13th Annual Clinical Trial Supply New England 2024

Arena will be returning to the Westin Waltham for our 2024 Clinical Trial Supply, New England conference. The event will showcase talks from top industry players, unrivaled networking opportunities and the chance to find cutting-edge solutions in the exhibition hall.

9 - 10

April

2024
  • The Westin Waltham Boston, MA, USA
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2024?

The annual Clinical Trial Supply conference is a leading summit for discovering exclusive expert-led insight, featuring major bio-pharma companies such as AstraZeneca 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. Anticipate comprehensive insights into regulatory frameworks from the FDA and US Customs and Border Protection, ensuring a robust understanding of compliance. Additionally, the conference will call attention to discussions on sustainability and drug waste management, emphasizing the industry’s commitment to responsible practices.

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

100+

Attendees

30+

Exhibitors

20+

Speakers

See What It's All About

2024 Agenda

  • 9 Apr 2024
  • 10 Apr 2024
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8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

9 AM

Importing FDA regulated Biological Products

  • Entry Screening/Admissibility
  • FDA Regulatory Requirements for CBER Regulated Products
  • Making ACE Work for You: Importing Biological Products

Speakers

9:30 AM

Reserved for N-Side

10 AM

Optimizing forecasting: size-phase appropriate approaches

  • Implementing forecasting techniques tailored to the specific size and phase of the project.
  • Discussing strategies for dynamically adjusting forecasting methods as the project progresses through different phases
  • Exploring how size-phase appropriate forecasting can enhance risk management and improve decision-making in diverse project scenarios

Speakers

10:30 AM

Morning refreshments and networking

11 AM

Modernizing the way drugs are made: a transition to continuous manufacturing

  • Exploring batch vs continuous manufacturing
  • Pinpointing benefits of continuous manufacturing- reduced manufacturing costs, particularly over the long term, shorter production times, improved quality
  • A challenging but worthwhile transition revamping industry infrastructure

Speakers

11:45 AM

Reserved for Mercalis

12:15 PM

State of the biopharma industry: the outlook for drugs, trials, and manufacturing

  • What’s coming in the pharma pipeline?
  • Drug manufacturing for clinical trials
  • Emerging trends: gene therapy, mRNA, and AI
  • Opportunities for contract development and manufacturing organisations (CDMOs)

Speakers

12:45 PM

Lunch and networking

1:45 PM

Optimizing drug utilization: strategies to tackle drug waste in healthcare

  • Exploring how precision medicine and personalized dosing can be leveraged to minimize drug overuse and reduce waste, considering factors such as patient variability and therapeutic response.
  • Discussing improvements in supply chain management to prevent overstocking and expiration of medications, emphasizing collaboration between healthcare providers and pharmaceutical suppliers to streamline inventory and reduce waste.
  • Highlighting the importance of patient education and adherence initiatives in reducing unnecessary drug consumption, and explore how healthcare professionals can work with patients to enhance understanding and compliance, ultimately minimizing medication waste

Speakers

2:15 PM

Reserved for Boostcode

2:45 PM

A greener future for patients: the pharma supply chain’s journey to net-zero

  • Starting sustainability
  • Discovering continuous manufacturing as a way to generate 80% less carbon emissions
  • Exploring new technology to entirely replace natural resources with a fermentation-based method
  • Reducing carbon emissions caused by cold chain shipping by investing in greener fuels and energy sources for transport vehicles

Speakers

3:15 PM

Afternoon refreshments and networking

3:45 PM

Investigating the necessities surrounding the import and export of biological materials

  • Emphasizing the critical role of thorough preparation
  • What relevant authorities to contact in advance to avoid unnecessary complications
  • CBP One – an application that allows scheduling inspection appointments in advance for biological products upon their air arrival into the U.S.
  • Understanding what Importer of Record is and how to become a registered one

Speakers

4:15 PM

Reserved for event sponsor

4:45 PM

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

  • Exploring the role of emerging technologies, such as blockchain, IoT, and AI, in revolutionizing the clinical supply chain and discuss how these innovations enhance visibility, traceability, and efficiency.
  • Discussing the evolving regulatory landscape and its impact on the clinical supply chain, focusing on how industry players are navigating compliance challenges and ensuring alignment with changing regulations.
  • Examining the shift toward patient-centricity in clinical trials and its influence on the supply chain, emphasizing how personalized medicine, decentralized trials, and direct-to-patient models are shaping the evolution of clinical supply strategies.

