2018 BIOFLORIDA CONFERENCE SPEAKERS
President Latin America
Sandoz, a Novartis division
Francisco Ballester (Paco) joined Sandoz in November 2012 as the President for Latin America where he has transformed the region by building a best-in-class team and creating a winning culture. His vision and commitment led to the turnaround of the Sandoz business within the region and drove consecutive double-digit growth in sales and profits in the last 4 years.
Previously, he led Novartis Pharma Spain, where since 2008; he held the role of Country Head. During his tenure there, he successfully grew the market share, built a talent pipeline and developed a strong, positive culture positioning Novartis as a marketplace leader and the #1 best place to work in Spain. Prior to this, Paco held roles of increasing responsibility both at the regional level, including Head Marketing / Sales and Strategy for Latin America, as well as several sales leadership roles locally within Spain. Paco joined Novartis in 1991. He also had previous experience in banking.
A Spanish national, he completed his Bachelor’s degree in Pharmacy at the University of Valencia (Spain) and his MBA at the Industrial Engineering School at the Polytechnic University. Married with three children, he enjoys playing soccer, running, traveling and technology.
Vice President of Medical Informatics
Judy Barkal currently serves as the Vice President of Medical Informatics at M2Gen. She brings deep experience in strategy, innovation and complex business and technology transformation. Judy’s most recent role was Head of Information Strategy and Innovation at Knight Cancer Institute, Oregon Health and Science University. At OHSU, Judy established a cancer informatics strategic roadmap and, as PI, led the creation of a clinical data repository integrated with genomics data to serve multiple cancer researchers and programs. Judy was previously a Partner at IBM, Global Business Services where she led complex business and technology transformations globally in financial services, healthcare, energy, and retail. Prior to IBM, Judy specialized in clusters and high performance computing at Sequent Computer Systems. In her early career, she developed safety-critical, real-time flight control systems at Rockwell Collins.
Florida State Senate
Lori is a lifelong and loyal Democrat who has fought for progressive values over her seven years in the Florida House. She serves as the Democratic Floor Leader and was one of only a handful of legislators to score 100% on the “People First Report Card” measuring legislative votes that put the interest of people over the powerful. She has a strong record of standing up for a woman’s right to choose, pushing for commonsense gun violence prevention measures, advocating for traditional public schools, expanding access to high quality healthcare, and fighting for seniors.
Lori has been a life-long resident of Florida, growing up in Plantation and graduating from Nova High School. She is a Magna Cum Laude graduate from Tufts University and received her law degree from the National Law Center at George Washington University. She also earned an LLM in Estate Planning from the University of Miami.
Lori has a long record of community service and has been actively working with many educational and social service programs. In high school, Lori became interested in the political process when she worked on the campaign of Charlie Friedman for Congress. Lori continued her interest and became actively involved in Palm Beach County politics during Robert Wexler’s first campaign for Congress, joining his team as a Legislative Aide during his first term. In 2010, she was elected to the Florida House of Representatives and has served for 7 years.
Vice President, Business Development
Graham joined Bristol-Myers Squibb in 2002 and has transactional responsibility for the full array of collaborations covering research, clinical and commercial stage assets across BMS' global pharmaceutical business. Graham is also responsible for Japan Partnering activities.
Prior to joining BMS, Graham was Senior Vice President, Corporate Development at 3-Dimensional Pharmaceuticals, a drug discovery company and before that Vice President, Worldwide Business Development at SmithKline Beecham Pharmaceuticals, where he spent 10 years.
Graham has successfully led and overseen numerous transaction teams involved in company acquisitions, co-development and co-promotion deals, compound in and out licensing, product disposals, research collaborations, patents licenses and other strategic transactions.
Guojun Bu, PhD
Mary Lowell Leary Professor of Medicine, Professor of Neuroscience, Department of Neuroscience, College of Medicine
Jorge and Leslie Bacardi Associate Director, Center for Regenerative Medicine
Associate Director, Alzheimer’s Disease Research Center
Co-Editor-in-Chief, Molecular Neurodegeneration
Dr. Guojun Bu is the Mary Lowell Leary Professor of Medicine, a Consultant in the Department of Neuroscience at Mayo Clinic Jacksonville, and the Jorge and Leslie Bacardi Associate Director of the Mayo Clinic Center for Regenerative Medicine. He is also an Associate Director for Mayo Clinic Alzheimer’s Disease Research Center. Prior to joining Mayo Clinic in 2010, he was a Professor of Cell Biology and Neuroscience at the Washington University School of Medicine in St. Louis. Dr. Bu received his B.S. degree in biology from Beijing Normal University, his Ph.D. degree in biochemistry from Virginia Tech, and completed his postdoctoral training in cell biology at the Washington University School of Medicine.
