22nd Annual Clinical Trial Supply East Coast 2024

Covering all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world.

5 - 6

November

2024
  • Sheraton Valley Forge, King of Prussia, PA, USA
  • Free
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
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  • Event Gallery
  • Sponsors
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Why attend?

BRINGING TOGETHER PHARMA AND BIOTECH EXPERTS TO DISCUSS NEW TRENDS AND OPPORTUNITIES

The Clinical Trial Supply East Coast is the meeting place for the pharmaceutical and biotechnology community to discover how to excel in clinical supply strategy as well as form key connections for long-term success. It’s time to build relationships and take away valuable lessons to for clinical trial success moving forward so we look forward to seeing you there!

300+

Attendees

35+

Exhibitors

20+

Speakers

300+

Attendees

35+

Exhibitors

20+

Speakers

See What It's All About

Agenda

  • 5 Nov 2024
  • 6 Nov 2024
Expand All

Streams

Stream one

Clinical Supply Logistics and Operations

Stream two

Clinical Supply Technology and Innovation

11 AM

PANEL: Incorporating artificial intelligence and machine learning into clinical supply chains

  • Opportunities created by AI and ML that can help optimize clinical supply chains
  • How AI and ML can help reduce costs and transit times while maintaining product integrity
  • Navigating regulatory factors linked to using AI and ML in clinical trials in the US
  • Utilizing AI to improve processes
  • Where to implement and integrate AI into supply chain processes in order to improve efficiency

Speakers

Deirdre Casale
Senior Director, Supply Chain, Alnylam Pharmaceuticals
Maxime Derep
Director of Solutions Engineering, N-SIDE

11:30 AM

Implementing sustainable sourcing practices for commercial medicines in your clinical trials

  • Understanding the commercial medicine supply chain inside out
  • Predicting the future: data, analytics, AI and market intelligence
  • Review regularly
  • Back-up and risk mitigation
  • Learn from experiences: case studies

Speakers

Ian Hoban
Business Development Director, Abacus Medicine
Lucy Fox
Business Development Director, Abacus Medicine

12 PM

CASE STUDY: The e-reader for clinical trial medication: a Digital Display Labeling (DDL) system to replace traditional paper labels and booklets in clinical trials

  • Clinical supply chain evolution: using new technology to adapt
  • Understanding Digital Display Label technology and integrating it into the clinical supply chain
  • Opportunities to benefit from the flexibility the Digital Display Label system can provide
  • Transformative vision for the pharmaceutical industry

Speakers

Jennifer Wittman
Associate Director, Global Clinical Supplies Project Manager, Merck

12:30 PM

Reserved for session sponsor

Speakers

Yves Dethier
Business Leader, Boostcode

1 PM

Lunch and networking

2 PM

How to recruit, train, and retain talent for Supply Chain 4.0

  • Addressing scarcity of supply chain talent in the market
  • Recruiting strategies: looking internally first, external hires to challenge thinking, recruiting from internal supply chain for customer-facing roles, and leveraging university co-op programs
  • Training and development should focus on comprehensive development plans, cross-functional exposure, leveraging tech eg AI/automation, encouraging risk-taking, and implementing mentorship programs
  • Diversity and inclusion: going beyond ethnicity to diversity of thought/experience, using employee resource groups, and fostering a sense of belonging
  • Building an agile team: storytelling/influencing skills, understanding the bigger picture impact, and challenging the status quo

Speakers

Nirav Shah
Director, Clinical Drug Supply & Logistics

2:30 PM

Reserved for session sponsor

3 PM

CASE STUDY: Development and training initiatives: considerations for supply chain teams

  • An overview of Takeda’s initiatives around staff development: what worked and what didn’t?
  • Effectiveness of different recruitment, training and long term development initiatives: how did this impact sourcing and retaining talent?
  • Looking forward: evolving current training initiatives to set up for future success

Speakers

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

3:30 PM

Afternoon refreshments and networking

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

4 PM

PANEL: Opportunities for innovation in clinical supply chains: what is on the horizon?

