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
  • Why attend?
  • 2024 Agenda
  • 2024 Speakers
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  • Sponsors
  • Media Centre
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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

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

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

Anthony Thomas
Consumer Safety Officer, FDA
Stephen King
Compliance Officer, FDA

9:30 AM

An insurance policy for your trial: Technology to enable a worry-free CTS execution

  • Overview of the challenges associated with drug shortages in clinical trials
  • Forecasting & planning technologies overview
  • How technology acts as a good insurance policy to prevent drug shortages and supply chain disruption
  • What if things don't go according to plan?

 

Speakers

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

10 AM

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

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

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

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

11:30 AM

Reserved for Mercalis

Speakers

Tom Gottschalk
Vice President, Business Development, Mercalis

12 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

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

12:30 PM

Reserved for S-Clinica

Speakers

Irena Seredina
Executive Director, S-Clinica
Jasvinder Osan
Vice President Business Development, S-Clinica

12:45 PM

Lunch and networking

1:45 PM

Digital supply chain and its impacts on clinical supply

  • Highlighting key challenges/complexities in the clinical supply chain
  • Digital Strategies for the optimal clinical supply chain
  • Discussing digital technologies (blockchain/AI) and its impact on the clinical supply chain

Speakers

Ajay Balasubramaniam
Associate Director Supply Chain Systems, Pfizer

2:15 PM

Fostering Skills Development and Mentorship in Clinical Supply Chain Management

  • Emphasizing the critical role of skills development and mentoring programs in fortifying the clinical supply chain against disruptions.
  • Highlighting the significance of these programs in enhancing patient experiences and achieving significant cost savings.
  • Showcasing attendees gaining insights into mitigating supply chain challenges through acquiring essential competencies and fostering mentorship relationships.
  • Demonstrating through real-world examples and interactive discussions the role of continuous learning and mentorship in promoting resilience, efficiency, and innovation in clinical trial supply chain management

Speakers

Yves Dethier
Business Leader, Boostcode

2:45 PM

Fostering a dynamic team culture for talent development within supply chain

  • 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

Paul Larochelle
Director, Global Clinical Supply Chain, Takeda
Sydney Reynolds
Postdoctoral Fellow - Global Clinical Supply Chain, Takeda

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

Sean Smith
Biological Threat Exclusion Coordinator, US Customs And Border Protection
Baljeet Kaur
Agriculture Operations Manager, US Customs and Border Protection

4:15 PM

Consolidate, Streamline, Scale: Achieve Operational Excellence with Unified EDC & RTSM

  • Consolidate Roles and Specs: Eliminate the need for separate EDC and RTSM requirements, builds and validation events, and manage both with a single, unified specification.
  • Streamline Workflows: Reduce complexity and bottlenecks by leveraging a single platform for EDC and RTSM, eliminating integration challenges.
  • Scale Efficiently: Focus on user acceptance testing vs software validation, reducing effort and complexity as your programs scale.

Speakers

William Lander
Sales Solutions Consultant, Presales, Oracle

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.
  • Effective use of technology to assist with planning and forecasting
  • 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

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData
Gilad Beck
Site Head, Operations and Manufacturing Director, Orgenesis
Kristen DeVito
Executive Director Clinical Supply Chain, Exelixis
Antoine Remiot
Director Solutions Engineering, N-SIDE

5:30 PM

Chairperson’s closing remarks

Speakers

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

END OF DAY 1 AND NETWORKING DRINKS

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 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 Baljeet Kaur, Agriculture Operations Manager, US Customs and Border Protection

ROUNDTABLE 2:

Fostering effective collaboration with suppliers and vendors across the clinical supply chain

Jillian Byrne, Senior Manager, Clinical Supply Chain, Disc Medicine

ROUNDTABLE 3:

Investigating the difference in forecasting perspective from a small company to a large one

Jennifer Case, Clinical Supply Chain Manager, Biogen

Speakers

Sean Smith
Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection
Baljeet Kaur
Agriculture Operations Manager, US Customs and Border Protection
Jennifer Case
Senior Manager, Clinical Asset Planning, Biogen
Jillian Byrne
Senior Manager, Clinical Supply Chain, Disc Medicine

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

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

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

Gilad Beck
Site Head, Operations and Manufacturing Director, Orgenesis

12:30 PM

The coming impact of new tissue stem cell quantification methods on cell supply for stem cell therapy and gene therapy clinical trials

