2019 Agenda

  • 7:45 am

  • Registration & Coffee/Tea hosted by:

  • 8:15 am

  • Chair's Opening Remarks

    Shawn Davis-2019-
    Shawn Davis, PhD
    Senior Director, Drug Delivery, AstraZeneca


  • 🔑 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, MIT

    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, MD, 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

  • Modality Fluid Development: Tales of Evolving Pipelines and Drug Delivery Solutions

    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_v2
    Allen Templeton, PhD

    VP, Pharmaceutical Sciences, Merck

  • 9:35 am

  • Grand Opening of the PODD Café & Networking Exhibit Room

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

  • Future Outlook for Novel Drug Delivery

    This panel will explore the value of drug delivery technologies both to patients and pharma with a focus on the future direction of the field. This will include a review of the state of the art for traditional modalities such as small molecules and biologics and then expand the conversation to the challenges for less common modalities such as peptides and nucleic acids. The panel members will discuss the potential scientific barriers for these future delivery technologies and the industry’s willingness to invest to address these barriers.

    Moderator:
    Shawn Davis-2019-
    Shawn Davis, PhD
    Senior Director, Drug Delivery, AstraZeneca

    Panelists:

    Advait Badkar
    Advait Badkar, PhD

    Senior Director, Novel Delivery Technologies, BioTherapeutics, Pfizer

    André LaFreniere
    André LaFreniere

    Director of Commercial Sales, Medical Devices & Diagnostics, Battelle

    Maria Teresa Peracchia
    Maria Teresa Peracchia, PhD

    Global Head, Drug Delivery and Product Integration, Biologics Drug Product Development, Sanofi


    Julia Rashba-Step, PhD
    VP, R&D and Alliance Management, Phosphorex

    Theresa Scheuble
    Theresa Scheuble
    Design Director, Value Chain Quality, Johnson & Johnson

  • 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.

    Moderator:


    Beate Bittner, PhD

    Senior Portfolio Strategy Director, Roche

    Panelists:

    Mary Nauffal
    Mary Nauffal, PharmD, MS, BCOP

    Hematology/ Oncology Clinical Pharmacist, Department of Pharmacy ServicesBrigham and Women’s Hospital

    Manuel Sanchez-Felix-2019
    Manuel Sanchez-Felix, PhD
    Senior Fellow, Novel Delivery Technologies Group, Novartis Institutes for BioMedical Research


    Anand Subramony, PhD

    VP, External innovation and Novel Product Technologies, AstraZeneca

    David Ting
    David Ting, MD

    Associate Clinical Director for Innovation, MGH Cancer Center / Assistant Professor of Medicine, Harvard Medical School

  • 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 three companies discussing their partnering philosophy, current needs and scouting interests, as related to drug delivery and enabling technologies.

    Presenting companies:

    Takeda
    Sujit Basu
    Sujit Basu, PhD

    Head, Medical Devices Center of Excellence

    GSK

    Nima Akhavein, PhD, MBA

    Associate Fellow and Scientific Leader, Drug Delivery

    Biogen

    Mandana Borna
    Mandana Borna, PhD

    Scientist II, ASO Drug Product Delivery

  • 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
    - 6:25 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.

    • 2:15 -4:12 pm

      Track 1A: Injectable Formulation Technologies

      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:

      2:20 – 2:35 pm

      Enabling and Enhancing Subcutaneous Administration of Monoclonal Antibodies Using ENHANZE® Drug Delivery Technology (Recombinant Human Hyaluronidase PH20)

      Tom Witt
      Tom Witt

      Executive Director, Business Development and Strategy,
      Halozyme Therapeutics


       

      2:35 – 2:50 pm

      SynBiosys  Microparticles for the development of long-acting injectable formulations for biological therapeutics

      Rob Steendam
      Rob Steendam, PhD

      Chief Technology Officer, InnoCore Pharmaceuticals


       

