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Agenda

  • 8:00 am

  • Registration & Coffee

  • 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 Breakfast & Break / Grand Opening of the Networking and Exhibit Room

    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


    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


    Johannes Schmidt, PhD

    Global Head, Product Optimization, F. Hoffmann-La Roche Ltd

  • 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

    • Presenting Companies:

      Enable Injections
      Innovators Bringing Combination Products to Life


      Mike Hooven
      , President and CEO


      Innocore Pharmaceuticals
      SynBiosysÒ – biodegradable polymer platform for development of long-acting injectable sustained release formulations for biological therapeutics


      Rob Steendam, PhD,
      Chief Technology Officer


      Halozyme Therapeutics
      The ENHANZE® Technology, Enabling Rapid Large Volume And Reduced Frequency Subcutaneous Delivery


      Michael LaBarre, PhD
      , VP, Product Development


      Evonik
      Complex Parenteral Drug Delivery Products:  Product-by-Process Scale Up and Advanced Product Development


      Thomas Tice, PhD
      , Senior Director, Global Technical Marketing


      Datwyler
      Innovation in Manufacturing of Parenteral Packaging Components with First Line USA


      Rahul Thakar, PhD
      , Technical Key Account Manager


      Cureport
      nPort – A Revolutional Technology for Liposomal Medicine Development and Manufacturing


      De-Min Zhu, PhD
      , Founder and CEO


      InnoMedica
      Novel Liposome Platform for Efficient Drug Delivery in Oncology and Neurology


      Stéfan Halbherr, PhD
      , Head of Research and Development


      Adocia
      Overcoming Formulation and Administration Challenges of Biomolecules


      Michael Nguyen
      , Head of Business Development – New Therapeutic Areas


       

    • 4:15 pm- 4:30 pm

      Afternoon Networking & Ice Cream Break

    • 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

    • Presenting Companies:

      Serina Therapeutics
      The Next Generation of Polymer Therapeutics


      Brendan P Rae, PhD, JD
      , Chief Business Officer


      DelSiTech
      Biodegradable Silica Matrix for Controlled Release of Biological Drugs


      Cora Griffin, PhD
      , Business Development Director


      Gerresheimer GmbH
      Walk Before You Run – Small Batch Production


      Aron Haber
      , Sales Manager


      Nanexa
      Long Acting Injectable Suspension with High Drug Load Aided by Inorganic Nanoshells


      David Westberg, MSc
      , CEO


      Interface Biologics
      A Novel Dexamethasone Intravitreal Implant designed to overcome the limitations of currently available intravitreal steroid implants


      Wendy Naimark, PhD
      , VP, Research and Development


      Ocular Therapeutix
      Transforming Ophthalmic Care with Sustained Delivery Therapies

      Art Driscoll
      Art Driscoll
      VP, Product Development


      Congruence Medical Solutions
      New, Novel Prefillable Microliter Injection Device For Intraocular Therapeutics


      Gautam Shetty
      , CEO

    • 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 TechnologiesChemical and Pharmaceutical Profiling, Novartis Institute for BioMedical Research

    • Presenting Companies:

      leon-nanodrugs GmbH
      Innovative Precipitation Nanotechnology: Bringing Added Value to Product Development and Patients


      Wolfgang Beier, PhD
      , CSO and Co-Founder


      Adare Pharmaceuticals
      Controlled Release Formulations: Scientific Considerations for Design and Development


      Chinmay Maheshwari, PhD,
      Director, Formulation Development


      Aquestive Therapeutics
      Pushing Boundaries to Optimize Drug Delivery on Oral Films


      Rajesh Kainthan, PhD
      , Principal Scientist, Formulation Sciences


      Recro Gainesville
      Technical Considerations for Changing from an Immediate Release to Modified Release Solid Oral Dosage Form


      Myke Scoggins, PhD
      , Director, Product Development


      BDD Pharma
      OralogiK™ – A New Approach to Complex Oral Drug Delivery Profiles


