PODD...Living in the World of RNAi Therapeutics Small interfering RNAs (siRNAs) are a new class of novel medicine and potent inhibitors of gene expression; and act through the natural

10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

WWW.THECONFERENCEFORUM.ORG

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Partnership opportunities in drug delivery

october 8 - 9 • Virtual

ANNUAL

Produced by the Conference Forum | www.theconferenceforum.org | #PODD2020

PODDth



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Scientific Keynote

10:10 amIn this fireside chat, we sit down with Dr. Sangeeta Bhatia, a Harvard-MIT physician, bioengineer and entrepreneur. We will hear about the technologies she has pioneered, companies founded, and her strong advocacy for women’s diversity in science.

Sangeeta Bhatia, MD, PhD, Wilson Professor of Engineering, Director of the Marble Center for Nanomedicine, MIT

Hosted with:

Barbara Lueckel, PhD, Global Head of Research Technologies Partnering,Roche Pharma Partnering

10:30 amVisit the Technology & More SectionThis 10 minute session is allotted to visit the Technology & More section of the virtual platform. Meet a wide range of delivery companies and more. When you meet the different companies through the platform and click, “register interest”, PODD will donate $1 to the Juvenile Diabetes Cure Alliance. It is a convenient way to meet lots of companies and fund raise all in one!

10:40 amTen Minute Break

10:50 amPharma’s Current and Future Needs in Drug DeliveryPartnering philosophies and interests are ever-changing in order to adapt to a company’s current needs and development strategy. In this session, we will hear various perspectives on partnering and utilizing novel delivery technologies, addressing questions such as:• Is there more emphasis on “product enabling” or “product

enhancing” technologies?• What is the ratio of internal technology development vs

external partnering to access novel delivery technology?• Which emerging technologies will be most impactful to the

future of drug development and why?Q&A with the audienceModerated by:Alpa Bhattacharyya, PhD, Associate Director, Strategic Product Innovation, BMSPanelists:Theresa Scheuble, Design Director, Value Chain Quality, Johnson & JohnsonJohannes Schmidt, PhD, Global Head Product Optimization,

DAY ONE - THURSDAY, OCTOBER 8TH, 20208:30 amPODD Virtual Platform OpensThis is an opportunity to explore the platform, reach out to fellow attendees and visit the Drug Delivery Technology and Service companies. Partnering Meetings will also be taking place during this time on the Meeting Mojo platform.

8:55 am Co-Moderator Opening Remarks

Valerie Bowling, Executive Director, PODD9:00 amChair’s Opening RemarksDr Barbara Lueckel will present her annual review on the drug delivery industry including notable highlights and partnerships.Barbara Lueckel, PhD, Global Head of Research Technologies Partnering,Roche Pharma Partnering

Annual Keynote Fireside Discussion

9:30 amAs one of history’s most prolific inventors and entrepreneurs in drug delivery, we are pleased to welcome Dr. Langer in this fireside chat to learn about his latest research in drug delivery and discuss what transformative innovations he feels will impact the future of medicine. More specifically, the fireside will cover Dr Langer’s view on:• Novel ways of delivering drugs• Entrepreneurship• How you translate invention into practicality and business• Most interesting drug delivery issues• Notable mentions on what’s coming down the pike in the

future• Getting to a successful path with drug delivery• Examples of learning from failures• We will also learn about the story of Inbrija®evolution of the

ARCUS particle technology in Dr. Langer’s lab and Acorda’s long journey developing and commercializing the first inhaled treatment for Parkinson’s disease.

Robert Langer, PhD, David H. Koch Institute Professor, MIT

Hosted with

Ron Cohen, MD, Founder, President and CEO, Acorda Therapeutics



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is used to treat polyneuropathy in patients with hereditary ATTR amyloidosis. The approval of ONPATTRO® paves the way for a whole new class of RNA-based medicines. Our research group demonstrated for the first time the human therapeutic applications of hepatocyte-targeting GalNAc (a carbohydrate) -conjugated oligonucleotides, a platform that has revolutionized the nucleic acid-based therapeutics field with several compounds including GIVLAARI® (givosiran), which was approved for treating Acute Hepatic Porphyria in 2019. Several current examples will also be presented to illustrate the life-saving potential of siRNAs (e.g., COVID-19 and HBV viral infections).Muthiah (Mano) Manoharan, PhD, Senior Vice President of Drug Innovation Chemistry, Alnylam Pharmaceuticals, Inc

