GCSG 2024 US Conference: Program

Day 1 : Sunday, April 21

7:30 am - 8:30 am
Conference Logistics

Boot Camp Registration Open

Boot Camps Sponsored by:
8:00 am - 4:30 pm
Boot Camp / Seminar

Expanded Access

This interactive seminar will give an overview of expanded access and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.

Speakers:

8:00 am - 4:30 pm
Boot Camp / Seminar

Interactive Response Technology (IRT) Deep Dive

Interactive Response Technology (IRT), IXRS, and RTSM all describe a system that is integral to managing both GMP and GCP activities in a clinical trial.  For supply managers this is the critical system for maintaining the supplies of all clinical materials.  Proper set-up of this system is critical to ensure smooth conduct of a clinical trial - absent of supply issues.  This Boot Camp will examine the details required to properly set up and manage an IRT.  Some of the topics that will be covered include: details to discuss when evaluating an IRT system, how to read specification documents, performing user acceptance testing and setting up parameters for supply strategies, do not ship & do not dispense dates.

This Boot Camp will not be a high-level overview of IRT basics but a detailed discussion of IRT parameters.  It will be assumed that attendees have a working understanding of IRT principles.

Speakers:

8:00 am - 4:30 pm
Boot Camp / Seminar

Mastering Clinical Supply Planning

Planning the clinical supply chain is a formidable task, full of challenges and complexities.  With the variety of information to consider, external influences, and the inherent uncertainties of clinical trials supply managers often find themselves under pressure to deliver a supply plan that is not only accurate but also highly efficient.  This advanced one-day bootcamp is tailored for supply chain managers and planners familiar with the basics who would like to elevate their skills and knowledge.  Together, we will address the main drivers of inefficiencies in clinical supply planning and navigate good practices to avoid them.

Speakers:

8:00 am - 4:30 pm
Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

This class is geared toward people new to the clinical trial supplies world, and focuses on drug development and what goes into planning for and delivering a study drug for 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, stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the EU and ROW. Attendees will hear a massive amount of information in a fun and interactive atmosphere.

Speakers:

2:00 pm - 5:30 pm
Conference Logistics

Exhibitor Setup

2:00 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

Conference Orientation - Start the Conference Right!

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 2024 Conference!

Sponsored by:
6:00 pm - 8:00 pm
Networking

Meet & Greet - "Hampton Social"

Step in to the feeling of long summer days spent along the coast at GCSG’s Hampton Social. This is the perfect opportunity to gather with friends and colleagues, enjoy great food and drinks, and experience the beachy vibes of Hampton Social. Don't miss out on this unforgettable evening as you mingle and network, enjoy a Gulf Coast inspired cuisine, music, and entertainment.

Sponsored by:
8:00 pm - 10:00 pm
Networking

After Hours Networking event

The night isn't over yet! Continue networking at the After Hours event sponsored by:

Day 2 : Monday, April 22

3:21 am - 3:21 am
Workshop

WS06 - 1 - Navigating Ancillary Management Challenges

This interactive discussion will cover topics such as:

- Identify important considerations for ensuring compatibility of IMP with common infusion materials & how they impact delivery of drug to the patient
- Identify key stakeholders (e.g. CMC, Clinical, CRO, CMO) involved in the process & how they may be leveraged to support the process
- Discuss how to develop a plan to ensure availability & continuity of compatible ancillaries across all regions within which the trials will be conducted
- Poll group & review pros & cons of different organizational approaches to management & delivery of ancillary supplies

Speakers:

7:30 am - 8:15 am
Break

Breakfast

Monday 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

8:50 am - 10:00 am
Presentation

Keynote Address: John O'Leary - Sponsored by BMClinical

In 1987, John O’Leary was a curious nine-year-old boy. Playing with fire and gasoline, John created a massive explosion in his home and was burned on 100% of his body. He was given less than a 1% chance to live.

This epic story of survival (first showcased in 2008 with his parents’ acclaimed book Overwhelming Odds) has never felt more relevant than as we live through the COVID-19 pandemic together.

John’s genuine, collaborative approach to partnering allowed him to understand early that clients’ biggest pain point in the wake of the fallout from the pandemic is team “burnout.” To address this, John expanded his Live Inspired Coaching program to bring his keynote from inspirational to transformational. Early successes in the program have clients saying their teams are more focused, collaborative and engaged than ever.

John’s award-winning Live Inspired Podcast has more than 2.5 million downloads and enjoys world-class guests like Brené Brown, Mitch Albom and Shawn Achor.

John considers his greatest success to be his marriage to his wife Beth, their four children and his relationships with friends and family.

Sponsored by:

Speakers:

10:00 am - 10:15 am
Conference Logistics

Transfer to Workshop

10:15 am - 11:15 am
Workshop

L1 - 1 - Cell and Gene Therapy Supply Chains - A Panel Discussion

Learn about the various supply chains of CGT and how they differ from traditional supply chains. Understand key considerations for both clinical and commercial and the support from digitization.

Speakers:

10:15 am - 11:15 am
Workshop

L2 - 1 - Data & Analytics to Drive the Clinical Supply Chain

This session offers a guide to establishing a robust foundation for data and analytics. Gain insights from industry experiences and real-world deployments, and explore practical examples of successful implementations that have driven significant value across the clinical supply chain.


Discover key areas where data and analytics can drive substantial improvements for your business. Participate in audience polling to select from a variety of case studies, and delve into emerging opportunities for added value. This session promises to be a game-changer for those ready to harness the power of data and analytics.

Speakers:

10:15 am - 11:15 am
Workshop

L3 - 1 - Using AI to Predict Enrollment

Clinical supply's greatest challenge is patient enrollment. It is the greatest cause of supply chain turmoil. This workshop will discuss how AI is being used to not only accelerate enrollment but to predict it and how those trends can be used by the clinical supply chain.

Speakers:

10:15 am - 11:15 am
Workshop

WS01 - 1 - Devices in combination with IP– Regulations for Packaging, Labels, Storage & Distribution

This workshop will discuss the challenges of “combination trials” involving an investigational product and a device in clinical trials. What are the standards and regulations which apply and what are the gaps we need to look for and address to remain compliant.

Speakers:

10:15 am - 11:15 am
Workshop

WS03 - 1 - Artificial Intelligence to Enhance and Streamline Your Daily Tasks

With the advent of AI and AI tools, the industry has evolved to better understand and use those tools to improve the clinical supply chain. This workshop will use one of those tools, ChatGPT, to demonstrate how this can be used to identify user requirement specifications and write user acceptance scripts to ensure an IRT has been built fit to purpose.

Speakers:

10:15 am - 11:15 am
Workshop

WS05 - 1 - Updates On New Regulations, Understanding Their Impact

We live in a highly regulated environment where new regulations are identified without much notice. This workshop will summarize a few of the latest regulations that have recently been released that will impact the clinical supply chain.

Speakers:

10:15 am - 11:15 am
Workshop

WS15 - 1 - VAT Recovery

Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).

Speakers:

10:15 am - 11:15 am
Workshop

WS20 - 1 - SMART Packaging for Adherence Measurement: Understanding the Impact on Your Supply Planning

Drug administration and compliance have always been a challenge. With the advent of SMART devices, this has become easier. This workshop will discuss how and why to integrate SMART technology into your supply chain to improve adherence

Speakers:

10:15 am - 11:15 am
Workshop

WS21 - 1 - Inspection Readiness Across the Pipeline

Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to discuss how to apply 80-20 rule, prepare for inspections & get ready for the inspection room as well as learn about some key tools to help you stay calm, succeed and always be inspection ready!

Speakers:

10:15 am - 11:15 am
Workshop

WS27 - 1 - Remote Working and Returning to the Office

During the pandemic, remote work became the standard for our industry. Now that the pandemic is behind us, there is an industry drive to bring people back into the office. This workshop will focus on adapting your communication and collaboration style to achieve the same level of success that a non-hybrid style provided pre-pandemic.

Speakers:

11:15 am - 11:30 am
Conference Logistics

Transfer to Workshop

11:30 am - 12:30 pm
Workshop

WS04 - 1 - Resources to Assist Patients in Identifying and Navigating Clinical Trials

This workshop will identify one of the largest challenges we have in the clinical trial industry, which is finding and enrolling patients. It will provide a different perspective to help understand how we can support patients in finding appropriate clinical trials to treat or cure many of the diseases from which they suffer today.

Speakers:

11:30 am - 12:30 pm
Workshop

WS08 - 1 - Understanding the Requirements & Challenges for Importer of Record (IoR)

Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.

Speakers:

11:30 am - 12:30 pm
Workshop

WS10 - 1 - Lessons Learned After 30 Years In Clinical Supplies

In 30 years, a lot could be learned in the clinical supply industry. This workshop will leverage SME's and participant's knowledge to provide solution to the attendee's biggest issues and questions.

