Speakers

Morning Keynote: Biotech Partnering Recipes

Francois Nader, M.D.Francois Nader, M.D. 
President, CEO and Director
NPS Pharmaceuticals

Francois Nader, MD, has been President, Chief Executive Officer and a member of the Board of Directors of NPS Pharmaceuticals since 2008. During his tenure, Dr. Nader transformed NPS into a leading global biotechnology company focused on pioneering and delivering innovative therapies that transform the lives of patients with rare diseases worldwide. NPS’ lead product, Gattex® (US)/Revestive® (EU) for adult Short Bowel Syndrome, was approved in the US and Europe in 2012. NPS has also developed Natpara® for hypoparathyroidism and submitted its Biologic License Application to the U.S. Food and Drug Administration in October 2013.

Dr. Nader is a 30-year veteran of the healthcare industry. He joined NPS in 2006 as chief medical and commercial officer and was promoted to chief operating officer in 2007. Previously, he was a venture partner at Care Capital. Dr. Nader served on the North America Leadership Team of Aventis and its predecessor companies and held a number of executive positions including senior vice-president, integrated healthcare markets and North America medical and regulatory affairs. Prior, Dr. Nader led the global commercial operations at the Pasteur Vaccines division of Rhone-Poulenc.

Dr. Nader earned his French Doctorate in Medicine from St. Joseph University (Lebanon) and his Physician Executive MBA from the University of Tennessee. Dr. Nader currently serves as chairman of the Board of Trustees for BioNJ, New Jersey’s trade organization representing the biotechnology industry.  Dr. Nader is a Board member of the Biotechnology Industry Organization (BIO) and the New Jersey Chamber of Commerce. He is also a Director of Trevena, Inc. and Chair of its Compensation Committee.

Morning Plenary: Building a Balanced Portfolio

Iain D. Dukes, D. Phil.Iain D. Dukes, M.A., D. Phil.
SVP, Business Development and Licensing
Merck Research Laboratories

Dr. Dukes joined Merck in 2013 and oversees all licensing deals at Merck Research
Laboratories, including external research, out-licensing regional deals and academic alliances,
and chairs the Merck Venture Research Fund. He has more than 20 years of experience in
pharmaceutical research, drug discovery, scientific and technology licensing, start-up company
leadership, consultant to numerous biotech and venture capital organizations.
Iain was with Amgen prior to joining Merck since August 2010 as Vice President of External
Research and Development. He led the External R&D department in identifying, assessing and
transacting scientific external licensing opportunities, as well as potential opportunities for
academic collaborations and platform technologies.
Previously, Iain was President and CEO of Essentialis Therapeutics, a small start-up company,
and before that he served as Vice President, Scientific and Technology Licensing at
GlaxoSmithKline, where he built a leading licensing organization. At an earlier point, he was the
Head of the Ion Channel Drug Discovery Group, and later Head of Exploratory Development in
Metabolic and Urogenital Diseases at GlaxoWellcome.
Iain pursued initial research training at the University of Leeds, UK, and received
his D.Phil. degree from the University of Oxford where he also received a B.A. in
Jurisprudence. He was a post-doctoral fellow in the Department of Physiology at the
University of Pennsylvania, while simultaneously completing training at Gray’s Inn, UK in
anticipation of being called to the Bar.

Brenda D. GavinBrenda D. Gavin, DVM, MBA
Founding Partner
Quaker Partners

Dr. Brenda Gavin is a founding partner of Quaker Partners. Previously, she was President of S.R. One, Limited (S.R. One), GlaxoSmithKline’s bioscience venture capital investment company, and a general partner of EuclidSR Partners, an independent venture capital limited partnership focused on healthcare and information technology. During Dr. Gavin’s tenure, S.R. One invested in more than 100 life sciences companies and 20 venture funds. Dr. Gavin was responsible for many of the direct venture and strategic investments made by S.R. One, and she served as a board member or active board observer for many of its portfolio companies.

Dr. Gavin is currently a board member of BioLeap, and recently served on the boards of Celator Pharmaceuticals and TetraLogic Pharmaceuticals. In addition, she serves on the boards  of BioAdvance (the Biotechnology Greenhouse Corporation of Southeastern Pennsylvania), and the Pennsylvania State University Research Foundation; she also serves on the International Advisory Board of the Monell Chemical Senses Center. Dr. Gavin is a past board member of Quaker portfolio companies Tengion and Tranzyme Pharma, and is also a past board member of the National Venture Capital Association.

Prior to her career in business, Dr. Gavin held a commission in the U.S. Public Health Service and served in the Epidemic Intelligence Service at the Centers for Disease Control and Prevention in Atlanta.

Dr. Gavin is a graduate of Baylor University. She received her Doctor of Veterinary Medicine from the University of Missouri and her Master of Business Administration from the University of Texas – San Antonio.

Michael Gutch, Ph.D.Michael Gutch, Ph.D.
Managing Director
MedImmune Ventures

Mike had experience as both a corporate and private venture capital investor prior to joining MedImmune Ventures in September 2011. He currently represents Medimmune Ventures as a Board Director on the investments in Coferon and G1 Therapeutics. Prior to MedImmune Ventures, Mike was a Director with H.I.G. BioVentures, a life-science focused investment fund and before that that was a Principal with Lilly Ventures, the corporate venture capital arm of Eli Lilly & Company. While at Eli Lilly, Mike was also in the Corporate Financing and Investment Banking group, where he focused on mergers and acquisitions and licensing transactions. Mike earned his Ph.D. in Cellular and Molecular Pathology from the State University of New York at Stony Brook and was a post-doctoral research fellow at both UCSF and the Cold Spring Harbor Laboratories. He earned his M.B.A. in finance from Indiana University. Mike currently serves as a member of the Board of Directors for Southeast BIO, a member of the Johns Hopkins Alliance for Science & Technology Development, and a member of the Business Advisory Boards for the Alzheimer’s Drug Discovery Foundation, the National Brain Tumor Society and Emory University New Venture Advisory Board.


Simon J Archibald, Ph.D.Simon J. Archibald, Ph.D.

Chief Scientist
Integra LifeSciences Corporation

Simon J. Archibald, Ph.D., is currently the Chief Scientist for Integra LifeSciences Corporation. He joined Integra in 1997 as Senior Director of Neurological Programs to oversee the clinical and commercial development of the NeuraGen nerve guide system and to explore the development of a neurosurgical product line from the existing Integra collagen wound care business and patent port-folio. In 1997 he initiated the program that resulted in the development of the DuraGen dural graft matrix for which he is a co-inventor. In 1999 he was promoted to Vice President of R&D for the new Integra NeuroSciences business and in 2001 he was promoted to Vice President of R&D & Vice President of Clinical Affairs, in 2005 he was promoted to Chief Scientific Officer, a post he held through to February 2014.

Previously Dr. Archibald was Assistant Professor in the Department of Neurosurgery at Duke University Medical Center, to which he was appointed after completing a research Fellowships in Department of Neurosurgery at Duke University Medical Center and in the Department of Neuropathology and Neuroscience at Harvard Medical School. He graduated with a degree in Zoology from the University of Reading in the UK, and has a Ph.D. in Biomedical Engineering from the University of North Staffordshire in the UK.

Currently Dr Archibald also serves as an Adjunct Professor in the department of Biomedical Engineering at Drexel University His primary research focus is in peripheral and central nervous system regeneration with a particular emphasis on national and international collaborations for translating discoveries in the basic sciences to clinical practice.

Panna SharmaModerator:
Panna Sharma
President & CEO

Cancer Genetics, Inc. 

Mr. Sharma became a member of Cancer Genetics, Inc.’s board of directors and Chief Executive Officer in May of 2010. Additionally Mr. Sharma serves as the General Manager of Oncospire Genomics, a joint venture with Mayo Clinic focused on next generation sequencing in oncology. Mr. Sharma was at TSG Partners, a specialty life sciences consultancy and advisory company, from 2001 to 2010, where he was the Managing Partner and founder. At TSG he led the development of strategic initiatives, corporate growth strategy and corporate turnarounds for both public and private companies. He also led over 70 buy and sell-side transactions for life sciences, healthcare and biopharma companies. At TSG, he established the Global Diagnostics Index, the Global Biotools Index and several other life science capital markets indices that are still used in the life science industry.

