Clinical Trial Supply New England 2023

Our flagship event bringing together clinical operations professionals to discuss pressing challenges in the running of a clinical trial

5 - 6

April

2023
  • The Westin Waltham, Boston, MA, USA
  • Complimentary
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2023 Sponsors Include:

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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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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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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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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

Acnos Pharma is privately-owned, specialized pharmaceutical company operating globally in the clinical trial supply landscape. The headquarter is in Germany, Aachen. We offer flexible, cost efficient and quality sensitive customized solutions for individual trial requirements. We offer a broad range of clinical trial services supply chain management, clinical trial procurement and logistics.

Th combination of passion and expertise leverages our global reach and maximizes customer satisfaction.

Company Website

To learn more , please visit our website - http://acnospharma.de/

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AWT Healthcare manufacturers clinical trial labels. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing.

 

For more information please contact Graig Daley – Business Development Manager and Jackson Young – Business Development Associate at sales@citlabels.com.

Company Website

To learn more , please visit our website - http://citlabels.com/

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Company Website

To learn more , please visit our website - http://www.bappharma.com/

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Bay Area Research Logistics (BARL) is known for its superior management of clinical trial services – from drug procurement to blinding, packaging, labeling, storing and distribution. We provide seamless coordination for all sizes of trials – from large, global phase IV trials to small-scale INDs, across many therapeutic classifications ranging from Phase I to Phase IV studies.”

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Bionical Emas is a global Contract Research Organization (CRO) combining Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) bringing life-changing medicines to patients around the world. Our Clinical Trial Supply Division has a global vendor network of manufacturers, wholesaler distributors and optimized sourcing strategies to support your study. Whether you require products locally sourced in emerging markets and distributed directly to trial sites, global sourcing of high-value commercial drug products, or a demand-driven sourcing approach, we have the right solution for you.

Company Website

To learn more , please visit our website - http://www.bionicalemas.com

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Company Information

CCL Label is the largest label company in the world and provides innovative and sustainable solutions to consumer markets worldwide. The company has developed Labels and Aleeves that wow consumers through premium appearance as well as ecological solutions that support recycling, reduction and reuse.

Company Website

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

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Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

Company Website

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

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Endpoint Clinical is an interactive response technology (IRT) solutions provider that supports the life sciences industry. Our innovative, high-quality randomization and clinical trial management technologies are backed by over a decade of award-winning experience and expertise. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.

Company Website

To learn more , please visit our website - http://www.endpointclinical.com/

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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 Website

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

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The Inceptua Group Group is a dynamic, enterprising, and future-oriented service provider operating within the clinical trial and unlicensed medicines supply chain at an international level.

Our multinational team provide connections to an extensive global network, offering our clients customized solutions ranging from strategic planning and sourcing, clinical manufacturing and global depot solutions, right through to early access to unlicensed medicines.

We are committed to safety, and reliably supporting our clients every step of the way, leaving them safe in the knowledge that every potential obstacle has been considered, and every eventuality planned for.

Our worldwide presence enables us to fulfil these services for the duration of trials, and our expert team work closely with our customers to ensure they receive full support throughout the lifecycle of their project.

Company Website

To learn more , please visit our website - http://www.inceptua.com/

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Myonex is a global complete clinical trial solutions provider. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. You might have known us as Myoderm as we have recently changed our name – but not our high-quality services as the complete clinical trial supply partner. We at Myonex add value to our clients by helping them always be prepared for what is next in their clinical trials.

Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises.

With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries, Myonex is your complete partner around clinical trials around the globe – reliable, trusted and by your side.

Company Website

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

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Pharmaceutical companies — and other organizations looking to make significant cost and quality improvements in their cold chains — are switching to Peli BioThermal for single-use and reusable temperature-controlled packaging. Our innovative, patented technologies and consultative services ensure product quality, mitigate excursion rates, reduce packaging costs and drive Total Cost of Ownership across your entire supply chain.