Speakers:

11:30 am - 12:30 pm
Workshop

WS11 - 1 - Understanding EU Labeling Regulations

Awareness of labeling regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the labeling requirements in the EU that when correctly implemented allow you to avoid delays and supply chain disruptions.

Speakers:

11:30 am - 12:30 pm
Workshop

WS12 - 1 - Regulatory Label Requirements for Comparators

This workshop will discuss the options for establishing labeling requirements for your comparator program. This discussion will also include the challenges for ensuring comparators are labeled correctly for global trials including use of authorized auxiliary medicinal products (AAMPs) and unauthorized auxiliary medicinal products (UAMPs).

Speakers:

11:30 am - 12:30 pm
Workshop

WS17 - 1 - Clinical Supply Chain Open Forum

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

WS23 - 1 - Latest ERP SYSTEMS / Solutions and What Challenges Are Faced

As our companies grow and evolve, clinical supply chain management can utilize better and better tools for success. This workshop will explore the options for enterprise resource planning (ERP) solutions and how they can be integrated into your clinical supply unit.

Speakers:

11:30 am - 12:30 pm
Workshop

WS24 - 1 - Comparator Sourcing Challenges & Supply Chains

Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success.

Speakers:

11:30 am - 12:30 pm
Workshop

WS26 - 1 - Essential Leadership Skills

With the ever-evolving clinical supply chain, leadership has become an essential aspect that all of us must demonstrate at any given time. This workshop will provide essential leadership tools and identify skills necessary for team success.

Speakers:

11:30 am - 12:30 pm
Workshop

WS28 - 1 - Building a High-Performance Culture Within Your Team

In this session, we will discuss and define accountability with case studies provided to demonstrate techniques and concepts to instill a culture of accountability within your team.

Speakers:

11:30 am - 12:30 pm
Workshop

WS29 - 1 - Navigating Direct-To-Patient - Stakeholder Perspectives & Challenges

Direct-To-Patient distribution is a complex process involving multiple stake holders including patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees and couriers to name a few.  GCSG's DTP Team will lead a discussion about varied stakeholder perspectives, experiences and lessons learned (sponsors, vendors, etc.).

Speakers:

12:30 pm - 1:30 pm
Networking

Lunch & Smoothie Bar / Exhibitor Displays Open

Monday meals sponsored by:


Along with the invention of refrigeration and electric blenders came the invention of the smoothie! Stop by our smoothie bar and enjoy a little treat after lunch.

Smoothies sponsored by:
1:30 pm - 2:30 pm
Workshop

L4 - 1 - Getting the Most Out of Your IRT User Experience

Over the past few years, the emphasis has been on more self-service tools to adapt more quickly to trial execution challenges. This workshop will focus on how to control clinical supply chain settings in IRT and discuss what the right level of control should look like.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS02 - 1 - Strategies to Evaluate & Mitigate Clinical Supply Risk

This session focuses on strategies that build understanding of risk assessment within clinical supplies. The focus will be on planning, a study's protocol requirements, drug characteristics, packaging specifications, vendor partnerships and collaboration and patient compliance concerns which must be identified and addressed in order to mitigate risk for successful clinical supply outcomes.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS07 - 1 - What to Consider When Getting into Cell & Gene Therapy

This workshop will be a discussion focused on the challenges of cell and gene therapy. Key topics to be discussed will include CGT's patient orientation, temperature controlled logistics, site requirements, manufacturing challenges and aggressive timing.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS09 - 1 - Overcoming the Black Box Effect in Forecasting and RTSM

Randomization and Trial Supply Management (RTSM) users sometimes do not trust the results they receive. This results in additional verification of the output. These systems are often complicated and lack transparency and therefore can be hard to understand. In this workshop, we explore how products can evolve and what users can do to reduce or eliminate the confusion of what happens inside the system (black box effect) and let the users truly benefit from their added value.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS13 - 1 - Japan: Direct to Patient and The Decentralized Landscape

As clinical supply chains evolve in Asia-Pac, two areas of opportunity identified during the pandemic were the implementation of decentralized trials (DCTs) and direct-to-patient distribution (DtP).This workshop will identify ways to leverage DtP while avoiding the pitfalls of working in these emerging markets.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS14 - 1 - Understanding the Importance and Required Processes of Reconciliation & Destruction

Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS16 - 1 - Clinical Supplies Stakeholder Management

Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how   clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution),   CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).