  • Emerging trends and technologies for clinical supply chains in the US: what’s new in 2024?
  • Exploring the potential of blockchain, IoT, and other digital technologies to revolutionize clinical supply chains
  • Automation in supply chains: how can this streamline processes and reduce human error
  • How IRT systems can optimize clinical supplies, improving efficiency and accuracy
  • An overview of new tools and solutions available on the market

 

Speakers

Deirdre Casale
Senior Director, Supply Chain, Alnylam Pharmaceuticals
Jennifer Wittman
Associate Director, Global Clinical Supplies Project Manager, Merck
Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals
Tom Gottschalk
Vice President, Business Development, Mercalis

4:30 PM

Reserved for session sponsor

5:30 PM

Chairperson’s closing remarks

Speakers

Paul Larochelle
Director, Global Clinical Supply Chain, Takeda

7:30 AM

Registration and refreshments

8:25 AM

Chairperson’s opening remarks

Speakers

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

8:30 AM

Selecting a CMO partner for your clinical supply chain: what are the main factors to consider?

  • Assessing the CMO's experience and track record in clinical trial supply management
  • Evaluating capabilities in placebo and comparator sourcing, including quality control measures
  • Understanding flexibility and scalability to accommodate varying trial requirements
  • Establishing clear communication channels and alignment of goals for seamless collaboration

Speakers

Joshua Anderson
Manager, Logistics Strategy Clinical Supply Chain, Janssen Research & Development

9 AM

Aligning clinical supply strategies with sustainability goals

Increasingly pharmaceutical companies are committing to reduce their carbon footprints in the execution of clinical trials. This session will cover how implementing innovative clinical trial supply technologies and sustainable processes can:

  • result in a more efficient use of human resources
  • reduce the number of logistical resources required
  • reduce waste
  • save money
  • lower the carbon footprint impact

Speakers

Robbie Hill
Director, Business Development, Mercalis

9:30 AM

Clinical supply chain innovation: insights into new technology and strategy

  • Cutting edge technologies and incorporating these into your clinical supply chain
  • Sustainability and incorporating eco-friendly initiatives in clinical supply chain management
  • Collaborative platforms: improving communication and efficiency among stakeholders
  • Success stories, transformative case studies and key takeaways

Speakers

Victoria Vargo
Director, Clinical Supply, Karyopharm Therapeutics

10 AM

CASE STUDY: A journey to achieving end-to-end clinical supply chain optimization

  • What is end-to-end optimization and why does it matter?
  • Insights from a real-world case study demonstrating significant cost & efficiency gains: Sanofi’s Demand and Supply Integration Ecosystem (DASIE) project
  • Journey encompassing all supply chain actors, key benefits, impact, and integration in the overall IT landscape
  • How you can enhance your clinical supply chain performance

Speakers

Isaac Greenslade
Director, Head of Demand and Supply Innovation and Transformation, Sanofi
Pauline Deplasse
Head of Marketing and Strategy, N-SIDE

10:30 AM

Morning refreshments and networking

11 AM

Topic TBC

Speakers

Christina Paleopanidis
Director, Global Clinical Supply Chain, Incyte

11:30 AM

Reserved for 4G Clinical

12 PM

Optimizing clinical trial supply chain efficiency through CTPAT/Trade Compliance

  • Ensuring compliance with Customs and Border Protection (CBP) regulations: a discussion of Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise (PHC-CEE), the benefits of joining the CTPAT Trade Compliance (TC) program and how to become eligible
  • Strengthening supply chain security and reducing the risk of delays at the border: understanding the CBP's expectations of importers and how the CTPAT TC program can assist in meeting these requirements
  • Enhancing the efficiency of clinical trial supply management: how participation in the CTPAT TC program can streamline the import process and lead to more timely and cost-effective delivery of materials

Speakers

Mary Zhang
National Account Manager, US Customs and Border Protection

12:30 PM

Reserved for CSI

Speakers

Vanessa Dekou
Managing Director, CSI

1 PM

Lunch and networking

2 PM

Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

  • Balancing cost alongside other considerations when selecting vendors
  • Key factors to consider when choosing vendors and partners in clinical supply
  • Advantages and disadvantages of choosing large vs small vendors
  • Working with international partners: additional challenges and how to address these

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

2:30 PM

Through the sponsors eyes: providing innovative clinical supply services through a sponsor-centric approach

  • Leveraging the power of people, experiences and technology to deliver results
  • Speed, flexibility, reliability, quality, cost: your clinical supply chain can have it all
  • Examples of innovative approaches that provide more efficient alternatives to traditional processes
  • Exploring technologies that can be used to reduce cycle time and cost

