BIO and Personalized Medicine
By Andrew Williams --
The 2011 BIO International Convention in Washington, D.C. begins next week. If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the convention. Today, in this final installment, we review just a few of the many opportunities for those interested in learning more about how the promise of personalized medicine is affecting the BIO industry. Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#4723 – Hall C).
It would be difficult to find a topic that has had more of an impact on the field of biotechnology in recent years than that of personalized medicine. In fact, there are two tracts at this year's BIO International Convention devoted to the topics of biomarkers and diagnostics: the Biomarker track, and the Diagnostics and Personalized Medicine track. The issues surrounding personalized medicine are not only being played out in the laboratory or the hospitals, but the U.S. court system is also weighing in. Patent Docs readers should be quite familiar with the ACLU's case against Myriad Genetics (see "AMP v. USPTO: Oral Argument at the Federal Circuit"), amongst others, in which the ACLU is alleging that genes are "products of nature," and therefore are not patent eligible. However, this case is centered on issues involving the genetic screening for breast and ovarian cancer risk. Moreover, on Monday this past week, the Supreme Court granted certiorari in the Mayo Collaborative Services v. Prometheus Laboratories Inc. case. The patents at issue in the Prometheus case claim tests for optimizing drug dosage in the treatment of autoimmune diseases such as Crohn's disease by determining the level of a metabolite in the patient. Mayo alleges that Prometheus' patents hinder a doctor's ability to consider a biological phenomenon in treating a patient. Prometheus counters by pointing out that its patents claim concrete and improved methods for treating patients. The Federal Circuit sided with Prometheus, finding that all of the claims were patent eligible. Because the Prometheus case is considered by many to be about the patent eligibility of diagnostic claims, any decision by the Supreme Court will have serious implications on the field of personalized medicine.
Last Friday, we highlighted various sessions that would address how the U.S. court system is impacting the BIO community. Two of those panels could easily be highlighted in today's review, because they involve issues that will impact diagnostics and biomarkers: "IP issues Affecting Biomarker-Based Diagnostics" on Monday, June 27 from 3:45 to 5:00 pm, and "The Myriad Case and the Patentability of Isolated DNA Molecules" on Tuesday, June 28 from 8:30 to 9:45 AM. Nevertheless, because these sessions were already described in detail, the present review will highlight four different sessions.
"IP Challenges for Personalized Medicine: Navigating Bilski, Myriad, and Prometheus," on Wednesday, June 29 from 2:00 to 3:30 PM, is sure to be of interest to Patent Docs readers. The session will address personalized medicines' reliance on "so-called" gene patents, and the public's perception of such patents. The panel promises to highlight the instrumental role that gene patents have played in the biotech industry, and to explore how companies can deliver on the promise of personalized medicine. The recent and upcoming cases of Bilski v. Kappos, Myriad, and Prometheus, among others, and their impact on biotechnology will be explored. The panel includes the Associate General Counsel of BIO, Hans Sauer, as well as Kristin Neuman of Proskauer Rose LLP and Mark Seka, Global Head of IP for Novartis Molecular Diagnostics. The session will be moderated by Jennifer Gordon of Baker Botts L.L.P.
Another session in the Diagnostics and Personalized Medicine track that should be of interest to Patent Docs readers is "Personalized Medicine and Already Approved Drugs: The Plavix Case Study and What You Don't Know Can Hurt You" on Tuesday, June 28 from 3:45 to 5:00 PM. The session will focus on the recent FDA decision to add genetic polymorphism information to the label for Plavix (clopidogrel), one of the biggest blockbuster drugs in the world. This decision could dramatically affect sales of the drug. The panel will consider this case study of how parties other than original drug developers can affect sales of leading drugs. The session will also describe strategies to help prevent drug developers from being blindsided with new information. The panel consists of Gabriela Lavezzari, Senior Manager Extramural R&D of Medco Research Institute; Joe Meyer, COO of Biomedicine Diagnostics for Eli Lilly & Co.; and Cecilia Schott, Business Development, Personalized Healthcare for AstraZeneca, Research & Development, Inc. The session will be moderated by Amit Agarwal of Scientia Advisors.
Another session of interest is unfortunately at the same time as the above panel (3:45 to 5:00 on Tuesday, June 28): "The Evolving Business Model for Biomarkers: Status and Future Perspectives." This session will highlight some of the newest developments in the area of biomarkers and personalized medicine, recognizing that a number of drugs on the market depend on companion diagnostics. The panel promises to outline the business models and economics of the future of personalized medicine. In addition, the new relationships between biotechnology, pharma, and diagnostic companies will be explored. The panel includes Bryan Dechairo, Senior Director, Development Head of Personalized Medicine at Medco Health Solutions, Inc.; Mark Erwin, Sr. Director, Reimbursement & Government Affairs of Prometheus Laboratories, Inc.; Jogaoro Gobburu, Director, Division of Pharmacometrics at the FDA; Stephen Little, VP for Personalized Healthcare for QIAGEN; and Bernhard Sixt, CEO of Agendia. The session will be moderatored by Christoph Huels of Merck Serono.
The final session that we will preview, but certainly not the final session dedicated to the topic of personalized medicine, is "Rediscovering the Promise of Biomarkers" on June 28 from 8:30 to 9:45 AM. The session will explore the regulatory challenges of bringing new biomarker products to market, despite the scientific and clinical rationale supporting their development. The panel will look at models, such as the Biomarkers Consortium, which can include federal regulatory participation, along with scientists and industry. International issues will also be explored. The panel includes Phil L'Huillier, Director of Business Management, Cancer Research Technology Ltd.; Shawnmarie Mayrand-Chung, Program Director for The Biomarkers Consortium, NIH; Janet Wilson-McManus, COO of PROOF Centre; and Issam Zineh, Associate Director for Genomics with the U.S. Food and Drug Administration.
Care for some updates on the conference? http://cbt20.wordpress.com/2011/06/29/biotechnology-news-69/
Posted by: shirley | June 29, 2011 at 04:25 PM