2021 Agenda


  • *All times are listed in Eastern Time

  • 7:30 am

  • Virtual Platform Opens

  • 8:00 am

  • PODD Welcome & Chair’s Opening Remarks


    Barbara Lueckel, PhD

    Global Head of Research Technologies Partnering, Roche Pharma Partnering


  • Opening Keynote Presentation

  • 8:20 am

  • Novel Delivery Systems for Drugs and Vaccines

    Robert Langer
    Robert Langer, PhD

    David H. Koch Institute Professor, MIT

    Moderator:


    Barbara Lueckel, PhD

    Global Head of Research Technologies Partnering, Roche Pharma Partnering

  • 8:50 am

  • Featured Covid Fireside Discussion with Pfizer

    In this session, we will learn what it took to develop the vaccine in record time at Pfizer, the role of drug delivery, how the key alliances were forged, the challenges overcome, and how this lays the framework for additional new product developments. 

    Advait Badkar
    Advait Badkar, PhD
    Sr. Director Drug Product Design & Development, Pfizer


    David Cirelli, MS
    Senior Director, Analytical Research & Development, Pfizer


    Paul Rohlfing
    Executive Director, Global CMC, Regulatory Affairs, Pfizer

    With Moderator:


    Barbara Lueckel, PhD

    Global Head of Research Technologies Partnering, Roche Pharma Partnering

  • 9:20 am

  • Nanotechnology Fireside Chat with Nanoform CEO, Edward Hæggström

    In this session, we will learn about the journey being undertaken to help pharma and biotech partners reduce attrition in clinical trials and enhance their molecules’ formulation performance through proprietary nanotechnology.

    Shawn Davis-2019-
    Shawn Davis, PhD

    Head of Drug Delivery, Biopharmaceuticals Development, AstraZeneca

    Hosted with:


    Prof. Edward Hæggström, PhD

    CEO, Nanoform

  • 9:40 am

  • PODD Morning Break

     

     

    • Breakout Sessions 
    • Meet the exhibiting drug delivery companies and more
    • Networking

     

  • 10:20 am

  • Company Spotlight Presentations with Amgen, Novartis and Leo Pharma

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


    Manuel Sanchez-Felix, PhD

    Senior Fellow, Novel Delivery Technologies, Novartis


    Darren Reid
    Director, Process Development, Amgen


    Ester Caffarel-Salvador, PhD

    Associate Director, Regenerative Medicine, LEO Pharma

  • 10:55 am

  • Digital Biomarker Development and Its Relationship to Drug Delivery

    This session will address what smart wearables and machine learning can teach us about a patient’s condition to enable better treatment.


    Uri Baruch

    Head of Drug Delivery, Cambridge Design Partnership

  • 11:15 am

  • Meeting the Formulation and Delivery Needs of Special Patient Populations: Focus on Pediatrics and Geriatrics

    With a growing and aging population, there are opportunities to develop improved formulations that are more patient-centric. It is well known that children and elderly patients have specific challenges when it comes to drug administration, yet there are still gaps in meeting their needs.  In this session, our panelists will identify the specific needs of these patient populations, the impact of these issues on patient outcomes, and potential drug delivery technology solutions.

    Moderator


    Cornell Stamoran, PhD
    Founder & Co-Chair, Catalent Applied Drug Delivery Institute

    with


    Biplob Mitra, PhD
    Associate Scientific Director, Drug Product Development, BMS


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


    Matthew Santangelo
    Principal Scientist, PharmSci Small Molecule, Drug Product Design, Pfizer


    Sven Stegemann, PhD
    Professor for Patient Centric Drug Development and Manufacturing, Graz University of Technology

     

  • 11:45 am

  • Lunch & Partnering Meetings

  • 12:25 pm

  • PODD Announcements

  • 12:30 pm

  • 11th annual PODD Track Choices Offering a Wide Variety of Drug Delivery Technology Presentations

     


    • Track 1A

      Injectable Formulation Technologies

      Companies will present novel technologies to improve injectable delivery. Examples of technologies presented: sustained release depots/microspheres, implants, nanoparticles, exosomes, vector delivery systems, and enabling technologies for high volume drugs.

      Track Chair:


      Srini Sridharan, PhD
      Executive Director, Drug Delivery & Product Integration, BMS


    • 12:30 pm

      Biodegradable Polymer-Based Long-Acting Injectable Drug Delivery Technologies for Development of Tomorrow’s Medicine

      InnoCore Pharmaceuticals is a biopharmaceutical drug delivery company offering a versatile portfolio of drug delivery systems (DDS) and development services for long-acting injectables to treat chronic and site-specific diseases. The differentiating features of our advanced biodegradable polymer-based DDS for sustained and site-specific delivery of various classes of therapeutic agents will be discussed.


      Rob Steendam, PhD
      Chief Technology Officer, InnoCore Pharmaceuticals

       

       

       

       

       

       

       


    • 12:45 pm

      Overview of Oakwood’s Labs Chroniject™ Technology for Long Acting Injectables

      A brief overview of our Chroniject™ process showcasing real life examples and solutions for developing, scaling up, and aseptically manufacturing sustained release injectable formulations.


