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2019 Agenda

  • 8:00 am

  • Registration & Coffee/Tea

  • 8:15 am

  • Opening Remarks


  • 🔑 Keynote Fireside Chat

  • 8:20 am

  • Building a Company around a Transformative Drug Delivery Invention

    Dr Robert Langer will be joined on stage with some of his co-founders and collaborators to discuss their insights on building a company around a transformative drug delivery invention, the evolution of the regulatory process for drug delivery products, and lessons learned while progressing from scientist to academic entrepreneur.

    Robert Langer
    Robert Langer, PhD

    David H. Koch Institute Professor, MIT

    with

    Sangeeta Bhatia
    Sangeeta Bhatia, MD, PhD

    John J. and Dorothy Wilson Professor of Engineering, Director, Laboratory for Multiscale Regenerative Technologies

    Jeffrey Karp
    Jeffrey Karp, PhD
    Professor of MedicineHarvard Medical School and Director of the Laboratory for Accelerated Medical InnovationBrigham and Women’s Hospital


    Giovanni Traverso, PhD

    Assistant Professor, Department of Mechanical Engineering, MIT and Assistant Professor of Medicine (part-time), Division of Gastroenterology, Brigham and Women’s Hospital, Harvard Medical School


  • 🔑 Industry Keynote

  • 9:05 am

  • Industry Keynote with Merck’s Dr Allen Templeton

    Merck has a long history of being open to utilizing a wide range of delivery technologies for both enabling and life cycle management. In this leadership keynote, hear how Merck’s strategy of utilizing DDS has evolved and the role of enabling drug delivery technologies play in the Merck R&D pipeline. What emerging DDS technologies and modalities does Merck view as the most promising, and why.

    Allen Templeton
    Allen Templeton, PhD

    VP, Pharmaceutical Sciences, Merck

  • 9:35 am

  • Grand Opening of the PODD Networking Exhibits Café & Partnering

    • Breakfast
    • Partnering Tables
    • Meet the Drug Delivery Technologies and More
    • Networking
     
  • 10:35 am

  • Future Outlook for Novel Drug Delivery

    In this panel, we will address the following:

    • Where do we see the value in Drug Delivery, and overall what are we trying to accomplish?
      • Value to the patient
      • Value to pharma
    • What is the current state of the art for various modalities?
      • Biologics
      • Small molecules
      • Peptides, Antisense Oligonucleotides (ASOs)
    • What will things look like in 5 years?
      • Move towards any other type of delivery? Needle-free, SR depots oral?
    • What are the barriers to some of these technologies?  Is industry willing to invest?
    • Looking beyond 5 years to the opportunity to hit new targets, what are the big challenges?
      • Intracellular
      • Inter-tumoral
      • Pulmonary delivery of biologics
      • Targeted delivery (e.g. brain)

    Moderator:

    Shawn Davis, PhD
    Senior Director, Drug Delivery, AstraZeneca

    Panelists:

    Advait Badkar
    Advait Badkar, PhD

    Senior Director, Novel Delivery Technologies, BioTherapeutics, Pfizer

    Andre LaFreniere
    Senior Medical Market Manager, Battelle 

     
  • 11:15 am

  • Formulation & Device Lifecycle Management for Biotherapeutics – Clinical and Industry Perspectives on Subcutaneous Delivery

    Subcutaneous (SC) delivery has become the norm for treating diseases such as rheumatoid arthritis and multiple sclerosis, and there remains great potential to offer home- or even self-administered SC delivery for several other biotherapeutics. Given that there are a number of products already on the market, they can be examined to understand what improvements and changes can be made to increase product development opportunities and also enhance the patient experience. In this panel, we will hear from clinicians (pharmacist and physician) and industry to gain insight into needs and preferences of future SC biotherapeutic formulations and devices. For example, panelists will address the issue of reducing costs and dose complexity, improving adherence, and also provide input on changes they would like to see in future SC biotherapeutics products.


    Beate Bittner, PhD

    Portfolio Strategy Director, F. Hoffmann-La Roche Ltd


    Johannes Schmidt

    Global Head of Product Optimization, F. Hoffmann – La Roche


    Anand Subramony, PhD

    VP, External innovation and Novel Product Technologies, AstraZeneca

    Additional panelists TBA

  • 11:55 am

  • Drug Delivery Pipeline and Technologies, A Year in Review

    Kurt Sedo
    Kurt Sedo

    VP, PharmaCircle

  • 12:15 pm

  • 9th Annual Company Spotlights Part I

    In this session, we feature two companies discussing their partnering philosophy, current needs and scouting interests, as related to drug delivery and enabling technologies.

