January 23, 2017: Novel Drug Delivery (NDDS) — Sprays, gels, capsules and MEMs, how do they best get where they need to go?
As we undergo major changes in the pharmaceutical sector it is important to remember that industrial transformations are not new in our industry. This presentation will highlight innovation dilemmas we face as they relate to several themes that are important to drug delivery technologies (i.e., Drug Metabolism & Pharmacokinetics, analytical, patient-centered design, business needs, etc.).
Examples will highlight some of the challenges and opportunities the pharmaceutical industry faces concerning the selection and implementation of new technologies related to the needs of patients with the goal of understanding how to get the dosages delivered with better distribution, improved targeting, lower dosages and more (and thus, improved efficacy).
Lastly, we will explore the need to seek patient input to validate our ideas and new processes using approaches that are currently being applied by start-up companies.
- Manuel Sanchez-Felix, Ph.D., FRSC, Senior Fellow, Novel Delivery Technologies, Novartis Institutes for BioMedical Research, Inc.
- Nick Pacelli, Vice President, Alliance Management & Business Development, Microchips Biotech, Inc.
- Jeannine Coburn, PhD, Assistant Professor of Biomedical Engineering, WPI
Professor Jeannine Coburn received her Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University in 2012. Before joining WPI in July of 2016, she worked as an NIDDK/NIH Ruth L. Kirschstein Postdoctoral Fellow in the laboratory of David L. Kaplan at Tufts University in Medford. Her research focuses on biomaterials for tissue engineering and drug delivery applications, specifically on developing functionalized biomaterials to elicit a desire response. Her research has been published in journals including Science Translational Medicine, the Proceedings of the National Academy of Science, Advanced Functional Materials, Biomaterials and the Journal of Controlled Release.
Dr. Coburn will discuss her work using implantable silk fibroin-based biomaterials for drug delivery applications, with a focus on sustained release of cytotoxic chemotherapy agents and briefly introducing clinically marketed implantable chemotherapy delivery systems. She will discuss some of the unique properties of silk fibroin which make it a unique material for drug delivery. From a drug carrier perspective, she will describe the mechanism of interaction of the two drugs she studied in-depth, doxorubicin and vincristine, and how she used this information to create modified silk fibroin materials for tuning drug-silk interactions thereby tailoring the drug release kinetics. From a translational prospective, she has been working with Dr. Bill Chiu at the University of Illinois at Chicago. She will describe some of theor findings using these drug delivery systems in a pre-clinical orthotopic human neuroblastoma model. Finally, she will offer her prospective on drug delivery systems for cancer therapeutics and the application of local delivery systems in more recent advances of cancer treatment therapeutics.
Nick Pacelli joined Microchips Biotech as Vice President of Alliance Management and Business Development in 2015, bringing 14 years of product development and partnering experience in the medical device and biologics sectors. Previously, he served as Associate Director, Project Management in the Early Intervention Business Unit at Zimmer Inc., where he held alliance management, technical sales support, and product management responsibilities for one of the company’s partnered products, Gel-One® Hyaluronate. During that time, he also evaluated external technologies for licensing or acquisition to expand the unit’s portfolio and pipeline. Prior to that, he held positions at Zimmer in product development and research where his work focused on the design and development of novel orthopedic device technologies for the spine and trauma markets.
Nick has proven experience across all stages of product development and has a successful track record of leading large-cross functional teams to support complex commercialization projects. In addition, he brings a significant background in international business, strategic planning and portfolio development. He holds a Bachelor of Science in Mechanical Engineering from the University of Notre Dame.
Dr. Manuel Sanchez-Felix is a Senior Fellow with the Chemical and Pharmaceutical Profiling (CPP) group at the Novartis Institutes for BioMedical Research in Cambridge, MA. He is a scientific leader with over 20 years of experience in Drug Discovery and development where he co-invented and contributed to the successful development and launch of various pharmaceutical products.
At Novartis, Dr. Sanchez-Felix leads a cross-functional group from Discovery and Development that is responsible for Novel Delivery Technologies. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Manuel was at Eli Lilly & Company for 20 years. His area of expertise includes Biopharmaceutics, drug delivery and patient-centered formulation design. Areas of drug discovery where he has developed products include CNS, infectious diseases (specifically tuberculosis), oncology, bone regeneration, and diabetes.
Dr. Sanchez-Felix received his B.Sc. Honors degree and Ph.D. in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he joined the Advisory Board for the Biomedical Program at Middlesex Community College and is a member of the Scientific Advisory Board member of an instrument company.
