Agenda at a Glance |
For presentation abstracts, download the conference brochure PDF |
Maximize the Potential of Your Drug Delivery System through
Drug Delivery Device Combination Products| 8:15 | Registration and Morning Coffee for Symposium Participants |
| 9:00 | Injection Device Combination Products: Key Market, Technical and Regulatory Trends Donna French, PhD, Senior Director, Device Development, GENENTECH |
| 9:45 | West and Janssen Biotech Discuss their Novel Self Injection Technology
and Unique Partnership Bart Burgess, Principal, Business Development, WEST PHARMACEUTICALS Peter Krulevitch, Ph.D., Engineer Director, Packaging, Devices & Delivery, JANSSEN R&D |
| 10:30 | 30 Minute Networking Break |
| 11:00 | Regulatory Update: Maneuver through the Changing Regulatory Landscape Mark Marley, Principal Research Scientist, Regulatory Affairs, ELI LILLY & COMPANY (invited) |
| 11:45 | IP Challenges Affecting the Device Industry |
| 12:30 | Luncheon for Symposium Participants |
| 1:30 | Human Factors: What Do These Studies Look Like and How Do We Implement
Them? Lee Leichter, President, P/L BIOMEDICAL |
| 2:15 | Integrate Large Molecule Formulations with Drug Delivery Devices Lisa Shafer, Director, CNS Drug Therapy R&D, MEDTRONIC |
| 3:00 | 30 Minute Networking Break |
| 3:30 | Making Effective Use of Quality Systems to Deliver a Combination Product Pedro Cruz, Project Manager, QUALCOMP CONSULTING SERVICES, LLC |
| 3:40 | Integrate QbD When Creating a Combination Product Robin Hwang, Principal, ICP CONSULTING |
| 4:15 | Patient Convenience and Compliance – How to Increase Patient Use Simon Exell, Director, Global Product Team Leader, Life Cycle Management, MERCK SERONO |
| 5:00 - 6:00 | Grand Opening Reception in the DDP Exhibit Hall |
AM: HALF DAY
SYMPOSIUM
| 8:15 | Registration and Morning Coffee for Symposia Participants |
| 9:00 | Start of Symposium |
| 12:30 | Luncheon for Morning Symposium Participants |
| 1:30 - 3:00 | DDP Speed Networking in the DDP Partnering Room |
Utilizing Pediatric and Geriatric Drug Delivery to Increase Revenue
and Postpone the Patent CliffSpeakers:
Sven Stegemann, PhD, President, GERIATRIC MEDICINE SOCIETY
Tim Wigal, PhD, Executive Director, Child Development Center, Adj Professor Pediatrics, UC IRVINE
Lee Shorter, Director, Platform Technology and Science Disruptive Technology, GLAXOSMITHKLINE
PM: HALF DAY
SYMPOSIA
| 1:30 | Symposia Begin |
| 5:00 | Symposia End |
| 5:00 | Grand Opening Reception in the DDP Exhibit Hall |
| 1:30 - 3:00 | DDP Speed Networking in the DDP Partnering Room |
 Two Steps Forward,
One Step Back: Biosimilar Drug Delivery Development Thomas Nikolai, Director, Biologics and Parenterals, HOSPIRA, INC. Harvinder Popli, PhD, Director, RANBAXY LABS, LTD Steven Miller, MD, Senior Vice President and CMO, EXPRESS SCRIPTS |
 5th Annual Specialty Pharma SymposiumTake Your Specialty Pharma Company through Commercialization: What Is the Optimal Business Plan for Your Company Woody Bryan, Vice President, Business Development and Project Management, SUPERNUS PHARMACEUTICALS Charles Williams, Director, Corporate and Business Development, MAP PHARMACEUTICALS Greg Flesher, Senior Vice President and Chief Business Officer, AVANIR PHARMACEUTICALS |
| 7:30 | Registration and Morning Coffee | |||
| 8:15 | Chairman's Kick-Off Sesha Neervannan, Vice President, Pharmaceutical Development, ALLERGAN |
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| 8:30 | KEYNOTE PRESENTATION When Drug Delivery Creates a Blockbuster – Allergan David Pyott, Chairman, President and CEO, ALLERGAN |
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| 9:15 | FEATURED KEYNOTE PANEL Where Does Drug Delivery Fit into the Pharmaceutical Pipeline? Moderator: Roy Waldron, Senior Vice President and Associate General Counsel, PFIZER Panelists: Christopher Seaton, Senior Vice President, Global Licensing, BAYER PHARMACEUTICALS James Hattersley, Vice President, Corporate Business Development, SUN PHARMACEUTICALS Simon Hartas, Vice President, Medicines Evalution, Pharmaceutical Development, ASTRAZENECA |
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| 10:00 | Intec Pharma Presents the Accordion Pill™: Providing Gastric
Retention Under Regular Calorie Diets, for Drugs with Narrow
Absorption Window and Drugs with pH Dependent Solubility Nadav Navon, PhD, Vice President, Research & Development, INTEC PHARMA |
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| 10:15 | Networking Break in the Drug Delivery Partnerships Hall | |||
| 11:00 | Partnering in 2013 and Beyond: Sustainable Strategies for Growth |
Life Cycle Management, Line Extensions and New Development Strategies for Continued Profitability |
Future Applications and Challenges to Drug Delivery |
Drug Delivery Technology Innovations |
| Structure Pharmaceutical Collaborations to Maximize Use of New Technologies Craig Sorensen, Vice President, R&D Alliance Design and Management, VERTEX PHARMACEUTICALS Andy Donnelly, Associate Director, Drug Delivery and Device Development, Formulation Sciences, MEDIMMUNE |
Evaluating Platform Technologies in Lieu of Single Molecule Technologies Julia Rashba-Step, Senior Director, Novel Delivery Technologies, Biotherapeutics R&D, PFIZER Keith Horspool, Vice President, Pharmaceutics, BOEHRINGER INGELHEIM |
Understand the Science of Delivery in Emerging Markets to More Successfully Market Your System Moderator: Deborah Bingham, Partner, VALEO PARTNERS Ian Hardy, Director, Pharmaceutical Development, Emerging Markets, MERCK Harvinder Popli, PhD, Director, RANBAXY LABS, LTD |
Systemic Delivery of Targeted 3DNA Nanoparticles Robert C. Getts, PhD, Vice President, R&D, CSO, GENISPHERE, LLC 11:30 Development of
Subcutaneous Implants for the
Controlled Release of APIs Alex Schwarz, PhD, VP, Implant Technology R&D, ENDO HEALTH SOLUTIONS 12:00 Microelectronics' Impact on Patient Compliance Lior Shtram, Director, Technology Management, FLEXTRONICS MEDICAL |
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| 11:45 | Connect Discovery with Development – Reinvent the Industry and Be More Efficient Dr. Geoffrey Hird, Principal Scientist, Formulation & Drug Delivery Technologies, EISAI Ping Yeh, Executive Director, Product and Process Development, AMGEN Julia Rashba-Step, Senior Director, Novel Delivery Technologies, Biotherapeutics R&D, PFIZER |
Create Value through Alternate-Route Delivery Ronald Smith, Executive Director and Head, Product Value Enhancement, MERCK |
Meeting the Delafoxacin Solubility Challenge with Captisol: A Partnering Case Study Glenn Dourado, MSc, MBA, Director of Business Development, LIGAND PHARMACEUTICALS INCORPORATED Jarrod Longcor, Vice President of Corporate Development, RibX PHARMACEUTICALS INC. |
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| 12:30 | Luncheon in the Drug Delivery Partnerships Hall | |||
| 1:45 | Creating New Products Using SoluMatrix™ Technology: 6 Products in Clinical Development, 3 NDA Filings in the Next 12 Months
and Commercial Scale-up Completed
Bill Bosch, PhD, Chief Scientific Officer, ICEUTICA, INC |
