Clinical Trial Supply West Coast 2023

Developing best practices and incorporating novel technologies to meet the demands of a more complex, international clinical trial supply chain

9 - 10

May

2023
  • Hyatt Regency San Francisco Airport, Burlingame, San Francisco
  • Complimentary
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Matt Burns​

Director Global Trade Compliance, Gilead Sciences Inc

Matt is a +20 year Trade Compliance and Transportation professional with a passion for all aspects of international trade and problem solving.  He is an US Licensed Customs broker, international tax expert and Logistician with a background in pharmaceuticals, chemicals, biotech, munitions, and cosmetics.  Whether dealing with imports or exports of controlled materials, Matt brings major bench strength to any project or workstream.

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Anwar Mahmood​

Director Clinical Technology Solutions, EXELIXIS

Anwar Mahmood has 16+ years of clinical system experience including IRT, CTMS, eCOA, and wearable device experience. He is currently a Director in the Clinical Technology Solutions Group at Exelixis where he oversees the IRT Team.

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Dr Prasun J Mishra, PhD​

Founder and CEO

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Ronald Schaefer​

Consulting Head of Certification Programs (CEIV Pharma), IATA

Ronald Schaefer is Senior Principal, Consulting. He is also the Consulting Head of the Certifications Programs (CEIV Pharma, CEIV Live Animals, CEIV Fresh, CEIV Lithium Battery, CBTA, etc.) at IATA. He was born in Hamburg, Germany, raised in Mexico and educated in the US. After long-term professional assignments in Germany, Spain, Malaysia, Kuwait, Venezuela and Canada, he has been based in Miami for the last 14 years working for IATA. Before joining IATA, Mr. Schaefer accumulated vast experience in the air transport field working as a consultant for Lufthansa Consulting GmbH, Roland Berger Strategy Consultants GmbH and Ferrostaal México. He has worked on corporate restructuring, strategy, post-merger integration, market and competitive analysis, safety, risk management initiatives among others, in the transportation industry on all continents. Throughout his career Ronald has held positions in Mexico, Stuttgart, Kuala Lumpur, Frankfurt, Cologne, New York, Montreal and Miami.

At IATA he developed in conjunction with the IATA Pharma subject matter expert the CEIV Pharma pre-assessment tools and materials to facilitate successful independent validation of organizations. He also led the initial independent assessment Proof-of-Concept for Singapore Air Terminal Services (SATS) and is now managing the program worldwide. Since its start he has managed ~450 certifications, +1000 assessments and +800 validations.

He is also jointly responsible for the development and implementation of new CEIV initiatives such as CEIV Live Animal, officially launched in April 2018 and CEIV Fresh launched in 2019. In conjunction with the IATA Live Animal and Perishable expert, he is also developing the pre-/assessment tools for validations of organizations and jointly managing the on-going pilots.

He holds a Bachelor of Science (B. Sc.) in Business Administration from California State University at Sonoma and Master of Business Administration (MBA) from Georgetown University.

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Brandy Porter​

Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

Brandy Porter is the Assistant Center Director for Enforcement, of CBP’s Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE). PHC CEE oversees imports of pharmaceuticals, healthcare, medical equipment, and chemicals into the United States. Prior to her work at PHC CEE, Ms. Porter was the Deputy Assistant Director for the Center for Intelligence, Targeting, and Enforcement, located in the New York Field Office.  She began her career with CBP in 2009, as an analyst.

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    2023 Sponsors Include:

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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

    Axiom is celebrating 22 years of delivering hundreds of studies in dozens of countries. Since its founding in 2001, Axiom has delivered data-driven, powerful, and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Axiom Fusion eClinical Suite is the most adaptable, Unified Platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Choose from 15+ unified modules on a single platform: EDC, DM, RTSM/IRT, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance.

    Company Website

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

    Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

    Company Website

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

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    Company Information

    Inceptua is a global pharmaceutical services company with market-leading capabilities across multiple business areas.

    – Inceptua Clinical Trial Supply and Clinical Services provides clinical trial supply, services and logistics, including comparator sourcing of medicines, packaging, labelling, storage, and distribution services

    – Inceptua Early Access offers strategic advice, design, facilitation, and implementation of global early access programs, and distributes unlicensed and other medicines worldwide.

    Inceptua has over 25 years of experience serving life science companies of various sizes, and has global operations with offices across Europe, North America, and Asia, including China.

    Additional information is available at: www.inceptua.com

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    Company Information

    IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Learn more at www.iqvia.com.

    Company Website

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

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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

    Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

    Company Website

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

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    Company Information

    Valeris is a trusted life sciences commercialization partner offering end-to-end solutions across the healthcare value chain. With deep industry expertise, advanced technology, and a patient-first approach, Valeris helps life sciences companies enhance access, adherence, and outcomes. Serving over 500 clients, the company delivers data insights, patient support, and provider engagement tools that drive product success. Headquartered in North Carolina and Indiana, Valeris has supported millions of patients. Learn more at www.valeris.com.

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    Company Information

    World Courier, part of the Cencora family of companies, provides specialty pharmaceutical logistics services to drive the clinical and commercial success of our partners around the globe. We deliver peace of mind through world-class supply chain programs, transport services, decentralized clinical trial support, and storage for time- and temperature-sensitive products, including innovative medicines like cell and gene therapies. Fueled by over 4,000 dedicated members, we operate an extensive specialty logistics network that spans more than 120 company-owned facilities across over 50 countries

    Company Website

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

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    Company Information

    Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

    Company Website

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

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      Why attend?

