Clinical Trial Supply East Coast 2022

Our Annual Clinical Trial Supply East Coast will take place on the 11th and 12th October 2023 in King of Prussia.

19 - 20

October

2022
  • King of Prussia, PA, USA
  • Complimentary
  • Why attend?
  • Agenda
  • 2022 Speakers
  • Event Gallery
  • 2022 Sponsors
  • Media Centre
  • Contact Us

2022 Featured Speakers

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ADAM BRADBURY​

Analyst, GlobalData

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    Featured Sponsors

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    Company Information

    4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

    Company Website:http://www.4gclinical.com/

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    Company Information

    Abacus Medicine Clinical Trial Services is part of The Abacus Medicine Group. Abacus Medicine was founded in 2004 by CEO Flemming Wagner to improve access to original prescription medicines throughout Europe.  Over the past five years, to expand its geographic footprint to the USA and APAC regions, the company has developed a range of Clinical Trial Services including tailored comparator sourcing and clinical packaging & labelling.

    Company Website

    To learn more, please visit our website - https://www.abacusmedicine-cts.com/

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    Company Information

    Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

    Company Website

    To learn more, please visit our website - https://www.calyx.ai

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    Company Information

    N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

    With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

    Company Website

    To learn more, please visit our website - https://lifesciences.n-side.com/

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    Company Information

    Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

    RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

    RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

    RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

    Company Website

    To learn more, please visit our website - www.mercalis.com

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      Why attend?

      Our Annual Clinical Trial Supply East Coast will take place on the 11th and 12th October 2023 in King of Prussia.

      The conference covers all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world. Our expert panel delivered case studies, thought leadership pieces, interactive panels and roundtable discussions.

      Clinical Trial Supply East Coast offers opportunities for both learning and networking with peers from across the CTS sphere, via informal networking breaks and lunches, as well as a relaxed drinks reception at the end of Day 1.

      Bringing together Pharma and Biotech experts to discuss new trends and opportunities

      The Clinical Trial Supply East Coast is the meeting place for the pharmaceutical and biotechnology community to discover how to excel in clinical supply strategy as well as form key connections for long-term success.

      It’s time to build relationships and take away valuable lessons to for clinical trial success moving forward so we look forward to seeing you there!

      300+

      Attendees

      		35+

      Exhibitors

      		20+

      Speakers
      300+

      Attendees

      		35+

      Exhibitors
      20+

      Speakers

      Testimonials

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      Agenda

      • 19 Oct 2022
      • 20 Oct 2022
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      Streams

      Stream one

      Clinical Supply Operations Stream

      Stream two

      Clinical Supply Technology and Innovation Stream

      9 AM

      CORE Elements of a Clinical Supply Project Manager

      • Key areas to focus on to become a successful Clinical Supply Project Manager
      • Core competencies and skillsets of a Clinical Supply Project Manager
      • Understanding the supply chain from a Clinical Supply Project Managers point of view

      Speakers

      Francesco Santo
      Associate Director Global Clinical Supply Chain, HUYABIO

      11:15 AM

      Deconstructing modern day labelling of investigational drugs

      • Innovation in labelling has changed the game but has it made things easier.
      • With the extra demand to go bigger with trials and pool supplies, can we keep up and does Just in Time labelling help.
      • How to effectively plan for a smooth international trial.
      • Should you leave label translation up to your CRO.

      7:45 AM

      Registration and refreshments

      8:15 AM

      Clinical Supply Technology and Innovation Stream

      8:25 AM

      Chairs opening remarks

      8:50 AM

      Chairs opening remarks

      2022 Speakers

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      Jeff Clement
      Executive Director, CDMO Business Development North America, PCI Pharma Services

      Jeff joined PCI in 2014 and he manages the North American Business Development Team for PCI’s Manufacturing and Development services.  Jeff has over twenty-five years in the biotech and pharmaceutical industries and his career includes experience in the pharmaceutical discovery sciences, high throughput automation, clinical formulation development, and cGMP analytical and manufacturing contract services.  All his business development experience is in the aseptic manufacturing and analytical fields. Prior to his current role, Jeff was previously the Director of Global Business Development at AMRI (Drug Product). Jeff received a B.S. in Biology from Keene State College and a M.S. in Quality Systems from The New England College of Business.

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      Ian Hoban
      Business Development Director, Abacus Medicine

      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.

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      Tom Skiendzielewski
      Associate Director Business Process And Integration, Takeda Pharmaceuticals

      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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      Bobbie L Whiddon
      Supervisory Consumer Safety Officer, Division Of Northeast Imports, Office Of Regulatory Affairs (ORA), U.S. Food & Drug Administration

      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.

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      Amaury Jeandrain
      Strategy Advisor, Clinical Supply, N-SIDE

      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.

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      Maxime Derep
      Director of Solutions Engineering, N-SIDE

      Maxime is an optimist and is passionate about problem solving. He is a Senior Consultant and has been working at N-SIDE for over 4 years. He supports pharma parters with the optimization of multiple trials and programs from different therapeutics area. He also helps those partners to understand the value of risk-based optimization and drive changes within their organizations. He loves to exchange ideas and discuss with people from the industry. Maxime has a Master in Business Engineering with a focus on supply chain.

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      EVAN HAHN
      VP North America, TSS,

      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 Have been an invited speaker at various conferences discuss topics including adaptive clinical trials, drug supply forecasting, and supply management technologies.

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      Steve Siron
      Statistical Design & Trial Supplies Consultant, CALYX
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      George Amerson
      Biological Threat Exclusion Coordinator, U.S. Customs And Border Protection

      George Amerson is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Biological Threat Exclusion. As a BTEC, Mr. Amerson 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. Amerson has more than 16 years of public service with CBP and has worked in a variety of environments, including air passenger, maritime, cargo and CBP Training Academy.

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      Gabriela Gottlieb
      Associate Director Clinical Quality Assurance, Fujirebio Diagnostics

      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.

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      Shanna Jackson
      Senior Director, Vendor Management & Strategy, Taysha Gene Therapies

      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.

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      HANEEN MAZAHREH-BOIVERT
      President, Pivot

      Haneen Mazahreh-Boivert is a global clinical supply expert and end to end supply chain advocate.  Throughout her 15+ year career, she has worked and consulted for numerous companies of varying footprints.  Haneen has successfully established and led numerous clinical supply chains from forecasting and planning, to vendor selection and management, clinical manufacturing and global distribution, to site management and drug accountability.  Her mantra is the right supplies at the right place at the right time and focuses her knowledge of operational excellence, KPI improvement, and process optimization to achieve this goal and build efficiencies into her projects. 

      She is a graduate of the American University, Rowan University, and Yale University with BS. Chemical Engineering, MS. Chemical Engineering, and Certification of Executive Leadership respectively.  Haneen is active in the Global Clinical Supply circuit, has published several articles and regularly speaks at industry conferences.  She is also active in Women in Engineering groups.   

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      Charlotte Moser
      Chief Medical Officer, Deka Biosciences

      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.

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      Pedro J Rodriguez-Cardona
      Clinical Supply Operations Manager, Janssen Research & Development, LLC

      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.

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      ADAM BRADBURY
      Analyst, GlobalData
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      Jennifer L. Northcott
      Director, West Point Clinical Supply Operations, Merck

      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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      Frank Leu
      CEO, Novapeutics,

      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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      ELVIRA D’MELLO
      Director Data And Digital Transformation, Clinical Supply Chain Technology, Bristol Myers Squibb

      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.

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      GORDON GREGORY
      Clinical Supply Integrator & Operations Lead, Janssen Research & Development (Tentative)

      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.

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      Anis Ghossain
      Enterprise Supply Chain Analytics, Bristol Myers Squibb

      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.

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      Sean Walsh
      Executive Director, Quality & Chief Compliance Officer, Adlai Nortye Biopharma

      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.

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      Bharat Dixit
      Chief Technology Officer, Adiso Therapeutics
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      Francesco Santo
      Associate Director Global Clinical Supply Chain, HUYABIO

      A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

      • Strategic Supply Chain Management
      • Regulatory Compliance
      • Cross-Functional Collaboration
      • Risk Management
      • Innovative Problem-Solving

      Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

      Session Details:

      CORE Elements of a Clinical Supply Project Manager

      2023-10-19, 9:00 AM

      View In Agenda
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      Sean Smith
      Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection

      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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      Joshua Anderson
      Manager, Logistics Strategy Clinical Supply Chain, Janssen Research & Development

      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.

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      Diego Montemeyor
      Sr Manager Global Trade Compliance, CSL Behring
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      Nick Spring
      CEO, FluoroMe

      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

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      Kim Buchanan
      Associate Director Development Quality, Merck

      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.

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      Ginelle Andrews
      Director Commercial Product Sourcing Strategy, Pfizer
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      Bringing together Pharma and Biotech experts to discuss new trends and opportunities

       

      The Clinical Trial Supply East Coast is the meeting place for the pharmaceutical and biotechnology community to discover how to excel in clinical supply strategy as well as form key connections for long-term success.

       

      It’s time to build relationships and take away valuable lessons to for clinical trial success moving forward so we look forward to seeing you there!

      See What It's All About

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      SPONSORSHIP ENQUIRIES

      Jaz Sidhu

      Senior Sponsorship Manager

      +44 (0) 207 9472755

      SPEAKER ENQUIRIES

      Douglas Webber

      Conference Producer

      MARKETING ENQUIRIES

      Moona Popal

      Marketing Manager

      SPONSORSHIP ENQUIRIES

      To enquire about sponsorship opportunities for the conference, please contact:

      Jaz Sidhu

      Senior Sponsorship Manager


      +44 (0) 207 9472755

      SPEAKER ENQUIRIES

      To enquire about speaking opportunities for the conference, please contact:

      Douglas Webber

      Conference Producer