Clinical Trial Supply New England 2021

Biography: Troy R. Petrillo has been employed by the Federal Government for over 33 years. He started his career with the Department of Commerce / National Oceanic and Atmosphere Administration/ National Marine Fisheries Service / Seafood Inspection Program in 1987, where he spent 11 years as a Consumer Safety Officer and HACCP Auditor within the seafood industry. In August of 1998, Mr. Petrillo joined the FDA / ORA Investigation Branch in the New England District Office as a Food Investigator. In December of 2004, Mr. Petrillo was promoted to the position of Food Specialist for the District where he conducted numerous inspections of food manufacturers domestically and internationally. In 2009, he accepted a position as a Supervisory Investigator with responsibility for import operations and is currently in that position reporting to the Division of North East Imports.

Session Details: INTERACTIVE SESSION: Pick & Mix: Q&A with the FDA - regulation 25-03-2020, 8:30 am View In Agenda

Biography: Stephen is a Compliance Officer within the Division of North East Imports for the FDA. He started his career with the FDA in 2008 as a Consumer Safety Officer assigned to the former New England District Office in the Investigations Branch. He started off working within the foods group conducting routine inspections, and a short time later, switched to the import group. During his time in imports, he has been proficient at entry review and field activities playing a key role in identifying violative products. Stephen has also been praised for representing the FDA, for always participating in broker outreach and inter-government relations, as well as training his peers. In 2018 he was promoted to a Compliance Officer.

Session Details: INTERACTIVE SESSION: Pick & Mix: Q&A with the FDA - regulation 25-03-2020, 8:30 am 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: KEYNOTE: How to ensure your clinical supplies pass US border control from the CBP perspective - logistics 24-03-2020, 8:30 am View In Agenda

Biography:

Session Details: KEYNOTE: How to ensure your clinical supplies pass US border control from the CBP perspective - logistics 24-03-2020, 8:30 am 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: Chairman’s Opening Remarks 24-03-2020, 8:20 am Updates in GS1 serialization clinical supply – packaging and labeling 24-03-2020, 9:30 am Connecting clinical and commercial supply chain – operational design 25-03-2020, 11:30 am View In Agenda

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

Session Details: View In Agenda

Biography: Tieming holds his Ph.D. in Mechanical Engineering from the Ohio State University and MBA from New York University. He led different combination product developments such as Auto-Injector, Prefilled Syringe, Large volume wearable injector. He has been working for various biotech and medical device companies in the past eighteen years and holds 15+ patents of drug delivery devices.

Session Details: REMOTE SATELLITE PRESENTATION: Advancements in combination products and how they fit into the supply chain – complex products 25-03-2020, 9:30 am 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: Special challenges in supply and partner-sourcing for stem-gene clinical trials – vendor relations and procurement 24-03-2020, 1:30 pm PANEL DISCUSSION: How can we enhance the vendor-sponsor partnership to encourage scientific and technical innovating for smooth supply chain operations? – vendor relations 24-03-2020, 2:30 pm 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: Updates in GS1 serialization clinical supply – packaging and labeling 24-03-2020, 9:30 am CASE STUDY: Innovation in supply-pooling models – new innovation 25-03-2020, 2:15 pm View In Agenda

Biography: Imran has 18 years of experience in the industry with the last 15 years focusing on IRT oversight from both the vendor and sponsor sides at companies that include ClinPhone, ICON, Takeda, Boehringer Ingelheim and currently Biogen. Imran is responsible for the clinical supply chain systems group where, in addition to IRT, he also oversees other supply chain capabilities like the demand planning and forecasting tool, temperature monitoring, and ERP systems.  Imran’s passion in clinical research, however, is devoted to thinking about how our industry can leverage the power of technology to make clinical trials more efficient and enable the delivery of effective investigational products to patients and their advocates.

Session Details: REMOTE SATELLITE Q&A SESSION: Capitalizing on Interactive Response Technology in Clinical Supply Management – tech and innovation 24-03-2020, 11:00 am FIRESIDE CHAT: Incorporating blockchain in clinical trial supply logistics – new innovation 25-03-2020, 1:45 pm View In Agenda

Biography:

Session Details: Utilizing tools for demand planning and to forecast your supply – tech and innovation 24-03-2020, 12:00 pm View In Agenda

Biography: Dr Aneja is Head of Digital Strategy at Sanofi with board member roles at MIT, Oliver Wyman, MedCity News and acting as an Advisor to Harvard Innovation Labs. Rajni was formerly the Global Head of Digital Strategy for Novartis. She is a Connection Science Fellow with expertise in population health management and digital health. Rajni is an advisor to a variety of health and wellness organisations.

