Posted by: Audrey Erbes | May 26, 2013

U.S. Clinical Trial Requirements Forecast to Change plus Events and Jobs


New Thinking on Clinical Development

Changes in the biomedical industry with the accompanying shifting of paradigms confront us now regularly. The new much higher pricing of many of the oncology and rare disease drugs which are now the focus of the biopharma R&D has become unacceptable to payers as the industry’s solution to making acceptable level of profits from smaller populations of patients. Pricing and reimbursement alongside the need for uniqueness in power of efficacy and safety take their place as preeminant in the funding of research and companies. The newer targeted therapies need to actually slow or stop chronic diseases and not just show a positive short-term benefit in the future. The cost of R&D under the old procedures, especially, the regulatory piece with the clinical requirements has made the traditional industry’s ROI unacceptable.

I’ve heard talk of having standing clinical trials with primary care docs in place that would be utilized by multiple companies to cut down on the cost of drug development. Now Janet Woodcock, MD, head of the FDA’s Center for Drug Evaluation and Research stated at recent Personalized Medicine Coalition conference, “We are going to have to change the way drugs are developed. Period.”

Clearly the accepted trial processes that accompanied blockbuster drug development and approval in the past are no longer feasible for treatment populations that are quite small. She was speaking specifically about clinical requirements for targeted personalized medicines but I wouldn’t be surprised if a reevaluation of the traditional drug development process isn’t reconsidered. Over the years, the requirements increased without adjustment–piling greater cost burden on companies.

Upcoming Meetings Week of May 26th

  • BioCentury This Week, See new program Webcast Starting Sunday, May 26, 2013, Available anytime starting at 9:00 a.m. EDT; Topic: Topic: “BioDefense Bulwarks: Did Billions Buy Safety?” Speakers: Dr. Robin Robinson, Director of the Biomedical Advanced Research and Development Authority (BARDA) and Dr. Luciana Borio, FDA Assistant Commissioner for Counterterrorism Policy and Director of FDA’s Office of Counterterrorism and Emerging Threats.
  • Bio2Device Group, Tuesday Morning, May 28, 2013; Topic: “Sleep Apnea”; Speaker: Nat Bowditch, founder and CEO of OrthoHub
  • Quintiles Webinar, Tuesday Morning, May 28, 2013; Topic: “Oncology Molecule Value Demonstration: The Shifting Sands of Stakeholder Expectations, and the Role of Real-World Evidence;” Speakers: Dr. John Doyle, Senior Vice President and Managing Director, Dr. Harish P. Dave, Global Medical Strategy Head, Hematology/Oncology and Transplantation, and Dr. Jean-Louis Merot, Senior Project Management Director at Quintiles
  • Silicon Valley LES Chapter Meeting, Wednesday, May 29, 2013; Topic: “Shhhh! It’s a (Trade) Secret – Trade Secrets in Licensing;” Panelists:Frank Bernstein, Partner, Kenyon & Kenyon LLP; Linda Rost, Partner, VLP Law Group LLP; Paul Stone, General Counsel and Chief Operating Officer, 5AM Ventures
  • Palo Alto AWIS, Wednesday Evening, May 29, 2013; Event: “Leadership Series: Public Policy, Service, and Leadership,” Speaker: Belinda Seto, Ph.D. Deputy Director, National Institute of Biomedical Imaging and Bioengineering
  • San Francisco State University, Thursday, May 30, 2013; Event: Personalized Medicine 6.0: Next Generation Sequencing for Targeted Therapeutics”
  • Triple Ring Technologies, May 30, 2013; Event: Technology Frontiers Symposium: Medical IT Networks and Connected Medical Devices

Next Upcoming UC Berkeley Extension Business and Marketing Courses

It’s not too late to sign up for my upcoming business development course which provides expert guest speakers in the trenches who influence the alliances, deals and collaborations process that are now critical to funding of new and ongoing biomedical companies. The classroom sessions are concentrated during two days with individual work on projects of student’s selection over two subsequent months with help of provided database resources graciously provided gratis by BioCentury and Deloitte Recap. I preach the value of hands on work to really incorporate the skills taught in the classroom into one’s own skill set or otherwise risk forgetting most of the knowledge conveyed. We know from adult learning theory that passive learning is not very effective versus active involvement this course provides.

  • UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; 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; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 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: $895, (EDP 405118). Register at

A subsequent intensive course in October focuses on how to do biomedical market and environment research in order to make more professional recommendations and decisions across all sectors and functions in the biomedical industry. The October course also provides the identification of online resources but also provides gratis access to selected Elsevier/Windhover resources.

  • 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 available in early August; Register at

You can download Audreys picks May 26, 2013 which includes all the details for this week’s meetings but also listing of meetings through next Oct. by right clicking on the highlighted title. I’ve provided Jobs That Crossed My Desk Through May 26, 2013 which includes the latest plus previous week’s jobs for your information. Again right click on the highlighted title to open the list in a new window. Share with colleagues who might find these useful. We all know someone who is looking for a position as the job market although much improved in the past year still hovers at 8%.






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