Why attend?
Agenda
Speakers
Plan Your Visit
Event Gallery
Sponsors
Media Centre
Contact Us
Download Agenda

Clinical Trial Supply East Coast 2023

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

11 - 12

October

2023

Sheraton Valley Forge, King of Prussia, PA, USA
Free

Back

Company Information

N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

Company Website

To learn more, please visit our website - https://lifesciences.n-side.com/

Next Sponsor

Back

Company Information

4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

Company Website:http://www.4gclinical.com/

Next Sponsor

Back

Company Information

Abacus Medicine Clinical Trial Services is part of The Abacus Medicine Group. Abacus Medicine was founded in 2004 by CEO Flemming Wagner to improve access to original prescription medicines throughout Europe. Over the past five years, to expand its geographic footprint to the USA and APAC regions, the company has developed a range of Clinical Trial Services including tailored comparator sourcing and clinical packaging & labelling.

Company Website

To learn more, please visit our website - https://www.abacusmedicine-cts.com/

Next Sponsor

Back

Company Information

Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

Company Website

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

Next Sponsor

Back

Company Information

YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

Company Website

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

Next Sponsor

Back

Company Information

Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

Company Website

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

Next Sponsor

Back

Company Information

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

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

Company Website

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

Next Sponsor

Back

Company Information

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

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

Company Website

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

Next Sponsor

Back

Company Information

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

Next Sponsor

Back

Company Information

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

Company Website

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

Next Sponsor

Back

Company Information

BMclinical, your global clinical trial supply partner. We offer worldwide commercial medicine supply, from analytical samples to bulk comparators, through to the supply of co-meds and pre-meds. We can pack and label your IMP/commercial medicines from our GMP facility, where we also offer storage and distribution services. BMclinical is uniquely positioned to offer solutions for overage and unused clinical trial stock.

Company Website

To learn more, please visit our website - https://www.bmclinical.com

Next Sponsor

Back

Company Information

Boostcode helps biotech companies to improve the performance of their clinical programs.

We are a small team of dynamic , multi-skills and motivated professionals (quality, CMC, Supply Chain, Procurement, Site engagement, Regulatory, …) available to provide strategic and operational support.

We also provide trainings and business coaching to your staffs.

Company Website

To learn more, please visit our website - https://www.boostcode.eu

Next Sponsor

Back

Company Information

Brocacef operates throughout the entire pharmaceutical chain, lending us an unique position as a wholesaler in the Dutch pharmaceutical healthcare industry. With expertise in global logistics, sourcing and supply chain experience Brocacef is able to offer a variety of services for clinical trials.

Company Website

To learn more, please visit our website - www.brocacef.nl

Next Sponsor

Back

Company Information

Labels for spirits are unique in their need for high-quality decorations and unique embellishments – no matter the size of the run. CCL Label is committed to delivering excellence in printing and service for all customers whether large or small.

Quality is never sacrificed: state-of-the-art technology and equipment guarantee the highest quality of label production.

Service is priority: CCL offers a strong customer service, building partnerships that last a lifetime.

Company Website

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

Next Sponsor

Back

Company Information

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

Company Website

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

Next Sponsor

Back

Company Information

Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

Company Website

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

Next Sponsor

Back

Company Website

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

Next Sponsor

Back

Company Information

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,160 employees in 108 locations in 53 countries as at June 30, 2023. For further information about ICON, visit: www.iconplc.com.

Company Website

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

Next Sponsor

Back

Company Information

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

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

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

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

Company Website

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

Next Sponsor

Back

Company Information

NULL

Company Website

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

Next Sponsor

Why attend?

We are excited to be hosting the next edition of Clinical Trial Supply East Coast on the 11th and 12th of October 2023 in the Sheraton King of Prussia.

The conference covers all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world. Our expert panel will deliver case studies, thought leadership pieces, interactive panels and roundtable discussions.

Clinical Trial Supply East Coast offers opportunities for both learning and networking with peers from across the CTS sphere, via informal networking breaks and lunches, as well as a relaxed drinks reception at the end of Day 1.

Our day one includes speakers from Pfizer, Merck, Janssen and many more who will be covering the latest innovations in the clinical supply industry. The day will be split into two different streams, with a clinical supply operations category as well as a stream highlighting great innovation and technological updates.

Our conference continues into day two with some exciting talks covering the latest in IRT systems, some exciting case studies and a talk from the FDA.

Don’t miss out, join us in King of Prussia on the 11^th and 12^th of October 2023.

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

Testimonials

See What It's All About

Agenda

11 Oct 2023
12 Oct 2023

Expand All

Download Agenda

Streams

Stream one

Clinical Supply Logistics and Operations

Stream two

Clinical Supply Technology and Innovation

11:15 AM

PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

Key considerations when choosing an IRT vendor: what questions should you be asking?
How to leverage your IRT systems effectively to get the most out of your technology
Incorporating data-driven technology such as AI and machine learning to maximize efficiency of your IRT systems
Understanding the key advantages and disadvantages of new IRT systems
Practical takeaways and lessons learned when it comes to using new IRT systems

