Do Niche CROs have a Role in Drug Development?

Transcription

1 Do Niche CROs have a Role in Drug Development? Dr Nermeen Varawalla, MD, DPhil (Oxon), MBA President & CEO ECCRO 1 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2

2 Role of Specialist CROs in Drug Development Agenda Definition and place in CRO Market Industry Analysis Sponsor s Perspective Best Working Practices 3 Segmentation of the CRO Industry Main Categories of CROs Large Full Service Global Over 75% Market Share Enjoy disproportionately large share of sector growth Annual Revenues range from $250M to over $1B Mid-Sized Approx. 15% Market Share At risk of being squeezed between two groups Annual Revenues range from $50M to $200M Niche / Specialist Less than 10% market share Highly fragmented, usually privately owned Include regional, therapeutic & functional specialists 4

3 Complexity of Drug Development is Increasing. Increase in Mean Number of diagnostic procedures performed per subject Driven by regulatory need to enhance pharmacovigilance quest for improved efficacy and outcome data Global reach escalating Spend per accrued subject increasing 5 In the Post Credit Crunch Environment Imperative to enhance the cost effectiveness of drug development is huge. Real pricing pressures and competition amongst CROs. William Blair and Company, LLC, April Survey of 19 biopharmaceutical sponsors 6

4 Sponsors want more for less from their CROs CROs able to meet sponsor expectations are valued and rewarded. William Blair and Company, LLC, April Survey of 19 biopharmaceutical sponsors 7 Engaging a Specialist CRO Common Reasons for Selecting a Specialist / Niche CRO Expertise in a geographical region Strength in a function Relationships with leadership Track record of delivery Innovation and consistent quality However, Fragmented market with a handful of leading players More than 30% of respondents have no experience with niche vendors Consistent usage is rare William Blair and Company, LLC, April Survey of 19 biopharmaceutical sponsors 8

5 Engaging Niche CROs: Customer Views Large Pharma Mixed Resourcing: in house + full service preferred provider Growing aversion to change orders Recognise and value specialist expertise Expect large CRO to subcontract as needed Virtual Model Limited in-house project / vendor management resource More personalised & better service from similar sized vendor, hence opt for mid-sized Cash available for high value projects, but must be wisely deployed Big is not always beautiful ECCRO survey of 6 sponsors, August The role of Specialist CROs What do Specialist / Niche CROs offer? Best in class expertise in a region or function Customised, flexible service Engagement of experience Potential to innovate and be creative Drug development today needs big and small vendors How best to work with Specialist / Niche CROs? Provision for resource cost for multiple vendor management Niche CROs must fit in with big, global player Clear and consistent value delivery 10

6 Questions.. Dr Nermeen Varawalla, MD, DPhil (Oxon), MBA President & CEO ECCRO London, UK Tel: