Join your colleagues for these in-depth interactive sessions where a panel of experts will share their findings and opinions, creating an extended discussion on focused topics.
Speakers subject to change.
Drug Delivery in the Context of Global Health
Sunday, July 17
3:00 - 4:30 — Room 6A
This panel will discuss the important role that companies, foundations and non-governmental organizations are playing in addressing global health challenges. Learn how the constraints facing emerging markets require new business models and innovation. Companies, foundations and non-governmental organizations increase access to health for the world’s most vulnerable by delivering simplified vaccinations, therapies and more effective contraceptives. Join the conversation with panelists from The Bill & Melinda Gates Foundation, the Washington Global Health Alliance, GlaxoSmithKline and more.
Ramin Darvari, Pfizer, Chair
Ramin Darvari is an Associate Research Fellow in Novel Delivery Technologies group at Pfizer, a strategic group focused on evaluation of external delivery technologies and internal delivery formulation development. Ramin leads the efforts on evaluation and development of particle- and gel-based drug delivery systems for variety of applications, from parenteral and pulmonary dosage forms, to targeted delivery and high-volume subcutaneous delivery. Prior to joining Pfizer in 2009, Ramin led the drug delivery technology development programs at Epic Therapeutics (a subsidiary of Baxter Healthcare Corporation), including particle engineering and formulations for pulmonary delivery of biologics, polymeric depot systems for long-acting biologics, and particle-based high concentration monoclonal antibody delivery. He also took part in developing medical diagnostics during his tenure at IGEN International (currently part of Roche Diagnostics). Ramin holds a BS in Molecular Biology and a MS in Biotechnology from Middle East Technical University in Ankara, Turkey, and a PhD in Biomedical Sciences from Northeastern University in Boston.
Debra Bingham, Valeo Partners, Moderator
Debra Bingham is a partner with Valeo Partners, headquartered in Washington, DC, a leading consultancy providing advisory services to large and emerging Pharma clients in North America, Europe, Asia, the Middle East, and Latin America. Debra has more than 16 years of experience working with clients in the drug delivery and pharmaceutical industries. Her clients include multi-national pharmaceutical, biotech, medical device, and chemical companies as well as medium to small specialty pharma and drug delivery companies. As a result of deep area expertise, Debra is often asked to consult in the area of drug delivery. Debra is the current President for the Controlled Release Society, a member of the Editorial Advisory Board for the Drug Delivery Technology Magazine, a member of the Advisory Board for the Drug Delivery Partnerships Annual Meeting 2009-2012, is an invited speaker at many industry conferences, and has written numerous articles and white papers on pharmaceutical markets and technologies.
Matthew Burke, GlaxoSmithKline, Panelist
Matt Burke serves as Head of Drug Delivery in the Platform Technologies & Science Department at GlaxoSmithKline. He leads a group guiding the drug delivery strategy at GSK which includes internal development and application of technologies as well as external evaluation. Dr. Burke also serves as a project lead for an asset in late phase clinical development and is a master subject matter expert on oral modified release and continuous manufacturing. Dr. Burke has worked at multiple sites in the US and UK within GSK, has approximately 30 articles, patents and symposium presentations. He has served as an adjunct professor at North Carolina State University Biomolecular and Chemical Engineering department and University of North Carolina at Chapel Hill School of Pharmacy and received his PhD in Oral Colonic Drug Delivery Systems.
Jessica Crawford, VillageReach, Panelist
Jessica Crawford is the Health Systems Group Lead at VillageReach, an organization dedicated to increasing access to quality healthcare in remote, underserved communities. Jessica has developed and led a broad portfolio of health innovations focused on health systems strengthening and improving performance at the last-mile of the health system with expertise in supply chain, human resources development, mHealth, and community health programs. Jessica has over ten years of experience in the design, implementation and evaluation of health system programs, more than five of which she spent living and working in sub-Saharan Africa. Jessica helped establish the VillageReach Malawi Country Office, serving as the first Malawi Country Director. Jessica has co-authored a number of journal articles focused on the impact and assessment of health interventions in the field. Prior to VillageReach, Jessica worked in Health Services Administration at the University of Washington, specializing in quality improvement. She holds a MPH in Health Services and a MA in Policy Studies from the University of Washington.