Speakers:

1:30 pm - 2:30 pm
Workshop

WS18 - 1 - How to Accomplish Drug Pooling in Europe

Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will focus on the challenges of doing pooling of supplies in Europe as well as provide some solutions to accomplish the most pooling possible.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS19 - 1 - Using Data to Find Wasteful Processes and Cost Savings

Data is available in multiple locations and in order to ensure its successful use, it must be properly collected, shared, organized, cleaned and visualized. Each step of this process increases its value tremendously. When properly queried, this data can be used to identify and eliminate waste as well as alert clinical supplies when the supply chain is destabilizing.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS22 - 1 - End-to-End Clinical Trial & Supply Program Management

Holistic program management integrates clinical research and supply processes providing consistency for an asset and continuous improvement. Key elements to program management involve flexibility balancing cost, time, risks, and expectations.  This workshop will discuss strategies for effective program execution through early engagement, planning, risk management and governance.

Speakers:

1:30 pm - 2:30 pm
Workshop

WS25 - 1 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process

As the incidence of outsourcing the clinical supply chain has increased, understanding the value of clinical supply management using your vendor as a partner has become essential. This workshop will explore how to best utilize your vendor partner as a seamless part of your supply chain while utilizing internal stakeholder inputs to update your metrics.

Speakers:

2:30 pm - 2:45 pm
Conference Logistics

Transfer to Plenary Hall

2:45 pm - 3:15 pm
Presentation

GCSG Membership Plenary Session & Introduction of e-Teams

This plenary will provide a GCSG membership update as well as introduce some of our eTeams (Cell and Gene Therapy, Expanded Access Resources Team, Regulatory and Education) and how you can learn more or join the team!

Speakers:

3:15 pm - 3:30 pm
Presentation

Closing Remarks and Raffle Drawings

3:30 pm - 4:30 pm
Networking

Exhibitor Displays Open

4:30 pm - 5:00 pm
Break

Free Time

5:00 pm - 8:00 pm
Networking

GCSG Night Out Event - Tropical Carnival - Sponsored by Yourway

A carnival is a vibrant spectacle of life, a riotous blend of sights, sounds and experiences that captivate the senses and invigorate the spirit. GCSG is adding a tropical spin to Monday's Night Out event. Join us at the Cypress Courtyard of the Coconut Point Resort (weather permitting) for mini-golf, pineapple bowling, the musical styling of Steel Band Delight, and more!

Sponsored by:

8:00 pm - 10:00 pm
Networking

After Hours Networking event

There is no such thing as too much networking! Join us 'after hours' to continue making connections.

Sponsored by:

Day 3 : Tuesday, April 23

7:30 am - 8:15 am
Break

Breakfast

Tuesday 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; Alicia Dellario - Sponsored by Midwinter Solutions

Alicia is a 9+-year survivor of ovarian cancer. She was diagnosed with late-stage, metastatic ovarian cancer in 2014 which was followed by 3 separate recurrences.   After years and years of standard-of-care chemo to address the disease, at the time of the 3rd recurrence / 4th battle, there was a clinical trial available for her unique tumor type. It was the first time she was treated with something targeted for ovarian cancer. After 4.5 years, the trial ended and Alicia has been in remission for 7 months as of December 2023!   She is incredibly grateful for the advances in science!!   Without them, she would not be here.

When she was originally diagnosed, her daughter was only 7 so she made a promise to herself to turn this into something positive. She has been heavily involved in raising awareness about this disease, funding for an early detection mechanism, and speaking of the value of clinical trials via an annual golf and barbecue tournament called Tee it Up for Teal, an annual “Alicia’s Army” walk and many events in partnership with the National Ovarian Cancer Coalition as well as the company for which she worked for 15 years (prior to retiring in 2021!).

Alicia never loses hope as science is making great advances. She is incredibly grateful and reminds herself to find the beauty in each day. It is there and it can change your outlook at even the most difficult times. Alicia lives in Pennsylvania with her husband, teenage daughter, dog (her cancer companion) and cat. Besides spending time with her family, which is her favorite past-time, she enjoys running, yoga, reading and times with dear friends.

Sponsored by:

9:45 am - 10:00 am
Conference Logistics

Transfer to Workshop

10:00 am - 11:00 am
Workshop

L1 - 2 - Cell and Gene Therapy Supply Chains - A Panel Discussion

Learn about the various supply chains of CGT and how they differ from traditional supply chains. Understand key considerations for both clinical and commercial and the support from digitization.

Speakers:

10:00 am - 11:00 am
Workshop

L2 - 2 - Data & Analytics to Drive the Clinical Supply Chain

This session offers a guide to establishing a robust foundation for data and analytics. Gain insights from industry experiences and real-world deployments, and explore practical examples of successful implementations that have driven significant value across the clinical supply chain.

Discover key areas where data and analytics can drive substantial improvements for your business. Participate in audience polling to select from a variety of case studies, and delve into emerging opportunities for added value. This session promises to be a game-changer for those ready to harness the power of data and analytics.

Speakers:

10:00 am - 11:00 am
Workshop

L3 - 2 - Using AI to Predict Enrollment

Clinical supply's greatest challenge is patient enrollment. It is the greatest cause of supply chain turmoil. This workshop will discuss how AI is being used to not only accelerate enrollment but to predict it and how those trends can be used by the clinical supply chain.

Speakers:

10:00 am - 11:00 am
Workshop

WS01 - 2 -Devices in combination with IP– Regulations for Packaging, Labels, Storage & Distribution

This workshop will discuss the challenges of “combination trials” involving an investigational product and a device in clinical trials. What are the standards and regulations which apply and what are the gaps we need to look for and address to remain compliant.

Speakers:

10:00 am - 11:00 am
Workshop

WS03 - 2 - Artificial Intelligence to Enhance and Streamline Your Daily Tasks

With the advent of AI and AI tools, the industry has evolved to better understand and use those tools to improve the clinical supply chain. This workshop will use one of those tools, ChatGPT, to demonstrate how this can be used to identify user requirement specifications and write user acceptance scripts to ensure an IRT has been built fit to purpose.

Speakers:

10:00 am - 11:00 am
Workshop

WS05 - 2 - Updates On New Regulations, Understanding Their Impact

We live in a highly regulated environment where new regulations are identified without much notice. This workshop will summarize a few of the latest regulations that have recently been released that will impact the clinical supply chain.

Speakers:

10:00 am - 11:00 am
Workshop

WS06 - 2 - Navigating Ancillary Management Challenges

This interactive discussion will cover topics such as:




  • Identify important considerations for ensuring compatibility of IMP with common infusion materials and how they impact delivery of drug to the patient

  • Identify key stakeholders (e.g. CMC, Clinical, CROs, CMOs) that are involved in the process and how they may be leveraged to support the process.

  • Discuss how to develop a plan to ensure availability and continuity of compatible ancillaries across all regions the trials will be conducted in

  • Poll group and review pros and cons of different organizational approaches to management and delivery of ancillary supplies

Speakers:

10:00 am - 11:00 am
Workshop

WS15 - 2 - VAT Recovery

Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).

Speakers:

10:00 am - 11:00 am
Workshop

WS20 - 2 - SMART Packaging for Adherence Measurement: Understanding the Impact on Your Supply Planning

Drug administration and compliance have always been a challenge. With the advent of SMART devices, this has become easier. This workshop will discuss how and why to integrate SMART technology into your supply chain to improve adherence

Speakers:

10:00 am - 11:00 am
Workshop

WS21 - 2 - Inspection Readiness Across the Pipeline

Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to discuss how to apply 80-20 rule, prepare for inspections & get ready for the inspection room as well as learn about some key tools to help you stay calm, succeed and always be inspection ready!

Speakers:

10:00 am - 11:00 am
Workshop

WS27 - 2 - Remote Working and Returning to the Office

During the pandemic, remote work became the standard for our industry. Now that the pandemic is behind us, there is an industry drive to bring people back into the office. This workshop will focus on adapting your communication and collaboration style to achieve the same level of success that a non-hybrid style provided pre-pandemic.

Speakers:

11:00 am - 11:15 am
Conference Logistics

Transfer to Workshop

11:15 am - 12:15 pm
Workshop

L4 - 2 - Getting the Most Out of Your IRT User Experience

Over the past few years, the emphasis has been on more self-service tools to adapt more quickly to trial execution challenges. This workshop will focus on how to control clinical supply chain settings in IRT and discuss what the right level of control should look like.

Speakers:

11:15 am - 12:15 pm
Workshop

WS04 - 2 - Resources to Assist Patients in Identifying and Navigating Clinical Trials

This workshop will identify one of the largest challenges we have in the clinical trial industry, which is finding and enrolling patients. It will provide a different perspective to help understand how we can support patients in finding appropriate clinical trials to treat or cure many of the diseases from which they suffer today.