Prior to founding TSG, Mr. Sharma was the Chief Strategy Officer for iXL Enterprises, Inc. (“iXL”), a public e-business consultancy where he led strategy development and acquisitions activity and was part of the management team that aided in taking the company public in June 1999. At iXL, he also managed the specialty e-business strategy practices group that grew from under $4 million in revenue in 1998 to over $75 million in 2000. From 1996 to 1998, Mr. Sharma was a partner at Interactive Solutions, Inc., a marketing and strategy consultancy focused on health care and financial services in Cambridge, Massachusetts, that was sold to Omnicom, Inc., one of the largest global market analysis and marketing companies. Prior to that time, Mr. Sharma served as a consultant to Putnam Investment Management, LLC and Bank of America Corporation. Mr. Sharma has also served on the board of directors of EpicEdge, a health care and government focused IT services firm, from 2001 to 2003 and as chairman of the Advisory Board for EndoChoice, a global leader for the gastrointestinal treatment market from 2008 to 2010. Mr. Sharma attended Boston University from 1987 to 1992 in the University Professor’s Program.

Luncheon Keynote: The State of Angel Investing

Katherine O'NeillKatherine O’Neill
Executive Director
JumpStart New Jersey Angel Network

Katherine O’Neill is the Executive Director for JumpStart New Jersey Angel Network, a member led angel investor group that invests in early stage companies in the Mid-Atlantic region. She is an investor in early stage growth companies. She currently serves on the Board of the Angel Capital Association (ACA) the national organization representing angel investor groups in North America. Katherine represents the ACA at both national and international events.

Katherine is a member of the NJ Economic Development Authority Edison Fund Advisory Board, Ben Franklin Technology Partners of SEPA Advisory Board, NJ Technology CFO Advisory Board, Princeton University MIRTHE Investment Focus Group and Rutgers Innovation Park Advisory Board. In recent years she has spoken at and judged business plan competitions both regionally and nationally at events such as IMPACT, Astia, Microsoft BizSpark NYC competition, Tri State Donald W. Reynolds Cup, Princeton University Jumpstart Innovation Forum, Temple University BOSS bowl and Start Up Weekend Princeton. She is a mentor at regional accelerators Princeton University E-Labs and TechLaunch.

Katherine is a seasoned financial executive and investor in early stage enterprises with extensive experience in start up and entrepreneurial operations as well as operational experiences in a diverse range of businesses.  She has particular expertise developing technology-based business as well as strategic business plans. She has extensive multi-national experience and financial operation management and expertise in healthcare, biotech, pharmaceuticals, information systems, e-commerce and social media. She is the president of O’Neill Associates and consults with growth companies and acts as interim CFO.

In addition to her entrepreneurial activities, she was a senior executive in corporate finance in both a Fortune 100 pharmaceutical company the now GlaxoSmithKline and Fortune 500 chemical company FMC. Katherine has served on many non-profit boards focusing on education and women in business.  Katherine is also currently active with the Forum of Executive Women and the New Jersey Technology Council. Katherine earned a BA in Economics from the University of Maryland Munich, Germany and College Park and a MA in Economics from the University of Pennsylvania.

Luncheon Plenary: Companies Sharing Stories

Panna SharmaPanna Sharma
President & CEO

Cancer Genetics, Inc. 

Mr. Sharma became a member of Cancer Genetics, Inc.’s board of directors and Chief Executive Officer in May of 2010. Additionally Mr. Sharma serves as the General Manager of Oncospire Genomics, a joint venture with Mayo Clinic focused on next generation sequencing in oncology. Mr. Sharma was at TSG Partners, a specialty life sciences consultancy and advisory company, from 2001 to 2010, where he was the Managing Partner and founder. At TSG he led the development of strategic initiatives, corporate growth strategy and corporate turnarounds for both public and private companies. He also led over 70 buy and sell-side transactions for life sciences, healthcare and biopharma companies. At TSG, he established the Global Diagnostics Index, the Global Biotools Index and several other life science capital markets indices that are still used in the life science industry.