Susan Hershenson, The Bill and Melinda Gates Foundation, Panelist
Susan Hershenson joined the Bill and Melinda Gates Foundation in 2013 as Deputy Director of Chemistry, Manufacturing and Controls (Integrated Development). She works closely with the foundation’s strategy teams and partners to provide technical expertise and strategic guidance for the therapeutics projects. Dr. Hershenson has over 25 years of experience in drug development. Prior to joining the foundation she founded Pharmaceutical Transformations LLC, a consulting service for the pharmaceutical, biotechnology, drug delivery, and related industries. Most recently she served as Vice President of Pharmaceutical and Device Development at Genentech and Vice President of Pharmaceutics at Amgen. Dr. Hershenson has made significant contributions to the development and commercialization of numerous therapeutic products including Betaseron®, Stemgen®, Kepivance®. She earned a B.A. in chemistry from University of Chicago, a Ph.D. in biochemistry from Yale University, and held a postdoctoral fellowship in the laboratory of Dr. Robert Stroud at University of California, San Francisco. Dr. Hershenson publishes and teaches actively and serves on scientific advisory boards.
Tina Vlasaty, Washington Global Health Alliance, Panelist
Tina Vlasaty is the deputy director of the Washington Global Health Alliance (WGHA), a coalition of the state’s leading global health research and development organizations. Tina manages WGHA’s operations and programs and supports the development of its strategic direction including mobilizing Washington state’s global health sector, cultivating global health champions and advocating on behalf of global health organizations. Prior to joining WGHA, Tina spent 20 years working in community and economic development, working both for community based organizations and local government. Her experience includes organizational development, finance and analytics, program and policy development, and collaboration and outreach. Most recently, Tina was Deputy Director for the City of Seattle’s Office of Economic Development. Her roles at the City of Seattle included Finance and Operations Manager and Business Development Manager. She also was a Senior Business Lender at Craft3. She received her MBA from Washington University and her undergraduate training in Russian and Eastern European Studies.
Enabling Patient Centric Products through Drug Delivery Technologies
Monday, July 18
8:30 – 10:00 a.m. — Room 6A
The session will focus on controlled release of peptides/proteins as well as the utility of nanomedicines for the development of innovative medicines. Nanomedicines can enable novel drug products by changing a molecule’s drug distribution and releasing at the site/tissue of interest. The biodistribution change in combination with controlled release from a nanoparticle has the potential to improve the therapeutic index. While the controlled release of small molecules is well understood, technologies for the programmed release of large molecules has been challenging due to the physicochemical aspects of such molecules particularly size and hydrophobic nature. Emerging approaches in the area of nanoparticles for targeted delivery and sustained release of large molecules will be reviewed.
- Anand Subramony, MedImmune
- Alexander Schwarz, MedImmune
- Marianne Ashford, AstraZeneca
Improving Complex Oral Development - New Modified Release Technologies and Accelerated Development Programs
Monday, July 18
1:15 - 2:45 p.m. — Room 6A
Moderator: Cornell Stamoran, Catalent Pharma Solutions
Michael Valazza, Catalent Pharma Solutions
Updates on Modified Release Technologies and Accelerated Development Approaches
Jeffrey Browne, Catalent Pharma Solutions
Lipid-based Formulations and Soft Capsules: A Novel Approach for Modified Release of Challenging Compounds
Emerging Companies and Technologies
Monday, July 18
4:00 - 5:00 p.m.— Room 6A
Moderator: Bastiaan de Leeuw, Oval Medical Technologies
Looking for the latest in delivery science and technology? Learn how these companies are changing the industry with their products and services. Each speaker will give a short presentation with time for questions and discussion at the end of the session.
- Iain Duncan, NeuMedics
- Stephen McCraith, RJS Biologics
- Steffen Panzner, Lipocalyx
- Euan Ramsay, Precision Nanosystems
Precision Medicine: Discovery and Development of Advanced Therapy Medicinal Products
Tuesday, July 19
8:00 - 9:30 a.m. — Room 6A
With data collected from individuals on genetic factors, environment and lifestyle, researchers are able to find innovative ways to prevent, treat and monitor disease. Join this discussion to learn how our speakers are revolutionizing the way to improve health on a personal basis.