Dr. Bu is a leader in the field of apoE and apoE receptors, which play critical roles in the pathogenesis of Alzheimer’s disease. His primary interest is to understand why APOE4 is a strong genetic risk factor for Alzheimer’s disease and how this pathway can be targeted for therapy by studying animal and stem cell-based cellular and organoid models. Dr. Bu has received numerous honors and awards including the Zenith Fellows Award from the Alzheimer’s Association, the Established Investigator Award from the American Heart Association, the Investigator of the Year award from the Mayo Clinic, and the MetLife Foundation Award for Medical Research in Alzheimer’s disease. He is the Co-Editor-in-Chief of Molecular Neurodegeneration and an Associate Editor for Science Advances.
Charles D. Burger, MD
Consultant, Division of Pulmonary Medicine, Department of Internal Medicine and Professor of Medicine
As Medical Director of the Mayo Clinic Florida Clinical Trials Office, Dr. Burger supports the Mayo Clinic School of Graduate Medical Education Clinician-Investigator Program based on his experience and expertise. He developed and lead the Pulmonary Vascular Disease Program on Mayo Clinic’s Florida campus that has national certification by the Pulmonary Hypertension Association as a Comprehensive Care Center excelling in clinical practice, education and research, the only such center in Florida. All of his research has focused on translational concepts in pulmonary vascular disease, rare cystic lung disease and liver-lung syndromes. He has served as principal investigator for multiple important studies in these growing areas of inquiry. The resulting body of work has led to his national recognition as a leader in the field. He has 100 peer reviewed articles, five book chapters, and multiple letters to the editor as well as many abstracts. Approximately one-half of these publications have involved academic mentoring of a trainee or junior staff.
Dr. Burger has held multiple leadership positions internal and external to Mayo Clinic. Within the institution, He has chaired the Department of Critical Care Medicine and Division of Pulmonary and Critical Care. Mayo Clinic is a physician led organization that assigns clinic-wide practice committees accountability to insure a patient-centered integrated practice. As head of the Florida hospital practice committee (the equivalent of President of the Medical Staff in most healthcare organizations), he oversaw the establishment of all solid-organ transplant programs; automation of the clinical record including orders; and the planning, build, and transition to a new hospital in April 2008. Externally, his leadership positions have ranged from local involvement as Chair, Florida Society of Critical Care Medicine to national as member of the Pulmonary Hypertension Scientific Leadership Council and Editor-in-Chief of Advances in Pulmonary Hypertension, 2015-2017.
Head of Healthcare Investment Banking
NOBLE Life Science Partners
Nathan Cali has more than 14 years of combined healthcare, biotechnology and pharmaceutical experience. Mr. Cali was previously a sell-side analyst for 9 years with expertise and publications cover many areas of biotechnology, specialty pharmaceuticals (branded and generics), medical devices, and regenerative medicine. He has been quoted in most business journals including Reuters, BioMed Reports and the Washington Business Journal. Mr Cali is the co-founder of Variant Pharmaceuticals an early stage biotechnology company advancing orphan drugs for the treatment of renal diseases. He is currently a Committee Member at the Moffitt Cancer Center for Commercialization and a member of the Development Board of Palm Beach County. Mr. Cali started his career in healthcare at Andrx Corporation, a biotechnology and specialty pharmaceuticals company known for its expertise in the development of controlled-release drugs. Mr. Cali was a corporate manager dealing in finance, state taxation, corporate governance, patents, drug distribution and business development for the biotechnology firm. Andrx was purchased by Watson Pharmaceuticals in 2006 for $2.0 billion in cash. Prior to joining NOBLE, Mr. Cali gained investment experience as a portfolio account analyst/manager at Franklin Templeton Investments. Mr. Cali holds a B.S. in Finance from The Florida State University and an M.B.A. in Finance from Nova Southeastern University. Nathan also currently holds series 7, 79, 86, and 87 FINRA designations.
