Conference Program and Resources - GCSG - Global Clinical Supplies Group

Day 1 : Sunday, April 23

7:00 am - 8:00 am

Conference Logistics

Boot Camp Registration Open

Boot Camps sponsored by:

8:00 am - 4:30 pm

Boot Camp / Seminar

How to Plan and Implement an Expanded Access Program

Expanded Access, Named Patient, Compassionate Use… the names for the process are as varied as the options for supporting them. This interactive course will give an overview of expanded access as well as discuss relevant regulations and their impact on operational and strategic planning. Atttendees will be able to hear from subject matter experts with many years experience on best practices and important questions to ask when supporting these types of studies. Come to this boot camp to discuss the regulations for Expanded Access and how they impact your operational and strategic supply planning.

Speakers:

8:00 am - 4:30 pm

Boot Camp / Seminar

Import/Export and VAT Boot Camp

The class is designed for clinical supplies professional that want to learn more about the fundamentals of international logistics as well as build more specific knowledge on trade compliance, Value Added Tax (VAT) and best practices when planning and executing global clinical trials. This class will cover international shipping regulations, temperature control during extended transit, customs clearance, VAT strategies and how to maximize logistics supply chain partnerships to ensure success with international distribution.

Speakers:

8:00 am - 4:30 pm

Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

This class, geared towards people new to the world of clinical trial supplies, focuses on drug development and what goes into planning for and delivering a study drug for a clinical trial. Topics include: reasons behind Good Manufacturing Practices (cGMPs), phases of new drug development and approval, randomizing and blinding clinical trial materials, quality assurance and documentation, protocol interpretation, patient compliance, labeling, standard operating procedures (SOPs), stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the European Union (EU) and rest of world (ROW). Attendees will hear a massive amount of information in a fun and interactive atmosphere.

Speakers:

8:00 am - 4:30 pm

Boot Camp / Seminar

Using IRT to Maximize Control & Minimize Outages

This class is geared towards people that have some experience in the clinical trial supplies world. Attendees will be provided with a quick overview and then will take a deeper dive into Interactive Response Technology (IRT). This will include the development path for IRTs; the stages of build, from creating the User Requirement Specification (URS) to quoting, coding, validation, user acceptance testing and go-live; the reasons to use an IRT as well as when NOT to use an IRT; build requirements, including randomization codes and med code IDs; ensuring modules are built to manage individual regulatory country approvals, shipping requests and returns and reconciliation; as well as timelines from concept development to system go-live.

Speakers:

3:00 pm - 5:30 pm

Conference Logistics

Exhibitor Setup

3:00 pm - 6:00 pm

Conference Logistics

Registration/Information/Welcome Table Open

Registration Welcome sponsored by:

4:30 pm - 5:00 pm

Conference Logistics

Speaker/Facilitator Meeting & Tour of Workshop Rooms

5:00 pm - 5:30 pm

Presentation

Start the Conference Right! - Conference Orientation - Sponsored by Medidata Solutions

Whether this is your first time attending or you are an 'old pro', plan to join us at the conference orientation to learn how you can make the most of your time at the GCSG 2023 Conference!

Sponsorsored by:

6:00 pm - 8:00 pm

Networking

Meet & Greet - "Cabana Nights"

Be transported to the islands with the sound of Caribbean steel drums and waterfalls as you mingle and network around the upper pool deck and play games on the beach.

Sponsored by:

Day 2 : Monday, April 24

6:30 am - 7:15 am

Networking

Yoga - Sponsored by Yourway

Start your conference with this outdoor gentle yoga class. Postures are practiced to align, strengthen and promote flexibility in the body. Breathing techniques and meditation are also integrated, surely leading to improved flexibility in the mind! You can expect an emphasis on simplicity, repetition, and ease of movement. Full body relaxation and balance are the goals to get your 2023 US Conference off to a great start. All levels are welcome and yoga mats are provided. Space is limited so pre-registration is required.

