Cambridge Healthtech Institute's 2nd Annual

Mastering an Outsourcing Strategy
( アウトソーシング戦略の確立 )

Making Meaningful Changes to Outsourcing Strategy & Vendor Selection
アウトソーシング戦略とベンダーの選定方法に関する有意義な変革の推進

2018年2月13-14日 | Hyatt Regency Orlando | フロリダ州オーランド

 

アウトソーシング戦略の確立をテーマにしたこのカンファレンスプログラムでは、ベンダーの選定プロセスと課題についての新たな見方が示されることになっており、標準的なベンダー選定プロセスの再検討を通じ、協力関係にある治験依頼者とベンダー双方の側で効率を高めていくための手がかりを得ることができます。

 

Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:30 - 8:30 pm SCOPE's Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall

OUTSOURCING TRENDS & STRATEGY: WHERE ARE WE HEADED?

10:45 Chairperson's Remarks

Charlotte French, Executive Director, Outsourcing & Contracts, Medical and Development, Astellas

10:50 Outsourcing Revolution: Where We Were to Where We Are

Ian_LaufIan Lauf, Head, Clinical Business Operations, Shionogi, Inc.

As clinical trials and outsourcing become more expensive, many in the pharma industry are evaluating their outsourcing practices. This presentation will discuss current outsourcing trends, what is affecting outsourcing trends, and where we are headed as an industry.


11:15 CO-PRESENTATION: Sourcing Model Considerations

Ratan_RatneshRatan Ratnesh, Director & Head, Clinical Outsourcing, Otsuka

David Freschi, Senior Director, R&D Procurement and Clinical Outsourcing, Regeneron

This presentation will focus on an approach to assessing and developing which sourcing model is right for your organization. We will define what a Sourcing Model is and how companies come to arrive at their current state. Then we will review sourcing options, considerations, and implications both on a functional level and organizational level. We will review the importance of assessing core competencies as well as a thorough market analysis. Then conclude with how all the pieces fit together to form a sourcing model that best fits your organization.

12:05 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Coffee and Dessert Break in the Exhibit Hall

MAKING MEANINGFUL CHANGE TO THE VENDOR SELECTION PROCESS FROM RFI TO BID DEFENSE

2:00 Chairperson's Remarks

Charlotte French, Executive Director, Outsourcing & Contracts, Medical and Development, Astellas

2:05 A Nimble, Rapid Approach to the RFI to Bid Defense Process

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

The RFI to bid defense process is notoriously time consuming and resource intense. One biopharmaceutical company presents their streamlined strategy for efficiently moving through the RFI to bid defense process while involving key stakeholders at every step and remaining nimble without sacrificing quality.

2:30 PANEL DISCUSSION: Request for Information (RFI) to Bid Defense - How Do Pharma and CROs Obtain the Most Value during This Process?

Moderator:
Charlotte_FrenchCharlotte French, Executive Director, Outsourcing & Contracts, Medical and Development, Astellas


Panelists:

Frank Carnevale, Senior Outsourcing Lead, Takeda

Chris_RullChristopher Rull, Principle Consultant, CR Consulting, LLC; Former Vice President, Head of Business Development & Account Management, UBC


Jeff Van Noy, Vice President, Global Proposal Development and Business Information, ICON

Jay Zinni, Associate Director, Procurement, Incyte Pharmaceuticals

Today this is a very time consuming and resource intense activity at both Pharma and CROs. This panel discussion will be focused on how we jointly become more innovative in approaching these activities. We will explore:

  • How to develop the most effective RFI to deliver the key information required to determine which CROs are short-listed for the Bid Defense meeting
  • How Pharma/CRO determine the participants at the Bid Defense meeting
  • What are the key deliverables for a CRO at a Bid Defense meeting?

3:20 Sponsored Presentation (Opportunity Available)

BREAKOUT DISCUSSION GROUPS

3:50 Find Your Table and Meet Your Moderator

4:00 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. 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.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: A New Way to Pay: SaaS Technology and Outsourcing How You Need It

Stuart Thiede, President, Payments, DrugDev


8:15 Session Break

UNDERSTANDING THE OUTSOURCING FUNCTION & YOUR CHOSEN SUPPLIERS

8:25 Chairperson's Remarks

8:30 Outsourcing versus Procurement: Is There a Difference?

Charlotte_FrenchCharlotte French, Executive Director, Outsourcing & Contracts, Medical and Development, Astellas

Today it can be difficult to navigate the various functions within Pharma, in particular relating to the roles and responsibilities of Outsourcing functions versus Procurement functions. In some instances, these are combined, but are there differences? And, if so, what are these? We will explore the advantages and disadvantages of separating these two functions within Pharma and review differences in the skill set that they should offer to an organization. Additionally, we will review how these functions work together, or in some instances, incorporate the vendor oversight responsibilities that are required under ICH E6. We will also discuss CRO's response to the ICH E6 guidelines when providing third party contracting and oversight for additional services.

8:55 A Small Company Perspective on Outsourcing

Maria Makarovskaya, Director, Clinical & Strategic Sourcing, Tesaro (tentative)

CONSTRUCTING YOUR CONTRACT FOR MAXIMUM BENEFIT

9:20 Contracting with CROs to Optimize Working Relationship and to Guarantee On-Time Study Starts

Rick_OHaraRichard O'Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

This presentation will focus on the best strategies to ensure a smooth study start from a contracting perspective. It will address agreement construction and helpful terms. Also addressed will be optimal lead times as well as governance and communication strategies.


9:45 Three Key Elements to Operationalizing CRO Oversight: A Sponsor's Story

Rick_MorrisonRick Morrison, Co-Founder and CEO, Comprehend Systems

Learn how a leading sponsor revolutionized its relationship with its CROs. Understand the best practices they put in place to continuously manage study quality and achieve milestones on-time and on-budget across their portfolio of trials. This, combined with real-time data delivery, enabled them to expand their portfolio of trials and build new relationships with more CROs, all at the same rapid pace of business.

10:10 Coffee Break in the Exhibit Hall

CONSTRUCTING YOUR CONTRACT FOR MAXIMUM BENEFIT

11:10 Chairperson's Remarks

11:15 PANEL DISCUSSION: Resource Allocation and Its Effect on Contracting between CROs and Sponsors

Greg_SkalickyGreg Skalicky, Chief Enterprise Business Officer, inVentiv Health


Ratan_RatneshRatan Ratnesh, Director & Head, Clinical Outsourcing, Otsuka

David Freschi, Senior Director, R&D Procurement and Clinical Outsourcing, Regeneron

Tara Dubois, MBA, Head, Clinical Trial Cost Management, Business Operations, Pfizer

Procurement, contracting, and clinical operations teams need transparency with their CRO partners in order to properly understand a CRO's allocation of resources and costs, especially when contracting key deliverables. This panel will address, from the Sponsor's and CRO's perspective, resource allocation considerations during the contracting process: potential challenges, what CROs wish pharma knew, and pitfalls to avoid.

12:05 pm Session Break

12:10 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


 

2018 SCOPE Conference at a Glance


* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)



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