DrugDDW: DRUG DELIVERY WEST 2021 Delivery WestAGENDA May 17-18, 2021 • Virtual

Targeted Delivery Immunotherapy

Partnerships and Networking Oral Delivery

Drug Delivery Long-Acting Technology Showcase Injectable Formulations

CNS Smart Drug Delivery

Lead Sponsor Executive Sponsors

Produced1 by The Conference Forum WWW.DRUGDELIVERYWEST.ORG www.drugdeliverywest.com #DrugDeliveryWest DDW: DRUG DELIVERY WEST 2021 AGENDA

DAY ONE - MONDAY MAY 17 , 2021 9:30 am Small is Powerful: From Small Molecules *All Times are Pacific Time to Biologic APIs Nanoparticle engineering holds the potential to transform 7:00 am Pharma. Controlled Expansion of Supercritical Solutions Meeting Mojo Partnering Platform Opens (CESS®) technology produces ‘designed-for-purpose’ API nanoparticles. This enables poorly soluble molecules 8:00 am in the pharmaceutical pipeline to progress into clinical DDW Virtual Stage Opens development by increasing their rate of dissolution and This is an opportunity to explore the platform, reach out improving their bioavailability. This presentation will give to fellow attendees and visit the Drug Delivery Technology an introduction to Nanoform and discuss several case and Service companies. studies demonstrating that Small is Powerful. Sergie Letser 8:20 am Vice President of US Business Development, Opening Remarks & Welcome Nanoform Valerie Bowling Executive Director, DDW 9:45 am 8:25 am Challenges and Opportunities to Improve Co-Chairs Opening Remarks CNS Delivery Panel • Limitations with current CNS approaches and how to Randall Mrsny, PhD address them Professor’s Chair, Department of Pharmacy and • Novel approaches and emerging alternative routes of Pharmacology, University of Bath administration (ie: Intranasal; vector) James Cunningham, PhD Moderated by: Executive Director, Drug Delivery, AbbVie Randall Mrsny, PhD Professor’s Chair, Department of Pharmacy and KEYNOTE Pharmacology, University of Bath Panelists: 8:30 am Bryn Martin, PhD Keynote: State of the Industry Address & Vice President of Research, Precision Delivery and Immunotherapy Drug Delivery Emerging Cerebrospinal Fluid Sciences, Alcyone Opportunities Andrew Goodearl, PhD Senior Director, Biologics Discovery Group, Jeffrey Hubbell, PhD AbbVie Eugene Bell Professor, Tissue Engineering & Robert G Thorne, PhD Deputy, Dean for Development, University of Fellow, Denali Therapeutics Chicago 10:15 am INDUSTRY KEYNOTE Visit the Technology & More Section This 10 minute session is allotted to visit the Technology 9:00 am & More section of the virtual platform. Meet a wide Industry Keynote: Antibody and Enzyme range of delivery companies and more. When you meet Transport Vehicles: Engineering the the different companies through the platform and click, Delivery of Large Molecules Across the “register interest”, DDW will donate $1 to the American Blood Brain Barrier Parkinson Disease Association. It is a convenient way to meet lots of companies and fund raise all in one! Robert G Thorne, PhD Fellow, Denali Therapeutics

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10:25 am Drug Delivery Technology Presentations These sessions feature companies developing a broad range of formulation and device technologies enabling the delivery of small and large molecules. Examples of technologies presented: enabling injectable systems, needle-free devices, nanoparticle platforms, subcutaneous formulations, oral delivery systems, and connected health platforms. These are “quick fire” presentations, with Q&A following each presentation.

Breakout 1A: Device Technologies & Platforms Breakout 2A: Enabling Formulation and Device Technologies Smart Autoinjector, Meeting Future Injection Needs DSM Biomedical in Sustained Drug Delivery – Today Novel platform for long-acting sustained delivery of challenging Although single use disposable autoinjectors have become the pharmaceuticals. gold standard for self-administration of drugs to treat chronic diseases, market trends around sustainability, performance and Gina Conti connectivity point towards the need for a fresh approach. In this Global Senior Marketing Manager, Drug Delivery, session we present our new device platform, Smart Autoinjector DSM Biomedical and our rationale for why it can offer pharma companies a usable, compact, flexible platform and a source of differentiation in increasingly competitive markets Kevin Deane VP Front-End Innovation and Connected Health, Phillips-Medisize

Getting Started With Wearable Injection Devices: BEPO®: A Versatile Long-Acting Injectable Drug How to Navigate Successfully Through Competing Delivery Technology for Intra-Articular Delivery Requirements Such as User Needs, Logistics and BEPO® is a clinically advanced and proprietary long-acting Process Considerations injectable drug delivery technology with outstanding versatility. This talk highlights opportunities and challenges arising BEPO® is an in situ forming depot technology which is well when creating a combination product composed of a protein suited to formulate a wide variety of APIs for both systemic and therapeutic and a wearable injection device. The presentation local applications. Following the introduction of our drug delivery outlines the device manufacturers perspective on this challenging platform, this presentation will exemplify BEPO®’s capabilities in and increasingly important topic. intra-articular delivery. Tom Mayer Sylvestre Grizot, PhD Business Unit Manager, Sonceboz Principal Investigator, MedinCell

Enabling Delivery Technologies for High Viscosity/ Polyaminoacid-Based Non-Viral Vectors for Gene High Volume Unmet Market Needs and mRNA Delivery Recent trends in formulations involving long acting injectables Polypeptide Therapeutic Solutions (PTS) developed a proprietary and intravenous to subcutaneous bio therapeutics are pushing library of non-viral vectors for both gene and mRNA delivery. The the limit of traditional drug-delivery platforms. There is an unmet library is represented by nanoparticles generated from natural need for a patient-centric delivery platform for high viscosity/ polyaminocids, making non-toxic, biodegradable, and safe high volume parenteral formulations. Oval Medical Technologies, material for both vaccine and gene therapy applications. The an SMC Ltd Company, has developed the ArQ-Bios platform for presentation provides examples of the successful application of the delivery of high viscosity/high volume formulations providing the technology and compares it to the other nucleic acid delivery enabling delivery technology for challenging formulations and platforms. better solutions to patients. Sergey Rakhilin, PhD Asmita Khanolkar Director, Product Development, PTS Senior Director, Cambridge Pharma, SMC Next Generation Needle-Free Drug Delivery: The Path to Commercialization Portal Instruments will share their latest developments in needle- free drug delivery and discuss learnings along the path towards commercialization. Patrick Anquetil, PhD, MBA CEO, Portal Instruments

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11:05 am Ten Minute Break Breakout 1B: Device Technologies & Platforms Breakout 2B: Enabling Formulation and Device T echnologies How we Scaled to Meet the Growing Needs of ENHANZE® Drug Delivery Technology: Facilitating Pharma Rapid Subcutaneous Administration of Large Credence is an innovator and manufacturer of drug delivery systems Volume Biologics that allows pharmas to use commercially available primary packaging ENHANZE Drug Delivery Technology facilitates large volume components – minimizing costly supply chain disruptions. subcutaneous administration using recombinant human hyaluronidase (rHuPH20). This presentation will introduce ENHANZE Continued device introductions for unmet injectable needs, and briefly review the mechanism of action of rHuPH20 and its use in coupled with recent – significant pharma collaborations, is driving large volume subcutaneous products. Credence manufacturing ‘scale-up’ of the ‘Companion’ and ‘Dual Chamber’ devices to meet increasing industry demands. Mark Hassett Michael LaBarre, PhD VP – Business Development, Credence Medsystems Chief Technology Officer, Halozyme Delivering Next Generation Vaccines Extended Release Injectables: Oakwood’s Approach Recent events have underscored the need for improved How do you scale-up a microsphere process from an idea in the mechanisms and logistics in vaccine delivery. In this session, lab to a multi-kilogram batch size for clinical trials and commercial we survey the challenges and discuss how design-thinking can success? Oakwood Labs has encountered numerous scale-up support innovators in revolutionizing the space. challenges, but through the use of the Chroniject™ technology platform and decades of experience, many of these obstacles have been overcome. Scott Thielman, PhD Tracy Richey, PhD Chief Technology Officer, Product Creation Studio Senior Director, Formulations, Oakwood Labs Optimizing Patient Experience with Autoinjectors, PROCELL® Battery Technology for Drug Delivery Even at Higher Viscosity Systems Battelle offers a novel approach to autoinjector design that provides PROCELL® understands the medical device market and is user’s control over and confidence in their injection experience, partnering with pharmaceutical and medical device companies to across a wide range of viscosities. Rethinking how we use the deliver innovation, high-quality batteries, and best-in-class technical stored energy in a spring allows for an enhanced patient experience customer support. including the minimization of injection time and eliminating the noise and recoil that can cause user anxiety and hesitancy. Aaron Arbesman, MBA Doug Boyd PROCELL Business Development Manager and Sr Vice President, Device Development, Battelle Principal Engineer, Duracell Voice Recognition in Injection Devices The push to collect information to support a more patient-centric healthcare system has triggered demand for new, simple but versatile user interfaces. Voice recognition systems, boosted by smartphone assistants and smartspeaker adoption, is paving the road for these new technologies to be integrated into medical products. Marco shows the benefits of adding voice recognition into a drug delivery device, and addresses the challenges inherent in a complex sound-processing architecture, and how they have been resolved by Flex R&D using a proprietary solution. Marco De Angeli Sr Director of Innovation, Flex Health Solutions 11:55 am Lunch & Partnering Meetings on the Meeting Mojo Platform

