Cambridge Healthtech Institute’s 3rd Annual

Mastering an Outsourcing Strategy

Defining Your Sourcing Strategy & Ensuring Harmony between All Stakeholders

February 19-20, 2019


Understanding outsourcing needs and optimizing the selection process of vendors lays the foundation for an efficient, cost-effective clinical trial. Cambridge Healthtech Institute’s 3rd Annual “Mastering an Outsourcing Strategy” conference provides a new perspective on key considerations for defining an organization’s sourcing strategy. The 2019 program focuses on case studies and interactive discussions with Sponsors, CROs, suppliers, and sites on outsourcing strategy, working with third party suppliers, and effective site sourcing.

Final Agenda

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

Monday, February 18

9:00 am 7:15 pm Registration Open

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

6:157:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall

CONSIDERATIONS FOR DEFINING YOUR SOURCING STRATEGY

10:35 Chairperson’s Remarks

Charlotte French, Principal, CAF Consulting LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

10:40 Considerations for Defining Your Sourcing Strategy

French_Charlotte_02f_5x7Charlotte French, Principal, CAF Consulting LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

In today’s world of significant pressure to deliver cost effective clinical trials in a highly competitive and fast paced environment, biopharmaceutical companies face many competing influences in developing the appropriate sourcing strategy that appropriately balances risk, reward and cost. Understanding that small biopharmaceutical companies through mid-to-large size pharmaceutical companies have different requirements, this presentation will outline an approach to evaluating the various areas to consider when developing a strategic sourcing strategy. These include a deep dive into your organization to include an evaluation of the portfolio, review of current personnel, competencies, roles and responsibilities, and commitment across the entire organization to implement the sourcing strategy.

11:10 INTERACTIVE PANEL: Considerations for Defining Your Sourcing Strategy

French_Charlotte_02f_5x7Moderator: Charlotte French, Principal, CAF Consulting LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

Ratan Ratnesh, Director, Head, Clinical Outsourcing, Otsuka

Hansu Dong, Director, Outsourcing, MedImmune


Daves_JulieJulie VanOrsdel Daves, MSHS, Director, Clinical Contracts & Outsourcing, miRagen Therapeutics, Inc.


Swilley_JudyJudy Swilley, PhD, Executive Vice President, Head of Strategic Alliance Management, Syneos Health


Forsthoffer_EricEric Forsthoffer, Global VP, Business Development, Bioclinica


Drake_MaryMary Dixon Drake, CEO & Founder, Innovenn

Stakeholders from small, large and mid-sized pharma/biotech as well as their CRO and service provider counterparts will come together to discuss how to successfully meet their outsourcing needs. Topics to be discussed include:


  • Defining an organization’s sourcing strategy
  • How to successfully implement a new sourcing strategy

12:10 Harmonizing Clinical Partnership Strategy and Procurement for Better Delivery 

Mark Scullion, Executive Vice President, Strategic Resourcing, Clinical Solutions, Syneos Health

Innovative partnerships between sponsors, CROs and tech companies are often misaligned with standard procurement process, characterized by broad criteria and comparison measures. This can negatively impact clinical solutions development from the start. We’ll discuss how partners can work with procurement to move from the standard bid defense and single POC buying mold to make space for more expert level collaboration to deliver better value clinical solutions.

12:40 Transition to Lunch

Greenphire_horizontal 12:45 LUNCHEON PRESENTATION to be Announced

1:25 Coffee and Dessert Break in the Exhibit Hall

MANAGING MIXED OUTSOURCING MODELS & THIRD PARTY SUPPLIERS

2:05 Chairperson’s Remarks

Anca Copaescu, CEO, Strategikon Pharma

2:10 INTERACTIVE PANEL: How are Patient-Centric Trials Changing How the Industry Is Working with Third Party Suppliers?

Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics

Melissa Hurst, MBA, Clinical Outsourcing Manager, CSL Behring

Hansu Dong, Director, Outsourcing, MedImmune

Adam Halbridge, Principal of Digital Health, PRA Health Sciences

As clinical trials become more patient-centric, there is increased pressure on CROs to deliver specialized services that they currently don’t offer. This panel will address the following questions:

  • How are CROs addressing the demand for specialized services?
  • How are sponsors and CROs approaching the need for third party suppliers?
  • How are CROs aligning themselves with specialty vendors and niche providers?
  • Is this the new industry trend?
  • How is oversight and accountability of deliverables being handled?
  • What are some best practices and lessons learned when sponsors are outsourcing multiple services?

3:10 Managing A Mixed Outsourcing Model

Michael Carpenter, Associate Director, Strategic Partnering, UCB

Oracle_goBalto3:40 Sponsored Presentation to be Announced

 

BREAKOUT DISCUSSION GROUPS

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. See website for details: www.SCOPEsummit.com/breakouts.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent

Delente_EricEric Delente, President, Patient Consent, DrugDev, An IQVIA Company

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

EFFECTIVE SITE SOURCING

8:20 Chairperson’s Remarks

Chairperson to be Announced

8:25 An Outsourcing Manager’s Role in Site Contracting and Site Oversight

Trevor_JenniferJennifer Trevor, PhD, Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma

Outsourcing managers play a pivotal role in parlaying their knowledge, skills, and abilities to oversee the execution of site contracts facilitated by a CRO. As an integral member of the study team, and a triage point for the sponsor, the outsourcing manager provides the internal Astellas stakeholders with historical country or provision-related knowledge and risk to provide context for the stakeholder. This enables the stakeholder to provide rapid, compliant, and informed decisions to drive negotiations further. Tracking and trending site escalations allows the sponsor to improve template language and develop improved fallback language and positions. Finally, the outsourcing manager has the leverage of representing the sponsor in difficult negotiations for which the site and the CRO have reached an impasse.

8:55 INTERACTIVE PANEL: Ensuring Harmony between All Stakeholders – Sponsor, CRO, and Site – When Site Sourcing

Moderator: Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.

Trevor_JenniferJennifer Trevor, PhD, Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma


Orantes_CarlosCarlos Orantes, CEO, Accel Research Sites


Sullivan_LindaLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC


Natalia Grassis, Vice President, Clinical Operations, Parexel

Topics to be discussed:

  • Working with stakeholders on setting appropriate site budgets, site contracting, site identification, selection of sites, and site oversight/ management

9:55 Sponsored Presentation (Opportunity Available)

10:25 Coffee Break in the Exhibit Hall

BECOMING A PREFERRED SPONSOR AMONG SITES

11:20 Chairperson’s Remarks

Brett Kleger, Chief Commercial Officer, DrugDev, An IQVIA Company

11:25 INTERACTIVE PANEL: How Emerging Biotechs Can Compete with Big Pharma and Become a Preferred Sponsor Among Sites

Kleger_BrettModerator: Brett Kleger, Chief Commercial Officer, DrugDev, An IQVIA Company


Adam Simmons, Clinical Program Manager, Alkermes

Brenda Medina, Director, Development Science Business Operations, BioMarin

Jennifer Heckman, Senior Director, Clinical Trial Logistics, Incyte

This panel will explore how small to mid-size pharma and biotech can leverage technology to even the playing field between themselves and “big pharma.” The panel will demonstrate how an outsourcing model that employs best-in-class technology together with the CRO of choice can help attract research sites to their studies and in turn make them a sponsor of choice. Topics to be discussed include:

  • The different types of clinical trial technologies and service models for smaller organizations
  • What to look for when picking clinical trial technology
  • Client success stories and real-world examples of how technology helped them become a sponsor of choice

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Close of Conference

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

Register!

“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions
Novartis


Signature Sponsors

IQVIA

Medidata


Premier Sponsors