Timothy J. Cartwright
Partner and Co-Founder, Fifth Avenue Advisors
Chairman, Tamiami Angel Fund III, LLC
Timothy J. Cartwright is a partner at Fifth Avenue Advisors, LLC specializing in venture capital, private equity and mergers & acquisitions. Prior, he co-founded By-Products Interactive, an electronic trading, market research and publishing company; and Benchmark Solutions, a supply chain consulting company. He began his career working with middle market companies at Arthur Andersen in Chicago, Illinois.
He received his Bachelor of Science Degree in Economics from the University of Wisconsin and his Masters of Management in Finance and Accounting from Northwestern University - J.L. Kellogg Graduate School of Management. He resides in Naples with his wife and three children. He is a softball coach, a soccer coach, and an active member of First Baptist Church of Naples.
Kathy Chiu is a Founding Partner of the FAN Fund, an early stage fund that invests in Florida startups. Previously Kathy had been a telecom venture capitalist, international business consultant, product marketing and product management executive, finance and economics analyst, as well as computer science and electrical engineer. Kathy has an MBA from Stanford Graduate School of Business, and BS and MS in Electrical Engineering from Massachusetts Institute of Technology. She is trilingual and speaks Chinese and Taiwanese with native fluency.
Executive Vice President, Technology & Marketing
Mr. Colapietro is a leader in the development of technology and marketing solutions supporting Life Sciences. He has more than 20 years of consulting expertise exclusively serving the Life Sciences industry. He has proven his ability to develop, manage, and deliver business strategies and technical implementations in Customer Engagement, Commercial Launch, CRM, Data & Analytics, MDM, Multi-Channel Marketing, Sales & Marketing Operations.
Mr. Colapietro oversees HighPoint’s Commercial Excellence, Research & Development, Pharmacovigalence, and ERP/HR practice areas. Mr. Colapietro has published articles in a number of industry publications, including: CBI Agg Spend: The Government Made Us Do It – Pharma Finally Has CRM, Money Matters TV: Effect of Healthcare Reform on Life Sciences Industry, Multi-Channel Marketing: Increasing Sales Through Diverse, Multi-Channel Initiatives, Social Media: What Can Pharma Learn, Life Sciences Executive Briefing, FirstWord: Closing the Loop - Beyond Digital Detailing, FirstWord: CLM Expert Insight, PharmaVoice: Changing Sales Force Models and Motivation, Pharmaceutical Commerce: Closed Loop Marketing Industry Perspective, BtoB Magazine: Vertical Marketing – The Leaner Drug Company, and Incentive Magazine: Novel Incentive Plan Design for New Product Launches.
Prior to joining HighPoint, Mr. Colapietro held leadership positions at PricewaterhouseCoopers, IBM, and CSC.
Douglas M. Crumb
President & CEO
Mr. Crumb has extensive experience with medical device companies in both the private equity and publicly traded sectors. His specialties are in lean manufacturing, project management, product development and driving profitability.
His experiences are both domestic and international. Mr. Crumb managed multiple large manufacturing operations domestically and internationally in NY, MX and CA for ConMed Corporation. Mr. Crumb also led manufacturing operations, quality assurance and engineering for DHD Healthcare and IZI Medical Products, successfully transitioning both medical device manufacturers from private equity holdings to new ownership. Mr. Crumb earned his Masters in Advanced Engineering from the State University of New York in 1999.
Ronald L. Davis, PhD
Professor and Founding Chair, Department of Neuroscience
Scripps Research - Florida Campus
Ron Davis is the Founding Chair of the Department of Neuroscience at the Scripps Research Institute, Florida. He is one of the nation’s leading experts on the molecular and cellular biology of learning and memory and the human disorders that disrupt memory, including bipolar disorder, schizophrenia, and Alzheimer’s disease. Prior to joining the Scripps Research Institute, he was the R.P. Doherty-Welch Chair of Science at the Baylor College of Medicine, holding professorial appointments in the Departments of Molecular and Cellular Biology, Human and Molecular Genetics, Psychiatry and Behavioral Sciences, and Neuroscience. He was Vice Chair for Research in the Department of Psychiatry and Behavioral Sciences as well as the Director for the Center for Memory and Learning at that institution. Prior to his academic appointments at the Baylor College of Medicine, he was the Senior Neuroscientist at the Cold Spring Harbor Laboratory in New York. Davis completed his doctorate in genetics at the University of California, Davis and postdoctoral research at the California Institute of Technology.
