Clinical Trial Supply East Coast 2022

Biography:

Session Details: Assessing Sourcing Models to Determine the Optimal Sourcing Strategy 19-10-2022, 2:00 pm View In Agenda

Biography: Experienced quality professional with strong leadership and exceptional background in packaging operations, technology, clinical supplies, commercial products, laboratory, and FDA & EU regulatory agency compliance and inspections. Cross functional roles include 2 interim clinical supply assignments, direct line supervision of Global Quality, Sterile & Biological Operations/Technology and Pharm Laboratory personnel.  Key in the development of Expanded Access Program at her company.

Session Details: Expanded Access – The Who, the What, the When, and the How 20-10-2022, 12:00 pm View In Agenda

Biography: Experienced, results-oriented executive with a strong track record of team building, strategic planning and tactical execution in high-paced organizations in med-devices, pharma, biotech, digital transformation - human and animal health. Utilizes keen analysis and insights and a collaborative team approach to drive commercialization, project planning, organizational improvements and implementation of best practices. Superior interpersonal skills, capable of resolving multiple and complex issues and motivating staff to peak performance. A leader with proven skills in: • Management & Leadership • Business Operations & Strategy • Effective Communication & Delegation • Adaptability & Determination • Forward Thinking & Calculated Risk Management • Working with investors & stakeholders • FDA compliant development & launch • Passion for healthcare devices, digital transformation, biotech, pharmaceuticals, consumer and professional products/brands

Session Details: Uncovering the ways that blockchain will make your supply chain run more efficiently 19-10-2022, 2:00 pm View In Agenda

Biography:

Session Details: Highlighting the importance of Customs Valuation and how you need to incorporate this into your trial forecasting 20-10-2022, 11:00 am View In Agenda

Biography: Senior logistics and supply chain professional with extensive experience leading across pharmaceutical and healthcare firms. Unique educational background in biology/chemistry combined with a MBA in Supply Chain Management. Expertise in managing research, clinical and commercial activities with regards to strategic planning, forecasting and design of high quality and cost-effective production through distribution of finished goods.

Session Details: Exploring the issues with your supply chain management in a modern decentralized trial: how to avoid the big mistakes 19-10-2022, 9:30 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: Q&A Discussion: Exploring the world of customs and how preparation is everything in the modern world 19-10-2022, 3:00 pm Speaker Hosted Roundtables 19-10-2022, 4:00 pm View In Agenda

Biography:

Session Details: CORE Elements of a Clinical Supply Project Manager 20-10-2022, 9:00 am View In Agenda

Biography:

Session Details: Panel Discussion: Investigating the difference in forecasting perspective from a small company to a large one 20-10-2022, 11:00 am View In Agenda

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.

Session Details: Improving the efficiency of shipments across borders in a post pandemic world; and not forgetting the war in Europe 19-10-2022, 8:30 am View In Agenda

Biography:

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Biography: Anis has an MBA from Rutgers University with a specialization in Supply Chain Management and Data Analytics . In my employment thus far, I've achieved a record of success in Electrical/Mechanical Engineering, Supply Chain Management, Business Analytics and Project Management. Anis’s key personal strengths include his ability to manage diverse teams, strategic thinking in optimizing processes and delivering results. Anis has extensive software knowledge, with proficiency in SAP, AWS, R, Python, Tableau, Spotfire and SQL; I'm also fluent in English, French, and Arabic. Specialties: Electrical/mechanical engineering, supply chain end to end visibility, distribution and transportation management, project management, data science, supply chain digitization & control tower.

Session Details: Supply Chain Digital Twin; using discrete event simulation to assess the health of our supply chain 19-10-2022, 3:00 pm View In Agenda

Biography: Gordon Gregory III, CCRP began his career in the Document Management field of Clinical Research Operations in 2008. He moved quickly from a Document Management Associate, through various Clinical Trial Associate roles, into Global Trial Leadership as a Clinical Trial Manager and GCDO Trial Leader and is currently forming a group within Clinical Supply Chain to oversee all of the patient scheduling on Janssen's CAR-T trials. In his 12 years in the industry, he has excelled at every turn and was even selected to be a part of the initial cohort of the GCDO Clinical Operations Leaders of Tomorrow Program.