7:30 am - 8:15 am

Conference Logistics

Breakfast

Monday's meals sponsored by:

7:30 am - 8:15 am

Networking

Exhibitor Displays Open

7:30 am - 4:30 pm

Conference Logistics

Registration/Information/Welcome Table Open

8:15 am - 8:30 am

Conference Logistics

Transfer to Plenary Hall

8:30 am - 8:50 am

Presentation

Welcome & Opening Remarks

8:50 am - 10:00 am

Presentation

Keynote Address: Anne Grady - Sponsored by Catalent

Anne Grady is a best-selling author, entrepreneur, and an expert in building resilient teams, leaders, and organizations. She is also a two-time TEDx speaker, trainer, survivor, optimist, and inspirer.

Anne has a master’s degree in organizational communication and has spent the last twenty years working with some of the largest organizations around the globe, including: Microsoft, Dell, Lockheed Martin, Johnson & Johnson, ADP, and Google. Anne is featured in press and media and contributes to Harvard Business Review, Entrepreneur, Fast Company, Inc. Magazine, FOX Business and more.

Anne is known for her ability to intertwine storytelling, neuroscience, and psychology with wit, humor, and authenticity. She shares inspiring personal stories, cutting edge, research-based content, and implementation tools to transfer learning into real life. And she’ll make you laugh while she does it.

In her first two books, Anne provides practical strategies to improve relationships, increase productivity, and reduce stress. Her latest book, Mind Over Moment: Harness the Power of Resilience, outlines a science-based approach to build a resilient mindset, skill set, and the ability to reset.

Anne is a mental health advocate and donates a portion of all book proceeds to the National Alliance on Mental Illness and was recently named as one of SUCCESS Magazine’s Best Motivational Speakers to Know in 2022.

Transfer to Workshop

10:15 am - 11:15 am

Workshop

Cell and Gene Therapy - End-to-End Supply Chain Requirements and Systems to Use (WS02)

Chain of Custody/Chain of Identity is critical in cell therapy. This lecture will discuss the different systems that can be used to manage Chain of Custody/Chain of Identity. The discussion would include the risks and advantages of each different tracking system to use.

Speakers:

10:15 am - 11:15 am

Workshop

Cell and Gene Therapy - Transitioning from Standard Clinical Supply Chains to Cell & Gene Supply Chains (WS03)

How to transfer from Clinical Supply Chain in traditional Pharma to Cell Therapy Pharma. There are similarities, but many more differences such as extreme cold chain, label text differences, Chain of Custody/Chain of Identity Requirements, etc. This presentation will provide an overview of the similarities and differences as well as explain the exciting aspects of the cell therapy clinical supply chain.

10:15 am - 11:15 am

Workshop

Changes in Decentralized Trials Affecting New Strategies in Direct-to-Patient Distribution (L02)

New concepts and execution with decentralized trials have had a large impact on direct-to-patient distribution of clinical supplies. This workshop will discuss new concepts and different techniques being used to connect the best direct-to-patient strategy with new techniques in decentralized trials.

Speakers:

10:15 am - 11:15 am

Workshop

Compare & Contrast the Diverse Types of Access (Compassionate Use, Off-label Access, Continued Access, Special License sales & Right-to-Try) (WS15)

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will go over all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to -try.

Speakers:

10:15 am - 11:15 am

Workshop

Instilling an Inspection-Ready Culture in Your Clinical Supply Chain (WS01)

Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to bolster your knowledge on how to always be inspection ready!

10:15 am - 11:15 am

Workshop

IRT Systems and How to Use Them for Forecasting & Data Analytics (WS06)

IRT systems have been in use for over 20 years yet there is still functionality that users may be unaware of that can improve their chances of clinical supply chain success. This workshop will focus on industry best practices to improve the forecast of study enrollment using data analytics to positively impact the clinical supply chain.

10:15 am - 11:15 am

Workshop

Label Design Considerations for Clinical Supplies - What Goes on the Label & Where? (WS07)

Labeling clinical supplies is complex and varies depending upon what countries we are conducting studies in. This workshop will discuss what should go on the labels for all different clinical trial materials, where it should go and how to ensure the right language is being used at the site.

Speakers:

10:15 am - 11:15 am

Workshop

LATAM Region Import/Export/Distribution Challenges (WS10)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

Speakers:

10:15 am - 11:15 am

Workshop

New Concepts in Pooling Supplies Using Protocol Masters and Submission Strategy (WS08)

Pooling of supplies has been in use for a number of years. Recently, there has been a new strategy to use master protocols for pooling somewhat similar to program-level pooling but with a single protocol. The greatest challenge when using this strategy is to align the regulatory filing requirements for each of the sub-protocols. This workshop will explain how to achieve the greatest success when using this pooling strategy.