      The 2023 programme of the Clinical Trial Supply West Coast will offer a fresh insight into the latest regulatory updates, global clinical supply chains, advanced technologies such as remote and hybrid trials, Artificial Intelligence, and more. With presentations, roundtables, and panel discussions on all the hottest industry trends and supply chain challenges, the 2-day event promises to provide the industry an unmissable opportunity to learn and network to help them succeed post-Covid.

      Get in touch now and secure your place!

      WHAT TO EXPECT FOR 2023?

      CTS West Coast is the meeting place for pharmaceutical and biotech experts to discuss key themes and opportunities to take control and optimize clinical supply chains.

      200+

      Attendees

      		25+

      Exhibitors

      		20+

      Speakers
      200+

      Attendees

      		25+

      Exhibitors
      20+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 9 May 2023
      • 10 May 2023
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      Streams

      Stream one

      Clinical Trial Supply Operations

      Stream two

      Clinical Trial Supply Innovation & Technology

      7:45 AM

      Registration and refreshments

      8:25 AM

      Chair’s opening remarks

      Speakers

      David Larwood
      CEO, Valley Fever Solutions

      8:30 AM

      FDA’s role in maintaining a secure and resilient supply chain

      • Supply Chain Resiliency
      • Lessons Learned
      • Government to Government Interactions
      • FDA Inspections and pre-arrival data
      • Role of CBP, FDA, and PGAs
      • 21 CCF
      • ACE 2.0
      • Communication with Import Divisions
      • Resources

      Speakers

      9 AM

      Clinical Trial Logistics: Evolving supply models and new therapies highlight emerging trends

      • Decentralized trial logistics
      o The role of DTP in maximizing benefits of DCT
      o Overcoming DTP complexities
      • Emergence of Cell and Gene Therapies
      o Unique logistics considerations for CGTs
      o Ensuring quality through technology solutions

      Speakers

      Jennifer Fenwick
      Senior Manager Personalized Supply Chain, World Courier

      9:30 AM

      Tackling global trade compliance in clinical supply chain to meet regulations and avoid unnecessary delays

      • Valuation of clinical items moving through borders
      • HTS codes for blinded clinical shipments versus clinical supplies moving to distribution sites
      • Overall best practices to approach your clinical studies from a customs perspective
      • VAT expenses: how they apply, when and how they can be recovered
      • Sanctions and exemptions in the pharmaceutical industry

      Speakers

      Matt Burns
      Director Global Trade Compliance, Gilead Sciences Inc

      10 AM

      Innovative Processes to Better Address Today’s Trial Dynamics

      • Supply chain efficiency
        • Why do extra work and spend more money than necessary?
      • Payment process efficiency
        • Leverage an existing workflow process that sites use everyday
      • Understanding the total value a vendor can provide
        • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

      Speakers

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      Fireside Chat: Forecasting effectively for clinical trials to save time and pre-plan efficiently for a small or startup company

      • Creating a strategy for small and startup companies to effectively forecast
      • Highlighting affordable forecasting alternatives for small companies to reduce time spent on manual processes
      • Considering pros and cons of using of IRT within small companies

      Speakers

      Margaret Pese
      Associate Director, Supply Chain, 89Bio

      11:45 AM

      Negentropy in clinical trial supplies “systems”

      • Entropy Cases - What’s not getting better
      • Negentropy Cases – when we allow new objects in a closed system see what happens
      • Enough with Physics - what about biochemistry and biology?? The latest trends in comparator sourcing

      Speakers

      Edo Madussi
      Managing Director, Euromed Pharma

      12:15 PM

      Contractual Obligations for Privacy in Clinical Trials – Three Pillars to Understanding New Privacy Requirements

      • What is a DPA or the SCCs
      • Standard requirements found in DPAs or SCCs
        • SCC based security measures and how to get there
        • GDPR based operational practices and how to get there
      • Why privacy laws matter beyond participant data

      Speakers

      Jenifer Shahan McIntosh
      Attorney, Ferguson Braswell Fraser Kubasta PC
      Paul Wartenberg
      Vice President/vCIO, Meriplex

      12:45 PM

      Lunch and networking

      2 PM

      Modifying standard supply chain requirements and processes to incorporate cell and gene therapy clinical trials

      • Transferring clinical supply chain from traditional pharma to cell therapy pharma
      • Understanding the requirements and importance of chain of identity and chain of custody within cell and gene therapy trials
      • Challenges and considerations for cell therapy cold chain logistics
      • Identifying technology and tracking systems to assist with cell and gene therapy supply chain tracking and monitoring

      Speakers

      Kevin Liao
      Associate Director Supply Chain, Caribou Biosciences

      2:30 PM

      DTP, DFP Considerations for Successful Execution of Decentralized Trials

      A speaker from Yourway will be sharing case study insights into clinical trial and supply chain logistics to help your trial run smoothly

      3 PM

      Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

      • Aligning early phase vs late phase quality assurance considerations with supply chain protocols to minimize disruptions and backlogs in supply chain
      • Understanding importance of role and responsibility of a Qualified Person and timelines required for QP release
      • Establishing challenges and differences between UK and EU site perspectives since changes to Brexit regulations
      • Uncovering common QA compliance oversights and how to avoid them
      • Improving communication channels between clinical supplies and QA teams

