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

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

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Morning Opening Plenary Keynotes

9:40 Grand Opening Coffee Break in the Exhibit HallHighthink_Med

UPDATING OUTSOURCING STRATEGIES IN A CHANGING LANDSCAPE

10:40 Chairperson’s Remarks

Todd Reul, Associate Director, Global Strategic Sourcing, BioMarin Pharmaceutical Inc.

10:45 How Evolving Technology Influences Sourcing Strategy

Tayyabkham_RebReb 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 Leveraging Category Management to Inform Clinical Outsourcing Strategy

Reul_ToddTodd Reul, Associate Director, Global Strategic Sourcing, BioMarin Pharmaceutical Inc.

This presentation will explore the what and why of Category Management and meeting the needs of all stakeholders, from operations, finance, and compliance to legal and executive management. We’ll discuss the relationship to Strategic Sourcing and how Category Management informs Clinical Outsourcing strategy by defining and prioritizing service categories, examining elements of a holistic Category Management Plan and exploring synergies with Supplier Management.

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

Scaife_RichardRichard 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_EleanoreEleanore Doyle, Executive Vice President, FSP Strategic Solutions, Syneos Health


Williams_ShaunShaun Williams, Executive Director of 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 Presentation to be Announced

1:20 Coffee and Dessert Break in the Exhibit Hall

CONSIDERATIONS FOR CHOOSING AND IMPLEMENTING AN OUTSOURCING STRATEGY

2:15 Chairperson’s Remarks

Gretchen Voolich, Associate Director, R&D External Operations, R&D Quality, Operations & Performance, Biogen

2:20 PANEL DISCUSSION: Considerations for Choosing and Implementing an Outsourcing Strategy

Ratnesh_RatanModerator: Ratan Ratnesh, Director, Head, Clinical Outsourcing, Otsuka


Dong_HansuPanelists: Hansu Dong, Director, Outsourcing, AstraZeneca


Kawaguchi_LyLy Kawaguchi, Senior Director, Head, Outsourcing and Procurement, MyoKardia


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


Copaescu_AncaAnca 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.

3:50 Talk Title to be AnnouncedGlobalCareClinical Trials_no_tagline

Adinamis_GailGail Adinamis, CEO, Founder, GlobalCare Clinical Trials


4:05 Sponsored Presentation (Opportunity Available)

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

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 (Sponsorship Opportunity Available)

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

REALIZING YOUR SPONSOR OF CHOICE STRATEGY

8:20 Chairperson’s Remarks

Mike Keens, COO, Firma Clinical Research

8:25 Being a Sponsor of Choice

Filling_RosalieRosalie 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_GeriGeri 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_LyModerator: Ly Kawaguchi, Senior Director, Head of Clinical Outsourcing, Site Budgets/CTAs, and Business Analytics, Outsourcing and Procurement, MyoKardia


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

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

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

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

9:55 Presentation to be Announced

 

10:25 Coffee Break in the Exhibit HallAris-Global

NAVIGATING SITE SOURCING AND CONTRACTING

11:20 Chairperson’s Remarks

Debora Araujo, Founder & CEO, ClinBiz

11:25 Site Contracting Oversight Strategy for Outsourced Trials

Araujo_DeboraDebora 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_ChrisChris Chan, Executive Director, R&D Finance, Fibrogen


Orantes_CarlosCarlos 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_JonathanJonathan 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 HallBioTelResearch

 

2:00 Close of Conference


Stay on and attend Part 2: Managing Outsourced Clinical Trials

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday 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

INTERACTIVE BREAKOUT DISCUSSION GROUPS

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