Session Details: Case Study: Building a CAR-T Clinical Supply Chain model and leveraging it for other Advanced Therapies 20-10-2022, 10:00 am View In Agenda

Biography: Summary: Leader in digitization excellence and technology transformation for Clinical Supply Chain in Bristol Meyers Squibb.  Results driven problem solver with cross-functional business expertise and technical knowledge, delivering success in energizing operational and systematic transformation.

Session Details: Panel: Exploring metric management - What are you measuring and why 19-10-2022, 11:15 am Speaker Hosted Roundtables 19-10-2022, 4:00 pm 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: Looking into global diversity, supply strategy diversity and vendor diversity 19-10-2022, 11:45 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.

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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.

Session Details: Panel: Getting the most out of the relationship with your CMO and what we can do for them 20-10-2022, 2:00 pm View In Agenda

Biography:

Session Details: Psychedelics Surge in the Pipeline: Implications for Clinical Trials and Manufacturers 20-10-2022, 10:00 am View In Agenda

Biography: Experienced Leader with a demonstrated history of working in the pharmaceuticals industry. Strong operations professional, skilled in U.S. Food and Drug Administration (FDA), Verification and Validation (V&V), Life Sciences, GMP, Supplier Management and Six Sigma.

Session Details: Case Study: Building a CAR-T Clinical Supply Chain model and leveraging it for other Advanced Therapies 20-10-2022, 10:00 am View In Agenda

Biography: Dr. Moser is an oncologist who has worked as a clinician and academic researcher for over 20 years and specialized in drug development for the past 10. She completed her PhD in Statistics working at the EORTC in Brussels and has led many multi-institutional trials and related cancer survivorship projects since. After completing her MBA at MIT Sloan School of Management (2017), she moved to the US and shifted focus from academic to commercial research. She has helped drive the clinical pipeline from early to late stage in larger (Elekta, Roche) and smaller (Augmenix, Kaiku, Artidis, Galera Therapeutics) companies and commercialization of several products including the post-marketing performance. Dr. Moser has obtained extensive clinical operational and regulatory experience dealing with different stakeholders (academic, industry, policymakers and patient advocates). Dr. Moser has helped direct the investment in private owned drug-development, as well as new cancer centers worldwide and was instrumental in launching Portugal’s National Cancer Institute. Dr. Moser previously served as the Vice President for Clinical Development for Galera Therapeutics, with who she went IPO in 2019 and SVP Clinical Strategy for ELEKTA Inc, a global radiation oncology device vendor (2017-2018). She founded Nanocan Therapeutics Corporation in 2020 and serves as the Chief Scientific Officer. Working with different academic groups she obtained over 5M of NIH-STTR awards to drive preclinical research and opening first in-human trials.

Session Details: Panel: Exploring metric management - What are you measuring and why 19-10-2022, 11:15 am Manufacturing and drug supply for early phase oncology trials from a start up perspective 19-10-2022, 12:15 pm View In Agenda

Biography:

Session Details: Changing in EU regulation and how it impacts on the clinical supply world. 20-10-2022, 1:30 pm View In Agenda

Biography: Experienced Clinical Operations professional with a demonstrated history of working in the pharmaceutical industry across multiple functions (research, development, operations, and outreach). I have had the privilege of being intimately involved in the development of a global orphan Oncology program from IND to NDA/MAA, commercialization, and post-market life cycle management. I look forward to the next opportunity that will directly contribute to the improvement of patients lives.

Session Details: How to coordinate with the Clinical Operations team to ensure your drug is delivered to time. 20-10-2022, 3:00 pm View In Agenda

Biography: Gabriela Gottlieb is an Associate Director of Clinical Quality Assurance at Astellas Pharmaceuticals, where she drives Clinical QA activities related to management of risks, non-compliance and auditing across a therapeutic program to treat Prostate Cancer. In this capacity she interacts with executive level management, external vendors, collaboration partners, clinical study and cross-functional groups to ensure compliance with regulations, Astellas business practices and clinical research program objectives. Prior to Astellas, Gabriela served in a variety of roles in the Medical Device industry in areas of Interventional Oncology, Orthopedics and Interventional Cardiology. She has a track record of implementing quality systems in Clinical Research and Regulatory Affairs. She also has led several regulatory inspections with FDA, EMA and other global regulatory bodies. She bases her approach to program implementation through change management principles with a focus on data integrity, human subject protection and quality.