Davis has received numerous awards for his research, including the Scholars and Development Awards from the McKnight Brain Research Foundation, the Michael E. DeBakey Excellence in Research Award, a Distinguished Investigator Award from the National Alliance for Research on Schizophrenia and Depression, a Senior Scholars Award in Aging from the Ellison Medical Foundation, and a Jacob Javits Neuroscience Investigator Award from the National Institutes of Neurological Disorders and Stroke.
Ken Dawson-Scully, PhD
Associate VP for Strategic Initiatives, Florida Atlantic University
Head of Institutional Partnerships, Max Planck Florida Institute for Neuroscience
Dawson-Scully was born and educated in Canada where he received his PhD from the University of Toronto. He came to FAU in 2008 and is currently an associate professor in the Department of Biological Sciences and a faculty member of the newly formed International Max Planck Research School for Brain and Behavior.
Dawson-Scully currently serves in a joint administrative appointment between Florida Atlantic University and the Max Planck Florida Institute. As Associate Vice President for Strategic Initiatives (FAU) and the Head of Institutional Partnerships (MPFI), he serves as a liaison between the two institutes to foster and prioritize partnerships in education, research, infrastructure, and regional affairs. FAU and MPFI currently have a number of joint educational programs including the newly formed FAU Max Planck Honors Program for undergraduates on the John D. MacArthur campus.
Dawson-Scully's laboratory investigates ways to protect the brain from neurodegeneration as a result of acute and/or chronic cellular stress using the genetic model organisms, the fruit fly D. melanogaster and the nematode worm C. elegans. His research has identified a number of molecular targets that can rescue high temperature, low oxygen and oxidative stress in the invertebrate nervous system as a model for human diseases, such as stroke, epilepsy, and most recently migraine, which has led to an FAU Tech Runway company called Neuropharmalogics Inc., a 2016 BioFlorida BioPitch finalist.
Maurice R. Ferré, MD
CEO & Chairman of Board
Maurice R. Ferré MD is INSIGHTEC’S CEO and Chairman of the Board of Directors. Dr. Ferré brings over 20 years of experience in the medical device industry. Before INSIGHTEC, Dr. Ferré served as Chairman of the Board and CEO of MAKO Surgical Corp, a transformational robotic surgical company that he co-founded in 2004. The company was IPO’d in 2008 and recently sold to Stryker Corp. for $1.65 billion in 2013. Prior to MAKO, Dr. Ferré was Founder, CEO and President of Visualization Technology Inc. (1993-2002). VTI became the world leader in image guided surgery for ENT, cranial and orthopedic procedures. The Company was acquired by GE Healthcare in 2002.
Dr. Ferré received his Doctor of Medicine and Master of Public Health from Boston University in 1992. He was also the recipient of the prestigious Ernest & Young 2007 Entrepreneur of the Year Award. Dr Ferre is currently active on the following boards: Advamed, The Everglades Foundation and Boston University.
Robert G. Finizio
CEO, Co-Founder and Director
Robert (Rob) G. Finizio is Chief Executive Officer, Co-Founder, and Director of TherapeuticsMD Inc., an innovative women’s health pharmaceutical company. With over 20 years of healthcare experience, Rob started his career in an operational role at Endoscopy Specialist, Inc. (ESI), a leader in laparoscopic equipment outsourcing and intraoperative technical support. During his tenure at ESI, Rob advanced to a regional management role, eventually leaving to join Omnicell Technologies (OMCL), a leader in pharmacy automation. While at Omnicell, Rob served as a sales director, ultimately leaving the company to co-found CareFusion in 2001. CareFusion was a pioneer in hospital patient safety systems for Medication, Blood, and Specimen verification at the point of care. The company was successfully sold to Cardinal Health in 2006. Rob co-founded TherapeuticsMD (TXMD) in 2008, combining his background in women’s healthcare, pharmaceutical technology, clinical software, and patient safety. Today, TXMD is a leader in women’s health, pharmaceutical development, and commercialization. In 2011, Rob took TXMD public, with a current market capitalization of over a billion dollars. Since inception, Rob raised more than $500 million in capital and listed TXMD on the NYSE before transferring to the Nasdaq in 2017. Rob sits on the Board of Directors for two non-profit organizations, BioFlorida and the Boca Raton Police Foundation. Prior to his healthcare career, Rob, a University of Miami graduate who earned a Bachelor of Arts degree majoring in Premed and Psychology, taught English in Osaka, Japan.
