FDA's, Dr Richard Moscicki Confirmed and Dr David Schenkein, CEO, Agios to Keynote the Boston Chief Medical Officer's Summit
New York, New York (PRWEB) April 08, 2015 -- The Chief Medical Officer's Summit for Biotechs announced today that FDA's Dr Richard Moscicki is confirmed to address an audience of CMOs on the unique regulatory challenges in the emerging biotech space. Together with Dr Thomas Lonngren, former head of the EMA, they present trends and case examples on breakthrough designation, fast track, priority review, orphan designations, accelerated approval, EMA’s pilot project on adaptive pathways, and other initiatives to early access to medicines.
Agios CEO, Dr David Schenkein is confirmed to keynote. “Dr Schenkein joins the Boston Chief Medical Officer Summit not only to share his story, but to provide insights and guidance on overcoming development barriers, prioritizing resources and withstanding hostile takeovers while leading R&D efforts,” said Jennifer Moran, Conference Producer, CMO Summit.
Dr Schenkein’s name rose to the top of recommendations for his insights into his journey from physician to CEO, which has been featured in Fierce, The New Yorker, The Street, Xconomy to name a few. The Boston Business Journal called Agios one of the “strongest biotechs to go public last year.”
Ken Getz, Director of Sponsored Programs, Tufts CSDD also joins CMO Summit to present his annual address on characterizing the high capitalized cost of drug development and the critical drivers of R&D inefficiency. His address will cover:
• Tufts CSDD’s new R&D cost study results
• Root causes of inefficiencies, low success rates and high costs
• Major strategies and operating models transforming the R&D paradigm
• The value proposition, impact and challenges of these strategies and operating models
“When we ask CMOs for speaker recommendations, Ken Getz always gets highly recommended because he truly understands the challenges in drug development for smaller pharmas,” said Valerie Bowling, Executive Director, CMO Summit.
Moscicki, Schenkein and Getz are joined by CMOs from Spectrum Pharmaceuticals, Wilson Therapeutics, Avaxia Biologics, Inc. Genocea Biosciences, SFJ Pharmaceuticals Group, G1 Therapeutics, Retrophin, Momenta Pharmaceuticals, Deciphera Pharmaceuticals, and Cara Therapeutics. Together they share best practices in:
• Driving company value
• Navigating the clinical and regulatory pathways
• Supporting business development
• Managing the expectations of the CEO and board
• Providing strategic insights in corporate investments
• Managing outsourcing
• Medical affairs and safety across therapeutic areas
• Transitioning company growth to include staffing, culture and organizational structure
• Preparing for exits
About the Chief Medical Officer Summit:
The Chief Medical Officer Summit is in thanks to the vision of Dr. Elizabeth Stoner of MPM Capital about the need for a forum specific to CMOs of small to mid-sized biotechs. The summit aims to address the unique challenges of these Life Science CMOs and to form a community where they can share ideas, solutions and support.
About The Conference Forum:
The Conference Forum has a very specific focus – developing specialized events both public and private as well as research groups and advisory boards for professionals in the life science industry. Its mission is to create the best content in an ideal forum for the exchange of ideas among peers and networking for Pharmaceutical and Biotech professionals. See more at: [http://theconferenceforum.org/
Jessica Rothenberg, The Conference Forum, http://www.theconferenceforum.org, 646-490-2712, [email protected]
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