Company Website

To learn more , please visit our website - http://pelibiothermal.com/

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QuickSTAT provides 24/7/365 trusted global life science logistics and transportation solutions for companies worldwide combining industry expertise and innovative technology. Our team of logistics experts specializes in time- and temperature-sensitive shipping of clinical research samples, CGT, vaccines, investigational drugs, CTS, etc., helping bring new drugs and medical protocols to market.

Company Website

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

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At RxSource, our passion drives us to be the bridge between pharma and patient. With offices in Canada, USA and Ireland we provide bespoke global clinical trial supply management services to pharma, biotech and CROs. Whether it’s employing demand-led packaging, a local sourcing model or another flexible option, we guarantee on-time delivery without compromising quality. Our clients are our partners; success for them = success for us.

Company Website

To learn more , please visit our website - http://rxsource.com/

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    Why attend?

    The event is a premium experience and an invaluable opportunity to learn from and connect with peers across the biopharma industry. The variety of talks, round tables and panels will provide relevant insight, bringing to light strategies to streamline supply chains and reduce wastage. Additionally, there are plenty of opportunities to network with industry peers over coffee, complimentary lunch and a relaxed drinks reception. Additionally, attendees will have opportunities to visit our exhibition hall featuring numerous vendor booths, with experts ready to help you find the latest, cutting-edge solutions and answer any questions you may have.

    WHAT TO EXPECT FOR 2023?

    The annual Clinical Trial Supply conference is a leading summit for discovering exclusive expert-led insight, featuring major bio-pharma companies such as Moderna, Sanofi and Takeda.

    In a post-pandemic world and with the current geo-political uncertainties this conference comes at the perfect time. The event will feature a selection of presentations, panels and round tables. All aspects of the supply chain will be covered from cold chain logistics to regulations and decentralized format. Leaders from top New England based companies will take to the stage to discuss the latest developments and the future of the CTS industry.

    Furthermore, the Clinical Trial Supply series is a unique platform for clinical trial sponsors and solution providers. This event is aimed at enabling knowledge-sharing, benchmarking and network-building amongst biopharma industry peers.

    200+

    Attendees

    		30+

    Exhibitors

    		20+

    Speakers
    200+

    Attendees

    		30+

    Exhibitors
    20+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 5 Apr 2023
    • 6 Apr 2023
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    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    9 AM

    State of the Biopharmaceutical Industry

    •    Gaining insight and understanding into themes that are shaping biopharmaceutical industry, both today and into the future

    •    Hearing about key emerging technologies and disrupters

    Reviewing industry, regulatory and macro-economic factors affecting pharma in 2023

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    9:30 AM

    Managing stockout risk without impacting patients and recruitment

    • How to identify, locate and quantify risks
    • To identify the main causes of risk in your clinical supply chain
    • Innovative ideas to solve risks without slowing down recruitment
    • How proactivity and collaboration in the clinical supply environment can alleviate
      stressful mid-trial situations.

    Speakers

    Antoine Remiot
    Director Solutions Engineering, N-SIDE
    Maxime Derep
    Clinical Supply Optimization Senior Solutions Engineer, N-SIDE
    Henk Dieteren
    Clinical Supply Chain Solutions Consultant, Suvoda

    10 AM

    Using Real World Data and Evidence to Accelerate Clinical Trials

    ·       Augmenting clinical trials with observational data gathered via hybrid trials, pragmatic trials, routine clinical practice and late phase trials to accelerate clinical validation and get new drugs to patients quicker

    ·       Deriving real world data from a range of sources including: electronic health records, product and disease registries, wearable devices, genomic data sets, medical claims registries and social determinants of health

    ·       Expanding patient population assessed beyond the formal clinical trial to ensure demographics or geographics are not overlooked when assessing efficacy of a trial drug 

    Speakers

    Tomasz Adamusiak
    Chief Scientist, Clinical Quality and Data Science, MITRE

    10:30 AM

    Morning refreshments and networking

    11 AM

    PANEL DISCUSSION: Looking at ethical and practical benefits of direct-to-patient models in clinical trials and the resulting challenges and expectations of the supply chain

    ·       Patient centricity: advances in technology enabling seamless data capture and reinforcing logistics networks to orchestrate decentralized supply chains

