GCSG – Global Clinical Supplies Group

Start the Conference Right!

Join the GCSG Board of Directors and Conference Committee for a virtual meet & greet to kick off the 2021 US Virtual Conference!

Lobby / Welcome Desk Open

Welcome & Opening Remarks – Keynote Address

Zap the Generational Gap!

Join Keynote speaker, Meagan Johnson, to learn what you can do now to make the most of each generation in your workplace!



 

Virtual Room Transfer Challenge

Take a selfie as you watch the keynote, Meagan Johnson. Post it on GCSG Group LinkedIn feed with #gcsginittogether & #zapthegap for a chance to win!

Unique Features of Small Pharma and How Challenges Can be Overcome (WS14)

Clinical Supply Chains teams in start-up and small sponsor companies do not have the availability of advanced systems, funding and resources. This workshop will discuss some specific challenges and potential solutions, in addition the advantages and disadvantages of working in a less developed organizational environment.

Objectives:

(1) Explain the dynamics of a clinical supply chain in a start-up or small sponsor company (2) Describe two (2) clinical supply chain challenges most small pharma companies are facing

Utilizing Operational Excellence to Improve the Clinical Supply Chain (WS07)

Operational Excellence (OE) is becoming a driver to improve the efficiency when applied to the clinical supply chain.  Whether that comes in the form of lean clinical supply chains, better KPIs or automation, it is essential that we implement one, if not more, of these concepts to adapt to ever-changing clinical supply requirements.  This workshop will identify the different aspects of Operational Excellence and how they can be used in your clinical supply chain.

Objectives:

The attendee will be able to:

1. Describe three (3) of the key elements required to initiate an operational excellence program
2. Compare and contrast the various tools provided by OE methodologies (Lean, TQM, Six Sigma) and how they can benefit an organization
3. Explain the concept of ‘Lean’ manufacturing and packaging and how it can be integrated into the clinical supply chain.

Overview of DtP models for Clinical Trials (MP1)

Direct-to-patient in clinical trial is not a buzzword anymore, it's a way to continue patient treatment and being patient centric.  This mini-presentation is designed to discuss DtP strategies, options to implement when planning a robust direct-to-patient supply chain model, risk management, resilient planning, reverse supply chain from the patient home, accountability and the future of decentralized clinical trials.

Objectives:

(1) Describe two (2) technology requirements to set up a successful DTP strategy (2) Explain why the consideration of technology when implementing a DTP strategy is essential (3) Compare and contrast the latest technological advancements to support DTP versus what was used pre-pandemic

Case Study: Use & Benefits of IRT for Managing Complex Adaptive Studies (WS11)

Clinical study design is evolving as we work to accommodate flexibility in protocol deliverables and execution. This session will discuss how design has a critical role for adaptive multi-product trials.

Objectives:

(1) Define what basket studies are and how they are used in clinical trials (2) Discuss regulatory nuances specific to basket studies (3) Describe at least two (2) options for maintaining supplies for adaptive trials

Brexit – Now We Know (WS18)

Welcome to 2021! The UK has officially exited the EU and now that we’ve got some experience with clinical trials post Brexit, let’s share those experiences! This workshop will discuss the implications of Brexit on Clinical Supplies – including EU27, the UK and NI.

Objectives:

(1) Identify the releases required to certify materials to be used in a clinical trial in both the UK and EU post Brexit. 2) Explain how the Northern Ireland Protocol impacts clinical supplies moving from UK (specifically Northern Ireland) to the EU. 3) Describe two (2) areas of potential impact to clinical trials as a result of the UK leaving the EU.

Virtual Room Transfer Challenge

Which workshop did you attend first? Take a selfie giving all your GCSG friends a virtual high five & post to the GCSG Group LinkedIn feed!

