Cambridge Healthtech Institute’s 2nd Annual

Clinical Supply Management

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

February 19-20, 2019


Successful, patient-centric clinical trials depend upon streamlined clinical trial supply processes that ensure that the study drug is properly handled and delivered to the right patient whether at the trial site, pharmacy or in their home. Cambridge Healthtech Institute’s 2nd Annual “Clinical Supply Management” conference offers practical solutions for effective clinical supply management. The program focuses on the intersection of clinical supply and clinical operations, offering best practices and case studies on partnering with clinical ops to streamline the process, the role of clinical supply in virtual, siteless trials, and tech tools to enable proper tracking and tracing of clinical supplies.

Final Agenda

Stay on and attend Part 2 (Wed-Thurs): Clinical Biospecimens and Central Lab Solutions

Monday, February 18

9:00 am 7:15 pm Registration Open

2:005:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:006:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award

6:157:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall

PARTNERING WITH CLINICAL OPS FOR CLINICAL TRIAL SUPPLY OPTIMIZATION

10:35 Chairperson’s Remarks

Jon Paras, Senior Manager, Electronic Trials Operations, Amgen

10:40 CO-PRESENTATION: Don’t Reinvent the Wheel: Leveraging Robust Enrollment Planning to Inform Clinical Supply Management

Christine Crandall, Head of Strategic Clinical Planning, Study Start Up, RD Projects Clinical Platforms & Sciences, GSK

Cara Woodruff, Trial Optimization Product Manager, Clinical Trial Optimization Solutions, IQVIA

Clinical supply budgets remain a big area of untapped potential efficiencies for both sponsors and CROs. While suppliers have focused on improving accuracy of their estimates, it’s usually in isolation and is often impacted by unexpected activities of upstream stakeholders. We’ll share details of a collaborative approach that allows a clinical supply organization to leverage existing clinical technology for enrollment and timeline planning to inform their supply strategy.

11:40 eLabels: A Catalyst for Supply Chain Transformation and Enhanced Patient Engagement

Hans Von Steiger, Group Leader, Clinical Supply Chain Management, Pfizer (tentative)

The TransCelerate eLabels Initiative aims to act as a catalyst for clinical supply chain transformation, enhanced patient utility, reduced clinical labeling timelines and costs, promotion of consistent, up-to-date information, and effective health authority engagement. The main output is not an eLabeling system, specifications, or standard, but an eLabels implementation toolkit to facilitate external engagement and uptake in the industry. This session will share real-world implementation experiences and learnings from eLabels pilots conducted in 2018.

12:10 pm The Next Frontier: New GCP Expectations of Sponsors & Suppliers for the eClinical Landscape

Kole_Todd_CSPTodd Kole, RPh, Vice President, Clinical Project Services, Almac Clinical Technologies

Global regulatory agencies are exhibiting greater scrutiny over both sponsor and vendor processes during eClinical system development and deployment. This session will shed light on the new areas of interest by regulators, and includes actionable insight on how to ensure both sponsor and vendor processes align with new expectations being set.

12:40 Transition to Lunch

12:45 LUNCHEON PRESENTATION to be Announced

1:25 Coffee and Dessert Break in the Exhibit Hall

TRANSFORMING CLINICAL SUPPLY CHAIN PLANNING

2:05 Chairperson’s Remarks

Jon Paras, Senior Manager, Electronic Trials Operations, Amgen

2:10 INTERACTIVE PANEL: Current Challenges in Demand and Supply Planning

Moderator: Bill Coakley, Senior Director, Global Supply Chain Planning, BioMarin Pharmaceutical Inc.

Panelist to be Announced, 4G Clinical

Topics covered include:

  • What are the best available technology solutions for clinical demand and supply planning? Are they different from commercial planning solutions? What are the must-have features planning tools need to satisfy for clinical supply chain professionals? How aligned is your CSC with your company’s commercial planning processes and tools?
  • What role does Clinical Supply Chain plan with respect to drug accountability and reconciliation? What role does Clinical Operations Play? Who has overall responsibility? How is that achieved?
  • What are some best practices on ensuring that clinical supply is meeting requirements of blinded studies? Is your CSC blinded or unblinded? Do they interact with study teams? Patient sites?

