The MDG events continue. We’ll see you there!
| Combination Products for Drug Delivery Oct 30 – WednesdayWhat are the opportunities and advances in drug delivery? What are the unique developmental challenges? What are the opportunities for funding? Success requires collaboration between drug developers and device engineers. This is a challenge as these groups are accustomed to functioning under different types of regulations, design criteria, and controls. This panel is a mix of entrepreneurs, big pharma, and biotech developers who will discuss the medical and business challenges where delivery innovations can provide a unique solution. Entrepreneurs will discuss strategies for funding and development issues specific to drug delivery products. Speakers from big pharma and biotech will discuss challenges across the value chain of manufacturing and selling combination products globally. Benefits of Drug/Device CombinationsFor many drugs, significant benefits could be obtained by combining the drug with a specialized delivery device, when compared to drugs which are primarily delivered by systemic means (e.g. orally, intravenously). Advantages of Combination Products:Targeted delivery Reduced dosing of expensive compounds More control over the delivery profile Greater patient convenience/compliance The ultimate goal is to improve patient outcomes. The success of many new therapies is contingent on the development of effective delivery systems as traditional delivery methods won’t work for some compounds and biologics. Opportunities exist for combination products to extend the patent life of existing drugs on the market. A diverse set of scientific and engineering disciplines can converge to create elegant solutions to drug delivery problems. System level solutions may involve advanced materials, chemistry, sensors and software for monitoring and control. Oct 30 – Wednesday 5:30-8:30 PM Regis College, Fine Arts Center Join Us for a Discussion on the Growing Opportunities for Development of Combination Products |
| Bios of Our Distinguished Panel Michael J. Cima, PhD Professor, Materials Science and Engineering, Massachusetts Institute of Technology Dr. Cima is Associate Dean of Innovation at MIT, where he is Professor of Materials Science and Engineering and holds the David H. Koch Chair of Engineering. He is author of over 250 scientific publications, 50 patents, and is a recognized expert in the field of medical devices and materials processing. Professor Cima also has extensive entrepreneurial experience. He is co-founder and director of MicroChips Biotech, a developer of microelectronic based drug delivery and diagnostic systems, and helped start Transform Pharmaceuticals Inc.(acquired by J&J). He is a co-founder and director at T2 Biosystems and Taris Biomedical. Professor Cima is an inventor of 3D printing. He is developing implantable MEMS devices for controlling drug delivery. Dan Groszmann, PhD Senior Manager, Device Technology Innovation Center, AmgenDan Groszmann has over 20 years of experience in medical devices, pharma, and engineering consulting. He is currently a Senior Manager in Amgen’s Device Technologies organization, leading an innovation team in drug delivery applications for combination products out of their Cambridge, MA facility. Prior to joining Amgen, Dan was the Advanced Technology Manager for GE Healthcare’s Surgical Navigation business. During his tenure with GE, Dan led teams developing medical device technologies, managing external engagements, and launching commercial products. Dan holds a PhD and BS in Mechanical Engineering from Tufts University and an MS in Aerospace Engineering from Virginia Tech. He sits on the industrial advisory board for the UMass-Lowell Biomedical Engineering Department and has more than 25 issued and pending patents Maria Palasis, PhDPresident and Chief Executive Officer, Lyra TherapeuticsMaria Palasis has extensive experience in combination products and drug-delivery innovation A repeat entrepreneur, her transformative leadership as CEO, and previously CTO, of 480 Biomedical and Arsenal Medical resulted in >$160 million of external and non-dilutive funding and the advancement of multiple programs into the clinic. Earlier in her career, she managed a portfolio of external biotech and medical device investments at Boston Scientific and led the development of several combination therapies. She is an inventor on more than 120 issued and pending patents. Maria received her BS and PhD in Chemical Engineering from the University of Cincinnati, and she held a postdoctoral fellowship in molecular biology at the University of Cincinnati School of Medicine. Rami Tzafriri, PhDDirector of Research and Innovation, CBSETCBSET is a not-for-profit pre-clinical research organization dedicated to research, education, and the advancement of early-stage biomedical technologies. He provides scientific direction to translational research and publications, leveraging institutional expertise in computational modeling, histopathology, animal models and interventions, imaging, and bioanalysis. Rami received his PhD from the Hebrew University of Jerusalem for his research on biodegradable controlled release devices targeted toward the treatment of gingivitis and mammary tumors. He joined Professor Elazer Edelman’s laboratory at MIT where he developed quantitative models for growth factor biology and endovascular drug delivery and worked on the first FDA Workshops on Computer Methods for Cardiovascular Devices. Maria Shepherd – MODERATOR President and CEO, Medi-VantageMaria launched Medi-Vantage in 2008 and has worked with over 250 medical device companies on strategy research for acquisitions, pricing, commercialization of new technologies and assisting product development teams. Previously, Maria was vice president of marketing for Oridion, a start-up company acquired by Covidien/ Medtronic. Maria served as director of marketing in the critical care patient monitoring division of Philips. Co-Champions Paul Hartung, MS Board Director MDG Geoff Moodie, PhDSenior Principal Scientist The Getinge Group |