      2:50 – 3:05 pm

      Recent Advances in Lipid Nanoparticle-Mediated Drug Delivery

      Norbert Maurer
      Norbert Maurer, PhD

      Director, Global Technical Business Development, Drug Delivery, Evonik Health Care


       

      3:05 – 3:20 pm

      Overcoming Microsphere Scale-Up Challenges

      Samantha Cramer
      Samantha Cramer

      Formulation Scientist II, Oakwood Labs


       

      3:20 – 3:35 pm

      DelsiTech Silica Matrix: Long-Acting and stabilized drug delivery for small molecules and biologics

      Frederic Dargelas
      Frederic Dargelas, PhD, MBA

      Director, Head of Business Development and Alliance Management, DelSiTech Ltd


       

      3:35 – 3:50 pm

      DEP – Developing Enhanced Therapies


      David Owen, PhD

      VP, Drug Discovery, Starpharma


       

      3:50 – 4:05 pm

      The Era of Once-weekly Continuous Drug Delivery in Parkinson’s Disease is Here


      Randall W Moreadith, MD, PhD

      President and CEO, Serina Therapeutics


       

      4:05 – 4:12 pm

      Drug Substance / Drug Product Characterization and Performance Prediction Using High Resolution 3D Micro-Imaging Analysis

      Shawn Zhang
      Shawn Zhang, PhD

      Founder, Managing Partner, DigiM Solution LLC

    • Networking Break

      4:15 pm- 4:30 pm


    • 4:30 – 6:22 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 Bruggemann
      Early Technology and Device Strategy, Takeda 

       

       

       

       

      Presenting Companies:

      4:30 – 4:45 pm

      Collaboration in the Supply Chain to Deliver the Innovative Dual Chamber Syringe to the Pharma Industry


      John Merhige

      Chief Commercial Officer, Credence MedSystems

      and

      Michael S Thomas
      Michael S Thomas

      Senior Research Scientist, Project Director, Lyophilization Technology, Inc


       

      4:45 – 5:00 pm

      Biologics ask for an optimized delivery system. Let’s find some answers.

      Polina Golovatch
      Polina Golovatch, PhD

      Sales Manager – Eastern Region for Gx Solutions and Syringes in North America, Gerresheimer


       

      5:00 – 5:15 pm

      Drug Product Characterization- A Key Factor in the Design of an Autoinjector


      Meredith Canty

      Director Drug Delivery Systems, SMC Ltd


       

      5:15 – 5:30 pm

      An Integrated Solution for Delivery Devices: Stevanato Group’s 4D Approach

      Steven Kaufman
      Steven Kaufman, MBA

      VP, Drug Delivery Systems, Stevanato Group


       

      5:30 – 5:45 pm

      Clinical Ready Auto Injector for High Viscous Drug Products


      Hans Jensen, MBA

      Global Business Development Director, Consort Medical, Bespak Europe Division


       

      5:45 – 6:00 pm

      Customization of Elastomer Components for Novel Devices

      Eugene Polini
      Eugene Polini, MBA

      Technical Key Account Manager, Datwyler


       

      6:00 – 6:15 pm

      Putting Patients First: Developing  Patient-centric Devices from Ideation through Manufacturing

      Isabelle Delcroix
      Isabelle Delcroix

      Strategy Director, Nemera

      Craig Scherer
      Craig Scherer, MBA

      Director of Marketing for Insight Innovation Center, Nemera


       

      6:15 – 6:22 pm

      Alerje: Proactive Patient Driven Design

      Javier Evelyn
      Javier Evelyn

      Founder and CEOAlerje

    • 2:15 – 3:41 pm

      Track 2A: Non-injectable Technologies

      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-2019
      Manuel Sanchez-Felix, PhD
      Senior Fellow, Novel Delivery Technologies Group, Novartis Institutes for BioMedical Research

      Presenting Companies:

      2:20 – 2:35 pm

      Clinical Strategies for Faster Development of Oral Modified Release Products

      Howard Stevens
      Howard Stevens, PhD

      Professor, BDD Pharma


       

      2:35 – 2:50 pm

      New Drug Delivery for Cannabis Formulations: Services from Idea to Production

      Elke Sternberger-Rützel
      Elke Sternberger-Rützel, PhD

      Scientific Director, Harro Höfliger


       

      2:50 – 3:05 pm

      Bringing More Drugs to Market: Unleashing the Potential of Poorly Soluble Drugs

      Andrea Cusack
      Andrea Cusack

      Managing Director & CBO, leon-nanodrugs


       

      3:05 – 3:20 pm

      Understanding The Disease and Patient Needs: Critical Insights for Successful Product Development


      Chinmay Maheshwari, PhD
      Director of Pharmaceutical Technology and Product Development, Adare 
      Pharmaceuticals


       

      3:20 – 3:27 pm

      Beyond Polymers – Next generation Oral Formulation

      Niall Hodgins
      Niall Hodgins

      Co-Founder and CEO, SeraNovo B.V.


       

      3:27 – 3:34 pm

      Segmented Intravaginal Rings: Opportunities for Multiple Indications


      David Friend, PhD

      Chief Scientific Officer, Daré Biosciences


       

      3:34 – 3:41 pm

      Converting Injectable Monoclonal Antibodies into Safe and Simple Oral Pills


      Vipul Yadav, PhD

      Director of Research, Intract Pharma

    • Networking Break

      4:15 pm- 4:30 pm


    • 4:30 – 5:52 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:

      4:30 – 4:45 pm

      Novel Biodegradable PolyEsterAmides for Controlled Drug Delivery Applications

      Lukasz Koroniak
      Lukasz Koroniak, PhD, EMBA

      Manager Business Development, DSM Biomedical


       

      4:45 – 5:00 pm

      Building a Global Pharma Leader through Long-acting Injectables

      Victor Aguilar Lopez
      Victor Aguilar Lopez, PhD

      Head of BD, EMEA, MedinCell


       

      5:00 – 5:15 pm

      Broadly Enabling the Power and Potential of Transdermal Drug Delivery

      Ryan Beal
      Ryan Beal, MD

      CEO, Dyve Biosciences


       

      5:15 – 5:30 pm

      Introduction of Fujifilm and its Liposome Technologies

      Hiroto_Bando
      Hiroto Bando, PhD, MBA

      Senior Manager, Pharmaceutical Products Division, FUJIFILM Pharmaceuticals


       

      5:30 – 5:45 pm

      The MIMIX Smart Release Patch Enables Sustained, Dermal Delivery of Everything from Small Molecules to Large Biologics

      Michael Schrader
      Michael Schrader, MBA

      CEOVaxess


       

      5:45 – 5:52 pm

      Mucosal targeting nanoparticle eye drop formulation with once a week dosing

      Frank Gu-bw
      Frank Gu, PhD

      Professor and NSERC Senior Industrial Research Chair / CSO and Co-founder, University of Toronto / MyX Therapeutics

    • 2:15 – 4:12 pm

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

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

      Chair:
      Dhairya Mehta
      Dhairya Mehta
      Director, eHealth & Connectivity, Medical Device & Combination Products, Takeda

       

       

       

       

       

       

      Presenting Companies:

      2:20 – 2:35 pm

      Innovating Across Continents: How Leveraging Technology and Process Enables a Transcontinental Design Team to Achieve Breakthrough Innovation with Clients Across the Globe

      Aki Laakso
      Aki Laakso

      Engineering Lead, Cambridge Design Partnership


       

      2:35 – 2:50 pm

      The Smart enFuse™: Live Demonstration of the Patient Experience with BlueTooth Connectivity and Real Time Data Transmission

      Michael Hooven
      Michael Hooven

      President and CEO, Enable Injections


       

      2:50 – 3:05 pm

      Next Generation Needle Free Drug Delivery


      Patrick Anquetil, PhD, MBA

      CEO, Portal Instruments


       

      3:05 – 3:20 pm

      How a Connected Device is Able to Revolutionize the Patient Experience?