Gregory Frost, PhD
Chairman & CEO
Dr. Frost currently serves as Chairman and CEO of F1 Oncology, a biotechnology company discovering and developing adoptive cellular therapies (ACTs) for solid tumors. F1 Oncology leverages its globally integrated science, development and informatics teams located across multiple time zones to accelerate the design, high-throughput screening, discovery and development of adoptive cellular therapy (ACT) candidates. The company is developing two CAB-based ACT platforms to develop TME-restricted CAR-T therapies for solid tumors, as well as developing highly scalable systems for global deployment, beginning in Asia.
Dr. Frost has been Managing Director of F1 BioVentures, LLC since 2015. Previously, he led the Health Sector of Intrexon Corporation, a multinational public biotechnology company, where he was responsible for expanding their oncology franchise and gene and cellular-based therapies for a number of orphan diseases. From 1999 to 2014, Dr. Frost was at Halozyme Therapeutics, a San Diego public biotechnology company he co-founded, focused on oncology biologics and medication delivery, where he served on the Board of Directors and in numerous operational roles, including Chief Scientific Officer since 2002, and CEO since 2010.
As an entrepreneur, Dr. Frost brought the founding platform technologies to Halozyme and secured the initial capital for the company. In 2012, Gregory Frost was named by Forbes as one of Americas 20 most powerful CEO's 40 and under, and was a finalist for Ernst and Young's Entrepreneur of the Year in San Diego. Dr. Frost additionally serves on the Board of Directors of BioCom, a member-driven organization serving the life science community of Southern California and BioAtla, LLC.
Behnaz Ghoraani, PhD
Faculty Fellow, Institute for Sensing and Embedded Network Systems
Engineering Assistant Professor, Department of Computer & Electrical Engineering and Computer Science
Florida Atlantic University
Dr. Ghoraani is a Faculty Fellow at the Institute for Sensing and Embedded Network Systems Engineering at Florida Atlantic University (FAU). She completed her Ph.D. in Electrical and Computer Engineering at Ryerson University, in Toronto, Canada, in 2010, and was a postdoctoral fellow in Faculty of Medicine at University of Toronto (2010-2012). Dr. Ghoraani is the founder and director of the Biomedical Signal and Image Analysis (BSIA) Lab at FAU. The multidisciplinary research at BSIA lab has largely focused on developing innovative signal analysis solutions to tackle big bottlenecks in data analytics with an emphasis on automated and reliable clinical decision-making, long-term and continuous health monitoring, and remote, personalized therapeutic management. Her research received the best paper awards of the IEEE Engineering in Medicine and Biology Society in 2016 and the Gordon K. Moe Young Investigator Award in 2015. Dr. Ghoraani has over 50 peer-reviewed journal and conference papers, one book, and two book chapters. She holds a research funding from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to develop a catheter guidance algorithm for identification of atrial fibrillation ablation targets.
Sharon Hrynkow, PhD
Senior Vice President for Medical Affairs
CTD Holdings, Inc.
Dr. Hrynkow was appointed by the Board of Directors in this role in September 2015 to lead the company's clinical and scientific program. Her leadership roles over the past twenty years include service as a Senior Executive at the National Institutes of Health (NIH), where she was the Deputy Director and Acting Director of the Fogarty International Center, the focal point for international research and training and for diplomatic relations for the NIH. Dr. Hrynkow also served as Associate Director of the National Institute on Environmental Health Sciences and Senior Advisor to the NIH Deputy Director. Since 2012, Dr. Hrynkow has been the President of the Global Virus Network, a non-profit organization working to combat pandemic viral disease.
A developmental neuroscientist by training, Dr. Hrynkow has worked passionately to advance science for the benefit of society. She serves on many advisory committees for national and international organizations, and has been recognized for her contributions to global health and global science by scientific and political leaders and organizations, including with the US President's Merit Award for Senior Executives, the Order of Merit from the King of Norway and elected Fellow of the American Association for the Advancement of Science. She is an elected member of the Council on Foreign Relations.
David E. Kang, PhD
Director, Division of Basic Research, Byrd Alzheimer's Institute
Fleming Endowed Chair in Alzheimer's Disease
Professor, Department of Molecular Medicine
USF Health Morsani College of Medicine
Dr. Kang is a Tenured Professor and Director of Basic Research at USF Health Byrd Alzheimer’s Institute, Morsani College of Medicine and a Research Neurobiologist at James A. Haley VA Hospital. He has been directing an active and collaborative research group focused on understanding the mechanisms of neurodegeneration in Alzheimer’s disease (AD) and related neurodegenerative disorders, such as Frontotemporal dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS). In his laboratory, they utilize various molecular, biochemical, cell biological, advanced imaging, and animal modeling (mouse & C. elegans) tools to answer important questions pertinent to healthy vs. pathological brain function. This goal is to gain insights from cutting-edge cell biology and neuroscience investigations to advance translational therapeutic strategies to treat or prevent neurodegenerative disorders. Specifically, they are interested in 1) mechanisms of Abeta production and neurotoxicity in AD; 2) signal transduction mechanisms between Abeta and tau in AD; 3) interplay between pathogenic proteins such as tau and the UPR activation in neurodegenerative processes; 4) tau triaging and aggregation mechanisms via RanBP9 and Hsp90/Hsc70 chaperone system in AD & TBI; 5) mechanisms underlying mitochondrial dysfunction in AD, FTD/ALS, and PD; 6) role of selective autophagy and mitophagy in the accumulation of toxic components in neurodegenerative processes; and 7) the study of extracellular vesicles (i.e. exosomes) as neurodegenerative disease biomarkers and agents of neurodegeneration. He has been fortunate to mentor successful postdoctoral fellows and graduate students, many of whom have established successful careers in academic research and/or medicine. Over the years, he has gained substantial administrative and leadership experience by serving as Director of Basic Research at the Byrd Institute as well as serving on key advisory committees, scientific panels, and editorial boards at multiple local and international institutions.
Gary S. Margules, Sc.D.
Vice President for Office of Research and Technology Transfer
Nova Southeastern University
Gary S. Margules, Sc.D. Dr. Margules has direct business experience in technology management, academic technology transfer, strategic planning, corporate ventures, R&D/project management, licensing, regulatory affairs, clinical trials, and product development. Prior to joining NSU, he gained twenty-nine years of research management experience; eight years with Cordis Corporation as Senior Scientist, three with Pfizer Hospital Products as Assistant Director of Technology Development, three with Senmed Medical Ventures as Director, Medical Technology, and fifteen with the University of Miami as Assistant Vice Provost for Technology Transfer and Industry Research.
Dr. Margules broad experience has given him an in depth knowledge in medical devices, therapeutics, biotechnology, and diagnostics. He earned Doctor of Engineering Science and Master of Science degrees in chemical/bio-engineering from Columbia University and a Bachelor of Science degree in mechanical/biomedical engineering from the University of Miami.
James J. Mulé, PhD
Associate Center Director, Translational Science
The Michael McGillicuddy Endowed Chair for Melanoma Research and Treatment
Scientific Director, Cell-Based Therapies
Moffitt Cancer Center
Dr. James Mulé is the Associate Center Director for Translational Science, the Michael McGillicuddy Endowed Chair for Melanoma Research and Treatment, and Scientific Director of Cell-Based Therapies at Moffitt Cancer Center. Dr. Mulé, who recently was designated a “Master of Immunology” by the American Association for Cancer Research, serves on Advisory Boards of numerous biotechnology and pharma companies (e.g., Fulgent Genetics, OncoPep, Iovance, GT Biopharma, Vault Nano, and Celgene, among others). Prior to his arrival in Tampa, Dr. Mulé helped to launch and scientifically direct two biotechnology companies in Palo Alto, CA, which were acquired by Sandoz (now Novartis). He also recently prepared both Novartis and Spark Therapeutics for presentations to the FDA, leading to the approval of Kymriah and Luxturnia, respectively. Dr. Mulé remains a long-standing special government employee to the FDA (both CDER and CBER) and the NCI. He was Chair of the Cellular, Tissue, and Gene Therapy Advisory Committee of CBER, FDA. Dr. Mulé has published nearly 200 articles in the areas of cancer vaccines and cancer immunotherapy.
Joshua M. Samek
Greenberg Traurig, P.A.
Josh Samek focuses his practice on mergers and acquisitions, public and private securities offerings, financing transactions and general corporate and business law matters. Josh represents a broad range of clients at all stages of development, including public companies, private equity funds and portfolio companies, start-up companies and private investors. Josh regularly counsels public companies and private investors on SEC reporting and compliance matters and serves as outside general counsel to various private companies. Josh received his J.D. from the University of Miami School of Law and a B.A. from the University of Michigan.
PAREXEL Access Consulting
Thom brings a broad array of experience to PAREXEL in his career in the life sciences industry and as a clinician. He brings significant experience in U.S. and global market access having worked in senior leadership roles in consulting organizations such as Double Helix Consulting, Heron Evidence Development, LLC, IMS (now IQVIA) Consulting and The Zitter Group.
In his role at PAREXEL he provides management and strategic oversight of engagements as well as acting in a project advisory capacity on content, methodology, quality and overall direction.
Relevant industry experience includes positions at Sanofi, as the Head of the Pricing & Contract Strategy team within their Pricing & Market Access group (U.S. and Global), and at Novo Nordisk, Thom was the head of the Pricing, Contract Operations, and Reimbursement team and has also worked BMS in Customer Channel Marketing, Policy and Reimbursement and has also worked at TAP Pharmaceuticals.
Thom holds professional credentials and has practiced as a Registered Physician Assistant, specialized in surgery and internal medicine. Relevant qualifications: Certified Physician Assistant (Surgery and Internal Medicine); Certificate of Professional Achievement (Wharton School of Business, University of Pennsylvania)
Dean J. Trantalis
City of Fort Laurderdale
Dean Trantalis was elected mayor of Fort Lauderdale on March 13, 2018. His election represented the largest victory in city history for a candidate running for a first term as mayor. Dean previously served on the City Commission representing District 2 from 2003 to 2006 and from 2013 until his ascension to the mayor's office. He twice served as vice mayor: from 2005 to 2006 and from 2016 to 2017. He has represented the city on the board of directors of the Broward League of Cities, the Broward County Homeless Continuum of Care Task Force, the Broward Water Resources Task Force and the Broward County-Palm Beach County Joint C-51 Reservoir Work Group.
Born and raised in Norwich, Connecticut, Dean attended high school at Norwich Free Academy. At Boston University, he majored in political science and graduated cum laude and with distinction in 1975. He received a Juris Doctorate in 1979 from Stetson University School of Law, while completing international law courses in Eastern Europe, Russia, and London. Dean was admitted to the Connecticut and Florida Bar Associations in 1980 and has practiced law in Broward County since 1982. He currently maintains a successful general law practice in Broward County with some emphasis in the areas of real estate, probate, estate planning, bankruptcy, and corporate matters. Commissioner Trantalis is a member of the Federal Bar and the National Association of Bankruptcy Attorneys.
Nicholas J. Virca
President & CEO
HedgePath Pharmaceuticals, Inc.
Nicholas Virca has served as President and Chief Executive Officer of HedgePath Pharmaceuticals, Inc. (HPPI) since August 2013. HPPI is a clinical stage biopharmaceutical company with a preliminary focus on the development of therapies for cancer in the United States of America market, with the first indication targeting basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome (also known as Gorlin Syndrome) for which HPPI intends to file an NDA with FDA in Q4 2018.
From 2008 until April 2012, Mr. Virca served as the Chief Operating Officer for LamdaGen Corporation, a privately held company focused on monitoring assays for biopharmaceutical development and manufacturing applications, as well as high-sensitivity detection for human diagnostic biomarkers, such as oncoproteins related to cervical cancer. From 2005 to 2008, Mr. Virca was Vice President for Global Biotechnology at Pall Life Sciences where he was responsible for growth strategies and programs in the biotechnology arena, including new technology and product initiatives, joint ventures, licensing and acquisitions. He also founded the first Scientific Advisory Board for Pall’s Biopharmaceuticals Division.
From 1997 to 2004, Mr. Virca was COO, and later CEO and President of Adventrx Pharmaceuticals focusing on anti-cancer drug development in human clinical trials. He was instrumental in transitioning the company from a private corporation to a listing on the American Stock Exchange. Mr. Virca held various marketing and general management positions at Damon Biotech, Promega Corporation, Nicolet Imaging Systems, Ortho Diagnostic Systems, Fisher Scientific, Waters, Ross Laboratories and Pfizer Diagnostics. He previously served on the boards of Adventrx Pharmaceuticals between 2001 and 2004, and Diametrix Detectors between 1991 and 1997. He earned a bachelor’s degree in Biology from Youngstown State University, is the co-inventor of packaging technology for enzyme research reagents, as well as co-inventor of three patents using itraconazole for treatment of cancer, and is a member of numerous biotechnology organizations for which he has been a speaker and organizer over the last several decades.