Brien |
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Vice President, Pharmaceutical Development |
Parabilis Medicines |
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Erin O’Brien is a collaborative, strategic, and solutions-oriented leader responsible for the development and manufacturing of small molecule drug candidates through clinical development and commercial life cycle management. Currently serving as the Head of Process Chemistry at Takeda Pharmaceuticals, she spearheads the development of synthetic molecule drug substances. Before joining Takeda, Erin held significant roles at Biogen, including Executive Director, Head of Small Molecule Development, where she led initiatives in drug product process development, technology transfer, and strategic collaborations. Erin’s career began as a research scientist at Roche Palo Alto, LLC. She then advanced through various roles at Millennium: The Takeda Oncology Company, eventually becoming a Group Leader. Her leadership expanded further at Biogen, where she oversaw the chemical Process Development group, focusing on innovative manufacturing processes and green chemistry. Erin holds a Ph.D. in Organic Chemistry from the University of Pennsylvania and a B.S. in Chemistry from Mount Allison University. She is active in professional circles, including International Consortium of Quality, contributing to developments in green chemistry and pharmaceutical manufacturing. Her published works span multiple journals and book chapters, reflecting her commitment to advancing sustainable and efficient chemical processes. |
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Gopi |
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Vudathala |
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Global Head, Regulatory Affairs CMC |
Incyte Corporation |
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Dr. Vudathala, Ph.D., is currently Global Head, RA CMC at Incyte Corporation. He was Formerly Executive Director of RA CMC at Intarcia Therapeutics, Head of Quality Advocacy at GSK Vaccines and Global Head of Regulatory CMC at Novartis Vaccines. He was also Associate Vice President of Regulatory Affairs CMC at Sanofi-Aventis. He has extensive experience in CMC regulatory strategy for Global Development and Life-Cycle Management Projects and contributed to over 30 NDA and BLA approvals and 60 INDs. Dr. Vudathala has had numerous interactions with global regulators on project related CMC matters as well as on key ICH initiatives. He has published extensively on drug development and regulatory CMC topics. He was on the Regulatory and Quality Advisory Board at the Parenteral Drug Association and a member of the PDA core team on ICHQ12/ Post Approval Changes. He was also previously Vice Chair of the Technical Development and Operations Committee at PhRMA and an active member of the PhRMA CTD Quality Task Force, Genotoxic Impurities Task Force, and a working group member of the FDA Subcommittee for Pharmaceutical Sciences on Process Analytical Technologies and Quality-by-Design. He was also the Chair of the Regulatory Sciences Section of AAPS. Dr. Vudathala is a well-recognized expert on Regulatory CMC and Quality matters and has made several presentations at AAPS, PDA, IIR, Barnett & Proventa International workshops and conferences on CMC, Regulatory, CTD, Drug Device Combination Products and Genotoxic Impurities topics. Dr. Vudathala graduated from the University of Alberta with a Ph.D. in Pharmaceutics and held positions with the Health Protection Branch, Canada, and Procter & Gamble Pharmaceuticals |
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Goldi |
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Kaul |
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Vice President, Head of External Alternative CMC Development |
Boehringer Ingelheim |
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Gregg |
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Keaney |
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Senior Vice President, CMC and Product Development |
Rapport Therapeutics |
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Gregory |
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Papastoitsis |
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Chief Process and Manufacturing Officer |
Ankyra Therapeutics |
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Dr. Gregory Zarbis-Papastoitsis is the Chief Process and Manufacturing Officer at Ankyra Therapeutics, an immune-oncology company, where he is responsible for all CMC activities. Prior to Ankyra, he was the EVP of Process and Manufacturing at Compass Therapeutics where he oversaw all CMC activities for a CD137 agonist, which is currently in Phase 1/2 clinical studies. Before he was the SVP of development and manufacturing at Eleven Biotherapeutics where he worked on an IL-1 inhibitor that reached pivotal clinical studies for Dry Eye Disease, and an anti-IL6 antibody (successful IND), for Macular Edema. Earlier, he was Associate Director of Process and Analytical Development at Syntonix Pharmaceuticals, where he was responsible for the early development of a long-lasting Factor IX (ALPROLIX®). He also worked on the commercial process of HUMIRA® (Abbott/Abbvie), on the purification process of ONTAK® , an IL2-diphtheria toxin fusion protein (Seragen), on the early development of an antibody-toxin conjugate (aPSMA-DM1) that reached Phase I clinical trials for prostate cancer and an aCCR2 antibody that was in Phase II clinical trials for autoimmune diseases (Millenium Pharma). He received his PhD in Biology at Binghamton University followed by 3 years of post-doctoral studies at Boston University School of Medicine investigating proteases in Alzheimer disease. |
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Hagen |
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Cramer |
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Chief Technology Officer |
QurAlis |
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Jamie |
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Gillette |
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Vice President, Head of Regulatory |
Cullinan Therapeutics |
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Jamie Gillette is Vice President, Head of Regulatory Affairs at Cullinan Oncology of Cambridge, Massachusetts. She is responsible for Regulatory strategy and operations for all Cullinan pipeline products.
