Cambridge Healthtech Institute’s Third Annual

Outsourcing for Clinical Trials

Building Effective Outsourcing Strategies and Relationships

May 8-9, 2018 | Aloft Boston Seaport | Boston, MA

As more clinical trial activities are outsourced to contract research organizations (CROs) and other third-party vendors, understanding outsourcing needs and forming effective, quality partnerships are paramount to successful clinical trial execution. Cambridge Healthtech Institute’s Outsourcing for Clinical Trials conference provides a new perspective on the entire outsourcing relationship from vendor selection and contracting through to vendor management and project performance and quality. The 2018 program focuses on case studies, lessons learned, and interactive discussion from sponsors, CROs, and other vendors on outsourcing strategy, the RFP and bid defense process, vendor selection, contracting, vendor quality and performance and working with third party suppliers.

Final Agenda

Tuesday, May 8

10:00 am Conference Registration


10:45 PLENARY KEYNOTE SESSION

Transformation through Digital Medicine: The Time is Now!!

Ashish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai

Value based healthcare and outcome based contracts are reshaping the entire health industry and major players including health systems, payers and pharma. Digital Medicine is an emerging discipline that can enable transformation of health systems to support both patient centered clinical care and research. Dr. Atreja, will provide an overview of current state of the art of digital medicine, review the challenges faced in digital medicine adoption and demonstrate how prescription of digital medicine can support care and research transformation.

As Chief Technology Innovation and Engagement Officer, Medicine, Dr. Atreja leads the Sinai AppLab (www.sinaiapplab.org), a one-of-a-kind collaborative hub to build and test disruptive mhealth technologies. Dr. Atreja leads scientific registries for the American Gastroenterology Association and serves on the Innovation Advisory Board for American College of Cardiology. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine. More recently, Dr. Atreja launched the first enterprisewide app curation and prescribing platform (www.rxuniverse.com) and established Network of Digital Medicine (www.nodehealth.org) to connect innovation centers worldwide and share best practices for digital medicine innovation and implementation.

11:50 Walking Lunch & Dessert Break in the Exhibit Hall

OUTSOURCING STRATEGY & BID DEFENSE

1:45 Chairperson’s Remarks

Erin O’Boyle, Senior Director, Clinical Contracts and Outsourcing, FibroGen, Inc.

1:50 Town Hall Discussion: Perspectives on Evolving Regulatory Outsourcing

Owen Charles, RN, MBA / HCM, Formerly Outsourcing Manager, Central Clinical Planning & Solutions, Bristol-Myers Squibb


Beatriz_RochaBeatriz Rocha, MD, PhD, Vice President, Head of Strategic Product Development Consulting, Covance


John_KleinJohn S Klein, MS, MBA, Director, Global Regulatory Affairs, IQVIA 

The Town Hall Discussion will start with an overview and end with a moderated audience discussion. The conversation will touch on the evolution of regulatory outsourcing including key topics such as:


  • Growth/trends in the industry
  • Strategy (service providers, models of outsourcing, functions and activities commonly outsourced, etc.)
  • And key challenges (e.g., what to outsource vs keep in house?, how to ensure oversight/quality?, preparing for EU CTR, etc.)

Comprehend 2:50 New Tufts Study: CRO Oversight Performance Market Survey

Beth_HarperBeth Harper, MBA, President, Clinical Performance Partners


Rick_MorrisonRick Morrison, President, Comprehend Systems, Inc.

This session provides an overview of a recent Tufts CSDD market research study focused on the effectiveness and impact of CRO Oversight programs. Join Beth Harper of Clinical Performance Partners as she explores results and implications. Learn about: CRO oversight models, oversight challenges, industry experience, performance metrics, insights into new approaches. Joining Beth is Rick Morrison of Comprehend, who will share industry directions and ways to overcome Oversight challenges including transparency, risk, and compliance.

3:20 Refreshment Break in the Exhibit Hall

4:05 PANEL DISCUSSION: Selecting Suppliers – Full-Service Providers, Functional Service Providers or Somewhere in the Middle?

Moderator: Erin O’Boyle, Senior Director, Clinical Contracts and Outsourcing, FibroGen, Inc.

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Maria Makarovskaya, Director, Vendor Management, Global Clinical Development, Tesaro

Charlotte French, Independent Consultant; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

As the pharma industry continuously reevaluates its outsourcing, the panel will bring together representatives from small pharma, large pharma and CROs to discuss outsourcing trends, the pros and cons with consolidating providers (and having 1 sole preferred provider) vs. maintaining multiple suppliers, scenarios when it is most beneficial to choose a full-service provider over functional service providers and vice versa, and the resulting trade-offs with each outsourcing strategy.