Prior to founding TSG, Mr. Sharma was the Chief Strategy Officer for iXL Enterprises, Inc. (“iXL”), a public e-business consultancy where he led strategy development and acquisitions activity and was part of the management team that aided in taking the company public in June 1999. At iXL, he also managed the specialty e-business strategy practices group that grew from under $4 million in revenue in 1998 to over $75 million in 2000. From 1996 to 1998, Mr. Sharma was a partner at Interactive Solutions, Inc., a marketing and strategy consultancy focused on health care and financial services in Cambridge, Massachusetts, that was sold to Omnicom, Inc., one of the largest global market analysis and marketing companies. Prior to that time, Mr. Sharma served as a consultant to Putnam Investment Management, LLC and Bank of America Corporation. Mr. Sharma has also served on the board of directors of EpicEdge, a health care and government focused IT services firm, from 2001 to 2003 and as chairman of the Advisory Board for EndoChoice, a global leader for the gastrointestinal treatment market from 2008 to 2010. Mr. Sharma attended Boston University from 1987 to 1992 in the University Professor’s Program.

Christian Kopfli, Esq.Christian Kopfli, Esq.
Chief Executive Officer
Chromocell Corporation

Christian co-founded Chromocell in 2002, serving initially as General Counsel before becoming Chief Executive Officer in 2005. Prior to joining Chromocell, he was an Associate at Davis Polk & Wardwell, working in its New York City, Tokyo and Frankfurt offices. At Davis Polk, Christian worked extensively in Mergers & Acquisitions, Capital Markets and Private Equity Transactions. He received a doctoral degree in law (magna cum laude) from the University of Zurich in 2000 and earned his LL.M. from Columbia Law School in New York City in 1998. Christian is a Board Member of BioNJ and admitted to the Bar in New York and Switzerland.

 

Donna Tempel, Ph.D., MBADonna Tempel, Ph.D., MBA
President and Chief Executive Officer
Drais Pharmaceuticals Inc.

Dr. Tempel is President, Chief Executive Officer and co-founder of Drais Pharmaceuticals Inc.  Drais is a venture-capital supported clinical drug development company, based in Bridgewater, New Jersey. The company specializes in early phase clinical development and seeks to establish close partnerships with larger pharmaceutical companies in order to build its pipeline and accelerate promising candidates to proof of concept.    Prior to founding Drais, Dr. Tempel was co-founder and Chief Operating Officer of AkaRx, Inc., also a venture-backed development company.  AkaRx was spun out of the merger of Yamanouchi and Fujisawa in 2005 with a focus in hematology/oncology.  AkaRx was acquired by Eisai Inc. in January of 2010.  Prior to the founding of AkaRx Inc., Dr. Tempel was  Vice President of Project Management at Yamanouchi, responsible for oversight of all clinical development programs for the company in the US and EU including the now-marketed products, Vesicare™ and Vaprisol™.  Prior to joining Yamanouchi in 1998, Dr. Tempel held various positions in Research and Development at Bristol-Myers Squibb and Johnson & Johnson, Inc.  Dr. Tempel received her B.S. in Psychology and Mathematics from Hunter College/CUNY, a Ph.D. in Neuroscience from CUNY/Mount Sinai School of Medicine and an MBA in Finance from Farleigh Dickinson University.

Forrest DoaneModerator:
Forrest Doane
Regional Director – DataSite

Merrill Corporation

Forrest Doane has been a Regional Director of DataSite for Merrill Corporation since 2008. DataSite is a leading provider of outsourced solutions for various complex business communication and information management needs. He works closely with business professionals to provide first class virtual data room (VDR) solutions for their transaction and due diligence needs.

Prior to joining Merrill, Forrest worked at Ernst & Young as a member of their Global Financial Information System team.

A graduate of Lehigh University, Forrest currently resides in Cedar Grove, New Jersey with his wife Gina and son James.