  • New technologies for rapid and accurate quantification of tissue stem cells used for stem cell and gene therapy clinical trials
  • New capabilities for certifying cells supplied for stem cell therapy and gene therapy clinical trials
  • Future regulatory impact of emerging methods for certifying the specific dosage stem cells in cell therapy products

Speakers

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

1 PM

Lunch and networking

2:15 PM

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

  • The emergence of net-zero commitments and science-based targets to tackle climate change
  • Greenhouse gas accounting 101 – climate hotspots in the pharma value chain
  • Opportunities to drive decarbonization in clinical trial supply
  • Recent learnings from the implementation of Takeda’s net-zero roadmap

Speakers

Jessica Vieira
Global Value Chain Environmental Sustainability Strategy Lead, Takeda
Sarah Mandlebaum
Lead, Global Environmental Sustainability & Life Cycle Assessment, Takeda

2:45 PM

Metrics and KPIs in the Clinical Supply Chain’

  • Identifying the key Clinical Supply Chain Metrics to measure organizational performance
  • Shaping KPI and metrics targets
  • Maximizing the value that metrics can provide
  • Improving metrics access

Speakers

Bjoern Rosner
Global Lead, Clinical IRT and Supply Chain Digital Operations, Biogen

3:15 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

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData
Rakibou Ouro-Djobo
Global Clinical Supply Chain & Logistics Lead, Bill & Melinda Gates Medical Research Institute
Jamie Myers
Senior Manager Clinical Supply Chain, Takeda
Andrea Emery
Senior Director, Head of Quality Assurance Operations

4 PM

Chairperson’s closing remarks

Speakers

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

END OF CONFERENCE

2024 Speakers

Select a speaker to learn more

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Stephen King
Compliance Officer, FDA

Stephen is a Compliance Officer within the Division of North East Imports for the FDA. He started his career with the FDA in 2008 as a Consumer Safety Officer assigned to the former New England District Office in the Investigations Branch. He started off working within the foods group conducting routine inspections, and a short time later, switched to the import group. During his time in imports, he has been proficient at entry review and field activities playing a key role in identifying violative products. Stephen has also been praised for representing the FDA, for always participating in broker outreach and inter-government relations, as well as training his peers. In 2018 he was promoted to a Compliance Officer.

Session Details:

Importing FDA regulated Biological Products

2024-04-09, 9:00 AM

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Anthony Thomas
Consumer Safety Officer, FDA

Anthony has worked for the FDA since April of 2010 as an investigator in the BIMO, Foods and now import program area’s.

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 within supply chain

2024-04-09, 2:45 PM

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Sydney Reynolds
Postdoctoral Fellow - Global Clinical Supply Chain, Takeda

Sydney Reynolds, PharmD, MS, is the First Year Global Clinical Supply Chain Fellow at Takeda. Sydney graduated in May of 2023 from The Ohio State University College of Pharmacy with her PharmD and MS in Translational Pharmacology specializing in Clinical Pharmacology and Clinical Trial Design. Before that, she received her BS in Chemistry and Biology from the University of Indianapolis. Throughout pharmacy school, she was a Clinical Pharmacy Intern at The OSU James Cancer Hospital, where she was also heavily involved in research. She held leadership positions in Student College of Clinical Pharmacy (SCCP) and was a PharmD Ambassador for the college. For Sydney, pharmaceutical research is where her two passions collide – science and healthcare. She is excited to jumpstart her career with her fellowship and begin improving the lives of patients in the biopharmaceutical industry.

Session Details:

Fostering a dynamic team culture for talent development within supply chain

2024-04-09, 2:45 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:

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, 12:00 PM

Session Details:

Chairperson’s closing remarks

2024-04-09, 5:30 PM

Session Details:

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

2024-04-09, 4:45 PM

Session Details:

Chairperson’s opening remarks

2024-04-10, 8:50 AM

Session Details:

Chairperson’s closing remarks

2024-04-10, 4:00 PM

Session Details:

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

2024-04-10, 3:15 PM

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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

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Jessica Vieira
Global Value Chain Environmental Sustainability Strategy Lead, Takeda

Jessica Vieira, PhD, leads the global value chain environmental sustainability strategy at Takeda Pharmaceutical Company. She has a decade of experience in environmental sustainability strategy across the chemical, consumer electronics and food technology industries and holds a PhD focused on life cycle assessment as well as a background in environmental engineering. In her role at Takeda, Jessica leads the Scope 3 greenhouse gas emissions reduction program aimed at achievement of the company’s goal to reach net-zero across the value chain before 2040.