Speakers

Rocco Barone
Senior Vice President, Clinical Supply Management, Clinigen
Randa Atiyeh
Vice President, CSM Client Services, Clinigen

3 PM

Mitigating risk and planning for unforeseen circumstances: protecting your clinical supply chain

  • Preparing for the unexpected: building contingency protocols in from the start of a trial
  • Planning for unforeseen events and incorporating this into your risk management strategy: what events such as the Baltimore Bridge collapse have taught us
  • Incorporating risk assessment into project management plans in order to be better prepared for every eventuality
  • How to reduce risk caused by supply chain delays

Speakers

Haneen Mazahreh-Boivert
Senior Director Global Clinical Supply, Boston Pharmaceuticals

3:30 PM

Afternoon refreshments and networking

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

4 PM

Optimizing comparator sourcing processes for your clinical trial

  • Designing your comparator sourcing strategy: key factors to consider for your clinical trial
  • Exploring strategies for reliable and cost-effective sourcing: what solutions are available?
  • Addressing regulatory considerations and compliance challenges for comparator sourcing both in the US and from overseas
  • Leveraging technology and data analytics to streamline comparator sourcing processes

Speakers

Francesco Santo
Associate Director, Clinical Supply Lead, Exelixis

4:30 PM

Reserved for session sponsor

5:30 PM

Chairperson’s closing remarks

Speakers

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

5:35 PM

NETWORKING DRINKS RECEPTION

Streams

Stream one

Clinical Supply Logistics and Operations

Stream two

Clinical Supply Technology and Innovation

9 AM

Transporting temperature sensitive drugs to remote areas: how to reduce risk

  • Tools and technology available to reduce the risk of excursions when transporting temperature sensitive drugs to rural or remote areas
  • Storage and warehousing of temperature sensitive drugs in areas with low levels of infrastructure
  • Effective planning and forecasting to ensure drugs are delivered in a timely manner and avoid risks associated with transport delays

Speakers

Bannikuppe Shivanna
Director, Quality Control

9:30 AM

Reserved for session sponsor

10 AM

CASE STUDY: Innovations in real time monitoring for temperature controlled clinical supply chains

  • An overview of solutions available for real time monitoring: pros and cons of different methods
  • Successfully integrating real time monitoring equipment while remaining cost-conscious
  • Risks and limitations of processes for monitoring temperature: how to mitigate against this to avoid temperature excursions and product waste

Speakers

Ellyn Ensby
Manager, Temperature Management and Control, Clinical Supply Chain, Janssen
Kristin Corcoran
Temperature Management and Control Lead, Janssen

10:30 AM

Morning refreshments and networking

11 AM

Optimizing cold chain logistics and improving green credentials to ensure the integrity of your products end-to-end

  • Latest technological advances and innovative systems adopted by the industry to enhance cold chain distribution: what should be on your radar?
  • Sustainability: aligning market growth with responsible practices to ensure businesses are making smarter decisions
  • Efficiently and effectively outsourcing management of temperature-sensitive materials to ensure your cold chain is never compromised
  • Expanding capacity on cold chain resources and enhancing end-to-end management to keep up with increasing demand and limited supplies

Speakers

Luiz Barberini
Head of External Manufacturing, Latin America, Bayer

11:30 AM

Reserved for session sponsor

12 PM

PANEL: Sustainability in temperature controlled logistics: ensuring you minimize your carbon footprint

  • • Making environmentally conscious choices when selecting packaging materials: what options are available and which are the most sustainable?
  • • Pros and cons of active and passive containers when it comes to sustainability
  • • Methods of lowering the carbon footprint of temperature supply chains beyond just packaging
  • • Balancing cost, quality and sustainability in temperature controlled supply chains
  • • How can your temperature related operations contribute to meeting both internal and external sustainability targets?

Speakers

Bannikuppe Shivanna
Director, Quality Control

12:30 PM

Lunch and networking

8 AM

Registration and refreshments

9 AM

PANEL: Considerations and best practice for working effectively with vendors and partners

  • The importance of integrated systems with CMOs: how much integration is useful?
  • Considerations when choosing technology partners in order to facilitate a strong partnership
  • Balancing degree of oversight over vendors and partners: how involved should you be?
  • Designing your vendor strategy: is it beneficial to work with multiple vendors or with one single partner?

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
Reid Tonik
Senior Director, Clinical Supply Chain, Eikon Therapeutics
Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals
Victoria Vargo
Director, Clinical Supply, Karyopharm Therapeutics

9:30 AM

Reserved for session sponsor

10 AM

Patient centricity in clinical trial supply chains: where could biopharma do more to support patients?

  • Ensuring timely delivery of trial medications to patients: options such as DTP and flexible scheduling
  • Avoiding one size fits all: exploring methods for gathering insights into patient preferences regarding medication packaging, delivery methods and scheduling
  • Exploring initiatives to involve patients in decision-making processes and clinical trial supply chain design

Speakers

Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

10:30 AM

Morning refreshments and networking

11 AM

Breaking down silos in the clinical supply chain: how transparency supports robust and efficient planning

  • Promoting open communication channels for timely information sharing
  • Aligning goals and timelines to optimize resource allocation
  • Utilizing digital tools for real-time data sharing and visibility
  • Fostering a culture of collaboration and mutual support
  • Implementing consistent metrics and reporting standards for continuous improvement

Speakers

George Cortez
Director, Clinical Supplies, on assignment at Endo

11:30 AM

Reserved for session sponsor

12 PM

CASE STUDY: IMP supply to EU countries under EU-CTR

  • The impact of the European CTR on IMP supply
  • Bridging the gap between CTD and CTR: what you need to know and how to navigate this
  • Challenges around labeling and ensuring your labels meet CTR requirements

Speakers

Yosuke Ito
Manager, Program Management, Research and Development, NS Pharma

12:30 PM

Lunch and networking

1:30 PM

Navigating multiple regulatory agencies to help expedite supply chain times

  • Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
  • Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
  • Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
  • Learning about valuable resources and contacts for assistance

Speakers

Elliot N. Ortiz
Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection

2 PM

Reserved for session sponsor

2:30 PM

Exploring expected trends with clinical supply chain needs from CDMOs

  • Emerging demands, flexibility and scalability in clinical supply chains
  • Integration of advanced technologies: AI, machine learning, and IoT for better tracking and efficiency
  • Assessing opportunities for incorporating sustainability practices and reducing carbon footprint
  • Enhanced collaboration and fostering stronger partnerships between sponsors and CDMOs
  • Data-driven decision-making: utilizing big data analytics for supply chain optimization

Speakers

Katarina Zahedi
Analyst, GlobalData Healthcare

3 PM

Afternoon refreshments and networking

3:20 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

3:30 PM

SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the clinical supply chain industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

ROUNDTABLE 1: Importing and exporting biological materials to or from the U.S
Elliot N. Ortiz, Chief Agriculture Specialist, Area Port of Philadelphia, U.S. Customs and Border Protection

ROUNDTABLE 2: Handling vendor relationships in clinical trial supply chains
Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

ROUNDTABLE 3: Just in time labeling: pros and cons for your trial
Chris Campbell, Associate Director, Clinical Drug Supply and Logistics, REGENERON

Speakers

Elliot N. Ortiz
Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection
Luiz Barberini
Head of External Manufacturing, Latin America, Bayer
Chris Campbell
Associate Director, Clinical Drug Supply and Logistics, REGENERON

4:30 PM

End of Conference

Streams

Stream one

Clinical Supply Logistics and Operations

4:30 PM

Reserved for session sponsor

Speakers

Select a speaker to learn more

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Ian Hoban
Business Development Director, Abacus Medicine

Ian has over 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle.

During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches.

Before joining Abacus Medicine Pharma Services Ian worked in senior roles at two leading global clinical solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful comparator sourcing solutions which helped successfully deliver their pivotal late phase clinical trials.

Session Details:

Implementing sustainable sourcing practices for commercial medicines in your clinical trials

2024-11-05, 11:30 AM

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Lucy Fox
Business Development Director, Abacus Medicine
  • 11 years clinical trial service experience
  • Worked closely with multinational pharmaceutical, virtual and biotechnology companies to define their clinical trial requirements. Acting as a consultant on technical aspects
  • Experienced in the management of IVRS technology for clinical trials
  • Worked closely with drug supply managers to effectively manage global supplies including forecasting and procurement from phase I to extensive phase III trials
  • Can develop creative solutions to fulfill customer needs

Session Details:

Implementing sustainable sourcing practices for commercial medicines in your clinical trials

2024-11-05, 11:30 AM

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Bannikuppe Shivanna
Director, Quality Control