    ·       DTP and real-world evidence: providing invaluable patient feedback and real-life contextual understanding of treatment efficacy leading to improved care and deeper understanding of patients on an individual, case-by-case level

    ·       Protecting patient confidentiality in direct to patient trials: adhering to data protection regulations by implementing strategies such as AI and smart packaging to avoid delays and improve patient retention

    Speakers

    Isaac Rodriguez-Chavez
    Former SVP-Scientific and Clinical Affairs & Former FDA Official
    John Gregg
    Chairman and CEO at BalinBac Therapeutics, Inc.
    Melissa Morandi
    Vice President, Head of Global Quality, Sumitomo Pharma Oncology
    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    11:45 AM

    An emerging clinical trials supply industry for therapeutic tissue stem cells

    ·       Exploring how trials cell and gene therapy will bring about new innovations and solutions that will ripple into other clinical supply chains, translating into huge advances

    ·       Overcoming operational complexity issues and increasing possibility with the help of lower barriers to market, technological developments and analysis of real-world data

    ·       Addressing issues surrounding the shortage of manufacturing capacity and talent, logistical issues, data protection and a fragmented market landscape

    Speakers

    James L. Sherley
    M.D., Ph.D. - President & Chief Executive Officer at Asymmetrex® LLC

    12:15 PM

    Lunch and networking

    2 PM

    Case study in clinical supply chain innovation by TrialCard

    Tom Gottschalk will be joining us to share insights into cutting edge innovation for clinical supply chains and an update on TrialCard’s latest technological developments

    Speakers

    2:30 PM

    Strategies for growing a pipeline, accelerating decision making, set up the organization, in order to improve drug development

    • Strategic design of pipeline growth
    • Methods to accelerate decision-making in Ph1-2 trials
    • Team culture by organizational design

    Speakers

    3 PM

    Afternoon refreshments and networking

    3:30 PM

    The Improving Clinical Trials Environment in Canada

    •         Harnessing many unique assets that span demographic diversity, to academic leadership, clinical expertise, government commitment and public-private collaboration, sustaining Canada’s role as a medical research and health innovation hub.

     

    •         Raising numerous interesting and difficult policy questions related to how Canadian and US pharma companies must collaborate and ready the system to address the “extraordinary” needs of rare patients including novel clinical innovation strategies, new regulatory and funding mechanisms, infrastructure accommodation and knowledge sharing across boundaries and through centres of excellence.  

     

    •         Focusing on the future of clinical innovation as a means to cultivate supportive conditions for improved care for rare patients in Canada.  Using scientific knowledge to improve patient impact and system receptivity.

    Speakers

    Susan Marlin
    President and CEO, Clinical Trials Ontario

    4 PM

    Navigating Ancillary Management Challenges through Collaboration and Centralized Teams

    •         Discussing important considerations for ensuring compatibility of your IMP with common infusion materials.

    •         Discussing the importance of strong relationships with CMC, Clinical, and CROs in assessing product compatibility.

    •         Developing a plan for ancillary supply needs.

    •         Sharing tips for establishing a centralized ancillary supply team in your organization to better serve the needs of studies.

    Speakers

    Tyler Wilson
    Global Clinical Supply Chain Fellow, Takeda
    Fred Moreau
    Director of Central Ancillary Supplies, Takeda
    Paul Larochelle
    Director, Global Clinical Supply Chain, Takeda

    4:30 PM

    Chairperson’s closing remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    9 AM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical supply chains. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    ROUND TABLE 1:  Q&A Session with U.S. Customs and Border Protection – Here to help with any questions you may have about how to import or export biological materials to or from the U.S.

