Understanding Risk-Based Monitoring – Pros, Cons & the Bottom Line

Thursday, August 7 2014
8:00 am – 10:00 am

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

The FDA has joined the growing consensus in the pharmaceutical industry that risk-based approaches to monitoring will help ensure subject protection and overall study quality.

How well do you understand risk-based monitoring?

In a recently issued Guidance, FDA now encourages sponsors to consider a change in approach to monitoring to risk-based approaches. 

Please join us to explore the implications and future of Risk Based Monitoring to your clinical programs. We will address such issues as:

  • What are the different approaches? 
  • What departments within your company will need to be involved in development? 
  • What are the regulatory implications?
  • Is this approach appropriate for all phases and all indications?
  • Is your company interested in taking this on and but you need to know how to get started? 

These questions and more will be answered by our panel of experts who have already faced these hurdles. Listen to a case study of how the approach was successfully implemented and what challenges were faced.  Bring your own questions and join us on August 7th to learn more.

Speakers:

  • Marc Buyse, Founder, CluePoints Inc.
  • Becky Carpenter, Vice President, Operations, ResearchPoint
  • Ken Light, EVP, Transformational and Professional Services, OmniComm

Moderator:

  • Kelly Blackburn, VP, Clinical Affairs at aTyr Pharma

This Forum is presented by the Biostatistics/Data Management/Clinical Trials Forum Working Group.

 

Bios

Kelly Blackburn, Vice President, Clinical Affairs, aTyr Pharma

Ms Kelly Blackburn has more than 20 years of experience in managing and leading clinical programs across a broad portfolio of innovative molecules.   Ms. Blackburn is currently Vice President, Clinical Affairs, for aTyr Pharma and is leading their efforts in bringing aTyr’s novel biology to the clinic.  Formerly, Vice President, Clinical Development Operations at Vertex Pharmaceuticals, where Kelly was responsible for the operational plans and strategy for the full product portfolio including two transformational programs, Kalydeco and Incivek.  Prior to Vertex, Kelly was Director of Clinical and Safety Operations at Millenium Pharmaceuticals where she was operationally responsible for their lead product, VELCADE.  Previous to this, she held several clinical operations roles of increasing responsibility at Genetics Institute and Bayer Corporation.  Ms. Blackburn received her B.S. in biochemistry from University of New Hampshire, MHA from Quinnipiac College and M.Ed. from Cambridge College.

Marc Buyse, Founder, CluePoints Inc.

Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He worked at the EORTC in Brussels and at the Dana Farber Cancer Institute in Boston. He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe. Marc currently lives in the Bay Area. His research interests include clinical trial design, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and meta-analysis (http://publicationslist.org/marc.buyse).

Becky (Causey) Carpenter, VP of Operations, ResearchPoint Global

Becky has over 23 years of experience leading teams within the CRO industry.  As VP of Operations at ResearchPoint Global, she is responsible for the Clinical Operations, Project Management, Data Management and Statistical service groups.  Prior to RPG, she was VP of Operations at INC Research where, in addition to leading the General Medicine and Women’s Health Division, her responsibilities included oversight for Project Management, Clinical Operations and specialty groups including study start-up, patient recruitment, and site contract management. Becky started her career at PPD where she held a succession of increasingly challenging roles including director level positions for several therapeutic areas, eventually serving as Executive Director of Project Management for the entire North American PM team.

Ken Light, EVP, Transformational and Professional Services, OmniComm

At OmniComm Systems, Ken oversees projects to support technology transfer, integration, training, migration and business process improvement for the global Life Sciences community.

Prior to joining OmniComm Systems, Ken oversaw similar clinical strategy and technology consulting practices for Oracle Corporation, BusinessEdge Solutions, and First Consulting Group.  For the past twenty years, Ken has delivered technology and business strategy services to the majority of top twenty pharmaceutical manufacturers, along with many smaller health and life sciences organizations. 

Mr. Light has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.

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