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

Add this event to your calendar:
01/11/2016 16:00 01/11/2016 19:00 America/Los_Angeles Why Ya Buggin’ Out? Regulatory Hurdles and Other Obstacles on the Path to Microbiome Market Johnson & Johnson Innovation, JLABS , 329 Oyster Point Blvd , South San Francisco , CA JLABS Bay Area false DD/MM/YYYY
November
1
Event

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

Johnson & Johnson Innovation, JLABS , 329 Oyster Point Blvd , South San Francisco , CA

November 01, 2016 from 16:00 PM to 19:00 PM (PDT)

$10 - $35


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?


Agenda:
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


Speakers:
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»

Fees:
$25 | General Public
$35 | Onsite


Venue:
JLABS @ SSF
329 Oyster Point Blvd - 3rd Floor
South San Francisco, California
Map It


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.
Connect with Stephanie:   Connect on LinkedIn



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


JLABS Bay Area

About Johnson & Johnson Innovation, JLABS Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and healthtech sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to ten global locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto, Beerse (Belgium), with New York City, opening in June 2018, and Shanghai in 2019. For more information please visit www.jlabs.jnjinnovation.com or follow @JLABS. About Johnson & Johnson Innovation Johnson & Johnson Innovation LLC focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson's global healthcare businesses. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, Johnson & Johnson Innovation | JLABS, Johnson & Johnson Innovation - JJDC, Inc. and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs in patients. For more information please visit www.jnjinnovation.com or follow @JNJInnovation.

Event contact


Related content