      Speakers

      Brittney Elko
      Senior Director, Technical Operations and Supply Chain, Aligos Therapeutics
      Isaac Blum
      Senior Clinical Supply Manager, ALX Oncology
      Chidi Umeh
      Director of Quality, Telios Pharma

      3:45 PM

      Afternoon Refreshments & Networking

      4:15 PM

      Evaluating and increasing use of decentralized and hybrid trials, reviewing the impact on supply chain whilst meeting patient centric demand

      • Implementing an effective DCT strategy defining which aspects can be carried out remotely and evaluating the best patient centric approach
      • Determining factors to outsource or run trials independently, assessing technology and tools to select appropriate vendors
      • Adapting trials to include more shipments, tracking multiple site delivery to overcome delays and wastage
      • Considering legal and regulatory challenges of decentralized trials to ensure safe, compliant, and successful trials
      • Analyzing the pros and cons of DCTs, lessons learned and if this remains the way forward post pandemic

      Speakers

      David Larwood
      CEO, Valley Fever Solutions

      4:45 PM

      Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

      • Discussing contingency planning to factor into your early stage trial planning to consider any form of unforeseen future disruption, learning from Brexit, Covid-19 and Russian war
      • Creating communication plans to enable a fast response to disruption
      • How to talk to clinical teams to prepare shipments and have more visibility on shipment strategies and options in face of disruption
      • Ensuring minimum impact to patients during disruption to support the ongoing clinical trial and supply

      Speakers

      Bonnie Bain
      Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData
      Yuyi Shen
      Vice President, Technical Operations, Abcuro
      Brandon Newell
      Executive Director Quality Assurance, Structure Therapeutics

      5:15 PM

      Chair’s Summary and Close of Day 1

      5:30 PM

      Drinks Reception

      11:15 AM

      What can we do to take advantage of high prevalence of disease in populous countries where systems are either rudimentary or non-existent?

      • Key drivers for trial enrolment and in time completion
      • Population and high prevalence of disease in developing countries
      • Barriers and hurdles to access vast pool of patients
      • Strategies and solutions to penetrate through barriers and pass hurdles

      Speakers

      11:45 AM

      Reducing the impact of emerging macroeconomic pressure on trial supply

      •  Clinical trial supply management in IRT – the past, present and future
        • Why optimizing your trial supply is more critical than ever
      • Automating the optimization of clinical trial supply
        • How sponsors are saving every day, with no additional effort
      • Reducing the risk in clinical supply chain
        • How to achieve even more automation and savings

      Speakers

      Chris Driver
      Director IT Architecture, IQVIA

      12:15 PM

      Utilizing IRT and understanding its essential role in decentralized clinical trials to simplify supply planning and management

      • Identifying key characteristics of IRT required for DCT or hybrid trials
      • Handling dispensing protocols, calculating dosage, predicting demand and inventory management
      • Strategies to planning for various doses, formulations, and titrating doses
      • Controlling dispensing logistics to track transit and monitor temperatures
      • Managing documentation including returns, reconciliation and accountability for drug
      • Strategies for direct-to-patients shipment

      Speakers

      Jennifer Banh
      Senior Manager Clinical Supply Chain, Formerly of GBT / Pfizer

      2 PM

      Leveraging RPA (Robotic Process Automation) to automate Clinical Supply activities

      • RPA Overview
      • Case Study: Proactively Monitoring Low Site Inventory using RPA
        • Problem Statement
        • How to leverage RPA tools to address issue
        • Reviewing a solution
      • Exploring other use cases
      • Lessons Learned

      Speakers

      Anwar Mahmood
      Director Clinical Technology Solutions, EXELIXIS
      Aviral Srivastava
      Senior Director, Digital Transformation, EXELIXIS

      2:30 PM

      Optimize your trial execution with the strategic use of an experienced IRT/RTSM technology solutions team

      • study design recommendations
      • blinding concerns
      • mid-study changes
      • supply management

      Speakers

      Tracy Robinson
      RTSM Solution Specialist, Medidata

      3 PM

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      • Future supply chain considerations since the impact of challenges provoked by regulatory changes, Covid-19, Brexit and the Russia-Ukraine conflict
      • Current opportunities to enhance supply chain and processes through data driven technologies
      • New and emerging technologies and concepts for future development

      Speakers

      Bonnie Bain
      Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData
      Christopher Ohms
      Executive Director Supply Chain, Rigel Pharmaceuticals

      4:15 PM

      CMO governance to support clinical supply for a virtual company

      • Regulations impacting a virtual company
      • Quality agreements
      • Vendor management
      • Change control
      • Deviations
      • Audits

      Speakers

      John McGinley
      Senior Director Quality Assurance, Pfizer

      Streams

      Stream one

      Clinical Trial Supply Operations

      8:15 AM

      Registration and Refreshments

      8:50 AM

      Chair’s Opening Remarks

      Speakers

      Bonnie Bain
      Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

      9 AM

      The State of the Biopharmaceutical Industry – 2023

      • Benchmark the impact of major themes on the biopharmaceutical industry in 2023, including:
      - Emerging technologies
      - Regulatory trends
      - Macroeconomic trends
      - Industry trends
      • Identify themes that will have the greatest positive or negative impact
      • Explore how inflation will affect the pharmaceutical industry

      Speakers

      Bonnie Bain
      Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

      9:30 AM

      Industry secrets to enhance clinical trial supply chain management

      • Discover why technology is critical in achieving and maintaining visibility and traceability of the clinical trial supply chain
      • Learn how oversight and control, through technology, improve the patient and site experience
      • Tips on what to look for in a clinical trial supply chain management technology vendor/partner
        • What questions to ask?
        • What roadblocks to acknowledge and plan for

      Speakers

      Melanie Manrique
      Associate Director, Quality Management , Endpoint Clinical

      10 AM

      Effective clinical distribution & label/pack vendor selection and management: creating agile relationships to ensure aligned goals and successful partnerships

      • Navigating the vendor market/how to assess vendors to find the best vendor(s) for your supply chain network needs
      • Maintaining real time conversations with vendors to monitor disruption and delays, contingency planning together through open discussions
      • Important capabilities to consider when completing your assessments
      • Overcoming challenges when working with multiple vendors to ensure aligned goals

      Speakers

      Brittney Elko
      Senior Director, Technical Operations and Supply Chain, Aligos Therapeutics

      10:30 AM

      Morning refreshments and networking

      11 AM

      Fireside Chat: Ascertaining the advantages and challenges of packaging and labeling strategies to enhance supply chain flexibility

      • Decreasing large batch labeling to improve efficiency and reduce wastage
      • Enabling differing label requests for new countries, sites or patients within trials
      • Maximizing use of drug product with short expiration dates
      • Reviewing the impact of just in time labelling on cost, forecasting and supply chain management in intensified timeframes

      Speakers

      Marc Trombella
      Associate Director Clinical Supply Chain Planning, BioMarin Pharmaceuticals

      11:30 AM

      Fireside Chat & Audience Q&A: Discussing autologous cell therapy supply chain challenges for start-ups

      • Resource considerations to solve the immediate need while considering future growth
        • Single product to multi-product
        • Demand growth
        • Clinical Site expansion
        • Gameplan for rapid expansion
      • Navigating clinical launch including onboarding and managing of clinical sites
      • Planning and scheduling considerations
      • Vetting critical partners

      Speakers

      Thomas Tredennick
      Associate Director, Supply Chain, ArsenalBio

      12 PM

      Clinical supply chain responsibilities for study close out, end of trial and returns

      • Clinical Trial Master File and Data Base Lock
      • IRT compliance – expected reports, accountability logs, what auditors are looking for
      • Requirements for temperature documentation and compliance
      • How to prepare for closeout at study design to ensure reporting is maintained throughout
      • Pre-planning for supply destroys and returns to ensure compliance destroying onsite or nearby to minimize transport and customs requirements

      Speakers

      Anu Arora
      Senior Manager Clinical Supply Chain, Agios Pharmaceuticals

      12:30 PM

      CEIV Pharma: Raising the standard of pharmaceutical logistics

      • Learn about risks and potential gaps in cold chain when transporting temperature-sensitive pharmaceutical products by air
      • Discover how IATA's standards and certification can improve handling of pharmaceutical cargo, ensuring compliance with regulations
      • Understand benefits of participating in IATA's CEIV Pharma program and how it can help organizations establish a complete cold chain logistical process to maintain shipment integrity
      • Engage in the process of a simplified audit solution against clear standard criteria developed by the industry and provide constructive feedback on IATA's proposed solution

      Speakers

      Ronald Schaefer
      Consulting Head of Certification Programs (CEIV Pharma), IATA

      1 PM

      Lunch, networking and prize draw

      2:30 PM

      Evolving use of AI and Big Data in clinical trial supply chain to reduce costs and streamline processes

      • Identifying where and how data-driven technologies can be incorporated to streamline processes within clinical supply chains and decentralized trials
      • Reviewing cost savings through use of AI and big data
      • Evaluating benefits of using blockchain technologies to enhance conduction and management of trials
      • Highlighting successes of implementing AI and machine learning tools through case study examples

      Speakers

      3 PM

      US Border Control: Hear from the Pharmaceuticals, Health & Chemicals Center

      • Overview of U.S. Customs and Border Protection’s Centers for Excellence and Expertise (CEE)
      • Focus on the Pharmaceuticals, Health, and Chemicals CEE and its role in the importation process
      • How Industry partnerships are mutually beneficial
      • Biologic import requirements

      Speakers

      Brandy Porter
      Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

      3:30 PM

      Speaker Hosted Round Tables

      Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable lasts for 30minutes, delegates can select up to 2 roundtables.

      RT 1 - Roundtable: Feasibility issues with study protocols and clinical development plans to recognize and overcome: best practices and common mistakes to avoid

      Jasmina Jankicevic, Consulting Dermatologist, Clinical Development & Medical Affairs, RAPT Therapeutics, Inc.