AI – Applications for the Clinical Supply Chain (WS15)

AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This presentation will explain what AI is and discuss how it is being implemented into the Clinical Supply Chain.(1) Describe what AI is and how it can help the clinical supply chain (2) Explain what must be done with the clinical supply chain now in order for us to get the most out of AI (3) Give examples of how AI can be used to accelerate the clinical supply chain

Objectives:

(1) Describe what AI is and how it can help the clinical supply chain (2) Explain what must be done with the clinical supply chain now in order for us to get the most out of AI (3) Give examples of how AI can be used to accelerate the clinical supply chain

Change Management (WS08)

Change is the standard when working within the clinical supply chain. When change must be implemented and adopted, change management becomes essential. The key to change management is not the system being changed, it's the people that must buy into and accept the change to be successful. This workshop will identify ways to ensure people more quickly transistion to the new way of working.

Objectives:

(1) Identify at least two (2) key concepts in implementing change successfully in any organization. (2) Explain how resistance to change can impact a project and describe two ways to reduce the risk of those happening by actively managing change. (3) Give an example of a desireable change in the clinical trial industry and provide two (2) reasons the change will benefit the industry.

Innovation & Covid-19: How the Pandemic Has Catalyzed New Approaches and New Ways of Working (WS05)

Innovation in our space of Investigational Products has customarily occurred with a very structured and slow approach. At times taking years to establish even small step order changes. However, when crisis occurs innovation does not have this luxury. Many of the changes we’ve been forced to undertake this year have catalyzed huge paradigm shifts occurring at record speed. Furthermore, Investigational Products has been wedged in the middle of extreme innovations in scientific discovery, technology, development, manufacture, distribution and flexibility in regulations. Come join us for a lively discussion!

Just in Time or Too Late? The Hurdles and Benefits of Introducing Make-to-Order Clinical Supply Chains (WS12)

Just-in-time is a key opportunity to resolve issues with clinical supply chains today. However, this strategy involves overcoming significant process and technology barriers in order to drive effective change. This workshop will explore these challenges, along with identifying digital solutions to maximize this opportunity.

Objectives:

(1) Describe three (3) market drivers changing the clinical supplies market (2) Identify three (3) challenges facing sponsors in an ever-changing clinical supplies market (3) List three (3) ways the JIT manufacturing solution can help overcome these challenges

Vaccine Supply Chain (WS19)

The greatest outcome of the pandemic was the accelerated creation and approval of the CoVid-19 vaccines. This workshop will focus on what was learned from the development of the vaccines and how our normal Clinical Supply Chain had to evolve quickly.

Objectives:

(1) identify two (2) ideas that were used in Operation Warp Speed that can be used for our Clinical Supply Chain (2) Explain the challenges of the Vaccine Supply Chain from a temperature controlled perspective (3) Compare and contrast the Vaccine Supply Chain with the standard Clinical Supply Chain

Exhibit Hall Open

Win $100, $150 or $200 Amazon vouchers by entering the GCSG Quiz the Exhibitor prize draw!  Visit our exhibitors to learn the answers to the questions.  Click the link and log into your Google account to complete the form.  Winners will be drawn from entries with at least 20 correct responses.  That's just 51%!

Take a screen shot / selfie while chatting with a vendor at their booth. Post on GCSG Group LinkedIn feed, tagging BOTH GCSG & the Exhibitor. Comment about their services or how they've helped you in the past. One entry per post. Post as often as you like!

GCSG Trivia Competition

We’re shaking up our virtual conference with a dose of fun and pop culture trivia with comedian Ryan Budds! For one hour, join us for a fast-paced, family-friendly virtual game, for all-time best kind of trivia pulled from pop culture. If you like movies, music, TV, comic books, video games and anything FUN, he’s got you covered. And don’t worry book-smarties, there’s always a good mix of Q&As for you too.

‘Distant Deceptions’ – Co-sponsored by TrialCard

Join us for an evening with Wayne Hoffman and his interactive, virtual mind-reading and illusion show entitled 'Distant Deceptions'. Wayne is a multi-award winning performer, recognized as one of the top mentalists in the world!  Come have your mind read, your future predicted, and witness magical moments!

Vendor Showcase – Integrated Partnerships − Take Control of Your Clinical Supply Chain Data Cascade and Ensure Trial Continuity – Hosted by endpoint

An efficient supply chain is critical to the success of clinical trials and is inextricably interwoven with all the essential connection points, systems, and tools. Thus, it only makes sense that the delivery and management of these crucial functions need to be conceived and implemented within an ecosystem model. A discrete system approach is no longer enough, but integration without intentional guidance leads to new problems of redundancy, reconciliation burdens, and often confusion.

To discover and learn how to get to this wholistic approach, endpoint invites you to enter the "Clinical Supplies Data Mesh."

In this collaborative session across sectors with TSS (Temperature Monitoring), encapsia (eSource), and McCreadie Group (site-based IDS software), we will discuss existing and accessible solutions to implement this hyper-integrated mesh and will also discuss the following topics:

- Real-time visibility and experience

- How to reduce redundancy and become more efficient

- How to protect your data and provide cleaner output

- How to handle and plan for complexity more effectively

- How to mitigate risk

Vendor Showcase – Digital Clinical Supply Chain Transformation During the Pandemic – Hosted by N-SIDE

In this showcase, N-SIDE will partner with Eli Lilly to share experiences from the digital transformation journey launched in 2020. It will focus on strategies for adopting new technologies and managing risk during the COVID-19 pandemic. Join us to learn all about our innovative solutions!

Lobby / Welcome Desk Open

Welcome & Opening Remarks – Patient Testimonial

The Importance of the Patient Voice in Clinical Research

Learn how Sateria Venable, founder of the Fibroid Foundation, helped to design the largest fibroid research study to date.

Virtual Room Transfer Challenge

Post about something you learned or now have a different perspective on after hearing Sateria Venable's Patient Testimonial.  Post to the GCSG group feed on LinkedIn.  Tag her & GCSG with #gcsginittogether

QP Expectations & Responsibilities (WS13)

QP responsibilities are continuously evolving based on the updated regulations that came out in Europe in 2016 (?) as well as Brexit. This workshop will review the current requirements and responsibilities for QPs.

Objectives:

(1) Compare and contrast the difference between previous QP roles and responsibilities and the updated requirements for QPs post regulation and Brexit (2) Identify the appropriate QP release process for clinical supplies (3) List two (2) ways you can adapt your clinical supply chain to comply with the new QP requirements

Strategies for Handling Ancillary Supplies (WS09)

Ancillary supplies are often the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.

Objectives:

The attendee will be able to:

1. Describe three (3) stocking and replenishment models used in the clinical supplies industry and how they are managed
2. Describe the procument timeline for optimal management of ancillary supplies
3. List a minimum of three (3) special considerations for ancillary supplies managed outside the United States

Planning Clinical Supplies in a Whole New World: 2020 and Beyond (WS16)

The pandemic's impact for the Clinical Supply Chain was intense and educational. Many of our companies adapted quickly to a new way of planning, forecasting and distributing clinical supplies. This workshop will identify a number of new concepts and ideas that have positively affected the Clinical Supply Chain.

Objectives:

(1) Identify two (2) ways that planning and forecasting were positively affected by the pandemic (2) Explain how direct to patient evolved into the industry standard for many of our companies (3) List three (3) ways you can implement these ideas to accelerate and improve your Clinical Supply Chain

Inspection Readiness (WS02)

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

Objectives:

The attendee will be able to:

1. List no fewer than two (2) ways to get team members to consider inspection readiness at all times
2. Describe how to build inspection readiness into clinical supply chain processes
3. Give at least three (3) examples of proper communication techniques during an inspection

Calculating Clinical Supply Valuation (WS20)

With global trials being the standard, it is incredibly important to understand the Customs value of clinical supplies that we have to account for in planning and budgeting for our Clinical Trials. This workshop will explore the different ways to value clinical supplies and how to choose the best way for the attendee.(1) List five (5) different ways to establish drug valuation (2) Identify two (2) common mistakes made when identifying the valuation of IMPs (3) Explain two (2) outcomes of incorrectly valuing our clinical supplies when shipping internationally

