The journey of a life science company from inception to market is ever evolving due to changes in technical focus, development milestones, funding sources, and business objectives. A company’s IP strategy should adapt to those changes. The expert panel will discuss practical considerations for streamlining IP to follow the current focus while safeguarding against competitors; capturing additional inventions from clinical and manufacturing development; and optimizing IP ownership and control when seeking financing or an exit.
Mary R. Henninger, JD, PhD
Finnegan, Henderson, Farabow, Garrett, & Dunner, LLP
Mary Henninger has practiced as a registered patent attorney for nine years at Finnegan’s Atlanta office. Her patent practice includes litigation, due diligence, strategic patent portfolio management and counseling, patent preparation and prosecution, and post-grant proceedings before the USPTO in the areas of biotechnology, pharmaceuticals, chemicals, medical devices, and solid particles.
Dr. Henninger holds a BS degree in Chemistry from Jacksonville University, a PhD in Molecular Genetics and Microbiology from the University of Florida, and a JD from the University of Florida.
Dr. Henninger focused her doctoral and post-doctoral research on embryonic and fetal gene therapy for the prevention and treatment of Pompe disease and other inherited metabolic and muscular disorders, and immunological considerations related to gene therapy. During the course of her research, she was involved in the clinical trial testing of the Myozyme® drug product. She also investigated murine embryonic stem cell transduction and differentiation; production and purification of recombinant viral vectors; in utero gene therapy methods in mice and nonhuman primates; catalytic RNAs (ribozymes); and lysosomal protein production, purification, and characterization.
Bruce J. Oberhardt, Ph.D.
Author, Dragonfly Thinking
Dr. Bruce Oberhardt, a biomedical engineer and entrepreneur, is known for promoting creative thinking and has been involved in recent years in consulting and biomedical technology incubation. He has led and/or participated in a number of first-of-a-kind technological developments including the extremely successful "CoaguChekR” product sold worldwide by Roche, a point-of care, hand-held monitoring system for CoumadinR and other warfarin and anticoagulant drugs (blood thinners). He invented, developed, and successfully transferred the technology for this product, which employs a disposable microfluidic element that today is perhaps the most widely used microfluidic system in the medical diagnostics field. Dr. Oberhardt previously served in management positions for major multinational medical products manufacturers and founded new companies, based on technologies he developed or co-developed, such as Cardiovascular Diagnostics, Inc., a successful IPO. He has developed technologies to help in diabetes, blood diseases, cardiovascular disease, and cancer – products based on these technologies are currently saving patients’ lives daily.
Dr. Oberhardt has served on boards of directors and scientific advisory boards for venture backed companies and on the board of directors for the Raleigh-Durham Chapter of the Association for Corporate Growth. He has also seen the other side of ventures as a member and officer of the Atlantis Group, a North Carolina-based angel investment group. He was involved in the development of many products now on the market and is author or co-author of more than 50 published journal articles and abstracts and inventor or co-inventor on more than 180 issued patents, worldwide. He has won numerous awards, such as the North Carolina Governor’s Award for Outstanding Entrepreneurial Contribution and the North Carolina Biomedical Entrepreneur of the Year award.
Dr. Oberhardt is also the author of a book published in 2013, titled: "Dragonfly Thinking, Problem Solving for a Successful Future” The eBook version was released on May 1st 2013 and is now available, as is the actual book, on Amazon.com and Barnes&Noble.com. The eBook version was released for Apple products in September 2013. After completing the book, Dr. Oberhardt has been following his passion in helping companies and associations large and small by conducting workshops and training sessions on how to solve big, important problems - in other words - Dragonfly Thinking! See: www.dragonflythinking.com .
Michael L. Wach
Mike specializes in leveraging innovation and intellectual property to create healthcare products and new ventures. His patent experience spans from high-stakes litigation as a sole inventor; to creating patent monetization programs for Fortune 100 companies; defeating, as the CEO, megacorporation-asserted patent infringement claims; practicing before the US Patent Office; and securing over $20 million in venture capital. He is an inventor of 43 issued US patents plus numerous pending and foreign patents that have been heavily litigated, subjected to serial reexaminations, and licensed for successful products.
William T. Lee, PhD, RAC
Vice President of Regulatory Affairs
Dr. William Lee received his B.A. from Johns Hopkins University, and Ph.D. from Cornell University Graduate School of Medical Sciences. Dr. Lee has twenty years of research and industry experience. His focus is on gene therapy with retroviral vectors, adeno-associated viral vectors and DNA vectors. He spent 9 years at the gene therapy start-up firm, Viagene, Inc., followed by 2 years at Chiron. In 1999, he joined Cato Research, in Durham, North Carolina, where he is currently Vice President, Regulatory Affairs. His projects have included the design of Phase 1 and Phase 2 protocols for a gene therapy drug and interactions with the FDA and NIH/OBA. Currently, he manages projects involving regulatory strategy and submissions of investigational new drug applications and marketing applications for biologics and drugs.
David W. Mullis, Jr., PhD, RAC, FRAPS
President, Mullis & Associates, Inc.
Associate Professor, Director,
BioPharma Regulatory Affairs Graduate Education Program
College of Pharmacy, University of Georgia
Dr. Mullis is President of Mullis & Associates, Inc., a regulatory affairs and clinical studies consulting firm that provides support services focusing on medical devices and biotechnology. He has served as a principal consultant since 1999 when the company was established. The firm has clients that range from start-up ventures to Fortune 500 medical device firms and large pharmaceutical companies. Dr. Mullis has over 25 years of successful senior management experience working in the FDA regulated health care industry. He held leadership positions directing regulatory affairs and clinical studies programs with Eli Lilly/CPI, Inc., C.R. Bard, Inc., and London International Group, plc. Also, Dr. Mullis is the Director of the BioPharma Regulatory Affairs Graduate Education Programs within the College of Pharmacy at The University of Georgia where he holds the rank of Associate Professor, Department of Pharmaceutical and Biomedical Sciences. He also serves on the Board of Directors of several companies. Dr. Mullis holds a BS degree from Appalachian State University, a Master of Science degree from The University of Tennessee, and a Ph.D. from The University of Tennessee.