Speakers

Simi Nischal

Senior Director, Digital, Data and Analytics, Clinical Supply Chain, GSK

Shawn Gehen

Clinical Demand Planning Manager (Contractor), Seagen

Jason Bellman

Manager, Clinical Supply Chain Systems, Apellis Pharma

Maxime Derep

Director of Solutions Engineering, N-SIDE

Paul Hingst

Supply Chain Consultant, Crinetics Pharmaceuticals

11:45 AM

Re-imagining IRT for modern clinical development

The vast majority of clinical studies are being run on technology that is over 10 years old, which limits the ability to innovate and optimally support modern trials
IRT can become a driver of innovation and not a constraint when advances in the broader technology landscape are applied to allow for more flexible solutions
Deliver scalable, robust, and future-proof IRT solutions by applying lessons learned from other industries
Examples include: A.I.-enabled datasets, no-code study deployment, automated excursion reviews, rapid prototyping, reduced (or removed) need for change orders, and ability to adapt to unforeseen challenges

Speakers

Evan Hahn

Senior Vice President, IRT Solutions, YPrime

12:15 PM

Revolutionizing clinical trial supply chains with Patient-Centric Hybrid Trials (PHTs) and Direct-to-Patient models

Designing clinical trials with patient needs at the center by leveraging hybrid trial models for supply chain efficiency and success
Investing in patient-centric methodologies to prioritize patient needs and preferences for optimal clinical trial supply chain outcomes
Empowering patients for clinical trial supply chain success: personalizing logistics, delivering human content, providing data access, and engaging patients in innovative ways.

Speakers

Vatsala Sadasivan

Global Operations Excellence Lead R&D, Sanofi

12:45 PM

Drug supply management: ensure supply safety while generating huge savings

Challenges and opportunities in the drug supply chain management
Best practices
Expected skills in clinical supply
Communication framework
Success stories

Speakers

Yves Dethier

Business Leader, Boostcode

1:15 PM

Lunch and networking

2:30 PM

CASE STUDY: Implementing an effective IRT system into your clinical trial supply chain

Choosing an IRT vendor that works for you: key considerations and factors in supplier choice
Overcoming challenges around implementation and use of a new IRT system
What do you need from your IRT system: measuring benefits and increased efficiency

Speakers

Paul F. Hughes

Director, Randomization and Trial Supply Management, Janssen

3 PM

CASE STUDY: Digital display labels transforming the clinical supply chain

Decreases turnaround timelines, increases flexibility and efficiency of scarce IMP inventory benefiting sponsors and study site personnel
Driving enhanced safety, understanding, and compliance for patients and clinical sites, enabled by immediate updates of IMP information and IMP label content
Leveraging technology enabling a more robust IMP data management, tracking of contents/changes as required by cGMP for patients, for clinical sites and for health authorities

Speakers

Kim Buchanan

Associate Director Development Quality, Merck

3:30 PM

INTERACTIVE WORKSHOP: Digitizing and optimizing clinical trial supply chain management

• Optimizing clinical trial supply chain management by digitizing processes and automating inventory management and forecasting
• Improving supply chain visibility and tracking from sourcing to distribution through integration
• Enhancing communication and collaboration across teams and stakeholders involved in clinical supply chain management through technology

Speakers

Jordan Ursino

Director, Clinical Supply Chain, Keros Therapeutics

4 PM

Afternoon refreshments and networking

4:20 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!

4:30 PM

INTERACTIVE DISCUSSION SESSION: Building the bench: developing robust training programs for new clinical supplies professionals

Training and inducting staff with technology and systems in order to ensure a smooth transition
The importance of your staff when it comes to supply chain efficiency: why you need to avoid overlooking this
Ensuring your new staff training programs are as effective as possible: what should you consider?

Speakers

Paul Larochelle

Director, Global Clinical Supply Chain, Takeda

Tyler Wilson

Global Clinical Supply Chain Fellow, Takeda

5 PM

Ensuring financial sustainability in the pharmaceutical industry: strategies for pricing, reimbursement, and cost containment

• Evaluating pricing strategies for pharmaceutical products in light of changing market dynamics and reimbursement policies: ensuring financial sustainability for both payers and pharma sponsors
• Navigating complex policy landscapes and balancing the needs of patients, providers, and payers when determining drug prices and reimbursement rates
• Mitigating the risk of drug shortages, inflation pressure and economic uncertainty by modifying cost-containment measures and exploring alternative payment models for medicines

Speakers

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

5:30 PM

Chairperson’s closing remarks and networking drinks

Speakers

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

7:30 AM

Registration and refreshments

8:25 AM

Chairperson’s opening remarks

Speakers

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

8:30 AM

Impact of drug pooling and just-in-time manufacturing on the clinical supply chain and related technologies

• Push vs. pull manufacturing
• How the Incyte supply chain has evolved
• System changes required for pooled supply and JIT manufacturing

Speakers

Dawn Wright

Director Global Supply Chain, Incyte

9 AM

Re-imagining planning for a best-in-class supply chain performance

Planning serves as the brain of the supply chain, orchestrating various activities and KPIs that profoundly impact its overall performance. Waste, cost, risk, shortages, CO2 emissions, bottlenecks, and workload are all outcomes tied to carefully planned operations. But today’s challenges are changing the paradigm of our supply chains. Join our talk to learn:

The current challenges that will force us to revolutionize our supply chain
How GSK is re-imagining the role of clinical supply planner and its place in enabling an ambitious R&D
How planning is increasingly important at all stages of the trial lifecycle
At any given time, how to always remain with the optimal supply chain strategy

Speakers

Amaury Jeandrain

Vice President of Strategy, N-SIDE

Linda Nichols

Director, Study Start Up and Optimization, GSK

Loïc Struyf

Associate Director, Head of Customer Success, N-Side

9:30 AM

PANEL DISCUSSION: Navigating uncertainty: strategies for enhancing supply chain security in times of geopolitical and economic instability