      Howard Stevens, PhD
      , Chairman


      Lyndra
      Ultra-Long-Acting Drug Delivery


      Tyler Grant, PhD
      , Associate Director, Product Engineering


      Matinas BioPharma
      Enabling the Intracellular Delivery of Life-Changing Medicines


      Raphael J Mannino, PhD
      , Chief Scientific Officer


      Ileo Science
      New Oral Nanotechnology Platform Challenges Injectables


      You Han Bae, PhD
      , Chief Science Officer


       

    • 4:15 pm- 4:30 pm

      Afternoon Networking & Ice Cream Break

    • 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

    • Presenting Companies:

      Pharmaero
      The Aqueous Droplet Inhaler


      Tomas Norling
      , Chief Scientific Officer


      Exicure
      Topical Application of Nucleic Acids

      David Giljohann 2017
      David Giljohann, PhD
      , CEO


      QPharma AB
      QPharma: Specialists in the Development and Manufacture of Controlled-release Polymeric Devices


      Susan Fetherston, PhD
      , Senior Development Engineer


      Intract Pharma
      Soteria®: Revolutionising Oral Delivery of Antibodies


      Vipul Yadav, PhD
      , Director of Product Development


      4P Therapeutics
      4P Novel Transdermal Technologies and Capabilities


      Alan Smith, PhD
      , Co-Founder and VP


      Harro Höfliger Verpackungsmaschinen GmbH
      Dry Powder Inhalation Formulation, Technology and Devices Manufacturing Control in Power Micro-dosing


      Phillip Michelfelder
      , Sales Manager


      Daré  Bioscience
      Optimizing Drug Delivery Through Novel Intra-Vaginal Ring (IVR) Technology


      David Friend, PhD
      , Chief Scientific Officer

    • 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

    • Presenting Companies:

      BD Medical
      Enabling High Dose Biologic Delivery for Targeted User Populations


      Megan Lan
      , Senior Manager, Strategic Marketing


      Bespak
      Unidose Xtra – Customizable Unit Dose Nasal Delivery Device


      Joe Masci
      , Business Development and Account Manager


      Credence MedSystems
      The Credence Dual Chamber Reconstitution Syringe: Multiple Devices in One


      John Merhige
      , Chief Commercial Officer


      Cambridge Design Partnership
      Klarus; Our Red Dot Design Award Winner


      Uri Baruch
      , Head of Drug Delivery


      BIOCORP
      Smart Drug Delivery Devices are Reality – But What are the Recipes for Succeeding in that Digital Move?


      Eric Dessertenne, PhD
      , Chief Operating Officer


      Sensile Medical
      The Correlations Between Viscosity, Needle Diameter, Flow Rate and Dose Accuracy in a Patch Pump Therapy


      Gerhard Mayer, PhD
      , VP, Business Development


      Phillips-Medisize
      Phillips-Medisize Low Cost Connectivity Module – The Next Frontier in Connected Health

      Kevin Deane
      Kevin Deane
      , EVP, Front-End Innovation


      Portal Instruments
      Advancements in Connected, Needle-Free Drug Delivery

      Taylor_Barbara copy-bw
      Barbara Taylor
      , Senior Director of Marketing


       

    • 4:15 pm- 4:30 pm

      Afternoon Networking & Ice Cream Break

    • 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

    • Presenting Companies:

      Vernay in partnership with Quantex
      A Novel Single-Treatment Programmable Driver Platform for the Quantex Micro-Pumps


      Paul Pankhurst, PhD
      , CEO, Quantex


      Common Sensing
      Disposable Injector Home Monitoring: Smart Insulin Pens and Beyond


      Kevin Schmid
      , Chief Operating Officer


      Altaviz
      New Technology Auto Injector Capability


      John Huculak
      , Chief Commercial Officer


      Cureport
      nPort – A Revolutional Technology for Liposomal Medicine Development and Manufacturing


      De-Min Zhu, PhD
      , Founder and CEO


      Sorrel Medical
      Your Way to Deliver More: Introducing Sorrel Medical’s Wearable Drug Delivery Platform

