OVERVIEW
FREE ON DEMAND WEBINAR AVAILABLE HERE.
Biologic therapy has revolutionized the medical treatment landscape. However, simplicity and ease of administration remains a challenge to achieve long-term patient compliance and optimal therapeutic outcomes. Given the high cost of biologic therapies, it is the duty of pharmaceutical companies to develop non-invasive formulations that improve patient acceptance and efficacy. Partnerships are an increasingly attractive pathway for accelerating development from basic biological understanding to formulation considerations.
Academic and industry drug delivery experts will share the current challenges and opportunities with alternate routes of delivering large molecules orally, via inhalation, using microneedles and minimally invasive methods for ocular delivery. Two case studies for oral delivery of large molecules will also be shared during the 60 minutes webinar. Q&A session will then follow.
Key Learning Objectives:
- Addressing the key challenges of large molecule delivery: physical, physiological & biochemical barriers
- The promise of alternate methods of delivery for patients and improved outcomes
- Building research collaboration networks
FREE ON DEMAND WEBINAR AVAILABLE HERE.
MEET THE EXPERT PRESENTERS
Randy Mrsny, Ph.D.
University of Bath, Chair of the NMDC
Randall Mrsny obtained a BS degree in Biochemistry and Biophysics and a PhD degree in Anatomy and Cell Biology from the University of California at Da avis undergraduate and medical school campuses, respectively. As an NIH post-doctoral fellowship he studies membrane lipid-protein interactions at the Institute of Molecular Biology located in the University of Oregon Eugene campus. Prior to taking Professors’ post in Cardiff University and now the University of Bath, Randy led research groups in two companies: ALZA and Genentech. He has been involved in starting two new biotech companies through the acquisition of venture capital funding. Randy has been elected president of an international society and organized international meeting. He currently serves as a reviewer or advisor for multiple international agencies and companies.
Dr. Siddhesh Patil
Takeda Pharmaceuticals, Oral Working Group, Industry Co-Chair, NMDC
Dr Siddhesh Patil, is a scientist and research leader at Takeda Pharmaceuticals. In his current role Siddhesh leads a group that develops dosage formu ulation using novel technologies that enhanced clinical differentiation and increase patient compliance. Siddhesh is passionate about adoption of pharmaceutical innovation to improve clinical outcomes. Siddhesh currently serves on the editorial board of the International Journal of Pharmaceutics. In his prior roles, Siddhesh has been a member of research teams that have successfully developed and commercialized protein/peptide formulations including injectables and microspheres. Additionally, he obtained his MS degree in Pharmaceutical Sciences in 2000 and his PhD degree in Pharmaceutical Sciences in 2002, both from the University of Connecticut.
Dr. Ralph W. Niven
MBA, Novartis, Pulmonary/Nasal Working Group, Industry Co-Chair, NMDC
Dr. Ralph W. Niven, MBA, serves on the site management team of Novartis in San Carlos. He has previously held executive positions within APT Pharmaceu uticals, Discovery Labs and Advanced Inhalation Research and started his industrial experience at Amgen developing proteins and peptides suitable for inhalation. Throughout his career he has had an ongoing interest and direct involvement in the development of numerous inhaled products. Ralph is the current treasurer of the International Society for Aerosols in Medicine. He received his PhD from the University of Kentucky and his MBA from George Washington University.
Dr. Justin Hanes
Johns Hopkins University, Ocular Working Group, Academic Co-Chair, NMDC
Dr. Justin Hanes is the Lewis J. Ort Professor and Director of the Center for Nanomedicine at the Johns Hopkins University School of Medicine. He hold ds faculty appointments in Biomedical Engineering, Chemical & Biomolecular Engineering, Environmental Health Sciences, Neurosurgery, Oncology, and Ophthalmology. He is a founder and former member of the board of directors of Kala Pharmaceuticals, and he is a founder, Chair of the Board of Directors, and former CEO of GrayBug, a company developing advanced drug delivery systems with a focus on the treatment of diseases that affect vision. He also recently co-founded Theraly Pharmaceuticals and Theraly Diabetes. He serves on the scientific advisory board of the Controlled Release Society and has served on the scientific advisory board for Genentech in the Drug Delivery Division. He serves on the editorial boards of ten journals focused primarily and nanotechnology, pharmaceutical science, biomaterials and drug delivery. He is the Chair of the Gene and Drug Delivery study section for the NIH. Justin is a fellow of CRS, AAPS, and the American Institute for Medical and Biological Engineering. He received a B.S. in Chemical Engineering from UCLA in 1991 and Ph.D. in Chemical Engineering from MIT in 1996. He did postdoctoral training in Oncology and Neurosurgery at the Johns Hopkins University School of Medicine in 1996-1998.
Dr. Mark Tomai
3M, Transdermal Delivery
Mark Tomai has a PhD in immunology from the University of Minnesota. For the past eight years he has been Head of Microneedle and Toll-like Receptor B Business Development at 3M Drug Delivery Systems. During his first 16 years in the industry he held a variety of positions with increasing responsibility in drug discovery and preclinical development. He is an author on over 80 publications and is an inventor on 12 issued patents in this area.
Julien Meissonier
Executive Board Member, Catalent Institute R&D Platform Director, Rx Softgel
Julien Meissonnier has 15 years of experience in pharmaceutical development and leads Catalent’s European R&D Platform for the development of lipid-based drug delivery solutions. He provides technical and scientific leadership for the development of poorly soluble drugs that lead to approvable regulatory dossiers. Mr. Meissonnier received his Engineering Degree in Physico-Chemistry from the ISMRa in Caen, France. He is an expert in his field and currently sits on the Board of Directors with the Alsace BioValley life sciences and healthcare cluster based in France. As a board member, he supports Alsace BioValley in its efforts to continue driving growth in the life sciences by identifying and coordinating ambitious projects that will create employment opportunities in the region.