      Brad Minrovic, PhD
      Formulation, Scientist I, Oakwood Labs


    • 1:00 pm

      BEPO® – an Enabling Long Acting Injectable Technology Platform for Drug Delivery Challenges

      Competitive advantages of the BEPO® Technology Platform. Highlight of recent progress in specific formulation challenges with peptides and proteins


      Adolfo López-Noriega, PhD
      Research Leader, MedinCell


    • 1:15 pm

      ENHANZE® Drug Delivery Technology: Facilitating Rapid Subcutaneous Administration of Large Volume Biologics.

      ENHANZE Drug Delivery Technology facilitates large volume subcutaneous (SC) administration using recombinant human hyaluronidase (rHuPH20).  This presentation will introduce ENHANZE and briefly review the mechanism of action of rHuPH20 and its use in large volume SC products.


      Michael LaBarre, PhD
      SVP, Chief Technology Officer, Halozyme


    • 1:30 pm

      Biodegradable Ionizable Lipids for Gene Delivery and mRNA Vaccines

      Ionizable lipid nanoparticles are gaining prominence as delivery agents for nucleic acid medicines yet there are concerns with dose limiting toxicity. This presentation will discuss how advances in highly biodegradable lipids can serve to reduce toxicity and enable repeat, high dose administration of DNA and RNA therapies.


      Syed Reza, MD, PhD
      Drug Delivery Consultant, NOF Corporation

       


    • 1:45 pm

      DSM Biomedical – Overcoming Initial API Burst and Controlled Release Challenges in Long-Acting Formulations

      The development of sustained drug delivery solutions often face formulation challenges associated with an initial API burst, and difficulties associated with achieving a controlled release profile. In our presentation, discover how DSM Biomedical’s novel polyesteramide (PEA) technology, supported by our internal expertise, enables the development of long-lasting sustained delivery products with minimal or no burst and tunable release profiles.


      Gina Conti
      Global Senior Marketing Manager – Drug Delivery, DSM


    • 2:00 pm

      StarPharma


    • 2:15 pm

      Reserved Session


    • 2:30 pm

      Innovative LNP Formulations to Achieve High Efficiency of RNA Transfection, Lymph-Targeting Delivery and Escaping from Liver-Retention

      The presentation will highlight the achievements of Cureport in cationic LNP development to promote the high efficiency of gene transfection, lymph system targeting, and escaping from liver retention.


      De-Min Zhu, PhD
      President, Cureport


    • 2:40 pm

      The Nanoprimer: a Nanoparticle Engineered to Improve the Efficacy of Nucleic Acid-Based Therapeutics.

      Intravenously administered nucleic acid-based therapeutics are massively cleared by the mononuclear phagocytic system. Curadigm developed a new approach based on the use of an engineered, biocompatible nanoparticle—the Nanoprimer—that is administered prior to the therapeutic to transiently occupy hepatic clearance and improve nucleic acid-based therapeutics bioavailability and subsequent accumulation in the target tissue.


      Matthieu Germain, PhD
      CEO, Curadigm

    • Track 2A

      Oral & Other Non-Injectable Technologies

      Companies will present non-invasive delivery technologies such as oral, mucosal, transdermal, ophthalmic, and pulmonary delivery systems.


      Maria-Teresa Peracchia, PhD
      Global Head, Drug Delivery and Product Integration, Sanofi

       

       

       


    • 12:30 pm

      Small is Transformative: Nanoparticle Solutions for Drug Delivery Innovation

      This talk will delve into the human trial results for the world’s first nanoformed drug, and discuss the ongoing industry collaborations investigating how nanoparticle engineering can facilitate drug delivery innovation to ultimately benefit patients.


      Eric Peter
      VP of US Business Development, Nanoform


    • 12:45 pm

      Lexaria Bioscience Corp. (Nasdaq:LEXX) Proprietary Drug Delivery Technology DehydraTECH™

      Lexaria Bioscience Corp.’s proprietary drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The Company’s technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules.


      John Docherty
      President and Director, Lexaria


    • 1:00 pm

      Multiparticulates-Based Technologies for Chronotherapeutics

      Diffucap technology is a proprietary multiparticulate-based system that offers customizable drug release and pulsatile dosage forms with various release profiles (time and site specific release) for use in chronotherapeutics. This is a great tool for dose flexibility and convenience, and improves patient acceptance and adherence all patient population.
      Diffucap technology is a proprietary multiparticulate-based system that offers customizable drug release and pulsatile dosage forms with various release profiles (time and site specific release) for use in chronotherapeutics. This is a great tool for dose flexibility and convenience, and improves patient acceptance and adherence all patient population.


      Srinivasan Shanmugam, PhD
      Sr Director, Pharmaceutical Sciences, Business Support, and New Technologies, Adare


    • 1:15 pm

      Lyndra

       

       

       

       

       

       

       


    • 1:30 pm

      Human Pharmacokinetics of New Breakable Extended Release Formulations of Tramadol Hydrochloride

      TramaFlex tablets are breakable 100mg, 200mg and 300mg once-a-day formulations of tramadol, bio-equivalent to a range of commercially available products. TramaFlex tablets are non substitutable offering six step flexible titration from 50mg to 300mg, in small 50mg increments. TramaFlex tablets provide patients with use the lowest dose suitable for their needs and are protected by issued patents expiring in 2038. TramaFlex tablets avoid the harmful dose-dumping that can occur with marketed once-a-day medicines.


      Damon Smith
      CEO, Altus Formulation


    • 1:45 pm

      Exploring the Benefits of Passive & Active Transdermal Drug Delivery Systems (TDDS) for People Around The World

      A transdermal drug delivery system is a technique that provides drug absorption through the skin and has garnered attention not only in the pharmaceutical industry but also in the OTC and cosmetic industry. Supporting these technologies are state-of-the-art transdermal manufacturing operations (inspected by the FDA, DEA, and international regulatory authorities) with the aggregate capacity to produce several hundred million patches per year, including those containing Schedule II controlled substances. Join us to learn about Hisamitsu’s advanced technology and expertise in product development, which enables the administration of drugs that could otherwise not be achieved with the use of conventional patches and will allow us to bring the benefits of transdermal delivery to patients, partners and consumers around the world.


      Atsushi Sonobe
      Research Scientist – Product Development, Noven Pharmaceuticals, Inc

       


    • 2:00 pm

      Fujifilm’s Capabilities for Manufacturing Lipid Nanoparticles

      FUJIFILM Corporation has started a CDMO business to manufacture Lipid nanoparticles. We would provide proprietary ionizable lipids and a one-stop service from formulation research to GMP manufacturing for lipid nanoparticles.


      Naoki Yamada
      Director Drug Development, FUJIFILM

       


    • 2:15 pm

      Next-Generation Long-Acting Dosage Forms Using Hydralese™ (PGSU) Surface-Eroding Elastomers

      Secant Group’s Hydralese™ (PGSU) technology for controlled release consists of biodegradable and shelf-stable polymers that can be manufactured into diverse forms such as implants, microspheres, coatings, and gastroretentive devices. These long-acting Hydralese formulations sustain zero-order release kinetics lasting many months to years at very high drug payloads, while simultaneously offering mechanical flexibility and excellent biocompatibility suitable for a variety of anatomical sites and therapies.


      Stephanie Reed, PhD
      Director, Translational Product Development, Secant Group

       

       


    • 2:30 pm

      SmartCelle TA-A001, a New Approach to Ocular Inflammation

      TA-A001 is a potent anti-inflammatory NCE with high specificity for the human CB2R. Formulated with SmartCelle technology to promote pan-ocular distribution TA-A001 prevents immune cell accumulation in the cornea, uvea and retina after topical application and is highly antiangiogenic. SmartCelle TA-A001 is being developed as a new treatment for dry-eye disease and age-related macular degeneration.


      Damon Smith
      CEO, TALLC Corporation Inc.

       


    • 2:40 pm

      SeraNovo

    • Track 3A

      Connected Delivery Devices, Wearables and Other Novel Devices (Part I)

      Companies will present digital health technologies, components, and a variety of novel devices such as wearables and connected injectors.


      Paul Upman
      Head, Smart Devices, Genentech/Roche

       

       

       

       


    • 12:30 pm

      Next Generation Needle-free Drug Delivery: The Path to Commercialization

      Portal will be sharing results from its 2 recent clinical trials.  The PRECISE II study, which showed a preference for Portal’s needle free injector over a PFS, was recently published in Drug Delivery.  Portal will also share results from its PIONEER 2 mL needle-free study


      Bart Burgess
      VP, Business Development and Product Strategy, Portal Instruments

       


    • 12:45 pm

      We’re Here for a Vial – How to Provide a Large Volume Wearable Injection Device That Works With Your Favorite Primary Container?

      Vials are the indisputable number one in primary packaging for parenteral drugs yet at the same time vials come with challenges related to usability and compatibility with automated injection devices. This presentation discusses the associated challenges and presents an intuitive and easy to use solution that opens the door to use vials of any volume and payload with a on-body injection device


      Tom Mayer
      Business Unit Manager, Sonceboz

       

       


    • 1:00 pm

      Future Connected Health Solutions – Learnings From 10 Years in the School of Hard Knocks.

      We all know it’s a lot more than a sensor, a Bluetooth stack, and an app; but how can we ensure that future connected health solutions scale and achieve the positive impact on patient lives that we are all hoping for? This session will draw upon 10 years of lessons learnt in developing drug delivery solutions and outline factors likely to be critical to future success.


      Steve Gowers
      Head of Drug Delivery & Digital Health, TTP

       

       


    • 1:15 pm

      Leveraging Medtech Innovation in Clinical Trials

      Topics discussed include: Developing enhanced patient engagement solutions via integrated, remote access sensor technologies with IoT and cloud support; Driving medication adherence through designing devices for the user and environment, dose and disease state tracking and adaptive AI for adherence; How to transform patient follow-up through novel remote imaging, wearable sensors, remote monitoring and therapy devices; Keeping patients engaged through multichannel communication including at home follow-ups, digital community of support and quality of life tracking


      Rebecca Ford
      Director of Program Management, Ximedica


    • 1:30 pm

      Eithan Medical

       

       

       

       

       

       


    • 1:45 pm

      PROCELL® The Right Battery For Drug Delivery Systems

      PROCELL® understands the medical device market and is partnering with pharmaceutical and medical device companies to educate on battery technology and deliver innovation, high-quality batteries, and best-in-class technical customer support.


      Aaron Arbesman, MBA
      PROCELL’s Sr. Application Engineer and Quality Lead, Duracell

       

       


    • 2:00 pm

      Neuroninfuse™: Enabling Direct-to-Target Delivery for a Broad Range of Neurological Applications.

      Learn how Renishaw’s neuroinfuse drug delivery platform can facilitate delivery of therapeutics for one-off or repeated administration regimes.


      Stuart Campbell
      Clinical Sales Development Manager, Renishaw

       

       

       


    • 2:15 pm

      Auto-Injector for Ultra-High Viscosity Drugs

      Auto-injectors have become the standard and preferred method for self-administration of injectable drug products, however most have been developed for low volumes and low viscosities, while many new biologics and long-acting drugs are higher volumes and/or high viscosities. The presentation will provide insights into Bespak by Recipharm’s Syrina® Viscala auto-injector platform device, and we are addressing the challenges of device selection, optimising the device to deliver viscous formulations, and developing a system that patients will prefer to use.


      Hans Jensen, BSc, MBA
      Global Business Development Director, Bespak by Recipharm

       

       


    • 2:30 pm

      Congruence Medical Solutions, LLC


      Gautam Shetty, PhD
      Founder and CEO, Congruence Medical Solutions, LLC

       

       

       


    • 2:40 pm

      Open Session

  • 2:50 pm

  • Afternoon Break

  • 3:00 pm

  • Technology Tracks


    • Track 1B:

      Self-Injection Devices, Syringes, Primary Container & Packaging Solutions

      Companies will present a variety of technologies including novel syringe systems, auto-injectors, as well as packaging and container closure systems.


      Josh Horvath, PhD
      Sr Director, Device and Packaging Development, Genentech

       

       


    • 3:00 pm

      Credence MedSystems and Phillips-Medisize: A Strategic Collaboration Enabling the Scaling of Credence’s Innovative Drug Delivery Systems.

      Credence has received an investment from Molex Ventures, and Phillips-Medisize is the healthcare development and manufacturing division of Molex. Credence and Phillips-Medisize have formed a strategic collaboration. This discussion will focus on the strategic fit between the companies and next steps for the scaling of production capacity for the Credence Companion® and Dual Chamber Reconstitution Syringe Systems.


      John Merhige
      Chief Commercial Officer, Credence MedSystems


      Bill Welch
      Chief Technology Officer, Phillips-Medisize


    • 3:15 pm

      Parenteral Packaging Selection Process for Drug Delivery Devices

      This presentation will introduce the audience to packaging components for cartridges used in drug delivery devices today and explore future trends that are emerging in the market.


      Jeff Smythe
      Commercial Development Manager, Datwyler

       

       


    • 3:30 pm

      A Forward Looking Approach Towards Design & Development of Patient-Centric Autoinjectors

      A look into the new mind set from learnings of the pandemic towards a forward looking design and development process for combination products. The focus on intuitive correct use requires more attention to drug-device combination for marketed products as a part of the product life cycle management. Especially as trends move away from the traditional hospital setting towards patient self-service, the importance of optimal drug-device combinations in terms of user needs is critical for successful outcomes. Oval’s approach to device development combines a deep understanding of the patient needs coupled with the technical needs towards developing patient centric autoinjectors that can be customized to deliver a wide range of drug formulations, including fragile molecules for both subcutaneous and intramuscular injection with high viscosities and a wide range of delivered volumes.


      Asmita Khanolkar
      Sr Director, Cambridge Pharma, SMC Ltd


    • 3:45 pm

      Providing Integrated Device Solutions for Biopharma: From Concept to Commercial Readiness

      Case studies on the following will be discussed: Contract Manufacturing of the Device; Primary Container expertise; Scalable Manufacturing; Hybrid Assembly Equipment; Advanced Lab Services; Proprietary and Licensed Devices


      Steven Kaufman, MBA
      VP of Drug Delivery Systems, Stevanato Group

       

       


    • 4:00 pm

      Advantages of Cartridge-based Autoinjectors Featuring Needle Isolation Technology (NIT®)

      SHL explores the benefits of Cartridge-based Autoinjectors featuring NIT, a pre-installed needle mechanism built to eliminate manual attachment of pen needles. SHL will explore the versatility, advantages and safety that cartridge-based autoinjectors can achieve.


      Taras Seniuch
      Director, Business Development, SHL Medical


    • 4:15 pm

      Proof of Processability for New Coated Stopper on Filling and Assembly Lines – A Collaborative Study by Bausch + Ströbel and BD Medical – Pharmaceutical Systems

      In addition to standard product development assessment on functions such as container closure integrity, drug – component interactions and mechanical performances where plunger stoppers play a pivotal role, the assessment of processability on industrial filling machines is a key factor for fast market adoption and launch success. During this technology talk the speaker will share results generated during BD SCF™ PremiumCoat™ 1 mlL development, which should be considered when developing new biologic drugs and associated delivery solutions for chronic disease applications.


      Camille Maury
      BD Medical – Pharmaceutical Systems, BD Medical


    • 4:30 pm

      D-Flex™ Dose Selector Technology: A Solution for Accurate Delivery of Peptides and Other Injectable Small Molecules

      Review device options for subcutaneous injection of peptides. Learn how Dose Selector Technology can bring your molecule to market faster with lower capital investment


      Chris Muenzer
      VP Innovation & Development, Haselmeier, a Sulzer Brand


       

    • 4:45 pm

      Reserved Session

    • Track 2B

      Novel Injectable and Non-Injectable Technologies

      Companies will present technologies and novel biomaterials, which improve or enable delivery via the injectable and/or non-injectable route. Examples of technologies presented include polymer delivery systems, nanoparticles, liposomes and lipid nanoparticles.


      Mahesh Chaubal, PhD
      VP R&D, Pharmaceuticals, Baxter


    • 3:00 pm

      Nanologica


      Gary Pitcairn 
      Chief Scientific Officer, Nanologica

       

       


    • 3:15 pm

      Polymeric Implants for the Long-Acting Delivery of Biologics

      Protein drugs, such as monoclonal antibodies, are vitally important in the treatment of various diseases – including cancer, autoimmune disorders, asthma, and diseases of the eye – and a system capable of sustained delivery of a protein would be attractive in a number of indications. We are developing a polymeric drug delivery implant for the long-acting delivery of a protein that addresses existing challenges to make this possible.


      Jeff Haley, PhD
      Sr. Manager, Pharmaceutical Development, Celanese


    • 3:30 pm

      Polysarcosine as a Nonimmunogenic Alternative to PEG

      Polysarcosine (poly-N-methylglycine) is a non-toxic, biodegradable, aminoacid-based polymer with low immunogenicity that could serve as a replacement for polyethyleneglycol (PEG). Our company Polypeptide Therapeutic Solutions (PTS) provides a custom-made synthesis and GMP-grade manufacturing of the drug substance.


      Sergey Rakhilin, PhD
      Director, Polypeptide Therapeutic Solutions (PTS)


    • 3:45 pm

      Microneedles for Drug Delivery

      Microneedles are used to deliver various types of drugs, including small molecules, peptides, recombinant proteins, viruses, and cells. This talk will focus on characteristics and use of Kindeva’s solid and hollow microneedles.

      John Vasilakos
      Global Head of MTS Business Development & Senior Research Immunologist, Kindeva


    • 4:00 pm

      DelSiTech


    • 4:15 pm

      Open Session


    • 4:30 pm

      Open Session


    • 4:45 pm

      The Hero Patch: Redefining Drug Delivery

      An introduction to Anodyne’s platform technology with the ability to painlessly deliver clinically meaningful doses of macromolecules through the skin.


      Jake Lombardo
      Co-founder & CEO, Anodyne


    • Track 3B

      Connected Delivery Devices, Wearables and Other Novel Devices (Part II)

      Companies will present digital health technologies, components, and a variety of novel delivery devices such as wearables and connected injectors.


      Sarah Tao, PhD
      Global External Technology and Innovation Lead, Sanofi

       

       

       


    • 3:00 pm

      Specialty LCP Compounds for Electronics Integration in Connected Devices

      Emerging challenges in connected medical devices will benefit from advanced materials created for rapidly evolving consumer electronics. As a key supplier to both industries, Celanese is positioned to adapt liquid crystalline polymer compounds developed for mobile phones, consumer wearables and 5G communications to meet the needs for wearable medical devices with constantly increasing functionality and decreasing overall size.


      Philip Wilson, PhD
      Marketing Director, Celanese

       

       

       

       


    • 3:15 pm

      Enhancing Patient Lives by Redefining the Delivery of Biologics

      Elektrofi partners with biopharmaceutical companies to manufacture proprietary microsphere suspension formulations for the SC delivery of protein therapeutics at ultra-high concentrations 300-500+ mg/mL. These formulations aim to free patients from the burden of taking their medicines by enabling at-home, self-administration of prefilled protein therapeutics.


      Daniel Dadon, PhD
      Director of Scientific Strategy, Elektrofi

       

       


    • 3:30 pm

      Value of Smart Drug Delivery Systems in Clinical Testing

      The challenges in clinical testing of subcutaneous drugs, relying on patients to self-inject at home will be explored. In addition, the value of a non-real-time connected drug delivery systems (i.e. without the need of a patient app & mobile phone) in the clinical setting will be outlined.


      Terry O‘Hagan, MBA
      General Manager, Haselmeier US

       

       

       


    • 3:45 pm

      Connected Drug Delivery Platform Expedites Creation of Combination Products

      FlexIT is a platform embodying transformational new technologies to help pharma companies create auto injection devices faster. The platform includes an advanced reusable drug delivery engine, a voice-activated, touchless user interface, RFID, drug recognition, authentication, and connectivity for data transfer.


      Christian Raineri 
      Director of Engineering, Flex

       

       

       


    • 4:00 pm

      Neuma


    • 4:15 pm

      Open Session 


    • 4:30 pm

      Open Session


    • 4:45 pm

      Open Session

  • 5:10 pm

  • The Future of Drug Delivery - A Roundtable Discussion for Your Thoughts and Perspectives.

    Please join us for an open, roundtable discussion with the conference Co-Chair, Shawn Davis, PhD

    As a precursor for Shawn Davis’ talk on October 29th with his opinion on the future of drug delivery, we invite you to share your thoughts on the subject. Shawn wants to know what other industry executives are thinking and will expand on this information in his closing talk on day two.

    Led by:

    Shawn Davis-2019-
    Shawn Davis, PhD
    Head of Drug Delivery, Biopharmaceuticals Development, AstraZeneca


2021 Agenda


  • *All times are listed in Eastern Time

  • 8:00 am

  • PODD Virtual Platform Opens

  • 8:20 am

  • Chair’s Opening Remarks

    Shawn Davis-2019-
    Shawn Davis, PhD

    Head of Drug Delivery, Biopharmaceuticals Development, AstraZeneca

  • 8:30 am

  • Keynote Fireside Chat

    Pfizer’s Dr Nicholas Warne will join us in a fireside chat on the future of pharmaceutical R&D and role of drug delivery innovations. He will also discuss the impact of the covid-19 pandemic and share insight related to developing the Pfizer vaccine in record time. 

    Shawn Davis-2019-
    Nicholas Warne, PhD

    Vice President, Pharmaceutical R&D, Pfizer

    Hosted with:


    Barbara Lueckel, PhD

    Global Head of Research Technologies Partnering, Roche Pharma Partnering


  • Scientific Keynote

  • 9:00 am

  • Development of the Lipid Nanoparticles that Enabled the Delivery of the Pfizer/BioNTech Covid-19 Vaccine

    Dr Pieter Cullis will discuss the path of discovery and innovation that led to the lipid nanoparticle delivery system driving one of the most successful vaccines against COVID-19.


    Pieter Cullis, PhD
    Professor, Biochemistry and Molecular Biology, UBC

     

  • 9:35 am

  • Orally Ingestible Devices for Biologics Delivery

    Given the growing market for biologics and patient preference for non-injections, oral delivery of biologics continues to be a priority for investment and development.  While there are many technology approaches under investigation, orally ingestible devices are showing promising results in early clinical trials. Our expert panelists will discuss these technologies as well as pros and cons of each.

    Moderator:

    Stephen T. Buckley
    Stephen Buckley, PhD
    Director, Oral Delivery Technologies, Novo Nordisk


    Karsten Lindhardt, PhD
    CEO and Founder, Biograil ApS


    Christopher Wahl, MD, MBA
    CEO, VP of Strategy and Operations, Progenity


    Thomas von Erlach, PhD 
    Chief Scientific Officer, Co-Founder and Director, Vivtex

  • 10:05 am

  • PODD Morning Break

     

     

    • Partnering Meetings 
    • Meet the exhibiting drug delivery companies and more
    • Networking

     

  • 10:50 am

  • Drug Delivery Pipeline and Technologies, A Year in Review

    Kurt Sedo
    Kurt Sedo 
    VP,  PharmaCircle 

  • 11:10 am

  • Drug Delivery Opportunities to Enable Cancer Care in the Out-Patient Setting

    Enabling cancer care, outside of a hospital setting or physician’s office is gaining increasing importance. The presentation will focus on drug delivery and product optimizations that reduce the overall dosing complexity and, thus, enable or facilitate home- or patient-self-administration. Patient, healthcare provider and treatment barriers will be discussed and ongoing efforts to overcome them. Current labels of products outside of oncology that can be administered without the supervision of a healthcare provider will be reviewed.


    Beate Bittner, PhD

    Product Optimization Franchise Leader, Roche

  • 11:30 am

  • Evaluating LVSC Injections Using a Translational Approach

    Emerging biotherapies are enabling transition from traditional intravenous therapies to subcutaneous administration. These formulations may present delivery challenges, such as larger volumes and viscosities that require innovative, patient-friendly delivery system design.  Dr. Pettis will discuss the impact of unique benchtop and preclinical methods as means to provide insight for subsequent pharmaceutical partner combination product development and clinical evaluation.


    Ronald J. Pettis, PhD

    Principal Scientist and Director of the Translational and Clinical Sciences Center of Excellence, BD Technologies

  • 11:45 am

  • Advances in Digital Drug Delivery

    Kevin Deane
    Kevin Deane

    VP, Innovation, Phillips-Medisize

    with

    Paul Upham
    Paul Upham

    Head, Smart Devices, Genentech/Roche

  • 12:00 pm

  • DDS Soapbox Session, sponsored by Pfizer


    Patrick Lim Soo, PhD

    Senior Principal Scientist, Novel Delivery Technologies, Pfizer


    Presenting companies to date:

    Biograil and BIONDDTM – a novel oral delivery technology of biomacromolecules

    Dr. Karsten Lindhardt, CEO of Biograil ApS will provide an overview of the BIONDDTM technology. The team behind the world’s first injection molded FDA approved oral administered delivery technology has created a new differentiated proprietary technology for effective oral delivery of antibodies, oligonucleotides, peptides, and proteins using intrawall delivery approach to overcome the barrier for absorption. This provides an opportunity to transform the biomacromolecule injectable market by use of a simple device technology fitting into a conventional oral 00-sized capsule.