      Andrei Yosef
      Andrei Yosef, PhD
      , CEO


      Ypsomed
      Ypsomed Large Volume Injection Platform Product Innovations


      Ian Thompson
      , VP Business Development


      Battelle
      Controllable Force Autoinjector Technology


      Bill Atterbury,
      Research Leader, Medical Devices and Health Analytics


      Ichor Medical
      TriGrid® Delivery System for Delivery of Nucleic Acid-based Drugs and Vaccines


      Drew Hannaman
      , VP, R&D

  • 6:15 pm

  • Networking Reception & Partnering Meetings

Agenda

  • 8:00 am

  • Breakfast & Partnering Meetings in the Networking & Exhibit Room

  • 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 on Drug Delivery and Connected Health

    Moderated by:


    Cornell Stamoran, PhD

    VP of Corporate Strategy and Government AffairsCatalent Pharma Solutions

    with


    Alex Rinaudo

    Patient Advocate

  • 9:35 am

  • Digital Health: Paradox or Paragon: Pragmatic Approaches to Execution

    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:


    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 grab your lunch and join the conversations.

    Sponsored by:

    Patient-Focused Drug Delivery


    Cornell Stamoran, PhD

    VP of Corporate Strategy and Government AffairsCatalent Pharma Solutions 

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

    Viral Kansara, PhD
    VP, Discovery, Clearside Biomedical

  • 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
    Evopump: the First Truly Bandage-like Patch Pump


    Larry Alberts
    , Co-Founder and CEO

    Cinti Medical
    Challenges of Lyophilized Drug Delivery


    Alex Wasson
    , CEO

    Consegna Pharma
    Accelerating Time-to-Market with Computational Drug Delivery


    Larry Zana
    , President and CEO

    Wyss Institute
    Highly Tunable Formulations of Biologic Drugs and Cell Therapies


    Frank Bobe, PhD
    , Entrepreneur-in-Residence

    Better Sense
    Blockchain and IoT Powered Smart Drug Delivery in Remote Care


    Shanglin Yang
    , Founder

    Massachusetts General Hospital
    Genotype-targeted Local Therapy of Tumors


    Ganesh Shankar, MD, PhD
    , Attending Neurosurgeon

    SiNON Therapeutics
    Carbon Quantum Dot Platform Technology for Target Drug Delivery


    Afreen Allam
    , Founder and CEO

  • 2:10 pm

  • Disruptive New Models for Advancing Drug Delivery Innovations Disruptive New Commercialization Models to Advance Drug Delivery Innovations: Looking at 2028

    This panel will discuss 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


    Christian W Mandl, PhD, MD

    Chair, Scientific Advisory Board and Co-founder, Tiba Biotech


    Jinjun Shi, PhD

    Associate Professor, Harvard Medical School and Faculty Member, Center for Nanomedicine at Brigham and Women’s Hospital


    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:

    Ann Daugherty
    Ann L Daugherty, PhD

    Senior Manager, Drug Delivery, Genentech

    Panelists:

    Mark Currie
    Mark Currie, PhD

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


    Mohamed E H ElSayed, PhD

    Research Fellow, 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 and the Impact on Drug Delivery

    The incorporation of digital monitoring biomarkers into drug delivery to enable and activate health, wellness and disease management is discussed. Harnessing the near limitless capacity of these approaches in the managed healthcare continuum can benefit from a systems-based architecture which captures data quality, quantity and ease of capture within a decision making dashboard. A framework is presented which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite and contextualized composite data can drive innovation for the application of digital biomarkers in healthcare with consideration of physiological, behavioral, and environmental factors in the context of biomarker capture and analysis. Application in disease and wellness is highlighted and incorporation in clinical feedback loops and closed-loop systems is illustrated. This will allow logical evolution of the field based on inputs from patients, physicians, healthcare providers, end-payors, actuarists, medical device manufacturers, and drug companies.


    Christopher Kovalchick, PhD

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

  • 4:20 pm

  • Conference Concludes