After a career spanning over 40 years, Tom Borgoyn has recently retired from Becton Dickinson. In that period of time, Tom has served in various roles in product development including designing electronics, developing software, leading product development core teams and managing an engineering department. Tom started his career working in the defense industry, designing and testing equipment for radar jamming pods, and he transitioned to working the majority of time in the medical diagnostics field. In his tenure in the medical field, he developed or led the development of instruments and systems for the detection of bacteria growth in normally sterile body fluids, rapid immunological tests for the flu, diagnostics tests to determine organism identification and antimicrobial susceptibility, and rapid molecular PCR tests for selective bacterial infections. Most recently, Tom was leading an effort in R&D in developing the process for coordinating multiple development projects to supply solutions for customers, in line with the recent focus on BD becoming more customer experience focused.
M. Jason Brooke is a Director in the Healthcare & Life Sciences Disputes, Regulatory, Compliance, and Investigations practice at Navigant Consulting, where he advises and assists medical device and connected health companies to overcome the challenges faced throughout the product lifecycle—from new product planning, research and development, and pre-market clearance/approval to post-market compliance. Jason is also the co-founder and General Counsel for Vasoptic Medical Inc., an early stage medical device company developing a mobile health solution for early detection of diabetic retinopathy. Mr. Brooke has nearly 15 years of experience in design, development, and commercialization of medical device and mobile health technology. Prior to joining Vasoptic Medical, Mr. Brooke was an Associate at Epstein Becker & Green P.C. where he counseled medical device, mobile health technology, and clinical decision support software companies on pre- and post-market legal and regulatory issues. In addition, he acted as co-counsel to the mHealth Regulatory Coalition and the CDS Coalition, developing policy recommendations on the regulation of mobile health technology and clinical decision support software.
Dr. Matthew Dowling, Ph.D. is Founder and Chief Scientific Officer of gel-e. Matt completed his graduate work at the Fischell Department of Bioengineering at the University of Maryland in May 2010 and has since pursued gel-e on a full-time basis. In 2005, after graduating in chemical engineering from the University of Notre Dame, he was awarded the Fischell Fellowship in Biomedical Engineering for his innovative ideas in drug delivery systems. Matt then co-created the gel-e platform, raising several initial grants to develop the technology, which led to being named the Dean’s Doctoral Research Award from the UMD Clark School of Engineering for his work on chitosan-based self-assembled soft materials for use in wound treatment. He has since successfully licensed gel-e from UMD and has raised another $2.0M in non-dilutive funding which has been astutely used to achieve a first FDA clearance for gel-e, a large and growing patent estate and numerous peer-reviewed publications in high-impact journals. Matt’s work was recently featured on the BBC TV program, Brave New World with Stephen Hawking.
Dr. Fischell is Professor of Medicine at Michigan State University and Medical Director of the Department of Cardiovascular Research as well as Director of the Interventional Cardiology Fellowship Program at the Borgess Heart Institute in Kalamazoo, Michigan. He has an active practice as an interventional cardiologist at the Heart Center For Excellence in Kalamazoo. After receiving his medical degree from Cornell University Medical Center in New York City, Dr. Fischell completed an internship and residency in internal medicine at Massachusetts General Hospital/Harvard University in Boston, and then completed his interventional cardiology fellowship at Stanford University Medical Center in Palo Alto, California. He was on the faculty at Stanford for five years, and then Director of the cardiac cath labs and interventional cardiology at Vanderbilt University from 1992-1996. Dr. Fischell is board certified in internal medicine, cardiovascular medicine and interventional cardiology. Dr. Fischell is an active inventor, with more than 90 medical device patents. He has served as principal investigator for 3 National Institutes of Health grants, as well as several other research grants. Dr. Fischell has research interests in vascular biology, interventional cardiology devices such as stents and renal denervation, and has presented more than 200 papers in the United States and abroad. A member of the editorial board of Cardiovascular Revascularization Medicine, Journal of Invasive Cardiology, and the Journal of Interventional Cardiology Dr. Fischell has authored more than 120 publications in peer-reviewed journals and more than 27 book chapters. He is founder or co-founder of ~10 medical device companies, and is currently founder and CEO of Ablative Solutions, Inc., a leading renal denervation company. He has received numerous awards and honors, including the Thorax Center Andreas Gruntzig Award for Inventor of the Year in 1997 and the CRT 2015 Innovation Award. He has had a longstanding interest in health and fitness and the effects on heart disease. Most recently he has authored the health and fitness book “Burn Calories While You Sleep; Change Your Metabolism to be Thin, Fit, healthy and live Longer,” with forward by Dr. Dean Ornish.