Jamie possesses 20+ years of global drug development, clinical trials, and Regulatory experience and has held leadership positions at multiple organizations in the biopharmaceutical industry. She has experience throughout the product life cycle, from INDs through Marketing Applications and across multiple therapeutic areas including oncology, inflammation, and vaccines.
As a community leader, Jamie has been an instructor and avid student in Budo Taijutsu for over 10 years. She is also Vice President of the Howard County Veterans Foundation whose mission is to develop and construct the Howard County Veterans Monument in Columbia, Maryland. |
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Jennifer |
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Taillie |
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Vice President, Business Development US |
AGC Biologics |
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Kwame |
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Nti-Addae |
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Executive Director, Head of CMC |
Frontier Medicines |
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Kwame is a pharmaceutical executive with over 15 years of experience in CMC, formulation, and process development. As Executive Director at Frontier Medicines, he leads Drug Substance, Drug Product, Analytical, and Supply Chain functions. At Lyndra Therapeutics, he played a key role in advancing long-acting oral dosage forms through pivotal trials. He has also held key roles at Ironwood, Cyclerion, and Vertex, driving preclinical and clinical programs and regulatory submissions. Known for his technical expertise, strategic leadership, and dedication to innovation and inclusion, Kwame delivers impactful results across early-stage development through to commercial readiness. |
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Mahesh |
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Padval |
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Chief Pharmaceutical Development Officer |
Relay Therapeutics |
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As Chief Pharmaceutical Development Officer, Mahesh Padval guides transition of the Company’s late research assets into development and oversees pharmaceutical development activities to support regulatory filings and product commercialization. Mahesh brings to Relay Therapeutics nearly 30 years of product development experience in the pharmaceutical industry. Prior to joining Relay Therapeutics, Mahesh was vice president of pharmaceutical sciences and product development at Verastem, Inc. There, he was responsible for preclinical development, CMC and clinical pharmacology activities in support of the company’s development programs through non-clinical, clinical development and regulatory filings, including the approval and commercial launch of COPIKTRA TM. Prior to Verastem, Mahesh held roles of increasing responsibility at Zalicus, Inc., culminating in his role as vice president of preclinical development and formulations. He also held roles at Charles River Discovery and Development Services and Genzyme Transgenics Corporation. Mahesh holds a Ph.D. and M.S. in industrial pharmacy from Massachusetts College of Pharmacy, CSS in administration and management from Harvard University and a Bachelor of Pharmacy from the University of Bombay, India. |
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Melissa |
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Morandi |
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Vice President and Head, Global Quality |
Sumitomo Pharma America, Inc. |
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Track: Outsourcing |
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Neera |
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Jain |
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Senior Vice President, CMC |
PureTech Health |
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Nelly |
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Viseux |
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Vice President, Cell Therapies Development, Manufacturing, Supply & Quality |
Regeneron |
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Olga |
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Paley |
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Director, Head US Downstream Process Development Late and Bioconjugation |
Takeda |
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Paul |
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Peng |
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Vice President, CMC |
City Therapeutics |
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Paul Peng, Ph.D., has about 20 years of experience in the oligonucleotide industry. Dr. Peng is currently leading the CMC function at City Therapeutics for second generation siRNA therapeutics. In his previous roles he made key CMC contributions to support early and late stage development and regulatory filings for oligonucleotide therapeutics (siRNAs, ASOs and RNA editing oligonucleotides) in small and large biotechnology companies including Alnylam, Stoke, Biogen and Korro. With a Ph.D. in nucleoside/nucleotide chemistry from McGill University, he is dedicated to |
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Robert |
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Gabriel |
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Board Member, Managing Partner |
Ashur Capital |
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Rowshon |
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Alam |
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Vice President, Chemistry and In-Process Analytics |
Prime Medicine, Inc. |
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Seshu |
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Tummala |
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Vice President, Drug Substance Process Development and Manufacturing |
Uniquity Bio |
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Yumiko |
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Mizuno |
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Head, Plasma-Derived Therapies (PDT) Drug Product Development |
Takeda |
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Dr. Yumiko Mizuno is the Head of Plasma-Derived Therapies Drug Product Development at Takeda, where she is responsible for all activities related to drug product and combination product development, as well as leading the early-stage portfolio. With over 14 years of experience in R&D CMC at Takeda, she brings deep expertise across all phases of development for a range of modalities. Dr. Mizuno has a proven track record of successfully leading diverse cross-functional and cross-regional teams, fostering collaboration, innovation, and excellence. Previously, she led global R&D strategic planning and change management at Takeda, developing practical skill sets in portfolio strategy and management. |
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Yu |
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Qian |
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Director, Head of Analytical Project Leads & Cell Therapies |
Novartis |
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Yu is the Head of the Cell Therapy Analytical Project team at Novartis. With a background in Immunology and Cancer Immunology, Yu has extensive experience in Analytical Development for Cell Therapies. Yu has a proven track record in developing integrated analytical strategies and guiding teams in creating fit-for- purpose assays to drive innovation and support various cell therapy modalities at different stages. Before joining Novartis, Yu was the Director of Cell Therapy CMC Analytical Innovation and Product Sciences at Takeda Pharmaceuticals and co-founded a start-up prior to joining Takeda. |