10:15 am - 11:15 am

Workshop

Overcoming sub-Saharan Africa Region (West, Central and East Africa) / Import / Export / Distribution Challenges (WS09)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of West, Central and East Africa countries for labelling and distribution as well as how they impact CT supplies timelines and planning.

10:15 am - 11:15 am

Workshop

The Clinical Trial Regulation - QP Perspective & What to Consider for Success (WS05)

Now that the Clinical Trial Regulation is in place in Europe, what should we know, what should we be doing to comply with it and what are the timelines for compliance? This workshop will provide an opportunity to discuss requirements and ask questions from a QP perspective.

Speakers:

10:15 am - 11:15 am

Workshop

What to Know & Avoid to Experience the Greatest Success when Sourcing Comparators (WS04)

Comparator sourcing, a complex and challenging activity, is required to conduct the majority of clinical trials today. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.

Speakers:

11:15 am - 11:30 am

Conference Logistics

Transfer to Workshop

11:30 am - 12:30 pm

Workshop

Breaking Silos to Drive Sustainability in the Clinical Trial Supply Chain (WS23)

We all know it's hard for employees or even individual departments to influence corporate policy. Let's discuss ways that clinical supply professionals can have a greater impact on corporate sustainability.

Speakers:

11:30 am - 12:30 pm

Workshop

Clinical Trial Regulation Discussion (WS16)

Come to this workshop to share your experiences and find out others experiences with the updates to the CTR.

Speakers:

11:30 am - 12:30 pm

Workshop

Creating Clinical Trial Supply Success for Small Start-ups in a Sea of Giant Companies (L04)

Leaders from small biopharma companies help you understand the challenges of working in a small organization and competing with mid-size to large companies for manufacturing and packaging slots while still delivering against tight timelines.

Speakers:

11:30 am - 12:30 pm

Workshop

Cultural Evolution Within the Clinical Supplies Industry (Post-pandemic) (L05)

Post-pandemic our industry has experienced a tectonic shift in how we accomplish our mission and how we work together as teams. This workshop will provide a facilitated approach to produce tips and techniques to help leaders evolve and create high-performing teams, no matter where they are.

Speakers:

11:30 am - 12:30 pm

Workshop

How to Plan & Execute an Efficient Study Closeout (WS11)

One of the last things considered when executing the clinical supply strategy for clinical studies is the study closeout. This workshop will provide guidance for how to plan for and accomplish a study closeout that ensures the highest level of efficiency and cost-savings for the clinical supply chain. This could not be more important due to the focus on returns and reconciliation in the clinical trial regulation.

Speakers:

11:30 am - 12:30 pm

Workshop

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS20)

In this workshop we will discuss ways to increase the influence of clinical supplies to achieve the best outcomes, the shortest timelines and the fewest number of changes to the clinical supply chain by working closely with our partners in clinical operations.

Speakers:

11:30 am - 12:30 pm

Workshop

Let's Discuss Unconscious Bias: How to Recognize and Address Behaviors that Disrupt Equity & Belonging in the Workplace (WS14)

An opportunity to talk about what our companies are doing (or what we'd like them to be doing) as it relates to increasing diversity, equity and inclusion (DEI) in hiring.

Speakers:

11:30 am - 12:30 pm

Workshop

Managing Import/Export Requirements for Your Products (WS18)

The global reach of today's clinical trials makes understanding your product and its specific transit & import/export requirements a must for any clinical supply chain. This workshop will discuss ways to navigate the myriad of complex regulations involved in the import and export of clinical trial supplies, including valuation and harmonized system tariff codes.

Speakers:

11:30 am - 12:30 pm

Workshop

Supply Chain Best Practices - Open Forum (WS39)

This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.

Speakers:

11:30 am - 12:30 pm

Workshop

Temperature Excursions & Some of the Latest Technical Innovations to Mitigate Them (WS19)

The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the latest innovation and technical solutions to control, track, trend and avoid temperature excursions for the life of the product. This workshop will also provide examples of systems in use that can decrease investigations, route case analysis and CAPA timelines for temperature excursions.