    Sean Smith, Biological Threat Exclusion Coordinator, U.S. Customs and Border Protection
    ROUND TABLE 2:  IRTs and just-in-time packaging, labelling, and shipment strategies for efficient CTS life cycle

    Hyun Kim, Vice President, Clinical Development, AOBiome Therapeutics

    ROUND TABLE 3: Innovation in integrating supply models, decentralized clinical trials and technology

    Isaac Rodriguez-Chavez, Former Senior VP-Scientific and Clinical Affairs and Former FDA officer
    ROUND TABLE 4: Best Practice for Comparator Labelling

    David Adams, Associate Director-Global Clinical Supply Chain, Takeda

    Bharti Kansara, Associate Director -Global Clinical Supply, Takeda

    ROUND TABLE 5: Best practices for clinical supply planning: brainstorming and sharing experiences

        Antoine Remiot, Director Solutions Engineering, Clinical Supply Optimization, N-SIDE

        Maxime Derep, Clinical Supply Optimization Senior Solutions Engineer , N-SIDE

    Speakers

    David Adams
    David Adams, Associate Director, Global Clinical Supply Chain, Takeda

    10:30 AM

    Morning refreshments and networking

    11 AM

    Lessons learnt: Strategy for Generation of Stability Data to Demonstrate and Justify Longest

    • Maximize expiration period of IMPs
    • Understand the meaning of the stability data generated as well as what is not reported • Maximize storage conditions (e.g., flexibility of storage at 30ºC as opposed to 25ºC)
    • Understand what data must be generated to support Temperature Excursions of IMPs
    • Leverage the ICH Guidelines – Topic ‘Q’ for Quality

    Speakers

    James Krupa
    Director-US Clinical Supplies, Takeda

    11:30 AM

    KEYNOTE Q&A Discussion: Explore importing and exporting requirements for biological materials and in the modern world

    • Important steps to take to help expedite the clearance of biological materials.
    • Case studies of inspections: when it really goes wrong and how to tackle it
    • Discover resources and contacts available to help facilitate your imports, especially time- dependent shipments, at U.S. ports of entry
    • Highlighting the key takeaways for ensuring a smooth inspection as we look to the future

    Speakers

    Sean Smith
    Biological Threat Exclusion Coordinator, U.S. Customs and Border Protection

    12 PM

    Management of the Cold Chain and Best Practices in the Shipping Process

    •Answering the question on how end users and solution providers can improve their management techniques and      implement newer practices for them cold chain operations

    • Detailing what are best practices in the supply chain

    • How to effectively manage cold chain operations

    • Discuss and elaborate on proper shipping management and regulations for products

    Speakers

    Eric Elbel
    Senior Manager, Supply Chain Logistics, AVROBIO

    12:30 PM

    Lunch and networking

    2 PM

    PANEL DISCUSSION: Maintaining optimal performance conditions of temperature sensitive products whilst ensuring compliance of complex regulations to ensure success of trials and ultimately their commercialization

    ·       Addressing  issues regarding transporting and storing vaccines, biospecimens and temperature sensitive specimens  to avoid compliance issues and wastage whilst ensuring product integrity and ultimately, consistent data results leading to trial success

    ·       Exploring the potential benefits to supply quality of real-time data monitoring and alerts to help to facilitate proactive, corrective response, while automatically documenting supply chain temperature data for compliance purposes.

     

    ·       Implementing holistic supply chain management in supply chain risk reduction. Enabling responsiveness, flexibility and facilitating cooperation between technology, logistics and manufacturing

    Speakers

    Eric Elbel
    Senior Manager, Supply Chain Logistics, AVROBIO
    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData
    Matthew L. Plaud
    Former President and Chief Operating Officer at SOTIO Biotech Inc.

    2:30 PM

    Building a strong foundation for proactive quality improvement

    •Overview of medication error risks for investigational products

    •Considerations for packaging and labeling to reduce risk of medication errors

    •Issue management when medication errors occur

    Speakers

    Kaitlin Bova
    Manager, Research Quality and Development, Moderna

    3:30 PM

    Chairperson’s closing remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    Speakers

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    James Krupa
    Director-US Clinical Supplies, Takeda

    James J. Krupa, Pharm.D.,  Director, Clinical Supply Team Lead, Operations at Takeda in Lexington, MA. In this position, I am responsible for providing the leadership and strategic direction in terms of planning, budget, coordination, scheduling, resources and tracking of global clinical trial materials. I have over 42 years of industrial pharmaceutical experience in multiple dosage form drug development. Building upon experience as a bench pharmacist in clinical and non-clinical supplies, formulations, process development, and technical services, I  have contributed to the success of early and late stage development programs intended for regulatory approvals in women’s health, pain, oncology, CNS disorders, anti-inflammatory diseases, metabolic disorders, anti-infectives, cardiovascular, gastroenterology, gene therapy, and rare disease therapeutic areas.