Assessing site selection in times of geopolitical tensions and uncertainty
Managing the impact of high inflation rates on the Medicare Part D Program
Enhancing supply chain security by understanding global socio-economic dynamics

Speakers

Ram Raju

Senior Vice President and Community Health Investment Officer, Northwell Health

David Sokoloff

Sr. Director Global Logistics and Materials Management, Novavax

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

10 AM

Partnering for progress in personalized medicine with CAR T-Cell therapies

CAR T-cell therapies have become an exciting new treatment path in treating advanced leukemias and lymphomas as well as multiple myeloma. Chimeric Antigen Receptor T-cell therapy, or simply CAR-T, is a type of immunotherapy that adapts T cells from your immune system to fight cancer. What makes CAR-T special is the drug is specific to the patient instead of using the same medication across the entire patient population. As a result, the RTSM design needs to adapt to this method to make the medication and ordering process patient-specific.

Join us for a dynamic presentation as Janssen and 4G Clinical share insights from their collaborative journey. Together, they have partnered on several clinical trials and have created standards, supporting the advancement of personalized medicine management and the secure encryption of

Speakers

David Bacskai

RTSM Design Lead, Janssen

Courtney Bortz

Principal Client Services Lead, 4G Clinical

10:30 AM

Morning refreshments and networking

11:15 AM

CEIV Pharma: raising the standard of pharmaceutical logistics

Risks and potential gaps in cold chain when transporting temperature-sensitive drugs by air
How IATA's standards and certification can improve handling of pharmaceutical cargo, ensuring compliance with regulations
Benefits of participating in IATA's CEIV Pharma program: how this can help you establish and maintain shipment integrity
Engage in the process of a simplified audit solution against clear standard criteria and provide constructive feedback on IATA's proposed solution

Speakers

Ronald Schaefer

Consulting Head of Certification Programs (CEIV Pharma), IATA

11:45 AM

Clinical trial logistics: evolving supply models and new therapies highlight emerging trends

Decentralized trial logistics:

The role of DTP in maximizing benefits of DCT
Overcoming DTP complexities

Emergence of cell and gene therapies

Unique logistics considerations for CGTs
Ensuring quality through technology solutions

Speakers

Jennifer Fenwick

Senior Manager Personalized Supply Chain, World Courier

12:15 PM

Clinical label development: sponsor’s consideration

• Reviewing regulatory requirements for clinical labeling, including country-specific requirements
• Demonstrating a typical process of clinical label development and key considerations
• Discussing frequent problems/risks that Sponsors face

Speakers

Naoya Matsuzaki

Associate Director, Program Management, R&D, NS Pharma

12:45 PM

Adapting to the changing landscape of clinical trials while driving down costs and waste through optimized clinical supply sourcing options and flexible operating models

• Alternatives for lowering comparator spend with escalating prices
• Importance of on-boarding vendors with multiple sourcing options and flexibility
• Limiting waste with innovative sourcing solutions

Speakers

Michelle Novak

Regional Director, Business Development, Inceptua

1:15 PM

Lunch and networking

2:30 PM

Assessing sourcing models to determine the optimal sourcing strategy

Overview of different sourcing models
Assessing options to determine optimal strategies
Working in a wholly outsourcing model: maintaining a strong supplier base

Speakers

Michael Wrigley

Senior Manager, Clinical Research Sourcing Strategist, Pfizer

3 PM

Innovative processes to better address today’s trial dynamics

Supply chain efficiency: why do extra work and spend more money than necessary?
Payment process efficient: leverage an existing workflow process that sites use everyday
Understanding the total value a vendor can provide
Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

Speakers

3:30 PM

Enhanced communication methods: building rapport between clinical supply groups and partners

Enhancing communication methods and tools to foster effective communication between global clinical supply groups and their partners
Building rapport through collaborative efforts to strengthen relationships
Establishing feedback mechanisms to provide a continuous loop of communication, allowing for ongoing improvement and increased understanding between stakeholders

Speakers

Haneen Mazahreh-Boivert

Senior Director Global Clinical Supply, Boston Pharmaceuticals

4 PM

Afternoon refreshments and networking

4:20 PM

EXHIBITION APPLE PRIZE DRAW

4:30 PM

INTERACTIVE DISCUSSION SESSION: Overcoming roadblocks in comparator sourcing and vendor management

Accessing supply: ensuring your supply chain is robust and planning timelines to avoid delays
Managing regulatory hurdles when importing comparators from overseas
Working efficiently with vendors when sourcing comparators for your clinical trial
What to consider in order to ensure your comparator sourcing processes meet cost and waste targets

Speakers

Lindsey Marshall

Director, Clinical Drug Supply, Regeneron

5 PM

A toolkit for sourcing commercial medicines for your clinical trials

Introduction to Abacus Medicine Pharma Services
Expect the unexpected
When to take action
Tools to minimize the risk of disruption

Speakers

Ian Hoban

Business Development Director, Abacus Medicine

5:30 PM

Chairperson’s closing remarks and networking drinks

Speakers

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

Streams

Stream one

Clinical Supply Logistics and Operations

Stream two

Clinical Supply Technology and Innovation

9 AM

Revolutionizing clinical trial supply management with AI powered IRT forecasting and optimization