Speakers:

11:30 am - 12:30 pm

Workshop

The Importance of Being Connected to and Engaged With our Analytical Group's Stability Program to Improve Clinical Supply Outcomes (WS21)

As stability testing and re-test dates are so critical to clinical supplies, this workshop will explore ways to improve oversight and understanding of stability protocols. We will also discuss the importance of building relationships with analytical to get timely updates for CofA's to positively impact CTM planning and forecasting.

Speakers:

11:30 am - 12:30 pm

Workshop

VAT Regulation & Rebate Options for Clinical Materials (WS12)

Value added tax (VAT) can significantly increase your clinical trial budget. This workshop will look at ways to maximize your ability to reclaim VAT as a clinical trial sponsor.

Speakers:

12:30 pm - 1:30 pm

Networking

Lunch & Liquid Nitrogen Ice Cream / Exhibitor Displays Open / Transfer to Workshop

Monday's meals sponsored by:

Enjoy a little treat after lunch with Liquid Nitrogen Ice Cream! Flash freezing ice cream reduces the size of ice crystals resulting in creamier tasting ice cream. Don’t miss out on a frozen treat!

Ice cream sponsored by:

1:30 pm - 2:30 pm

Workshop

Clinical Supplies Unblinding Risk Assessments (L01)

There are so many ways we can unblind our clinical trials. This workshop will discuss many of the different ways our clinical supply chain can contribute to unblinding. These can include differences in packaging configuration between arms in a trial, shipping to a clinical site with documents that could unblind the trial or IRT challenges that lead to unblinding.

1:30 pm - 2:30 pm

Workshop

DTP in Action: Exchange on Direct to Patient Experiences & Lessons Learned (WS24)

In working to increase the use of DTP in clinical trials, the GCSG DTP subteam (under the Regulatory e-Team) sent out an industry survey. This workshop will review the findings, trends and possible directions forward to increase the adoption of DTP as a clinical supply distribution model.

Speakers:

1:30 pm - 2:30 pm

Workshop

How to Partner with Your Quality Assurance Organization (WS17)

As the world of clinical supplies becomes increasingly complex, it is essential that Clinical Supply partners with Quality to achieve the best outcomes. An essential step in this process is to build a quality culture within the clinical supply unit while developing excellent relationships between the two groups. This session will discuss ways to build that culture and partnership within your own organization.

Speakers:

1:30 pm - 2:30 pm

Workshop

Mind The Gap: The Shortage of Clinical Supply Professionals (WS36)

In current times we are seeing a dramatic disconnect between the demand for clinical supplies staff and the available resource of talent. Consider the causative factors and explore winning solutions we can bring back to our organizations.

Speakers:

1:30 pm - 2:30 pm

Workshop

New Concepts in Pooling Supplies Using Protocol Masters and Submission Strategy (WS08)

1:30 pm - 2:30 pm

Workshop

Overcoming sub-Saharan Africa Region (West, Central and East Africa) / Import / Export / Distribution Challenges (WS09)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of West, Central and East Africa countries for labelling and distribution as well as how they impact CT supplies timelines and planning.

Speakers:

1:30 pm - 2:30 pm

Workshop

Planning Studies Using Auxiliary Supplies with the EU Regulation Changes (WS30)

Under the Clinical Trial Regulation, Auxiliary Medicines have been categorized as Authorised and Unauthorised, and there are requirements that go along with each. What does the Regulation have to say about Auxiliary Medicines and how does that impact sponsors and how these are sourced and labelled? We also invite attendees to share different strategies they have used under the CTR for auxiliary medicines.

1:30 pm - 2:30 pm

Workshop

Preparing to Outsource & Selecting the Right Vendor (WS25)

Outsourcing has become the norm in our industry, yet we still see issues on both sides of the table. This workshop will provide insights into how to decrease risk and increase success when partnering.

Speakers:

1:30 pm - 2:30 pm

Workshop

The Clinical Supply Chain Professional Toolkit (WS32)

This workshop will focus on innovative tools and techniques to address legacy and present day challenges within Clinical Supply Chain.