Session Details: REMOTE SATELLITE PRESENTATION: The future of Direct-to-Patient trial supply – emerging models 24-03-2020, 3:30 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: Best practices for aligning clinical trial supply to adaptive design – operational design 25-03-2020, 12:00 pm Speaker Hosted Roundtables 25-03-2020, 3:15 pm View In Agenda

Biography: Katie Bielat is a Clinical Supply Manager at Apellis Pharmaceuticals in Waltham, MA where she provides clinical supply chain support for 10+ Phase 1, 2, and 3 global studies in hematology, nephrology, ophthalmology, and other various therapeutic areas. Ms. Bielat drives end-to-end supply chain execution, including the delivery of cold-chain and ambient ancillary supplies to clinical sites and distribution depots worldwide. She is a member of Global Clinical Supply Group (GCSG) and recently attended the 2019 European Knowledge Forum in Cascais, Portugal. Ms. Bielat received a B.S. in Business from the University of Dayton and an MBA from the University of Delaware, and has completed a certificate in Clinical Research at Boston College.

Session Details: Temperature control 101: How to best ship and store your IMPS – complex products 25-03-2020, 10:00 am View In Agenda

Biography: Dr McGrath, brings 30+ years of quality management expertise in monitoring and assessment of quality systems. She previously served as a vendor quality manager for McCormick and Company for 5 years, and prior to that spent 17+ years in the water industry in various quality management roles. Dr McGrath is an Exemplar Global certified ISO9000 and ISO17025 auditor with 15 years of experience in compliance auditing. Her role at inRegen is oversight of Cayman operations with responsibility for company administration, data analysis and reporting. Dr McGrath received a BSc in Microbiology and Chemistry from University College Dublin, Ireland, an MSc in Environmental Management from the University of Bath UK and a PhD in Microbiology from University of Birmingham UK.

Session Details: Global supply chain: managing an international clinical trial for autologous cell therapy.- emerging markets 24-03-2020, 4:00 pm View In Agenda

Biography: Janel joined Biogen’s Clinical Drug Supply group as an IRT Specialist in August 2017. As an IRT Specialist Janel worked on approximately 30 studies. As of July 2019, Janel took a new role as a clinical supply manager within Clinical Drug Supply, shifting her focus to drug supply forecasting and distribution. In this new role, Janel manages 6 clinical trials under 4 clinical assets, acting as an interface between clinical operations and the supply chain team. In addition to her Supply Manager responsibilities, Janel supports Biogen’s Clinical Drug Supply group by leading the inspection readiness team. Prior to Biogen Janel worked as a Project Manager at PAREXEL.

Session Details: REMOTE SATELLITE CASE STUDY: Are you prepared for an inspection? Lessons learned from a MHRA inspection - regulation 25-03-2020, 9:00 am View In Agenda

Biography: Matthew Leets holds a biology degree and has worked in pharma since 2013; the last 4 years have been in logistics and trade compliance.

Session Details: Logistics and Compliance 101: Importing international materials for US Clinical Trials - logistics 24-03-2020, 10:00 am View In Agenda

Biography: Dr. Ron has over 30 years of experience in the development of drugs, biomaterials, devices and drug delivery systems. He has a record of accomplishments for combining science with innovative business strategies, having developed and implemented the scientific, regulatory and clinical strategy for several companies. He has in-depth understanding of total development process including project management, Manufacturing scale-up, clinical trials, regulatory, formulations, drug delivery systems, QC & QA. Dr. Ron is the author of over 100 papers, book chapters and abstracts. He is also the inventor of over 50 patents principally in the area of drug formulations, drug delivery, tissue engineering, devices and biomaterials. Dr. Ron is a regular invited lecturer in the area of innovative approaches to create trusted partnership with service providers. Dr. Ron facilitated the formation of over 12 Biotech companies and under his leadership over ten products were brought to market.

Session Details: PANEL DISCUSSION: How can we enhance the vendor-sponsor partnership to encourage scientific and technical innovating for smooth supply chain operations? – vendor relations 24-03-2020, 2:30 pm View In Agenda

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.

Session Details: Planning for supply and storage during feasibility – operational design 25-03-2020, 11:00 am 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: Speaker Hosted Roundtables 25-03-2020, 3:15 pm View In Agenda

Biography: Nicole Gray is Director, Strategic Supply Solutions responsible for developing Direct to Patient and other new strategic service offerings.  She has been in the Pharmaceutical industry for 15 years and has held multiple roles in clinical supplies project management, most recently as the Director of Project Management for the Catalent Philadelphia site.

Session Details: DTP Clinical Supply: Industry Perceptions & Practical Applications - logistics 24-03-2020, 9:00 am View In Agenda

Biography: Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

Session Details: Proven Technology Driven Clinical Trial Supply Alternative – tech and innovation 24-03-2020, 11:30 am View In Agenda

Biography:

Session Details: Rethinking drug product delivery and packaging – new solutions to old challenges - procurement 24-03-2020, 2:00 pm View In Agenda