Afternoon Plenary: The Path to Payers

Charles GerritsCharles M. Gerrits
VP-Global Evidence & Value Development, Global Medical Affairs
Sanofi

Charles Gerrits attended Pharmacy School, and Medical School at the University of Utrecht, The Netherlands, where he also obtained his PhD in Pharmaco‐epidemiology and Respiratory Diseases. After having worked for 10 year in clinical practice, Charles started his career within the Pharmaceutical Industry in 2001 at Abbott Laboratories, North Chicago, IL, where he served as Associate Director, Pharmaco‐epidemiology. Since then he has worked for Takeda Pharmaceuticals, Abbott Laboratories and Pfizer in positions with progressively increasing levels of responsibility.

Prior to joining Sanofi as Vice President, Global Evidence and Value Development, he worked at Abbott Laboratories where he served as Vice President of Global Health Economics & Outcomes Research, Epidemiology and Value Analytics, and subsequently as Vice President, Global HEOR, Pricing, Reimbursement and Market Access at Pfizer, Inc., New York, NY.

Charles is also a visiting Professor at various national and internal universities.

Jacqueline Threadgill, MBAJacqueline Threadgill, MBA
Principal Managed Care & Reimbursement Consultant
Senergene Solutions

Jacqueline Threadgill, a visionary healthcare executive with over 20 years of experience, is recognized for the development and implementation of managed care, pricing, marketing, reimbursement, and coding strategies within start-up and multi-billion dollar biotech and healthcare companies. Ms. Threadgill has served as a managed care and reimbursement consultant for payers and laboratories focused in the areas of oncology, hematology, cardiology, pharmacogenomics, prenatal, toxicology, and hereditary genetic diseases within the US, Europe, and Canada. As a Senior Leader and Principal Consultant, she has optimized revenue through the implementation of unique commercialization and reimbursement strategies, and has advised diagnostic laboratories and payers on the implementation of the new CMS MoPath codes and coverage policies. As the VP of Managed Care for Ambry Genetics, she was responsible for leading payer adoption of genetic tests including hereditary breast and colorectal cancer panels and the first to launch, Whole Exome Sequencing for clinical diagnosis. Prior to her role with Ambry Genetics, she served as the Director of Managed Care for Signature Genomics. Earlier in her career, Ms. Threadgill served as a senior leader responsible for the launch and leadership of Partnership Health Plan, a Managed Medicaid Plan and held roles with Highmark BCBS. Ms. Threadgill received her MBA from the NJ Institute of Technology and her BA in Microbiology from Penn State University. She currently serves as a Principal Consultant for her firm, Senergene Solutions.

Keith WhiteKeith White
Director, US Market Access and Reimbursement
ThromboGenics, Inc. 

Keith White is US Head, Market Access, Reimbursement and Strategic Accounts at ThromboGenics.  Prior to ThromboGenics, he spent 12 years at Genentech in various commercial roles, including sales, marketing, managed care marketing, contract strategy, commercial and public account management, government affairs and strategic leadership.  He holds a BA form Lycoming College and an MBA from Syracuse University.

 

Laurie Smaldone, M.D.Moderator:
Laurie Smaldone, M.D.
President & CSO

PharmApprove

Laurie Smaldone has over 25 years of global leadership experience in the pharmaceutical and biotechnology industries in drug development, regulatory strategy and regulatory approvals across all major therapeutic areas.

Dr. Smaldone served in clinical and regulatory roles of increasing responsibilities and scope while at Bristol Myers Squibb, including former Senior Vice President of Global Regulatory Science and Vice President of Corporate Strategy and Business Risk Management. During this time she led multiple teams in both US FDA and European EMA proceedings, including preparations for numerous key FDA meetings, Advisory Committee hearings and EU Scientific Advice and Oral Arguments. In this role she has led the development and commercialization of drugs for cardiovascular, metabolics, immunology, oncology, HIV/AIDS, infectious diseases, neuroscience, dermatology, inflammatory and immune-based diseases.  Laurie received her MD at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology.