Why Ya Buggin’ Out? Regulatory Hurdles and Other Obstacles on the Path to Microbiome Market

Nov 1 2016https://www.eventbrite.com/e/why-ya-buggin-out-regulatory-hurdles-and-other-obst...

Along with the enormous promise there's lot of uncharted territory in the world of Microbiome. Separating what we believe we know and what we truly know about the microbiome is essential to directing research and commercialization efforts. From scoping microbiome-based modalities and sourcing new platforms, to identifying regulatory strategies and insights there are a number of steps to development and commercialization from both the industry and startup point of view.

To explore the latest on this topic from the bench through clinical solutions Johnson and Johnson Innovation gathered a panel of trailblazers for a look at case studies and historical learnings to help better understand if this is truly the golden age of microorganisms.

Topics covered:

  • What are the regulatory hurdles? Will the European laws affect the US market?
  • What are the concerns of the FDA and how are they viewing?
  • What are the clinical hurdles to be overcome?.
  • What is the consumer path for microbiome based solutions?
  • How will products be marketing in terms of different regulations?
  • What are the thoughts on the intellectual property challenges?
  • How have startups thought about the regulatory approach and the IP concerns?

3:00 PM | Registration Opens and Networking
3:30 PM | Introductions
3:35 PM | Panel Presentation
5:00 PM | Networking Reception
6:00 PM | Program Close

Vern Norviel | Partner, Wilson Sonsini Goodrich & Rosati read bio»
Tom Parks | Director of Product Development, Osel read bio»
Emma Taylor | Co-Founder & CEO, Naked Biome read bio»
[Moderator] Stephanie Robertson, PhD. | New Ventures, Johnson & Johnson (J&J) Innovation, California read bio»

$25 | General Public
$35 | Onsite

329 Oyster Point Blvd - 3rd Floor
South San Francisco, California
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Speakers' Biographies:

Vern Norviel | Partner, Wilson Sonsini Goodrich & Rosati
Vern Norviel is a partner at Wilson Sonsini Goodrich & Rosati, where he leads the patents and innovation counseling practice. Vern has three decades of experience in formulating successful strategies for life science companies and the development of their IP programs. He represents a wide variety of companies, as well as venture capital firms, in areas such as therapeutics, diagnostics, nanotechnology, genomics, proteomics, and personalized medicine. In fact, Vern's interest in the field of personalized medicine prompted him to become the first attorney to have had his or her entire genome sequenced and made available in a public database. Before joining the firm in 2003, Vern was the general counsel and corporate secretary of Perlegen Sciences, Inc., a start-up biotechnology company that scans the entire human genome for important therapeutic and diagnostic products. Previously, as senior vice president and general counsel, he was an early employee of Affymetrix, the biotechnology company that pioneered and developed DNA chip technology. He also had been a partner at Townsend and Townsend and Crew in Palo Alto. During his career, Vern has authored or prosecuted more than 20 patents that have been litigated in the United States and abroad, and has overseen intellectual property lawsuits throughout the world. Vern currently serves as a member of Wilson Sonsini Goodrich & Rosati's Executive Committee and on the board of the WSGR Foundation. In addition, he is a lecturer in biotechnology law at UC Berkeley School of Law
Connect with Vern: Connect on LinkedIn

Tom Parks, Ph.D. | Director of Product Development, Osel
Dr. Parks is the Director of Product Development at Osel, overseeing the development and manufacturing of live biotherapeutic products, including LACTIN-V and MucoCept. He also plays a role in clinical operations and regulatory affairs. Prior to joining Osel, Dr. Parks served as the Director of Molecular Biology and Experimental Therapeutics at Cellegy Pharmaceuticals, where he established research and drug development programs in the areas of skin inflammation and gastrointestinal diseases, and at Boehringer Ingelheim Pharmaceuticals, where he spearheaded drug discovery programs in inflammation and autoimmune diseases. Dr. Parks received his doctorate in physiology and pharmacology from UCSD and was a research fellow at Yale University.
Connect with Tom: Connect on LinkedIn

Stephanie Robertson, PhD. | New Ventures, Johnson & Johnson (J&J) Innovation, California
Stephanie is part of the New Ventures Team at J&J Innovation. As part of her role at J&J Innovation, she works closely with the Janssen Human Microbiome Institute and with J&J Consumer Emerging Sciences to create collaborations with academic experts and biotech companies with a goal of accelerating the translation of microbiome research into breakthrough solutions that promote health. Previously Stephanie was at the University of California, San Francisco UCSF where she helped to establish and grow translational efforts on campus including her role as Program Director for the Sandler Center for Drug Discovery, and for the Grand Multiple Myeloma Translational Initiative. She later took on the role of Director, Strategic Alliances where she led business development and alliance management activities for the campus. Prior to joining UCSF, Stephanie worked for over a decade at Exelixis, Inc, where she held diverse leadership roles including leading a computational biology team and acting as scientific project leader for numerous drug discovery programs in cancer, cardiovascular disease and metabolism as well as managing early oncology clinical programs and alliances for several programmatic collaborations with large pharma. Stephanie earned an undergraduate degree in chemistry (Honors) at the University of Michigan, Ann Arbor, and a Ph.D. in chemistry at the University of California, Berkeley.
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Emma Taylor, MD | Co-Founder & Chief Executive Officer, Naked Biome
Emma Taylor, MD is the CEO and founder of Naked Biome, a microbiome-based therapeutics company. She is a UCLA-trained and board-certified Dermatologist and Dermatopathologist, and was a former assistant professor at UCLA before she transitioned to full-time CEO at Naked Biome. Emma has published in notable journals including Nature, Journal of the American Academy of Dermatology, and Dermatology and Therapy. As CEO, she has successfully secured seed funding to take the company through Phase 1 clinical trials.
Connect with Emma : Connect on LinkedIn