Speakers:

1:30 pm - 2:30 pm

Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (WS22)

Blockchain is a type of distributed ledger, an expanding chronologically ordered list of cryptographically signed, irrevocable transactional records shared by all participants in a network. AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This workshop will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implemented into the Clinical Supply Chain.

1:30 pm - 2:30 pm

Workshop

Ways of Working in the PM and CSC Relationship (WS33)

The PM and CSC overlap – How to leverage PM practices in day-to-day Clinical Supply Chain management

Speakers:

2:30 pm - 2:45 pm

Conference Logistics

Transfer to Plenary Hall

2:45 pm - 3:15 pm

Presentation

GCSG Membership Plenary Session

There's so much going on at GCSG beyond our annual conferences. This session will update you on some of the advancements we've made to better serve our members and the benefits of GCSG membership.

Speakers:

3:15 pm - 3:30 pm

Presentation

Closing Remarks & Raffle Draw

3:30 pm - 4:45 pm

Networking

Exhibitor Displays Open

4:45 pm - 5:15 pm

Break

Free Time

5:15 pm - 5:30 pm

Conference Logistics

Bus Loading / Departure

6:00 pm - 9:00 pm

Networking

GCSG Night Out Event at Universal CityWalk - Sponsored by Marken

Get ready for one of the most incredible parties GCSG has ever thrown—a huge bash that fills three different clubs in Universal CityWalk at Universal Orlando Resort. Take a trip to New Orleans at Pat O’Brien’s®, explore the home of the king of reggae at Bob Marley—A Tribute to FreedomSM, and take the stage at CityWalk’s Rising Star nightclub. It’s an entire evening of excitement!

Sponsored by:

9:00 pm - 11:00 pm

Networking

GCSG After Glow Party at the Red Coconut Club - Sponsored by Xerimis

Get ready to celebrate with a huge party at Universal CityWalk. GCSG has reserved the Red Coconut Club just for you! Enjoy the trendy, tropical cool of Orlando’s hottest ultra-lounge where you can take in the view on the balcony, mellow out at intimate tables inside, or mix with lively crowds around the bars.

Sponsored by:

Day 3 : Tuesday, April 25

7:30 am - 8:15 am

Conference Logistics

Breakfast

Tuesday's meals sponsored by:

7:30 am - 8:15 am

Networking

Exhibitor Displays Open

7:30 am - 4:30 pm

Conference Logistics

Registration/Information/Welcome Table Open

8:15 am - 8:30 am

Conference Logistics

Transfer to Plenary Hall

8:30 am - 8:45 am

Presentation

Welcome & Opening Remarks

8:45 am - 9:45 am

Presentation

Patient Testimonial: Katie Ortman Doble - Sponsored by Midwinter Solutions

Katie Ortman Doble is a patient advocate, writer and motivational speaker who inspires through her witty and optimistic outlook as a stage 4, ocular melanoma survivor. Doble credits a mix of integrative healing, positive attitude, and Western medicine for allowing her to survive cancer for nine years and counting. Her blog, Future Happy Self, is part self-exploration about her own journey to finding health and happiness and part advice column so that others may learn from her experiences. Doble works as a headhunter in the Colorado market in addition to doing patient advocacy and public speaking.

In 2017, Doble was given the Courage Award from the Melanoma Research Foundation. In 2018, a 5-part series on living wills written by Doble was featured on the Denver Hospice blog and picked up by Denver’s local Fox affiliate. Doble was the 2021 recipient of First Descents' Out Living It Award.

Doble lives in Denver with her husband, Nick, whom she met after first connecting on LinkedIn, and their dog Alice. Thanks to ocular melanoma, Doble and Alice have matching heterochromatic eyes. The Doble family loves to hike, bike, cook and travel.

Transfer to Workshop

10:00 am - 11:00 am

Workshop

Allogeneic Supply Chain –(Matched DONOR and Traditional) (WS37)

Things to consider and how to develop a robust allogeneic supply chain for your cell or gene therapy.

