2020 Archived Content

Cambridge Healthtech Institute’s 4th Annual

Mastering an Outsourcing Strategy

Defining Your Sourcing Strategy & Ensuring Harmony between All Stakeholders

February 19-20, 2020

The landscape of how sponsors approach their outsourcing strategy continues to adapt as new methods and technologies become available. CHI’s 4th Annual Mastering an Outsourcing Strategy conference provides a number of perspectives on approaching an overall outsourcing strategy and will address how both internal considerations and external forces can influence the process. The program will also offer case studies and discussions with input from sponsors, CROs, sites, and suppliers on navigating the outsourcing process.

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

Final Agenda

The landscape of how sponsors approach their outsourcing strategy continues to adapt as new methods and technologies become available. CHI’s 4th Annual Mastering an Outsourcing Strategy conference provides a number of perspectives on approaching an overall outsourcing strategy and will address how both internal considerations and external forces can influence the process. The program will also offer case studies and discussions with input from sponsors, CROs, sites and suppliers on navigating the outsourcing process.

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 S) provided by

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

10:40 Chairperson’s Remarks

Reb Tayyabkhan, Head, R&D Sourcing and Procurement, Merck

10:45 How Evolving Technology Influences Sourcing Strategy

Tayyabkham_Reb Reb Tayyabkhan, Head, R&D Sourcing and Procurement, Merck

Sourcing approaches which to date have been isolated based on functional area or scope of services needs to be evolve, as there is a clear interplay between technology and services; and with the rapid evolution in technology, the ability to look ahead is more important than ever when considering your sourcing strategy.

11:15 Talk Title To Be Announced

Stephens Rene Rene Stephens, MSHS, President, Renatus Consulting, LLC

11:45 Double Vision – Lessons From the Biotech Outsourcing Perspective that Larger Pharma Can Learn From

Scaife_Richard Richard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG)

The volume of program-level clinical trials that Biotech companies are outsourcing is increasing. Is this due to increased availability of funding or also because Biotechs are more effective in their outsourcing and trial management? Decision-making, contracting, trust, payment, interaction and limited resource to micro-manage are just some of the different perspectives between leaner, meaner Biotech companies and bigger sponsors. This session will explore some essential the truths and myths of outsourcing at the sharp end of the spectrum. Lessons that can be viable for both sponsors and providers.

12:15 pm CO-PRESENTATION: Evolved FSP Models are Meeting the Industry Need for Organizational Agility

Doyle_Eleanore Eleanore Doyle, Executive Vice President, FSP Strategic Solutions, Syneos Health

Williams_Shaun Shaun Williams, Executive Director, Investigator Management Solutions, Syneos Health

As customers look to consolidate outsourced Clinical Solutions, typical static outsourcing models fail to meet their increasingly complex scientific and operational needs.Rather than think of outsourcing or insourcing as single function engagements, sponsors can combine the stability and infrastructure of a full service organization and a flexible FSP team to quickly respond to evolving development needs. Syneos Health will provide a case study that demonstrates, improved efficiencies and cost reductions by leveraging multi-function FSP models to support the growing need for organizational agility.

12:45 Transition to Lunch

12:50 LUNCHEON CO-PRESENTATION: The Importance of Open Systems in eClinical Technology

Nielsen_Jan Jan Nielsen, Community Manager, Life Sciences, BSI Business Systems Integration AG

Thuesen_Jens Jens Thuesen, Business Development, BSI Business Systems Integration AG

An open system, in the context of computing, is a computer system that combines portability and interoperability, and makes use of open software standards. It typically refers to a computer system that is interoperable between different vendors and standards, allowing for modularity so that hardware and software need not to be attached to a single vendor or platform. This presentation focus on the importance of selecting Open Systems when evaluating new eClinical technologies.

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

2:15 Chairperson’s Remarks

Scott Sawicki, R&D Sourcing Consultant, Adare Pharmaceuticals

2:20 To Strategize or Not to Strategize: That is the Question!

Sawicki_Scott Scott Sawicki, R&D Sourcing Consultant, Adare Pharmaceuticals

Size does matter: in terms of volume, volume in terms of number of assets and planned studies within a given portfolio, which should definitely drive whether or not an outsourcing strategy is needed. The presentation will cover the different sourcing models, key differences in defining and developing a strategy in a large pharma vs a small pharma, what works well and not so well in both environments, and ways to deal with the adversity that may exist in both environments.

2:50 PANEL DISCUSSION: Considerations for Choosing and Implementing an Outsourcing Strategy

Stephens Rene Moderator: Rene Stephens, MSHS, President, Renatus Consulting, LLC

Dong_Hansu Panelists: Hansu Dong, Head, Technology Alliances, AstraZeneca

Kawaguchi_Ly Ly Kawaguchi, Senior Director, Head, Outsourcing and Procurement, MyoKardia

Tayyabkham_Reb Reb Tayyabkhan, Head, R&D Sourcing and Procurement, Merck

Copaescu_Anca Anca Copaescu, CEO, Founder, Clinical Maestro by Strategikon Pharma

Choosing, updating and implementing an outsourcing strategy is a daunting task with so many methodologies, business needs and resource needs to consider. Stakeholders in outsourcing will discuss key considerations for defining outsourcing needs, choosing an effective outsourcing strategy and implementing the strategy across the organization.

