Posted by: Audrey Erbes | January 20, 2013

New U.S. Law to Speed Up Breakthrough Drug Development


As noted by Luke Timmerman in Xconomy, FDA actions speak louder than words. He covers a new regulation by FDA developed out of July legislation that encourages true breakthrough innovations in his blog entitled. He covers a new regulation by FDA developed out of July legislation that encourages true breakthrough innovations in his blog entitled “If You’ve Got a Real Breakthrough, the FDA Wants To Talk.” You can find the details on this new federal law at the FDA website.

Two companies have already applied for the breakthrough designation for two drugs and more will follow once the guidelines are developed. The FDA was instructed to prioritize reviews on such drugs based on July 9, 2012 law Food and Drug Administration Safety and Innovation Act (FDASIA). See section of law below as to intended impact of the designation.

“The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”

Check this comment on the new law by Woodcock on an FDA blog last month: “The new law is designed to get “breakthrough” therapies developed as quickly and safely as possible so they can be available to treat the patients who need them. We’re excited about it! In fact, although the law is only a few months old, we’re already putting it to use. Recently we identified the first therapy to receive this special designation. And it likely won’t be long before we have more. Several other drug developers have already made inquiries and there is lots of interest in the pharmaceutical industry in taking advantage of this new development tool.”

This new category joins the three programs used for many years to help speed up development of drugs under what were called “expedited drug development and review” programs. They include “Fast Track,” “Priority Review” and “Accelerated Approval.” See more at  This is encouraging as it harks back to moves in the 1990s when AIDS therapies were approved under the Accelerated Approval designation.

Highlights for Upcoming Meetings Week of Jan. 20

  • BioCentury TV Today, See new program Webcast Starting Sunday, Jan. 20, 2013, Available anytime starting at 9:00 a.m. EDT; Topic: “Winning in Europe: Biotech VCs See Upside;” Speakers: Dr Antoine Papiernik of Sofinnova Partners; Gilles Nobécourt of Edmond de Rothschild Investment Partners
  • Bio2Device Group, Tuesday Morning, Jan. 22, 2013; Topic: “Lean Drug Development Platform;” Speaker: Madhav Reddy, President, Maya Clinicals
  • Deloitte Recap Complimentary Webinar, Tuesday Morning, Jan. 22, 2013; Topic: The Deloitte Recap of 2012 Deals
  • VLAB, Tuesday Evening, Jan. 22, 2013; Topic: “Programming Nature: How Entrepreneurs are Transforming Synthetic Biology into Real Dollars?” Moderator: Megan Palmer, Deputy Director, Synthetic Biology Engineering Research Center (SynBERC) & Siebel Scholar and Researcher, Stanford University; Panelists: Dan Widmaier, CEO, Refactored Materials, Nathan J. Hillson, Founder & Chief Scientific Officer, Teselagen; Sasha Kamb, Executive Director, Amgen; Warren Hogarth, Partner, Sequoia Capital
  • BioScience Forum, Wednesday, Jan. 23, 2013; Event: “Trends in Life Science Venture Capital;” Speaker: Andrew J. Schwab, Founder and Managing Partner of 5AM Ventures
  • ASQ NCDG, Wednesday Evening, Jan. 23, 2013; Topic “Write Right”: Defensive Writing and Deposition Protection Avoiding Documentation, Email, and Deposition Problems”
  • ShareVault Webinar Series, Thursday Morning, Jan. 24, 2013; Topic: “Valuation of Your Drug Candidate;” Speaker: Linda Pullan of Pullan Consulting
  • The East Bay Association for Women in Science, Thursday Evening, Jan. 24, 2013; Event: “January Networking Event”
  • RAPS, Friday, Jan. 25, 2012; Topic: “Strategies for Developing a Successful 510(k)”
  • WIB-San Francisco Bay Area, Friday Evening, Jan. 25, 2013; Event: East Bay Speed Networking Event
  • NCC ACRP Annual Planning Meeting, Saturday Morning, Jan. 26, 2013

Reminder about Upcoming Life Science Product Marketing Course in Belmont

UC Berkeley Extension, Thursday Evenings, Feb. 14-28, March 7-14 and 28; Topic: “Life Science Product Marketing: It’s All in the Plan;” Instructor: Audrey S. Erbes, Ph.D.; Guest Speakers: Deb Donovan, Director of Marketing at Avantis Medical Systems – “e-Marketing: Connecting with Providers and Patients;” Christian Schuler, Partner, Simon Kucher – “Role of Pricing and Reimbursement in Product Management Strategic Planning;” Stanley Skrzypczak, M.S., M.B.A., Senior Director, Commercial Development, Genomic Health – “Product Management 101 – Developing/Executing The Tactical Plan;” Charles Versaggi, President, Versaggi Biocommunications “Building Value through Strategic Marketing Planning and Communications;” Steven Wong, Senior Consultant, Plan A “Market Research Information Resources;” Location: UC Berkeley Extension, 1301 Shoreway Road, Suite 400, Belmont, CA 94002. See more details and register at in early December.

Course Description: This science product marketing course introduces industry relevant product planning knowledge and skills required for successfully marketing life science products and, specifically, explores the development of strategic and tactical marketing programs for their launch. Topics include learning about different market research approaches; information resources critical for developing a successful plan, product strategy and positioning with differentiated claims; and how to identify the most lucrative target audience. Course activities include a team-developed preliminary marketing plan. See further details in LSProdMkt flyerspring2013.

I’ve provided the detailed listing of upcoming events Audreys picks as well as the latest listing of positions that have come to my attention in the past three weeks. See JobsThatCrossedMyDesk Jan20, 2013.



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