    Session Details:

    Lessons learnt: Strategy for Generation of Stability Data to Demonstrate and Justify Longest

    2023-04-06, 11:00 AM

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    Eric Elbel
    Senior Manager, Supply Chain Logistics, AVROBIO

    Session Details:

    Management of the Cold Chain and Best Practices in the Shipping Process

    2023-04-06, 12:00 PM

    Session Details:

    PANEL DISCUSSION: Maintaining optimal performance conditions of temperature sensitive products whilst ensuring compliance of complex regulations to ensure success of trials and ultimately their commercialization

    2023-04-06, 2:00 PM

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    Isaac Rodriguez-Chavez
    Former SVP-Scientific and Clinical Affairs & Former FDA Official

    Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in decentralized clinical trials (DCTs) and Digital Medicine Tools applied to multiple therapeutic areas including Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. Currently, he is an independent consultant for Scientific-, Clinical-, Regulatory-affairs, and digital medicine for modern trials such as DCTs enabled by Digital Health Technologies (DHTs). Past positions in the last 20+ years include: Senior Vice President for Scientific, Clinical Affairs, leading the Strategy of the Global Center of Excellence for DCTs and Digital Medicine at PRA Health Sciences and ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Real World Evidence and DCTs enabled by DHTs and electronic Clinical Outcome Assessments (eCOAs); CEO and Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs at National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH); Senior Clinical Scientist, Schering Plough Corp. – Merck & Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research and Health Sciences; and a B.S. in Biology. He also has 5 years of postdoctoral specialty experience in Clinical Research (phases 1 & 2 trials) linked to AIDS Malignancies, Immuno-Oncology and Viral Immunology (Infectious Diseases) done at the U.S. NIA and NCI, NIH. Dr. Rodriguez-Chavez is a Founding Board Member of the Digital Medical Society (DiME). He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally. He is an Advisory Board Member of BlueCloud by HealthCarePoint; a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering industry standards on DCTs and DHTs. He is a former Leadership Council Board Member of the Decentralized Trials & Research Alliance (DTRA). He is a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA) and a Health Equity Board Council Member for equity, diversity and inclusion in rare diseases at the Global Genes. He is a global content editor for regulatory science and an Editorial Board Member of the DIA Global Forum Magazine. He is also an active member of sixteen professional associations, including the Infectious Disease Society of America, American Federation for Medical Research, American Association of Immunologists, American Society for Virology, American Society of Microbiology, Society of Quality Assurance, Association of Clinical Research Professionals, New York Academy of Sciences, International AIDS Society, International Association for Dental Research, American Association for Dental Research, and Regulatory Affairs Professional Society.

    LinkedIn: https://www.linkedin.com/in/isaacrc/

     

    Session Details:

    PANEL DISCUSSION: Looking at ethical and practical benefits of direct-to-patient models in clinical trials and the resulting challenges and expectations of the supply chain

    2023-04-05, 11:00 AM

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    Sean Smith
    Biological Threat Exclusion Coordinator, U.S. Customs and Border Protection

    Sean Smith 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, Mr. Smith is charged with supporting and developing CBP operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Mr. Smith has more than 18 years of public service with CBP, and has worked in a variety of environments, including on the southern land border, maritime, air passenger, and cargo locations.  He has also been able to assist in several past domestic and international CBP disaster recovery operations.