Improving the efficiency and agility of clinical trial supply management through the use of AI-powered IRT forecasting
Optimizing the allocation of clinical trial supplies across sites and reducing waste by using advanced AI algorithms to forecast IRT needs
Leveraging real-time data and machine learning to enhance IRT forecasting accuracy and improve supply chain resilience in clinical trials

Speakers

Shawn Gehen

Clinical Demand Planning Manager (Contractor), Seagen

9:30 AM

PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

Benefits to patients of direct-to-patient models: how can DTP make clinical trials more accessible?
Where are the benefits and disadvantages of DTP from a patient perspective?
Implementing a DTP strategy that works for your clinical study
Understanding how DTP can optimize supply chain flexibility for clinical trials
The regulatory environment surrounding DCT and DTP in the US: what you need to be aware of

Speakers

Amaury Jeandrain

Vice President of Strategy, N-SIDE

Blake Edward Wilson

Partner (FDA Regulatory), Hogan Lovells

Vatsala Sadasivan

Global Operations Excellence Lead R&D, Sanofi

Jen Horonjeff

CEO, Savvy Cooperative

Jennifer Fenwick

Senior Manager Personalized Supply Chain, World Courier

10:15 AM

Morning refreshments and networking

11 AM

Importation of biological materials into the U.S.

• Understanding CBP and Partner Government Agency regulations to ensure a seamless process at U.S. Ports of Entry
• Why public partnerships are critical for biological threat exclusion efforts
• Learn how to avoid delays and issues by covering real non-compliant biological material encounters
• Take away resources and contacts to support your biological material shipments

Speakers

Elliot N. Ortiz

Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection

Sharon Taylor

Biological Threat Operations Specialist, US Customs and Border Protection

11:30 AM

PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology 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
Remote communications: best practice for selecting and working with partners when working remotely

Speakers

Amaury Jeandrain

Vice President of Strategy, N-SIDE

Susan Marlin

President and CEO, Clinical Trials Ontario

Simi Nischal

Senior Director, Digital, Data and Analytics, Clinical Supply Chain, GSK

12 PM

Lunch and networking

8 AM

Registration and refreshments

9 AM

The improving clinical trials environment in Canada

Harnessing unique assets to sustain Canada’s role as a medical research and health innovation hub
Raising numerous interesting and difficult policy questions related to Canadian and US collaboration when addressing ‘extraordinary’ needs of rare disease patients
Clinical innovation as a means to cultivate supportive conditions for improved care for rare patients in Canada
Using scientific knowledge to improve patient impact and system receptivity

Speakers

Susan Marlin

President and CEO, Clinical Trials Ontario

9:30 AM

PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

Using technology to mitigate against risk of changing supply and demand
Shipping internationally outside of the US: common hurdles and how to overcome these
The changing regulatory environment in the US and how to ensure you stay up to date with new regulations

Speakers

Dawn Wright

Director Global Supply Chain, Incyte

Lindsey Marshall

Director, Clinical Drug Supply, Regeneron

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

10:15 AM

Morning refreshments and networking

11 AM

Revolutionizing clinical trials with accelerating clinical evidence models: enhancing efficiency, collaboration, and patient access

• Implementing a novel approach for drug approvals with accelerated approval pathway to streamline processes
• Enhancing collaboration between the FDA and CMS in developing new payment methods for drugs approved via accelerated approval to promote the completion of confirmatory trials
• Improving patient access to post-market safety and efficacy data by utilizing the Accelerating Clinical Evidence model, leading to better healthcare outcomes and cost savings

Speakers

Blake Edward Wilson

Partner (FDA Regulatory), Hogan Lovells

11:30 AM

Driving successful clinical trials with complex supply chains

• Identifying and implementing continuous improvements in the supply chain: where are the main opportunities for higher efficiency?
• Understanding additional needs of more complex supply chains and how to meet these
• Taking advantage of new technology and systems in order to streamline and maximize the efficiency of your clinical supply chain

Speakers

Francesco Santo

Associate Director Global Clinical Supply Chain, HUYABIO

12 PM

Lunch and networking

1 PM

CASE STUDY: End to end logistics in temperature controlled pharma supply chains

Speakers

Ellyn Ensby

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

Kristin Corcoran

Temperature Management and Control Lead, Janssen

1:30 PM

Optimizing clinical trial supply chain efficiency through CTPAT/Trade Compliance

Ensuring compliance with CBP regulations: a discussion of 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 support you
Enhancing the efficiency of clinical trial supply management: how participation in the CTPAT TC program can streamline import processes and lead to timely and cost-effective delivery

Speakers

Mary Zhang

National Account Manager, US Customs and Border Protection

2 PM

PANEL DISCUSSION: Advancing diversity, equity, and inclusion in clinical trial supply chain management: best practices and future directions

Designing for diversity: strategies for inclusive clinical trial supply chain management
Increasing vaccine awareness and acceptance through inclusive clinical trials
Addressing genetic differences and promoting equity in clinical trial supply management
Developing cultural competence in clinical trial supply chain management to ensure equity and inclusion

Speakers

Ram Raju

Senior Vice President and Community Health Investment Officer, Northwell Health

Jen Horonjeff

CEO, Savvy Cooperative

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

2:30 PM

Afternoon refreshments and networking

2:50 PM

EXHIBITION APPLE PRIZE DRAW

3 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: Planning for a smooth import/export at the border: considerations when working with CBP

Mary Zhang, National Account Manager, US Customs and Border Protection

ROUNDTABLE 2: Ensuring regulatory compliance in clinical trial supply: best practices and guidelines

ROUNDTABLE 3: Navigating inflation and economic uncertainty: clinical supply chain considerations

Milena Izmirlieva, Head of Health Economics and Market Access Research and Analysis, GlobalData

Speakers

Mary Zhang

National Account Manager, US Customs and Border Protection

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

4 PM

End of Conference

Speakers

Select a speaker to learn more

Back

Jason Bellman

Manager, Clinical Supply Chain Systems, Apellis Pharma

Jason has over 7 years experience in clinical trials. He spent time on both the vendor and sponsor side as a project manager and an IRT manager, respectively. Jason spent the past 3 years as a Manager of Clinical Supply Chain Systems at Apellis Pharmaceuticals. During this time he was also the SME for their supply forecasting tool and spent about one year as a supply manager for a phase 3 trial. Jason is married with two kids, a son who is 4 and a daughter, who is 2. He also has a 12 year old dog.

Session Details:

PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

2023-10-11, 11:15 AM

View In Agenda

Next speaker

Back

Susan Marlin

President and CEO

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

Susan served as President of the Canadian Association of Research Ethics Boards, and as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research Ethics Board, the Tri-Agency Panel on the Responsible Conduct of Research, and the Ontario Government Life Sciences Working Group. She is currently a member of the Life Sciences Ontario Board of Directors and the Management Team for the Ontario SPOR (Strategy for Patient Oriented Research) Support Unit.

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

Next speaker

Back

Blake Edward Wilson

Partner (FDA Regulatory), Hogan Lovells

Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group. He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University. Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University. His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry. He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough. In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters. By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

Session Details:

Revolutionizing clinical trials with accelerating clinical evidence models: enhancing efficiency, collaboration, and patient access

2023-10-12, 11:00 AM

Session Details:

PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

2023-10-12, 9:30 AM

View In Agenda

Next speaker

Back

Dawn Wright

Director Global Supply Chain, Incyte

Accomplished leader experienced in clinical trials and CROs looking for an opportunity to grow into a new area by building on knowledge and skills acquired over many years in the industry. Proven track record for managing global teams across multiple sites in the US and UK. Extensive background in planning of clinical study activities and leading matrix teams. Experienced in leading after action reviews and implementing process improvements that address the root cause and improve processes.

Session Details:

Impact of drug pooling and just-in-time manufacturing on the clinical supply chain and related technologies

2023-10-11, 8:30 AM

Session Details:

PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

2023-10-12, 9:30 AM

View In Agenda

Next speaker

Back

Ronald Schaefer

Consulting Head of Certification Programs (CEIV Pharma), IATA

Ronald Schaefer is Senior Principal, Consulting. He is also the Consulting Head of the Certifications Programs (CEIV Pharma, CEIV Live Animals, CEIV Fresh, CEIV Lithium Battery, CBTA, etc.) at IATA. He was born in Hamburg, Germany, raised in Mexico and educated in the US. After long-term professional assignments in Germany, Spain, Malaysia, Kuwait, Venezuela and Canada, he has been based in Miami for the last 14 years working for IATA. Before joining IATA, Mr. Schaefer accumulated vast experience in the air transport field working as a consultant for Lufthansa Consulting GmbH, Roland Berger Strategy Consultants GmbH and Ferrostaal México. He has worked on corporate restructuring, strategy, post-merger integration, market and competitive analysis, safety, risk management initiatives among others, in the transportation industry on all continents. Throughout his career Ronald has held positions in Mexico, Stuttgart, Kuala Lumpur, Frankfurt, Cologne, New York, Montreal and Miami.

At IATA he developed in conjunction with the IATA Pharma subject matter expert the CEIV Pharma pre-assessment tools and materials to facilitate successful independent validation of organizations. He also led the initial independent assessment Proof-of-Concept for Singapore Air Terminal Services (SATS) and is now managing the program worldwide. Since its start he has managed ~450 certifications, +1000 assessments and +800 validations.

He is also jointly responsible for the development and implementation of new CEIV initiatives such as CEIV Live Animal, officially launched in April 2018 and CEIV Fresh launched in 2019. In conjunction with the IATA Live Animal and Perishable expert, he is also developing the pre-/assessment tools for validations of organizations and jointly managing the on-going pilots.

He holds a Bachelor of Science (B. Sc.) in Business Administration from California State University at Sonoma and Master of Business Administration (MBA) from Georgetown University.

Session Details:

CEIV Pharma: raising the standard of pharmaceutical logistics

2023-10-11, 11:15 AM

View In Agenda

Next speaker

Back

Shawn Gehen

Clinical Demand Planning Manager (Contractor), Seagen

Shawn is a Clinical Demand Planning Manager with 24 years of experience in Clinical and Commercial Supply Chain, currently under contract with Seagen Biotech.

Session Details:

PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

2023-10-11, 11:15 AM

Session Details:

Revolutionizing clinical trial supply management with AI powered IRT forecasting and optimization

2023-10-12, 9:00 AM

View In Agenda

Next speaker

Back

RAM RAJU

Former CEO, NYC Health & Hosptials Corporation

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.

Next speaker

Back

David Sokoloff

Sr. Director Global Logistics and Materials Management, Novavax

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

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

Session Details:

PANEL DISCUSSION: Navigating uncertainty: strategies for enhancing supply chain security in times of geopolitical and economic instability

2023-10-11, 9:30 AM

View In Agenda

Next speaker

Back

Lindsey Marshall

Director, Clinical Drug Supply, Regeneron

Lindsey Marshall is a Director of Clinical Drug Supply & Logistics at Regeneron Pharmaceuticals. She holds a Master in Clinical Research from Drexel University and has been working in the industry for nearly 20 years. Lindsey currently oversees a team responsible for forecasting, planning, and distribution of clinical drug supply for Regeneron’s portfolio.

Session Details:

INTERACTIVE DISCUSSION SESSION: Overcoming roadblocks in comparator sourcing and vendor management

2023-10-11, 4:30 PM

Session Details:

PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

2023-10-12, 9:30 AM

View In Agenda

Next speaker

Back

Vatsala Sadasivan

Global Operations Excellence Lead R&D, Sanofi

Session Details:

Revolutionizing clinical trial supply chains with Patient-Centric Hybrid Trials (PHTs) and Direct-to-Patient models

2023-10-11, 12:15 PM

Session Details:

PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

2023-10-12, 9:30 AM

View In Agenda

Next speaker

Back

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:

INTERACTIVE DISCUSSION SESSION: Building the bench: developing robust training programs for new clinical supplies professionals

2023-10-11, 4:30 PM

View In Agenda

Next speaker

Back

Tyler Wilson

Global Clinical Supply Chain Fellow, Takeda

BS Chemistry from University of Minnesota in 2017

PharmD from University of Minnesota College of Pharmacy in 2022

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

Session Details:

INTERACTIVE DISCUSSION SESSION: Building the bench: developing robust training programs for new clinical supplies professionals

2023-10-11, 4:30 PM

View In Agenda

Next speaker

Back

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:

SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

2023-10-12, 3:00 PM

Session Details:

Optimizing clinical trial supply chain efficiency through CTPAT/Trade Compliance

2023-10-12, 1:30 PM

View In Agenda

Next speaker

Back

Simi Nischal

Senior Director, Digital, Data and Analytics, Clinical Supply Chain, GSK

A seasoned professional and thought leader in IRT space, Simi heads ‘Digital Innovation & Technologies’ function within clinical supply chain at GSK. She lead’s GSK on strategic and operational activities, with a strong focus end to end connected digital supply chain. She has a broad range of industry insight having worked for both CROs and for sponsors, and has a wide portfolio of systems delivery from IRT systems to supply chain management systems and more recently advanced analytics for the digital supply chain. She is committed to innovation in the clinical trials arena and has keen interest in building and developing IRT solutions that are patient & site centric and create enhanced user experience.

Simi is a resident of Pennsylvania. Outside of work she enjoys traveling, poetry and classical music. She has an affinity for spiritualism and hopes to find her guru for the teachings of Vedas and Gita.

Session Details:

PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

2023-10-11, 11:15 AM

Session Details:

PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

2023-10-12, 11:30 AM

View In Agenda

Next speaker

Back

Haneen Mazahreh-Boivert

Senior Director Global Clinical Supply, Boston Pharmaceuticals

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.

Session Details:

Enhanced communication methods: building rapport between clinical supply groups and partners

2023-10-11, 3:30 PM

View In Agenda

Next speaker

Back

Francesco Santo

Associate Director Global Clinical Supply Chain, HUYABIO

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:

Driving successful clinical trials with complex supply chains

2023-10-12, 11:30 AM

View In Agenda

Next speaker

Back

Jennifer Fenwick

Senior Manager Personalized Supply Chain, World Courier

Jennifer is part of World Courier's team leading the cell and gene therapy and direct-to-patient service lines, focusing on defining strategy, driving growth, and solving operational and process challenges arising from these shipments' complexity. With experience in roles on both the sponsor and vendor side for clinical and commercial pharmaceutical logistics, Jennifer has served in many leadership roles in the clinical trial supply chain, project management, vendor and alliance management before joining World Courier in 2022. Jennifer is helping the health tech sector integrate and grow within the continuously shifting landscape.

Session Details:

Clinical trial logistics: evolving supply models and new therapies highlight emerging trends

2023-10-11, 11:45 AM

Session Details:

PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

2023-10-12, 9:30 AM

View In Agenda

Next speaker

Back

Kim Buchanan

Associate Director Development Quality, Merck

Experienced quality professional with strong leadership and exceptional background in packaging operations, technology, clinical supplies, commercial products, laboratory, and FDA & EU regulatory agency compliance and inspections. Cross functional roles include 2 interim clinical supply assignments, direct line supervision of Global Quality, Sterile & Biological Operations/Technology and Pharm Laboratory personnel. Key in the development of Expanded Access Program at her company.

