Clinical Trial Supply Southern California 2020

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.

Session Details: Problem Solving Interactive Workshop 23-06-2020, 4:30 pm View In Agenda

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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, speaker, moderator, and facilitator for many life-sciences and drug development events.

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Biography: Ben is the CEO of LedgerDomain, founded in 2016 to bring blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies. In partnership with the Clinical Supply Blockchain Working Group (CSBWG), the world's largest pharmaceutical blockchain consortium, LedgerDomain developed the world's first iOS blockchain app for the clinical supply chain. In 2019, LedgerDomain also partnered with UCLA on a pilot for the US Food & Drug Administration (FDA) on a last-mile application that helps deliver lifesaving medications to babies.

Session Details: The Blockchain Conundrum: How Can It Benefit The Industry 23-06-2020, 10:00 am View In Agenda

Biography: Manage all aspects of the clinical supplies packaging, labeling, storage, distribution and returns accountability process. Specialties: Clinical Supplies packaging strategies and IRT integration NJ registered Pharmacist

Session Details: Fireside Chat: Supply Chain 101 – What Your Startup Needs To Know 23-06-2020, 11:00 am View In Agenda

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.

Session Details: 4 Tips When Outlining the Right CMO For You To Avoid Disappointment 23-06-2020, 2:30 pm View In Agenda

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Session Details: Analyzing The GxP Quality System For Your Supply Chain 24-06-2020, 2:45 pm View In Agenda

Biography: Extensive experience in the execution & management of global cold chain clinical trial material (CTM) in support of global clinical studies. Collaborates effectively with cross-functional teams & contract facilities to manage project timelines and deliver on the clinical supply plan. Partners with manufacturing, QA, CMC, affiliates and contract facilities for the timely production of clinical bulk drug product. Partners with Clinical Operations to identify clinical study demand assumptions. Builds strategic relationships and looks at innovative approaches to address issues & opportunities. Successfully managed budget and contained annual costs exceeding management objective. Proven ability to lead and mentor.

Session Details: Speaker Hosted Roundtables 24-06-2020, 3:15 pm View In Agenda

Biography: I am the Senior Director, External Drug Product Supply Strategy, within Pharmaceutical Sciences Small Molecule (PSSM) at Pfizer. I am currently based in La Jolla, CA following 25 years at the Groton, CT site. My current areas of focus include strategic sourcing, vendor relationship management, and integration process improvement within the clinical drug product manufacturing space. I joined Pfizer in 1992 and have held several positions within the Pharmaceutical Sciences organization that covered a broad span of responsibilities. These roles have included leadership of global teams and initiatives, accountability for sourcing and manufacturing oversight of development and commercial stage products for clinical trial use, direct facility support for clinical scale sterile manufacturing, external drug delivery technology evaluation and development, as well as formulation development and analytical characterization responsibilities. I have a BS degree in Chemistry from Central Connecticut State University.

Session Details: Commercialisation Dilemma: Go it Alone or Double Up? 24-06-2020, 9:00 am View In Agenda

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Session Details: Guidelines In Developing a Successful Team To Ensure Progression Of Your Business 23-06-2020, 4:00 pm View In Agenda

Biography: Dr. Deng joins Viracta from Kura Oncology, Inc. and Wellspring Biosciences, where he was Senior Director, Head of CMC.  Dr. Deng led the CMC function - including development, manufacture, quality control, and clinical supply - of multiple programs through various phases of development (I, II and III and registrational).   Prior to Kura, Dr. Deng spent thirteen years at Janssen Pharmaceutical Companies of Johnson & Johnson in various roles of increasing responsibility associated with process chemistry R&D, CRO management, and project management of discovery/preclinical development.  He has more than 30 peer-reviewed journal publications, a book chapter and 14 issued patents to his credit.  Dr. Deng holds a Ph.D. in organic chemistry from Emory University and MS and BS in chemistry from Fudan University.

Session Details: Deep Dive: Managing Your Supply Chain 23-06-2020, 12:00 pm View In Agenda

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Session Details: Panel Debate: Understanding The Fundamental Differences Between Ocean and Air Freight 24-06-2020, 11:30 am View In Agenda

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.

Session Details: KICK-OFF KEYNOTE: Convergence of Big Data and Artificial Intelligence in Augmenting Drug Discovery, Development and Supply Chain Management 23-06-2020, 8:30 am View In Agenda

Biography: Near 20 years profound global leadership in Oncology Clinical Research, Regulatory Filing, Product Launch, and Business Development at the prestigious pharmaceutical companies such as Merck, Novartis, Pfizer, innovative biotech Exelixis, well-established Asian pharmaceutical company Sihuan, and cell therapy start-up CARsgen. Holding in-depth knowledge and practical leadership skills to strategically manage cross functions and efficiently deliver the results and bet the company objectives in widespread areas, including but not limited to, Pharmaceutical Quality/CMC, Nonclinical Pharmacology and Toxicology, Global Clinical Development (early to late phase, innovative & generic), Global Regulatory Submission (NDA/BLA/aNDA), Global Commercial and Product Launch, Global Business Development (Licensing In/Out, Mergers and Acquisitions), and Asset Life Cycle Management. Leading and being major contributor for multiple oncology global regulatory submissions, including one BLA, one NDA, two MAAs, and three INDs. Proactively planned and attended numerous TC/F2F meetings (i.e. post-IND, End of Phase 2, pre-BLA, pre-MAA, post-BLA orientation, etc) with FDA, EMA, and managed numerous response and interactions to address the inquiries from ROW regulatory agencies (i.e. SWISS MEDIC, Health Canada, Australia TGA, Japan PMDA/MHLW, China FDA, etc)

Session Details: Guidelines for Managing Your Global Supply Chain More Efficiently 24-06-2020, 11:00 am View In Agenda

Biography: ANTHONY OROSZ is Assistant Director, Pharmaceutical CEE at Customs and Border Protection.  Mr. Orosz began working for CBP in 1995 as a Customs Inspector at JFK Airport in New York.  During his time at JFK he was a member of the Anti-Terrorism Contraband Enforcement Team and was a National Instructor for Customs and Border Protection.  Mr. Orosz has been with the C-TPAT program since its inception in 2003 and served as a supervisor in the C-TPAT Newark Field Office.  He is now currently assigned as an Assistant Director in the newly established Pharmaceutical, Health and Chemical Center of Excellence and Expertise in New York City

Session Details: Tips for Ensuring Your Product Passes Customs Without Delay 24-06-2020, 1:30 pm View In Agenda

Biography: Experienced Project Manager in Product Development, Supply Chain, Business Operations and Logistics, and Change Management

Session Details: Forecasting Your Clinical Supply Need To Avoid Disappointment 23-06-2020, 12:30 pm View In Agenda

Biography: Clinical Operations Leader with extensive industry and clinical trial management experience with ability to manage high-performance teams and develop cost effective solutions. Experience covers a multitude of aspects of clinical programs in Phase I, II, III, IIIB, and IV, globally. Ethical and sequential problem solver with multi-therapeutic acumen in clinical study management; and a proven track record of establishing, strengthening, and improving the processes and infrastructures through interfacing with various arms of organizations including Regulatory Affairs, CMC, Project Management Teams, and other KOLs and clinical team members.

Session Details: Panel: Vendor Management And Oversight To Ensure Product Efficiency 23-06-2020, 2:00 pm View In Agenda

Biography: A result-oriented technical leader with extensive drug product (solid oral, oral liquid, parenteral) development experience ranging from Discovery Support through clinical development.

• Direct experience in managing multiple CDMOs to plan, coordinate, and execute external drug product development and manufacturing activities.
• Proven record of excellence at project management, workflow development, innovative technology implementation, and timeline/budget management.
• Technical expertise: pre-formulation, formulation and process development, biopharmaceutics, and PBPK modeling.
• Broad knowledge in drug development and direct experience in managing CMC team functions within multi-disciplinary (Discovery, CMC, Drug Safety, DMPK, Clinical Operations) development team.
• Highly collaborative, change-agile, and strong problem-solving ability in a fast-paced matrix environment.

Session Details: CMC 101: Understanding The Fundamental Importance For Your Supply Chain 23-06-2020, 3:00 pm View In Agenda

Biography: 23+ years of analytical, formulation and process development from early clinical to commercial products. More than 12+ years in cross-funtional team project, tech transfer, scale-up manufacture and CRO/CMO management. Specialties: Tech transfer, optimal lyophilization, GLP/GMP investigation, problem-solving skills. Formulation concepts and development strategies for oral, parenteral, ophthalmic, topical and inhalation products, including nano-emulsion and nanotechnology. Preformulation, shelf life prediction, specifications, protein stability and CMC. Take initiatives. Strive for quality, teamwork, and honest communication.

Session Details: Speaker Hosted Roundtables 24-06-2020, 3:15 pm View In Agenda

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.

Session Details: Considerations Needed When Auditing your Suppliers To Avoid Delays To Your Supply Chain 24-06-2020, 2:15 pm View In Agenda

Biography: Experienced Import Director with a demonstrated history of working in the government administration industry. Skilled in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Import, Government, and Life Sciences. Strong operations professional with a MHA focused in Health/Health Care Administration/Management from University of La Verne.

Session Details: Ask The Regulatory Expert 24-06-2020, 12:00 pm View In Agenda