Executive Sponsor

3M

Associate Sponsor

Catalent

Technology Sponsors

Alcyone Lifesciences
Aptalis Pharamatech, Inc
Battelle
Biocorp
Credence MedSystems
Cristal Therapeutics
Enable Injections
Enteris BioPharma
Insulet Corporation
IntraTab
Kala Pharmaceuticals
LyoGo
MedinCell
Nanologica
Nanomi
Nanovelos
Nitto Denko
Novozymes Biopharma
OctoPlus
Oval Medical
Patheon
Renishaw
Salvona
scPharmaceuticals
SkyePharma
SPI Pharma
StarPharma
SwRI
Vetter
Viscogel
West
Unilife

Supporting Sponsor

Ximedica

Exhibitors

BBraun
Formex
Manta
PA Consulting
Phosphorex
PolyPeptide Laboratories
Polysciences

Soapbox Sponsors

4P Therapeutics
BeRNA Therapeutics, LLC
Cureport, Inc.
Fluonic, Inc.
Intensity Therapeutics
iVeena
LayerBio
MedPatch
Pfizer
Protocell Therapeutics
Therakine

Media Partners

On Drug Delivery
Big3Bio
BioPharm Insight
BioPortfolio
Bloomberg Brief
Can Biotech
CenterWatch
Clinical Informatics News
Clocate.com
Drug Development & Delivery
Fierce Drug Delivery
HealthEconomics.Com
iptechex
Larta Institute
Life Science Leader
Massachusetts Life Sciences Center
MassBio
MCD Group
Medical News Today
Medtech Boston
OINDPnews
Pharmaphorum
PharmaVOICE
Technology Networks

Agenda

Tuesday, October 14, 2014

  • 8:00 am

  • Breakfast & Registration

  • 8:45 am

  • Chair’s Opening Remarks

    Chair’s Opening Remarks

    Barbara Lueckel, PhD
    Global Business Development Director, Roche

  • 9:00 am

  • Keynote Fireside Chat with Dr. Robert Langer, MIT

    Keynote Fireside Chat with Dr. Robert Langer, MIT

    Robert Langer, PhD
    David H. Koch Institute Professor, MIT

     

    with

    Barbara Lueckel, PhD
    Global Business Development Director, Roche

    Arthur Tipton, PhD
    President & CEO, Southern Research Institute and
    President, Controlled Release Society

  • 9:50 am

  • Current Thinking on Scouting External Drug Delivery Technologies

    • Understanding the process and specific technology interests
    • Methods of sourcing external delivery technologies and DDS-enabled products
    • Key factors and criteria used during a scouting/evaluation process
    • Types of collaborations and deal terms
    • Examples of “high priority” DDS technologies of interest
    • Licensing platform technologies vs. drug-specific delivery system

    Moderator:
    Richard Korsmeyer, PhD
    Senior Research Fellow, Head of External Technology & Collaborations, Pfizer

    Panelists:
    Jason Ehrick, PhD
    Associate Director, Respiratory Product Development, Merck

    Mary Gardner, MBA, BEngSc
    Director of Technology Assessment, Hospira

    Keith Horspool, PhD
    VP, Pharmaceutical Development, Boehringer Ingelheim

    Riccardo Panicucci, PhD
    Global Head of Chemical & Pharmaceutical Profiling (CPP), Novartis Institutes for BioMedical Research, Inc.

  • 10:30 am

  • Networking Break & Partnering Meetings

  • 11:15 am

  • Non-invasive Delivery of Biotherapeutics: Progress, Hurdles, and Commercialization Prospects

    Biologic drugs, such as insulin and antibodies, are currently delivered via injection, one of the least desirable routes of administration.  Despite improvements in delivery devices, there remains great interest in non-invasive delivery of these drugs.  Pulmonary, nasal, transdermal and oral delivery represent promising alternatives.  With biologics representing a $120 billion market, non-invasive biologic formulations address a significant unmet need for patients around the world.

    • Is oral delivery of macromolecules still considered the Holy Grail of drug delivery?
    • Technical challenges associated with non-injectable administration
    • Which non-invasive delivery approaches show the most promise and why?
    • What criteria are used to evaluate non-invasive delivery technologies?
    • What is the future of inhaled insulin (or biologics in general)?

    Moderator:
    Julia Rashba-Step, PhD
    Senior Director, Novel Delivery Technologies, Pfizer BioTherapeutics

    Panelists:
    Barbara Fox, PhD
    CEO, Avaxia Biologics, Inc.

