Clinical Trial Supply New England 2023

Arena International are thrilled to announce we will be returning with full force to Waltham in 2023 to celebrate another edition of the Clinical Trial Supply show. We are back to in-person!

  • The Westin Waltham, Boston, MA, United States
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2023?

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.

100+

Attendees

30+

Exhibitors

20+

Speakers

65%

Attendees at Director+ level

100+

Attendees

30+

Exhibitors

20+

Speakers

65%

Attendees at Director+ level

See What It's All About

2023 Agenda

  • 5 Apr 2022
  • 6 Apr 2022
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8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

OPENING KEYNOTE: Ensuring that quality patients are enrolled and retained using AI to help generate quality data and reduce wastage of time sensitive products

  •          Mitigating huge financial loss as an incentive to using AI in the initial stages of clinical trial, finding eligible participants via simplification of data entry criteria, analysis of hospital records and social media, direct communications with clinicians and patients

             Improving patient experience through AI by facilitating access to information and contact points whilst reducing dropout rate via identification of non-compliance or prediction of adverse events

             Addressing issues with data management and inherent bias in datasets when implementing AI to help streamline cohort selection resulting in increased trial efficacy potential

Speakers

9:30 AM

Reserved for N-Side

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

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

11:45 AM

Reserved for Event Sponsor

12:15 PM

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

12:45 PM

Lunch and networking

1:45 PM

GlobalData research

         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

2:15 PM

Reserved for Trial Card

2:45 PM

Growing pipeline strategy, metres to accelerate decision making, organisational design all to improve drug development

·       Strategic design of pipeline growth

·       Methods to accelerate decision-making in Ph1-2 trials

·       Team culture by organizational design

Speakers

3:15 PM

Afternoon refreshments and networking

3:45 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

4:15 PM

Available for event sponsor

4:45 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

5:15 PM

Chairperson’s closing remarks

Speakers

8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

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.

 

ROUNDTABLE 1:  IRTs and just-in-time packaging, labelling, and shipment strategies for efficient CTS life cycle

Hyun Kim, Vice President, Clinical Operations, AOBiome Therapeutics

ROUNDTABLE 2: Best practice for Comparator Labelling

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

   

 

ROUNDTABLE 3:  Effectively strategizing cold chain logistics operations

David Sokoloff, Sr. Director Global Logistics and Materials Management, Novavax

ROUNDTABLE 4: Innovation in integrating supply models, decentralized clinical trials and technology

Isaac Rodrigues-Chavez, Former Senior VP-Scientific and Clinical Affairs and FDA officer

 

Speakers

10:30 AM

Morning refreshments and networking

11 AM

Lessons learnt: Stability of IMPs

         Considering the numerous situations that can render IMPs entirely ineffective or even toxic. How to avoid errors made in transit and storage to avoid products being rejected or causing safety concerns.

 

         Communicating stability data as a function of temperature and cumulative time to determine of the IMP is still feasible based on documented time-out-of-environment (TOE).

 

         Maintaining consistent environmental conditions and avoiding weak management and monitoring of sensitive materials so avoid impacts to study outcomes and extremely costly delays. 

Speakers

11:30 AM

Available for event sponsor

12 PM

Keynote: The CBP perspective, ensuring youR Clinical Supplies pass US border control

         Understanding CPB and FDA requirements, documentation and permit requirements to expedite smooth import and export of clinical supply shipments 

         Pinpointing the importance of adhering to packaging and labelling criteria with regards to infectious IPs and global biosecurity

 

         Outlining which biological products may have transportation restrictions that must be factored into you clinical supply chain strategy

Speakers

12:30 PM

Lunch and networking

1:30 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

2:15 PM

Building strong foundations for proactive quality improvement to mitigate medication errors in clinical Research

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

2:45 PM

Future Technologies that could Power Drug Development

Frank Leu, CEO, Novapeutics

Speakers

3:15 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

3:45 PM

Chairperson’s closing remarks

2023Speakers

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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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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, 3:15 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, 1:30 PM

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Tomasz Adamusiak
Chief Scientist, Clinical Insights and Innovation Cell, 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, 3:45 PM

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John Gregg
Chairman and CEO, 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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Amanda Murphy
Director of Product Management, GlobalData

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:

Chairperson’s opening remarks

2023-04-06, 8:50 AM

Session Details:

GlobalData research

2023-04-05, 1:45 PM

Session Details:

Chairperson’s closing remarks

2023-04-05, 5:15 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, 1:30 PM

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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 strong foundations for proactive quality improvement to mitigate medication errors in clinical Research

2023-04-06, 2:15 PM

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Giovanni Abbaessa
VP, Head, Oncology Early Development, Sanofi Genzyme

Session Details:

Growing pipeline strategy, metres to accelerate decision making, organisational design all to improve drug development

2023-04-05, 2:45 PM

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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 CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S. Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England.

Session Details:

Keynote: The CBP perspective, ensuring youR Clinical Supplies pass US border control

2023-04-06, 12:00 PM

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David Sokoloff
Sr. Director Global Logistics and Materials Management, Novavax

David Sokoloff is the Director of Global Logistics & Materials Management for Novavax, Inc. He manages the storage and transportation of Novavax’s products through its global network. David founded For Granted, Inc. in 2006, a nonprofit supporting community driven programming in education, water and sanitation, micro-finance, and child health.

 

David has managed supply chains for emergency relief efforts across the Globe. He ran operations in the field for several years with Doctors Without Borders, prior to working in Washington, D.C., leading logistics operations for the U.S. Office of Foreign Disaster Assistance. At the onset of the COVID-19 outbreak, David joined Novavax, Inc. He supports their global supply chain to deliver products preventing a broad range of infectious diseases. Novavax produces vaccine candidates in response to both known and emerging disease threats, including the company’s CoVID-19 vaccine.

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, 1:30 PM

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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: Stability of IMPs

2023-04-06, 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, 4:45 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, 4:45 PM

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Angelo Termine
CEO and Director, New England Institute for Clinical Research

Angelo Termine is the Chief Executive Officer and President of Ki Health Partners LLC doing business  as New England Institute for Neurology and Headache,  New England Institute for Clinical Research, our clinical research center, as well as Ki Clinical Research, a site  management organization (SMO) providing business, development and regulatory expertise to medical practices wishing to engage in clinical research.

Angelo started his career in research at Yale University, School of Medicine, Department of Psychiatry in New Haven.  He then transitioned to Research Manager at a large neurology practice in Fairfield, where he participated in more than 100 studies, and successfully lead a team of clinical research coordinators for more than eight years before the launch of Ki Health Partners, LLC. In addition to holding master’s degrees in science management and business administration, Angelo is certified as a Clinical Research Associate, Clinical Research Coordinator,  and Clinical Research Contract Professional. He is a certified rater with extensive experience on the following scales: NIH Stroke Scale, ADAS-Cog, NPI, MMSE and multiple clinical psychiatric assessment certifications. He is a member of MAGI (Models Agreements and Guidelines International) as well as the Headache Cooperative of New England, has lectured extensively on clinical research throughout the country,  and has coauthored numerous scientific papers.

Session Details:

OPENING KEYNOTE: Ensuring that quality patients are enrolled and retained using AI to help generate quality data and reduce wastage of time sensitive products

2023-04-05, 9:00 AM

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Hyun Kim
Vice President, Clinical Operations, AOBIome Therapeutics

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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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, 12:15 PM

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Frank Leu
CEO, Novapeutics

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

Session Details:

Future Technologies that could Power Drug Development

2023-04-06, 2:45 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, 4:45 PM

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Isaac Rodriguez-Chavez
Former Senior VP-Scientific and Clinical Affairs and FDA officer

Isaac R Rodriguez-Chavez, PhD, is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology.  His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research, and post-marketing studies.  Currently, he is a Senior Vice President for Scientific & Clinical Affairs, leading the Strategy of the Decentralized Clinical Trials, ICON plc. Past positions in the last 33 years include FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Decentralized Clinical Trials enabled by Digital Health Technologies; CEO/Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs, NIH; Senior Clinical Scientist, Schering Plough Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He issued the first US Good Clinical Laboratory Practice (GCLP) Guidelines to improve the consistency of clinical laboratory endpoints supporting trials globally, published numerous scientific and technical articles, and has been an invited speaker in over 100 global conferences.  He has a PhD in Virology and Immunology; an MS in Microbiology; an MHS in Clinical Research; and a BS in Biology.  He has 5 years of post-doctoral specialty training in Infectious Diseases, Viral Immunology, Viral Oncology, and Clinical Research.  Dr Rodriguez-Chavez is a Board Member of the Scientific Leadership of the Digital Medical Society (DiME).  He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally.  He is a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering initiatives on DCTs and DHTs.  He is a Leadership Council Board member of the Decentralized Trials & Research Alliance (DTRA) and Co-Chair of DTRA’s Regulatory Council; a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA); and a Rare Disease Health Equity Board Council member of the Global Genes.  He is a Global Content Editor for Regulatory Science at the DIA Global Forum Magazine.  He is also an active member is fourteen professional associations, including the 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.  

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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Plan Your Visit

Venue

The Westin Waltham Boston 70 Third Avenue, Waltham, USA, MA 02451

Sponsors

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SESSION SPONSORS

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Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Jaz Sidhu

Senior Sponsorship Manager

+44 (0) 207 9472755

SPEAKING OPPORTUNITIES

Flora Bagnall

Event Producer

+44 (0)207 936 6870

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

Sponsorship Enquiries

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

 

Jaz Sidhu

Senior Sponsorship Manager


+44 (0) 20 7947 2755

Speaker Enquiries

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

 

Flora Bagnall