Clinical Trial Supply East Coast 2022

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

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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: 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: Seasoned R&D Industry professional with over 30 years of experience in large pharma, mid-sized, start-up and virtual settings. Career appointments span the full spectrum of product life-cycle management, across every phase of development and every research platform, including pharmaceuticals, biologics, devices, combination products, gene and stem cell therapeutics, Phases I-IV. Achievements include contribution to the US and International market approval of 6 biopharmaceutical products.

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Biography: As a professional with an extensive background in IRT development and management, I am highly knowledgeable about the research industry for multiple functional areas. Based on the knowledge, I ensured the Clinical Trial Teams has an IRT leader for guiding them through the whole process and guarantee timely and high-quality services. In addition, I am a leading industry subject matter expert for IRT, vendor management, and building standards and procedures. Moreover, I employ this knowledge to keep the company updated with processes and industry standards implement SOPs quickly to fulfill regulatory expectations.

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Biography: Pharmaceutical and Biotechnology professional with over fifteen years of experience in manufacturing, packaging, labeling, and clinical supply chain management. Special expertise in forecasting, planning and budgeting of clinical supply chain. Supplied and managed clinical materials from preclinical through Phase III. Extensive abilities in project management and process improvement. Highly trained in GXPs and ICH guidelines, FDA, and EMA regulations.

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Biography: Accomplished leader experienced in clinical trials and CROs looking for an opportunity to grow into a new area by building on knowledge and skills acquired over many years in the industry. Proven track record for managing global teams across multiple sites in the US and UK. Extensive background in planning of clinical study activities and leading matrix teams. Experienced in leading after action reviews and implementing process improvements that address the root cause and improve processes.

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Biography: An agile CPM certified project manager currently working within the clinical supply chain managing a team of project managers eager to optimize and strength the the supply chain and get medicine to patients more efficiently. Prior 13 years of pharmaceutical experience, 5 years' managing clinical trials and 8 years’ experience executing high level scientific engagement meetings for various therapeutic areas, orchestrating cross-functional presence at international and national congresses, and managing clinical and pre-clinical investigator initiated trials.

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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.

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Biography: Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

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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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