Biopharmaceutical professional of over 20 years with demonstrated capability across broad areas of CMC functions, specialized in cGMP analytical methods, technology transfer and CRO/CSP management. Over 15+ years of QC and technical operations management including compliant labs, quality systems, robust stability program, global reference standard and critical reagent program. Expertise in bioanalysis of small molecule, protein, mAb, vaccine products and biomarker for PK/PD, release, stability and product characterization studies. CMC support for IND, NDA and BLA submissions. Expertise in cGMP method validation for product/process/equipment/facility and systems. Contributed to success of commercial programs of anthrax vaccine and Erbitux; multiple oncology mAb products including cancer immunotherapy product Keytruda®. Depth in diverse areas of structure-function and applied studies on proteins. Enterprise focused leader of high quality results and project deliverables with team work and collaboration. Strategic and motivational leader committed to build high-performance teams with mentoring and coaching. Thorough understanding of regulatory guidelines, operational excellence, continuous process and performance improvements. Detail oriented, adept in written, verbal and interpersonal communication, and business savvy public speaking. Creation and setting-up of new functional biophysical and immunochemistry labs.
GOALS: Work for companies and organization engaged in innovation and problem solving in vast areas of pharmaceutical development for human needs.

Session Details:

Transporting temperature sensitive drugs to remote areas: how to reduce risk

2024-11-06, 9:00 AM

Session Details:

PANEL: Sustainability in temperature controlled logistics: ensuring you minimize your carbon footprint

2024-11-06, 12:00 PM

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Deirdre Casale
Senior Director, Supply Chain, Alnylam Pharmaceuticals

Session Details:

PANEL: Incorporating artificial intelligence and machine learning into clinical supply chains

2024-11-05, 11:00 AM

Session Details:

PANEL: Opportunities for innovation in clinical supply chains: what is on the horizon?

2024-11-05, 4:00 PM

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Nirav Shah
Director, Clinical Drug Supply & Logistics

Pharmaceutical professional with 20 years experience in managing global clinical supply chain activities including strategic planning and forecasting of clinical supply budgets, FTE's, supply requirements and IRT development. Also responsible for managing and maintaining relationships with CRO's, distribution vendors, suppliers, and packaging vendors.

Session Details:

How to recruit, train, and retain talent for Supply Chain 4.0

2024-11-05, 2:00 PM

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HANEEN MAZAHREH-BOIVERT
Sr. Director, Global Clinical Supply, Optinose

Haneen Mazahreh-Boivert is a global clinical supply expert and end to end supply chain advocate.  Throughout her 15+ year career, she has worked and consulted for numerous companies of varying footprints.  Haneen has successfully established and led numerous clinical supply chains from forecasting and planning, to vendor selection and management, clinical manufacturing and global distribution, to site management and drug accountability.  Her mantra is the right supplies at the right place at the right time and focuses her knowledge of operational excellence, KPI improvement, and process optimization to achieve this goal and build efficiencies into her projects. 

She is a graduate of the American University, Rowan University, and Yale University with BS. Chemical Engineering, MS. Chemical Engineering, and Certification of Executive Leadership respectively.  Haneen is active in the Global Clinical Supply circuit, has published several articles and regularly speaks at industry conferences.  She is also active in Women in Engineering groups.   

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Vanessa Dekou
Managing Director, CSI

Vanessa is the MD of Clinical Services International (CSI) a leading provider of Clinical Trial Supplies to the Biopharmaceutical Industry. Vanessa started her career as a research associate at Scotland Yard. Subsequently she worked for leading CROs and with some of the largest biopharmaceutical and Biotechscompanies to provide innovative solutions. She has extensive experience in drug development from Preclinical to registration and commercialization strategies and has secured product registration for several orphans and first in class drugs. She has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and Masters in Market Access from University m University of Lyon.

Session Details:

Reserved for CSI

2024-11-05, 12:30 PM

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Reid Tonik
Senior Director, Clinical Supply Chain, Eikon Therapeutics

Global clinical supply chain expert with over 20 years of industry experience and a proven track record of successfully managing multiple clinical trial programs and teams from initial design through study close-out. Experience includes a 2-year international assignment, team and budget management, and optimizing departmental productivity by identifying opportunities for greater efficiencies and quality.