    Session Details:

    KEYNOTE Q&A Discussion: Explore importing and exporting requirements for biological materials and in the modern world

    2023-04-06, 11:30 AM

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    David Adams
    David Adams, Associate Director, Global Clinical Supply Chain, Takeda

     David Admas David is a top performing Clinical Supply Chain Manager with over 15 years of pharmaceutical experience, ranging from stability testing, clinical packaging & labeling, and global clinical supply chain management.  He is both a leader and contributing member to many process improvement workstreams at Takeda that include being the Head of the Label Focus Group, developing and implementing clinical label text translation phrase library, guidance on Compassionate Use clinical programs, decentralized trials, and is the packaging & labeling subject matter expert for the Clinical Supply team.  David has presented at CTS conferences before on the topic of Direct-to-Patient delivery of IP supplies, but today is here to speak about best practices for Comparator Sourcing and Labeling.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-04-06, 9:00 AM

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    John Gregg
    Chairman and CEO at BalinBac Therapeutics, Inc.

    John Gregg, Pharmaceutical industry executive, John Gregg, has extensive experience in worldwide clinical development and commercialization of new anti-infective drugs. He has spent much of his career in senior roles directing the development and commercialization efforts for a large number of antibiotic, anti-protozoal, anti-fungal and anti-viral drugs. He is a veteran of new product development leadership positions at Pfizer, Novartis, J&J, BMS, and more recently his start-ups, Symbiomix Therapeutics, LifeQual Pharmaceuticals, and AkaRx. He is now the CEO of a BalinBac Therapeutics, Inc., a specialty infectious disease and microbiome modulation company. He was trained as a microbiologist and has led multi-disciplinary anti-infective drug development teams at the largest pharmaceutical companies, as well as small, private specialty firms directing the work of colleagues and contract laboratories

    Session Details:

    PANEL DISCUSSION: Looking at ethical and practical benefits of direct-to-patient models in clinical trials and the resulting challenges and expectations of the supply chain

    2023-04-05, 11:00 AM

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    Tyler Wilson
    Global Clinical Supply Chain Fellow, Takeda

    BS Chemistry from University of Minnesota in 2017

    PharmD from University of Minnesota College of Pharmacy in 2022

     

    Started as postdoctoral fellow in global clinical supply chain at Takeda in July 2022

    Session Details:

    Navigating Ancillary Management Challenges through Collaboration and Centralized Teams

    2023-04-05, 4:00 PM

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    Fred Moreau
    Director of Central Ancillary Supplies, Takeda

    Fred Moreau is the Director of Centralized Ancillary Supply Management at Takeda Pharmaceuticals.  His responsibilities include development & implementation of supply strategies to facilitate and support the delivery of ancillary supplies.

     

    Fred has over 20 years of experience in the pharmaceutical and medical device industry.  In his career he has been responsible for clinical and commercial supply planning for multiple programs; product lifecycle management; strategic sourcing; and planning for new product launches.  

    Session Details:

    Navigating Ancillary Management Challenges through Collaboration and Centralized Teams

    2023-04-05, 4:00 PM

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    Paul Larochelle
    Director, Global Clinical Supply Chain, Takeda

    Paul is an experienced, motivated, and enthusiastic professional/pharmacist specializing in the area of Clinical Supplies/Investigational Product Management. He aspires to make an impact on patient lives by motivating, inspiring, guiding, and mentoring teams to see the value of the work that they do and the contribution it makes to the lives of the patients we serve globally. With over 15 years of training and experience in this area, he has served in a multitude of roles, including study supply management, asset management (DS/API/DP Management), management and oversight of a secondary packaging operations team, site and resource planning, and development of multiple custom systems and tools to enable staff to work more efficiently and distribute information more readily.

    Session Details:

    Navigating Ancillary Management Challenges through Collaboration and Centralized Teams

    2023-04-05, 4:00 PM

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    Tomasz Adamusiak
    Chief Scientist, Clinical Quality and Data Science, MITRE

    Tomasz Adamusiak MD Ph.D. is a Chief Scientist in the Clinical Insights & Innovation Cell at MITRE. He leads a multi-disciplinary group driving high-impact contributions to private and public sectors in the Real-World Evidence, Genomic Data Science, and Digital Health space.

    Before MITRE, Tomasz was the Head of Data Science in the Pfizer Innovation Research (PfIRe) Lab. His team was responsible for developing novel digital endpoints, designing decentralized approaches for clinical trials, and applying AI/machine learning methods to generate novel insights from clinical data. He served in leadership and advisory roles in the American Medical Informatics Association, the SNOMED International, and the Epic Research Data Network. He published several highly-cited research papers in peer-reviewed journals and is a frequent speaker at life sciences conferences.

    Tomasz's interests are in the use of digital technology to improve health and healthcare. He believes strongly in empowering individuals to better manage their health and is passionate about the power of technology to facilitate these efforts and more broadly transform healthcare.

    Session Details:

    Using Real World Data and Evidence to Accelerate Clinical Trials

    2023-04-05, 10:00 AM

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    Susan Marlin
    President and CEO, Clinical Trials Ontario

    Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established by the Province of Ontario in 2012 to make Ontario a preferred location for global clinical trials while maintaining the highest ethical standards. Prior to joining CTO served as the Associate Vice-Principal at Queen’s University. Susan worked with the Canadian Cancer Trials Group for many years coordinating cancer clinical trials and leading the development and implementation of the Ethics, Regulatory, and International Office.

    Susan has actively engaged in research ethics for many years.  She served as President of the Canadian Association of Research Ethics Boards, as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research Ethics Board and the Tri-Agency Panel on the Responsible Conduct of Research. Susan is on the Board of Directors and Executive Committee of Life Sciences Ontario and the Management Team for the Ontario SPOR (Strategy for Patient-Oriented Research) Support Unit.  She is an Adjunct Lecturer at Queen’s University in Kingston, Ontario and is the nominated principal investigator on the CHEER Project, a Canadian Institutes of Health Research funded project to streamline research ethics review for child health research across Canada. 

    Susan was born and raised in Halifax, Nova Scotia. She holds a BSc (Hons) from Dalhousie University and an MSc in Community Health and Epidemiology from Queen’s University. She was awarded the Queen’s Elizabeth II Diamond Jubilee medal in 2012 in recognition of her work in support of military and veteran health research.

    Session Details:

    The Improving Clinical Trials Environment in Canada

    2023-04-05, 3:30 PM

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    James L. Sherley
    M.D., Ph.D. - President & Chief Executive Officer at Asymmetrex® LLC

    As President and CEO, James lead the development team of Asymmetrex® LLC. Asymmetrex® is a for-profit limited liability company with a mission of developing innovative tissue stem cell biotechnologies for applications in cellular medicine and drug development.

     

    Asymmetrex's lead tissue stem cell biotechnology is the first-in-kind method for specific and accurate counting of tissue stem cells. Asymmetrex's TORTOISE Test^TM kinetic stem cell (KSC) counting technology is freely available to the stem cell research, biomanufacturing, medical, and pharmaceutical communities. By providing early and easy access to the new technology (https://lnkd.in/dGru6Tc), Asymmetrex® is achieving its vision of accelerating progress in tissue stem cell science and medicine by enabling, for the first time in the 60+ year history of stem cell science and medicine, the routine determination of tissue stem cell number and treatment dosage.

    Session Details:

    An emerging clinical trials supply industry for therapeutic tissue stem cells

    2023-04-05, 11:45 AM

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    Kaitlin Bova
    Manager, Research Quality and Development, Moderna

    Kaitlin is working on the NIBR CQA team to manage quality issues by supporting clinical operations teams with root cause analysis and CAPA management to ensure patient safety and data integrity. She is also, actively involved in cross-divisional quality improvement projects focused on informed consent, inspection readiness, and quality culture.

    Session Details:

    Building a strong foundation for proactive quality improvement

    2023-04-06, 2:30 PM

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    Hyun Kim
    Head, Clinical Operations, AOBiome

    Hyun has been a part of AOBiome's clinical pipeline leadership since 2016. Hyun brings over 25 years of drug development experience in the pharma and biotech industry.  Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech.  He started his career at Genetics Institute and Wyeth, advancing R&D programs into the clinic.  He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

     

    AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes multiple clinical-stage programs in atopic dermatitis, rosacea, and acne, as well as additional programs targeting diverse inflammatory indications. 