Speakers:

11:15 am - 12:15 pm
Workshop

WS08 - 2 - Understanding the Requirements & Challenges for Importer of Record (IoR)

Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.

Speakers:

11:15 am - 12:15 pm
Workshop

WS11 - 2 - Understanding EU Labeling Regulations

Awareness of labeling regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the labeling requirements in the EU that when correctly implemented allow you to avoid delays and supply chain disruptions.

Speakers:

11:15 am - 12:15 pm
Workshop

WS12 - 2 - Regulatory Label Requirements for Comparators

This workshop will discuss the options for establishing labeling requirements for your comparator program. This discussion will also include the challenges for ensuring comparators are labeled correctly for global trials including use of authorized auxiliary medicinal products (AAMPs) and unauthorized auxiliary medicinal products (UAMPs).

Speakers:

11:15 am - 12:15 pm
Workshop

WS17 - 2 - Clinical Supply Chain Open Forum

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

WS23 - 2 - Latest ERP SYSTEMS / Solutions and What Challenges Are Faced

As our companies grow and evolve, clinical supply chain management can utilize better and better tools for success. This workshop will explore the options for enterprise resource planning (ERP) solutions and how they can be integrated into your clinical supply unit.

Speakers:

11:15 am - 12:15 pm
Workshop

WS24 - 2 - Comparator Sourcing Challenges & Supply Chains

Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success.

Speakers:

11:15 am - 12:15 pm
Workshop

WS26 - 2 - Essential Leadership Skills

With the ever-evolving clinical supply chain, leadership has become an essential aspect that all of us must demonstrate at any given time. This workshop will provide essential leadership tools and identify skills necessary for team success.

Speakers:

11:15 am - 12:15 pm
Workshop

WS28 - 2 - Building a High-Performance Culture Within Your Team

In this session, we will discuss and define accountability with case studies provided to demonstrate techniques and concepts to instill a culture of accountability within your team.

Speakers:

11:15 am - 12:15 pm
Workshop

WS29 - 2 - Navigating Direct-To-Patient - Stakeholder Perspectives & Challenges

DTP is a complex process with multiple stake holders with patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees and couriers to name a few.  GCSG DTP Team will lead discussion about varied stakeholder perspectives, experiences and lessons learned (sponsors, vendors, etc.).

Speakers:

12:15 pm - 1:30 pm
Networking

Lunch & Snow Cones / Exhibitor Displays Open

Tuesday meals sponsored by:



Do you need some relief from the Florida heat? Come by the Snow Cone Station for a cool treat before heading to the vendor showcases!

Snow Cones Sponsored by:

1:30 pm - 2:30 pm
Showcase

Vendor Showcase - Acceleration to Market Through Innovation & Integration - Hosted by Thermo Fisher Scientific

Learn how Thermo Fisher Scientific is helping you accelerate to market through two key areas: clinical trial innovation and CRO/CDMO integration. By introducing many market leading innovative clinical trial services across our end-to-end suite of solutions as well as our integration of CRO and CDMO capabilities, Thermo Fisher has proven an industry differentiating ability to drive increased speed, efficiency, and flexibility in drug development.  ​

Hear from industry experts on how we've successfully executed I these two areas and how the combination our innovation and integration efforts uniquely enables Thermo Fisher to support acceleration of your molecule to market. ​

Presented by: Jason Ruch & Sarah Englert

1:30 pm - 2:30 pm
Showcase

Vendor Showcase - Evolution of RTSM Forecasting Technology in the Face of Increasing Trial Protocol Complexity - Hosted by 4G Clinical

Clinical trials are increasingly complex and expensive, meaning that RTSM forecasting technology has to evolve to keep up. Instead of the single forecasting algorithm which was previously used in all trials, modern RTSM platforms support a portfolio of forecasting algorithms to choose from. To leverage this technology, RTSM vendors are collaborating with sponsors to identify and implement the optimal forecasting setup for each trial.

Presented by: Nicolas Biber, Forecasting and Resupply Operations Lead at 4G Clinical
1:30 pm - 2:30 pm
Showcase

Vendor Showcase - Smart Supply Strategies to Reduce Complexity & Delays - Hosted by Clinigen

Clinical studies are becoming increasingly complex, with increased pressure on budgets and timelines. This session will discuss the most common pitfalls that lead to delays and how to boost your clinical supplies' cycle time with the right people, processes, and tools.