    Tomas Landh, PhD
    Director, Strategy & Sourcing, Diabetes Research Unit, Novo Nordisk

    Andy Lewis, PhD
    Director Novel Formulation Technologies, CMC & Engineering Peptides, Ipsen

    Rob Saklatvala, PhD
    Director, Discovery Pharmaceutical Sciences, Merck

    Ping Yeh, PhD
    Executive Director, Drug Product Development, Process and Product Development, Amgen

  • 11:55 am

  • Drug Delivery Partnering Case Study featuring BIND Therapeutics, Inc. and AstraZeneca

    Successful Partnerships in Nanomedicine: The BIND-AstraZeneca AZD1152 Collaboration

    Vahe Bedian, PhD
    Director, Oncology External Projects, AstraZeneca

    Detlev Biniszkiewicz, PhD
    VP, Oncology-Strategy, External Science & Licensing, AstraZeneca

    Dan Koerwer, MBA
    SVP, Business Development & Commercial, BIND Therapeutics

    Stephen Zale, PhD
    VP, Development, BIND Therapeutics

  • 12:25 pm

  • Technology Spotlight: Progress on Developing 3M’s Hollow and Solid Microneedle Systems

    Mark Tomai, PhD
    Head of TLR and MTS Business Development, 3M Drug Delivery Systems

  • 12:45 pm

  • Luncheon & Partnering Meetings

  • 2:00 pm

  • Drug Delivery Presentations in Three Tracks

     

    Track One – Non-Injectable Formulation Technologies

    Chaired by:
    Abla Creasey, PhD
    Senior Scientific Director, Primary Container & Drug Delivery Systems/PDMS, Janssen

    Approximately 12-14 companies present non-invasive formulation technologies that can enhance, enable, or facilitate delivery of a drug. Examples include: orally disintegrating tablets/films, modified release oral dosage forms, bioavailability enhancement technologies, ophthalmic delivery platforms, mucosal penetration systems, buccal dosage forms, and topical/transdermal delivery systems.

    Non-Injectable Formulation Presenting Companies:

    • SkyePharma
    • Patheon
    • Enteris
    • SWRI
    • SPI Pharma
    • Catalent
    • Aptalis Pharmatech
    • Kala
    • Nanologica
    • Salvona
    • IntraTab

     

    Track Two – Injectable Formulation Technologies

    Chaired by:
    Bruce Kerwin, PhD
    Scientific Director, Amgen

    Approximately 12-14 companies present novel injectable formulation technologies. Examples include: sustained release depots and implants, targeted nanoparticles, controlled release microspheres, microparticles, modified release hydrogels, biodegradable polymeric systems, and drug conjugate technology.

    Injectable Formulation Presenting Companies:

    • OctoPlus
    • Novozymes
    • Nitto Denko
    • StarPharma
    • Nanomi
    • Cristal Therapeutics
    • Nanovelos
    • Medincell
    • Viscogel

     

    Track Three – Device Technologies

    Chaired by:
    Shawna Gvazdauskas
    Global Head of Device Strategy, External Opportunities & IP Liaison, Sanofi

    Approximately 12-14 companies present innovative delivery devices. Examples include: needle-free delivery devices, auto injectors, pen injectors, powder injection devices, microneedle systems, inhalation devices, nasal delivery devices, non-biodegradable implants or similar, transdermal patches, patch pumps and other wearable drug administration systems, etc.

    Device Presenting Companies:

    • 3M
    • Lyogo
    • Renishaw
    • West
    • Enable
    • scPharmaceuticals
    • Battelle
    • Oval Medical
    • Credence MedSystems
    • Insulet
    • Vetter
    • Unilife
    • Biocorp
    • Alcyone Lifesciences

     

    3:30 pm – 3:45 pm Break & Meetings

  • 6:00 pm

  • Networking Reception & Partnering Meetings

Agenda

Wednesday, October 15, 2014

  • 8:00 am

  • Breakfast & Partnering Meetings

  • 8:30 am

  • Chair’s Opening Remarks

    Chair’s Opening Remarks

    Barbara Lueckel, PhD
    Global Business Development Director, Roche

  • 8:45 am

  • Pharma Keynote Presentation: Innovation Matters – The Future of Pharmaceutical R&D

    James Spavins
    SVP, Head of Pharmaceutical Sciences, Pfizer

  • 9:30 am

  • Delivery Device Platforms: A Strategy for Improving Development Cycle Times and Reducing Costs

    A platform drug delivery device can be attractive for pharma and biotech companies, potentially offering shorter development timelines and lower manufacturing costs. Companies are moving away from the bespoke device and exploring platform devices for pipeline and portfolio drugs, but this requires implementing a new device strategy which presents a new set of challenges. Therefore, this panel will discuss:

    • What steps should be taken to determine if a platform device strategy makes sense internally?
    • How do you implement and manage a platform device strategy
    • Pros and cons of licensing a platform device technology vs. developing internally
    • How have other industries done this successfully

    Moderator:
    Paul Jansen
    VP, Medical Device Development, Sanofi

    Panelists:
    Eric Chanie
    Director, Head of Innovation Medical Devices, Merck Serono

    Kevin Deane
    Partner, Technology Group, PA Consulting Group

    Peter Krulevitch, PhD
    Engineering Director, Fellow, Primary Container and Drug Delivery Systems, Janssen R&D, Johnson & Johnson