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| 2:00 | KEYNOTE The 2012 Election: Where Does this Leave the Pharmaceutical Industry? Billy Tauzin, Former U.S. Congressman (Republican – Louisiana), Former President and CEO, PhRMA |
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| 2:45 | KEYNOTE PANEL How Has the Political Climate Affected Drug Development and Delivery and How is the Industry Coping? Moderator: Sesha Neervannan, Vice President, Pharmaceutical Development, ALLERGAN Panelists: Billy Tauzin, Former U.S. Congressman (R-LA), Former President and CEO, PhRMA Steven Miller, MD, Senior Vice President and CMO, EXPRESS SCRIPTS Steve Phillips, Senior Director, Health Policy & Reimbursement, JOHNSON & JOHNSON Brian Harvey, Vice President, US Regulatory Strategy, PFIZER |
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| 3:30 | Networking Break in the Drug Delivery Partnerships Hall | |||
| Partnering in 2013 and Beyond: Sustainable Strategies for Growth |
Life Cycle Management, Line Extensions and New Development Strategies for Continued Profitability |
Future Applications and Challenges to Drug Delivery |
Drug Delivery Technology Innovations |
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| 4:15 | Strategic Innovation – Pro-Active IP
Creation for Competitive Advantage Denise Hickey, Senior Director of IP Strategy, ABBOTT LABORATORIES |
Fixed Dose Combinations: Use Predictive Studies to Establish Potential for Success or Failure Keith Horspool, Vice President, Pharmaceutics, BOEHRINGER INGELHEIM David Lyon, Senior Vice President, Research, BEND RESEARCH |
Formulation and Analytical Tools for development of Lipid Based Drug Delivery Systems Stephen Tindal, Director, Softgel Formulation, CATALENT |
EyeSol™ – an Advanced
Ocular Drug Delivery
Technology Dieter Scherer, Ph.D., CBO and Head, Business Development, NOVALIQ GMBH |
| 4:40 Building A Better SubQ Product: Improved Subcutaneous Delivery With ENHANZE™ Technology Mike LaBarre, VP, Product Development, HALOZYME THERAPEUTICS |
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| 5:00 | Wall Street Address David Steinberg, Managing Director, Equity Research, Specialty Pharmaceuticals & Drug Delivery, DEUTSCHE BANK |
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| 5:45 | Delivering Better Outcomes: The New Delivery Imperative Cornell Stamoran, Vice President, Corporate Development & Strategy, Investor Relations Officer, CATALENT |
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| 8:00 | Morning Coffee | ||
| 8:30 | Chairman's Recap of Day One Lee Shorter, Director, Platform Technology and Science Disruptive Technology, GLAXOSMITHKLINE |
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| 8:45 | KEYNOTE Driving Innovation in Healthcare for the Bottom of the Pyramid: Opportunities, Pitfalls... and Copious Doses of Reality! Myshkin Ingawale, Inventor, co-founder, BIOSENSE TECHNOLOGIES, TED speaker |
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| 9:30 | CASE STUDY PRESENTATION A "Patient-first" Approach to Drug Delivery: Easy-to-Use, Safe Transdermal Systems for Biologics Peter Staple, President and CEO, CORIUM |
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| 9:45 | KEYNOTE PANEL Drug Delivery Devices: How Are Devices and Combination Products Changing the Drug Delivery Game? Moderator: Philip Green, Senior Director, Biologics Device Strategy, MERCK Panelists: Paul Jansen, Global Head, Medical Devices, SANOFI-AVENTIS Patrick Jones, Global Director, Commercial Development, BD MEDICAL - PHARMACEUTICAL SYSTEMS Donna French, PhD, Senior Director, Device Development, GENENTECH James J. Collins, Vice President, Drug Delivery and Device Research and Development, ELI LILLY & COMPANY |
