A VIRTUAL Success!

The GCSG 2020 Global Virtual Conference

COVID-19 kept us from meeting face-to-face, but it couldn’t keep us from coming together to network, learn and work together!  This year’s GLOBAL conference brought together the best of GCSG from around the world.  Thank you to all our registrants, exhibitors and sponsors for making this yet another successful GCSG event!

Presentation

Keynote Address: Leading in a Peak Performance Culture

This powerful program focuses on the leadership characteristics that are the foundation of the most successful organizations worldwide.  Attendees will discover the behaviors embodied by leaders that instill a desire in others to perform at a high level while avoiding environmental stress and burnout.  Notable in the content is that these are behaviors, processes and approaches that are easy to replicate, not nebulous values that can be subjective and hard to manifest.  They are designed to help all leaders drive corporate ideology throughout the organization and reconcile the challenge facing leadership of being the fulcrum between authority (ownership/C-Suite leadership) and impact (line level execution).  The content is a preview of Dave’s next book, Peak Performance Culture: The Five Metrics of Peak Performance Culture and represents data collected from over 1000 organizations over the last 25 years.

Location
Auditorium
Workshop

Project Management Skills (WS31)

Everyone in the clinical supply chain uses some sort of project management in their daily jobs. Come to this session to discuss some project management best practices or share some of yours! Whether you are new to clinical supplies or a seasoned professional, there is something for everyone in this workshop!

Location
Suvoda Breakout Room
Workshop

Approaches for Forecasting Clinical Trials with Limited Data (WS01)

When forecasting clinical trial supply needs we bring as much data to the table as possible in order to better understand inventory requirements, overages, campaigns and the overall supply chain.  What happens when our data is limited and it impacts the value or quality of the forecast? This workshop will discuss ways to get the best forecast when data is scarce.

Location
Suvoda Breakout Room
Workshop

Role of the Qualified Person (QP) Post-Brexit (WS07)

The quality and regulatory units and Qualified Persons (QPs) in the EU are adjusting post-BREXIT. This workshop will provide an opportunity to discuss the QP role post-BREXIT as well as give you an opportunity to ask questions and discuss requirements with a QP from the EU.

Location
PCI Breakout Room
Workshop

Understanding Your Responsibilities as Importer of Record (IOR) (WS03)

Importation and movement of clinical supplies internationally will typically bring up questions about ownership of supplies, importation processes and Importer of Record (IOR) responsibilities. Knowing the specific obligations of the sponsor, clinical research organizations (CRO) and vendors will help to ensure maximum efficiencies when importing. This workshop will clarify the responsibilities surrounding IOR and ownership of clinical trial materials.

Location
BionicalEMAS Breakout Room
Workshop

Developing CTS Strategies for Adaptive Clinical (Basket/ Umbrella) Studies (WS04)

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.

Location
ISS Breakout Room
Workshop

Challenges of the Cell, Gene, CAR-T and Personalized Medicine Supply Chains (MP1)

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including cell, gene and immunotherapy treatments. Due in part to advancements in science and the availability of more sophisticated diagnostic tools, which give the medical community a better understanding of the human genome and make it easier to detect genetic mutations affecting individual patients, the outlook is positive. Come to this workshop to learn more about the challenges of cell, gene, CAR-T and personalized medicine supply chains.

Location
BionicalEMAS Breakout Room
Workshop

Brexit Update: Impact on the Clinical Supply Chain (MP4)

The session will share an understanding of the current state of the impact of the United Kingdom’s exit from the European Union as it relates to clinical trials. Information from the EU and UK regulatory agencies will be discussed and experiences of how clinical trial supply chains have reacted.

Location
Brizzey Breakout Room
Workshop

Benefits of Utilizing a Demand-Led Approach to Manage Clinical Supplies, Reduce Supply Chain Risk and Improve Flexibility (WS06)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

Location
PCI Breakout Room
Workshop

Clinical Supply Horror Stories (WS10)

Horror stories in clinical supplies…we've all had them! Share your stories and mitigations with your colleagues.

Location
Brizzey Breakout Room
Workshop

Cold Chain Distribution and Temperature Excursions (WS16)

This workshop will define time out of environment (ToE) and  provide a forum for discussing both challenges and solutions for managing labeled storage conditions and ToE.  The workshop will address multiple ways the time out of label storage conditions can be minimized during distribution as well as ways to set up a successful temperature management program.  Attendees will  be able to identify successful strategies for managing temperature excursions when they occur.

Location
PCI Breakout Room
Workshop

Distribution Planning and the Role of Depots post COVID-19 (WS08)

As the clinical supply chain expands into more and more countries, distribution planning has become exponentially more complex. This session will delve into the requirements for clinical supply chain distribution planning and where depots and and a knowledge of customs requirements are essential

Speakers
Location
Suvoda Breakout Room
Workshop

How has COVID-19 changed eClinical technology and what changes do we think will be needed in the future? (WS15)


  • Direct to patient shipping, remote acceptance of shipments

  • Remote access to IRT system over mobile web

  • Need for rapid system implementation

  • eConsent to allow patients to remotely provide consent

  • New patient engagement tools for medication compliance, eCOA, etc.

  • Temperature excursion tracking

  • Drug accountability systems – in IRT and outside of IRT

Location
Suvoda Breakout Room
Workshop

Outsourcing Clinical Supply Management (WS09)

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.

Location
PCI Breakout Room
Workshop

Sourcing and Labeling Biologics (WS21)

Are you working with biologic comparators/ co-meds? Sourcing and labeling biologic clinical trial material presents unique challenges. This workshop will discuss practices used to procure, maintain stock and label biologics.

Location
BionicalEMAS Breakout Room
Workshop

Supply Chain Integrity and the Impact of Falsified Medicines (MP5)

The EU Falsified Medicines Directive became effective in February 2019.  The aim of the directive is to prevent falsified medicines entering the supply chain to ensure that medicines are safe and that trade is rigorously controlled.  This presentation will explain how this directive impacts Sponsors, the clinical supply chain and steps that should be taken to ensure compliance.

Location
ISS Breakout Room
Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (MP2)

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 presentation will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implented into the Clinical Supply Chain.

Location
ISS Breakout Room
Presentation

Patient Testimonial: Amanda & Dylan Ross

Dylan Ross, an active GCSG member, is familiar with clinical trials due to the 15 years he’s spent working in pharmaceutical packaging and logistics.  He and his wife, Amanda, are also the proud parents of Charlie and Layla.  These two facts rather suddenly intersected in November of 2017 when Charlie, a fit and healthy 15-year old, was diagnosed with Stage 3 Nasopharyngeal Carcinoma (NPC).  This would be the start of a journey that no parent ever wants to see their child take.

Location
Auditorium
Workshop

Pooled Supplies (WS27)

Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared.

Location
PCI Breakout Room
Workshop

Challenges of Returns and Reconciliation – Including COVID-19 (WS20)

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.

Location
ISS Breakout Room
Workshop

Protocol Interpretation for Clinical Supply Design: A Case Study (WS13)

Protocol interpretation has become increasingly challenging as protocols have become more complex. This workshop will utilize a case study to demonstrate key processes to utilize to ensure the best protocol interpretation.

Location
Brizzey Breakout Room
Workshop

The Clinical Trial Regulation and its Evolving Regulatory Impact on Europe & ROW (MP3)

Clinical supply chains are adjusting to recent changes in the regulations. This workshop will provide an opportunity to discuss the recent changes and ask questions of a QP from the EU.

Location
PCI Breakout Room
Workshop

Pharmacy Manuals – A Critical Link in the Clinical Supply Chain (WS19)

As the dispensing requirements for novel therapies become increasingly complex and clinical sites are faced with limited resources and frequent staff rotation, the pharmacy manual has become a critical document in providing clear instruction on the proper way to prepare and handle investigational product.  This workshop will assess the site pharmacist’s challenges and relevance of the pharmacy manual, as well as discussing key components of the development of a pharmacy manual.

Location
Brizzey Breakout Room
Workshop

Pathways for Patient Access to Investigational Drugs (MP6)

This class provides a broad overview of the different mechanisms to support patients ability to access investigational drugs. Each mechanism has different requirements, which will be covered in this course, enabling you to successfully understand which is the best pathway based on the patient need. Topics covered will include Expanded Access, Right To Try (RTT), Continued Access, Clinical Trials and Patient Assistance.

Location
BionicalEMAS Breakout Room
Workshop

Direct to Patient Distribution – The New Normal? (WS26)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct-to-patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct-to-patient supply chain model.

Location
Suvoda Breakout Room
Workshop

Clinical Supply Connections with Clinical Operations and CROs (WS29)

As the clinical supply chain has become increasingly outsourced, understanding the value of creating better relationships with Clinical Operations and clinical research organizations (CROs) has become imperative. This workshop will describe ways to improve collaboration between clinical supplies and its key partners, Clinical Operations and CROs.

Location
ISS Breakout Room
Workshop

Approaches for Forecasting Clinical Trials with Limited Data (WS01)

When forecasting clinical trial supply needs we bring as much data to the table as possible in order to better understand inventory requirements, overages, campaigns and the overall supply chain.  What happens when our data is limited and it impacts the value or quality of the forecast? This workshop will discuss ways to get the best forecast when data is scarce.

Location
Suvoda Breakout Room
Workshop

Brexit Update: Impact on the Clinical Supply Chain (MP4)

The session will share an understanding of the current state of the impact of the United Kingdom’s exit from the European Union as it relates to clinical trials. Information from the EU and UK regulatory agencies will be discussed and experiences of how clinical trial supply chains have reacted.

Location
Brizzey Breakout Room
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (MP7)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging. Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region. This workshop will discuss best practices for storage, distribution, import/ export and reverse logistics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines. You will also get some hands on experience by working through a scenario for an Asia Pac study!

Speakers
Location
ISS Breakout Room
Workshop

Cold Chain Capabilities and the Rise in Biologics (WS33)

Biologic development now comprises half of all clinical studies. Understanding temperature controls when developing biologics is essential. This workshop will do a deep dive into temperature control requirements of biologics.

Speakers
Location
Brizzey Breakout Rooms
Workshop

Maximizing Performance with Virtual Workers (WS34)

The paradigm shift to remote working scenarios can have an effect  on communication, productivity, job satisfaction and teamwork. Learn the warning signs of negative impact and ways to optimize performance in this workshop.

Location
PCI Breakout Room
Workshop

Packaging Temperature-Sensitive Products (WS32)

As our products become diverse, so do their handling requirements. Many innovative products now must maintain temperature at ultra-low conditions throughout the supply chain. This can present challenges when looking at the ‘traditional’ pack/label/ ship clinical supply chain. This workshop is designed to discuss challenges and potential solutions when handling, storing, labeling and shipping ultra cold / sensitive materials.

Location
BionicalEMAS Breakout Room
Workshop

Project Management Skills (WS31)

Everyone in the clinical supply chain uses some sort of project management in their daily jobs. Come to this session to discuss some project management best practices or share some of yours! Whether you are new to clinical supplies or a seasoned professional, there is something for everyone in this workshop!

Location
Suvoda Breakout Room
Workshop

Understanding Your Responsibilities as Importer of Record (IOR) (WS03)

Importation and movement of clinical supplies internationally will typically bring up questions about ownership of supplies, importation processes and Importer of Record (IOR) responsibilities. Knowing the specific obligations of the sponsor, clinical research organizations (CRO) and vendors will help to ensure maximum efficiencies when importing. This workshop will clarify the responsibilities surrounding IOR and ownership of clinical trial materials.

Location
BionicalEMAS Breakout Rom
Presentation

Keynote Address: Live Yes And….

 “It’s not the note you play that’s the wrong note — it’s the note you play afterwards that makes it right or wrong.” —Miles Davis

Great teams that are sustained in the long run are built on the successful foundation of great cultures. It is the culture that reinforces the purpose and values as the team grows and expands. By focusing on individual and shared purpose, and fostering an environment of trust which leads to authenticity, you can build a culture that promotes life-transforming collaboration. Performance coach and professional improviser, Travis Thomas is also the author of "3 Words for Getting Unstuck: Live, Yes And!"
Social media: @LiveYesAnd

Get Unstuck with 3 Words. Buy Travis’ book!

Listen to Travis on The Weekly Yes, And Podcast on iTunes!

 

Location
Auditorium
Workshop

Benefits of Utilizing a Demand-Led Approach to Manage Clinical Supplies, Reduce Supply Chain Risk and Improve Flexibility (WS06)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

Location
ISS Breakout Room
Workshop

Challenges of the Cell, Gene, CAR-T and Personalized Medicine Supply Chains (MP1)

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including cell, gene and immunotherapy treatments. Due in part to advancements in science and the availability of more sophisticated diagnostic tools, which give the medical community a better understanding of the human genome and make it easier to detect genetic mutations affecting individual patients, the outlook is positive. Come to this workshop to learn more about the challenges of cell, gene, CAR-T and personalized medicine supply chains.

Location
BionicalEMAS Breakout Room
Workshop

Clinical Supply Horror Stories (WS10)

Horror stories in clinical supplies…we've all had them! Share your stories and mitigations with your colleagues.

Location
Brizzey Breakout Room
Workshop

Developing CTS Strategies for Adaptive Clinical (Basket/ Umbrella) Studies (WS04)

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.

Location
PCI Breakout Room
Workshop

Direct to Patient Distribution – The New Normal? (WS26)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct-to-patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct-to-patient supply chain model.

Location
PCI Breakout Room
Workshop

Distribution Planning and the Role of Depots post COVID-19 (WS08)

As the clinical supply chain expands into more and more countries, distribution planning has become exponentially more complex. This session will delve into the requirements for clinical supply chain distribution planning and where depots and and a knowledge of customs requirements are essential

Speakers
Location
BionicalEMAS Breakout Room
Workshop

Outsourcing Clinical Supply Management (WS09)

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.

Location
PCI Breakout Room
Workshop

Role of the Qualified Person (QP) Post-Brexit (WS07)

The quality and regulatory units and Qualified Persons (QPs) in the EU are adjusting post-BREXIT. This workshop will provide an opportunity to discuss the QP role post-BREXIT as well as give you an opportunity to ask questions and discuss requirements with a QP from the EU.

Location
Suvoda Breakout Room
Workshop

Supply Chain Integrity and the Impact of Falsified Medicines (MP5)

The EU Falsified Medicines Directive became effective in February 2019.  The aim of the directive is to prevent falsified medicines entering the supply chain to ensure that medicines are safe and that trade is rigorously controlled.  This presentation will explain how this directive impacts Sponsors, the clinical supply chain and steps that should be taken to ensure compliance.

Location
ISS Breakout Room
Workshop

Challenges of Returns and Reconciliation – Including COVID-19 (WS20)

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.

Location
Suvoda Breakout Room
Workshop

Cold Chain Distribution and Temperature Excursions (WS16)

This workshop will define time out of environment (ToE) and  provide a forum for discussing both challenges and solutions for managing labeled storage conditions and ToE.  The workshop will address multiple ways the time out of label storage conditions can be minimized during distribution as well as ways to set up a successful temperature management program.  Attendees will  be able to identify successful strategies for managing temperature excursions when they occur.

Location
PCI Breakout Room
Workshop

How has COVID-19 changed eClinical technology and what changes do we think will be needed in the future? (WS15)


  • Direct to patient shipping, remote acceptance of shipments

  • Remote access to IRT system over mobile web

  • Need for rapid system implementation

  • eConsent to allow patients to remotely provide consent

  • New patient engagement tools for medication compliance, eCOA, etc.

  • Temperature excursion tracking

  • Drug accountability systems – in IRT and outside of IRT

Location
Suvoda Breakout Room
Workshop

Pathways for Patient Access to Investigational Drugs (MP6)

This class provides a broad overview of the different mechanisms to support patients ability to access investigational drugs. Each mechanism has different requirements, which will be covered in this course, enabling you to successfully understand which is the best pathway based on the patient need. Topics covered will include Expanded Access, Right To Try (RTT), Continued Access, Clinical Trials and Patient Assistance.

Location
BionicalEMAS Breakout Room
Workshop

Pharmacy Manuals – A Critical Link in the Clinical Supply Chain (WS19)

As the dispensing requirements for novel therapies become increasingly complex and clinical sites are faced with limited resources and frequent staff rotation, the pharmacy manual has become a critical document in providing clear instruction on the proper way to prepare and handle investigational product.  This workshop will assess the site pharmacist’s challenges and relevance of the pharmacy manual, as well as discussing key components of the development of a pharmacy manual.

Location
Brizzey Breakout Room
Workshop

Protocol Interpretation for Clinical Supply Design: A Case Study (WS13)

Protocol interpretation has become increasingly challenging as protocols have become more complex. This workshop will utilize a case study to demonstrate key processes to utilize to ensure the best protocol interpretation.

Location
ISS Breakout Room
Workshop

Sourcing and Labeling Biologics (WS21)

Are you working with biologic comparators/ co-meds? Sourcing and labeling biologic clinical trial material presents unique challenges. This workshop will discuss practices used to procure, maintain stock and label biologics.

Location
BionicalEMAS Breakout Room
Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (MP2)

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 presentation will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implented into the Clinical Supply Chain.

Location
Brizzey Breakout Room
Presentation

Patient Testimonial: The Emily Whitehead Foundation

Tom and Kari Whitehead founded The Emily Whitehead Foundation in honor of their daughter Emily. A leukemia survivor, Emily was the first child in the world to receive CAR T-cell therapy. They have seen first hand how cancer research is saving lives! Come hear about the Whitehead Family's journey over the past 10 years.

Location
Auditorium
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (MP7)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging. Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region. This workshop will discuss best practices for storage, distribution, import/ export and reverse logistics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines. You will also get some hands on experience by working through a scenario for an Asia Pac study!

Speakers
Location
Suvoda Breakout Room
Workshop

Clinical Supply Connections with Clinical Operations and CROs (WS29)

As the clinical supply chain has become increasingly outsourced, understanding the value of creating better relationships with Clinical Operations and clinical research organizations (CROs) has become imperative. This workshop will describe ways to improve collaboration between clinical supplies and its key partners, Clinical Operations and CROs.

Location
ISS Breakout Room
Workshop

Cold Chain Capabilities and the Rise in Biologics (WS33)

Biologic development now comprises half of all clinical studies. Understanding temperature controls when developing biologics is essential. This workshop will do a deep dive into temperature control requirements of biologics.

Speakers
Location
Suvoda Breakout Room
Workshop

Direct to Patient Distribution – The New Normal? (WS26)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct-to-patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct-to-patient supply chain model.

Location
BionicalEMAS Breakout Room
Workshop

Maximizing Performance with Virtual Workers (WS34)

The paradigm shift to remote working scenarios can have an effect  on communication, productivity, job satisfaction and teamwork. Learn the warning signs of negative impact and ways to optimize performance in this workshop.

Location
ISS Breakout Room
Topic
Maximizing Performance with Virtual Workers
Workshop

Packaging Temperature-Sensitive Products (WS32)

As our products become diverse, so do their handling requirements. Many innovative products now must maintain temperature at ultra-low conditions throughout the supply chain. This can present challenges when looking at the ‘traditional’ pack/label/ ship clinical supply chain. This workshop is designed to discuss challenges and potential solutions when handling, storing, labeling and shipping ultra cold / sensitive materials.

Location
Brizzey Breakout Room
Workshop

Pooled Supplies (WS27)

Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared.

Location
Brizzey Breakout Room
Workshop

The Clinical Trial Regulation and its Evolving Regulatory Impact on Europe & ROW (MP3)

Clinical supply chains are adjusting to recent changes in the regulations. This workshop will provide an opportunity to discuss the recent changes and ask questions of a QP from the EU.

Location
PCI Breakout Room
Workshop

Speaker Wrap Up & Feedback

Please take this time to complete the survey below on your experience as a speaker/facilitator at the 2020 Virtual Conference.

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