3:10 CO-PRESENTATION: Enhancing Clinical Supply Using Integrated IRT with Mobile Technology and IP Temperature Monitoring

Deepa Subramanian, Senior Manager, Development Information Systems, Amgen

Jon Paras, Senior Manager, Electronic Trials Operations, Amgen

Amgen has traditionally relied on manual processes at clinical sites to facilitate investigational product management. As part of a company-wide streamlining clinical trials initiative, technology was implemented to automate data capture, enable systematic controls and gain visibility to clinical product at sites. The technology will prevent dosing of temperature compromised product, as well as reduce temperature excursion management processes impacting clinical customer service and clinical quality.

3:40 Presentation to be Announced

BREAKOUT DISCUSSION GROUPS

4:10 Find Your Table and Meet Your Moderator

4:15 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.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION to be Announced

8:15 Session Break

TECH INITIATIVES TO ENHANCE CLINICAL SUPPLY CHAIN MANAGEMENT

8:20 Chairperson’s Remarks

Chairperson to be Announced, 4G Clinical

8:25 How Can Blockchain Improve Traceability of Clinical Trial Supply Chain?

Gummadi_BaskerBasker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC

Blockchain technology has the potential to positively impact clinical trial supply chains by improving the traceability of medications from active pharmaceutical ingredient (API) to patient. The chain between a clinical study sponsor, study patient, and site is long and involves the use of multiple IT systems. In a world where all parties are linked via a blockchain, it would be possible to leverage encryption and access control so that the members (trusted participants) could get confirmation of the receipt of the product without having access to protected patient information and, in turn, provides the ability to validate patient identity.

8:55 Cross-Industry Collaboration Evaluating How Blockchain Can Transform the Pharmaceutical and Healthcare Industry, Part of Emerging Trends & Technology PhUSE Workgroup

Ibrahim_AdamaAdama Ibrahim, Associate Director, Clinical Operations, Biogen

This presentation will describe the current landscape in the pharma and healthcare settings, exploring the areas where Blockchain could be used and presenting two detailed use cases (a. Drug Supply Chain using Smart Contracts; b. Patient Data Access/Transparency) to support future development and implementation for an upcoming proof of concept.

9:25 Diving into Innovations that Will Change Your Clinical Trials

Moyer_MattMatthew Moyer, Director, Clinical Supply Technology, Merck

This presentation will review innovations expected to change the landscape of clinical trial supply and conduct in the years to come, and the efforts within and across industry to support their installation. This includes use of mobile healthcare technology to enable siteless clinical trials and improved patient monitoring, opportunities for use of Blockchain to secure data sharing and communication between all the parties involved in trials, and the potential for social robotics to play a role in patient engagement.

9:55 Presentation to be Announced

10:25 Coffee Break in the Exhibit Hall

DIRECT-TO-PATIENT CONSIDERATIONS OF CLINICAL TRIAL SUPPLY

11:20 Chairperson’s Remarks

Gerald Finken, CEO, Center Point

11:25 INTERACTIVE PANEL: Clinical Supply in Virtual Trials – Direct-to-Patient Distribution

Moderator: Finken_GeraldGerald Finken, CEO, Center Point

As the pharma industry moves towards virtual trials and more patient-centric initiatives for clinical trials, one challenge that is often overlooked is direct-to-patient distribution of clinical supplies. Topics discussed in this panel include:


  • Technologies that can offer solutions in tracking and tracing supplies direct to patients
  • Investigator and site buy-in and support for direct-to-patient initiatives
  • Logistical, cost and regulatory considerations
  • Challenges with patient handling of IMPs.

12:25 pm Transition to Lunch

12:30 LUNCHEON PRESENTATION: Approaches to the Efficient Deployment of System Change Requests

Rohrbaug_Andrew_CSPAndrew Rohrbaugh, Director, Client Delivery, Cenduit

Configurable vs. customizable systems are not a one size fits all approach. Study protocols are becoming more complex in today’s environment. Sponsors must be nimble enough to adapt, to serve the needs of patients. We explore the benefits of a hybrid approach, and attendees will learn how: IRT standardization is beneficial, regardless of the build approach; Some components will always be custom, or unique; The benefits of standardization in conjunction with a configurable/hybrid approach.

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Close of Conference

Stay on and attend Part 2 (Wed-Thurs): Clinical Biospecimens and Central Lab Solutions

Register!

“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions
Novartis


Signature Sponsors

IQVIA

Medidata


Premier Sponsors

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