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2018 Agenda

  • 8:00 am

  • Registration & Breakfast, Exhibits Open

  • 8:45 am

  • A Year in Review and PODD Welcome


    Barbara Lueckel, PhD

    Global Business Development Director, Roche Partnering Innovation, Roche

  • 9:15 am

  • Keynote Fireside Chat

    Dr Robert Langer and Amy Schulman, two dynamic entrepreneurs in biotech, will be joined together in a fireside chat to discuss:

    • Working together to accelerate new innovations in drug delivery:  Lyndra, Suono Bio and SQZ Biotech
    • The “Lyndra” story and how the ultra-long-acting oral technology has the potential to significantly improve patient outcomes
    • How to successfully move a technology out of the lab and into the market
    • Raising funds and structuring deals for startup companies

    Robert Langer
    Robert Langer, PhD

    David H. Koch Institute Professor, MIT

    and

    Amy Schulman
    Amy Schulman, JD

    Co-Founder and CEO, Lyndra and Partner, Polaris Partners

  • 10:00 am

  • Stories from Bioinspiration to Innovation

    When developing technologies to solve medical problems, often one encounters significant hurdles, that at times seem insurmountable. Overcoming these hurdles requires new ways of thinking. One approach is to turn to nature for inspiration.  Millions and millions of years of research and development at our fingertips, and all we need to do is look outside to the amazing creatures that inhabit our planet. This talk will explore medical technologies being developed that harness lessons from nature for inspiration. Some of the technologies that will be described are rapidly advancing to the clinic and some are already on the market helping patients.

    Jeffrey Karp
    Jeffrey Karp, PhD

    Professor of Medicine, Harvard Medical School and Director of the Laboratory for Accelerated Medical Innovation, Brigham and Women’s Hospital

  • 10:30 am

  • Networking Break & Partnering Meetings, Exhibits Open

  • 11:15 am

  • Drug Delivery Case Study

    Speakers TBA

  • 11:45 am

  • Pharma's Perspective on Partnering to Advance Drug Delivery Innovation in the R&D Pipeline

    This panel will include business development and technology assessment professionals actively involved in the scouting and evaluating of novel delivery technologies for such areas as oncology, ophthalmology, diabetes, and CNS. The audience will hear pharma’s general perspective on partnering, and will also gain insight into key strategic considerations in evaluating external drug delivery technologies vs. building internal capabilities.

    Moderator:

    Ronald Smith
    Ronald L Smith, PhD 

    Scientific AVP, Pharmaceutical Sciences, Merck Research Laboratories

    Panelists:

    James Cunningham
    James Cunningham, PhD

    Executive Director, Drug Delivery, Allergan

    Terry Reed
    Director, Business Development, AstraZeneca
  • 12:20 pm

  • Drug Delivery – Innovative Clinical Stage Pipeline

    PharmaCircle will present a brief overview of drug delivery pipeline and then highlight and examine innovative and potentially impactful drug delivery based clinical stage pipeline with both formulation and device based technologies.

    Kurt Sedo
    Kurt R Sedo

    VP Operations, PharmaCircle

  • 12:35 pm

  • Lunch & Partnering Meetings

  • 2:00 pm
    - 6:00 pm

  • Drug Delivery Technology Presentations, six sessions

    Attendees can choose between the following sessions: Drug Delivery Devices, Injectable Technologies and Non-Injectable Technologies (oral, transdermal, transmucosal and ophthalmic). In these tracks, a wide range of delivery technologies will be presented such as wearable patch pumps, subcutaneous formulation enhancing technologies, sustained release delivery systems, nanoparticle technologies, novel auto-injector devices, “connected” drug delivery systems (digital devices), bioavailability enhancing technologies, long-acting ocular implants, microneedle patches, and orally-disintegrating dosage forms.

    • Track 1A: Injectable Technologies

      Companies will present sustained release, targeting, nanoparticles, as well as pre-filled syringes, vials and similar technologies.

