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2018 Agenda

  • 8:00 am

  • Registration & Breakfast, Exhibits Open

  • 8:30 am

  • A Year in Review and PODD Welcome


    Barbara Lueckel, PhD

    Global Business Development Director, Roche Partnering Innovation, Roche

  • 9:00 am

  • Keynote Fireside Chat

    Dr Robert Langer and Amy Schulman, two dynamic entrepreneurs in biotech, will reveal their insights on drug delivery innovation and partnering in a fireside chat interview with Barbara Lueckel. Topics include:

    • Case studies of drug delivery spin-outs from Dr Langer’s lab
    • The path from lab to the clinic for a drug delivery biotech
    • Positioning of drug delivery in the broad space of life science innovation

    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

  • 9:45 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, PhD

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

  • 10:15 am

  • Networking Break & Partnering Meetings, Exhibits Open

    Sponsored by:

  • 11:00 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


    Dan Groszmann, PhD

    Principal Engineer, Device Technologies Innovation CenterAmgen


    Barbara Lueckel, PhD

    Global Business Development Director, Roche Partnering Innovation, Roche


    Imran Nasrullah, MS, JD

    Director, Strategic Partnering, BD&L, Boehringer Ingelheim Pharmaceuticals

    terry reed
    Terry Reed
    Director, Business Development, AstraZeneca
  • 11:45 am

  • 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

    Strategic Design ConsultantCoactuate


    Beate Bittner, PhD

    Senior Portfolio Strategy Director, Roche


    Shawn Davis, PhD

    Head of Drug Delivery, Medimmune

    Robert Epstein, MD
    CEO, Epstein Health

    Peter Quinn
    Platform Leader – Wearable Injection Systems, BD Medical – Pharmaceutical Systems

  • 12:45 pm

  • Lunch & Partnering Meetings

  • 2:00 pm

  • A Year in Review on the Drug Delivery 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

  • 2:15 pm
    - 6:15 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 Formulation & Device Technologies

      Companies will present technologies to improve the formulation and delivery of injectable drugs. Examples of technologies presented: sustained release microspheres, nanoparticles, enabling formulation system for high volume drugs, novel injectors, pre-filled syringes, and multi-vial/multi-syringe systems.

      Chair:

      Michael Cucolo
      Michael Cucolo

      Director of Business Development, BMS

    • Examples of Presenting Companies:

      Enable Injections

      Innocore Pharmaceuticals

      Halozyme

      Evonik

      Datwyler

      Cureport

      InnoMedica

      Adocia

    • Track 1B: Injectable Formulation & Device Technologies

      Companies will present technologies to improve the formulation and delivery of injectable drugs. Examples of technologies presented: sustained release microspheres, nanoparticles, enabling formulation system for high volume drugs, novel injectors, pre-filled syringes, and multi-vial/multi-syringe systems.

      Chair:


      Nima Akhavein, PhD

      Associate Fellow and Scientific Leader, GSK

    • Examples of Presenting Companies:

      Serina Therapeutics

      DelSiTech

      Gerresheimer Regensburg GmbH

      Nanexa

    • Track 2A: Non-Injectable Technologies: Oral 

      Companies will present controlled release, modified-release, colon-targeted, and orally-disintegrating delivery systems, as well as 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

      Harro Hofliger Verpackungsmaschinen GmbH

      Recro Gainesville

      BDD Pharma

      Lyndra

      Matinas BioPharma

      Ileo Science

    • Track 2B: Non-Injectable Technologies: Oral, Mucosal, Transdermal, Ophthalmic and Pulmonary

      Companies will present a wide range of technologies for oral, mucosal, buccal, ophthalmic, transdermal, vaginal, and pulmonary delivery. Examples of technologies presented: polymeric delivery systems, dermal nanoparticle systems, and next-generation inhalers.