    Karsten Lindhardt, MSc, PhD, DBE
    CEO and Founder, Biograil


    Nasus Medical: A Self-Administered Targeted Approach to Intranasal Drug Delivery

    Nasus Medical is developing a novel approach to targeted intranasal drug delivery that allows patients to self-administer medication directly to the intranasal target anatomy. We have completed two human clinical trials demonstrating excellent device tolerability and spray deposition patterns. 


    Shira Koss, MD
    CMO, Nasus Medical


    GastroIntestinal Organ Robotic Interface System for Oral Drug Delivery Applications

    GastroIntestinal Organ Robotic Interface System (GI-ORIS) is a technology that enables high throughput screening experiments with fully intact gastrointestinal tissue for oral drug delivery applications. This presentation will touch on the GI-ORIS technology and its application for oral peptide and antisense oligonucleotide delivery.


    Thomas von Erlach, PhD 
    Chief Scientific Officer, Co-Founder and Director, Vivtex


    Asan Therapeutics

     

    If you are interested in applying to present email service@tcfllc.org

  • 12:35 pm

  • Luncheon + Roundtables and Partnering Meetings

    Luncheon round table topic choices will be on offer as an option for attendees as well as partnering.

  • 1:35 pm

  • PODD Announcements

  • 1:40 pm

  • Afternoon Breakout Sessions: Two Track Choices

    • Track 1: Devices and Connected Digital Health

      Track Chair:


      Quentin Le Masne, PhD 
      Head of Business Development & Innovation, Merck Group

    • Track 1: Devices and Connected Digital Health

      1:45 pm – 2:10 pm

      Digital Health’s Role in Making Personalized Medicine a Reality

      The pandemic has forced us to rely on digital technologies more than ever, and with this comes a renewed and increased interest in applying these technologies to provide more personalized healthcare. Pharma companies are increasingly looking beyond the drug product itself and assessing how to use digital health to improve outcomes and enhance the overall well-being of the patient.  Digital technologies can play a role in diagnosing symptoms and disease, monitoring patient response and adherence, and determining patient-specific dosage and dosing frequency needs. Our panelists will discuss taking on this comprehensive approach by speaking about:

      • Utilizing data and digital technologies to add value to patient care
      • Increased focus on diagnostic aspects to improve overall patient well-being
      • Building organizational support for digital health initiatives, development pathways and challenges
      • Regulatory considerations for this dynamic space (US and abroad)
      • Future direction and innovation in this space

      Sujit Basu
      Sujit Basu, PhD
      SVP & Head, Global Manufacturing & Technical Operations, Fore Bio

      with

      Jim Collins, PE, MBA
      Vice President, Device Development Unit, Sanofi

      Paul Upham
      Paul Upham
      Head, Smart Devices, Genentech/Roche


      Kal Patel, MD
      CEO & Founder, BrightInsight


      Quentin Le Masne, PhD 
      Head of Business Development & Innovation, Merck Group


    • 2:15 pm – 2:50 pm

      Advancing Next-Generation Device Technologies 

      To meet the growing need to accommodate more complex drug formulations and offer more patient-friendly devices, there is a welcome rise in drug delivery device innovation. A number of novel platform type devices are in development that can offer benefits to both patients and pharma partners.  Our expert panelists will address:

      • Biggest hurdles to developing and adopting these new technologies and approaches to overcome them
      • De-risking strategies for patient and pharma acceptance 
      • Gaining maximum value out of collaborations; examples of creative partnering models

      Moderator


      John Merhige
      Chief Commercial Officer, Credence MedSystems


      Sherri Biondi, PhD 
      Senior Director and Head of Device Development, AstraZeneca


      Mark Howansky, MBA
      Director, Device Development, BMS


      Quentin Le Masne, PhD
      Head of Business Development & Innovation, Merck Group

       


    • 2:50 pm – 3:10 pm

      Miniature Active Implants: The Key Area for Innovation in Next-Generation Drug Delivery  

      Innovation in drug delivery devices has evolved at a constant pace for 30 years, improving outcomes with better delivery of lifesaving drugs. This session gives the audience an update on the innovation and commercial opportunity in active implants.


      Harshal Shah
      Head of Oncology Innovations, Global Medical Technology, Cambridge Consultants

       

       

    • Track 2: Delivery of Next-Generation Therapies

      Track Chair:

      Kathleen Lin
      Kathleen Lin, PhD
      Director, External Innovation Delivery Devices, Eli Lilly


      1:45 pm – 2:10 pm

      The Promise and Potential of Lipid Nanoparticles

      With the recent utilization of lipid nanoparticles (LNP) in the life-saving mRNA vaccines, the demand for LNP has never been higher. LNP have been investigated extensively over the years and can play a key role in delivering a wide range of drugs across various therapeutic areas, especially nucleic acid-based therapies. Given this broad potential, our panelists will talk about the current status, advantages and opportunities related to LNP, but also address challenges related to materials, process, scale-up and manufacturing. 

      Moderator

      Rashba_Step_Julia
      Julia Rashba-Step
      Phosphorex

      Panelists:


      Richard Gray
      Commercial Director, Dolomite Microfluidics

      Sanya Puri, PhD
      Associate Director, Advanced Drug Delivery, AstraZeneca


      Syed Reza, MD, PhD
      Drug Delivery Consultant, NOF Corporation


      Greg Troiano
      Chief Manufacturing Officer, Translate Bio

       


    • 2:10 pm – 2:40 pm

      Non-invasive Delivery of Biologics: Potential for Pulmonary and Nasal Administration

      In this panel, we will explore the potential advantages as well as challenges related to the oral and nasal inhalation of large molecules, including antibodies.  Some of the key discussion points include:  

      • Formulation Aspects:
        • Desired attributes for an inhaled biologic formulation
        • Key barriers and what is needed to overcome them
      • Device Aspects:
        • Special device considerations: moisture protection, stability, and higher doses
        • Managing device transitions during development pivotal to commercial
      • New Frontiers: 
        • Lung delivery for covid therapies
        • Understanding Immunogenicity in the lung and developing tools for interrogating drug candidates for immunogenicity

      Moderator


      Vidya Swaminathan, PhD  
      Strategic Capabilities, Global Inhaled Product Development, AstraZeneca

      Panelists


      Darren Reid 
      Director, Process Development, Amgen


      Hugh D. C. Smyth, PhD
      Alcon Centennial Professor, College of Pharmacy, The University of Texas at Austin


      Vu Truong, PhD
      Founder and CEO, Aridis Pharmaceuticals


    • 2:40 pm – 3:10 pm

      The Shift to Large-Volume (over 10mL) Subcutaneous Infusions From a Physician and Patient Perspective

      • How the Covid-19 pandemic has changed cancer care
      • Advantages of Conversion of IV formulations to SQ
      • Facilitating Telemedicine
      • Facilitating drug delivery (simple pumps + hyaluronidase)
      • How we envision the future


      Jorge Nieva, MD 
      Associate Professor of Clinical Medicine, Keck School of Medicine of USC

  • 3:10 pm

  • PODD Announcement

    Afternoon Plenary Sessions: Cell and Gene Therapy Innovation

  • 3:15 pm

  • Cell and Gene Therapies Landscape Presentation

    Luis Santos, PhD
    Drug Delivery Team Leader, Biopharmaceutical Development, Cell and Gene Therapies Innovation, AstraZeneca

  • 3:35 pm

  • Exploring Next-Generation Cell and Gene Therapies

    The field of cell and gene therapy is rapidly evolving and making tremendous progress, with more than 10 product approvals to date.  These advanced treatments can offer long-term treatments and possibly cures for a broad range of diseases such as blood disorders and eye disorders, cancer and musculoskeletal diseases. Though promising, a number of challenges remain which will be addressed by our expert panelists.

    • Viral vs. non-viral vectors
    • Reaching targets within cells
    • Speeding up delivery to the patient
      • Potential of off-the-shelf solutions/cell therapy technologies
    • New approaches to drug development and manufacturing

    Moderator

    Sudhakar Garad
    Sudhakar Garad, PhD 
    Global Head of Chemical and Pharmaceutical Profiling, Discovery Pharmaceutical Sciences, Novartis

    with

    Annette Bak
    Annette Bak, PhD  
    Head of Advanced Drug Delivery, AstraZeneca


    Richard Colvin, MD, PhD 
    SVP, Severe Genetic Diseases, Bluebird bio

    Manmohan Singh, PhD
    Senior VP, Head, Pharmaceutical Sciences and Delivery Technologies, Beam Therapeutics

    Bharathi Vellalore, PhD
    Scientist, BioTherapeutics Drug Product Development, Janssen

  • 4:05 pm

  • Accelerating Innovation in Drug Delivery to Support Public Health Preparedness

    As we consider the latest drug delivery techniques, we must also consider whether they are rapidly scalable and can support population needs during the next pandemic or public health crisis. Learn how BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research Authority (BARDA) is supporting innovation with the potential to enhance drug delivery for pandemic preparedness, in areas such as:·       Improved efficiencies in drug delivery

    • Non-needle administration mechanisms
    • Enhanced distribution and storage capabilities
    • Tailored approaches for at-risk or vulnerable populations

    Rachel Rath, MBA  
    Director, BARDA Alliance, Johnson & Johnson Innovation

  • 4:25 pm

  • Closing Plenary Presentation: Blue Sky Ideas for the Future of Drug Delivery

    Shawn Davis-2019-
    Shawn Davis, PhD

    Head of Drug Delivery, Biopharmaceuticals Development, AstraZeneca

  • 4:45 pm

  • Conference Concludes