5:05 Close of Day

5:05 Dinner Short Course Registration

Wednesday, May 9

8:30 am Interactive Breakout Discussion Groups with Continental Breakfast

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. 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.

9:25 Session Break

BUILDING MORE EFFECTIVE PARTNERSHIPS

9:40 Chairperson’s Remarks

Mark Milberg, MBA, MSW, Director, Clinical Procurement and Outsourcing, Ultragenyx

9:45 PANEL DISCUSSION: Rethinking Bid Defense with All Stakeholders – Sponsors, CROs & Third Party Vendors

Mark MilbergModerator: Mark Milberg, MBA, MSW, Director, Clinical Procurement and Outsourcing, Ultragenyx


Panelists:

Owen Charles, RN, MBA / HCM, Formerly Outsourcing Manager, Central Clinical Planning & Solutions, Bristol-Myers Squibb

René Wheat, Senior Director, Global Project Management, Infectious & Rare Diseases, Clinical Research Service, ICON

Scott_OhanesianScott Ohanesian, Senior Vice President, Commercial Operations, QuickSTAT

Bid defense is typically a very repetitive and unimaginative process across pharma for both the sponsor and CRO. And as CROs are tasked with outsourcing more services on behalf of sponsor companies, CROs are often conducting their own sourcing of third party vendors. This panel discussion will focus on how to innovatively approach bid defense and involve all stakeholders: CROs, sponsors, and third party vendors. We will explore:

  • How Pharma/CRO determine the participants at the bid defense meeting
  • What are the main objectives of each party at the bid defense meeting, and how are they achieving them?

11:00 Coffee Break

11:30 The Evolution of KPIs to KxIs in Strategic Relationships - Getting Value in Your Ability to Report by Leveraging a Holistic Approach to Metrics and Reporting during the Setup of the Relationship

Christopher RullChristopher Rull, Vice President, Solutions Consulting Leader, PAREXEL Access

This session will look at some best practices and lessons learned in the creation of your metrics and reporting in new strategic relationships by 1.) empowering the study teams to create the operational and performance metrics they need to work, and 2.) focusing in a balanced suite (Performance, Quality, Finance, and Relationship) of KxIs that can truly provide insight into the value of the partnership and investment.

12:00 pm KPI Development, Deployment, and Revision: A Case Study in Finding the Metrics to Evaluate Our Vendor Relationships

Eric StaryEric Stary, Manager, Clinical Outsourcing, Pharmacyclics

PCYC is a mid-size biotech with several key vendor relationships across multiple service lines. In the last several years, PCYC and its vendor partners have developed and deployed KPIs for these key partners. In the rollout of these KPIs, it became evident that an element of revision and regrouping is key to refining and further developing those relationships. This talk will be a case study in this iterative process highlighting what went right, what went wrong, and what we have learned together.

12:30 Luncheon Presentation (Sponsorship Opportunity Available)

1:15 Session Break

VENDOR QUALITY, PERFORMANCE & OVERSIGHT

2:15 Chairperson’s Remarks

Mark Milberg, MBA, MSW, Director, Clinical Procurement and Outsourcing, Ultragenyx

2:20 Minimizing Duplication of Resources between BioPharma and Service Providers Teams while Managing Risk

Charlotte FrenchCharlotte French, Independent Consultant; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

This session will provide insight into the importance of the appropriate linkages between the Trial Oversight Plan and an integrated Project Management Plan. How can BioPharma minimize duplication of effort in an outsourced model and effectively meet the oversight requirements of ICH E6? What are some of the challenges in implementing change from management to oversight within the BioPharma?

2:50 PANEL DISCUSSION: Balancing Oversight in the Wake of ICH E6 R2

Moderator: Melissa A. Hurst, MSM, MBA, Clinical Outsourcing Manager, CSL Behring

Michele Stonier, CRO Infrastructure Lead, Vendor & Outsourcing Management, BMS

Dennis SalottiDennis Salotti, Vice President, Operations, The Avoca Group


With the industry’s need to comply with recent changes in the ICH E6 R2 addendum, how is pharma balancing oversight with their desired number of suppliers? The panel will bring together representatives from small pharma, large pharma and CROs to discuss setting up governance structures, vendor quality, and oversight in light of the new ICH E6 R2 changes.

3:50 Close of Conference


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