      Chair:

      Michael Cucolo
      Michael Cucolo

      Director of Business Development, BMS

    • Examples of Presenting Companies:

      Enable Injections

      Innocore Pharmaceuticals

      Halozyme

      Evonik

      Datwyler

      Cureport

      InnoMedica

    • Track 1B: Injectable Technologies

      Companies will present sustained release, targeting, and drug-conjugate technologies, as well as pre-filled syringes, vials and similar technologies.

      Chair:


      Nima Akhavein, PhD

      Associate Fellow and Scientific Leader, GSK

    • Track 2A: Oral & Transmucosal Technologies

      Companies will present controlled release, modified-release, colon-targeted, and orally-disintegrating delivery systems, as well as buccal dosage forms and bioavailability & solubility enhancing technologies.

      Chair:


      Manuel Sanchez-Felix, PhD

      Senior Fellow, Novel Delivery Technologies / Chemical and Pharmaceutical Profiling, Novartis Institute for BioMedical Research

    • Examples of Presenting Companies:

      leon-nanodrugs GmbH

      Adare Pharmaceuticals

      DS Technology / Harro Hofliger

      Recro Gainesville

      BDD Pharma

    • Track 2B: Ophthalmic, Transdermal and Inhalation Technologies

      Companies will present a variety of ophthalmic, transdermal, pulmonary, nasal, and related delivery technologies and devices.

      Chair:

      Ann Daugherty
      Ann L Daugherty, PhD

      Senior Manager, Drug Delivery, Genentech

    • Examples of Presenting Companies:

      Pharmaero

      Exicure

    • Track 3A: Device Technologies

      Companies will present a wide range of novel delivery devices such as needle-free delivery devices, auto injectors, patch pumps/wearable delivery systems, and similar devices. This session also includes “connected” devices and digital health technologies.

      Chair:


      Ulrich Brüggemann

      Head Academics and Innovation, Global Medical Devices Development, Sanofi

    • Examples of Presenting Companies:

      BD Medical

      Bespak

      Credence MedSystems

      Cambridge Design Partnership

      BIOCORP

      Insulet Corporation

      Phillips-Medisize

      Portal Instruments

    • Track 3B: Device Technologies

      Companies will present a wide range of novel delivery devices such as needle-free delivery devices, auto injectors, patch pumps/wearable delivery systems, and similar devices. This session also includes “connected” devices and digital health technologies.

      Chair:


      Mathias Romacker

      Senior Director, Device Strategy, Pfizer

    • Examples of Presenting Companies:

      SMC Ltd /Oval Medical

      Vernay

      Common Sensing

      Altaviz

      Cureport

      Sorrel Medical


  •  

    We are still accepting abstracts to present on the technology tracks. Please email Meredith Sands at Meredith@tcfllc.org for information.

     

  • 6:00 pm

  • Networking Reception & Partnering Meetings

2018 Agenda

  • 8:00 am

  • Breakfast in Exhibit Hall and Partnering Meetings

  • 8:45 am

  • Chair’s Welcome


    Barbara Lueckel, PhD

    Global Business Development Director, Roche Partnering Innovation, Roche

  • 9:00 am

  • Industry Keynote

    Justin Wright 2018
    Justin M Wright, PhD

    Global Head of Innovation, Novartis


  • Harnessing the Digital Exhaust: Incorporating Wellness into the Pharma Model and How Drug Delivery will be a Key Enabler

    The pharmaceutical sector remains one of the largest components of the US and global economy with sales exceeding $450B domestically and $900B worldwide. Historically the industry has relied on the ‘blockbuster’ model for drug entry, where drugs with >$1B+ annual sales allow investments to be made in early stage projects and smaller markets. However, the industry is undergoing a pivotal transformation as traditional drugs are supplanted by next generation product systems where, in some cases, the drug is only a component of the overall product offering. This situation has created a compelling entry point for non-traditional competitors and start-ups to access this market and potentially re-define the value model associated with drug pricing.

