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 (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)

CONSIDERATIONS FOR DEFINING YOUR SOURCING STRATEGY
Orlando L

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.


David Burnham, Senior Vice President, 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 CO-PRESENTATION: Global Site Payment Transformation

Murphy_JimJim Murphy, CEO, Greenphire


Joe Robbins, Senior Manager, Global Clinical Pricing & Payments, Amgen

Attend this joint presentation to learn how Amgen chose Greenphire’s eClinicalGPS to automate its site payments for a more transparent, reliable process that eliminated as many manual points of intervention as possible.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

MANAGING MIXED OUTSOURCING MODELS & THIRD PARTY SUPPLIERS
Orlando L

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?

Moderator: Melissa Bomben, Vice President, Key Account Management, Syneos Health

Hurst_MelissaMelissa Hurst, MBA, Clinical Outsourcing Manager, CSL Behring


Hansu Dong, Director, Outsourcing, MedImmune

Halbridge_AdamAdam 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 Biotech vs. Big Pharma Outsourcing Strategies in Practice

Scaife_RichardRichard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG)

A change in outsourcing strategies and practice are emerging from the increased funding available to Biotechs globally. Once forced to partner with Pharma early in the clinical development pathway due to financial and subsequent resource constraints, more Biotechs are now developing concepts into Phase II and beyond. Yet these often scientifically-led companies can lack the expertise to comprehensively develop and manage an outsourcing strategy and its implementation. This can increase sponsor dependency on CROs who are now acting as outsourcing managers on behalf of their smaller sponsors. Where is this trend heading and what are the implications in terms of strategy, budget and resource management in a constantly consolidating CRO marketplace?

Oracle-Health-Sciences 3:40 RFPs and Bids Slowing You Down?  New Strategies Can Help Speed the Outsourcing Process

Smiley JulieJulie Smiley, Senior Director, Life Sciences Product Strategy, Oracle Health Sciences

Outsourcing your trials to CROs can be difficult since each trial has its own set of assumptions, and RFP creation and management generally requires manual effort. Additionally, each vendor organizes tasks and resources differently, so evaluating bids is like comparing apples to oranges. These challenges can ultimately lead to study start delays and change orders because tasks were left out, misunderstood, or under-bid. What if you were able to significantly shorten your RFP and bid management cycle times? In this session, we will discuss not only how to gain efficiencies in your outsourcing processes, but also how you can determine the optimal outsourcing model for your trial and leverage industry intelligence for better negotiations.

 

BREAKOUT DISCUSSION GROUPS
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. See website for details: www.SCOPEsummit.com/breakouts.

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)

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

Delente_EricEric Delente, Head, Patient Consent, DrugDev, 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

EFFECTIVE SITE SOURCING
Orlando L

8:20 Chairperson’s Remarks

Katie Gaiek, Account Executive, Bio-Optronics

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

Quest-Diagnostics 9:55 Talk Title to be Announced

David Freeman, GM Ventures, Ops Admin/Clinical Data Support, Quest Diagnostics

Rich Franco, Vice President, Clinical Strategy, Quest Diagnostics

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

BECOMING A PREFERRED SPONSOR AMONG SITES
Orlando L

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 (Plaza International Ballroom)

2:10 Close of Conference

| Day 2 | SCOPE Final Brochure | Budgeting, Outsourcing, Supply Brochure

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

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


Signature Sponsors

IQVIA

Medidata

Oracle-Health-Sciences


Premier Sponsors

Appian
Axiom

BBK-Worldwide

Bioclinica_new

ClinicalInk

Covance

ERT
Mendel Health

PRA Health Sciences 
Saama-Technologies

Syneos Health

UBC_new

Veeva