February 27: The Human Microbiome - I Contain Multitudes
Over 150 years ago, Walt Whitman captured the timeless observation: 'I contain multitudes,' in his first edition of Leaves of Grass. Little could he have imagined during the Antebellum, the deep biological truth his commentary on the American condition would foreshadow. Today new advances in molecular and cellular biologies along with high-fidelity sequencing methods have allow us to begin to catalog the zoo of organisms that co-inhabit our bodies. These organisms are not part of the human genome yet play profound roles in determining our health, well-being and medical responses. A co-evolutionary manifold of interactions has led to a dynamic world of life within us.
Our guts, mouths, noses and ears, skin, birth canals and, in some minds, even our appendixes host a collective microbial and fungal ecosystem expressing over 3 million genes while we as humans have just over 20,000 expressed genes ourselves. Come hear our panel of experts discuss the latest understandings of this fascinating microcosm in terms of nutrition, disease, healthcare and personalized medicines.
The significance of these early findings might stand as being as important as germ theory developed in Whitman's world as Ed Young's recent book, I Contain Multitudes, has become to us and our descendents today.
- Shrish Budree, MD MBChB DCH FCPeds, currently pursuing his PhD
- George "Buzz" Kenney, PhD, President & CEO - EntraTympanic, Founding Principal - Great Dome Associates
- Beth A. McCormick, Ph.D., Vice Chair, and Founding Executive Director, University of Massachusetts Center for Microbiome Research
- David A. Sela, PhD, UMass-Amherst
Moderated by Mark Hediger, PhD
Shrish Budree, MD MBChB DCH FCPeds is a pediatrician and pediatric gastroenterologist from South Africa and is currently pursuing his PhD. His research is focused on the role of the intestinal microbiome in childhood disease. He completed his medical, pediatric and pediatric gastroenterology training at the University of Cape Town and the Red Cross Children’s Hospital in South Africa. He worked as a research fellow for a year on a large Gates Foundation funded pediatric cohort study based in Cape Town, South Africa. He was then awarded the Discovery Foundation research fellowship with the aim to learn how to conduct computational analysis of the intestinal microbiome and spent a year in the Xavier microbiome laboratory at the Broad Institute of Harvard and MIT in Boston. His interest in fecal microbiome transplantation stems from both his clinical gastroenterology background and his current microbiome research and he is enthusiastic to pursue further research in this exciting field.
George "Buzz" Kenney, PhD, President & CEO - EntraTympanic, Founding Principal - Great Dome Associates, Board Member,The CENE holds his SB, SM & ScD, Materials Science & Engineering fro MIT and has 30 years of experience in building technology development teams in advanced materials at MIT and in startups. He was the Associate Director of the Materials Processing Center and the Microphotonics Center at MIT. He was also the Director of MIT’s Materials Processing Center Industry Collegium.
Dr. Kenney specializes in the creation of vertically integrated multidisciplinary technology to enhance performance, develop innovative new solutions, or address unmet needs in technologies from electronics and microphotonics to medical devices.
Dr. Beth McCormick is Professor and Vice Chair, and Founding Executive Director of the University of Massachusetts Center for Microbiome Research. Her academic career has been dedicated to gastrointestinal research, and she has made seminal contributions toward the understanding of how enteric bacteria (commensal, pathogenic, or probiotic) colonize the intestine and interact with the host. Dr. McCormick’s work provided the first evidence that epithelial cells in response to pathogen contact orchestrate a pro-inflammatory program, which recruits inflammatory cells. She has since identified new, previously unidentified and unexpected virulence mechanisms that are key to the inflammatory response, leading to both novel biological principles of host-microbe interactions and therapeutic intervention strategies for the treatment inflammatory bowel disease, and cancer. Research programs in Dr. McCormick’s laboratory are focused on Mucosal inflammation, cancer biology, and host:microbe interactions (including microbiome sciences). Her research interest in the microbiome field is centered on understanding the role of the intestinal microbiota in autoimmune diseases, such as multiple sclerosis, and inflammatory bowel disease.
Dr. Sela’s research group at UMass-Amherst investigates molecules secreted in breast milk that are not directly digested by the infant. Instead these exogenous molecules (e.g. glycans) direct the establishment and function of the infant microbiota. Thus a central thrust of the Sela Lab's research mission examines the ecological interactions between microbiota and their host in response to shifts to dietary molecules. In addition, Dr. Sela is interested in translating fundamental science to deliver and optimize molecules to manipulate one's microbiome at several stages of development. Ultimately, Dr. Sela’s lab seeks to characterize the molecular mechanisms underlying host-microbial interactions to enhance human health through nutritional interventions.
March 20, A Biopharma CRO/CMO Panel Discussion
with Shelley Amster and panel.
Committee: Jerry Shapiro & Barbara Finer, co-chairs, Mark Hediger, Carmel Denis, Howard Lin, Bruce Rogers