Presented by: Randa Atiyeh, VP, Client Management, Clinical Supplies Management, Clinigen and Lisa McConnell, Team Lead, US Project Management, Clinigen
2:30 pm - 2:45 pm
Conference Logistics

Transfer to Plenary Hall

2:45 pm - 3:45 pm
Presentation

Plenary Session - The Bioethics Associated with Expanded Access / Early Access

This panel will address questions as to why some companies actually implement expanded access or named patient programs for specific small groups or individuals and some companies do not. Panel will discuss what ethical issues companies must wrestle with to ensure they are doing the best for expanded access patients. The panel will be composed of a diverse representation from EAP and NPP supply chain and advocacy groups.

Speakers:

3:45 pm - 4:00 pm
Presentation

Closing Remarks and Raffle Drawings

4:00 pm - 6:00 pm
Networking

Vendor Reception / Exhibitor Displays Open

8:00 pm - 10:00 pm
Networking

After Hours Networking event

Don't miss your last chance for After Hours networking! Sponsored by:

Day 4 : Wednesday, April 24

7:30 am - 8:45 am
Break

Breakfast

Wednesday meals sponsored by:
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

Team Building, Retention and Trust

The best teams can accomplish the most amazing things and are an asset to their organization. The worst teams can waste thousands of manhours, cost millions of dollars and still accomplish nothing. This workshop will identify the stages of team dynamics and provide ways to move your team from forming to high performing. We will also explore the dynamics of trust-building and how it can directly impact employee retention.

Speakers:

10:30 am - 10:45 am
Conference Logistics

Transfer to Workshop

10:45 am - 11:45 am
Workshop

WS02 - 2 - Strategies to Evaluate & Mitigate Clinical Supply Risk

This session focuses on strategies that build understanding of risk assessment within clinical supplies. The focus will be on planning, a study's protocol requirements, drug characteristics, packaging specifications, vendor partnerships and collaboration and patient compliance concerns which must be identified and addressed in order to mitigate risk for successful clinical supply outcomes.

Speakers:

10:45 am - 11:45 am
Workshop

WS07 - 2 - What to Consider When Getting into Cell & Gene Therapy

This workshop will be a discussion focused on the challenges of cell and gene therapy. Key topics to be discussed will include CGT's patient orientation, temperature controlled logistics, site requirements, manufacturing challenges and aggressive timing.

Speakers:

10:45 am - 11:45 am
Workshop

WS09 - 2 - Overcoming the Black Box Effect in Forecasting and RTSM

Randomization and Trial Supply Management (RTSM) users sometimes do not trust the results they receive. This results in additional verification of the output. These systems are often complicated and lack transparency and therefore can be hard to understand. In this workshop, we explore how products can evolve and what users can do to reduce or eliminate the confusion of what happens inside the system (black box effect) and let the users truly benefit from their added value.

Speakers:

10:45 am - 11:45 am
Workshop

WS10 - 2 - Lessons Learned After 30 Years In Clinical Supplies

In 30 years, a lot could be learned in the clinical supply industry. This workshop will leverage SME's and participant's knowledge to provide solution to the attendee's biggest issues and questions.

Speakers:

10:45 am - 11:45 am
Workshop

WS13 - 2 - Japan: Direct to Patient and The Decentralized Landscape

As clinical supply chains evolve in Asia-Pac, two areas of opportunity identified during the pandemic were the implementation of decentralized trials (DCTs) and direct-to-patient distribution (DtP).This workshop will identify ways to leverage DtP while avoiding the pitfalls of working in these emerging markets.

Speakers:

10:45 am - 11:45 am
Workshop

WS14 - 2 - Understanding the Importance and Required Processes of Reconciliation & Destruction

Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Speakers:

10:45 am - 11:45 am
Workshop

WS16 - 2 - Clinical Supplies Stakeholder Management

Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).

Speakers:

10:45 am - 11:45 am
Workshop

WS18 - 2 - How to Accomplish Drug Pooling in Europe

Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will focus on the challenges of doing pooling of supplies in Europe as well as provide some solutions to accomplish the most pooling possible.

Speakers:

10:45 am - 11:45 am
Workshop

WS19 - 2 - Using Data to Find Wasteful Processes and Cost Savings

Data is available in multiple locations and in order to ensure its successful use, it must be properly collected, shared, organized, cleaned and visualized. Each step of this process increases its value tremendously. When properly queried, this data can be used to identify and eliminate waste as well as alert clinical supplies when the supply chain is destabilizing.

Speakers:

10:45 am - 11:45 am
Workshop

WS22 - 2 - End-to-End Clinical Trial & Supply Program Management

Holistic program management integrates clinical research and supply processes providing consistency for an asset and continuous improvement. Key elements to program management involve flexibility balancing cost, time, risks, and expectations.  This workshop will discuss strategies for effective program execution through early engagement, planning, risk management and governance.

Speakers:

10:45 am - 11:45 am
Workshop

WS25 - 2 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process

As the incidence of outsourcing the clinical supply chain has increased, understanding the value of clinical supply management using your vendor as a partner has become essential. This workshop will explore how to best utilize your vendor partner as a seamless part of your supply chain while utilizing internal stakeholder inputs to update your metrics.

Speakers:

11:45 am - 12:45 pm
Networking

Lunch & Puppy Party

Wednesday meals sponsored by:

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

Transfer to Vendor Showcase

1:00 pm - 2:00 pm
Showcase

Vendor Showcase - Clinical Process Transformation with Cloud & Artificial Intelligence - Hosted by SAP America

Join us for an immersive session where we delve into the cutting-edge realm of accelerating clinical trials and optimizing supply chains with the power of AI integration. Discover how innovative technologies are revolutionizing the drug development process and streamlining manufacturing and distribution channels.

In this dynamic session, gain insights from industry trailblazers as they share real-world examples of leveraging digital transformation to achieve operational excellence in both early and late-stage clinical trials.

Presented by: Aparna Seksaria, Global Life Sciences Solutions Strategy Lead, SAP; Mike Wheeler, Director of Product Marketing, Life Sciences and Healthcare, SAP; Buz Hillman, Associate Director, Clinical Supply Digital Solutions, Johnson & Johnson and Jean-Michel Carpet, Director Life Sciences R&D Practice, Tenthpin

1:00 pm - 2:00 pm
Showcase

Vendor Showcase - The Five Habits of Highly Effective Clinical Trial Supply Professionals - Hosted by Abacus

The key to unlocking a secure Commercial Medicine Supply Chain

Understanding the Commercial Medicine Supply Chain inside out
Predicting the future - Data, Analytics, AI and Market Intelligence
Review Regularly
Back-up & Risk Mitigation
Learn from experiences – Case studies

Presented by Ian Hoban & Lucy Fox, Business Development Directors, Abacus Medicine

1:00 pm - 2:00 pm
Showcase

Showcase: Five Habits of Highly Effective Clinical Trial Supply Professionals - Hosted by Yprime

Clinical sites and clinicians play crucial roles in patient recruitment, and in ensuring that trial protocol is followed. Join us for an engaging discussion on how we, as clinical supply professionals and IRT vendors, can better ease the burden on our stakeholders at the site level, and how YPrime supports enabling speed, flexibility, and certainty.

Presented by: Jon Paras, Senior Vice President, IRT Strategy, YPrime, Rob Delaney, Associate Director, Clinical Supply Systems, Regeneron & Craig Mooney, Founder, Craig Mooney Consulting Partners

2:00 pm - 2:15 pm
Conference Logistics

Transfer to Plenary Hall

2:15 pm - 3:15 pm
Presentation

Achieving Sustainability Without Compromise in the Clinical Supply Chain

What does it mean to be a sustainable business in our industry? During this session we will explore how we can have a positive impact on society and the environment without compromise to business objectives. For example, governments around the world have signed up to climate objectives, but a large part of the achievement of these goals in reality will come down to the efforts of companies and individuals. We will outline what this means, what our collective responsibilities are within the Pharma Industry and the role we all play – suppliers, vendors, trial Sponsors and individuals - towards defining and achieving meaningful progress on sustainability. We will also include a practical example in the form of a case study showing how suppliers can achieve sustainability goals hand in hand with Partners.

Speakers:

3:15 pm - 3:45 pm
Presentation

Closing Remarks and Raffle Drawings

Become a member

Global Clinical Supplies Group

Join GCSG for full access...

to our educational resources, conference materials and our directory of more than 480 Clinical Supply colleagues. Experience the culture of collaboration, It only takes approximately 3 minutes 22 seconds.

Please note that membership is included and FREE of charge when you sign up for an event.