Session Details:

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

2024-04-10, 2:15 PM

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

Sarah Mandlebaum is a dedicated sustainability professional serving as the Lead for Global Environmental Sustainability & Life Cycle Assessment at Takeda in Lexington, Massachusetts. With a strong foundation in sustainability, she currently leads Takeda’s work around measuring the sustainability performance of Takeda’s products. Sarah holds a Master of Business Administration (MBA) from the Yale School of Management and a Master of Public Health (MPH) in Environmental Health from the University of Michigan.

Session Details:

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

2024-04-10, 2:15 PM

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

Rakib Ouro-Djobo is an empowering servant and a dedicated supply chain management leader focused on providing global access to life-saving treatments and life-changing opportunities. He has over 12 years of experience supporting mission-driven organizations in the life science and biotech industries. Currently, he works as the Clinical Supply Chain Lead for the 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, 3:15 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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Jamie Myers
Senior Manager Clinical Supply Chain, Takeda

Jamie Myers is a skilled and experienced pharmacist with a strong background in clinical research and inpatient hospital pharmacy operations. With a Pharm.D. from Saint Louis College of Pharmacy and a PGY-1 Residency from Duke University Medical Center, Jamie has a solid foundation in pharmaceutical knowledge and patient care.

Currently serving as Senior Manager of Global Clinical Supply Chain at Takeda, Jamie oversees the coordination and management of investigational oncology medication for phase I/2 research studies. Prior to this role, Jamie worked as a Clinical Research Pharmacist Specialist at Brigham and Women’s/Dana Farber Inpatient Hospital. There, she worked for investigational drug services and dispensed research medications for therapeutic areas like critical care, emergency room, oncology, neurology, dermatology, and rheumatoid arthritis. Jamie gained first-hand experience with gene therapy, viral vectors, and COVID-19 vaccines, and was involved in the design and implementation of clinical research studies.

Before joining Mass General Brigham, Jamie served as a Clinical Coordinator for Drug Trials at Maine Medical Center, where she handled both clinical research and pharmacy responsibilities. Jamie was responsible for dispensing, accountability, and advising for phase II through IV studies, and worked closely with CRAs for site evaluations, audits, and closeouts.

Jamie's career also includes experience as a Pharmacy Operations Manager at Winchester Hospital and as a Medical Science Liaison (Clinical Science Manager) at Abbott. She has been involved in accelerated oncology programs, served as a preceptor for fellowship programs, and has been recognized as a subject matter expert in temperature excursions. Jamie has also contributed to various publications and research studies in the field of pharmacy.

With a strong commitment to patient care and research excellence, Jamie has demonstrated her ability to effectively manage clinical trials, collaborate with multidisciplinary teams, and ensure the highest standards of pharmaceutical care.

Session Details:

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

2024-04-10, 3:15 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, 10:00 AM

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Baljeet Kaur
Agriculture Operations Manager, US Customs and Border Protection

Baljeet Kaur is an Agriculture Operations Manager (AOM) for U.S. Customs and Border Protection (CBP) at the Boston Field Office (BFO) consisting of six New England States (MA, ME, VT, NH, CT, and RI).  As an AOM, Ms. Kaur is charged with providing guidance to personnel within the BFO on various agriculture matters including, but not limited to: regulated garbage compliance, regulation of biological material, and entry requirements for regulated agriculture commodities.  Ms. Kaur has more than 15 years of public service with CBP, and has worked in a variety of environments including, air passenger, air cargo, and maritime.

