Dr. Matthew DowlingDr. 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.

Woodie Kessel

Woodie Kessel, B.S.E.E., M.D., M.P.H., is a 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 U.S. 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. Ivor KnightDr. 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.

Claudio KnizekAdvisory 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

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.    SBLehrer LLC works with life science companies to develop and introduce drugs worldwide.  Steve has extensive experience in pharmaceutical, biopharmaceutical and biosimilar R&D, regulatory, operations and commercialization. In addition, his companies and businesses have developed and commercialized 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 US, EU, Brazil, China, India, Japan and SEA.  Steve previously 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 B.S.E. in Chemical Engineering as well as a B.A. in Economics from the University of Maryland.

David Lindsay

David Alexander Lindsay, PhD is the Directorate Head of the Vaccine Clinical Materials Program (VCMP), within the Clinical Research Directorate at the Frederick National Lab (FNL) in Maryland, He is responsible for the scientific, technical and administrative oversight and operation of a good manufacturing practices (GMP) vaccine pilot plant. The mission of the VCMP at FNL is to advance the development, manufacture, analytical testing, release and regulatory support of biologically-derived clinical materials, discovered/developed by the Vaccine Research Center (VRC) at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), for subsequent evaluation in Phase I/II clinical trials in humans. While the focus to date has been on broadly neutralizing monoclonal antibodies (mAbs) 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, Tuberculosis and ZIKA. At present, the pilot plant is engaged in all aspects of product development relating to novel, structure-based vaccines, nanoparticles and peptide conjugates for HIV and Influenza, as well as a variety of different mAbs directed at different HIV epitopes, and unique Ebola virus and Malaria targets.  David holds a B.S. degree in Chemical Engineering from Lafayette College (Easton, PA) and a PhD from Johns Hopkins University (Baltimore, MD). With research interests straddling the fields of Virology and Bio/Chemical Engineering, David is a passionate leader that believes in advancing science-based, collaborative partnership-based solutions to public health challenges faced by patients nationally and globally. He has over 24 years of industry experience, including cell culture process development to tech transfer to clinical and commercial manufacture of biologics/recombinant vaccines. Prior to joining the FNL in March 2015, David worked at MedImmune LLC-Astra Zeneca in both Gaithersburg and Frederick locations (2002-2014), Schering-Plough Research Institute in Union, New Jersey (1995-2002), and the University of Maryland at College Park’s bioprocess scale-up facility (1994-1995).

Naresh MenonAs 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. Susanna Naggie

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 with Tenure and currently holds appointments at the Duke University School of Medicine, 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 current member of the DHHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and was a prior co-Chair of the AASLD/IDSA HCV Guidance Committee. She services the Duke SOM as the Associate Dean of Clinical Research and Regulatory Affairs.

Dr. Michael O'ConnorDr. Michael O’Connor is the Director, 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 28 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 Clark School of Engineering. He was selected as an American Society for Quality (ASQ), Quality Fellow, Fellow of the American Academy of Project Management (FAAPM) and selected as a Medtronic, (TF) Technical Fellow. He is currently a Minnesota PMI Board Member and Director at Large. He is on the Biomedical Engineering Society (BMES) Educational Committee and is also a member of the BMES Wallace H. Coulter Healthcare Innovation Award Subcommittee. He is also an Adjunct and Community Faculty Member teaching graduate-level Project Management, Project Capstone, Project Procurement, and Culture/Organizational course(s).

Todd PantezziTodd 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 PhamDr. 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. Jon Rowley

Dr. Jon A. Rowley is the Founder & Chief Product 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. Reg Seeto

Dr. Reginald Seeto has over 20+ years of experience in the healthcare and life sciences field. He is the President and CBO of CareDx a public biotech that is a leader in transplant diagnostics, where his responsibility includes the business development, commercial units, manufacturing and operations, R&D and international operations. Prior to this, he was the Chief Operating Officer of Ardelyx, a public biotech where he oversaw business development, commercial operations, corporate strategy and medical affairs. His experience also included being a member of executive leadership team at MedImmune, the Biologics unit for AstraZenecan in his roles as Head of Partnering & Strategy, and as Executive Vice President of Corporate Development and Strategy. He first joined MedImmune as Head of Global Strategic Marketing and Portfolio Management and later worked as a country General Manager for AstraZeneca in Asia. Earlier in his career, Dr Seeto led the Fertility and Emerging Biotech Franchises (oncology, immunology, vaccines) for Organon Biosciences as the Vice-President of Global Marketing and Flomax for Boehringer Ingelheim, which he grew to be a blockbuster and company’s largest selling US product at that time. He started his career as a physician, before then joining the strategy consulting firm, McKinsey and Company.

 

Dr. Peter Soltani

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 focused medical device company, in 2000, where he led the company’s Women’s Health business segment. Notable accomplishments included helping develop Hologic’s digital mammography platform, and development and commercialization of the first 3D digital mammography system for early cancer detection. Peter joined Siemens Medical Solutions between 2014-2016 to lead its North American Healthcare Services business, helping develop solutions to meet the changing and complex needs of the healthcare delivery market. Peter has been with Beckman Coulter Diagnostics, Inc. (a Danaher company) since early 2016, leading its Hematology and Urine Analysis businesses.

 
Dr. Adam SteelDr. 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 YoonDr. 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.

 

Emeritus Members

 

Dr. Tim Fischell

Dr. Fischell is Professor of Medicine at Michigan State University, Clinical Professor of Medicine at Western Michigan 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. He is an active inventor and serial entrepreneur, with more than 100 medical device patents, founder or co-founder of 7 medical device companies, and recently was elected (2017) as a Fellow in the National Academy of Inventors (NAI).

Dr. Leonard Pinchuk

Dr. Leonard Pinchuk has 129 U.S. patents, 90 publications and founded 10 companies.  His major accomplishments include the invention of the Nylon 12 angioplasty balloon, the helical wire stent, the modular stent-graft, a drug-eluting stent (TAXUS®), several biomaterials (Bionate® and SIBS), a novel glaucoma tube (the InnFocus MicroShunt®) and the next generation intraocular lens.   His inventions are used in hundreds of millions of patients with a financial impact well over $100 billion.  He was inducted into the National Academy of Engineering in 2012, was awarded the 2017 Society for Biomaterials Innovation and Technology Award, San Antonio’s BIOMED SA Award (2017) and the National Academy of Engineering 2019 Fritz J. and Dolores H. Russ Prize. He received a B.Sc. in chemistry from McGill University (1976) and a Ph.D. interdisciplinary in Engineering and Chemistry from the University of Miami (1984).  Dr. Pinchuk co-founded Corvita Corporation (1987) which went public in 1994, was acquired by Pfizer, Inc. (1996) and then sold to Boston Scientific (1998).  He then founded Innovia LLC (2002), which spun-out InnFocus, Inc. (2004) which was acquired by Santen Pharmaceuticals in 2016.  Dr. Pinchuk also enjoys an appointment as Distinguished Research Professor of Biomedical Engineering at the University of Miami.


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