How to Develop and Manage Successful Sponsor-CRO/CMO Relationships Part II: Manufacturing

Thursday, November 21 2013
8:00 am – 10:00 am

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

Please join us for the second 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 Manufacturing.

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

 

Speakers:

  • Joe Cobb CPIP, Director, Pharmaceutical Development, Metrics, Inc.
  • Ed Price, President, PCI Synthesis
  • Kirsty Shipulski, Director of Supply Operations, Vertex
  • Raymond Skwierczynski, Senior Director, Formulation Sciences, Millennium: The Takeda Oncology Company

Moderator:

  • Bhavishya Mittal PhD, Scientist II, Formulation Sciences, Millennium: The Takeda Oncology Company

 

Speaker Bios:

 

Joe Cobb CPIP, Director, Pharmaceutical Development, Metrics, Inc.

As Director of Pharmaceutical Development at Metrics, Inc. in Greenville, NC Joe is responsible for all aspects of solid oral dosage form development for fee-for-service clients that contract Metrics for early phase development and clinical trial material (CTM) manufacturing.  He has a staff of 10 specialists/scientists ranging in experience levels from 1 year to 35 years in the industry who work with external clients exclusively.  Joe has worked in the pharmaceutical industry for 21 years total and the last 11.5 at Metrics with previous experience coming from sites such as DSM and Sandoz (formerly known as Geneva Pharmaceuticals).

Joe was awarded with the Certified Pharmaceutical Industry Professional designation from the ISPE Professional Certification Commission in September, 2010.  He currently serves on that organization’s international Examination Development Committee, responsible for the construction of, vetting and maintenance of the actual examinations taken by candidates for certification.  He has also served on the East Carolina University Engineering Advisory Board since 2011.  Joe graduated from The Ohio State University with a bachelor’s degree in Chemical Engineering in 1992.

Bhavishya Mittal PhD, Scientist II, Formulation Sciences, Millennium Pharmaceuticals

Bhavishya Mittal is a formulation scientist at Millennium Pharmaceuticals Inc, Cambridge, MA.  Bhavi has earned a PhD in Materials Engineering from the Pennsylvania State University and a BS in Chemical Engineering from Regional Engineering College, Jalandhar (India).  Bhavi has 10 years of industrial experience in formulation and process development of various solid oral dosages of small therapeutic molecules (oncology, inflammation, and CNS indications) aimed for NDA and ANDA filings.  He is the author/co-author of 1 patent application, 10 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences.  He is an active member of various international professional societies such as AAPS and ISPE.  His research interests include formulation design, process engineering, scale-up and tech-transfer, and modeling of pharmaceutical unit operations for solid oral dosage manufacturing.

Edward Price, President & CEO, PCI Synthesis

Ed serves as President and Chief Executive Officer of PCI Synthesis (http://pcisynthesis.com/), a 12 year-old chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products.  With more than 20 years of experience in chemical operations, engineering, and cGMP manufacturing, Ed has grown PCI from a basic chemical manufacturer into the leading CMO that it is today. With a robust product pipeline, PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules and APIs used in generic pharmaceuticals.

Prior to founding the company, Ed served in numerous positions at several leading custom chemical manufacturers including ChemDesign and PolyOrganix (previously Borregaard Synthesis). He holds a B.S. in Chemical Engineering from the University of Massachusetts, Amherst.

Kristy Shipulski, Director, Supply Chain Management, Vertex Pharmaceuticals, Inc.   

Kristy has over 14 years of experience in Clinical Supply Chain.  In her current role, Kristy is responsible for forecasting, packaging and distribution of Investigational Medicinal Product for global clinical studies in phases 1-4.  Kristy received her BS in Biology from Tufts University and an MBA from University of Massachusetts Boston.

Raymond Skwierczynski, PhD, Senior Director, Formulation Sciences, Millennium: The Takeda Oncology Company

Raymond D. Skwierczynski, Ph.D. is Senior Director of Formulation Sciences at Millennium: The Takeda Oncology Company, where he is responsible for formulation and process development of small-molecule drug products from pre-IND to commercialization.  He is also leader of the CMC team for ixazomib citrate, an oral proteasome inhibitor that is in pivotal clinical trials.  Previously, he led Analytical Development-Small Molecules at Millennium and was responsible for leading an initiative for optimizing nonclinical development from discovery transition to proof-of concept.

He has previously worked in parenterals development in Baxter Healthcare (1984-87), materials characterization at Hoffmann-LaRoche (1994-96), and the Pharmaceutics and Analytical R&D Departments at 3M Pharmaceuticals (1996-2003).  Dr. Skwierczynski received B.S. degrees in chemistry and mathematics from the University of Wisconsin-Eau Claire and M.S. and Ph.D. degrees in pharmaceutics from the University of Wisconsin-Madison.  He received postdoctoral training in physical organic chemistry at UW-Madison as a PhRMA Foundation Fellow.  He taught courses on  preformulation and stabilization of pharmaceuticals at the University of Minnesota, where he was Adjunct Associate Professor in the Pharmaceutics Department, and through the University of Wisconsin Extension Services in Pharmacy.  In addition, he serves on the USP Expert Committee General Chapters – Dosage Forms, the Steering Committee for the AAPS Nonclinical Dose Formulation Analysis Focus Group, and the Executive Board for the Yankee Clipper Council, Boy Scouts of America.

 

Share MassBio

 

 

MassBio Golf Classic

BioProcess

EvaluatePharma