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2019 Agenda

  • 8:00 am

  • Registration and Morning Coffee/Tea

  • 8:30 am

  • Co-Chairs Opening Remarks

    Ann Daugherty
    Ann Daugherty, PhD

    Senior Manager, Drug Delivery, Genentech

    James Cunningham
    James Cunningham, PhD

    Executive Director, Drug Delivery, Allergan


  • Keynotes, Intracellular Delivery, Brain Delivery, Peptide & Ophthalmology Delivery Alternatives and Pharma Delivery Needs

  • 8:40 am

  • 🔑Keynote: State of the Industry Address & Nano-medicine’s Current Clinical Reality: An Analysis of Recent Results


    David W Grainger, PhD

    University Distinguished Professor, Chair, Department of Biomedical Engineering, Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah

  • 9:20 am

  • Intracellular and Tissue Specific Delivery of Therapeutic Payloads

    • Targeted Therapeutics team at Janssen is focused on addressing the challenges of intracellular and tissue specific delivery across modality spectrum
    • A focus on understanding parameters of receptor-specific uptake and internalization and using relevant assays for proper ligand selection
    • Examples of using these methods for specific functional delivery of nucleic acids and nanoparticles


    Vadim Dudkin, PhD

    Head of Targeted Therapeutics at Janssen Discovery Sciences, Johnson & Johnson

  • 9:40 am

  • Grand Opening of the Exhibit & Networking Café

  • 10:20 am

  • 🔑Keynote: MRI-Guided Focused Ultrasound and the Delivery of Therapeutics to the Brain

    Dr Isabelle Aubert, University of Toronto, will provide an introduction to MRI-guided focused ultrasound (MRIgFUS), which in presence of intravenously injected phospholipid microspheres is used to increase the permeability of the blood-brain barrier (BBB) in a localized, controlled, and transient manner. She will review applications in preclinical models of neurodegenerative disorders where therapeutic molecules, gene therapy vectors, and progenitor cells are injected intravenously and delivered from the blood to targeted areas of the brain with MRIgFUS. Dr Aubert will describe the seminal work of the Sunnybrook team on MRIgFUS-BBB modulation, without exogenous therapeutic, leading to glial plasticity, amyloid pathology reduction, hippocampal neurogenesis and improved cognitive functions in a preclinical model of Alzheimer’s disease (AD). The presentation will conclude with the clinical evaluation of MRIgFUS and BBB modulation in people with AD.


    Isabelle Aubert, PhD

    Professor, Department of Laboratory Medicine and Pathobiology, University of Toronto

  • 10:50 am

  • 🔑Keynote: Updates on Alternative Administration of Peptides - Bioavailability and Capability of Delivering Peptides and Non Small Molecules Through the Oral Route

    • What are the delivery options outside the traditional subcutaneous injections moving forward?
    • What strategies are showing success in improving the oral absorption of peptide-based drugs?

    Randy Mrsny
    Randall Mrsny, PhD

    Professor’s Chair, Department of Pharmacy and Pharmacology, University of Bath

  • 11:10 am

  • Ophthalmology: Exploring Other Routes of Administration

    • Barriers/challenges associated with drug delivery to the back of the eye
    • Prolonging delivery & reducing frequency of administration
    • Alternative/less invasive routes of administration for delivery to the back of the eye
    • Delivery for emerging modalities
    • Impact of delivery system design choices on development/scalability
    • How to effectively assess novel delivery approaches

    Moderated by:

    James Cunningham
    James Cunningham, PhD

    Executive Director, Drug Delivery, Allergan

    Panelists:


    James E Chastain, PhD

    Executive Director, PK Sciences – Ophthalmology, Novartis Institutes for BioMedical Research, Inc


    Susan “Susie” Crowell, PhD

    Scientist, Preclinical and Translational PKPD, Genentech

    Kansara_Viral
    Viral Kansara, PhD

    VP, Discovery, Clearside Bio

  • 11:50 am

  • Pharma Spotlights on Drug Delivery Needs

    In this session, pharma companies discuss their current needs, partnering philosophy and scouting interests, as related to drug delivery.

    GSK

    Nima Akhavein

    Associate Fellow and Scientific Leader

    Biogen

    Lani Hack

    Engineer I, ASO Formulation Development and Manufacturing

    EMD Serono

    Simon Geißler, PhD
    Director Drug Delivery and Innovation, 
    Healthcare R&D, CPD, Pharmaceutical Technologies

  • 12:35 pm

  • Transforming Cardiovascular Treatment with Pulmonary Delivery: Every Breath You Take is Shot Through the Heart

    • Pioneering a novel approach for treating cardiovascular conditions by the oral inhalation route
    • Will be the ONLY non-invasive, self administered product for acute management of Paroxysmal Atrial Fibrilation, providing rapid cardioversion
    • In Phase 2: Dose dependent conversion observed
    • Working on enhancements to greatly improve speed of delivery


    Carlos Schuler, PhD

    Chief Operating & Technology Officer & Co-Founder, Incarda Therapeutics

  • 12:50 pm

  • Networking Lunch & Partnering Meetings

  • 1:50 pm

  • How to Realize your Next Drug Delivery Innovation: A Practical Guide to Getting your Innovation to Market


    Uri Baruch

    Director, Head of Drug Delivery, Cambridge Design Partners

  • 2:10 pm

  • Delivering an Innovative, Patient-Centric Delivery System as a Result of Strong Collaborations Between Flex and Amgen

    A new way of doing business was required to achieve the mission of serving patients suffering from rheumatoid arthritis. Learn how Amgen and Flex created an integrated, single team with co-executive sponsorship and overarching program management that enabled the successful development and launch of a novel combination product.


    Daniele Fazio
    VP, Design & Engineering, Flex


    William (Bill) Rich

    VP, Final Drug Product Technologies, Amgen


  • Tech Presentations

    The afternoon sessions feature companies enabling the delivery of small and large molecules across a broad range of technologies including: Needle-free Delivery Systems, Enabling Injectable Systems, Oral Platform Technologies and Injectable Formulation & Devices. These are “quick fire” presentations, with Q&A following each presentation.  Half way into the tech presentations,  we will have an “ice cream delivery” break.

    Chaired By:

    Mitch Zhao, PhD

    Engineering Director, Primary Container and Drug Delivery Systems, Janssen R&D, Johnson & Johnson

  • 2:30 pm

  • Drug Delivery Presentations: Part I

    Dry Powder Inhalation: Formulation, Filling Technology and Devices


    Philipp Michelfelder
    Business Development Manager, Harro Höfliger



    Overcoming Microsphere Scale-Up Challenges


    Michael Strozewski
    Formulation Scientist II, Oakwood Labs



    Controllable Force Autoinjector


    Bill Atterbury
    Research Leader, Medical Devices and Health Analytics, Battelle



    Implications of Shifting Therapy from the Clinic to the Home


    Dave Siet
    Director of Business Development, Portal Instruments



    Drug Delivery Experts and Baywind Bioventures present Propel Biologics™ JetCAP™ Revolutionary Oral Delivery Technology

    Christopher-Rhodes
    Christopher Rhodes, PhD
    President and CEO, Drug Delivery Experts

  • 3:35 pm

  • Ice Cream Delivery Break

  • 3:50 pm

  • Drug Delivery Presentations: Part II

    BioQ Pharma’s invenious™ Platform – Making Infusible Drugs Truly Ready-to-use via Proprietary Connect-and-go Technology


    Josh Kriesel, PhD
    CEO, BioQ Pharma


    DEP – Developing Enhanced Therapies


    Tony Eglezos, PhD, MBA
    VP, Business Development, Starpharma



    Innovative Device Solutions in Response to Specific Market Needs


    Mark Hassett
    VP, Business Development, Credence MedSystems



    Why Oral Thin Films Can Be Exactly What You Are Looking For: Case Studies on the Mucofilm® and the Rapidfilm®


    Ahmad Ghoniem, PhD
    Pharmacist, Manager Business Development & Sales, tesa Labtec



    Novel Exosome-based Delivery of Therapeutic Proteins

    Chulhee Choi
    Chulhee Choi, MD, PhD
    CEO, Ilias Biologics

  • 5:00 pm

  • End of Day One & Networking Reception

2019 Agenda

  • 8:00 am

  • Morning Coffee/Tea

  • 8:30 am

  • Co-Chair's Opening Remarks

    Ann Daugherty
    Ann Daugherty, PhD

    Senior Manager, Drug Delivery, Genentech

    James Cunningham
    James Cunningham, PhD

    Executive Director, Drug Delivery, Allergan


  • Keynotes, Investment Decision Making, Precision Medicine, Digital and Connected Delivery and Nanostructured Materials

  • 8:40 am

  • Panel: Investor Perspectives on Drug Delivery Needs and Investments

    • What are VCs investing in, trends they are seeing, competition and concerns?
    • Before VCs invest, what decision making criteria are they using?
    • What VCs think is important and what pharma thinks is important. Those don’t always match up, how can we better align. What are those differences and what are the rationales?
    • Is there a specific revenue target for a startup company that they would look at before making an investment?

    Moderator:


    David Allison, PhD

    Partner, 5am Ventures

    Panelists:


    Andrew ElBardissi, MD

    Principal, Deerfield Management


    Karim Helmy, MD, PhD

    VP, Healthcare Investor, Venrock


    Lori Hu, MBA

    Principal, Vertex Ventures HC


    Aaron Royston, MD, MBA

    Partner, venBio

  • 9:20 am

  • 🔑Keynote: Leveraging Physiology for Bioresponsive Precision Drug Delivery & The Future Impact of Precision Medicine on Drug Delivery

    Spurred by recent advances in materials chemistry, molecular pharmaceutics and nanobiotechnology, stimuli-responsive “smart” systems offer opportunities for precisely delivering drugs in dose-, spatial- and temporal-controlled manners. In this talk, Dr Zhen Gu, UCSF, will discuss: 

    • The ongoing efforts in developing physiological signal-triggered bioinspired drug delivery systems
    • Glucose-responsive synthetic systems for biomimetic delivery of insulin for diabetes treatment 
    • Bioresponsive microneedle patches and vesicle fusion-mediated synthetic beta cells will be emphasized 
    • Local and targeted delivery of immunomodulatory therapeutics for enhanced cancer therapy 
    • An introduction to their latest study utilizing platelets, cell conjugates and sprayable gels for delivery of immune checkpoint inhibitors 
    • Insights on the future of precision medicine and the impact on drug delivery moving forward


    Zhen Gu, PhD

    Professor, Department of Bioengineering, California NanoSystems Institute (CNSI)University of California, Los Angeles (UCLA)

  • 9:50 am

  • Morning Networking Break & Partnering Meetings

  • 10:35 am

  • 🔑Keynote: Nanostructured Materials for Enhanced Therapeutic Delivery

    In this session, Dr Tejal Desai, UCSF, will discuss recent advances in using micro and nanotechnology to enhance the delivery of therapeutics across biologic barriers.


    Tejal Desai, PhD

    Ernest L. Prien Endowed Professor and Chair, Department of Bioengineering and Therapeutic Sciences, UCSF Schools of Pharmacy and Medicine

  • 11:05 am

  • 🔑Industry Keynote: Harnessing the Digital Exhaust: Incorporating Wellness into the Pharma Model

    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. At the core of such an evolved model will certainly be a dynamic patient interface which leads to extraordinary patient engagement. 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 for “beyond the pill solutions”.

    Justin Wright 2018
    Justin M Wright, PhD
    Global Head of Innovation, Novartis

  • 11:35 am

  • Navigating Across Classifications: The Connected Device Regulatory Landscape


    Kimberly Ringenberger, PhD

    Associate Engineering Advisor, Eli Lilly

  • 12:05 pm

  • Advancing the Connected and Smart Drug Delivery Ecosystem: A Path Forward

    The connected drug delivery device market is expected to grow tremendously with emerging technologies that connect patients, physicians, researchers, health systems, etc, while reducing burden to all. Drug delivery manufacturers of inhalers to treat asthma and chronic lung disease for example are fast developing the next generation of smart devices with sensors to monitor if patients are using their devices correctly. In this panel discussion, we focus on next generation emerging technologies, design needs and challenges, and regulatory hurdles to advance the drug delivery smart and connected world.

    Moderated by:
    Justin Wright 2018
    Justin M Wright, PhD

    Global Head of Innovation, Novartis

    Panelists:


    Kimberly Ringenberger, PhD

    Associate Engineering Advisor, Eli Lilly


    Rajan Patel

    CEO and Founder, iO Life Science


    Dirk Schapeler

    VP, Digital Health, Bayer

  • 1:00 pm

  • Networking Lunch and Partnering Meetings


  • Early Stage Technologies and Evaluations

  • 2:00 pm

  • Early Stage Technology Showcase

    This session features five-minute talks on cutting-edge technologies, inventions and ideas. The showcase is open to start-up companies, entrepreneurs, investors, licensing officers and university researchers.

    Chaired by:


    Jason Olbrich, PhD

    Principal Engineer, Final Product Technologies, Amgen

    Presentations by:


    Sheauyu Teddy Hsu, PhD, MBA

    Managing Director, Adepthera, LLC



    Alex Wasson

    CEO, Cinti Medical, Inc



    Bryce Beverlin II, PhD

    Founder and CEO, Quench Medical



    Abhita Batra, MBA

    CEO, Otomagnetics



    Vadim Yuzhakov, PhD

    CEO, AdminMed

  • 2:40 pm

  • How Do We Overcome the Barriers of Getting New Technologies Evaluated and Brought in Earlier in Product Development?

    Pharma companies often face challenges when it comes to working with external drug delivery technologies as a result of cost and resources. Because pharma’s primary focus is developing molecules, developing drug delivery strategies doesn’t always get worked into the pipeline early enough.This panel will delve into the following:

    • How can we get drug delivery technologies earlier in the pipeline development of molecules?
    • How can we lower the upfront risks?
    • What are the work arounds?

    Moderator:
    Ann Daugherty
    Ann Daugherty, PhD

    Senior Manager, Drug Delivery, Genentech

    Panelists:


    Nima Akhavein

    Associate Fellow and Scientific Leader, GSK

    Christopher Kovalchick
    Chief Engineer, Delivery Device and Connected Solutions Innovation Center, Eli Lilly


    Jason Olbrich, PhD

    Principal Engineer, Final Product Technologies, Amgen

  • 3:25 pm

  • End of Day Two