Session Details: Planning and preparation of your audit so as to not fall behind on clinical trials 20-10-2022, 3:30 pm View In Agenda

Biography:

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Biography: Aimee Hodge is the VP/GM of Technical Operations at PCI Pharma Services located in Bedford, NH.  In this role, Aimee oversees the technical transfer, project management, validation and manufacturing technical science (MTS) groups supporting PCIs North American business units related to the contract manufacturing of sterile drug products and medical devices.  Aimee is a member of New England PDA and International Society for Pharmaceutical Engineering.  She is an active member of the NH EPSCoR Research and Industry Council.  She earned her B.S. in Biology from the University of New Hampshire and holds numerous patents for medical devices. 

Session Details: From First Vial to Final Mile 19-10-2022, 2:30 pm View In Agenda

Biography:

Session Details: Using IRT to reduce effort and optimize clinical supplies 19-10-2022, 2:30 pm View In Agenda

Biography: Throughout my career, I have focused on driving innovation by applying sophisticated approaches to leveraging data to life sciences. My previous companies are recognized as industry leaders in their respective spaces; TSS clearly fits that mold in the area.

• At Medidata, the leading eClinical platform provider, I led the growth of the of their RTSM solution from product startup to an industry leader.
  • Responsibilities included RTSM go-to-market strategy, solution roadmap development, subject matter expert consulting, strategic partnership development
  • Had the opportunity to meet with 100’s of supply chain leaders globally, gaining broad insights into the challenges they face
  • Received feedback from large pharma, startup biotech’s, CRO’s, and regulatory agencies such as the FDA, and the NCI on biopharma supply challenges.
  • Served as a delegate to the FDA to promote innovation in clinical trial approaches
• At Cytel, a company that provides analytical software and knowledge intensive services, I promoted the industry adoption of adaptive clinical trial designs to streamline drug development

Session Details: Opportunities for savings by automating temperature monitoring in clinical trials 20-10-2022, 11:30 am View In Agenda

Biography:

Session Details: How to make clinical supply more sustainable in a world of finite resources? 19-10-2022, 9:00 am View In Agenda

Biography: Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

Session Details: How to make clinical supply more sustainable in a world of finite resources? 19-10-2022, 9:00 am View In Agenda

Biography: Bobbie Whiddon is presently the supervisor over the FDA imports group in Philadelphia.   He has been with the FDA for almost nine years.  Bobbie has acquired over 20 years of public health and environmental health experience through various positions in both government and industry. FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food Drug and Cosmetic Act (FFD&C Act). Importers of products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements.  Imported products are subject to FDA inspection when offered for import at U.S. ports of entry. FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements. Both imported and domestically-produced foods must meet the same legal requirements in the United States.

Session Details: An Update from the FDA 20-10-2022, 9:00 am View In Agenda

Biography: Tom is currently serving as the Associate Director of Business Process and Integration in Takeda’s Clinical Supply Chain  group within the Lexington, MA office.  Within this role, he is responsible for the optimization and utilization of the in-house Clinical Supply Management Database (SmartSupplies) currently deployed for all of Takeda’s clinical trials managed out of the Lexington, MA office.  In addition, Tom is also responsible for the Clinical Supply chain integration activities related to any mergers and / or acquisitions made by Takeda’s Lexington office.  Prior to joining Shire, Tom lead the Logistics and Supply Chain Operations teams at two large Contract Manufacturing Organizations.  Tom has been responsible for the implementation of multiple ERP systems / IRT solutions at a number of organizations throughout his career.  These software solutions include SAP, Oracle, as well as a number of software applications developed “in-house”.  Tom has over 15 combined years of Clinical Supply experience from both the CMO and Pharma sides of the industry.

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Biography: Ian has over 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle. During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches. Before joining Abacus Medicine Pharma Services Ian worked in senior roles at two leading global clinical solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful comparator sourcing solutions which helped successfully deliver their pivotal late phase clinical trials.

Session Details: Speaker Hosted Roundtables 19-10-2022, 4:00 pm View In Agenda