Session Details:

PANEL: Considerations and best practice for working effectively with vendors and partners

2024-11-06, 9:00 AM

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George Cortez
Director, Clinical Supplies, on assignment at Endo

As Director and Principal Consultant, George leads the Clinical Supply Consulting (CSC) team, providing strategic planning support to customers and partners. With over two decades of clinical supply chain experience, his focus is on patient-centric innovation, fostering collaboration, and driving results.  George is currently on assignment at Endo USA leading their Clinical Supplies department.

Prior to joining CSC, George held previous leadership positions at Almac Clinical Services, ICON, Janssen Biotech, and Merck & Co., where he served as subject matter expert in multiple areas within the global clinical supply chain. George has a proven track record of spearheading high-profile programs across diverse therapeutic areas in R&D, affirming his expertise as a clinical supplies leader.

Session Details:

Breaking down silos in the clinical supply chain: how transparency supports robust and efficient planning

2024-11-06, 11:00 AM

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Francesco Santo
Associate Director, Clinical Supply Lead, Exelixis

A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

  • Strategic Supply Chain Management
  • Regulatory Compliance
  • Cross-Functional Collaboration
  • Risk Management
  • Innovative Problem-Solving

Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

Session Details:

Optimizing comparator sourcing processes for your clinical trial

2024-11-05, 4:00 PM

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Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

Session Details:

PANEL: Considerations and best practice for working effectively with vendors and partners

2024-11-06, 9:00 AM

Session Details:

Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

2024-11-05, 2:00 PM

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Ellyn Ensby
Manager, Temperature Management and Control, Clinical Supply Chain, Janssen

Ellyn Ensby is a self-proclaimed generalist, with roles and experiences across plan, source, make, and deliver functions, and through the varied lenses of commercial, R&D, pharmaceuticals and consumer products.  She is a passionate people leader and is focused on evolving temperature management into a key capability and advantage for the Clinical Supply Chain.  Ellyn holds a B.S. in Interdisciplinary Engineering & Management from Clarkson University, and an MBA from DeSales University.  

Session Details:

CASE STUDY: Innovations in real time monitoring for temperature controlled clinical supply chains

2024-11-06, 10:00 AM

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Kristin Corcoran
Temperature Management and Control Lead, Janssen

With an extensive background in pharmaceutical chemistry, Kristi brings a vast knowledge of product quality to the table. Utilizing her innovative strategic thinking and patient centricity, she focuses on delivering projects with emphasis on improving quality within the Clinical Supply Chain. Kristi holds a BS in Chemistry from Delaware Valley University, a Masters in Analytical Pharmaceutical Chemistry from The Illinois Institute of Technology, and several industry certifications.

Session Details:

CASE STUDY: Innovations in real time monitoring for temperature controlled clinical supply chains

2024-11-06, 10:00 AM

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Jennifer Wittman
Associate Director, Global Clinical Supplies Project Manager, Merck

Session Details:

CASE STUDY: The e-reader for clinical trial medication: a Digital Display Labeling (DDL) system to replace traditional paper labels and booklets in clinical trials

2024-11-05, 12:00 PM

Session Details:

PANEL: Opportunities for innovation in clinical supply chains: what is on the horizon?

2024-11-05, 4:00 PM

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Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

Session Details:

Patient centricity in clinical trial supply chains: where could biopharma do more to support patients?

2024-11-06, 10:00 AM

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Yosuke Ito
Manager, Program Management, Research and Development, NS Pharma

Session Details:

CASE STUDY: IMP supply to EU countries under EU-CTR

2024-11-06, 12:00 PM

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Chris Campbell
Associate Director, Clinical Drug Supply and Logistics, REGENERON

Session Details:

SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

2024-11-06, 3:30 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:

CASE STUDY: Development and training initiatives: considerations for supply chain teams

2024-11-05, 3:00 PM

Session Details:

Chairperson’s closing remarks

2024-11-05, 5:30 PM

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Elliot N. Ortiz
Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection

Elliot Ortiz is a Chief CBP Agriculture Specialist with U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO) in the Area Port of Philadelphia.  Mr. Ortiz began his career in December 2000 in the Port of Mayaguez, Puerto Rico.  Mr. Ortiz has more than 22 years of public service with CBP, and has worked in a variety of environments, including on the pre-clearance, maritime, air passenger, and cargo locations.  He has also been able to assist in several past domestic and international CBP events.