Speakers

5:30 PM

Chairperson’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into three ‘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:

A Q&A session examining U.S. Customs and Border Protection – help with any questions about how to import or export biological materials to or from the U.S.* 

Sean Smith, Biological Threat Exclusion Coordinator, US Customs and Border Protection

ROUNDTABLE 2:

Effective strategies for strengthening the relationship with CDMOs 

Rajiv Panwar, VP, CMC, Technical Operations and Clinical Supply Chain, Disc Medicine

ROUNDTABLE 3:

Exploring Effective Strategies for Small Sponsors to Select the Right Vendor and Ensure High Quality Output

ROUNDTABLE 4:

Understanding Impacts of New EU Clinical Trial Regulation on Supply ChainSean Smith

Speakers

10:30 AM

Morning refreshments and networking

11 AM

Understanding strategies for preventing shortages and enhancing resilience in supply chain

  • Delving into the importance of building resilient clinical supply systems, exploring technologies and methodologies that enhance agility and responsiveness to prevent shortages in the face of unforeseen challenges
  • Discussing strategies for effective comparator sourcing, addressing potential bottlenecks, and exploring partnerships or alternative sourcing approaches to ensure a stable and consistent supply of comparators for clinical trials
  • Explore considerations and approaches for removing comparators from the free market, examining the potential impact on supply stability and discussing measures to mitigate market-related risks, ensuring a reliable and sustainable clinical supply chain

Speakers

11:30 AM

Reserved for event sponsor

12 PM

Exploring how decentralized manufacturing can enhance clinical trial supply

  • High level overview of decentralized manufacturing – understanding what it means, the approach and how it’s done in practice
  • Recognizing how decentralized manufacturing can improve resilience of clinical trial supply
  • Maximizing upstream and downstream clinical supply efficiency through a decentralized framework
  • Envisioning the future of decentralized manufacturing and exploring its potential

Speakers

12:45 PM

Lunch and networking

2 PM

Fostering a Dynamic Team Culture for Talent Development

  • Cultivating collaborative team dynamics
  • Emphasizing the value of diverse thinking for problem-solving and creative solutions
  • Implementing ongoing training programs to upskill team members and address skill gaps
  • Providing mentorship and coaching opportunities to nurture individual growth

Speakers

2:30 PM

PANEL DISCUSSION Harmonizing temperature excursion management: navigating conflicting policies at investigative sites

  • Addressing the challenges of integrating site-specific temperature excursion policies with the sponsor's requirements and proposing effective strategies for alignment.
  • Emphasizing the importance of open communication between sponsors and investigative sites to identify and resolve conflicts in temperature excursion management procedures.
  • Exploring the implementation of standardized procedures that accommodate both site-specific policies and sponsor requirements, ensuring effective temperature excursion management while respecting local protocols

Speakers

3 PM

Chairperson’s closing remarks

END OF CONFERENCE

2024 Speakers

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Anthony Thomas
Consumer Safety Officer, FDA

Session Details:

Importing FDA regulated Biological Products

2024-04-09, 9:00 AM

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Sean Smith
Biological Threat Exclusion Coordinator (BTEC), 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/ Biological Threat Exclusion. 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 has more than 17 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:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-04-10, 9:00 AM

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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:

Fostering a Dynamic Team Culture for Talent Development

2024-04-10, 2:00 PM

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Sydney Reynolds
Postdoctoral Fellow - Global Clinical Supply Chain, Takeda

Session Details:

Fostering a Dynamic Team Culture for Talent Development

2024-04-10, 2:00 PM

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Amanda Murphy
Senior Director, Data Intelligence & Solutions, Global Data

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:

Chairperson’s opening remarks

2024-04-09, 8:50 AM

Session Details:

State of the biopharma industry: the outlook for drugs, trials, and manufacturing

2024-04-09, 12:15 PM

Session Details:

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

2024-04-09, 4:45 PM

Session Details:

PANEL DISCUSSION Harmonizing temperature excursion management: navigating conflicting policies at investigative sites

2024-04-10, 2:30 PM

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Scott Sutton
Senior Director, Clinical Supply Chain, Constellation Pharmaceuticals, a MorphoSys company

Scott Sutton is an accomplished supply chain professional with over 15 years bio-pharma experience, currently leading global supply chain Stealth BioTherapeutics, a clinical phase bio-pharmaceutical company working the rare disease space.  He has managed global clinical supplies for Stealth BioTherapeutics, Flexion Therapeutics, and Karyopharm Therapeutics across all phases of clinical development and expanded access programs.  Scott also has many years commercial supply chain leadership experience, including 2 successful US product launches.

Session Details:

Optimizing forecasting: size-phase appropriate approaches

2024-04-09, 10:00 AM

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Rajiv Panwar
VP, CMC, Technical Operations and Clinical Supply Chain, Disc Medicine

Session Details:

Modernizing the way drugs are made: a transition to continuous manufacturing

2024-04-09, 11:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-04-10, 9:00 AM

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Jessica Vieira
Global Value Chain Environmental Sustainability Strategy Lead, Takeda

Session Details:

A greener future for patients: the pharma supply chain’s journey to net-zero

2024-04-09, 2:45 PM

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Sarah Mandlebaum
Lead, Global Environmental Sustainability & Life Cycle Assessment, Takeda

Session Details:

A greener future for patients: the pharma supply chain’s journey to net-zero

2024-04-09, 2:45 PM

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Rakibou Ouro-Djobo
Global Clinical Supply Chain & Logistics Lead, Bill & Melinda Gates Medical Research Institute

Session Details:

Understanding strategies for preventing shortages and enhancing resilience in supply chain

2024-04-10, 11:00 AM

Session Details:

PANEL DISCUSSION Harmonizing temperature excursion management: navigating conflicting policies at investigative sites

2024-04-10, 2:30 PM

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Gilad Beck
Site Head, Operations and Manufacturing Director, Orgenesis

Gilad Beck serves as the Natick, MA Site Head, Operations and Manufacturing Director at Orgenesis. He holds a BSc in Biotechnology and has over 10 years of experience working in the cell and gene therapy industry, in leading manufacturing, process development and project management roles. His background includes extensive knowledge of various cell and gene therapy processes, process development, tech transfer, closed and automated systems and GMP operations. Mr. Beck is also an expert in building cross-functional high performing teams. He utilizes his skills and experience to lead the Natick, MA site set up and operations as part of Orgenesis’ POCare Network that brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of life-saving therapies.

Session Details:

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

2024-04-09, 4:45 PM

Session Details:

Exploring how decentralized manufacturing can enhance clinical trial supply

2024-04-10, 12:00 PM

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Agnes Jung
VP, Head of Clinical Development and Operations, Bridge Biotherapeutics

Session Details:

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

2024-04-09, 4:45 PM

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Jamie Myers
Senior Manager Clinical Supply Chain, Takeda

Session Details:

PANEL DISCUSSION Harmonizing temperature excursion management: navigating conflicting policies at investigative sites

2024-04-10, 2:30 PM

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Lisa Kaufman
Director, Quality, Process and Risk Management, AstraZeneca

Seasoned R&D Industry professional with over 30 years of experience in large pharma, mid-sized, start-up and virtual settings. Career appointments span the full spectrum of product life-cycle management, across every phase of development and every research platform, including pharmaceuticals, biologics, devices, combination products, gene and stem cell therapeutics, Phases I-IV. Achievements include contribution to the US and International market approval of 6 biopharmaceutical products.

Session Details:

Optimizing drug utilization: strategies to tackle drug waste in healthcare

2024-04-09, 1:45 PM

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Plan Your Visit

Venue

The Westin Waltham Boston

70 Third Avenue, Waltham, MA 02451, US

Accommodation

Please be aware that should you be contacted by any 3rd party housing companies that they are not affiliated with us or the hotel.

Sponsors

Select a sponsor to learn more

FEATURED SPONSOR

SESSION SPONSOR

EXHIBITORS

Why partner?

Your brand will be in direct contact with end users who need to explore solutions and new offerings that tailor to consumer trends within a wide range of beverage categories such as juice, water, tea, energy drinks, no and low, carbonated, and other.

This conference presents a vital chance for you to engage with decision-makers, demonstrate your solution’s value proposition in an intimate, industry-specific environment, and help you cut through the noise of your competitors.

Contact us to become a partner

Partnership Opportunities

We work with you to design a bespoke package to meet your business needs, where you could:

  • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
  • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

Event reach

  • 150+ attendees each year
  • 80% attendees C-suite level

 

Take a look at our current sponsors

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Jaz Sidhu

Senior Sponsorship Manager

+44 (0) 207 9472755

SPEAKING OPPORTUNITIES

Joanne Murphy

Conference Producer

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate 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:

 

Ralitsa Pashkuleva

Conference Producer