In 2012, Kurt Nielsen, Ph.D. was named Chief Technology Officer and Senior Vice President – Research & Development at Catalent Pharma Solutions. He is responsible for driving innovation activities and investments across Catalent’s broad range of advanced dose forms. His expertise in scientific strategy development, oversight of clinical development, medical affairs and research and development combines scientific and business acumen in the service of Catalent’s customers. Dr. Nielsen joined Catalent in 2010, and served as CTO and SVP of Innovation & Growth. Dr. Nielsen has applied his extensive pharmaceutical, scientific and academic background and connections to form the Catalent Applied Drug Delivery Institute where he currently serves as acting chairman. The Institute’s initiatives and activities allow for cultivation of leadership and excellence in drug development and delivery through education, training and innovation. Dr. Nielsen holds a PhD in chemistry from Villanova University and a BS in chemistry from the University of Delaware.
Mark Tomai, Ph.D.
Head of TRL and MTS Business Development, 3M Drug Delivery Systems
Mark Tomai has a Ph.D. in Immunology from the University of Minnesota. For the past 8 years he has been the Head of Microneedle and TLR Business Development at 3M Drug Delivery Systems. Prior to 3M and for his first 16 years in the industry, he held a variety of positions with increasing responsibility in drug discovery and preclinical development. Dr. Tomai’s an author on over 80 publications and is an inventor on 12 issued patents.
Director, Formulations Development at Catalent Pharma Solutions
Irena McGuffy joined Catalent in 2007, and leads a team of experts responsible for lipid-based formulation and softgel development. She is also a member of Catalent’s Softgel IP Review Board. Prior to Catalent, Irena’s experience and background was primarily in solid dosage form development, specifically in generics, immediate and controlled release products, as well as formulation of poorly soluble compounds.
Irena has over 12 years of experience in the pharmaceutical industry and is an active member of the AAPS. She holds a Bachelor’s degree in Pharmacy and a Master’s degree in Pharmaceutical Sciences from the University of Zagreb, Croatia. She is a registered pharmacist and working towards her Pharm.D. degree at the University of Florida.
Dr. Conrad Winters
Director Drug Product Development, Hovione
Conrad has a background in solid state pharmaceutics with a PhD in Pharmaceutical Technology from the University of Bradford, UK and 20 years’ experience in the Pharmaceutical industry. He has worked on a number of programs that became marketed drugs and has extensive experience in particle design, materials characterization and formulation development. He has worked on oral, parenteral, topical and inhalation formulations while always focusing on material properties, interactions and the effects of processing. Conrad leads the Drug Product Development group at Hovione, in Portugal. Prior to joining Hovione, Conrad led the Compound Properties group at Xenon Pharmaceuticals in Vancouver and spent thirteen years in Pharmaceutical Research and Development with Merck and Co. in Canada and the U.S. He was an invited speaker at conferences in Canada, the U.S. , Asia and Europe and has presented to the FDA and MHRA.
Dr. Marshall Crew
President and CEO, Agere Pharmaceuticals
Dr. Marshall Crew has 17 years of experience improving oral bioavailability with solubilization technologies. Marshall has spent his career developing technologies for the delivery of poorly soluble drugs, and then managing their application to achieve client success. Recognized as an innovator in drug delivery and solubilization, he has over 28 patents and patent applications to his name on various drug delivery platforms including controlled release, nanotechnology and solid dispersions. His scientific expertise includes formulation design and development, solid state characterization of drug substance and product, and computational modeling (predicting shelf-life and pharmacokinetic and bioavailability for oral, devices and parenteral delivery). Marshall holds a PhD in Physical Chemistry from Oregon State University, and is a member of Agere’s Board of Directors.
Dr. Scott Burton
Senior Research Specialist, 3M Drug Delivery Systems
Dr. Scott Burton has 25 years of experience in pharmaceutical research and development, and leads the 3M Hollow Microstructured Transdermal System (hMTS) New Technology team. He provides pre-clinical and clinical technical leadership creating the technical basis for commercializing hMTS. Dr. Burton received his Ph.D. in Pharmacology from the University of Utah. He is also an expert in transdermal drug delivery and chronic wound dressings holding 14 patents.
Dr. Ralph Lipp
Founding Advisory Board Member, Catalent Institute
President & CEO of Lipp Life Sciences, LLC
Dr. Ralph Lipp has more than 20 years of experience in the life sciences industries. Before founding Lipp Life Sciences LLC, where he advises clients on innovation-based value creation, he served as Vice President Pharmaceutical Sciences R&D at Eli Lilly and Company and Head Pharmaceutical Development at Schering AG. He holds a degree in Pharmacy from Johannes Gutenberg University (Germany) and obtained a Ph.D. in Medicinal Chemistry as well as a Habilitation for Pharmaceutical Technology from Free University Berlin (Germany). He graduated from INSEAD’s (France) International Executive Program and from Harvard Business School’s (USA) Advanced Management Program. Ralph’s scientific contributions comprise over 120 publications, including more than 20 patents, covering 5 marketed medicines.
Dr. Donn M. Dennis, M.D., F.A.H.A.
Chief Science Officer and Co-Founder, Xhale Inc.
Dr. Donn Dennis, a board-certified anesthesiologist and is Chief Science Officer and co-founder of Xhale. He had previously served in executive leadership positions at various pharmaceutical companies in the San Francisco area. In addition to his work with Xhale, Dr. Dennis is a professor in the Departments of Anesthesiology, Psychiatry and Pharmacology and Experimental Therapeutics in the College of Medicine at the University of Florida, where he also holds the Joachim S. Gravenstein, MD Endowed Chair in Anesthesiology. Dr. Dennis and his colleagues have secured numerous federal, state, and foundation awards, including ten SBIR grants (nearly $8.5 million dollars) from the National Institutes of Health and National Science Foundation to develop drug delivery-related technologies. He is a prolific inventor, and was inducted in 2013, as a Charter Fellow of the National Academy of Inventors.