Session Details:

SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

2024-11-06, 3:30 PM

Session Details:

Navigating multiple regulatory agencies to help expedite supply chain times

2024-11-06, 1:30 PM

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Mary Zhang
National Account Manager, US Customs and Border Protection

Mary Zhang – National Account Manager since 2009, at the Center of Excellence and Expertise for the Pharmaceuticals, Health and Chemicals (PHC-CEE) with U.S Customs and Border Protection (CBP). Ms. Zhang's previous experience includes serving as a Senior Import Specialist for the Trade Operations Division in the Port of New York/Newark, and Chicago. Previously she worked for the Revenue Management at the United Airlines.

Session Details:

Optimizing clinical trial supply chain efficiency through CTPAT/Trade Compliance

2024-11-05, 12:00 PM

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Maxime Derep
Director of Solutions Engineering, 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:

PANEL: Incorporating artificial intelligence and machine learning into clinical supply chains

2024-11-05, 11:00 AM

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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

2024-11-05, 8:25 AM

Session Details:

Chairperson’s closing remarks

2024-11-05, 5:30 PM

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Katarina Zahedi
Analyst, GlobalData Healthcare

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Exploring expected trends with clinical supply chain needs from CDMOs

2024-11-06, 2:30 PM

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Christina Paleopanidis
Director, Global Clinical Supply Chain, Incyte

Christina has over 20 years experience in Pharma holding various positions within Clinical Operations, Medical Affairs, Project Management, and the last 5 years in Global Clinical Supply Chain.

Throughout the course of her career, she has provided support across all phases of Sponsor Clinical Studies at Incyte, GSK, Bristol Myers Squibb, and Gilead Sciences, as well as management of Expanded Access Programs and Investigator initiated trials.

She currently holds the position of Director, Global Clinical Supply Chain at Incyte, with a focus in patient-centric forecasting, strategic planning, and distribution of drug supply for Incyte's portfolio.

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Topic TBC

2024-11-05, 11:00 AM

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Joshua Anderson
Associate Director, Logistics Strategy, Clinical Supply Chain, Johnson & Johnson Innovative Medicine
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Rocco Barone
Senior Vice President, Clinical Supply Management, Clinigen

Rocco joined Clinigen in 2022 to spearhead the Clinigen Clinical Supplies Management (CCSM) business unit.  His background of 20+ years in clinical supply along with his passion for operational excellence and continuous improvement have helped transform CCSM into an industry leading provider of clinical services.

Prior to his time at Clinigen, Rocco spent 18 years in the clinical supply division at Merck & Co., Inc. His last position, before joining Clinigen in 2022, was Director and Site Head of Merck US Clinical Supply Operations.

Rocco holds a Bachelor’s in Chemistry and a Master’s in Business from Moravian University.

Session Details:

Through the sponsors eyes: providing innovative clinical supply services through a sponsor-centric approach

2024-11-05, 2:30 PM

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Randa Atiyeh
Vice President, CSM Client Services, Clinigen

Randa is a proven leader committed to building high-performing teams and robust processes to deliver exceptional service.  She has over 20+ years as sponsor and vendor in the clinical supply industry making her an expert in the end-to-end supply chain.

Her areas of expertise are Forecasting & Planning, Supply Planning, Project Management, Comparator Sourcing, Demand & Supply Balancing, Business Analytics, System Implementation and Continuous Improvement.

Randa joined Clinigen in 2022 and has global oversight of the Project Management team and Proposals & Contract Management.

Prior to her time at Clinigen, Randa was at Merck & Co. in various roles focused in clinical supply.

Randa holds a Bachelor’s in Commerce and Engineering from Drexel University.

Session Details:

Through the sponsors eyes: providing innovative clinical supply services through a sponsor-centric approach

2024-11-05, 2:30 PM

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Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

Session Details:

PANEL: Considerations and best practice for working effectively with vendors and partners

2024-11-06, 9:00 AM

Session Details:

PANEL: Opportunities for innovation in clinical supply chains: what is on the horizon?

2024-11-05, 4:00 PM

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Victoria Vargo
Director, Clinical Supply, Karyopharm Therapeutics

Session Details:

Clinical supply chain innovation: insights into new technology and strategy

2024-11-05, 9:30 AM

Session Details:

PANEL: Considerations and best practice for working effectively with vendors and partners

2024-11-06, 9:00 AM

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Robbie Hill
Director, Business Development, Mercalis

Session Details:

Aligning clinical supply strategies with sustainability goals

2024-11-05, 9:00 AM

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Tom Gottschalk
Vice President, Business Development, Mercalis

Tom has worked in the life sciences industry for over 26 years, with the first 10 as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis 16 years ago, created the RxStudy Card offering in 2009 and for the past 14 years has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency through the RxStudy Card.