      Eric Dessertenne-2019
      Eric Dessertenne, PhD

      Chief Operating Officer, BIOCORP


       

      3:20 – 3:35 pm

      BD Libertas™ Wearable Injector – An Integrated Drug Delivery System that Enables Large Volume / High Viscosity Biologic Delivery


      Peter Skutnik
      Wearable Injector Platform LeaderBD Medical-Pharmaceutical Systems

       

      3:35 – 3:50 pm

      The Phillips-Medisize New Reusable Connected Autoinjector

      Kevin Deane
      Kevin Deane

      EVP, Front-End Innovation, Phillips-Medisize


       

      3:50 – 4:05 pm

      Wearable Injectors: Configuration Challenges and Opportunities

      Nicholas Ciccarelli
      Nicholas Ciccarelli

      President, Neuma


       

      4:05 – 4:12 pm

      Evopump: Where innovation meets discreet convenience. The first low-profile patch pump that let’s you get back to your normal life sooner.


      Larry Alberts, MBA

      Co-founder and CEO, Cam Med Inc

    • Networking Break

      4:15 pm- 4:30 pm


    • 4:30 – 6:22 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:

      4:30 – 4:45 pm

      A New Micro-Pump for Advanced Parkinson’s Treatment

      Gerhard Mayer
      Gerhard Mayer, PhD

      VP, Business Development, Sensile Medical


       

      4:45 – 5:00 pm

      Drug Delivery Meets Automotive – Wearable Injection Device Platform the Sonceboz-Way

      Tom Mayer
      Tom Mayer

      Business Development Manager, Sonceboz


       

      5:00 – 5:15 pm

      Quantex 4C Lite: A New Addition to the Drug Delivery IoT Platform Enabled by Quantex Micro-Pumps

      Rachel An
      Rachel An

      Medical Device Manager, Quantex Arc


       

      5:15 – 5:30 pm

      Reducing Risk in Route to Delivering  High-Volume Wearable Devices

      Bill Jaworski
      Bill J Jaworski
      Director of Business Development – Life Sciences, ATS Automation


       

      5:30 – 5:45 pm

      Your Primary Container’s Customizable Wearable Device Platform

      Michael Ratigan
      Michael Ratigan

      CCO, Sorrel Medical


       

      5:45 – 6:00 pm

      Avoiding the Typical Pitfalls in Commercializing Devices

      Rob States
      Rob States, MBA

      Principal, Medical Practice Lead, Stress Engineering


       

      6:00 – 6:15 pm

      Minimally-invasive, Endovascular Catheter for Direct Drug Delivery to the Brain

      Adel Malek
      Adel Malek, MD, PhD

      Chief, Neurovascular Surgery, Tufts Medical Center / Professor, Tufts University School of Medicine / Co-founder, CereVasc, LLC


       

      6:15 – 6:22 pm

      Introducing a Novel Dosage Manager

      martin olovsson
      Martin Olovsson

      CEO & Co-founder, 
      OnDosis

  • 6:25 pm

  • PODD 9th Annual Networking Reception & Partnering

    PODD Annual Reception

2019 Agenda

  • 8:00 am

  • Coffee/Tea & Partnering Meetings

  • 8:25 am

  • Chair's Opening Remarks

    Shawn Davis-2019-
    Shawn Davis, PhD
    Senior Director, Drug Delivery, AstraZeneca


  • 🔑 Gene Therapy Keynote

  • 8:30 am

  • Turning Genes into Medicines: Gene Therapy for Genetic Disease

    One of the goals of the Human Genome Project was to improve therapeutic options for those born with serious inherited diseases. Today gene therapy is beginning to realize this promise, with the ever-increasing level of clinical investigation in the space, and the first products coming to licensing in the last few years.  This talk will review the current state of gene therapy, including the development of therapies for diseases that were previously untreatable, and, for diseases where therapeutics already existed, the development of therapies that greatly lessen the burden of treatment for the patient and the family. Hurdles in clinical development of gene therapy will be discussed. Examples will be drawn from already approved products and from investigational agents in late stage development. 