3:35 Decentralized Trials - Providing Patient-centric Services via Mobile Healthcare Providers

Adinamis_Gail Gail Adinamis, CEO, Founder, GlobalCare Clinical Trials

Industry is embracing the virtual/decentralized study model. Many benefits exist for patients, sites, sponsors and ultimately consumers. Learn how mobile healthcare providers play an important role and how to incorporate them into your decentralized study.

3:50 The Language of Collaboration - How to Maintain Oversight in a Complex Partner Environment

Darmer_Franciska Franciska Darmer, Global Head of Clinical, NNIT

When process and technology meet, our ability to define and communicate requirements outside the scope of the clinical trial becomes imperative. Learn from customer use cases the practical approach to setting up a collaborative framework, and how new technology once again shifts our foundation for collaboration. Going forward, in what way do we ensure a successful system of communication?

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)

(Co-Sponsorship Opportunities Available)

6:45 Close of Day

Day 1 | Day 2 | Download Brochure

Thursday, February 20

7:15 am Registration Open (Regency Rotunda)

7:45 Breakfast Presentation to be Announced (Regency Ballroom T)

8:15 Session Break

8:20 Chairperson’s Remarks

Mike Keens, COO, Firma Clinical Research

8:25 Being a Sponsor of Choice

Filling_Rosalie Rosalie Filling, Vice President, Clinical Operations, Research and Development, Endo Pharmaceuticals

This talk will be outlining what it takes to not only be a sponsor of choice for personnel joining your organization, but also for vendors and partners.

8:55 Investigator Payments: A Critical Component in Realizing Your Sponsor of Choice Strategy

Masessa_Geri Geri Masessa, Senior Resource Manager, Clinical Operations, Bayer Healthcare

Feedback from Bayer’s clinical sites delivered the news loud and clear: investigator payments were one of the most pressing and enduring clinical operations challenges. Investigator payment cycle times, payment transparency and traceability had a direct link to site satisfaction and retention. We will highlight the key initiatives undertaken to reduce the administrative burden associated with managing the site payment process in the US, and increase site satisfaction because of the improved payment transparency and accuracy of on-time payments. We will discuss how the implementation of a new investigator site payment solution will not only further Bayer’s sponsor of choice initiative by increasing site satisfaction, payment accuracy and cycle times, but will drive operational efficiencies within the company, and has already driven other departments to start their own sponsor of choice initiatives.

9:25 INTERACTIVE PANEL: Sponsor of Choice – Small Company, Different Needs, Same Desires

Kawaguchi_Ly Moderator: Ly Kawaguchi, Senior Director, Head of Clinical Outsourcing, Site Budgets/CTAs, and Business Analytics, Outsourcing and Procurement, MyoKardia

Robinson_Adrienne Panelists: Adrienne Robinson, Associate Director, Clinical Outsourcing, MyoKardia

Janet Pak, Senior Manager, Business Analytics and Resource Management, MyoKardia

White_Audrey Audrey White, Associate Director, Clinical Site Budgets/CTAs, MyoKardia

The panelists will share their perspectives on Sponsor of Choice and how they go about leading this effort within each function.

9:55 Embracing the Future in Research & Development Operations

Andy Greenberg, Accenture Leadership, Accenture

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

11:20 Chairperson’s Remarks

Debora Araujo, Founder & CEO, ClinBiz

11:25 Site Contracting Oversight Strategy for Outsourced Trials

Araujo_Debora Debora Araujo, Founder & CEO, ClinBiz

The right CRO or functional service provider (FSP) can be an excellent and strategic partner in helping sponsors have a wider and farther reach. This is no different when it comes to outsourced site contract negotiations. As the CRO/FSP is an extension of the sponsor’s brand and reputation, it is vital that study sponsors develop, execute and train on an appropriate oversight strategy for all outsourced work, including site contract negotiations, and apply it consistently. In this session, we’ll explore the main components of this site contracts oversight strategy.

11:55 CO-PRESENTATION: SPAR WARS*: The Sponsor Menace vs. The Revenge of the Site

Chan_Chris Chris Chan, Executive Director, R&D Finance, Fibrogen

Orantes_Carlos Carlos Orantes, CEO, Meridien Research

*(Site and Pharma Arguing Relentlessly). This will be a discussion on significant budgeting, contracting and payment issues within the site-sponsor relationship.

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Data Certainty from Source to Submission: Addressing Disparate Data Challenges with eSource

Andrus_Jonathan Jonathan Andrus, Chief Business Officer, Clinical Ink

Poor clinical trial data collection can delay decisions that help study stakeholders confidently move products to market. This presentation covers:

The benefits of direct data capture using eSource technologies
How eSource solutions improve data capture, access and interoperability
How eSource helps companies enable true risk-based and remote monitoring approaches
How ePRO and eCOA improve site and patient engagement
Why investing in a disruptive solution both decreases study cost and creates a new revenue stream

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

2:00 Close of Conference

Stay on and attend Part 2: Managing Outsourced Clinical Trials

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

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