Objectives:

(1) List five (5) different ways to establish drug valuation (2) Identify two (2) common mistakes made when identifying the valuation of IMPs (3) Explain two (2) outcomes of incorrectly valuing our clinical supplies when shipping internationally

Cell Therapy Orchestration Platform (WS06)

Cell Therapy clinical trials are becoming prevalent in the Pharmaceutical industry; identifying ways to orchestrate collection of starting material, cell therapy manufacture, logistics and patient delivery becomes essential to the success of these therapies. This workshop will provide an introduction to key aspects of supply chain management for cell therapies and how you can implement software to manage these complex supply chains.

Objectives:

Objectives:

Attendee will be able to explain the importance of and the requirements for chain of identity management
Attendee will be able to describe the features and functions required for orchestrating advanced therapy supply cycles
Attendee will be able to compare and contrast supply chain requirements of autologous and allogeneic cell therapies

Virtual Room Transfer Challenge

Share how working in clinical supplies & helping patients impacts you.  Post to the GCSG group feed on LinkedIn. #GCSGinittogether

Unique Features of Small Pharma and How Challenges Can be Overcome (WS14)

Clinical Supply Chains teams in start-up and small sponsor companies do not have the availability of advanced systems, funding and resources. This workshop will discuss some specific challenges and potential solutions, in addition the advantages and disadvantages of working in a less developed organizational environment.

Objectives:

(1) Explain the dynamics of a clinical supply chain in a start-up or small sponsor company

(2) Describe two (2) clinical supply chain challenges most small pharma companies are facing

Utilizing Operational Excellence to Improve the Clinical Supply Chain (WS07)

Operational Excellence (OE) is becoming a driver to improve the efficiency when applied to the clinical supply chain.  Whether that comes in the form of lean clinical supply chains, better KPIs or automation, it is essential that we implement one, if not more, of these concepts to adapt to ever-changing clinical supply requirements.  This workshop will identify the different aspects of Operational Excellence and how they can be used in your clinical supply chain.

Objectives:

The attendee will be able to:

1. Describe three (3) of the key elements required to initiate an operational excellence program
2. Compare and contrast the various tools provided by OE methodologies (Lean, TQM, Six Sigma) and how they can benefit an organization
3. Explain the concept of ‘Lean’ manufacturing and packaging and how it can be integrated into the clinical supply chain.

DtP a Covid-19 Solution or a Long-Term Change to Clinical Trial Conduct? (WS21)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors shifted to direct-to-patient and decentralized clinical trials. This workshop will focus on the positive aspects and outcomes of the amazing pivot that the industry accomplished in adopting these new models.

Objectives:

(1) Describe two (2) benefits from using a direct to patient model for our Clinical Trials (2) Explain the importance of coordination and collaboration with a home health care organization to ensure direct to patient clinical supply distribution accomplishes the end goal of decentralized trials (3) Compare and contrast the planning, cost and execution between DTP and standard clinical supply distribution to sites

Partnering with Clinical Operations Stakeholders (WS03)

In order to shorten clinical trial timelines and increase efficiency of the clinical supply chain, it is essential to develop an excellent rapport with our Clinical Operations stakeholders. This workshop will explore how to better partner and collaborate with Clinical Operations in order to get the best out of our clinical supply chain

Objectives:

(1) Describe the best way to improve your upstream clinical supply chain customer relations

(2) Explain how improving the relationship and trust between Clinical Operations and Clinical Supplies can positively impact country selection and the timing of first patient in

(3) Give two (2) examples of how good relationships with Clinical Operations has improved Clinical Supplies forecasting and fulfillment

Maximizing IP Supply Through Effective Use of the IRT (WS10)

With the rising costs of investigational supplies for clinical trials, it is becoming ever more important to maximize the use of IMP.  This session will explore different methods that can be employed through an IRT to best avoid waste and lower the overall cost of a clinical trial.  This will cover the study set-up, execution, and close-out phases of a clinical trial with an eye towards optimizing performance.

Objectives:

(1) Identify two (2) areas of IRT design that are impacted by the increase in complexity of clinical trials. (2) Describe how an IRT system can help with distribution of a clinical trial more efficiently. (3) Explain the advantages of IRT in a dose escalation or titration study.

IoR, Import Licenses and VAT (WS17)

With global trials being the standard, it is incredibly important to understand the clinical supplies value and the value added tax we have to account for in budgeting for our Clinical Trials. This workshop will also discuss the importance of Import Licenses and the Importer of Record when shipping globally.

Objectives:

(1) Explain valuation of clinical supplies and identify one (1) of the best valuation techniques for IMP (2) List two (2) requirements for being an Importer of Record (IOR) (3) Identify two (2) items needed to recover VAT for clinical supplies

Virtual Room Transfer Challenge

Share something you learned in your last workshop on the GCSG Group LinkedIn feed. Tag your facilitators and #gcsginittogether.

Networking Event – Travel with TrialCard 2.0

Join us for another fun-filled journey around the world with travel trivia, tips and prizes while we discover interesting stories and shenanigans from our friends at GCSG.

Vendor Showcase – Fully Integrated RTSM & Forecasting Solutions for Optimal Supply Management – Hosted by 4G

The seamless workflow between 4G Clinical’s Prancer RTSM^Ⓡ and 4C Supply^Ⓡ solutions will be showcased. Together, these solutions provide simplicity and control over supply chain decisions. Attendees will see first-hand a case study of the decision support provided by both solutions as they transition through early stage feasibility planning, RTSM setup, revisions to plans based on actual enrollment, and updates to resupply parameters based on the revised plans.

Vendor Showcase – Next Generation Cold Chain Solutions – Hosted by Cryoport

Please join us for a discussion on takeaways from shipping Cold Chain during a pandemic and discussion on how to plan for time critical shipments going forward.

Virtual Room Transfer Challenge

What's for lunch / dinner / bedtime snack? Post to the GCSG group feed on LinkedIn with #GCSGinittogether for your chance to win!

Virtual Comedy Club – Co-sponsored by Ancillare

We all need a little humor in our lives - dedicate an hour of your day to join us for some laughs with comedians Andy Hendrikson and Joe Zimmerman.

 

Vendor Showcase – The All-In-One Toolkit for Life Science Training Departments – Hosted by learnaboutGMP

In this showcase we will show you how we help life sciences organizations deliver continuous regulatory and compliance training that ensures positive behavioral changes and ongoing regulatory compliance.

Vendor Showcase – What is the Future of Clinical Scale Sterile Filling? – Hosted by Sharp

Advanced robotics, innovative isolator lines, decontamination chambers, and more. What do these have in common? They are all a part of tomorrow’s advanced filling lines. Innovative leaps in manufacturing are redefining the quality and sterility assurance standard for injectables.
In this one-hour presentation, Berkshire Sterile Manufacturing, a partner of Sharp, will present the latest technology in small scale sterile filling, how it works, and the advantages this offers to the client. You will also be able to tour BSM’s state-of-art sterile manufacturing facility with the company’s cofounder and CTO.
Join us for an hour filled with discovery, technology, and innovation.

Lobby / Welcome Desk Open

Welcome & Opening Remarks – Panel Discussion

Clinical Supply Chain Technology Driven Trends

With the advent of the pandemic and the adjusted vaccine supply chain, new technology has become the focus for all Pharma and Biotech companies. This Session will identify a number of new technological trends that can be implemented in the Clinical Supply Chain.

Virtual Room Transfer Challenge

Take a selfie as you listen to the panel discussion. Extra points for showing you had your camera on during the session in your picture! Post on the GCSG Group LinkedIn feed to be entered to win!

Case Study: Use & Benefits of IRT for Managing Complex Adaptive Studies (WS11)

Clinical study design is evolving as we work to accommodate flexibility in protocol deliverables and execution. This session will discuss how design has a critical role for adaptive multi-product trials.

Objectives:

(1) Define what basket studies are and how they are used in clinical trials (2) Discuss regulatory nuances specific to basket studies (3) Describe at least two (2) options for maintaining supplies for adaptive trials

Change Management (WS08)

Change is the standard when working within the clinical supply chain. When change must be implemented and adopted, change management becomes essential. The key to change management is not the system being changed, it's the people that must buy into and accept the change to be successful. This workshop will identify ways to ensure people more quickly transistion to the new way of working.

Objectives:

(1) Identify at least two (2) key concepts in implementing change successfully in any organization.

(2) Explain how resistance to change can impact a project and describe two ways to reduce the risk of those happening by actively managing change.

(3) Give an example of a desireable change in the clinical trial industry and provide two (2) reasons the change will benefit the industry.

Brexit – Now We Know (WS18)

Welcome to 2021! The UK has officially exited the EU and now that we’ve got some experience with clinical trials post Brexit, let’s share those experiences! This workshop will discuss the implications of Brexit on Clinical Supplies – including EU27, the UK and NI.

Objectives:

(1) Identify the releases required to certify materials to be used in a clinical trial in both the UK and EU post Brexit. 2) Explain how the Northern Ireland Protocol impacts clinical supplies moving from UK (specifically Northern Ireland) to the EU. 3) Describe two (2) areas of potential impact to clinical trials as a result of the UK leaving the EU.

AI – Applications for the Clinical Supply Chain (WS15)

AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This presentation will explain what AI is and discuss how it is being implemented into the Clinical Supply Chain.

Objectives:

(1) Describe what AI is and how it can help the clinical supply chain (2) Explain what must be done with the clinical supply chain now in order for us to get the most out of AI (3) Give examples of how AI can be used to accelerate the clinical supply chain

Autologous vs. Allogeneic Supply Chains (WS04)

As the number of new Cell and Gene therapies grows in the clinical development space, it becomes increasingly important to understand the supply chain challenges of these unique therapies. This workshop will identify and differentiate the challenges of the autologous and allogeneic clinical supply chain requirements

Objectives:

Virtual Room Transfer Challenge

Post a picture or graphic of what you'd like to learn about next year on the GCSG Group LinkedIn feed

Strategies for Handling Ancillary Supplies (WS09)

Ancillary supplies are often the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.

Objectives:

The attendee will be able to:

1. Describe three (3) stocking and replenishment models used in the clinical supplies industry and how they are managed
2. Describe the procument timeline for optimal management of ancillary supplies
3. List a minimum of three (3) special considerations for ancillary supplies managed outside the United States

Vaccine Supply Chain (WS19)

The greatest outcome of the pandemic was the accelerated creation and approval of the CoVid-19 vaccines. This workshop will focus on what was learned from the development of the vaccines and how our normal Clinical Supply Chain had to evolve quickly.

Objectives:

(1) identify two (2) ideas that were used in Operation Warp Speed that can be used for our Clinical Supply Chain (2) Explain the challenges of the Vaccine Supply Chain from a temperature controlled perspective (3) Compare and contrast the Vaccine Supply Chain with the standard Clinical Supply Chain

Innovation & Covid-19: How the Pandemic Has Catalyzed New Approaches and New Ways of Working (WS05)

Innovation in our space of Investigational Products has customarily occurred with a very structured and slow approach. At times taking years to establish even small step order changes. However, when crisis occurs innovation does not have this luxury. Many of the changes we’ve been forced to undertake this year have catalyzed huge paradigm shifts occurring at record speed. Furthermore, Investigational Products has been wedged in the middle of extreme innovations in scientific discovery, technology, development, manufacture, distribution and flexibility in regulations. Come join us for a lively discussion!

Objectives:

Planning Clinical Supplies in a Whole New World: 2020 and Beyond (WS16)

The pandemic's impact for the Clinical Supply Chain was intense and educational. Many of our companies adapted quickly to a new way of planning, forecasting and distributing clinical supplies. This workshop will identify a number of new concepts and ideas that have positively affected the Clinical Supply Chain.

Objectives:

(1) Identify two (2) ways that planning and forecasting were positively affected by the pandemic (2) Explain how direct to patient evolved into the industry standard for many of our companies (3) List three (3) ways you can implement these ideas to accelerate and improve your Clinical Supply Chain

Just in Time or Too Late? The Hurdles and Benefits of Introducing Make-to-Order Clinical Supply Chains (WS12)

Just-in-time is a key opportunity to resolve issues with clinical supply chains today. However, this strategy involves overcoming significant process and technology barriers in order to drive effective change. This workshop will explore these challenges, along with identifying digital solutions to maximize this opportunity.

Objectives:

(1) Describe three (3) market drivers changing the clinical supplies market (2) Identify three (3) challenges facing sponsors in an ever-changing clinical supplies market (3) List three (3) ways the JIT manufacturing solution can help overcome these challenges

Inspection Readiness (WS02)

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

Objectives:

The attendee will be able to:

1. List no fewer than two (2) ways to get team members to consider inspection readiness at all times
2. Describe how to build inspection readiness into clinical supply chain processes
3. Give at least three (3) examples of proper communication techniques during an inspection

Exhibit Hall Open

Vendor Showcase – Clinical Trial Pitfalls and Covid – What GCSG Delegates Said in 2020 and What Has Changed in 2021 – Hosted by Aposave

• A review of the Annual Survey of Clinical Trial Supply Professionals conducted at GCSG 2020


• Some familiar foes and surprises (Meet the Covid timebomb)


• What now? The 2021 survey


• Questions and issues facing the clinical trial supplies world post Covid


• The Aposave perspective

Vendor Showcase – Using IRT Beyond Randomization to Reduce Drug Wastage – Hosted by Calyx

Through advanced IRT settings, sponsors can reduce the quantity of medication wasted at sites and depots and the number of shipments to sites. Learn how you can adapt your protocol design to optimize the costs of drug management.

Virtual Room Transfer Challenge

The one word that best describes the GCSG conference is: __________.  Post to the GCSG group feed on LinkedIn. #GCSGinittogether

Virtual Mixology Class – Co-sponsored by Pelican BioThermal

Join us for a little fun at the end of the day to learn how to shake, pour and sip your own fresh cocktails during this virtual mixology course!  Grab the recipe and shopping list here.

Vendor Showcase – Using IRT to Manage the Allogeneic Clinical Supply Chain – Hosted by YPrime

Cell and gene therapies have altered the ‘standard’ view of IRT design and application in clinical trials. This showcase will explore ways that IRT can improve Supply Chain Managers' oversight of the allogeneic clinical supply chain – especially in small population clinical trials.

Vendor Showcase – Virtual Clinical Supplies 2.0: Handling Site Sourcing Barriers/Management – Hosted by TrialCard

Join TrialCard for a discussion on reducing steps, saving time, and reducing waste in clinical supplies.  Learn about TrialCard's NEW offering that simplifies local site sourcing, medication management, and product reimbursement.

Lobby / Welcome Desk Open

Welcome & Opening Remarks

Keynote Address

Plant your Feet Firmly - in Mid-Air! How to stay focused and optimistic when everything is changing around you

People in our supply-chain world will thrive with three learnable skills, no matter how many unknowns they face. After this fast-paced, high-energy session, you’ll have these three skills in your backpack. * Stay focused, stay on track, and move to a higher place. * Take a quick self-assessment to see how much stress you have, and how to re-balance. * Inspired to move higher and further during this time; with change always comes opportunity if you know what to look for!

Virtual Room Transfer Challenge

What did you think of Dr. Janet Lapp, our 2nd Keynote of the week? Post your thoughts on the GCSG group feed on LinkedIn.  Tag Dr. Janet & #gcsginittogether

Calculating Clinical Supply Valuation (WS20)

With global trials being the standard, it is incredibly important to understand the Customs value of clinical supplies that we have to account for in planning and budgeting for our Clinical Trials. This workshop will explore the different ways to value clinical supplies and how to choose the best way for the attendee.

Objectives:

(1) List five (5) different ways to establish drug valuation (2) Identify two (2) common mistakes made when identifying the valuation of IMPs (3) Explain two (2) outcomes of incorrectly valuing our clinical supplies when shipping internationally

DtP a Covid-19 Solution or a Long-Term Change to Clinical Trial Conduct? (WS21)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors shifted to direct-to-patient and decentralized clinical trials. This workshop will focus on the positive aspects and outcomes of the amazing pivot that the industry accomplished in adopting these new models.

Objectives:

(1) Describe two (2) benefits from using a direct to patient model for our Clinical Trials (2) Explain the importance of coordination and collaboration with a home health care organization to ensure direct to patient clinical supply distribution accomplishes the end goal of decentralized trials (3) Compare and contrast the planning, cost and execution between DTP and standard clinical supply distribution to sites

IoR, Import Licenses and VAT (WS17)

With global trials being the standard, it is incredibly important to understand the clinical supplies value and the value added tax we have to account for in budgeting for our Clinical Trials. This workshop will also discuss the importance of Import Licenses and the Importer of Record when shipping globally.

Objectives:

(1) Explain valuation of clinical supplies and identify one (1) of the best valuation techniques for IMP (2) List two (2) requirements for being an Importer of Record (IOR) (3) Identify two (2) items needed to recover VAT for clinical supplies

Maximizing IP Supply Through Effective Use of the IRT (WS10)

With the rising costs of investigational supplies for clinical trials, it is becoming ever more important to maximize the use of IMP.  This session will explore different methods that can be employed through an IRT to best avoid waste and lower the overall cost of a clinical trial.  This will cover the study set-up, execution, and close-out phases of a clinical trial with an eye towards optimizing performance.

Objectives:

(1) Identify two (2) areas of IRT design that are impacted by the increase in complexity of clinical trials. (2) Describe how an IRT system can help with distribution of a clinical trial more efficiently. (3) Explain the advantages of IRT in a dose escalation or titration study.

Partnering with Clinical Operations Stakeholders (WS03)

In order to shorten clinical trial timelines and increase efficiency of the clinical supply chain, it is essential to develop an excellent rapport with our Clinical Operations stakeholders. This workshop will explore how to better partner and collaborate with Clinical Operations in order to get the best out of our clinical supply chain

Objectives:

(1) Describe the best way to improve your upstream clinical supply chain customer relations

(2) Explain how improving the relationship and trust between Clinical Operations and Clinical Supplies can positively impact country selection and the timing of first patient in

(3) Give two (2) examples of how good relationships with Clinical Operations has improved Clinical Supplies forecasting and fulfillment

QP Expectations & Responsibilities (WS13)

QP responsibilities are continuously evolving based on the updated regulations that came out in Europe in 2016 (?) as well as Brexit. This workshop will review the current requirements and responsibilities for QPs.

Objectives:

(1) Compare and contrast the difference between previous QP roles and responsibilities and the updated requirements for QPs post regulation and Brexit (2) Identify the appropriate QP release process for clinical supplies (3) List two (2) ways you can adapt your clinical supply chain to comply with the new QP requirements

Virtual Room Transfer Challenge

What was your favorite workshop this week? Post on the GCSG Group LinkedIn feed with #gcsginittogether

Vendor Showcase – Reduce Drug Quarantines by 93% – End-to-End Visibility & Automation in Your Temperature Management – Hosted by TSS

Despite most excursions falling within pre-defined stability budgets, they trigger a quarantine while a time-consuming and inefficient manual review is conducted.  Sponsors are now automating the review process – reducing quarantines by >90% while eliminating the associated efforts and delays - and still ensuring that treatments are safe and available for patients.

Virtual Room Transfer Challenge

LAST CHANCE! Post a selfie holding a sign with one thing you liked about the conference! Don't forget #gcsginittogether

Post on the GCSG group feed on LinkedIn

Closing Remarks & GCSG/Vendor Prize Draws

Don't miss your chance to win some great prizes!  Join us in the Auditorium!