Moderator: Keith Horspool, Boehringer Ingelheim
- Pieter Cullis, University of British Columbia
- Peter Senter, Seattle Genetics
Challenges and Opportunities: Subcutaneous Delivery of High Volume/High Viscosity Biologic Formulations from Combination Devices
Tuesday, July 19
1:30 – 3:00 p.m. — Room 6A
Over the last few years there has been a dramatic increase in the market for monoclonal antibody drugs. These drugs are typically administered intravenously in hospital or office settings. For certain chronic diseases that require frequent injection over prolonged periods, there is a growing interest in subcutaneous delivery to enhance the convenience for a healthcare professional or to facilitate self-administration by patients at home. A major challenge is that the high doses required can result in large liquid volumes (>1.5 mL) or viscous formulations that are typically difficult to administer in a single injection.
A number of leading biopharmaceutical thought leaders have been assembled to outline the opportunities and challenges in this area. The panelists will discuss recent data and outline various device strategies that are being explored in this exciting new area.
Moderator: Philip Green, Merck & Co.
- Shawn Davis, Amgen
- Justin Wright, Eli Lilly & Co.
- J. Anand Subramony, MedImmune
Current Trends in Bioavailability Enhancing Technologies
Wednesday, July 20
8:00 - 9:30 a.m. — Room 6A
More than 60% of the compounds in pharmaceutical pipelines today are considered to be poorly bioavailable due to slow dissolution rate or poor solubility. This has led to a need for using increasingly sophisticated delivery technologies. These technologies range from particle size reduction technology aimed at increasing dissolution rates to amorphous dispersions and lipid delivery technologies.
Expert panel members will participate from the pharmaceutical, contract research, market intelligence industries and academia. During this roundtable, we will share viewpoints on bioavailability enhancing technologies and how to rationally choose the best technology.
Moderator: David Lyon, Bend Research
Drug supersaturation in the gastrointestinal tract and its influence on bioavailability
Colin Pouton, Monash University, Australia
Lopinavir & Ritonavir ASD by HME – truly global products
John Morris, AbbVie
New methods for choosing the right bioavailability enhancing technology the first time
David Vodak, Bend Research/Capsugel
Bioavailability enhancing technologies: A view straddling the fence between industry and academia
Patrick Marsac, University of Kentucky (invited)
Does bioavailability enhancement fit into the continuous processing paradigm?
Jonathan Miller, Vertex Pharmaceuticals
Data-Driven Formulation Development – An Agnostic Approach
Bryan Knox, Pharmatek
Clinical Advances in Cancer Nanomedicines
Wednesday, July 20
8:00 - 9:30 a.m.— Room 606-607
Despite significant technical advances in drug delivery systems over the past three decades, finding clinical applications where cancer nanomedicines can make a transformative impact on treatment practice has remained elusive. However, we are now seeing evidence of marked improvements in cancer patient outcomes for both liposome- and nanoparticle-based nanomedicines, particularly when applied in a setting of combination therapy. This session will review the challenges historically facing the development of high-impact cancer nanomedicines and provide recent examples where significant improvements in patient outcomes have been achieved in late-stage clinical trials.
Moderator: Mark Davis, California Institute of Technology
- Mark Davis, California Institute of Technology
- Scott Eliasof, Cerulean Pharma Inc.
- Lawrence Mayer, Celator Pharmaceuticals, Inc.
Consumer Connected Delivery
Wednesday, July 20
9:45 - 11:15 a.m. — Room 6A
Sponsored by the Consumer & Diversified Products Division of CRS
Controlled release is expanding beyond the classic materials and related sciences that dominate our literature and meetings. With the proliferation of a connected society and greater access to data, the divide between personal health and healthcare is disappearing. Consumers are gaining more control over their choices and the technology used to improve their health. From smart patches and pills to apps and information technology, modern day consumer electronics are facilitating the connection between drug delivery, diagnostics, care management, and the consumer. This symposium brings together leaders in the area of connected delivery devices to present and discuss their solutions and vision for enabling consumer-controlled healthcare.
Christopher McDaniel, White Creek Pharma Advisors
James Oxley, Southwest Research Institute
The Future of Personalized Drug Delivery
Jenny Hapgood, Chrono Therapeutics
Healthcare Uses of Wearable Sensors
Russell Potts, Russ Potts Consulting, LLC
Smart Pharmaceuticals for the Precision Medicine Era
Jeff Shimizu, Medimetrics
Connected Sensing: Challenges and Opportunities
Janet Tamada, J. Tamada Consulting