Session Details:

PANEL: Opportunities for innovation in clinical supply chains: what is on the horizon?

2024-11-05, 4:00 PM

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Pauline Deplasse
Head of Marketing and Strategy, N-SIDE

Pauline has over 7 years of dedicated experience in clinical supply optimization, working with more than 30 sponsor companies of all sizes. She specializes in enhancing supply chain resilience and efficiency through advanced forecasting and planning techniques. Her work integrates technology and data to streamline processes, reduce environmental impact, and boost overall efficiency.

Session Details:

CASE STUDY: A journey to achieving end-to-end clinical supply chain optimization

2024-11-05, 10:00 AM

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Isaac Greenslade
Director, Head of Demand and Supply Innovation and Transformation, Sanofi

Isaac Greenslade has over 18 years of experience in clinical supply chain, clinical development, and CMC project management. He is currently the Head of Demand and Supply Innovation and Transformation at Sanofi, where he drives strategic initiatives to enhance operational efficiency, foster innovation, and optimize supply chain planning across the R&D organization.

Session Details:

CASE STUDY: A journey to achieving end-to-end clinical supply chain optimization

2024-11-05, 10:00 AM

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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:

CASE STUDY: Development and training initiatives: considerations for supply chain teams

2024-11-05, 3:00 PM

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Jennifer Fenwick
Senior Manager, Logistics and Distribution, Vertex Pharmaceuticals
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Chris Wallace
Head of Distribution EMEA, Argenx

Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution EMEA.

He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.

Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

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Luiz Barberini
Head of External Manufacturing Latin America, Bayer
  • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
    Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
  • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
  • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
  • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
  • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
  • Solid team management skills, as well as Customer Service relationship and management
  • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

Session Details:

PANEL: Considerations and best practice for working effectively with vendors and partners

2024-11-06, 9:00 AM

Session Details:

PANEL: Opportunities for innovation in clinical supply chains: what is on the horizon?

2024-11-05, 4:00 PM

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Francesco Santo
Associate Director, Clinical Supply Lead, Exelixis

A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

  • Strategic Supply Chain Management
  • Regulatory Compliance
  • Cross-Functional Collaboration
  • Risk Management
  • Innovative Problem-Solving

Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

Session Details:

Optimizing comparator sourcing processes for your clinical trial

2024-11-05, 4:00 PM

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Arnaud Dourlens
Head of Clinical Trial Supply, Sanofi

Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group. During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio. Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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Paul Larochelle
Director Global Clinical Supply Chain Planning, Takeda

Paul Larochelle has over 17 years of experience in a variety of positions within Clinical Supplies, including roles in clinical planning, production scheduling and planning, secondary packaging operations management, and business expert for a clinical inventory management system. Paul currently leads a team of Clinical Planning Leads at Takeda and is a member of the Global Clinical Supply Chain (GCSC) Leadership Team. He also oversees Takeda’s GCSC Post-PharmD Fellowship Program in partnership with the Massachusetts College of Pharmacy and Health Sciences (MCPHS). Paul’s prior organizations include Genzyme/Sanofi and Biogen, supporting therapies across all indications and stages of development.

In addition to his primary responsibilities, Paul served as a coordinator of Pharmacy Industry Fellowships for the Genzyme/Sanofi MCPHS Fellowship Program (2009-2014) and precepted over 50 pharmacy students interested in a career in industry for several schools. He is currently the Chair of the Dean’s Advisory Board for MCPHS Boston School of Pharmacy and a member of the Pharmacy Advisory Board for Western New England University. He is also a member of the Clinical Trial Supply Conference Series Advisory Board.

Paul completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with Genzyme/MCPHS, a Doctorate in Pharmacy from MCPHS, an MBA from Worcester Polytechnic Institute, and a degree in Biology from Providence College. Paul has also served previously as President of the Board of Directors for the Massachusetts Pharmacists Association (MPhA), and as President of the MCPHS Alumni Association.

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+44 (0) 207 9472755

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+44 (0) 20 4540 7796