The CRO –Sponsor Interaction

Regulatory Affairs

Chris Ingram BSc (Hons)

Director, Regulatory Affairs

OCT Europe – 17 May 2016

‘80s-90’s 2000s Mid 2000s-Present

Consolidation of service offerings:

• Clinical operations

• Biometrics

• Safety

• Laboratories: central,

bioanalytical, biorepository,

imaging

• Therapeutic expertise

• Quality assurance

• Regulatory affairs/study start-

up

• RWE/Late phase

• Medical devices

Risk-based sharing execution models

Expansion of service offerings:

• Project management

• Regulatory affairs

• Scientific affairs

• Medical affairs

• Medical writing

• Clinical operations

• Laboratory services

Adoption of preferred provider lists

by pharma/biotech

Limited service offerings:

• Data management

• Biostatistical analysis

• Clinical site monitoring

Primarily used as additional capacity

by pharmaceutical companies

CRO-Sponsor Interface Evolution

Physician Led | Therapeutically Focused2

Functional Service Provider Preferred Vendor Strategic Partnership

Keys to a Productive Alliance

Transactional: Tactical and

Episodic

Preferred: Tactical and

Repetitive

Partnering: Strategic and

Episodic

Integration: Strategic and

Holistic

Level of Collaboration

Level

of

CRO

Input

Physician Led | Therapeutically Focused3

Keys to a Productive Alliance

Trust Knowledge Collaboration

Physician Led | Therapeutically Focused4

The Vision is the Thing

Physician Led | Therapeutically Focused5

The CRO Regulatory Experience

Seamless Transitions• Across regions

• Throughout development cycle

Objectively Different Focus Up-to-Date Global Perspective

Therapeutic Target Expertise Broad Array of Regulatory

Expertise

Physician Led | Therapeutically Focused6

Key Factors for Positive CRO-Sponsor Relationships

The Sponsor

Shares

Thinking

Shares

Data

Shares

Objectives

Key Factors for Positive CRO-Sponsor Relationships

The CRO

Shares

Intelligence

Shares

Expertise and

Experience

Shares

Perspective

Embraces

the Sponsor

Objective

Physician Led | Therapeutically Focused8

Key Factors for Positive CRO-Sponsor Relationships:

The partnership

Develops Fully

Integrated

Development

Strategy

Communicates

Openly

Executes

with

Consistency

Physician Led | Therapeutically Focused9

Key Factors for Positive CRO-Sponsor Relationships

Regulatory Affairs

Global Understanding

Local Expertise

Technical Mastery

Physician Led | Therapeutically Focused10

What’s Coming – What’s Trending –What’s Challenging

Patient-Centered

Health Care

Outcomes, Surrogates and

Biomarkers

Fast-Track, Accelerated,

and Breakthrough

Novel Populations

Physician Led | Therapeutically Focused11

Early Engagement is Critical

Physician Led | Therapeutically Focused13

Thank you

Chris Ingram

c.ingram@Medpace.com