DIA 2016 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Genentech Research and Early Development (gRED), in partnership with two CROs, has created a novel outsourcing model. This forum will detail the gOVERN model in the areas of partnership, operations, contracting and governance.

Learning Objectives

Discuss the partnership build and structure for the gOVERN model in Genentech Research and Early Development (gRED); Share key structure, learnings and innovation for this novel partnership which promotes transparency, cross-company commitments, and therapeutic-area program-level allocation.

Chair

Hilary Nelson

Speaker

Panelist
Margaret Taylor

Panelist
Jami Norris, MS

Panelist
Kerryn Cress

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the value that can be gained from alliances built between a large global CRO and small or emerging biopharmaceutical companies. Attendees will learn what both the CRO and the biopharmaceutical company must do to build a successful alliance and how to diagnose early on what is needed for a collaborative alliance culture.

Learning Objectives

Identify what large CROs and small biopharmaceutical companies must do to successfully build an alliance with each other; Explain how to build a collaborative alliance culture and what the key questions that must be asked to determine if two companies will have good “chemistry”; Discuss meaningful and effective risk-sharing strategies.

Chair

Solomon Babani, MBA

Speaker

Applying Alliance Management Principles to Help CROs Build Successful Relationships with Small and Emerging BioPharma Companies
Solomon Babani, MBA

New and Emerging Skillsets Needed to Manage Strategic Partnerships
Andrew Townshend

Panelist
Deirdre F BeVard

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The session provides an overview of outsourcing models for regulatory activities to achieve a scalable, flexible model, while decreasing the complexity of internal regulatory affairs activities and assuring full regulatory compliance. Both industry and consultant company perspectives will be shared.

Learning Objectives

Describe the benefits of outsourcing of regulatory activities to allow focus on core strategic aspects of the company; Recognize different models of outsourcing of regulatory activities and how to best apply them to your own business; Identify the key success factors to ensure cost efficient and compliant outsourcing.

Chair

Andrew S. Verderame

Speaker

Regulatory Outsourcing: Consultant Perspective
Andrew S. Verderame

Regulatory Outsourcing: Industry Perspective
Dietmar Boecker, PhD

Outsourcing Life Cycle Management: A Model of Efficiency
Alistair Davidson

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss the concept that there is no agreed upon or standardized approach to outsourcing pharmacovigilance. Other industries use the safety case model so vendors present a common model for sponsors to examine and the latest thinking will be applied to pharmacovigilance outsourcing.

Learning Objectives

Discuss a more standardized approach to outsourcing pharmacovigilance; Identify a common model for pharmacovigilance outsourcing.

Chair

Brian David Edwards

Speaker

Pharmacovigilance Sourcing, Emerging Business Models
Kelly Traverso

Pragmatic Approach to Pharmacovigilance Outsourcing
Lillian M. Kirk, DrSc

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Outsourcing has been a major topic in the pharmaceutical industry over the last decade. As drug development costs increase, trial complexity grows, and work in emerging markets becomes more important, the industry has looked toward outsourcing to help combat these challenges. But what impact has the rising proportion of outsourcing had on operational performance? How is the effect being measured or tracked? This panel will explore the dynamic between CROs and sponsors and their expectations, the operational benefits of outsourcing, as well as the challenges from outsourcing. It will examine performance and the crucial factors that influence internally-conducted trials versus outsourced trials, how these differences are being managed, and what changes have occurred over time.

Learning Objectives

Recognize the operational benefits and challenges of outsourcing clinical trials; Classify the different approaches to outsourcing and the strategic trade-offs.

Chair

Scott R Martin, JD

Speaker

Creating an External Alliances Structure
John F. Kurtz

How Real World Research Challenges Outsourcing Strategies
Michael George Minor

Controlling Study Level Budgets with CROs
Michael Williamson, MSc

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will present data on industry challenges/opportunities for improvement in sponsor oversight of CROs and service providers. Collaborative efforts for developing and implementing industry leading practice guidelines and tools will be shared.

Learning Objectives

Discuss the oversight requirements and expectations from regulators, sponsors and providers; Explain the collaborative effort to develop and utilize industry leading practices for the oversight of outsourced clinical programs; Demonstrate examples of vital guidelines and tools for achieving top-tier success through appropriate oversight practices.

Chair

Mike Collins, PhD

Speaker

Panelist
Grace M Crawford, MS

Panelist
Joseph Anthony Fortunato

Panelist
Steven B. Whittaker

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will present data on industry challenges related to prequalification of technical service providers. Industry leading initiatives to standardize requirements and processes, and regulatory, sponsor and provider perspectives will be shared.

Learning Objectives

Identify risks, challenges, issues and industry dysfunction related to prequalifying technical service providers; Describe new industry standards/processes/approaches for prequalification of technical providers; Explain sponsor/provider/regulator perspectives regarding implications for standardizing and centralizing prequalification to ensure high quality, efficiency and confidence in processes and results.

Chair

Dawn M Niccum, BSN, MS, RN, PMP

Speaker

Panelist
Marta Haley Fields, MBA

Panelist
Mitchell A. Katz, PhD

Panelist
Dennis Salotti, MBA, MS

Panelist
Sean Y. Kassim, PhD

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

With ever increasing rates of outsourcing and new outsourcing models being created, pharmaceutical companies are seeking new ways to collaborate with CROs. Whether its data, documents, team collaboration, etc., sponsors and CROs need easier ways to communicate. We will discuss how to solve these challenges.

Learning Objectives

Discuss how to efficiently collaborate with CROs; Explain how to easily understand study metrics and status for a fully outsourced portfolio; Describe how to utilize a CTMS to collaborate between sponsors and CROs.

Chair

Matthew J. Kiernan, MBA

Speaker

Optimizing Collaboration Between Sponsors and CROs Using CTMS in Today's eClinical Landscape
Lynn Fraser, MS

Outsourcing and the Clinical Data Mess, and Why It Isn’t Acceptable
Matthew J. Kiernan, MBA

Building an Integration Platform for Collaborating with CROs
Jennifer Bush, MS

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

A moderated panel of phase 1 clinical research experts, representing sponsor, CRO and site perspectives, will identify and discuss several hot button issues that can provoke conflict between sponsors and sites or diminish conduct efficiency. Attendees will be invited to join in.

Learning Objectives

Recognize issues that can provoke sponsor/site conflict or diminish conduct efficiency when they arise in the course of preparing to conduct or conducting phase 1 studies; Discuss how to handle such issues with counterparts when they arise; Describe ways to formulate/negotiate when issues resolution.

Chair

Gary L. Steinman, MS

Speaker

Tales from the Front Lines: An Introduction
Gary L. Steinman, MS

Panelist
William B Smith

Panelist
Mary L. Westrick, PhD