    Presenting companies:

    Abbvie

    Eli Lilly

  • 12:40 pm

  • Luncheon & Partnering Meetings

    PODD lunch

  • 1:45 pm

  • Delivering Flexible Dosage Forms for Innovative Modalities and an Evolving Development Plan

    Advait Badkar
    Advait Badkar, PhD

    Senior Director, Novel Delivery Technologies, BioTherapeutics, Pfizer

  • 2:10 pm
    - 5:50 pm

  • Drug Delivery Technology Presentations, 6 Tracks

    (There is a scheduled 15-minute break for partnering, networking and refreshments)

    Attendees can choose among six different sessions covering a wide range of technologies ranging from sustained release oral and injectable systems to novel connected and wearable delivery systems.

    • Track 1A: Injectable Formulation Technologies

      2:15 pm

      Companies will present technologies to improve the formulation and delivery of injectable drugs. Examples of technologies presented: sustained release microspheres, nanoparticles, and enabling technologies for high volume drugs.

      Chair:

      Srini Sridharan, PhD
      Head, Materials Science & Engineering, BMS

      Presenting Companies:

      Halozyme

      Innocore

      Evonik

      Oakwood Labs

      DelSiTech

      Altaviz

      Serina Therapeutics

    • Break

      4:05 pm- 4:20 pm

    • Track 1B: Pre-Filled Syringes, Auto-injectors and Pen Injectors

      Companies will present injectable drug delivery devices including pre-filled syringes, multi-vial/multi-syringe systems, pens, and auto-injectors.

      Chair:
      Ulrich Brüggemann
      Ulrich Brüggemann
      Head, Academics and Innovation, Global Medical Devices, Sanofi

      Presenting Companies:

      Credence Medsystems

      Gerresheimer

      SMC Ltd

      Stevanato Group

      Consort Medical, Bespak Europe Division

      Datwyler

      Nemera

    • Track 2A: Non-injectable Technologies

      2:15 pm

      Companies will present non-injectable/non-invasive delivery technologies such as oral, mucosal, transdermal, ophthalmic, and pulmonary delivery technologies. Examples of technologies featured:  oral controlled release delivery systems, nanoparticles/nanoemulsions, mucoadhesive dosage forms, and aerosol technologies.

      Chair:
      Manuel Sanchez-Felix
      Manuel Sanchez-Felix, PhD
      Senior Fellow, Novel Delivery Technologies, Novartis

      Presenting Companies:

      BDD Pharma

      Harro Höfliger

      Leon-nanodrugs

      Adare

    • Break

      4:05 pm- 4:20 pm

    • Track 2B: Novel Injectable and Non-Injectable Formulation Technologies

      Companies will present a range of novel formulation technologies such as those offering site-specific delivery, extended release, and improved solubility or Examples of featured technologies include: bioerodible implants, transdermal patches, and ophthalmic delivery devices.

      Chair:
      Ann Daugherty
      Ann Daugherty, PhD
      Senior Manager, Drug Delivery, Genentech

      Presenting Companies:

      DSM Biomedical

      MedinCell

    • Track 3A: Connected Delivery Devices, Wearables & Other Novel Delivery Devices, Part 1

      2:15 pm

      Companies will present innovative delivery devices such as wearable delivery systems, needle-free and connected health devices.

      Chair:
      Dhairya Mehta
      Dhairya Mehta
      Director, Connected and Software Medical Connected Devices, Takeda

      Presenting Companies:

      Cambridge Design Partnerships

      Enable Injections

      Portal Instruments

      BioCorp

      BD

      Phillips-Medsize

      Neuma

    • Break

      4:05 pm- 4:20 pm

    • Track 3B: Connected Delivery Devices, Wearables & Other Novel Delivery Devices, Part 2

      Companies will present innovative delivery devices such as wearable delivery systems, needle-free and connected health devices.

      Chair:
      Diane Doughty
      Diane Doughty, PhD
      Senior Scientist, Device Development Group, AstraZeneca

      Presenting Companies:

      Sensile Medical

      Sonceboz

      Vernay/Quantex

      ATS Automation

      Sorrel Medical

      Stress Engineering

  • 6:05 pm

  • PODD 9th Annual Networking Reception & Partnering

    PODD Annual Reception

2019 Agenda

  • 8:00 am

  • Coffee/Tea

  • 8:25 am

  • Opening Remarks


  • 🔑 Gene Therapy Keynote

  • 8:30 am

  • Katherine High
    Katherine High, MD

    President and Head of R&D, Spark Therapeutics


  • Zeitgeist Presentation

  • 9:00 am

  • The Immune Targeting Nanomedicine Approach

    Systemic approaches to immune system activation using nanoparticles containing the right molecules and their ability to prevent immune suppression routes such as the adenosine pathway presents futuristic drug delivery opportunities for nanoparticles that can target the immune system. In the immune targeting nanomedicine approach, nanoparticles may positively influence the immune system towards destructing the tumor rather than targeting the tumor tissues. Utilizing the intrinsic properties of nanoparticles for immune targeting as opposed to targeting the tumor can bring about a fundamental difference in the approach. The heterogenous biodistribution of nanoparticles lends itself to stimulating immune cells systemically in a “global” manner and with the right therapeutic combinations will be able to trigger tumor antigens to continually activate, retain memory effects, and destroy tumor cells. In this talk, we will follow the progress of nanotechnology in pharmaceutical applications with key insights towards cancer immunotherapy and targeted therapy and how to retune our thinking to better utilize and develop nanomedicines for oncology.


    Anand Subramony, PhD

    VP, External innovation and Novel Product Technologies, AstraZeneca

  • 9:30 am

  • 9th Annual Company Spotlights Part II

    In this session, we feature two companies discussing their partnering philosophy, current needs and scouting interests, as related to drug delivery and enabling technologies.

    Presenting companies:

    Merck KGaA

    Teva

  • 9:55 am

  • PODD Networking Exhibits Café & Partnering

    • Breakfast
    • Partnering Tables
    • Meet the Drug Delivery Technologies and More
    • Networking
     PODD Networking
  • 10:55 am

  • Case Study: Forming and Managing a Drug Delivery Alliance

    Michael Cucolo
    Michael Cucolo

    Director of Business Development, Bristol-Myers Squibb

    Brian Davideit
    Associate Director, Alliance Management, Bristol-Myers Squibb

    Renee Tannenbaum
    VP, Global Alliances, Halozyme

    Tom Witt
    Executive Director, Business Development and Strategy, Halozyme

  • 11:25 am

  • MedTech Fireside Chat: The Journey of an Emerging Medical Device Company: From a Blank Piece of Paper toward Commercialization

    • The early days: starting the company and inventing with implementation in mind
    • The importance of listening to the customer and incorporating feedback early – and why that can be difficult
    • Staying in the long game – the mindset, endurance and approach to ensure you are ready when opportunity appears
    • Collaborating within the supply chain – why it’s challenging and the right approach


    John A Merhige

    Chief Commercial Officer, Credence MedSystems, Inc


    Mathias Romacker

    Senior Director, Device Strategy, Pfizer

  • 11:45 am

  • DDS Technology Soapbox, hosted by Pfizer

    This section of PODD features really young start-ups, entrepreneurs, inventors, licensing officers and university researchers. They get five minutes to tell us about their cutting-edge technologies, inventions and ideas. Many thanks to Pfizer for supporting the PODD DDS Technology Soapbox.

    Moderator:

    Patrick Lim Soo, PhD
    Senior Principal Scientist, Novel Delivery Technologies, Pfizer

    Presenting Companies:

    Queen’s University Belfast

    Neuroparticle Corporation

    Curadigm

    Harvard University

    Dendropharm

  • 12:20 pm

  • Lunch & Partnering

    PODD lunch

  • 1:15 pm

  • Breakout Choices

    • Breakout 1: Devices

      1:20 pm

      Device Platforms – the Good, the Bad and the Ugly

      The panel will examine the advantages and downsides of injection platform devices, as well as considerations for implementing a device platform vs. when does it not make sense to pursue one?

      Moderators:

      Mathias Romacker

      Senior Director, Device Strategy, Pfizer


      Chris Coletta, PhD

      VP of Business and Strategy, Alcyone Sciences

      Panelists:
      Tommaso Borghi
      Tommaso Borghi, PhD
      Principal, Design Project Management, Flex

      Stephen Fournier, MBA
      Director Device Platform Management, Alnylam

      Lidia Massimi
      Lidia Massimi

      Advisor, Biomedicines Device, Delivery & Packaging Strategy, Eli Lilly


      Ian Thompson

      VP, Business Development, Ypsomed

    • 2:05 pm

      Transforming the Injection Experience through a Patient-Centric Approach

      In this session, panelists will address the following:

      • Industry Trends moving towards self-administration
      • Patient Perspective: Challenges with using complex drug delivery devices and training materials. 
      • Pharma Perspective: What can we as pharma companies do better with training materials? Performance & Usability Testing? Other blue sky ideas
        • Demo Units- how can they mimic the actual device in terms of use or performance
        • Training Videos & IFU- making it less cumbersome for our users.

      Moderator:
      Sudeshna Dutta Ray
      Sudeshna Dutta Ray
      Senior Engineer, Advanced Device Technology and Innovation, Amgen

      Panelists:

      Lilly Stairs

      Patient Advocate and Head of Growth & Partnerships, Savvy Cooperative

      Molly Story
      Molly Story, PhD
      Head, Global Usability Engineering and Risk Management, MED, Sanofi

      Rémy Vomscheid
      Rémy Vomscheid, PhD

      Director, Device Development & Technologies, Ipsen

    • Breakout 2: Formulations

      1:20 pm

      Smart Drug Design and Development – from Candidate to Phase I

      The panel brings together scientists across disciplines involved in early development to explore the key considerations for transitioning a molecule from discovery to clinic including API and formulation development, pharmacokinetics, quality and CMC requirements, and patient-focused drug product design principles. The goal is to demonstrate how every design decision has potential to influence patient outcomes.

      Moderator:

      Cornell Stamoran, PhD
      President, Strategy & Govt. Affairs, Founder & Co-Chair, Catalent Applied Drug Delivery Institute

      Panelists:

      Rebecca Carrier, PhD
      Professor and Associate Chair for Research, Chemical Engineering, Northeastern University

      Sudhakar Garad, PhD
      Global Head of Pharmaceutical and Chemical Profiling, Novartis Institutes for Biomedical Research


      Keith Horspool, PhD

      VP, Pharmaceutics, Boehringer Ingelheim

      Ronak Savla, PhD, PharmD
      Manager Scientific and Technical Affairs, Catalent


      James Spavins

      Spavins Consulting LLC, former SVP, Global PTx Pharmaceutical Sciences, Pfizer

      Katarina Vulic, PhD
      Principal Scientist, Novartis Institutes for Biomedical Research

    • 2:05 pm

      The Therapeutic & Delivery Potential of Biologically-Derived Delivery Systems

      This panel discussion is focused on the latest progress and utility of emerging bio-derived technologies such as exosomes, cell-based systems, viral vector and bacterial-based systems. More specifically:

      • Therapeutic and delivery potential
        • Small molecules, proteins, RNA, CRISPR gene-editing tools
        • Targeting capabilities (e.g. enhancing delivery to tumors or across the BBB)
      • Advantages of these carriers over synthetic delivery systems
      • Challenges in clinical and commercial translation
        • Production methods, including isolation, purification and storage
        • Efficient drug loading and targeting

      marian gindy
      Marian Gindy, PhD

      Executive Director, Pharmaceutical Sciences, Merck

      Rishab Shyam
      Rishab Shyam, PhD

      Executive Director, PureTech Health


  • Plenary Afternoon on Connected Health & Drug Delivery

  • 2:35 pm

  • Defining the Value Proposition and Supporting Business Models for Scaled Connected Health Drug Delivery Products

    How are industry leaders looking to bridge the gap from pilot systems to scaled solutions in the market? This panel of Connected Health leaders in the industry will provide their views on how they are developing value propositions that resonate with internal and external stakeholders.  Defining business and operational models that benefit patients and support evolving healthcare payment structures, while delivering strong returns to the business is central to this discussion.

    Kevin Deane
    Kevin Deane

    EVP, Front-End Innovation, Medicom Innovation Partner, a Phillips-Medisize Company

    Paul Upham
    Paul Upham

    Senior Principal, Smart Device Technology Center, Roche / Genentech

    Additional panelists TBA


  • Plenary Closing Presentation:

  • 3:05 pm

  • Drug Delivery’s Relationship to Digital Health Data to Achieve the Ultimate Outcome for Patients

    From Disease Management to Wellness


    Chris Kovalchick, PhD

    Chief Engineer, Drug Delivery & Devices R&D Innovation, Eli Lilly

  • 3:30 pm

  • PODD 2019 Concludes