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Panel A: Oral Delivery of Peptides and Biologics Panel B: Advancements of Long-Acting Injectable Formulations 12:45 pm PST 12:45 pm PST With recent promise in the clinic and even an approved There is an increasing need for patient-friendly delivery of product, interest in oral peptide delivery is growing. therapeutics to treat chronic and site-specific diseases. This However, low bioavailability as compared to the parenteral panel will provide an overview of drug delivery technologies route is still the norm, so the time is ripe to raise the bar. In using long-acting injectable formulations (LAIFs), formulation this discussion we’ll have the opportunity to share ideas for design and the impact on injections, limitations, and improving oral peptide delivery, from new mechanisms on addressing challenges. permeability enhancement to biomechanical methods such as microneedles. Moderated by: Matthew O’Brien, PhD Moderated by: Former Drug Delivery and Technical Strategy Lead, John Higgins, PhD Medicinal Sciences – Pharmaceutical Sciences Small Executive Director, Discovery Pharmaceutical Sciences, Molecule, Pfizer Merck Research Labs Panelists: Panelists: Frederic Dargelas, PhD, MBA Aktham Aburub, PhD Director, Head of Business Development, Research Fellow – Pharmaceutical Product Design, DelSiTech SMDD, Eli Lilly and Company Tejal Desai, PhD Ernest L Prien Endowed Professor and Chair, Department Ester Caffarel-Salvador, PhD of Bioengineering and Therapeutic Sciences, Associate Director of Regenerative Medicine, UCSF LEO Pharma Schools of Pharmacy and Medicine Randall Mrsny, PhD Professor’s Chair, Department of Pharmacy and Anthony Listro, MBA Vice President of Technology, Foster Delivery Science Pharmacology, University of Bath Cindy Wu, PhD Fiona McCartney, PhD Director, Drug Delivery and Biomaterials, AbbVie Post-Doctoral Researcher, University College Dublin

1:15 pm 2:00 pm Five Minute Break 3rd Annual Pharma Spotlights In this session, we feature companies discussing their 1:20 pm partnering philosophy, current needs and scouting interests, as related to drug delivery and enabling technologies. Novartis Case Study: Novel Device for Pediatric IVT Injection Presenting companies: Frank Van Reeth Eli Lilly Group Head, Device Portfolio Optha & IHD, Kathleen Lin, PhD Novartis External Innovation Search and Evaluation

1:40 pm AbbVie Long-Acting Injectable Formulations: James Cunningham, PhD Executive Director, Drug Delivery A Comprehensive Landscape and the Challenges of Generic Development 2:20 pm This session will address the complexities of generic development of long-acting injectable drug delivery systems Day One Concludes and how industry is responding to these challenges, Partnering Meetings Continue to 5:00pm PST on the Meeting including the pursuit of 505b2 products rather than direct Mojo Platform copy generics (which opens up the possibility for new technologies) and how the FDA is instituting changes to ease the development process. Case studies will be provided that illustrate specific and under-appreciated challenges that face the industry. Matthew O’Brien, PhD Former Drug Delivery and Technical Strategy Lead, Medicinal Sciences – Pharmaceutical Sciences Small Molecule, Pfizer