Session Details:

CASE STUDY: Digital display labels transforming the clinical supply chain

2023-10-11, 3:00 PM

View In Agenda

Next speaker

Back

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:

A toolkit for sourcing commercial medicines for your clinical trials

2023-10-11, 5:00 PM

View In Agenda

Next speaker

Back

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:

Drug supply management: ensure supply safety while generating huge savings

2023-10-11, 12:45 PM

View In Agenda

Next speaker

Back

Milena Izmirlieva

Head of Health Economics and Market Access Research and Analysis, GlobalData

Milena Izmirlieva heads GlobalData’s Health Economics and Market Access research and analysis team which comprises senior analysts, analysts and health economists covering developed and emerging markets worldwide. Since joining one of GlobalData’s predecessor companies in 2003 as a pharma research analyst for Western European and Central and Eastern European markets, she has developed extensive knowledge of the healthcare systems and pharmaceutical markets of numerous countries in Europe, North America and various emerging markets. Prior to that, Milena worked in healthcare marketing communications for the EURO RSCG group in New York, US, and Sofia, Bulgaria, where she specialized in pharmaceutical and medical device companies. Her main areas of research interest are pricing and reimbursement and market access for originator drugs, the market dynamics for biosimilars and generics, health system efficiency indicators and health system capacity, and forecasting of healthcare spending and pharmaceutical sales. She holds an MSc degree in Health Economics, Policy and Management from the London School of Economics and Political Science (LSE), an MSc degree in Communication with a focus on Science Writing from Iowa State University, and a joint BA degree in Journalism and Mass Communication and International Relations from the American University in Bulgaria. Milena is a regular speaker at pharmaceutical conferences and is often interviewed about pharmaceutical-related issues in the media. She regularly presents peer-reviewed research at ISPOR and has a strong interest in pharmaceutical pricing and reimbursement developments and cost-containment strategies (including international reference pricing). Milena is a Fulbright scholarship recipient and member of the following honor societies: Phi Kappa Phi, Alfa Delta Sigma, and Kappa Tau Alfa.

Session Details:

Chairperson’s opening remarks

2023-10-11, 8:25 AM

Session Details:

PANEL DISCUSSION: Navigating uncertainty: strategies for enhancing supply chain security in times of geopolitical and economic instability

2023-10-11, 9:30 AM

Session Details:

SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

2023-10-12, 3:00 PM

Session Details:

PANEL DISCUSSION: Advancing diversity, equity, and inclusion in clinical trial supply chain management: best practices and future directions

2023-10-12, 2:00 PM

Session Details:

Chairperson’s closing remarks and networking drinks

2023-10-11, 5:30 PM

Session Details:

Ensuring financial sustainability in the pharmaceutical industry: strategies for pricing, reimbursement, and cost containment

2023-10-11, 5:00 PM

Session Details:

Chairperson’s closing remarks and networking drinks

2023-10-11, 5:30 PM

Session Details:

PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

2023-10-12, 9:30 AM

View In Agenda

Next speaker

Back

Linda Nichols

Director, Study Start Up and Optimization, GSK

Linda leads Study Start Up and Optimization for GSK clinical trial supplies, pulling together a broad range of internal and external data sources to reduce risk and drive value. Linda has worked in product development (Janssen and Corning), tech transfer (Bristol Myers Squibb) and process development (Merck). She has a B.S. Chemical Engineering and an M.B.A. with a concentration in Finance.

Session Details:

Re-imagining planning for a best-in-class supply chain performance

2023-10-11, 9:00 AM

View In Agenda

Next speaker

Back

Michelle Novak

Regional Director, Business Development, Inceptua

Michelle has spent over 25 years in healthcare working at both large and small medical device and pharmaceutical companies in a myriad of different positions in both a sales and training capacity. For the last 6 years her focus has been on the vendor side assisting sponsors and CRO’s with their clinical supply needs. She currently assumes the role of Regional Director of Business Development for Inceptua, a global clinical supply company. Michelle is a proud member of the Global Clinical Supplies Group and has supported the organization as a volunteer in numerous positions including, secretary to the board (as well as her current role) as GCSG Brand Ambassador.

Session Details:

Adapting to the changing landscape of clinical trials while driving down costs and waste through optimized clinical supply sourcing options and flexible operating models

2023-10-11, 12:45 PM

View In Agenda

Next speaker

Back

Paul F. Hughes

Director, Randomization and Trial Supply Management, Janssen

Paul Hughes is a career RTSM professional.

Paul started in the early days of ClinPhone in 2001, and then continued his RTSM career at Janssen and Pfizer. Paul is excited to be on his second stint at Janssen as Director of Randomization and Trial Supply Management (RTSM) within Clinical Supply Chain. Paul’s focus now is on applying his experience to successfully support increasingly complex trials, while also being an influencer within the RTSM industry, pushing for new and better solutions to current and emerging challenges.

Connect with Paul at: linkedin.com/in/rtsm-leader

Session Details:

CASE STUDY: Implementing an effective IRT system into your clinical trial supply chain

2023-10-11, 2:30 PM

View In Agenda

Next speaker

Back

Amaury Jeandrain

Vice President of Strategy, N-SIDE

Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

Session Details:

Re-imagining planning for a best-in-class supply chain performance

2023-10-11, 9:00 AM

Session Details:

PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

2023-10-12, 9:30 AM

Session Details:

PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

2023-10-12, 11:30 AM

View In Agenda

Next speaker

Back

Loïc Struyf

Associate Director, Head of Customer Success, N-Side

Loïc heads the Customer Success team at N-SIDE Life Sciences, accompanying pharmaceutical companies in the optimization of their clinical supply chain. Prior to joining N-SIDE, Loïc was responsible for the commercial launch of new drugs for Celgene and Galapagos, and worked as a strategy consultant at Accenture. Loïc holds a Master Degree in Business Engineering and International Management (CEMS).

Session Details:

Re-imagining planning for a best-in-class supply chain performance

2023-10-11, 9:00 AM

View In Agenda

Next speaker

Back

Session Details:

Innovative processes to better address today’s trial dynamics

2023-10-11, 3:00 PM

View In Agenda

Next speaker

Back

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:

Importation of biological materials into the U.S.