    Atul Patel
    Director, Technical Development, Devices, Biogen Idec

    Anand Subramony, PhD
    VP, Drug Delivery & Device Development, MedImmune

  • 10:10 am

  • Networking Break & Partnering Meetings

  • 11:10 am

  • Fourth Annual Company Spotlights

    Biogen Idec’s Unmet Patient Needs – How can your Drug Delivery & Device options help us?
    Biogen Idec
    Jessica Ballinger
    Senior Director, Protein Pharmaceutical Development

    Drug Delivery Partnering and Endo’s Approach to Addressing Unmet Patient Needs
    Endo Pharmaceuticals
    Frank Diana, PhD
    VP, Pharmaceutical Development

    Drug Delivery Technologies Affinitized to the GSK Portfolio
    GSK
    Matt Burke, PhD
    Head of Drug Delivery, Global Formulations, RD Platform Technology & Science

    Role of Platform Technology in New Therapeutic Entities
    Teva Pharmaceutical Industries
    Catherine Soldano, MBA
    VP, R&D, New Therapeutic Entities

  • 12:30 pm

  • Luncheon Roundtable Sessions & Partnering Meetings

    Delivery Challenges of Low Potency/High Dose Drugs with Low Bioavailability
    Moderator:
    Sandra O’Connor
    Director, Sterile Product Development, Cubist Pharmaceuticals

    Alternative Vial Systems
    Moderator:
    Mary Gardner, MBA BEngSc
    Director of Technology Assessment, Hospira

    Impact of Excipients on Drug Product Stability and Bioavailability
    Moderator:
    Ajit Narang, PhD
    Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb

    What Must Drug Delivery Companies Offer as a Value Proposition to be Successful?
    Moderators:
    Lew Bender
    President & CEO, Intensity Therapeutics

    Alex Zisson
    Partner, Thomas McNerney & Partners

  • 1:45 pm

  • Technology Spotlight: Lipid-based System for Oral Peptide Delivery

    Stephen Tindal
    Director, Softgel Formulations, Catalent Pharma Solutions

  • 2:05 pm

  • The Drug Delivery Investor Climate

    In this session, a panel of investors will discuss the current investment climate for drug delivery companies.  Key discussion points:

    • Overall market outlook for drug delivery investing
    • Trends in small company investing
    • Trends in drug delivery partnering
    • Sources of funding:  traditional and non-traditional
    • Technology areas generating “buzz” and attracting investors

    Moderator:
    Alex Zisson
    Partner, Thomas McNerney & Partners

    Panelists:
    Lew Bender
    President & CEO, Intensity Therapeutics

    David Berry, MD, PhD
    Partner, Flagship Ventures

    Brian Gallagher, Jr., PhD
    Partner, SR One, Ltd.

    David Hirsch, MD, PhD
    Managing Director, Longitude Capital

    William Podd, JD
    President & Executive Director, Landmark Angels, Inc.

  • 2:45 pm

  • DDS Technology Soapbox@PODD sponsored by Pfizer

    This session features five-minute talks on cutting-edge technologies, inventions and ideas. The PODD Soapbox section is open to start-up entrepreneurs, inventors, licensing officers and university researchers.

    Moderator:
    Julia Rashba-Step, PhD
    Senior Director, Novel Delivery Technologies, Pfizer BioTherapeutics

    Soapbox Presenting Companies:

    • 4P Therapeutics
    • BeRNA Therapeutics
    • Cureport, Inc.
    • Fluonic, Inc.
    • Intensity Therapeutics
    • iVeena
    • LayerBio, Inc.
    • MedPatch, Inc.
    • Protocell Therapeutics (Oncothyreon)
    • Therakine

    If you are interested in presenting on the Soapbox, please let us know at service@theconferenceforum.org.

  • 3:45 pm

  • Game-Changing Technologies for Targeted Delivery & Therapy for Chronic Brain Disorders

    Many diseases, such as Parkinson’s disease and epilepsy, are caused by the misfiring of neurons in the brain. The most promising treatments involve targeted delivery to the brain, but this remains a challenge, primarily due to the blood-brain barrier (BBB). This panel will explore cutting-edge targeting technologies that have the potential to change the way brain disorders are treated.

    Moderator:
    PJ Anand
    Founder, President and CEO, Alcyone Sciences, Inc.

    Panelists:
    James Callaway, PhD
    President & CEO, ArmaGen Technologies, Inc.

    Jay D. Kranzler, MD, PhD
    Global Head, Neuroscience, Pain & Sensory Disorders, External R&D Innovation (ERDI), Worldwide Research & Development
    Pfizer, Inc.

    Corey McCann, MD, PhD
    Founder and CEO, Pear Therapeutics

    Raghu Raghavan, PhD
    Partner and President, Therataxis, LLC

    Ajay Verma, MD, PhD
    VP, Experimental Medicine, Biogen Idec

  • 4:30 pm

  • Conference Concludes