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9:30 am DAY TWO - TUESDAY MAY 18 , 2021 Drug Delivery Initiatives for Global Health *All Times are Pacific Time Applications Susan Hershenson, PhD Deputy Director, Chemistry, Manufacturing and 7:30 am Controls, Bill and Melinda Gates Foundation Meeting Mojo Partnering Platform Opens 9:50 am 8:00 am Challenges and Opportunities in Integrating DDW Virtual Stage Opens New Technologies into Smart Drug Delivery This is an opportunity to explore the platform, reach out to The connected drug delivery device market is expected fellow attendees and visit the Drug Delivery Technology and to grow tremendously with emerging technologies that Service companies. connect patients, physicians, researchers, health systems, etc, while reducing burden to all. In this panel discussion, 8:20 am we focus on next generation emerging technologies, design needs and challenges, and regulatory hurdles to Opening Remarks & Welcome advance the drug delivery smart and connected world. Valerie Bowling Moderated by: Executive Director, DDW Justin M Wright, PhD 8:25 am Global Head, Connected Health, Novartis Co-Chairs Opening Remarks Panelists: Randall Mrsny, PhD Kevin Deane Professor’s Chair, Department of Pharmacy and VP, Front-End Innovation and Connected Health, Pharmacology, University of Bath Phillips-Medisize Daniele Fazio James Cunningham, PhD Vice President, Global Account Management and Executive Director, Drug Delivery, AbbVie Business Development, Flex Health Solutions Pari Gaikwad, MBA KEYNOTE Head of Product Management, MED Tech, Sanofi Quentin Le Masne, PhD 8:30 am Director, Connected Health & Devices, Merck Group Opening Keynote: Intersections Between Drug Delivery and Regenerative Medicine 10:40 am • Overview of the regenerative medicine field • Challenges and opportunities Ten Minute Break • Examination of class of materials, their advances and impact on drug delivery 10:50 am Kevin Healy, PhD Zeitgeist: Machine Learning & The Impact Jan Fandrianto Distinguished Professor, Departments of Bioengineering, Materials Science and on Drug Delivery Engineering, In this session, Dr Keith James, SVP, Drug Discovery University of California, Berkeley for Insitro will share examples of how machine learning (ML) is applied to tackle R&D and explore what would be involved in applying ML in drug delivery. Furthermore, this INDUSTRY KEYNOTE session will address challenges, opportunities and future directions for machine learning and drug delivery. 9:00 am Keith James, PhD Industry Keynote: Advances in Intracellular SVP, Drug Discovery, Insitro Targeting Delivery Sarah Hymowitz, PhD VP, Protein Science, Genentech

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11:20 am Panelists: Antibody Drug Conjugates: From Early Stage Tony Haight, PhD Research to Clinically Approved Drugs Distinguished Research Fellow, Novel Therapeutic • Antibodies are distinguished from small and Platforms, AbbVie macromolecular molecules because of their biological Young Jik Kwon, PhD stabilities and pharmacokinetic properties. Professor, Pharmaceutical Sciences, University of • Antibody drug conjugates have had a high impact in clinical oncology, with 7 approved agents and many California, Irvine that are in advanced clinical trials. Julia Rashba-Step, PhD • Some of the key considerations in developing effective VP, Research & Development; Alliance and safe ADCs include choice of target, payload, linker Management, technology, systemic stability, and conjugation technology. Phosphorex These aspects will be discussed in the presentation. Niklas Sandler, PhD Peter Senter, PhD Chief Technology Officer, Nanoform VP, Chemistry, Seagen 12:10 pm 11:40 am Designing For Patient Engagement– Emerging Opportunities in Targeted Drug Insights From The Consumer Sector Delivery Panel The consumer sector has been striving for years to This panel will discuss where the field is going, what engage more with consumers. Through engagement, challenges lie ahead, drug approvals, strengths and liabilities consumers become “loyal” to a product and make an as well as what needs to be done to continue to advance effort to use it. Attaining engagement can be achieved the field significantly. through product personalization. This requires a deeper Additional areas of discussion include: understanding of your target audience and segmentation • Antibody-based delivery mechanisms into different engagement models to better customize the • Molecularly based delivery mechanisms engagement. This approach is especially powerful when • Nanotechnology used in designing for digitization and patient adherence • New types of polymers as those different engagement models can support both • Microspheres and nanoparticles role in drug onboarding and retention more successfully. development and delivery Uri Baruch, MEng Moderated by: Partner & Head of Drug Delivery, Cambridge Peter Senter, PhD Design Partnership VP, Chemistry, Seagen