Speakers:

10:00 am - 11:00 am

Workshop

Changes in Decentralized Trials Affecting New Strategies in Direct-to-Patient Distribution (L02)

Speakers:

10:00 am - 11:00 am

Workshop

Clinical Supplies Unblinding Risk Assessments (L01)

10:00 am - 11:00 am

Workshop

Creating Clinical Trial Supply Success for Small Start-ups in a Sea of Giant Companies (L04)

Speakers:

10:00 am - 11:00 am

Workshop

Instilling an Inspection-Ready Culture in Your Clinical Supply Chain (WS01)

Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to bolster your knowledge on how to always be inspection ready!

10:00 am - 11:00 am

Workshop

Let's Discuss Unconscious Bias: How to Recognize and Address Behaviors that Disrupt Equity & Belonging in the Workplace (WS14)

An opportunity to talk about what our companies are doing (or what we'd like them to be doing) as it relates to increasing diversity, equity and inclusion (DEI) in hiring.

Speakers:

10:00 am - 11:00 am

Workshop

Mind The Gap: The Shortage of Clinical Supply Professionals (WS36)

Speakers:

10:00 am - 11:00 am

Workshop

Planning Studies Using Auxiliary Supplies with the EU Regulation Changes (WS30)

10:00 am - 11:00 am

Workshop

Preparing to Outsource & Selecting the Right Vendor (WS25)

Speakers:

10:00 am - 11:00 am

Workshop

The Clinical Supply Chain Professional Toolkit (WS32)

This workshop will focus on innovative tools and techniques to address legacy and present day challenges within Clinical Supply Chain.

Speakers:

10:00 am - 11:00 am

Workshop

Ways of Working in the PM and CSC Relationship (WS33)

The PM and CSC overlap – How to leverage PM practices in day-to-day Clinical Supply Chain management

Speakers:

11:00 am - 11:15 am

Conference Logistics

Transfer to Workshop

11:15 am - 12:15 pm

Workshop

Autologous Supply Chains (WS38)

Autologous cell therapies are at the forefront of the cell and gene therapy revolution. Come to this workshop to contribute and learn about Vein to Vein activities, Considerations when setting up a Patient centric supply chain organization, identify resources early to support Chain of Identity / Chain of Custody, and how to manage distribution of these precious cells. If you have a hot topic, please bring it with you and we can utilize the knowledge of the room.

Speakers:

11:15 am - 12:15 pm

Workshop

Cell and Gene Therapy - End-to-End Supply Chain Requirements and Systems to Use (WS02)

Speakers:

11:15 am - 12:15 pm

Workshop

Cultural Evolution Within the Clinical Supplies Industry (Post-pandemic) (L05)

Speakers:

11:15 am - 12:15 pm

Workshop

How to Plan & Execute an Efficient Study Closeout (WS11)

Speakers:

11:15 am - 12:15 pm

Workshop

IRT Systems and How to Use Them for Forecasting & Data Analytics (WS06)

11:15 am - 12:15 pm

Workshop

Label Design Considerations for Clinical Supplies - What Goes on the Label & Where? (WS07)

Speakers:

11:15 am - 12:15 pm

Workshop

LATAM Region Import/Export/Distribution Challenges (WS10)

Speakers:

11:15 am - 12:15 pm

Workshop

Supply Chain Best Practices - Open Forum (WS39)

This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.

Speakers:

11:15 am - 12:15 pm

Workshop

The Clinical Trial Regulation - QP Perspective & What to Consider for Success (WS05)

Speakers:

11:15 am - 12:15 pm

Workshop

VAT Regulation & Rebate Options for Clinical Materials (WS12)

Value added tax (VAT) can significantly increase your clinical trial budget. This workshop will look at ways to maximize your ability to reclaim VAT as a clinical trial sponsor.

Speakers:

11:15 am - 12:15 pm

Workshop

What to Know & Avoid to Experience the Greatest Success when Sourcing Comparators (WS04)

Speakers:

12:15 pm - 1:30 pm

Networking

Lunch & Oxygen Bar / Exhibitor Displays Open

Tuesday's meals sponsored by:

Need a pick-me-up after GCSG’s Night Out? Come by the Oxygen Bar for an energy boost to increase concentration (or relieve a headache!)

Oxygen bar sponsored by:

1:30 pm - 2:30 pm

Showcase

Vendor Showcase - Insights Into the Factors That Continue to Undermine the Supply of Commercial Medicines for Use in Clinical Trials - Hosted by Abacus Medicine

Brief introduction to Abacus Medicines Pharma Services (AMPS)

Overview of the key issues that commonly impact the supply of medicines into clinical trials

What are the underlying factors that make it difficult to avoid these issues?

What has been the experience of people attending this session? An interactive discussion.

Thinking outside the box and innovative solutions

What are we all going to do differently moving forward?

1:30 pm - 2:30 pm

Showcase

Vendor Showcase - Leveraging 4C Supply® for Improved Drug Supply Forecasting - Hosted by 4G Clinical

In the pharmaceutical industry, efficient and accurate supply forecasting is crucial for ensuring timely and cost-effective production and distribution of IMP. This session will explore several use cases for 4C Supply®, a powerful tool for modeling study demand and forecasting drug supply, and how it can help stakeholders make better, more informed decisions.

This vendor showcase will discuss how 4C Supply® puts data visibility and scenario planning in the hands of clinical supply professionals, allowing them to have greater control over the production and distribution processes. By providing sponsors with the data they need to make informed decisions, 4C Supply® can help organizations streamline their supply chains and reduce costs while ensuring sufficient supplies for patient treatment.

Attendees will leave the presentation with a deeper understanding of the benefits of 4C Supply® and how it can help them improve their drug supply forecasting processes. They will also gain valuable insights into how to use data effectively to plan production and make better decisions in the face of challenging scenarios.

Speakers:

1:30 pm - 2:30 pm

Showcase

Vendor Showcase - Reimagine Clinical Supply Chain Operations Through Automation - Hosted by SAP

Learn how to harmonize your clinical and commercial supply chain to achieve quality assurance, development, and operational excellence. The head of clinical supply chain planning at Roche will share how they have reinvented and standardized their clinical processes to support new types of clinical trials and medicines giving them full visibility of their global supply chain status to proactively avoid shortages and waste.

1:30 pm - 2:30 pm

Showcase

Vendor Showcase - Trial Design Optimization: How to Make Your Trials More Supply Friendly - Hosted by N-SIDE

Busting the concepts in clinical supply management - Forecasting, optimization, simulations, what’s the difference

With pharma and biotechs’ ambitions to do more with less, the supply chain easily becomes the center of attention in the attempt to supply trials faster, more efficiently and with lower waste levels

See how a trial can be patient-friendly, site-friendly and more supply-friendly!

Supply-friendly trials: case studies

Discover how some often overlooked parameters can have a significant impact on IMP waste and supply risk

How fostering cross-department collaboration can help achieving true efficiency

2:30 pm - 2:45 pm

Conference Logistics

Transfer to Plenary Hall

2:45 pm - 3:45 pm

Presentation

Increasing Diversity in Clinical Trials & How It Relates Back to DEI at Your Company

Speakers:

3:45 pm - 4:00 pm

Presentation

Closing Remarks & Raffle Draw

4:00 pm - 6:00 pm

Networking

Vendor Reception

Day 4 : Wednesday, April 26

7:30 am - 8:45 am

Conference Logistics

Breakfast

7:30 am - 9:00 am

Networking

Exhibitor Displays Open

7:30 am - 2:30 pm

Conference Logistics

Information/Help Desk Open

9:00 am - 9:30 am

Presentation

Welcome & Opening Remarks

9:30 am - 10:30 am

Presentation

Clinical Supplies - The Next 10 Years (Vision for the Future)

Post-pandemic, the clinical supply chain has changed dramatically. This presentation will provide more information and trend analysis of where we will be 10 years from now.

Speakers:

10:30 am - 10:45 am

Conference Logistics

Transfer to Workshop

10:45 am - 11:45 am

Workshop

Breaking Silos to Drive Sustainability in the Clinical Trial Supply Chain (WS23)

Speakers:

10:45 am - 11:45 am

Workshop

Cell and Gene Therapy - Transitioning from Standard Clinical Supply Chains to Cell & Gene Supply Chains (WS03)

10:45 am - 11:45 am

Workshop

Clinical Trial Regulation Discussion (WS16)

Come to this workshop to share your experiences and find out others experiences with the updates to the CTR.

10:45 am - 11:45 am

Workshop

Compare & Contrast the Diverse Types of Access (Compassionate Use, Off-label Access, Continued Access, Special License sales & Right-to-Try) (WS15)

Speakers:

10:45 am - 11:45 am

Workshop

DTP in Action: Exchange on Direct to Patient Experiences & Lessons Learned (WS24)

Speakers:

10:45 am - 11:45 am

Workshop

How to Partner with Your Quality Assurance Organization (WS17)

Speakers:

10:45 am - 11:45 am

Workshop

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS20)

Speakers:

10:45 am - 11:45 am

Workshop

Managing Import/Export Requirements for Your Products (WS18)

Speakers:

10:45 am - 11:45 am

Workshop

Temperature Excursions & Some of the Latest Technical Innovations to Mitigate Them (WS19)

Speakers:

10:45 am - 11:45 am

Workshop

The Importance of Being Connected to and Engaged With our Analytical Group's Stability Program to Improve Clinical Supply Outcomes (WS21)

Speakers:

10:45 am - 11:45 am

Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (WS22)

11:45 am - 12:45 pm

Networking

Lunch & Puppy Party!

Come enjoy a little puppy love to decrease your stress levels! We’ll have an animal shelter mobile unit on site with puppies of all shapes and sizes just waiting to be loved on.

Puppy party sponsored by:

12:45 pm - 1:00 pm

Conference Logistics

Exhibitor Display Breakdown

12:45 pm - 1:00 pm

Conference Logistics

Transfer to Vendor Showcase

1:00 pm - 2:00 pm

Showcase

Vendor Showcase - Future-Proofing Clinical to Commercial Storage and Distribution Leveraging a Ready-Now Network - Hosted by Marken [Regency 3]

Join us in a Jeopardy-style game where we will explore rapidly evolving clinical storage and distributions complexities that require careful orchestration of all pieces of the pharmaceutical journey. From clinical to commercial, it is critical to remain resilient against unpredictable challenges and global disruptions. A patient-centric supply chain strategy that includes a single-source ready-now network with the right people in the right locations powered by the right technology provides the ability to be proactive and agile amid ongoing clinical trial transformation.

Our presenters are Mark Newman and Abigail French. Both are Business Development Directors.

Speakers:

1:00 pm - 2:00 pm

Showcase

Vendor Showcase - How Modern Software Architecture Is Driving Next-Gen IRT Solutions - Hosted by YPrime [Regency 2]

Clinical trials have become more complex over the last 20+ years, requiring IRT technologies to support a continuously expanding array of functionality and scenarios. In this session, we will examine the evolution of IRT and where it is heading. Most importantly, we will cover how the underlying architecture of your IRT impacts its ability to handle protocol amendments and how it can better integrate with your broader eClinical ecosystem.

1:00 pm - 2:00 pm

Showcase

Vendor Showcase - Optimizing Your Clinical Drug Forecast and Supplies Using IRT - Hosted by Endpoint Clinical [Regency 4]

An interactive workshop where we will go into details and best practices on how you can utilize your IRT functionality to improve your clinical trials supply management. This session will include an overview of how to utilized IRT to make better informed decisions about your demand & supply plan. We will also review important IRT settings for creating the user specifications, how they impact your demand & supply plan, and common pitfalls and ways to solve them in supply forecasting.

1:00 pm - 2:00 pm

Showcase

Vendor Showcase - Where do the majority of your temperature excursions occur? Why not eliminate them? - Hosted by TSS [Regency 1]

Come and learn what it would take and be prepared to discuss turning that ideal state into reality for you and your company.

2:00 pm - 2:15 pm

Conference Logistics

Transfer to Plenary Hall

2:15 pm - 3:00 pm

Presentation

Regulatory Q & A Panel

Everyone in clinical supplies knows we work in a complex and highly regulated space. One of our biggest challenges is that our scientific and technical advances can move faster than the competent authorities.
Please join us for a multinational panel composed of members from our very own GCSG Regulatory eTeam, who will share their updates and insights on the changing regulations that guide our industry.
The panel will provide an opportunity for conference attendees to ask their regulatory questions and provide an open forum to share knowledge and discuss issues.

Speakers:

3:00 pm - 3:45 pm

Presentation