    And while, for more than a decade, the pharmaceutical industry has been caught up discussing its role in “beyond the pill” solutions, it will now need to realize a rapid evolution of its current business model in order to remain competitive. The opportunity to reimagine this and move from a reactive to prevention model, and in many cases a fully “closed loop” solution, has finally arrived. At the core of such an evolved model will certainly be a dynamic patient interface which leads to extraordinary patient engagement. And with the delivery system being one of the most intimate parts of this interface, there is no question they will serve as a key enabler going forward. As evidenced by a number of franchises over the past 20 years, a great delivery system can be a true differentiator or can it be a debilitating handicap.

    A review of the current and future state along with perspective and case studies will be provided in order to help shed light on the areas of needed focus and corresponding opportunity.  

  • 9:30 am

  • Digital Health: Paradox or Paragon?

    In today’s digital world, we are seeing self-driving cars taking the first leap, while Amazon’s Alexa, Google Assistant and Apple’s Siri are becoming commonplace in our households.  We are also experiencing increased adoption of digital or “smart” technology to improve healthcare. On one side, we view the “smart” ecosystem and connected medical devices as a way to improve patient adherence and help healthcare providers make evidence-based personalized care decisions; but on the other hand there is the debate about the value, return on investment, etc. for digital health.

    This panel discussion not only touches on the strategic topic of digital health but also dives deeper into more pragmatic approaches to execution, value propositions, etc. Our panel consists of bio-pharma executives and strategic partners who are not only KOLs but also possess a successful track record of implementing digital health solutions in the field.  The panel will also help to shed light on current digital health strategies currently employed while providing “food for thought” for organizations interested in adopting new digital technology but still looking for the right value proposition.

    Moderator:

    Dhairya Mehta
    Dhairya Mehta

    Director, eHealth & Connectivity, Medical Device & Combination Products, Shire

    Panelists:

    Kal Patel
    Kal Patel, MD

    SVP of Digital Health, Flex

    Paul Upham
    Paul Upham
    Senior Principal, Smart Device Technology Center, Roche/Genentech


    Neil Williams

    Director Front-End Innovation – Head of Connected Health, Medicom Innovation Partner Ltd, a Phillips-Medisize Company

    Eli Lilly
    (speaker TBA)

    Additional panelists TBA

  • 10:15 am

  • Networking Break in Exhibit Hall and Partnering Meetings

  • 11:00 am

  • DDS Technology Soapbox@PODD

    sponsored by:

    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:


    Patrick Lim Soo, PhD

    Senior Principal Scientist, Novel Delivery Technologies, Pfizer

    Presenting Companies:

    Cam Med LLC

    Cinti Medical

    Consegna Pharma

    Wyss Institute

  • 11:45 am

  • Disruptive New Models for Advancing Drug Delivery Innovations

    This panel will discuss the 2028 model of commercialization – new game-changing models of commercialization that accelerate the development and commercialization of early stage drug delivery technologies.

    Moderator:


    Rosemarie Truman

    Founder and CEO, The Center for Advancing Innovation

    Panelists:


    Bharatt Chowrira, JD, PhD

    President and Chief of Business and Strategy, PureTech Health

    Kristen Kosofsky
    Kristen C Kosofsky

    Senior Managing Director, Life Sciences, Hercules Capital

    Scott Pappas
    Scott E Weiner, MBA

    Partner, Pappas Capital

    Additional panelists TBA

  • 12:20 pm

  • Luncheon Roundtable Session & Partnering Meetings

    Investor Roundtable – TBA

    On Market/ Post Market Surveillance for Sustaining Combination Products
    Led by:
    Margaret Reiff
    Maggie Reiff
    Device Engineer, Pfizer

    Long-acting Ocular Drug Delivery Technologies: Challenges and Opportunities 
    Led by:

    Viral Kansara, PhD

    Head of Pharmacology and Drug Discovery Lab, Global Project Team Leader,  Ophthalmology, Novartis

  • 1:20 pm

  • 8th Annual Company Spotlights

    In this session, we highlight four companies to discuss their partnering philosophy, current needs and scouting interests, as related to drug delivery.

    Advait Badkar
    Advait Badkar, PhD

    Senior Director, Novel Delivery Technologies, BioTherapeutics, Pfizer

    Lubomir Gradinarsky, PhD
    Science and Innovation Leader – Packaging, Devices and Sensors, AstraZeneca


    Grégoire Schwach, PhD

    Head of Drug Delivery, F. Hoffmann-La Roche Ltd


    Srini Sridharan, PhD

    Head, Materials Science & Engineering, Bristol-Myers Squibb

  • 2:00 pm

  • Delivering mRNA Drugs and Vaccines: Progress and Future Outlook

    mRNA vaccines represent a promising alternative to conventional vaccine approaches for infectious diseases as well as oncology indications, including an emerging application for personalized cancer vaccines. As a technology, mRNA has the potential to enable more rapid design and optimization of antigens, improve quality of immune response due to in situ antigen production, permit expression of multiple antigens, and support more rapid and versatile development and manufacturing platforms.

    This panel will discuss current state of mRNA vaccines research and opportunities related to:

    • mRNA design optimization for improved stability and antigen translation
    • next-generation delivery approaches for mRNA vaccines
    • mRNA drug substance and drug product CMC
    • safety and regulatory considerations

    Moderator:

    marian gindy
    Marian Gindy, PhD

    Executive Director, Discovery Pharmaceutical Sciences, Merck

    Panelists:

    Orn Almarssonon
    Örn Almarsson, PhD

    Head of Formulations, Moderna Therapeutics


    Danilo Casimiro, PhD

    VP & Head, External R&D and Vaccine Platforms, Sanofi


    Sybil Williams, PhD

    Senior Principal Scientist, Personalized Cancer Vaccines Biology Lead, Merck

    Additional panelists TBA

  • 2:45 pm

  • Innovations and Advances in Protein and Peptide Drug Delivery

    This panel will discuss the latest strategies for improving the delivery of protein and peptide drugs, including methods and technologies to improve stability and half-life, as well as administration to the patient. Panelists will also review progress and challenges related to non-invasive delivery, including oral administration.

    Moderator:


    Joël Richard, PhD

    SVP, Peptides, Ipsen

    Panelists:

    Mark Currie
    Mark Currie, PhD

    SVP, Chief Scientific Officer, and President of R&D, Ironwood Pharmaceuticals

    Adam Mezo, PhD
    Sr. Director, Head of Molecular Design, Ferring Research Institute, Inc


    Douglas P Nesta, PhD

    Director, Biopharmaceutical Product Sciences, GSK

    Additional panelists TBA

  • 3:30 pm

  • High Volume Subcutaneous Drug Delivery: Challenges, Opportunities, and What the Future Holds

    Over the past few years, there has been a dramatic increase in the number of therapeutic proteins delivered through intravenous infusion and subcutaneous delivery. Conversion of high volume intravenous infusion products to subcutaneous injection as well as optimization of subcutaneously delivered products can reduce treatment burden for patients, save provider time, and potentially reduce health care costs.

    Leading biopharmaceutical thought leaders will outline the challenges, opportunities, and emerging trends associated with high volume subcutaneous delivery. The panel participants will discuss the technical considerations, development approaches, and commercial implications.

    Moderator:


    Cindy Atwell

    Senior Director, Business Development and Strategy, Halozyme

    Panelists:


    Nancy Barbour, PhD

    VP, Drug Product Science & Technology, BMS


    Chris Coletta, PhD

    Drug Delivery Technology Expert, Coactuate


    Beate Bittner, PhD

    Portfolio Strategy Director, Roche

    Additional panelists TBA

  • 4:15 pm

  • Patient-Centric Design: The Patient Voice Matters

    This panel discussion will feature patient perspectives on current drug delivery formulations and products. Patients will highlight their experience with particular products and address where they feel improvements are still needed. Industry will gain a better understanding of the patient viewpoint and considerations for future product development. Several therapeutic areas will be covered including autoimmune disorders, ophthalmology, oncology and CNS conditions.

    Speakers TBA

  • 4:45 pm

  • Networking & Partnering Meetings, Conference Concludes