12:25 pm - Early Stage Technologies & Evaluation 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. Nasus Medical – Targeted Topical Intranasal Medication Delivery: A Platform Technology Nasus Medical is developing an at home, self-administered, drug-device combination solution for those suffering from chronic sinusitis. Ashley Seehusen, PhD, MBA , CEO, Nasus Medical DiaCyt: A Platform Technology for Targeted BBB Delivery of a Wide Variety of Therapeutic Cargoes SRI International’s proprietary DiaCyt platform technology identifies peptide-based delivery agents that can selectively transport molecular cargos into the CNS without physically disrupting the blood-brain barrier. These delivery agents, known as molecular transport systems (MTS), can be conjugated to a wide variety of therapeutic molecules including monoclonal antibodies, enzymes, nucleic acids for gene therapy, small-molecule therapeutics, and diagnostic and imaging agents. Kathlynn Brown, PhD, Senior Director of Macromolecular Bioscience and Cancer Biology, Senior Scientific Director of SRI-Shenandoah Valley Labs, SRI Biosciences Miniaturized Injectable Drug Delivery Systems for Ocular Conditions Oculinea’s core technology developed at UCSF is a nano-engineered polymer thin film encapsulating drug payload in various configurations for ocular drug delivery of both small molecules and biologic therapeutics. The bio-resorbable drug delivery implant allows transport of drug molecules from a reservoir payload through a micro- and nano-structured porous polymer layer providing zero-order drug delivery for a few months to a year. This miniaturized injectable drug delivery product platform administered in an office setting provides an ideal solution to address compliance issues in treating chronic ocular conditions like glaucoma. The presentation will provide results from the progress made by Oculinea towards clinical translation of this novel technology. Murty Vyakarnam, PhD, Cofounder and CEO, Oculinea, Inc 7 WWW.DRUGDELIVERYWEST.ORG DDW: DRUG DELIVERY WEST 2021 AGENDA

Early Stage Technologies & Evaluation Showcase The PassPort® System: Painless Transdermal Delivery of Small Molecules and Biologics The PassPort® System is an active transdermal technology to create innovative drug-device combination products. The versatile platform enables efficient delivery of both small molecules and macromolecules (peptides, proteins, mAb, etc.) through a combination of electronic device and patch formulation technologies. Aqueous micropores are painlessly created in the stratum corneum and enable drugs to flow from a transdermal patch, enter the viable epidermis, and then the systemic circulation. The patch may be formulated to provide for either immediate or sustained delivery. The PassPort System offers novel, self-administered drug delivery in a convenient, patient-friendly manner. Jared Hahn, BSc, Head of Business Development, PassPort Technologies High-Concentration Suspension Platform for Subcutaneous Delivery of Biologics Lindy Biosciences’ dehydration technology combines the stability of solid formulations with particle-engineering expertise. The resulting dense protein particles are ideal for developing stable, high-concentration, injectable suspensions of biologics. Deborah Bitterfield, PhD, CEO & Founder, Lindy Biosciences

12:50 pm 2:00 pm Lunch and Partnering Meetings via Closing Panel: Partnering Academic and Meeting Mojo Industry in Drug Delivery: Whats Works, What Doesn’t 1:20 pm Technology transfer from academic/university labs to industry for development and commercialization is Novel SubQ Drug Delivery Approaches for often easier said than done. Many barriers hinder early Biotherapeutics technology de-risking, assessment and confidence • How to transform an IV to a SubQ dose from industrial licensing partners. This panel comprising • What factors impact the absorption property, experienced academic and industrial translational mechanism of delivery? partners will examine these issues and describe pathways for achieving better partnerships and results in Moderated by: academic-industrial partnering with new technology. Randall Mrsny, PhD Moderator: Professor’s Chair, Department of Pharmacy and David Grainger, PhD Pharmacology, University of Bath University Distinguished Professor, Chair, Department of Biomedical Engineering, Department of Pharmaceutics Panelists: and Pharmaceutical Chemistry, University of Utah Hunter H Chen, PhD Associate Director, Formulation Development, Panelists: Regeneron Pharmaceuticals David Bearss, PhD Senior Managing Director, U2TAH Therapeutics Daniel Dadon, PhD Accelerator Hub, University of Utah Director of Scientific Strategy, Elektrofi Glenn Prestwich, PhD Jim Leamon President’s Distinguished Professor, Washington Director, Biologics Device Development, Jazz State University Pharmaceuticals Ellen S Kats, PhD Assistant Director, Office of Technology Management, UCSF Innovation Ventures

2:40 pm Closing Remarks and Meeting Concludes Partnering Meetings Continue to 4:30pm PST on the Meeting Mojo Platform and continue on Wednesday and Thursday May 19th and 20th

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