      RT 2 - Roundtable: US Border Control: Ask the Experts

      Brandy Porter, Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

      Gina Reneau, Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection

      RT 3 - Roundtable: Current challenges and issues in supply chain

      Ying Cai, Director Supply Chain, Ashvattha Therapeutics, Inc

      RT 4 - Roundtable: Managing expiry dates to comply with regulation and avoid wastage

      Margaret Pese, Associate Director, Clinical Supply Chain, Olema Oncology

      Speakers

      Jasmina Jankicevic
      Clinical Development and Medical Affairs, RAPT Therapeutics
      Brandy Porter
      Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection
      Gina Reneau
      Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection
      Ying Cai
      Director Supply Chain, Ashvattha Therapeutics, Inc
      Margaret Pese
      Associate Director, Supply Chain, 89Bio

      4:30 PM

      Chair’s Summary and Close of Conference

      Speakers

      Select a speaker to learn more

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      Session Details:

      FDA’s role in maintaining a secure and resilient supply chain

      2023-05-09, 8:30 AM

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      Matt Burns
      Director Global Trade Compliance, Gilead Sciences Inc

      Matt is a +20 year Trade Compliance and Transportation professional with a passion for all aspects of international trade and problem solving.  He is an US Licensed Customs broker, international tax expert and Logistician with a background in pharmaceuticals, chemicals, biotech, munitions, and cosmetics.  Whether dealing with imports or exports of controlled materials, Matt brings major bench strength to any project or workstream.

      Session Details:

      Tackling global trade compliance in clinical supply chain to meet regulations and avoid unnecessary delays

      2023-05-09, 9:30 AM

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      Anwar Mahmood
      Director Clinical Technology Solutions, EXELIXIS

      Anwar Mahmood has 16+ years of clinical system experience including IRT, CTMS, eCOA, and wearable device experience. He is currently a Director in the Clinical Technology Solutions Group at Exelixis where he oversees the IRT Team.

      Session Details:

      Leveraging RPA (Robotic Process Automation) to automate Clinical Supply activities

      2023-05-09, 2:00 PM

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      Aviral Srivastava
      Senior Director, Digital Transformation, EXELIXIS

      Aviral has 20 years of experience in Software Engineering field and has worked across Life Sciences, Banking, Utilities and Telecom industries in US, UK, and India. He is currently Senior Director within Digital Transformation group at Exelixis and oversees Business Process Automation and Quality Engineering teams.

      Session Details:

      Leveraging RPA (Robotic Process Automation) to automate Clinical Supply activities

      2023-05-09, 2:00 PM

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      Yuyi Shen
      Vice President, Technical Operations, Abcuro

      Experienced and self-motivated process development scientist and team leader with specialty in process improvement, scale up, technical transfer to bioprocess manufacturing in cGMP environment. Strong subject matter experts in design robust processes for protein purification with monoclonal antibody, antigen and VLP etc, ensuring Critical Quality Attributes are achieved.

      Solid trouble shooting and problem solving skills and encouraging innovation technology to achieve high efficiency and avoid repetitive work.

      Strong proven track of define, design, manage and deliver projects upon all milestones, goals and cost target.

      Build, develop, train and supervise team members and engage and motivate members to ensure the overall success and growth.

      Session Details:

      Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

      2023-05-09, 4:45 PM

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      Session Details:

      What can we do to take advantage of high prevalence of disease in populous countries where systems are either rudimentary or non-existent?

      2023-05-09, 11:15 AM

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      Jasmina Jankicevic
      Clinical Development and Medical Affairs, RAPT Therapeutics

      Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. She holds medical license issued by Serbian Medical Chamber. She is also a Certified Clinical Research Professional, and a trained journalist. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals.

      Session Details:

      Speaker Hosted Round Tables

      2023-05-10, 3:30 PM

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      Jennifer Banh
      Senior Manager Clinical Supply Chain, Formerly of GBT / Pfizer

      Jennifer Banh is an experienced clinical supply chain professional currently working in the rare disease (sickle cell disease) space. Jennifer has vast experience in end-to-end clinical supply chain from study start up to close out. She also has extensive experience with Interactive Response Systems (IRT), inventory planning and forecasting, and CMO management and oversight.

      Session Details:

      Utilizing IRT and understanding its essential role in decentralized clinical trials to simplify supply planning and management

      2023-05-09, 12:15 PM

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      Margaret Pese
      Associate Director, Supply Chain, 89Bio

      High performing, excellence-driven, end-to-end Clinical Supply Chain Professional carrying over 20 years of industry experience in pharmaceuticals and biotechnology. Over 10 years of clinical and commercial supply chain experience. Proven success in leading study teams, including external partners, to target milestones on time and on budget. Highly skilled at supply and demand planning, developing distribution strategies, scenario planning and risk mitigation, troubleshooting, streamlining processes, saving on costs, and increasing the speed to clinics and to markets without compromising product quality.

      Session Details:

      Fireside Chat: Forecasting effectively for clinical trials to save time and pre-plan efficiently for a small or startup company

      2023-05-09, 11:15 AM

      Session Details:

      Speaker Hosted Round Tables

      2023-05-10, 3:30 PM

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      David Larwood
      CEO, Valley Fever Solutions

      Dr. David Larwood brings a rare combination of scientific innovation and business acumen to the fight against Valley Fever, a serious and often overlooked fungal disease. While pursuing his PhD in chemistry and chemical biology at UCSF, Dr. David Larwood explored the therapeutic potential of brilacidin, an antimicrobial compound with promising activity against fungal pathogens such as coccidioides, the organism responsible for Valley Fever, which disproportionately affects immunocompromised individuals. At UCSF, he invented PEGylated lipids and with his advisor made the first ever PEGylated liposomes, which lets the “payload” content circulate much longer in the bloodstream, making new forms of delivery possible. The delivery system is integral to Doxil, a drug that treats various cancers. It also is critical to the mRNA COVID vaccines. He was also the first to synthesize Iotrolan, a widely used contrast agent in medical imaging such as X-rays and CT scans, producing more effective clinical diagnostics. His doctoral work was the foundation of a robust career at the convergence of pharmaceutical chemistry and biotech innovation.