Dr. Woodie Kessel, M.D., MPH is a community pediatrician and child advocate with experience as an educator, investigator, and practitioner in medicine, public health, bioengineering, community-based programming, and public policy. Dr. Kessel is currently the CEK Senior Child Health Scholar in Residence at the C E Koop Institute, Dartmouth College and Medical School; Professor of Pediatrics, Geisel School of Medicine, Dartmouth College; and Professor of the Practice at the University of Maryland’s School of Public Health. Previously, Dr. Kessel served in the US Public Health Service as an Assistant Surgeon General and senior advisor on child and family health matters to the White House, Cabinet Secretaries, Surgeons General, and Health and Human Services officials spanning eight administrations. Dr. Kessel is actively involved in projects focused on eliminating child poverty, advocacy and science related the care and cure of rare diseases, community-based strategies to prevent gun violence for children, advancing prevention teaching and research, community data systems, eliminating e-cigarette use among teens; reducing childhood obesity and improving nutrition, and standards of care for newborns and children requiring cardio-thoracic surgery. Dr. Kessel serves on numerous boards, professional society committees, and an adviser to PBS, Sesame Workshop, and the Dairy Council.
Dr. Knight recently joined Penn State to lead research and graduate programs at the Behrend College in Erie, Pennsylvania. Prior to this academic appointment he was senior VP and CTO at Canon U.S. Life Sciences and Canon BioMedical, Inc., where he oversaw the R&D functions of both companies. During his career at Canon he established Canon’s biomedical research and development organization and facility in Rockville, Maryland, and led the development of the first products brought to market. Prior to joining Canon, Dr. Knight was a professor at James Madison University, where he taught and conducted research in molecular genetics and microbiology. He has published widely in his field and is an inventor on numerous patents in the area of diagnostic instrumentation and chemistry. He holds a Ph.D. from the University of Maryland and is a Fellow of the American Association for the Advancement of Science.
Advisory Board Chair
Claudio Knizek joined The Boston Consulting Group in January 2006 and is a Partner and Managing Director in BCG's Washington D.C. office. Throughout his tenure at BCG, he has focused on a variety of operational and strategic issues affecting the Industrial and Consumer Goods sectors. The majority of Claudio's work at BCG has been focused on operational topics, particularly manufacturing and supply chain. Claudio currently co-leads BCG's Manufacturing Topic globally. Prior to joining BCG, Claudio worked at A. T. Kearney for five years. Claudio has a B.S. and M.S. from Stanford University and an M.B.A. from Harvard Business School.
Steven Lehrer brings over 30 years of experience starting, growing and running life science-based businesses focused on commercializing new technology and expanding businesses globally. Steve has extensive experience in pharmaceutical, biopharmaceutical and biosimilar R&D, regulatory, operations and commercialization. In addition, he had led the development and commercialization of new drug delivery approaches for pharmaceuticals, multiple molecular genetic diagnostic tests and developed outcomes databases for bioinformatics and healthcare econometric modeling. Steve has built and run businesses in the U.S., EU, Brazil, India, Japan and SEA. He has managed several programs in China and served on the Board of Directors of a Chinese biopharmaceutical company. Steve Lehrer served as Head of Biologicals at Cipla Ltd., CEO at Cipla BioTec, President at Glycominds, EVP at Adamas Pharma, CEO at GeneOs Ltd, CEO at DNA Sciences and division President at Monsanto. Prior to Monsanto, Steve worked for McKinsey & Co. and P&G. Steve has a Master’s Degree from The Graduate School of Business at Harvard University and a BSE in Chemical Engineering, as well as a BA in Economics from the University of Maryland, College Park.
