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 (Convention Level)

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 (Regency PQ)

6:157:15 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)

Blue Spring I & II

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

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

Porter TonyTony 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.

Marken 11:40 Trends and Innovative Solutions for Optimizing Your Clinical Supply Chain

Hanlon_PaddyPaddy Hanlon, Vice President, Commercial Operations, Marken LLP

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

Bracket_CRF_NEW 12:45 LUNCHEON PRESENTATION: Achieving Extended Enterprise Supply Chain Maturity Within a Clinical Supply Environment

Cunningham_OliverOliver 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)

Blue Spring I & II

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

Paras_JonJon Paras, Senior Manager, Electronic Trials Operations, Amgen

Ward_ConstantineConstantine 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

Ward_ConstantineConstantine 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

Allen_EvaEva 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.

Regency R

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.

Advarra 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)

IQVIA 7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)

Delente_EricEric 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

Blue Spring I & II

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?

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 Utilization of Drug Pooling to Optimize Complex Drug Management

Collier_KevinKevin Collier, Senior Director, Product Management, Medidata

Grimes_BlairBlair 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: Finken_GeraldGerald Finken, CEO, Center Point

Sparozic_MichaelMichael Sparozic, RPh, Lead Trial Supply Operations Manager, Clinical Supplies Chain Operations, Distribution, Sanofi

Ward_ConstantineConstantine 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)

Rohrbaug_Andrew_CSPAndrew 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

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

video recap

SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

Read More…

“SCOPE Featured Author”
Emmanuel Fombu, MD, MBA
Global Commercial Strategy and
Digital Innovation, Johnson & Johnson

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