MA CRO/CMO: Improving Speed to Clinic Using External Sourcing
Friday, November 16 2012
8:00 am – 10:00 am
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA
How do you get your product from discovery to the clinic faster, and with less expense and risk?
How can CROs and CMOs enhance the R&D process?
Hear about strategies from experts with years of preclinical/clinical experience:
- Early Preclinical Biological Reagents
- Process and Analytical Development
- Quality and Regulatory Challenges
- Manufacturing and Operations
- Program Management
- Howard L. Levine, Ph.D., Founder, President, and Principal Consultant, BioProcess Technology Consultants, Inc.
- Teresa G. Cachero, Ph.D., Vice President, Alliance and Project Management, OvaScience, Inc.
- David Karakas, Principal Partner, Belvaros Group
Howard Levine has over 30 years of experience in successful product companies and as founder of BioProcess Technology Consultants, Inc., the leading CMC consulting group in the biopharmaceutical industry. Throughout his career, Dr. Levine has assisted in the development of over 20 different biological products and the successful commercialization of three of these products.
Dr. Teresa Cachero is Vice President of Alliance and Project Management at OvaScience, a life science company focused on the discovery, development and commercialization of new treatments for infertility. Dr. Cachero is a CMC specialist who, at Vertex Pharmaceuticals, participated in the development of KalydecoTM, VX-809 and VX-661 for the treatment of cystic fibrosis and in the development of VX-509 for the treatment of immune-related inflammatory diseases. Prior to Vertex, Dr. Cachero was a group leader at Altus Pharmaceuticals where she oversaw the development of ALTU-237 for the treatment of hyperoxaluria. Dr. Cachero also worked as a Scientist at Biogen Idec where she investigated tumor necrosis factor signal transduction pathways.
Dr. Cachero has previously worked at Vertex Pharmaceuticals, Altus Pharmaceuticals and Biogen Idec. Dr. Cachero received her Ph.D. in Biochemistry from the University of Valladolid (Spain) and completed her post-doctoral studies at Harvard University. Dr. Cachero has authored or co-authored more than 25 peer-reviewed scientific publications and is a named inventor on 4 issued U.S. patents.
David Karakas is a Principal Partner of Belvaros Group. Most recently, David served in a critical program management roles at Amgen, a major biotechnology firm. While at Amgen, he lead multiple sourcing work streams that included both direct and indirect categories from Research and Development to Operations and Sales and Marketing to Regulatory Support. As a result of his contributions to the organization, David was recognized, "as a leader critical to helping achieve Amgen's goals in support of our mission to serve patients" by Kevin Sharer, Amgen's Chairman of the Board and Ex-CEO. He also managed Amgen's North American Procurement Operations.
Prior to Amgen, he worked as a Lead Consultant with QP Group Americas serving multiple Fortune 500 clients. In addition to David's consulting background, he has held other key sourcing roles within the Novartis Institutes of BioMedical Research and Pfizer (formerly Wyeth). David's strategic sourcing background is complimented by his knowledge with enterprise-wide procurement platforms and tools such as Ariba Buyer, Ariba Contracts Workspace, SciQuest, and SAP.
David's entrepreneurial work ethic is complimented by his Masters degree (MBA) in Business from the F.W. Olin School of Business at Babson College.