Clinical Trial Supply USA 2021 - Virtual Conference

Biography: Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman,

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Biography: Dr. Mishra (Ex-Genentech, Ex-NCI, Ex-NIH) is the Founder and CEO of Agility Pharmaceuticals. He is a serial entrepreneur who founded his first company after graduating high school, and second company during his PhD. Since then, he has accumulated a wealth of experienced by building, investing and advising numerous other companies. He is an investor/ co-founder/ board member of a few US based corporations focused on accelerating drug discovery & development, blockchain & digital health. Dr. Mishra is also founding president & CEO of American Association for Precision Medicine (AAPM) and is leading research efforts focused on preventing & curing chronic diseases; not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives. Widely recognized as a thought leader in the field of Technology and Healthcare, Dr. Mishra has keynoted, chaired, curated and organized numerous successful international conferences. Prior to Agility Pharma, Dr. Mishra served as a scientist and Principal Investigator at Genentech, Roche. Moreover, his passion for drug development and precision medicine has led to identification of new drug targets, biomarkers, companion diagnostics and several drugs/ combinations in the clinic. His research work has been recognized globally by over 40 prestigious awards and honors. Due to his unique perspective & selfless service, he is highly respected & sought-after mentor to many. The companies that he has advised have raised multimillion dollars. Notably, he serves as a mentor and advisor to startup accelerators such as IndieBio, Health2.0’s Project Zygote and CLSI FAST program, to help grow California’s life sciences innovation ecosystem.

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Biography: David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in summer 2020. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis). Their NikZ will transform the standard of care. Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today, where he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. As a bench chemist, he was the first to make Iotrolan, a CT contrast agent, now generic. Moving to law, he advised well known companies on patent matters, later moving to Apple Computer. Later, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through acquisition in 2005. Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a clinician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in about 1998 and raised some $20M for research into vaccines against Valley Fever.

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Biography: Peter Shapiro, PhD, is the Senior Director of Drugs and Business Fundamentals for the Pharma Intelligence Center. He also serves as the Editor-in-Chief of GlobalData PharmSource. Peter previously was involved in the leading the integration of BioPharm Insight, Lead Sheet and PharmSource into GlobalData. Prior to joining GlobalData, Peter was an Assistant Manager at Target Health, a Contract Research Organization (CRO) where he helped a diverse set of clients with the demands of bringing biologics, devices, and drugs to the market successfully. Peter also worked in small molecule drug development for Abbott Labs and on in vitro diagnostics at Ambergen, a diagnostic startup. Peter holds a PhD in Molecular and Cellular Biology from the Sackler Institute of New York University Langone Medical Center and is located in GlobalData’s office in New York City.

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Biography: Experienced Technical Operations Lead with a demonstrated history of advancing clinical development programs in the biotechnology industry. Strong operations professional skilled in Manufacturing, Development, Supply Chain and Quality Operations for both large pharma and small biotech.

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Biography: Derrick L. Kearney – Supervisory Import Specialist - Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise, Partnership Division, U.S. Customs and Border Protection (CBP). Mr. Kearney joined CBP in 2007, and is currently assigned to the Port of Philadelphia, PA. Previous positions within CBP include Import Specialist and Trade Operations Program Manager at the Port of JFK, New York. Prior to joining CBP, Mr. Kearney worked for the New York City Office of the Comptroller. Mr. Kearney is an Air Force veteran. Educational accomplishments include numerous classes, seminars and workshops as a member of CBP, and a Master’s of Public Administration (MPA) Degree from Baruch College, City University of New York.

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Biography: Luke has worked in Clinical Supply Chain Planning for nearly 20 years with Incyte, Janssen, Merck and Almac.  He has experience in supply-planning, forecasting and simulation technologies, packaging/labeling design, distribution, cold chain, IRT, vendor selection and management, project management, comparator purchase, and CMC regulatory requirements.  He has direct supply management experience for small molecule, biologics, devices, and stem cell medicines.

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Biography: Judy is a Nurse and has 20+ years in the Pharmaceutical Industry with various roles and for the past 7 years in  Biopharmaceutical and Medical Device Research & Development with Windtree Therapeutics, Inc.   She is currently overseeing the clinical team, closing 2 clinical trials and preparing for the next Phase 2 Clinical Trial that will hopefully launch into Phase 3 shortly thereafter.

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Biography: Ph.D. Team/Project Leader with 20 years progressive experience in Global Bio/Pharmaceutical Development from Discovery to Clinical and Commercial Manufacturing. Lead increasing multifunctional groups of scientist, engineers and managers. Thrive in high-pressure environments of biotech start-ups, medium size companies, Big Pharma, CRO/CMO and virtual companies focusing on accomplishments and timely delivery of milestones. Adept in pharmaceutical project management, vendors and contract team management. Certified Project Manager and Supply Chain Manager.

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Biography: Extensive experience in the quality arena of biotech/pharmaceutical production, including roles in management. CQA certified professional with a background in vendor/supplier management, internal/external audits and SCAR/vendor change notification management.

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Biography: Matt is leading Merck adherence tracking technology and digital platform development and deployment efforts.

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Biography: Laurel Ferenchick is a Senior Clinical Supply Manager at PCI Pharma Services.  She has over 14 years of experience in Clinical Trials with a background in Packaging, Logistics, IRT, and Supply Chain Management. She earned an MBA in Pharmaceutical Business from the University of the Sciences in Philadelphia. Laurel currently lives outside of Philadelphia with her husband and 2 sons and enjoys geeking out with Legos, Harry Potter, and Star Wars.

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Biography: Ed Groleau is a Director, Clinical Supply Chain for North America at PCI Pharma Services. Ed leads the Supply Management And Readiness Team (SMART) at PCI where his team partners with clinical trial sponsors to manage drug supply from protocol development through final destruction. He has a Bachelor of Science in Chemistry from Illinois State University and over 30 years of experience in the Pharmaceutical industry. Prior to PCI, Ed worked in numerous departments at Eli Lilly; small molecule drug development laboratories, Clinical Trial Supplies group, CM&C team, and the animal health division.

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Biography: John has been with Prevail for just under 12 years, most of which have been managing and developing of Prevails RTSM system and managing clinical drug supply. John manages development of Prevail's RTSM platform, and configures Preclinical to Phase IV trials on those platforms. John works directly with Prevails development team and external clinical teams to deliver quality systems designed specifically for each study.

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