       

      Today, Dr. Larwood is founder, president, and CEO of Valley Fever Solutions, where he leads a team working to advance Nikkomycin Z (NikZ), a targeted antifungal therapy. With $7 million in NIH support and a collaborative research team, Dr. Larwood is driving efforts to improve treatments in the regions most affected by Valley Fever, including the Southwestern U.S., Mexico, and Central and South America. Dr. Larwood's 2020 review of NikZ therapy has been cited more than 37 times and continues to inform the field.

      Session Details:

      Chair’s opening remarks

      2023-05-09, 8:25 AM

      Session Details:

      Evaluating and increasing use of decentralized and hybrid trials, reviewing the impact on supply chain whilst meeting patient centric demand

      2023-05-09, 4:15 PM

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      Ying Cai
      Director Supply Chain, Ashvattha Therapeutics, Inc

      Ying Cai is a Director of Supply Chain at Ashvattha Therapeutics with 16 years industrial experience, specializing in clinical supply chain. Ying uses that experience to ensure end to end supply chain efficiency and integrity from raw materials to patients.

      Session Details:

      Speaker Hosted Round Tables

      2023-05-10, 3:30 PM

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      Session Details:

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      2023-05-09, 3:00 PM

      Session Details:

      Evolving use of AI and Big Data in clinical trial supply chain to reduce costs and streamline processes

      2023-05-10, 2:30 PM

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      Brandon Newell
      Executive Director Quality Assurance, Structure Therapeutics

      Well seasoned Quality Professional with a demonstrated history of working in the biotechnology industry. Strong quality assurance professional skilled in Quality Systems, CMC, QC, Regulatory, and overall GxP (GMP, GCP, GLP) Operations, including supplier oversight, investigations and CAPAs, change management, audits, vendor qualification, and Trial Master Files. Ability to navigate from Phase 1 up to and including commercialization.

      Session Details:

      Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

      2023-05-09, 4:45 PM

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      Christopher Ohms
      Executive Director Supply Chain, Rigel Pharmaceuticals

      Session Details:

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      2023-05-09, 3:00 PM

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      John McGinley
      Senior Director Quality Assurance, Pfizer

      Session Details:

      CMO governance to support clinical supply for a virtual company

      2023-05-09, 4:15 PM

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      Kevin Liao
      Associate Director Supply Chain, Caribou Biosciences

      Kevin Liao is Associate Director of Supply Chain at Caribou Biosciences where he is responsible for the planning and logistics of raw materials and delivering investigational allogeneic products to patients. He has more than a decade of experience in Supply Chain Planning, Logistics, Procurement, and Systems. Prior to Caribou, he was Head of Supply Chain and Procurement at insitro and Vor Biopharma building the Supply Chain functions and defining processes to support manufacturing and sourcing.

      Session Details:

      Modifying standard supply chain requirements and processes to incorporate cell and gene therapy clinical trials

      2023-05-09, 2:00 PM

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      Brittney Elko
      Senior Director, Technical Operations and Supply Chain, Aligos Therapeutics

      Brittney is currently Senior Director, Technical Operations & Supply Chain at Aligos where she is responsible for the supply chain department and external vendors accountable for packaging, labeling and distribution of clinical trial materials to investigational sites.

      Brittney has more than 15 years of experience working in both technical development and supply chain organizations in the consumer products and pharmaceutical/biotech industries.  Prior to Aligos, she was at Tricida, Intarcia, and Genentech where she managed all aspects of supplying 40+ clinical trials across the world in over 30 countries for thousands of patients. She also managed the commercial supply chain for the Clorox Disinfecting Wipes business, dealing with un-precedented demand changes through the H1N1 flu outbreak.

      Session Details:

      Effective clinical distribution & label/pack vendor selection and management: creating agile relationships to ensure aligned goals and successful partnerships

      2023-05-10, 10:00 AM

      Session Details:

      Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

      2023-05-09, 3:00 PM

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      Anu Arora
      Senior Manager Clinical Supply Chain, Agios Pharmaceuticals

      Experienced Clinical Supply Chain Professional with holistic understanding of the pharmaceutical industry and GXP requirement for clinical trials, Phase I-IV, with extensive experience in managing and leading the end to end execution of clinical trials ensure effective and efficient supply of Investigational Product (IP) across the globe. Having collaborated with several clinical service providers and cross functional groups, Anu has exhaustive experience and unique insight on managing processes related to setting up and winding down of clinical trials.

      Session Details:

      Clinical supply chain responsibilities for study close out, end of trial and returns

      2023-05-10, 12:00 PM

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      Bonnie Bain
      Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

      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:

      Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

      2023-05-09, 4:45 PM

      Session Details:

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      2023-05-09, 3:00 PM

      Session Details:

      Chair’s Opening Remarks

      2023-05-10, 8:50 AM

      Session Details:

      The State of the Biopharmaceutical Industry – 2023

      2023-05-10, 9:00 AM

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      Isaac Blum
      Senior Clinical Supply Manager, ALX Oncology

      Isaac Blum has served as Senior Manager of Clinical Supply at ALX Oncology since June 2021. Previously, Isaac served in operational roles of increasing responsibility at BioMarin Pharmaceutical, Sangamo Therapeutics and Puma Biotechnology. Isaac is excited about developing global supply strategies and systems to help advance innovative, life-saving treatments. He has used his expertise to launch multiple global oncology clinical trials, and has shared his expertise at numerous speaking events. Isaac holds a B.A. from the University of Puget Sound.