      Chair:

      Ann Daugherty
      Ann L Daugherty, PhD

      Senior Manager, Drug Delivery, Genentech

    • Examples of Presenting Companies:

      Pharmaero

      Exicure

      Qpharma

      Intract Pharma

    • 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

      Sensile Medical

      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:

      Vernay

      Common Sensing

      Altaviz

      Cureport

      Sorrel Medical

      Ypsomed

      Battelle

      Ichor Medical


  •  

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

     

  • 6:15 pm

  • Networking Reception & Partnering Meetings

2018 Agenda

  • 8:00 am

  • Breakfast in Exhibit Hall and Partnering Meetings

  • 8:30 am

  • Chair’s Welcome


    Barbara Lueckel, PhD

    Global Business Development Director, Roche Partnering Innovation, Roche

  • 8:40 am

  • Industry Keynote: 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.

    Justin Wright 2018
    Justin M Wright, PhD

    Global Head of Innovation, Novartis

  • 9:10 am

  • The Pediatric Patient Perspective

    Moderated by:

    Cornell Stamoran, PhD
    VP of Corporate Strategy and Government AffairsCatalent Pharma Solutions

    with

    Alex Rinaudo
    Patient Advocate

    Valerie Bowling
    Patient Advocate

  • 9:35 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:


    Rhett Alden, PhD

    Sr Advisor/Chief Digital Architect for Connected Care, Eli Lilly and Company 


    Supriya Lagu, PhD

    Director, Digital Health Technology, Biogen

    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

  • 10:15 am

  • Networking Break in Exhibit Hall and Partnering Meetings

  • 11:00 am

  • Maximizing the Value of Collaboration for Novel Device Design

    Partnering is a vital aspect of medical device development; it provides necessary resources and expertise for development, and brings in new viewpoints and experiences, which truly drive product innovation. This type of collaboration, however, also adds a layer of complexity to a development project that must be carefully managed to successfully reach the end goal. In this session, the speakers will present challenges, best practices and lessons learned for partnering, using case studies for illustration. The speakers will highlight ways they maximized the value of collaboration from the outset, including: how they identified and moved forward with the “right” partner; built a productive multi-partner team; productively managed communications and expectations throughout the development cycle; measured performance; and made critical decisions to reach a successful outcome.


    Doug Boyd, PE, PMP

    Manager, Medical Devices and Health Analytics, Battelle


    Gary Henniger

    Senior Director Global Device R&D Operations, Teva

  • 11:30 am

  • 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


    Grégoire Schwach, PhD

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


    Srini Sridharan, PhD

    Head, Materials Science & Engineering, Bristol-Myers Squibb


    Simon Todd

    Science and Innovation Lead, AstraZeneca

  • 12:30 pm

  • Luncheon Roundtables & Partnering Meetings

    The PODD Luncheon Roundtables are open to all delegates and feature a dedicated moderator for each topic. Participating in a Roundtable session is an excellent way to engage in in-depth discussions and meet colleagues with similar interests. Be sure to pick up your Grab-and-Go lunch and join the conversation.

    Sponsored by:

    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

  • 1:30 pm

  • 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

    Better Sense

    Massachusetts General Hospital

    SiNON Therapeutics

  • 2:10 pm

  • 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:


    Eric Elenko, PhD

    Chief of Research 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

  • 2:40 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

  • 3:20 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

    Head of Technical and Pharmaceutical Operations, MedinCell

    Panelists:

    Mark Currie
    Mark Currie, PhD

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


    Mohamed E H ElSayed, PhD

    Sr. Research Advisor, BioTDR Formulation/Delivery, Eli Lilly and Company


    Adam Mezo, PhD

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


    Douglas P Nesta, PhD

    Senior Director, Biopharmaceutical Product Sciences, GSK


    Julia Rashba-Step, PhD

    VP, Research & Development and Alliance Management, Phosphorex

  • 4:00 pm

  • The Role of Digital Biomarkers in the Future of Drug Delivery


    Christopher Kovalchick, PhD

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

  • 4:20 pm

  • Conference Concludes