Commercializing Genetic Therapies: Innovating Science, Supply Chain and Reimbursement
Mike Rice, Senior Consultant, Defined Health
Paul Gallagher, MBA, President, Compass Strategic Consulting, Inc.
Boro Dropulic, Chief Science Officer, Lentigen Technology, a wholly owned subsidiary of Miltenyi Biotec
According to FDA, genetic therapy products are all products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome, and that are administered as nucleic acids, viruses, or genetically engineered microorganisms. The products may be used to modify cells in vivo or transferred to cells ex vivo prior to administration to the recipient.
Genetic and cell therapies hold promise to potentially cure devastating inherited diseases and rare disorders for which there is no current conventional care. Recently this sector of the life sciences industry has been among the hottest biotechnology arenas for IPOs and licensing deals.
The recent significant biopharma investment in genetic and cell therapies makes it clear that the industry sees gene therapies as the next step in the evolution and advancement beyond conventional biologics and it is committed to the space. However, genetic therapies require complex processes, which involve not only new devices, but new manufacturing infrastructure for individualized therapies, new channels for delivering individualized cellular therapies to patients, and new approaches for reimbursement for one-time administration that offers the hope of cures, but as yet, durability is uncertain. In many ways it is a complete paradigm shift from the traditional pharma business model.
The interactive panel discussion will shed light on the current dynamic landscape of genetic therapies and their commercialization. Topics to be discussed include but are not limited to:
- Evaluation of the clinical need in specific therapeutic areas for gene- and gene-modified cell therapies
- Comparison of the available and emerging technology platforms
- Discussion of what pieces of products and services need to converge to deliver gene therapies to patients
- A glimpse at the current landscape of business models and licensing deals
- Market access evaluation, reimbursement perspectives for new gene therapies and their implications on clinical and commercial development
By Monday, February 29, 2016
LES Members: $65
Academia and Government Employees: $40
At the Door
LES Members: $75
6:00 - 7:00 pm Networking Reception
7:00 - 7:10 pm Introductions and Announcements
7:10 - 8:30 pm Panel Discussion
8:30 - 9:00 pm Q&A, Coffee and Deserts
Since joining Defined Health in 2005, has participated on project teams and managed projects pertaining to cardiovascular disease, oncology and a variety of other therapeutic areas, as well as those focused on complex therapeutics such as protein and gene-based therapies for monogenetic diseases. Mike brings to Defined Health over 10 years of experience as a biotech entrepreneur. Most recently, as Strategic Business Development Analyst for Tapestry Pharmaceuticals, Mike combined technical knowledge and business analytics to evaluate early stage development pipelines for partnering and licensing efforts. He was previously involved in translational research and technology transfer as Project Leader in Genomics at the Delaware Biotechnology Institute. Mike gained exposure to the venture capital community as a technological founder and New Product Development Manager of the genomics and gene therapy firm, Kimeragen, Inc. Mike studied the molecular basis of cancer at the Kimmel Cancer Institute and is recognized for his extensive intellectual property and publication portfolio pertaining to cancer genetics, DNA repair, human gene therapy, molecular diagnostics, and agricultural trait improvement.
Mike holds an MBA, New Venture Creation, Biotechnology Degree from the Alfred Lerner School of Business and Economics, an MS in Molecular Pharmacology from Thomas Jefferson University and a BS in Biology from the University of Delaware.
Paul has over 35 years in healthcare that is characterized by its breadth and extensive experience in the development and commercialization of innovations. Before founding Compass in 1994, Paul worked for legacy companies of Novartis (Ciba-Geigy), Sanofi (Merrell Dow) and Pfizer (Wyeth), holding positions of increasing responsibilities in marketing research, product management, sales management and executive commercial management, including Vice President of Global Marketing. Compass specializes in global market access intelligence and strategies. Compass provides pricing, value, and access assessments and strategies in the pharma, biotech, and diagnostic sectors. Paul holds a BA in economics from Columbia University and an MBA in marketing from George Washington University. He has been a member of the Faculty of the Drug Development Boot Camp at Harvard University from 2011 through 2015, moderated a Panel on Commercialization and Reimbursement of Gene Therapies, at the Genetic Rx Conference, been a Panelist on What's Hot & What's Not in Gene Therapies for Rare Disorders, Webinar sponsored by BIO, and moderated an industry-payor panel on Addressing Payer’s Heightened Aggressiveness in Managing Price and Access in Forecasting, Valuations, and Deal Terms at the 2015 Licensing Executives Society annual meeting.
Dr. Boro Dropulic, PhD, MBA is the Chief Science Officer and General Manager of Lentigen Technology Inc (LTI), a wholly owned subsidiary of Miltenyi Biotec GmbH. Prior to LTI, Dr. Dropulic founded Lentigen Corporation in December 2004 and served as its Chief Scientific Officer and President.
Previously, he was the Founder and Chief Scientific Officer at VIRxSYS Corporation, where he successfully led a multidisciplinary team to initiate and complete the first lentiviral vector clinical trial in humans. Prior to that, Dr. Dropulic was an Instructor and Adjunct Assistant Professor at The Johns Hopkins University School of Medicine, where he was the first to develop an HIV-based vector targeted to inhibit the replication of the HIV/AIDS virus. He was previously a Fogarty Fellow at the National Institutes of Health, where he worked on developing transgenic animals using embryonic stem cell technology, understanding molecular aspects of HIV replication and gene therapy for HIV/AIDS. Dr. Dropulic obtained his PhD from the University of Western Australia, focusing upon how viruses gain entry into the brain to cause encephalitis. He also holds an MBA from The Johns Hopkins University and a BSc, with honors, from the University of Western Australia. Dr. Dropulic has served on a number of committees, including grant review committees at the NIH, EU and CIRM, and as a member and Chair of several committees for the American Society for Gene and Cell Therapy.
Dolly Koltchev, PhD firstname.lastname@example.org
Lori M. Waldron, Esq. email@example.com
Daisy Rivera-Muzzio, RPH, MBA firstname.lastname@example.org
UPCOMING EVENTS FOR MARCH ALSO INCLUDE:
IP Basics course will be held on March 15 in Princeton. For more information, please click here.