Exchange Ideas
BIOCOM is consistently working to keep its members abreast of current trends and issues impacting their business as well as expanding members’ professional network through our more than 100 networking opportunities annually. It is via these events that we are able to provide a supportive environment to facilitate technology convergence that will assist our medical device, diagnostic, biotechnology and pharmaceutical member companies to continually increase their technology synergies to fill their pipeline. BIOCOM’s event programming includes intimate events targeted at specific life science professionals as well as large scale events that bring together the Southern California industry as a whole.
If you are interested in sponsoring a BIOCOM event, please contact Shaye Exner.
Past Event Information
On August 26th, 2010 BIOCOM hosted a program featuring information about the latest National Cancer Institute (“NCI”) Small Business Innovation Research (SBIR) & Small Business Technology Transfer (“STTR”) funding opportunities.
There are many benefits to applying for NCI SBIR & STTR funding opportunities, such as:•SBIR & STTR awards provide recognition, verification, and visibility•SBIR & STTR funding can be a leveraging tool to help attract additional funding from other third-party investors•Awards are not loans; no repayment is required•SBIR & STTR funding is non-dilutive capital (i.e., an award does not impact the company's stock or shares in any way). Intellectual property rights to technologies developed under these programs are retained by the small business concern.
Speakers:
Michael Weingarten, Director, NCI SBIR Development Center, National Cancer InstituteMichael Weingarten is the Director for the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute, one of 27 Institutes of the National Institutes of Health (NIH) in Bethesda, Md. In this role, Mr. Weingarten manages all aspects of the NCI SBIR and Small Business Technology Transfer (STTR) programs including a portfolio of over $100M in grants and contracts annually. The SBIR and STTR programs are NCI's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. In his current role, Mr. Weingarten led a team that developed a set of key recommendations for optimizing the performance of the NCI SBIR program at the NIH. Those recommendations included the establishment of an SBIR Development Center to manage the NCI SBIR program. This Center is staffed with talented leaders from both industry and the NIH who have expertise in the development and commercialization of technology in the cancer field to optimize the returns the NCI achieves through this program.
Ali Andalibi, Ph.D., Program Director, NCI SBIR Development Center, National Cancer InstituteDr. Ali Andalibi is a molecular biologist and geneticist by training with extensive experience in both academia and industry. He received his PhD from the UCLA department of Microbiology and Molecular Genetics and later joined the faculty in the UCLA department of Medicine. After leaving UCLA he was involved in several early stage biotechnology companies. He then joined the House Ear Institute (HEI), where he served as the Director of New Technology and Project Development and was also an adjunct Assistant Professor of Otolaryngology, at the University of Southern California, School of Medicine. Dr. Andalibi then joined the National Science Foundation as a Program Director in the Division of Industrial Innovation and Partnerships, where he oversaw the NSF's medical biotechnology SBIR/STTR grant portfolio. Dr. Andalibi is currently a Program Director in the National Cancer Institute's SBIR Development Center, where he leads the Therapeutics Cluster.
Click here to view Michael Weingarten's presentation.
Click here to view Ali Andalibi's presentation.
BIOCOM Reimbursement Series - Generating Evidence of Product Value
Tuesday, May 11, 2010
As the cost of new health technologies rises much faster than healthcare budgets around the world, the need to generate robust evidence of value becomes an increasingly critical component of healthcare product development. Understanding how to generate high quality evidence of product value alongside clinical trials is a key strategic capability for developers of drugs, devices and diagnostic tests. Without robust evidence of value, gaining product coding, coverage and reimbursement will be difficult, if not impossible, and commercial goals will be hard to achieve. The presentations from this event are available below.
Jan Hirsch, PhD, Assistant Professor of Clinical Pharmacy, UCSD’s Skaggs School of Pharmacy and Pharmaceutical Sciences. To view her presentation, click here - Jan Hirsch.
Nick Poulios, PhD., Head, Global Health & Economics, Pricing and Reimbursement Strategy, Gen-Probe. To view his presentation, click here - Nick Poulios.
DeviceFest 2010
For your convenience, all approved slide presentations from this year's DeviceFest conference are hyperlinked below:
Keynote Address: The new future of the medical technology industry
Featuring: James V. Mazzo, President, Abbot Medical Optic
Breakout Session I: FDA's 510(k) Process: Reform or Ruin?
A panel comprised of industry and legal experts will address the current status of ongoing efforts to evaluate, and possibly significantly change, the primary pathway by which medical devices are authorized for U.S. marketing. The panel will discuss the recent FDA public meeting on the 510(k) process and comments submitted to the related public docket, the Institute of Medicine's consideration of 510(k) issues, and possible regulatory or statutory changes that may result. The panel will also provide a forum for open discussion of industry concerns, suggestions, and comments related to the 510(k) pathway.
Speakers:
Richard J. DeRisio, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics (access presentation here)
Elaine Tseng, Partner, FDA & Life Sciences Practice, King & Spalding (access presentation here)
Michael Minogue Chairman, President & Chief Executive Officer, ABIOMED, Inc.
Breakout Session II: Implementing an Effective Corporate Compliance Program - Does it meet the Stress Test?
Medical device companies continue to struggle with developing and implementing an effective corporate compliance program. What do I need to implement? How do I know whether my program is "effective"? Compliance cannot be achieved with a "one size fits all" approach, a concept that small medical device companies understand. This session will provide an overview of the key elements of a corporate compliance program and discuss what needs to be done today to get your program off the ground.
Moderator:
Norm Raffish, Product Manager, California Manufacturing Technology Consulting
Speakers:
Wendy C. Goldstein, Member of the Firm, Chair of Health Practice, EpsteinBeckerGreen (access presentation here )
Karen A. Weaver, JD, RPh, Vice-President, Assoc. General Counsel, Regulatory, CareFusion Corporation
Breakout Session III: Taking the Mystery out of the CPT Code Process
During this hour hear from experts who will speak about the CPT code process and how the AMA CPT code panel and insurance carriers decide how much medical device companies are reimbursed for their devices. What are the stipulations and guidelines medical device companies can follow in order to get the most money for their devices? And lastly learn priceless "tips" on ways companies can more likely get a new CPT code approved.
Speakers:
Grant Bagley, M.D., Chariman HillCo HEALTH
Robert C. McDonald, MD, MBA President, Aledo Consulting, Inc.
(Access both presentations here)
Breakout Session IV: Should you Build it or Get Acquired?
Do your Regulatory, IP, Reimbursement and Financing Strategies Need to Adjust?
The Pulse of the Industry - Medical Technology Report by Ernst & Young (access presentation here)
Presented by: Rich Ramko, Partner, Assurance, Ernst & Young