Session Details:

Investigating the necessities surrounding the import and export of biological materials

2024-04-09, 3:45 PM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-04-10, 9:00 AM

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Bjoern Rosner
Global Lead, Clinical IRT and Supply Chain Digital Operations, Biogen

Session Details:

Metrics and KPIs in the Clinical Supply Chain’

2024-04-10, 2:45 PM

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Jennifer Case
Senior Manager, Clinical Asset Planning, Biogen

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-04-10, 9:00 AM

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Irena Seredina
Executive Director, S-Clinica

Irena Seredina’ background is medicine, economics and management. She holds an MD, honors diploma and a MSc in Health Economics. During her medical practice,  Irena  worked in clinical research as a researcher and an investigator. The results of her research have been published in a number of articles and she is a recognized speaker at several industry forums and international conferences.  Irena worked at Amgen, and then joined S-Clinica in 2004. Now, as  Executive Director Irena gives direction for the product strategy and customer relationships.

Session Details:

Reserved for S-Clinica

2024-04-09, 12:30 PM

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Jasvinder Osan
Vice President Business Development, S-Clinica

Jas started his career in the 90s, as a data manager within clinical trials when these were done predominantly on paper - and has over the years seen the industry change and evolve.

He has a degree in Applied Physics, and has worked over the last 25 years within eClinical technologies and solutions, with global responsibilities in project management, solutions consulting and sales. Jas's role within S-CLINICA is to bring new business, and build strategic relationships with customers.

Session Details:

Reserved for S-Clinica

2024-04-09, 12:30 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:

The coming impact of new tissue stem cell quantification methods on cell supply for stem cell therapy and gene therapy clinical trials

2024-04-10, 12:30 PM

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Yves Dethier
Business Leader, Boostcode

Yves Dethier, a distinguished figure in clinical supply chain management, serves as CEO of Boostcode, enhancing supply chain efficiency for biotech firms. With a rich background advising industry leaders like GSK and J&J, he's also the founder of ClinOps Academy, a platform nurturing talent and skills in clinical operations through mentoring and development programs.

Session Details:

Fostering Skills Development and Mentorship in Clinical Supply Chain Management

2024-04-09, 2:15 PM

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Jillian Byrne
Senior Manager, Clinical Supply Chain, Disc Medicine

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-04-10, 9:00 AM

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Kristen DeVito
Executive Director Clinical Supply Chain, Exelixis

Kristen DeVito is a dedicated leader in the Clinical Trials industry, with a strong commitment to optimizing global supply chains and prioritizing patient needs. As the Executive Director of Clinical Supply at Exelixis, she leads a team that supports the development of the company’s oncology pipeline. With over twenty-five years of experience, she has a proven track record in clinical supply chain solutions, clinical supplies management, operations improvement, and client engagement.

In her past roles, she served as the Vice President of North America Operations and Vice President of Customer Service Excellence and Project Management in Clinical Supplies at Catalent Pharma Solutions.

Beyond her professional commitments, Kristen actively contributes to the industry. She is a committee member of the Biotech Supply Management Alliance (BSMA) and has previously held positions as a committee member and chair of the ISPE Investigational Products CoP Steering Committee.  She has also shared her expertise as an instructor for the Center for Professional Advancement course on Clinical Trial Materials.

Session Details:

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

2024-04-09, 4:45 PM

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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:

PANEL DISCUSSION Discovering the evolution in the clinical supply chain

2024-04-09, 4:45 PM

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Jake Levine
Solutions Engineer, N-SIDE

Session Details:

An insurance policy for your trial: Technology to enable a worry-free CTS execution

2024-04-09, 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 partners with the optimization of multiple trials and programs from different therapeutics areas. 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:

An insurance policy for your trial: Technology to enable a worry-free CTS execution

2024-04-09, 9:30 AM

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Ajay Balasubramaniam
Associate Director Supply Chain Systems, Pfizer

Digital Supply Chain Enthusiast. Built a career in Digital Supply Chain while working through ERP and other implementations in various healthcare organizations. Led Digital transformation programs for large Biotech's and other global Supply Chain Planning initiatives. Experienced in systems integrations through M&A's. Very excited with what the future holds from a Digital Supply Chain standpoint.

Session Details:

Digital supply chain and its impacts on clinical supply

2024-04-09, 1:45 PM

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Andrea Emery
Senior Director, Head of Quality Assurance Operations

Andrea earned her B.S. in Biotechnology and M.S. in Biology and then began her career in the lab working on process development and validation before transitioning to a quality role.  Andrea has spent time in Quality Systems, Compliance, and Operations positions but now specializes in leading a QA Operations team supporting the CMC functions of early phase clinical programs through commercialization.

Session Details:

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

2024-04-10, 3:15 PM

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