    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

  • 9:25 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
    Simon Geißler
    Simon Geißler, PhD
    Director, Drug Delivery and Innovation

    Novo Nordisk
    Kristian Kolind
    Kristian Kolind, PhD
    Head of Front End and External Innovation, Device R&D

  • 9:50 am

  • PODD Networking Exhibits Café & Partnering

    • Breakfast
    • Partnering Tables
    • Meet the Drug Delivery Technologies and more
    • Networking
     PODD Networking
  • 10:45 am

  • Case Study: Forming and Managing a Drug Delivery Alliance

    Effective drug delivery collaborations combine a wide range of experiences and viewpoints with common goals to achieve successful clinical and regulatory outcomes. But the path to developing this eventual relationship is not without challenges, as partnerships that are not clearly defined upfront or effectively managed downstream can quickly derail the best of intentions.  Through the different lenses of Big Pharma and a leading drug delivery technology company, BMS and Halozyme panelists will shed light on key considerations, challenges and lessons learned during the pre-deal courting process as well as their ongoing successful alliance.

    Moderator:

    Jennifer Guzman
    Jennifer Guzman, MBA

    Director of Marketing, ENHANZE, Halozyme Therapeutics

    Panelists:

    Michael Cucolo
    Michael Cucolo

    Director of Business Development, Bristol-Myers Squibb

    Brian Davideit
    Brian Davideit, MBA
    Associate Director, Global Alliances, Bristol-Myers Squibb

    Renee P Tannenbaum
    Renee P Tannenbaum, PharmD, MBA, CSAP

    VP, Global Alliance Management, Halozyme Therapeutics

    Tom Witt
    Tom Witt

    Executive Director, Business Development and Strategy, Halozyme Therapeutics

  • 11:15 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

  • 11:35 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
    COMMAND Nanotech: One-step Nanomedicine Manufacturing

    Justin YW Tian
    Justin YW Tian, PhD
    , Royal Academy of Engineering Enterprise Fellow, Lecturer (Assistant Professor) in Pharmaceutics

    Neuroparticle Corporation
    Painting the Brain and Spinal Cord Using Drug-eluting Magnetic Alginate Capsules


    Lamar Mair, PhD
    President

    Curadigm
    Curadigm platform: Shifting the Therapeutic Paradigm to Elevate Treatment Outcomes for Every Patient

    Matthieu Germain
    Matthieu Germain, PhD
    , CEO

    i2O Therapeutics
    Delivering Biologics Orally 

    Tyler Brown
    Tyler Brown, PhD, Co-Founder

    DendroPharm
    Transdermal Drug Delivery and Novel API to Solve US Opiod Crisis

    Sam Dylan More
    Sam Dylan Moré, PhD, Founder and CEO

    DIANT Pharma
    Continuous Processing Technology for Liposomal Drug Products

    Antonio Costa
    Antonio Costa, PhD, Founder and CEO

    Pleryon Therapeutics
    Sustained Delivery of Anti-VEGF Protein Therapeutics for the Treatment of wAMD 

    Yu Yu
    Yu Yu, PhD

    CEO, CSO and Co-founder

    EnClear Therapies
    Comparison of Intrathecal Bolus Delivery to EnClear Therapies System Delivery in Porcine Model

    Laura Paulsen
    Laura Paulsen, MBA

    Director of BD and Clinical

  • 12:20 pm

  • Lunch & Partnering Meetings

    PODD lunch

  • 1:15 pm

  • Two Breakout Choices

    • Breakout 1: Devices

      1:20 – 2:00 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
      Stephen Fournier, MBA

      Director Device Platform Management, Alnylam

      Lidia Massimi
      Lidia Massimi, MBA

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


      Ian Thompson

      VP, Business Development, Ypsomed

    • 2:00 – 2:40 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:

      Natacha Montemuino
      Natacha Montemuino, MD

      Associate Director, Medical Affairs, BD Medical

      Bryce Rutter
      Bryce G Rutter PhD

      Founder & CEO, Metaphase Design Group, Inc


      Lilly Stairs
      Patient Advocate and Head of Client Relations, Savvy Cooperative

      Alex Therrien
      Alex Therrien

      Director of User Centered Design, Sunrise Labs, Inc 

      Rémy Vomscheid
      Rémy Vomscheid, PhD

      Director, Device Development & Technologies, Ipsen

    • Breakout 2: Formulations

      1:20 – 2:05 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
      Founder & Co-Chair, Catalent Applied Drug Delivery Institute

      Panelists:

      Rebecca Carrier
      Rebecca Carrier, PhD

      Professor, Chemical Engineering, Northeastern University

      Sudhakar Garad
      Sudhakar Garad, PhD

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

      Keith Horspool-2019
      Keith Horspool, PhD

      VP of External Alternative CMC Development (EACD), Boehringer-Ingelheim Pharmaceuticals


      Jim Spavins
      Principal, Spavins Consulting LLC / former SVP, Global PTx Pharmaceutical Sciences, Pfizer

      Katarina Vulic
      Katarina Vulic, PhD

      Principal Scientist, Novartis Institutes for BioMedical Research

    • 2:05 – 2:35 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

      Moderator:

      Robert Saklatvala
      Robert Saklatvala, PhD

      Director, Discovery Pharmaceutical Sciences, Merck

      Panelists:

      Daniel-G-Anderson
      Daniel G Anderson, PhD

      Professor, Department of Chemical Engineering; Institute for Medical Engineering and Science; Harvard-MIT Division of Health Sciences & Technology; David H. Koch Institute for Integrative Cancer Research, MIT

      Amy S Espeseth
      Amy S Espeseth, PhD

      Executive Director, Infectious Disease and Vaccines, Merck

      Rishab Shyam
      Rishab Shyam, PhD

      Executive Director, PureTech Health

      Marija Tadin-Strapps
      Marija Tadin-Strapps, PhD

      VP, Exploratory Biology, SQZ Biotechnologies

      Nele Van Dessel
      Nele Van Dessel, PhD

      CEO, Ernest Pharmaceuticals


  • Plenary Afternoon on Connected Health & Drug Delivery

  • 2:40 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.

    Moderated by:

    Kevin Deane
    Kevin Deane

    EVP, Front-End Innovation, Phillips-Medisize Company

    Panelists:

    Dhairya Mehta
    Dhairya Mehta
    Director, eHealth & Connectivity, Medical Device & Combination Products, Takeda

    Paul Schultz
    Paul Schultz

    Sr. Director, Commercial Development, BrightInsight

    Paul Upham
    Paul Upham

    Senior Principal, Smart Device Technology Center, Roche / Genentech


    Amir Zur, MBA

    Head of Product and Quality, Digital Health, Teva Pharmaceuticals


  • Plenary Closing Presentation:

  • 3:10 pm

  • Achieving the Ultimate Outcome for Patients- Utilizing Digital Health Data to Improve Disease Management, Prevention and Overall Wellness

    Given the increase in focus on digital health and connected device development to improve “patient centricity” and the user experience, there is a large amount of clarity and evidence needed on how to truly ladder in these efforts to achieve the ultimate outcome for patients. The answer lies in leveraging the power of contextualized, extrinsic data that while readily available given the acceleration of technologies and tools available today, are not readily apparent to connected therapeutic ecosystems as a whole – patients, clinicians, and developers of products and solutions. This talk will pull out examples from both inside and outside the drug delivery industry to demonstrate how interrogating the massive amount of environmental and background information readily available can be used to activate the seismic shift needed to move us all towards the ultimate goal for all of our customers -improved wellness and awareness.


    Chris Kovalchick, PhD
    Associate Engineering Advisor; Delivery, Device and Connected Solutions, Eli Lilly and Company

  • 3:30 pm

  • PODD 2019 Concludes