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| 10:30 | 4th Annual Drug Delivery Innovation Awards Technology Innovation "On the Rise" Company Industry Achievement Lifetime Achievement Award: Tomas Landh, NOVO NORDISK |
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| 10:45 | Networking Break in the Drug Delivery Partnerships Hall | ||
| Partnering in 2013 and Beyond: Sustainable Strategies for Growth |
Life Cycle Management, Line Extensions and New Areas of Development for Continued Profitability |
Drug Delivery Technology Innovations |
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| Chair: Robert Bloder, Vice President, Business Development, AVEVA DRUG DELIVERY SYSTEMS |
Chair: Dr. Ralph Lipp, Vice President, Pharmaceutical Sciences R&D, ELI LILLY |
Chair: Bob Nissen, Former Vice President, Business Development & Licensing, NOVARTIS CONSUMER HEALTH, President, NISSEN CONSULTING |
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| 11:30 | Determine Where the Industry Is Headed
and Why: Large vs. Small Molecules Weiguo Dai, Scientific Director, JOHNSON & JOHNSON Vito Maioriano, Director, Business Development, BAXTER HEALTHCARE Kevin Taylor, Vice President Business Development, CANGENE CORPORATION |
MedinGel: A Universal Platform for Local and Subcutaneous Controlled Release Delivery Mark Wilson, VP, Business Development MEDINCELL CORPORATION |
Sustained Drug Delivery for Multi-Weeks to Multi-Months, through Implantable and Injectable Polyesteramides Jens Thies, PhD, MBI, RT&D Manager Drug Delivery, DSM BIOMEDICAL |
| 12:15 | Top Down and Bottom Up: How Do You Involve Both Discovery and Commercial Teams in the Drug Delivery Strategy? Michael Cucolo, Director, External Science, TECHNOLOGY & LICENSCING James (Jim) Dishong, CEO/Founder, PEOPLE VECTOR, LLC Will Clodfelter, Director, Global Device Development and New Product Planning, AMYLIN PHARMACEUTICALS |
Quicker Feasibility Studies to Speed Up
Technology Assessment Andrew Phimister, Fellow, NOVARTIS Sara Henneman, BD MEDICAL |
On the Rise Nanotechnology-based Drug Delivery Approaches from a CRO Perspective Robert Lee, Vice President, Pharmaceutical Development, PARTICLE SCIENCES, INC. Use of Innovative Drug Delivery Platform to Generate New IP and Accelerate Drug Development James Smith, PhD, President, NANOSMART PHARMACEUTICALS Peptelligence, the Solution to Oral Peptide Delivery Nozer Mehta, Ph.D., Chief Scientific Officer, UNIGENE AB001, A Novel Prescription-Strength Topical Patch for Site-Specific Pain Relief CJ Wang, Ph.D., CEO, ABSIZE INC Amorphous Dispersions for Improving Solubility of Poorly Soluble Compounds David Lyon, Senior Vice President, Research, BEND RESEARCH An Internal Cavity Drug Retention System via Novel Reverse Thermal Gelation Technology Ronen Rosenberg, VP Business Development, THERACOAT Session Title to Come Robert Bianchi, VP, and chief of Scientific and Technical Affairs PRESCRIPTION DRUG RESEARCH CENTER |
| 1:00 | Convenience vs. Compliance: Understanding the Current Standards for Reimbursement John Liu, Senior Director, Reimbursement Strategy, ASTELLAS PHARMA |
Create a new OTC brand with Novel Drug Delivery Bob Nissen, Former Vice President, Business Development & Licensing, NOVARTIS CONSUMER HEALTH, President, NISSEN CONSULTING |
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| 1:45 | Close of Conference – See You at the 18th Annual Drug Delivery Partnerships! | ||
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