How to Develop and Manage Successful Sponsor-CRO/CMO Relationships Part I: Clinical Trials and Data Management

Tuesday, October 29 2013
8:00 am – 10:00 am

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

Please join us for the first of a two part Forum to hear industry experts discuss finding the right fit and building better Sponsor-CRO/CMO relationships from a clinical as well as a manufacturing perspective.

Outsourcing has emerged as a successful business model for numerous pharmaceutical companies.  Due to increased competitive and market pressures to contain fixed costs, all pharmaceutical companies are looking for ways to strategically increase their outsourcing capabilities and to augment their in-house resources.  To a large extent, these sponsor companies rely on outsourcing service providers more than ever to fulfill their tasks, solve their problems, and improve their efficiency and productivity. 

Typically a huge emphasis is placed on selecting the right CMO/CROs based on their costs, experience, technical expertise, and financial stability.  However, sponsors are also realizing that the key to long-term success in outsourcing depends on developing and maintaining effective and trustworthy relationships (e.g., transparency of information, better project management, avenues for issue escalation, etc.) with their CMO/CROs. 

Today’s panel will address Clinical Trials and Data Management.

Speakers:

  • Corey B. Dunham, Senior Vice President, Global Data Management, Aptiv Solutions
  • Rick Falzone, Director, Clinical Operations, Alnylam Pharmaceuticals, Inc.
  • Cindy Henderson, VP Operations, Veristat
  • Ross Pettit, Vice President Clinical Operations, AMAG Pharmaceuticals

Moderator:

  • Kathleen Kirby, Principal, Viridian Strategies

 

This Forum is presented by the Biostatistics / Data Management / Clinical Trials and CRO/CMO Forum Working Groups.

 

Speaker Bios

 

Corey B. Dunham, Senior Vice President, Global Data Management, Aptiv Solutions

Corey B. Dunham is the Senior Vice President of Data Management at Aptiv Solutions. He has over thirteen years’ experience in the CRO industry with over a decade at Aptiv Solutions. In his current position, Mr. Dunham oversees Global Data Management projects and activities, which encompasses Data Technologies, Clinical Data Management and Data Entry. He is responsible for a team of over one hundred Data Management professionals in 7 locations worldwide. In addition, Mr. Dunham serves as the senior member of Aptiv Solutions technology team responsible for the growth and development of AptivAdvantage™ The Integrated Technology Platform. 

Rick Falzone, Director, Clinical Operations, Alnylam Pharmaceuticals, Inc.

Rick has been working in the biotech industry since 2001 in roles of increasing responsibility and currently holds the position of Director, Clinical Operations at Alnylam Pharmaceuticals, Inc., a leading RNAi company based in Cambridge, MA. While at Alnylam, Rick has been overseeing early stage clinical trials using an outsourced model and preparing the team for entering Ph III in the near term. 

Rick’s interests lie in developing innovative drugs for rare diseases and has done so at 4 different biotech companies, 3 of which have taken candidates to Phase III.   

Rick has a Bachelor’s of Science in Microbiology from the University of New Hampshire and a Master’s in Public Health from Tufts University School of Medicine. 

Cindy Henderson, VP Operations, Veristat

Leading Executive Management Professional with over 20 years of drug development experience in Project Management, Operations, Information Technology and Finance.  Primarily concentrated on providing innovative functional and operational support to a diverse set of clinical studies across multiple therapeutic categories.  Key areas of operational expertise include the ability to lend deep insight into the sequence of events clinical studies take as they advance toward the goal of product regulatory submission, the ability to collaborate with sponsor companies in the design of medical product and drug development plans, managing the assessment of client needs, and outlining the required resources for clinical programs. Key contributor in all tactical strategic planning both within Veristat and within client projects. Prior to joining Veristat in 2007, served as Senior Manager of Training, Innovations and Processes at Averion International Corporation and as the Associate Director of Data Management at PAREXEL International Corporation.

Kathleen Kirby, Principal, Viridian Strategies

Kathleen has been in the biotech / biopharma industry for over 25 years and is a senior leader in Clinical Operations.  Most recently, Kathleen held the position of Vice President, Clinical Operations at bluebird bio, a Cambridge-based gene therapy company.  Her small but highly experienced team was responsible for the conduct of extremely complex clinical trials using ex vivo gene therapy delivered by stem cell transplantation.  Kathleen’s expertise also includes global clinical program management, both strategic and tactical implementation, personnel and team development, vendor out-sourcing, contract negotiation and regulatory interactions.  

Kathleen was a key contributor on the initial release of the DIA TMF Reference Model. Kathleen’s interest is primarily focused on supporting start up companies using novel therapies to treat rare diseases, with strong attention towards patient recruitment and process optimization.  Kathleen has returned to consulting, which is what she did prior to joining bluebird bio.  She has consulted for Shire HGT, Altus, Stromedix and other small start up companies.

Kathleen graduated from Rochester Institute of Technology with a bachelor’s degree in Biotechnology.

Ross Pettit, Vice President Clinical Operations, AMAG Pharmaceuticals

Ross Pettit has spent the past 25 years in drug development focusing primarily on clinical development operations.  He has been Vice President, Clinical Operations at AMAG Pharmaceuticals since April 2010 where he is responsible for the execution of all clinical trials globally, focused on novel therapies in Iron Deficiency Anemia. 

Prior to joining AMAG Ross was VP Clinical Operations with ARIAD Pharmaceuticals where he led the global clinical trial program for a novel oncology therapeutic. During his career Ross has held various positions in Biotech, Pharma and CROs at companies including Coley, Serono, Otsuka and Parexel working primarily in Clinical Operations, Regulatory Affairs, Data management, and Program management.

Ross received his M.B.A. in Healthcare management from the University of Phoenix and his Bachelors in analytical sciences from Kingston University in London.

Ross is interested in the areas of Quality by design, efficiency in drug development, and clinical business process, speaking regularly on these topics as well as outsourcing management, patient recruitment and retention, pharmaceutical development metrics, and global conduct of studies. He is an active member of the Drug Information Association and currently serves as a member of the DIA content advisory committee.

 

 

 

 

 

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