Cambridge Healthtech Institute’s 3rd Annual

Clinical Supply Management

Streamlining Clinical Supply Tracking, Management & Distribution for Patient-Centric Trials

February 19-20, 2020


Successful patient-centric clinical trials are underpinned by efficient, streamlined clinical trial supply processes that ensure the investigational drug is properly handled and delivered to the right patient, whether it be at the trial site, pharmacy, or at home. Cambridge Healthtech Institute’s 3rd Annual Clinical Supply Management meeting focuses on the partnership of clinical supply and clinical operations. This meeting shares case studies and best practices that emphasize the critical role of clinical supply management for ever-more complex trials.

Stay on and attend Part 2 (Thurs-Fri): Managing Outsourced Clinical Trials

Final Agenda

Tuesday, February 18

9:00 am - 7:15 pm Registration Open (Regency Rotunda)

2:00 - 5:00 pm User Group Meetings

2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific Symposium*

*Separate registration required. Must be a Best Value registered attendee.

5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards (Regency Ballroom S)

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)

8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom Sprovided by Clinical_Ink_NoTagline

9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)Highthink_Med

AUTOLOGOUS THERAPIES: END-TO-END SUPPLY LOGISTICS
Celebration 9-10

10:40 Chairperson’s Remarks

Disa Lee Choun, Head of Innovation, Global Clinical Sciences and Operations, UCB

10:45 The N=1 Clinical Supply Chain

Davis_LauraLaura Davis, Business Technology Leader, Biotherapeutic Development, Information Technology, The Janssen Pharmaceutical Companies of Johnson & Johnson

Autologous therapies, such as CAR-T, have challenged us to re-evaluate our clinical supply chains to accommodate the needs of personalized manufacturing: harvesting raw material from the patient and tracking material through the production process until the drug product is infused back into the patient. This talk discusses the challenges and opportunities of building a personalized logistics network in this novel therapeutic modality, including new stakeholders and differing capabilities in hospital networks, while reducing vein-to-vein time and maintaining an end-to-end chain of custody.

11:15 NEW: Role of Blockchain and Converging Technologies to Optimizing Clinical Trials Supplies Management

Nitin Naik, Vice President, Transformational Health, Global Life Sciences, Frost & Sullivan

With the portfolio of drugs shifting toward temperature-sensitive biologics and targeted therapeutics drugs, the need for quality compliance for cold-chain logistics and visibility from large molecule APIs to final drug delivery is becoming critical. Lack of trust and auditability around current clinical supplies and logistics workflows and increasing protocol complexities for targeted therapeutics often create supply chain disruptions and quality compromises, resulting in waste of time- and cost-sensitive clinical supplies. Blockchain-based chain-of-custody log to track each step of the clinical supplies, and its convergence potential with IoT based drug temperature monitoring system can offer desired end-to-end visibility, auditability, and quality compliance for temperature-controlled clinical supplies and logistics. As part of this interacting presentation, Frost & Sullivan and an industry expert will provide a prospective on how biopharma companies can leverage the best of breed technologies and cross-industry partnerships to address the critical operational challenges pertaining to clinical trial supplies management.

11:45 Navigating the Supply Chain and Supplier Challenges in Cell Therapy 

Smith_AlanAlan K. Smith, PhD, Executive Vice President, Technical Operations, Bellicum Pharmaceuticals, Inc.

Developing a supply chain required to develop and manufacture GMP cell therapy products presents some unique challenges to typical biologics or small molecule drugs. Identification and qualification of suppliers and consideration of best practices is essential. Successful strategies in negotiating supply and quality agreements, establishing and managing lead times and supply inventory considerations are also critical to the successful manufacture and release of cell therapy products for clinical use.

12:15 pm Direct to Patient: Choosing the Right Distribution Model for Your Study

Jennifer Fenwick, Director, Project Management, Americas, Marken

-Direct to Patient
-HHC
-Protocol Considerations
-Operational and Regulatory Factors to Consider

12:45 Transition to Lunch

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own


1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)Abond

BLOCKCHAIN: SUPPORTING EFFICIENCY AND VISIBILITY ACROSS THE CLINICAL TRIAL
CELEBRATION 9-10

2:15 Chairperson’s Remarks

Adama Ibrahim, EMBA, Associate Director, Global Clinical Operations, Biogen

2:20 CO-PRESENTATION: Blockchain Clinical Trials: Truth or Dare?