      Session Details:

      Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

      2023-05-09, 3:00 PM

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      Marc Trombella
      Associate Director Clinical Supply Chain Planning, BioMarin Pharmaceuticals

      Marc has 20+ years of Biopharmaceutical experience overseeing global clinical supply chain activities for oncology and rare disease clinical programs. Cold chain logistics experience in managing clinical supply inventory in the US, APAC, EU, US and AU regions.

      Session Details:

      Fireside Chat: Ascertaining the advantages and challenges of packaging and labeling strategies to enhance supply chain flexibility

      2023-05-10, 11:00 AM

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      Thomas Tredennick
      Associate Director, Supply Chain, ArsenalBio

      Thomas started his career at Baxter Biosciences (later Baxalta) where he worked in the External Manufacturing and Supply group managing fill/finish CMO's. Thomas took a role at Vetter Pharma as a Customer Project Manager responsible for early phase clinical tech transfers. Thomas then worked for Kite Pharma's Supply Chain group managing critical raw material suppliers. He then joined ArsenalBio where he is leading the Strategic Supply Chain group responsible for managing clinical supply and production planning.

      Session Details:

      Fireside Chat & Audience Q&A: Discussing autologous cell therapy supply chain challenges for start-ups

      2023-05-10, 11:30 AM

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      Chidi Umeh
      Director of Quality, Telios Pharma

      Session Details:

      Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

      2023-05-09, 3:00 PM

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      Ronald Schaefer
      Consulting Head of Certification Programs (CEIV Pharma), IATA

      Ronald Schaefer is Senior Principal, Consulting. He is also the Consulting Head of the Certifications Programs (CEIV Pharma, CEIV Live Animals, CEIV Fresh, CEIV Lithium Battery, CBTA, etc.) at IATA. He was born in Hamburg, Germany, raised in Mexico and educated in the US. After long-term professional assignments in Germany, Spain, Malaysia, Kuwait, Venezuela and Canada, he has been based in Miami for the last 14 years working for IATA. Before joining IATA, Mr. Schaefer accumulated vast experience in the air transport field working as a consultant for Lufthansa Consulting GmbH, Roland Berger Strategy Consultants GmbH and Ferrostaal México. He has worked on corporate restructuring, strategy, post-merger integration, market and competitive analysis, safety, risk management initiatives among others, in the transportation industry on all continents. Throughout his career Ronald has held positions in Mexico, Stuttgart, Kuala Lumpur, Frankfurt, Cologne, New York, Montreal and Miami.

      At IATA he developed in conjunction with the IATA Pharma subject matter expert the CEIV Pharma pre-assessment tools and materials to facilitate successful independent validation of organizations. He also led the initial independent assessment Proof-of-Concept for Singapore Air Terminal Services (SATS) and is now managing the program worldwide. Since its start he has managed ~450 certifications, +1000 assessments and +800 validations.

      He is also jointly responsible for the development and implementation of new CEIV initiatives such as CEIV Live Animal, officially launched in April 2018 and CEIV Fresh launched in 2019. In conjunction with the IATA Live Animal and Perishable expert, he is also developing the pre-/assessment tools for validations of organizations and jointly managing the on-going pilots.

      He holds a Bachelor of Science (B. Sc.) in Business Administration from California State University at Sonoma and Master of Business Administration (MBA) from Georgetown University.

      Session Details:

      CEIV Pharma: Raising the standard of pharmaceutical logistics

      2023-05-10, 12:30 PM

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      Jenifer Shahan McIntosh
      Attorney, Ferguson Braswell Fraser Kubasta PC

      Jenifer Shahan McIntosh counsels clients on privacy, data security, and data governance. She has significant experience with legal, operational, and reputational risk guidance, particularly as it relates to compliance initiatives, EU & UK clinical trial privacy requirements, product design, mergers, acquisitions, and tech transactions. She counsels clients on domestic and international privacy laws and regulations, including cross-border data transfers.

      Jenifer has an extensive and diverse background in commercial litigation, including complex contract and licensing disputes, patent litigation, business torts and regulatory investigations defense—all of which she brings to her privacy and data security work. Her cybersecurity experience includes working with clients to stand-up security programs, helping clients establish robust privacy-by-design in product development, advising and guiding clients in the conduct of cyber and data governance due diligence during M&A transactions, and advising on vendor and licensing agreements regarding the transfer and security of data. She has advised leading pharmaceutical trials companies, private equity firms, SaaS service providers, health-tech, ad-tech, and e-commerce clients on privacy and data security issues in technology-driven transactions.

      Jenifer is a Certified Information Privacy Professional for for the United States (CIPP/U) and licensed in New York, Colorado and Texas. Prior to her relocation to Dallas, she served as in-house counsel for a clinical trials company and web-based educational technology company. Jenifer has been quoted in the Law360 on legislation regarding privacy and big-tech tracking, and is a prolific writer on international and domestic privacy and data security law developments.

      Session Details:

      Contractual Obligations for Privacy in Clinical Trials – Three Pillars to Understanding New Privacy Requirements

      2023-05-09, 12:15 PM

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      Paul Wartenberg
      Vice President/vCIO, Meriplex

      Session Details:

      Contractual Obligations for Privacy in Clinical Trials – Three Pillars to Understanding New Privacy Requirements

      2023-05-09, 12:15 PM

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      Chris Driver
      Director IT Architecture, IQVIA

      Chris Driver is currently Director, IT Architecture at IQVIA, with over 21 years of experience in the IRT and Biotechnology space, and across a number of R&D and Information Technology functions. Chris’s experience and background in infrastructure architecture, global health platforms and more recently, decentralized trial adoption through real-time integrations, drives his enthusiasm for the future state of patient-centered health care.  In his “downtime”, Chris enjoys spending time with his growing family, advocating for adoption, especially for those blessed with an extra chromosome!

      Session Details:

      Reducing the impact of emerging macroeconomic pressure on trial supply

      2023-05-09, 11:45 AM

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      Edo Madussi
      Managing Director, Euromed Pharma

      Edo Madussi is the Managing Director, of Euromed Pharma US and Business Unit head of the Clinical Trial Division at the Petrone Group.

      His business experience combined with his academic background and four spoken languages - English, German, French, and Italian - brought him to develop an extensive network within the global clinical supply chain space.  He is currently developing one of the latest ventures of the Petrone Group: a US-based integrated platform to support Clinical Trial Sponsors and other industry players around the world with a wide range of services in the R&D space.

      Session Details:

      Negentropy in clinical trial supplies “systems”

      2023-05-09, 11:45 AM

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      Session Details:

      Innovative Processes to Better Address Today’s Trial Dynamics

      2023-05-09, 10:00 AM

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      Melanie Manrique
      Associate Director, Quality Management , Endpoint Clinical

      Melanie has worked in Quality since starting her career in 2007 and spent six years with a pre-clinical CRO before making a switch to software and the clinical trial industry. Started working for endpoint Clinical in 2013 and has worked with the Quality leadership team in building up the quality management system. She has helped endpoint establish a robust remote client audit and inspection support program that allows the company to respond to requests and questions efficiently and in a timely manner.

      Session Details:

      Industry secrets to enhance clinical trial supply chain management

      2023-05-10, 9:30 AM

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      Jennifer Fenwick
      Senior Manager Personalized Supply Chain, World Courier

      Jennifer is part of World Courier's team leading the cell and gene therapy and direct-to-patient service lines, focusing on defining strategy, driving growth, and solving operational and process challenges arising from these shipments' complexity. With experience in roles on both the sponsor and vendor side for clinical and commercial pharmaceutical logistics, Jennifer has served in many leadership roles in the clinical trial supply chain, project management, vendor and alliance management before joining World Courier in 2022. Jennifer is helping the health tech sector integrate and grow within the continuously shifting landscape.

      Session Details:

      Clinical Trial Logistics: Evolving supply models and new therapies highlight emerging trends

      2023-05-09, 9:00 AM

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      Tracy Robinson
      RTSM Solution Specialist, Medidata

      Tracy is an RTSM Solutions Specialist at Medidata with 26+ years of experience in the Life Sciences Industry including 25 years specializing in Interactive Response Technology (IRT)/Randomization and Trial Supply Management (RTSM) for large and small study systems for both US based and global projects in multiple trial phases and indications. Prior to joining Medidata, Tracy was a Client Oversight Manager at PPD whose responsibilities included ensuring project/study activities were in compliance with company and sponsor requirements; meeting with internal teams to coordinate efforts, providing recommendations and risks, and serving as an escalation contact with clinical project management teams and sponsors for PPD’s proprietary IRT platform as well as Medidata Rave RTSM at PPD (as an accredited Medidata partner). With her years of experience and knowledge in the pharmaceutical industry and the clinical trial space, she has a great understanding of what it takes to work with CROs and Sponsors and to help them navigate and troubleshoot their varying system needs.

      Session Details:

      Optimize your trial execution with the strategic use of an experienced IRT/RTSM technology solutions team

      2023-05-09, 2:30 PM

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      Brandy Porter
      Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

      Brandy Porter is the Assistant Center Director for Enforcement, of CBP’s Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE). PHC CEE oversees imports of pharmaceuticals, healthcare, medical equipment, and chemicals into the United States. Prior to her work at PHC CEE, Ms. Porter was the Deputy Assistant Director for the Center for Intelligence, Targeting, and Enforcement, located in the New York Field Office.  She began her career with CBP in 2009, as an analyst.

      Session Details:

      US Border Control: Hear from the Pharmaceuticals, Health & Chemicals Center

      2023-05-10, 3:00 PM

      Session Details:

      Speaker Hosted Round Tables

      2023-05-10, 3:30 PM

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      Gina Reneau
      Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection

      Gina Reneau is a Biological Threat Exclusion Coordinator (BTEC) for U.S. Customs and Border Protection (CBP) in the Office of Field Operations

      Agriculture Programs and Trade Liaison/ Biological Threat Exclusion.  As a BTEC, Ms. Reneau is charged with supporting and developing CBP operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Ms. Reneau has more than 27 years of public service with CBP, and has worked in a variety of environments, including in air passenger, cargo, maritime, and express consignment locations.

      Session Details:

      Speaker Hosted Round Tables

      2023-05-10, 3:30 PM

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