David A. Lindsay is Director of the Vaccine Clinical Materials Program (VCMP) at the Frederick National Lab (FNL), operated by Leidos Biomedical Research. He is responsible for the scientific/technical and administrative oversight of a cGMP pilot plant. The VCMP mission is to enable early phase I/II studies of candidate biologics-based vaccines developed by the Vaccine Research Center, an intramural research program at NIAID/NIH. While the focus to date has been on broadly neutralizing monoclonal antibodies for passive treatment of HIV-AIDS, there is a renewed emphasis on universal flu/influenza, and emerging/re-emerging infectious diseases of global significance including Chikungunya, Ebola, Malaria, RSV and ZIKA. David holds a bachelors of science degree in Chemical Engineering from Lafayette College (Easton, PA) and a Ph.D. from Johns Hopkins University (Baltimore, MD). He has 23 years of industry experience, beginning with cell culture process development to tech transfer to clinical and commercial manufacture of biologics. Prior to joining the FNL in 2015, David worked at at Schering-Plough Research Institute (now Merck) in Union, New Jersey, and most recently at MedImmune LLC-Astra Zeneca in Maryland.
As the founder of ChromoLogic, Dr. Menon is passionate about developing novel biomedical solutions that result in new biological insights and lead to superior patient outcomes while ensuring that the solutions are cost effective and affordable. Dr. Menon received his Ph.D. in physics from Purdue University, with an emphasis in sensor fabrication, instrumentation and novel data analytic methods that were applied at multiple national and international laboratories toward fundamental physics discoveries. Dr. Menon's early career was spent at Corning Incorporated and Northrop Grumman Mission Systems, where he was groomed for leadership positions in multiple businesses. Founded in 2007, ChromoLogic is a boutique product development organization developing innovative solutions that save lives and make the world secure. ChromoLogic's products range from bioinspired solutions for establishing traceability of items, such as medical implantables, to at-home HIV viral load analysis kits, and from an ophthalmic system to assess physiological stress to a unique digital telehealth platform. In addition to the company's broad product portfolio, ChromoLogic continues to develop instruments and assays that lead to new fundamental insights into the biome.
Dr. Antonios G. Mikos is the Louis Calder Professor of Bioengineering and Chemical and Biomolecular Engineering at Rice University. His research focuses on the synthesis, processing, and evaluation of new biomaterials for use as scaffolds for tissue engineering, as carriers for controlled drug delivery, and as non-viral vectors for gene therapy. He is the author of over 550 publications and 28 patents. He is a Member of the National Academy of Engineering, a Member of the National Academy of Medicine, and a Member of the Academy of Athens. He is a Founding Fellow of the Tissue Engineering and Regenerative Medicine International Society, a Fellow of the American Association for the Advancement of Science, a Fellow of the American Institute of Chemical Engineers, a Fellow of the American Institute for Medical and Biological Engineering, a Fellow of the Biomedical Engineering Society, a Fellow of the Controlled Release Society, a Fellow of the International Union of Societies for Biomaterials Science and Engineering, and a Fellow of the National Academy of Inventors.
Dr. Susanna Naggie completed her undergraduate degrees in Chemical Engineering and Biochemistry at the University of Maryland, College Park and her medical education at Johns Hopkins School of Medicine. She completed her internal medicine and infectious diseases fellowship training at Duke University Medical Center. She joined the faculty in the Duke School of Medicine in 2009. She is an Associate Professor of Medicine and currently holds appointments at DUMC (Director, Department of Medicine Clinical Research Unit), at the Duke Clinical Research Institute (Director of ID Research), and at the Durham Veterans Affairs Medical Center. Dr. Naggie is a clinical investigator with a focus in clinical trials and translational science in HIV and HCV. Dr. Naggie is a co-Chair of the AASLD/IDSA HCV Guidance Committee, and a member of the CDC/NIH/IDSA-HIVMA Opportunistic Infections Guideline Committee and the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents.
Dr. Michael O’Connor is the Director of Strategy and Project Management with Medtronic, Plc. Medtronic is a global healthcare solutions company committed to improving the lives of people through their medical technologies, services, and solutions. O’Connor has over 26 years of professional experience in the Medical Device Industry developing products from idea to commercialization. He holds patents in the areas of medical catheters and stents. He holds Graduate degrees in Project Management, Technology Management and Business Administration. O'Connor earned his Ph.D. in Civil Engineering, majoring in Project Management, from the University of Maryland A. James School of Engineering. He was selected as an American Society for Quality (ASQ), Quality Fellow and selected as a Medtronic, (TF) Technical Fellow. He is a former Director at Large for the Product Development and Management Association (PDMA) and has volunteered his time with many Professional Societies and Universities/Colleges over the past 15 years. He is also an Adjunct Faculty Member teaching graduate-level Project Management, Project Capstone and Culture and Organizational course(s). In addition to Medtronic, his corporate experience also includes 3M and Pfizer and three start up medical device companies.
Todd Pantezzi is a Senior Vice President with ICF, representing the firm’s public health, biomedical research, health informatics, information technology, management consulting, health communications, cyber security, survey research, and digital media consulting practices. He has been a growth executive and consultant in the federal health industry since 1992, primarily focusing on civilian health agencies (NIH, CDC, FDA, and EPA) representing corporations including CSRA, General Dynamics, United-Health Group, and Northrop Grumman, as well as small and mid-size firms. Mr. Pantezzi holds industry leadership positions including Trustee with The Children’s Inn at NIH, and chair of the Professional Services Council’s annual survey of the U.S. Department of Health & Human Services. He was named to the FedHealthIT100 in 2017.
Dr. Minh-Quan K. Pham is a patent attorney with over ten years of experience in protecting innovations and providing creative legal solutions through a unique combination of perspectives, including as an inventor, a scientist/engineer, an entrepreneur, an examiner, and an attorney. Dr. Pham is experienced in all aspects of intellectual property protection, including counseling, prosecution, litigation, licensing, and portfolio management. He has represented authors, artists, educators, engineers, physicians, scientists, as well as universities, small companies, and international corporations. Prior to his legal practice, Dr. Pham was a patent examiner in group 1600, examining biotechnology patent applications. He was also a founder of Chesapeake PERL, a recombinant protein production company. Dr. Pham received his B.S. and Ph.D. in Chemical Engineering from the University of Maryland, and his J.D. from the Georgetown University Law Center.
Dr. Leonard Pinchuk is a serial inventor and entrepreneur with 126 issued U.S. patents, 90 publications and 10 companies that he co-founded. His major accomplishments include the invention of the modern-day angioplasty balloon, the helical wire stent, the modular stent-graft, a drug-eluting stent (TAXUS®), several biomaterials, a novel glaucoma shunt and the next generation intraocular lens material. He received a B.Sc. in chemistry from McGill University (1976), a Ph.D. interdisciplinary in Engineering and Chemistry from the University of Miami (1984) and an honorary Doctor of Science degree from McGill University (2005). He was inducted into AIMBE in 2007 and the National Academy of Engineering in 2012. Dr. Pinchuk began his career in 1983 at Cordis Corporation and left in 1987 to co-found Corvita Corporation (angioplasty catheters, stents, stent-grafts), which went public in 1994, was acquired by Pfizer, Inc. (1996) and then sold to Boston Scientific (1998). Dr. Pinchuk founded Innovia LLC (2002), which incubated and spun off eight new companies working in the fields of intraocular lenses, glaucoma shunts, other catheters and biomaterials. His current company, InnFocus, Inc., which has developed a novel treatment for glaucoma, was acquired by Santen Corporation in May 2016, where he will be serving as CSO for the next three years. Dr. Pinchuk also enjoys an appointment as Research Professor of Biomedical Engineering at the University of Miami.
Dr. Jon A. Rowley is the Founder & Chief Technology Officer of RoosterBio Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. Jon holds a Ph.D. from the University of Michigan in Biomedical Engineering and has authored over 35 peer-reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. Jon started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr. Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon most recently spent five years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business, and currently resides in Walkersville, MD with his wonderful wife and their three young children.
Dr. Reginald Seeto, also known as Reg, M.D., MBBS, has been the Chief Operating Officer of Ardelyx, Inc. since October, 2016 and serves as its Executive Vice President. Dr. Seeto has more than 13 years of experience in strategic corporate development and senior marketing roles at major global pharmaceutical companies. Prior to joining Ardelyx, he spent eight years in roles of increasing responsibility at AstraZeneca and MedImmune, the Biologics Division of AstraZeneca. He served as Head of Partnering & Strategy and Vice President since 2013. From 2011 to 2012, he was on an expatriate assignment as the President of AstraZeneca Thailand, where he was the first MedImmune Executive to participate in a talent exchange and development program with AstraZeneca. Under his leadership, Thailand achieved its sales targets for the first time in 5 years and was awarded the RVP Award for Leadership for management of its worst floods in more than half a century. Before this he served as Executive Vice President of corporate development and strategy for MedImmune, where he was responsible for Business Development and Strategy teams that deliver external partnership strategy including academic collaborations, licensing of innovative assets and technologies and government alliances/partnerships and for all therapy area strategies. He had originally joined as Vice President of Global Strategic Marketing & Portfolio Management in 2008. Prior to MedImmune, he served as Vice President of Global Marketing for Schering Plough/Organon Biosciences. He worked as the Executive Director of US Marketing at Boehringer Ingelheim Pharmaceuticals and had served as an Engagement Manager at McKinsey & Company. He started his career as a Medical Doctor involved in both clinical practice and research. He has published several publications in peer-reviewed journals, including publications focused on his work in gastrointestinal research. Dr. Seeto earned both his B.S. and MB.BS. in medical studies from the University of Sydney, Australia and practiced medicine in Australia early in his career.
Dr. Michael L. Shuler is the Eckert Professor of Engineering in the Meing Department of Biomedical Engineering and in the School of Chemical and Biomolecular Engineering at Cornell University, and director of Cornell’s Nanobiotechnology Center. Shuler has degrees in chemical engineering (B.S., Notre Dame, 1969 and Ph.D., Minnesota, 1973) and has been a faculty member at Cornell University since 1974. Shuler’s research includes development of “Body-on-a-Chip” for testing pharmaceuticals for toxicity and efficacy, creation of production systems for useful compounds, such as paclitaxel from plant cell cultures, and construction of whole cell models relating genome to physiology. Shuler is CEO and President of Hesperos, a company founded to implement the “Body-on-a-Chip” system. Shuler has been elected to the National Academy of Engineering and the American Academy of Arts and Science.
Dr. Peter Soltani is a native of greater Washington, D.C. and has been involved in the medical device and diagnostics space for nearly 20 years. Peter’s early career involved technology innovation involving semiconductor and optical materials for energy conversion and imaging. He joined Hologic, Inc., a women’s health focus medical device and diagnostics company, in 2000 to lead their digital x-ray capture technology development, and eventually lead its global Women’s Health business segment. Notable accomplishment included helping develop Hologic’s digital mammography platform, now the leading product of its kind, the development and commercialization of the first 3D digital mammography system for early cancer detection, as well as innovations in tumor biopsy, tumor characterization, and surgical devices. Peter joined Siemens Medical Solutions in 2014 to lead its North American Healthcare Services business, helping develop solutions to meet the changing and complex needs of the healthcare delivery market. Peter joined Beckman-Coulter Diagnostics (a Danaher company) in January 2016 as Senior Vice President and General Manager, and leads its Hematology and Urine Analysis businesses based out of Miami, FL. Peter is a Maryland alumni, holding a BS in Chemistry (’83) and Ph.D. in Materials Science & Engineering (’94).
Dr. Adam Steel is the R&D Engineering Leader for Molecular and Microbiology platforms for Becton Dickenson’s Diagnostic Systems business unit. He leads a team of over 100 engineers across the disciplines of Mechanical, Electrical, Software, Systems, and Test Engineering. Adam is a member of the Molecular Leadership Team and works closely with business leaders in that capacity to drive new growth opportunities via technology and product development. He has been Vice President of R&D Product Development and GPDS since 2016. Adam received a B.S. in Chemistry and Mathematics from Gettysburg College and a Ph.D. in Analytical Chemistry from the University of Maryland, College Park. He has several U.S. and worldwide patents and has published over 20 papers.
Dr. Diana Yoon has been working as a regulatory scientist in the U.S. Food and Drug Administration (FDA) since 2011. She started as a Commissioner’s Fellow working on a project evaluating standards for premarket review of bone regenerative medicine products. During her tenure at the FDA, she has conducted premarket regulatory review in the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health. She is currently a Senior Scientific Reviewer for product classification and jurisdiction in the Office of Combination Products. In 2003, she received a B.S. in Chemical Engineering, Biomedical Engineering (Double Major) from Carnegie Mellon University. She attended University of Maryland, College Park (UMD) for her Ph.D. in Chemical and Biomolecular Engineering and graduated in 2008. During her time at UMD, she was awarded the Fischell Fellowship in 2006 for translational research in cartilage tissue engineering. She attended Rice University as a postdoctoral fellow to conduct bone tissue engineering research and was awarded the Gulf Coast Consortia Nanobiology Fellowship.