Choun_Disa_LeeDisa Lee Choun, Head of Innovation, Global Clinical Sciences and Operations, UCB


Ibrahim_AdamaAdama Ibrahim, EMBA, Associate Director, Global Clinical Operations, Biogen

In this presentation, we will show how blockchain can be used for the design and implementation of faster, less onerous user identification processes through permissioned access to a federated database pointing to a variety of traditionally siloed sources (inc. EMR, wearables, IoT, etc.) We will also describe how a blockchain-powered health wallet could support greater efficiencies across the clinical trial process.

2:50 Can We Use Blockchain for Clinical Trial Efficiency?

Gummadi_BaskerBasker Gummadi, MS, PMP, PgMP, Director, Technology and Innovation, Celgene

The healthcare clinical trials domain is ripe to leverage core benefits of blockchain technology. We must also identify challenges and map blockchain solutions based on a ‘fit-for-purpose’ approach. Some of the most pressing challenges in clinical trials include access and management of clinical trial data; data integrity and provenance for regulatory purposes; updating and maintaining patient consent; and patient recruitment. We will describe blockchain approaches to address clinical trial management challenges and illustrate the variety of blockchain designs.

3:20 Transforming Clinical Supply with Blockchain 

Ben Taylor, Member, Clinical Supply Blockchain Working Group & CEO, LedgerDomain

With active clinical studies on the rise and personalized medicine on the horizon, clinical pharmacies are struggling to keep up with growing demand. The sheer number of systems used by sponsors and CROs means that many sites have fallen back on paper documentation. This talk explores a landmark pilot program in which a working group with broad industry participation scoped, developed, and tested a collaborative blockchain solution aimed at delivering a win for patients awaiting new medicines.

Bloqcube 3:50 CO-PRESENTATION: Blockchain in Clinical Trials - The Bloqcube /NTT DATA Experience

Rama Krishna Rao, MBA, Founder, CEO, Bloqcube Inc.

Chetan Kothari, Director, Business Services, NTT Data

We propose to share our experience in leveraging innovation especially blockchains in the conduct of clinical studies and its usage in the Supply Chain Management space

4:05 Late Breaking Presentation

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

For more details on the Breakout Discussions: https://www.scopesummit.com/breakouts

4:25 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.

5:10 Welcome Reception in the Exhibit Hall (Windermere Ballroom)d_wise_NEW

(Co-Sponsorship Opportunities Available)

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open (Regency Rotunda)

7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share (Regency Ballroom T)

Nolte_MikeMike Nolte, Chief Executive Officer, Signant Health


8:15 Session Break

DIRECT TO PATIENT (DTP): END-TO-END SUPPLY MANAGEMENT
CELEBRATION 9-10

8:20 Chairperson’s Remarks

Gerald Finken, CEO, RXE2

8:25 DtP Case Study: Planning, Implementation, Ensuring On-Going Success and Lessons Learned

Halmrast_SarahSarah Halmrast, Vice President, Global Project Management, Clinical Supplies Management, Inc.

A Clinical Supplies discussion on planning packaging & labeling, delivery, storage and return of supplies for clinical trial that will have a positive impact on patients participating in a DtP study. We will also discuss challenges encountered to successfully get medication in the patients’ hands throughout the study.

8:45 Clinical Patient Management for Specialty Pharmaceuticals

Faulks_JeremyJeremy Faulks, PharmD, Director, Specialty Pharmacy and Pharmacy Procurement, Pharmacy Operations, Thrifty White Pharmacy

This presentation will cover Specialty Pharmacy Patient Management Programs for a variety of medications. These programs include benefit investigation, insurance and funding support, clinical patient counseling and ongoing patient assessment and management through clinical surveys and data analysis. We currently offer 200+ clinical protocols, each specific to the medication therapy and disease state undergoing treatment. These clinical protocols support gathering of real-world evidence and patient outcomes from their medication therapy.

9:05 Clinical Trials from the Patient Perspective: What Matters Most?

Benger_JasmineJasmine Benger, Senior Project Manager, Research Services, Center for Information and Study on Clinical Research Participation (CISCRP)

Excerpts from CISCRP’s 2019 Perceptions and Insight Study: A Global Online Survey of Patients and Public. Take a deep dive into the findings from CISCRP’s most recent study. What are patients’ thoughts on remote trial models? How can trials be designed to reduce the burdens associated with participation? Learn about patient preferences around medicine being delivered to their home, thoughts on the use of technology and more.

9:25 Considerations for Use of IRT in Novel Clinical Trial DesignsBioclinica

Kevin BishopVice President, RTSMBioclinica

As clinical trial design evolves, the clinical supply plan can become increasingly complex. This is particularly evident with the adoption of novel trial designs such as Master protocols as well as the emergence of ‘direct-to-patient’ clinical supply chain needs. Traditionally, systems such as IRT have enjoyed widespread adoption for the management of randomization and supply chains – this presentation will provide an overview of the important considerations when using IRT and supply chain forecasting/optimization systems in these newer supply paradigms.  

9:55 PANEL DISCUSSION: Patient-Focused Clinical Supplies

Finken_GeraldModerator: Gerald Finken, CEO, RXE2


Panelists:

Benger_JasmineJasmine Benger, Senior Project Manager, Research Services, Center for Information and Study on Clinical Research Participation (CISCRP)


Faulks_JeremyJeremy Faulks, PharmD, Director, Specialty Pharmacy and Pharmacy Procurement, Pharmacy Operations, Thrifty White Pharmacy


Halmrast_SarahSarah Halmrast, Vice President, Global Project Management, Clinical Supplies Management, Inc.


Topics to be discussed:

  • Best Practices for Patient-Focused Supplies
  • Packaging and Labeling/Dispensing
  • Delivery – Site Dispensing/DtP
  • Storage
  • Returns
  • Patients and Their Medication – Ensuring Adherence, Compliance and Therapeutic Outcomes
  • Packaging and Labeling Site’s Role
  • Clinical Site’s Role
  • Dispensing Pharmacy’s Role

 

10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)Aris_Global_New

ADOPTING DATA TECHNOLOGY: PATIENT & PRODUCT MONITORING
CELEBRATION 9-10

11:20 Chairperson’s Remarks

Kimberly Finn is Vice President, Global Patient Centric Services, Marken

11:25 Electronic Labels in Clinical Supplies: Understanding the Benefit for Patients, Sites and Sponsors

Moyer_MatthewMatthew Moyer, MS, MBA, PMP, Director, Clinical Supply Technology, Global Clinical Supply, Merck & Co., Inc.

Paper booklet labels used in clinical trials are static, have very low utility and focus primarily on meeting regulatory requirements. If there are changes to the study the label must be reprinted or supplies must be reworked. Data suggests that the patients do not open the booklets to review the information. The TransCelerate eLabel initiative envisions a future where this patient-centric technology can minimize current challenges faced by both patients and sponsors. The eLabel can be a digital channel to the patient as well as enable future opportunities to expand the e-medicines platform.

11:45 Analytical Risk-Based Approach to Investigational Product Monitoring Activities: A Practical Case

Ortiz_JulianJulian Ortiz, Associate Director, Risk Management and Central Monitoring, Infectious Diseases and Vaccines, Integrated Data Analytics and Reporting, Janssen Research and Development

ARBM methodology allowed the use of centrally available drug accountability data to guide the CRAs to perform tailored review and targeted verification of IP processes. IP tSDV methodology was implemented to verify data of 10% of subjects. IP SDR was implemented in sites with possible issues, based on centrally calculated number of unaccounted for bottles and possible missing/overdoses. After ARBM IP implementation, the data quality and OSVM efficiency were increased.

12:05 pm Change Management Clinical Supply Chain Considerations for Digitally Enabled Patient-Centric Clinical Trials

Moyer_MatthewMatthew Moyer, MS, MBA, PMP, Director, Clinical Supply Technology, Global Clinical Supply, Merck & Co., Inc.

This presentation will focus on considerations when leveraging new digital health and supply chain technologies to improve clinical trial planning and execution, and how we are engaging internal (sponsor) and external (regulators, clinical sites, patients) stakeholders to drive and manage change, and accelerate adoption of these new technologies. A vision for trials of the future will also be shared.

12:25 Transition to Lunch

12:30 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)BioTelResearch

 

2:00 Close of Conference


Stay on and attend Part 2: Managing Outsourced Clinical Trials

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning and Thursday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts