Posted by: Audrey Erbes | September 8, 2013

Market Success Requires Breakthrough Products Plus Events and Jobs

The cost of innovation of life science products is closely associated with regulatory requirements along with other factors, such as, the waste in development research by big corporate players. Pharma, diagnostic and medical device companies have all learned the lesson that breakthrough products are required today to get the pricing and reimbursement they want and need, and that modest improvements won’t cut it any longer. They have recognized that lean biotech companies get more results for their dollars spent.

A major change at the FDA in providing pathways for speeding up the approval of breakthrough drugs will help lower the costs of drug development based on regulatory hurdles. Now there’s the need to insure that the pathway for breakthrough diagnostics is also modernized to help bring these new drugs to market.

See BioCentury This Week for more on this important topic.

Highlights of The Coming Week’s Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday, Sept. 8, 2013, Available anytime starting at 9:00 a.m. EDT; Topic: “Saving Diagnostics: Breakthroughs Needed;” Speakers: Dr. Jeff Allen, Executive Director of Friends of Cancer Research; Kate Claessens, R.N., Senior Director of Health Policy and Reimbursement at Roche Diagnostics; Dr. Robert McCormack, Head of Technology Innovation, Janssen Diagnostics and Dr. Sheila Taube of ST-Consulting, former Associate Director of the NCI Cancer Diagnosis Program
  • NHLBI, Tuesday, Sept. 10, 2013; Event: “NHLBI Regional Innovation Conference”
  • Medical, Marketing, Media Free Webcast, Tuesday Morning, Sept. 10, 2013; Topic: “Using Analytics to Maximize Copay Program Effectiveness;” Featured speakers: Paul LeVine, Vice President of Analytic Services, TrialCard
  • Bio2Device Group, Tuesday Evening, Sept. 10, 2013; Topic: “The Implantable, Bioartificial Kidney;” Speaker: Shuvo Roy, PhD, Professor, University of California, San Francisco, Department of Bioengineering and Therapeutic Sciences (BTS), a joint department of the UCSF Schools of Pharmacy and Medicine; Director, Biodesign Laboratory and Director, The Kidney Project
  • SF AWIS, Wednesday Evening, Sept. 11, 2013; Topic: “Science and Consulting: A Panel Discussion;” Panelists:  Johanna Lang, PhD, CMC Consultant, Lang Consulting, Inc; Catherine Magill, PhD, Preclinical Pharmacology Consultant and Medical Writer, Magilla Consulting; Lynne Sopchak, PhD, Scientific Analyst/ Consultant, HighTech Business Decisions; Rohini Mehtani, PhD, Manager, Pipeline and Portfolio Planning, Genentech
  • TIE, Thursday Evening, September 12, 2013; Topic: “The Role of Big Data in Healthcare;” Moderator: Justin Graham, Chief Innovation Officer, Healthcare, Hearst Business Media; Panelists : Darren Schulte, M.D., M.P.P., President; Apixio, Inc; Scott Clarke, VP & GM, Life Sciences and Healthcare, Saama Technologies; Jonathan Palma, MD, MS, Assistant Professor of Clinical Neonatology, Stanford University/Medical Director of Clinical Informatics, Packard Children’s Hospital

Next Upcoming UC Berkeley Extension Business and Marketing Courses

  • UC Berkeley Extension Course, Thursday and Friday, Oct. 3-4, 2013; Course: “Life Science Business and Marketing: Their Integral Role for Success,” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and blog; Guest Speakers: Joyce Chiarenza,  Regulatory Consultant; Linda Schock, Director, Commercial Compliance and Government Programs, CIS; Bev Hudson, MBA, Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research; Julie Tompkins, MBA, Sr. Vice President, Timely Data Resources, Inc. Dates and Time: Thursday and Friday, Oct. 3-4, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $795, online registration now available; Fee: $795, course ID is BUS ADM X442.4; Register at
  • UC Berkeley Extension Course, Thursday and Friday, Dec. 5-6, 2013; Course: “Life Science Business Development,” (formerly known as Biotechnology Business Development); Lead Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and blog; Guest Speakers: Allison Dupuy, Ph.D., is a Senior Director in the Life Sciences division of Simon-Kucher & Partners; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP’s intellectual property practice group; Chris Dokomajilar, Deal Operations Manager at Recap LLC; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Cost: Fall term—fee: $895, (440.8-001). Register at

You can download all the details for these Audreys picks Sept 8, 2013 plus those through Jan. 2014 as well as Jobs That Crossed My Desk Through Sept. 8, 2013 by right clicking on the highlighted titles. This latter list includes jobs I discovered this past week as well as the previous two weeks.


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