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
Monday, February 18
9:00 am – 7:15 pm Registration Open (Convention Level)
2:00 – 5:00 pm User Group Meetings
Shared Investigator Platform User Forum
Trifecta Annual User Group Forum
5:00 – 6:15 pm Pre-Conference Plenary Keynote Panel &
Participant Engagement Award (Regency PQ)
6:15 – 7:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)
7:15 pm Close of Day
Tuesday, February 19
7:15 am Registration Open and Morning Coffee (Convention Level)
8:15 Opening Plenary Keynotes
9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Ballroom)
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
Tony Porter, Associate Director, Consultative Solutions, IQVIA Technologies
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 Trends and Innovative Solutions for Optimizing Your Clinical Supply Chain
Paddy Hanlon, Vice President, Commercial Operations, Marken LLP
12:10 pm The Next Frontier: New GCP Expectations of Sponsors & Suppliers for the eClinical Landscape
Todd 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: Achieving Extended Enterprise Supply Chain Maturity Within a Clinical Supply Environment
Oliver Cunningham, Director, Client Enablement, CRF Bracket
Clinical supply chains are well known to be immature within the industry, and some way behind their commercial counterparts. This session will explore the different stages of evolution within clinical supply chains, and some key indicators
to enable you to determine the level of maturity your company is at.
1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)
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.
Jan Pieter Kappelle, Vice President, Strategy, 4G Clinical
Jon Paras, Senior Manager, Electronic Trials Operations, Amgen
Constantine Ward, Owner & Supply Chain Consultant, Optimal
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 Navigating Clinical Trial Supply Optimization Vendors and IRT ROI
Constantine Ward, Owner & Supply Chain Consultant, Optimal
How much do I need to label & package? Explore the various clinical trial supply chain optimization software packages in the market. Do they work with budget IRT systems? Do they work with sophisticated highly bespoked IRT systems? How
do they compare to commercial systems? How is the supply chain Optimization market coping with new IRT functionality?
3:40 Turning Up the Heat: The Effect of Pipeline Success on Clinical Supplies
Eva Allen, Senior
Clinical Supplies Manager, Clinical Supply Services Business Solutions, Catalent
For many sponsors, advancing promising investigational medicines from Phase I to Phase II means the introduction of complex protocols and design elements such as blinding, arms, placebos, comparators and more that can quickly increase the
potential for significant clinical supply-related issues. Sponsors with young pipelines moving into Phase II or Phase III for the first time are particularly at risk of encountering clinical supply challenges that can delay studies and
waste limited resources.
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 (Plaza International Ballroom)
6:30 Close of Day
Wednesday, February 20
7:15 am Registration Open (Convention Level)
7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)
Eric Delente, Head, Patient Consent, IQVIA Technologies
This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs
from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.
8:15 Session Break
8:20 Chairperson’s Remarks
Jan Pieter Kappelle, Vice President, Strategy, 4G Clinical
8:25 How Can Blockchain Improve Traceability of Clinical Trial Supply Chain?
Basker 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
Adama 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
Matthew 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
Utilization of Drug Pooling to Optimize Complex Drug Management
Kevin Collier, Senior Director, Product Management, Medidata
Blair Grimes, Manager, Supply Chain, Dermavant Sciences, Inc.
Despite the potential to deliver significant efficiencies and cost savings, pooling inventory across clinical studies has more often been an approach discussed in our industry than applied in practice. This presentation will cover how drug
pooling at the site and depot levels was applied to an innovative oncology program, enabling for the implementation of a complex adaptive design while decreasing costs, shortening timelines, and, ultimately, leading to better treatments
for patients sooner.
10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)
11:20 Chairperson’s Remarks
Gerald Finken, CEO, Center Point
11:25 INTERACTIVE PANEL: Clinical Supply in Virtual Trials – Direct-to-Patient Distribution
Moderator: 
Gerald Finken, CEO, Center Point
Michael Sparozic, RPh, Lead Trial Supply
Operations Manager, Clinical Supplies Chain Operations, Distribution, Sanofi
Constantine Ward, Owner & Supply Chain Consultant, Optimal
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: Putting the Patient at the Center: A New Approach to System Change Requests (SCRs)
Andrew Rohrbaugh, Director, Client
Delivery, Cenduit
Clinical studies are not a one-size fits all approach. A purely “configured based system” is a myth. This session focuses on the evolving role of system change request (SCRs): putting the patient at the center. 1) Hear an academic
review on protocol amendment impact in clinical studies 2) Learn how an agile, configurable approach can reduce timelines, keeping patient benefit at the forefront 3) Understand an Operational Excellence (OpEx) approach to IRT system changes.
1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)
2:10 Close of Conference