Clinical Trial Supply USA 2021 - Virtual Conference

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: Convergence of Big Data and artificial intelligence in augmenting drug discovery, development and supply chain management 11-05-2021, 12:30 pm View In Agenda

Biography: Lisa is a seasoned R&D Industry professional with 28 years’ employment in the biopharmaceutical/biotech space, spanning the full spectrum of lifecycle management across every phase of development and every research platform including pharmaceuticals, biologics, devices and combination products, gene and stem cell therapies. Her career appointments reflect the full spectrum of clinical operations roles from QA/Compliance oversight of a 44 bed Phase I ‘in-patient’ clinic/treatment unit & laboratory facility; work as a Clinical Research Associate (CRA), materials management, project management and advancement through introductory to executive management positions in Clinical Operations/Clinical Affairs.

Session Details: ROUNDTABLE DISCUSSION: Embedding effective risk management and resiliency strategy into your supply planning 11-05-2021, 3:00 pm PANEL DISCUSSION: Managing clinical trials during COVID-19 and beyond 11-05-2021, 3:30 pm View In Agenda

Biography: James L. Sherley, M.D., Ph.D. is the founder and director of Massachusetts stem cell biotechnology company Asymmetrex, LLC.  Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first-in-kind technology for specific counting of adult tissue stem cells.  This technology is also applied to design optimized procedures for more effective manufacturing of therapeutic adult tissue stem cells at greatly reduced cost.  Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees.  Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute.  Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Session Details: Stem cell therapy clinical trial supply: what's on the near horizon? 11-05-2021, 11:00 am View In Agenda

Biography: Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has about 15+ years of experience in chemistry, manufacturing, and controls (CMC) and has held roles of increasing responsibility at Gilead Sciences, Merck, Sanofi and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA.  Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University's Stern School of Business in New York, NY.

Session Details: Uncovering new trends within the clinical supply chain 11-05-2021, 2:30 pm View In Agenda

Biography: Shell has over 19 years of cGXP global supply chain, operations, and logistics experience with no disruption to supply in cGXP pharma/biotech industry. He has an MBA and 2 Engineering degrees, plus Lean & Six Sigma skills (business, technical, & optimization skills). He has a deep understanding of clinical and commercial supply chain management, procurement, strategic sourcing, production planning and control, contract/external manufacturing, as well as global logistics (Import/Export), and business and supplier management. He is regularly involved in professional presentations, panel/roundtable discussions, and publications.

Session Details: Connecting clinical and commercial supply chain: operational design 11-05-2021, 12:30 pm View In Agenda

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Session Details: Accelerating the path to clinic for early phase trials 11-05-2021, 10:30 am View In Agenda

Biography: Scott Sutton is an accomplished supply chain professional with over 15 years bio-pharma experience, currently leading global supply chain Stealth BioTherapeutics, a clinical phase bio-pharmaceutical company working the rare disease space.  He has managed global clinical supplies for Stealth BioTherapeutics, Flexion Therapeutics, and Karyopharm Therapeutics across all phases of clinical development and expanded access programs.  Scott also has many years commercial supply chain leadership experience, including 2 successful US product launches.

Session Details: Innovation in supply-pooling models 11-05-2021, 12:30 pm View In Agenda

Biography: Elizabeth has been an expert in the cold chain life sciences healthcare industry for over 10 years. Her experience spans operations, account management, and business development. She established herself as a subject matter expert on active and passive packaging, and collaborated on education and a solutions portfolio for cold chain pharmaceutical logistics. As part of the DHL Life Sciences & Healthcare sector, Elizabeth drives the cross-divisional development of clinical trials logistics offering. She sits at the head of the marketing work stream, and is a primary stakeholder for marketing collateral and content. She is also a primary contributor to the commercial aspect of the company’s COVID-19 vaccine distribution strategy and public sector initiatives.

Session Details: Shifting gears: accelerating clinical trial logistics in 2021 and beyond 11-05-2021, 2:00 pm View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: KEYNOTE TALK: The state of the biopharmaceutical industry 11-05-2021, 8:30 am View In Agenda

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Session Details: Harnessing the benefits of e-labelling; accelerating packaging and labelling processes through technological innovation 11-05-2021, 1:30 pm View In Agenda

Biography: Kaitlin is working on the NIBR CQA team to manage quality issues by supporting clinical operations teams with root cause analysis and CAPA management to ensure patient safety and data integrity. She is also, actively involved in cross-divisional quality improvement projects focused on informed consent, inspection readiness, and quality culture.

Session Details: Factoring USP800 regulation into your supply chain to protect site staff from hazardous drugs 11-05-2021, 11:00 am 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: 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: Commercialization dilemma: go it alone or double up? 11-05-2021, 1:30 pm View In Agenda

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Session Details: The future of direct-to-patient trial supply: emerging models 11-05-2021, 11:00 am View In Agenda

Biography: As Director of Services Delivery, Ben oversees services delivery out of Suvoda’s Bucharest office. Ben has over 11 years of experience in the software industry, holding a variety of positions in professional services, global operations and business development. He has consulted with Fortune 2000 clients across a variety of industries on how to best leverage technology to solve mission-critical business challenges

Session Details: Optimizing supply chain with enhanced dynamic IRT 11-05-2021, 1:00 pm View In Agenda

Biography: Federico is an experienced Design Consultant based in Suvoda’s Barcelona office. Federico has designed and overseen the development of over 50 IRT builds in a variety of therapeutic areas such as oncology and rare diseases in all phases. With a focus on providing excellent service and collaboration, he has fostered meaningful partnerships with sponsors by delivering timely and efficient IRT solutions for complex clinical trials.

Session Details: Optimizing supply chain with enhanced dynamic IRT 11-05-2021, 1:00 pm View In Agenda

Biography: Mgr Clinical Supply Chain Project Management, Global Clinical Operations, Global R&D, TEVA Hadar has a B.Sc. in Chemical engineering From BGU (Ben-Gurion University of the Negev) & B.Sc. in Polymer engineering from Shankar College of Engineering. Experienced in leading R&D projects in Biopharmaceutical companies. Worked in Perrigo API performing commercial procurement for the API division, then joined Teva in 2011 as Senior procurement manager in R&D performing global procurement. Since joining Clinical Supply Chain group, within TEVA's R&D global clinical operations in 2018, Hadar been leading clinical supply chain projects within a variety of programs and TAs, each one includes multiple clinical trials in different clinical phases, identifying unique challenges and tailoring the project planning accordingly with ongoing risk management in accordance with international guidelines and regulations. She holds various responsibilities including plan efficient drug product demands, coordinating the manufacturing with CMC in all TEVA's manufacturing plants, sourcing of comparators, plan and design the clinical drug packaging and labeling, Design IRT/RTSM system, set-up and oversee maintenance and overall ensure timely delivery within specifications, quality and standards. Hadar initiated and led new approach for P&L at Teva, following by process change.  

Session Details: Adapting your labeling creation process in a changing environment 11-05-2021, 2:30 pm View In Agenda

Biography: Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S. Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017). Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California. Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

Session Details: How to ensure your clinical supplies pass US border control from the CBP perspective 11-05-2021, 10:00 am View In Agenda

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Session Details: How to ensure your clinical supplies pass US border control from the CBP perspective 11-05-2021, 10:00 am View In Agenda

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Session Details: Deploying adherence packaging in human subject research: validating the value proposition of packaging innovation 11-05-2021, 11:30 am View In Agenda

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Session Details: CASE STUDY: Direct-to-patient shipments in orphan drug trials and how to navigate hurdles to deliver drugs safely and efficiently 11-05-2021, 1:30 pm View In Agenda