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    Session Details:

    Strategies for growing a pipeline, accelerating decision making, set up the organization, in order to improve drug development

    2023-04-05, 2:30 PM

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    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

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

    Session Details:

    PANEL DISCUSSION: Looking at ethical and practical benefits of direct-to-patient models in clinical trials and the resulting challenges and expectations of the supply chain

    2023-04-05, 11:00 AM

    Session Details:

    State of the Biopharmaceutical Industry

    2023-04-05, 9:00 AM

    Session Details:

    Chairperson’s closing remarks

    2023-04-05, 4:30 PM

    Session Details:

    Chairperson’s opening remarks

    2023-04-06, 8:50 AM

    Session Details:

    Chairperson’s closing remarks

    2023-04-06, 3:30 PM

    Session Details:

    PANEL DISCUSSION: Maintaining optimal performance conditions of temperature sensitive products whilst ensuring compliance of complex regulations to ensure success of trials and ultimately their commercialization

    2023-04-06, 2:00 PM

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    Matthew L. Plaud
    Former President and Chief Operating Officer at SOTIO Biotech Inc.

    Session Details:

    PANEL DISCUSSION: Maintaining optimal performance conditions of temperature sensitive products whilst ensuring compliance of complex regulations to ensure success of trials and ultimately their commercialization

    2023-04-06, 2:00 PM

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    Melissa Morandi
    Vice President, Head of Global Quality, Sumitomo Pharma Oncology

    Session Details:

    PANEL DISCUSSION: Looking at ethical and practical benefits of direct-to-patient models in clinical trials and the resulting challenges and expectations of the supply chain

    2023-04-05, 11:00 AM

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    James L. Sherley
    M.D., PH.D, President & Chief Executive Officer, Asymmetrex

    James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex®, LLC.  Asymmetrex® develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting.  Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells.  Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees.  Prior to founding Asymmetrex®, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute.  Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.  He is also the author of a recently published new book, Missing Elements in the Public Science Supporting the COVID-19 Spread Narrative in the US.

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    Bharti Kansara
    Associate Director, Global Clinical Supply Chain, and Vendor Management, Takeda
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    Antoine Remiot
    Director Solutions Engineering, N-SIDE

    Antoine Remiot is N-SIDE's Director of Solutions Engineering. Over the past years, Antoine has been sharing his enthusiasm for lean clinical supply chain management, waste reduction, and sustainability with various pharma partners he supported in their change management journey toward digitalization.

    Antoine is passionate about leveraging data and AI to improve clinical supply efficiency. He gained expertise in forecasting, planning, IRT configuration, and end-to-end clinical supply chain optimization through his work on hundreds of trials on multiple indications.

    Session Details:

    Managing stockout risk without impacting patients and recruitment

    2023-04-05, 9:30 AM

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    Maxime Derep
    Clinical Supply Optimization Senior Solutions Engineer, 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.

    Session Details:

    Managing stockout risk without impacting patients and recruitment

    2023-04-05, 9:30 AM

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    Session Details:

    Case study in clinical supply chain innovation by TrialCard

    2023-04-05, 2:00 PM

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    Henk Dieteren
    Clinical Supply Chain Solutions Consultant, Suvoda

    As Clinical Supply Chain Solutions Consultant, Henk has been assisting Suvoda with his knowledge in various areas of clinical trial supply management since October 2020. Prior to joining Suvoda, Henk co-founded the clinical supply chain department at Grünenthal GmbH (Aachen - Germany) and served as Associate Director of this department for 10 years. At Grünenthal, Henk developed operational processes and promoted risk management procedures to establish the company as a clear market leader in the area of the clinical trial supply chain.

    Following his time at Grünenthal, Henk moved to BioNTech S.E. (Mainz - Germany) where he assumed the role of Senior Investigational Medicinal Product Manager. At BioNTech, he streamlined data processing in the clinical supply chain for personalized oncology therapies.

    Henk is an innovative expert in IRT, temperature excursion management and direct-to-patient logistics and a member of the DtP sub-team of the GCSG Regulatory e-Team.

    Session Details:

    Managing stockout risk without impacting patients and recruitment

    2023-04-05, 9:30 AM

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