2023-10-12, 11:00 AM

View In Agenda

Next speaker

Back

Michael Wrigley

Senior Manager, Clinical Research Sourcing Strategist, Pfizer

Michael is a strategic pharmaceutical professional currently holding a role as a Senior Manager, Clinical Research Souring Strategist at Pfizer. In this role, he develops innovative strategic sourcing strategies for open-label commercial products across diverse therapeutic areas while overseeing vendor operations and relationships. Michael’s background includes experience in category management and full-service outsourcing in Global R&D Procurement at Organon, both before and after the spin-off from Merck & Co. Michael entered the pharmaceutical industry during his time at Almac Group where he held multiple roles within the Business Development team. He holds an MBA and a Bachelor’s degree in Business Management and Marketing from Penn State University and multiple certificates and certifications.

Session Details:

Assessing sourcing models to determine the optimal sourcing strategy

2023-10-11, 2:30 PM

View In Agenda

Next speaker

Back

Sharon Taylor

Biological Threat Operations Specialist, US Customs and Border Protection

Sharon Taylor is a Biological Threat Operations Specialist (BTOS) with U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO) in the Area Port of Philadelphia. Ms. Taylor began her career in October 2006 at JFK International Airport, NY before transferring to her hometown of Philadelphia, PA in 2009. Ms. Taylor has 17 years of public service with CBP working in a variety of environments such air passenger, maritime and express carrier locations. During that time, she has worked as an Agriculture Specialist, K9 Handler and with several specialized units/teams within CBP.

Session Details:

Importation of biological materials into the U.S.

2023-10-12, 11:00 AM

View In Agenda

Next speaker

Back

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: End to end logistics in temperature controlled pharma supply chains

2023-10-12, 1:00 PM

View In Agenda

Next speaker

Back

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: End to end logistics in temperature controlled pharma supply chains

2023-10-12, 1:00 PM

View In Agenda

Next speaker

Back

Naoya Matsuzaki

Associate Director, Program Management, R&D, NS Pharma

Naoya Matsuzaki is a CMC specialist in the pharmaceutical industry with over 14 years of experience in researching and developing innovative medical products. During his engagement in new drug development as an analytical chemist in Astellas Pharma in his early career, he collaborated with many CMOs, CTOs, and business partners globally. He experienced global regulatory submission and commercial product launch. Naoya moved to NS Pharma (a US subsidiary of Nippon Shinyaku) in 2022 and began to work as a CMC US lead for multiple global development projects with various CMC responsibilities, such as a lead of CMC members, CMC RA strategy and clinical trial supply. Naoya has a Ph.D. (Pharmaceutical Science) from the University of Shizuoka and is a 2024 MBA candidate at the University of Massachusetts Lowell.

Session Details:

Clinical label development: sponsor’s consideration

2023-10-11, 12:15 PM

View In Agenda

Next speaker

Back

Courtney Bortz

Principal Client Services Lead, 4G Clinical

Courtney Bortz, Principal Client Services Lead at 4G Clinical, has vast experience in RTSM system implementation, configuration, and project management. She's worked on various software platforms and infrastructures including IRT and Accounting & Property Management Software. Courtney graduated from the University of Cincinnati with a BBA in Accounting & Information Systems

Session Details:

Partnering for progress in personalized medicine with CAR T-Cell therapies

2023-10-11, 10:00 AM

View In Agenda

Next speaker

Back

David Bacskai

RTSM Design Lead, Janssen

David Bacskai is currently an RTSM Design Lead within Clinical Supply Chain at Janssen. In his current role of RTSM Design Lead, David leads the development and design for IRT studies in the Oncology and CAR-T therapeutic areas. David also ensures current CAR-T and Oncology IRT Best Practices are implemented to promote consistency across all trials. David has been in the IRT industry for over 20 years. During his career, David has worked at an IRT vendor and sponsor where he has had the opportunity to lead process improvement initiatives, lead User Acceptance Testing efforts at both platform and protocol level, and support standards implementation/change control

Session Details:

Partnering for progress in personalized medicine with CAR T-Cell therapies

2023-10-11, 10:00 AM

View In Agenda

Next speaker

Back

Kelly Franchetti

Global Head of Growth and Insights, Savvy Cooperative

Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

Next speaker

Back

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 DISCUSSION: Analyzing the opportunities offered by effective use of IRT

2023-10-11, 11:15 AM

View In Agenda

Next speaker

Back

Evan Hahn

Senior Vice President, IRT Solutions, YPrime

Evan Hahn is Senior Vice President of IRT Solutions at YPrime, a global leader in eClinical systems that provides cloud-based solutions for clinical trials. He has over 20 years of experience in the life sciences industry promoting innovative approaches to drug development. Evan leads a team with a particular focus on applying technology and sophisticated applications of data to drive insights and efficiencies to trial design and execution.

Session Details:

Re-imagining IRT for modern clinical development

2023-10-11, 11:45 AM

View In Agenda

Next speaker

Back

Jordan Ursino

Director, Clinical Supply Chain, Keros Therapeutics

Jordan lives in south Jersey and has been involved with clinical supply management for the last 7 years. Currently he works for a small biotech, Keros, located just outside of Boston.

Session Details:

INTERACTIVE WORKSHOP: Digitizing and optimizing clinical trial supply chain management

2023-10-11, 3:30 PM

View In Agenda

Next speaker