12:10 pmThe Evolving Pharmaceutical and Biotechnology Landscape in Healthcare: Where are we and where are we going?PharmaCircle will discuss the transition from traditional pharma to antibodies/proteins to advanced biologics (cell therapy, gene delivery, and similar). We will show trends in pipelines, companies, and investments. We will also discuss the ever expanding role of CMO’s and CRO’s especially in the manufacture of the actives and finished products and how this is playing out in traditional pharma products as well as these new advanced biologics.Kurt R. Sedo, Vice President Operations, Pharmacircle

12:25 pmLunch/Partnering Meetings on the Meeting Mojo Platform

1:00 pm - 3:00 pmDrug Delivery Technology Presentations

11:20 am 10th Annual Company SpotlightsIn this session, we hear directly from pharmaceutical companies regarding current partnering interests and needs as related to drug delivery, as well as their general partnering philosophy.Eli LillyKathleen Lin, PhD, External Innovation Search & EvaluationFerring PharmaceuticalsJanet Halliday, PhD, Associate VP, Ferring Controlled Therapeutics & External TechnologySanofi PartneringHubert Haag, PhD, Director, Innovative Technologies

11:50 am Living in the World of RNAi TherapeuticsSmall interfering RNAs (siRNAs) are a new class of novel medicine and potent inhibitors of gene expression; and act through the natural RNA interference (RNAi) pathway. Although there is much hope and speculation regarding the therapeutic potential of RNAi, there have been challenges in realizing this potential, most related to difficulties in efficient delivery into the cells of specific organs or tissues. Alnylam have developed a three-pronged approach with the goals of enabling delivery to hepatocytes after both intravenous and subcutaneous administration. These methods include chemical modification of siRNAs, lipid nanoparticle (LNP) formulation of siRNAs, and multivalent N-acetylgalactosamine (GalNAc, a carbohydrate) conjugation of siRNAs. The LNP strategy with a partially chemically modified siRNA resulted in the first RNAi therapeutic approved by the US FDA in 2018 and it is now approved for use in Europe, Canada, and Japan. This drug, ONPATTRO®,

Track 1A - Injectable Formulation Technologies

Track 2A - Non-Injectable Technologies Track 3A - Connected Delivery Devices, Wearables & Other Novel Devices, Part 1

Chair: Matthew O’Brien, PhD, Drug Delivery and Technical Strategy Lead, Pfizer

Chair: Keith Horspool, PhD, VP of External Alternative CMC Development (EACD), Boehringer Ingelheim

Chair: Dhairya Mehta, Head, Connected and Software Medical Devices, Takeda

1:00 pm - 1:10 pm: Halozyme 1:00 pm - 1:10 pm: BDD Pharma 1:00 pm - 1:10 pm: BD Medical

1:10 pm - 1:20 pm: Innocore 1:10 pm - 1:20 pm: Lyndra 1:10 pm - 1:20 pm: Biocorp

1:20 pm - 1:30 pm: Curadigm 1:20 pm - 1:30 pm: Adare 1:20 pm - 1:30 pm: Neuma

1:30 pm - 1:40 pm: Pendant Biosciences 1:30 pm - 1:40 pm: Nanoform 1:30 pm - 1:40 pm: Phillips-Medisize

1:40 pm - 1:50 pm: ProMed Pharma 1:40 pm - 1:50 pm: SeraNovo B.V. 1:40 pm - 1:50 pm: Portal Instruments

1:50 pm - 2:00 pm: Sonceboz

Track 1B - Self-injection Devices, Connected Syringes, Primary Container and Packaging Solutions

Track 2B - Novel Injectable & Non-Injectable Technologies

Track 3B - Connected Delivery Devices, Wearables & Other Novel Devices, Part 2

Chair: Ulrich Bruggemann, Medical Device Strategy and Early Programs, Takeda

Chair: Marian Gindy, PhD, Executive Director, Pharmaceutical Sciences, Merck

Chair: Courtney Nicholas, Senior Device Engineer, AstraZeneca

2:10 pm - 2:20 pm: Credence Medsystems 2:10 pm - 2:20 pm: Battelle 2:10 pm - 2:20 pm: Sensile Medical

2:20 pm - 2:30 pm: Gerresheimer 2:20 pm - 2:30 pm: Medincell 2:20 pm - 2:30 pm: Sorrel Medical

2:30 pm - 2:40 pm: Stevanato Group 2:30 pm - 2:40 pm: DSM 2:30 pm - 2:40 pm: Key Tech

2:40 pm - 2:50 pm: Flex 2:40 pm - 2:50 pm: DelSiTech 2:40 pm - 2:50 pm: Common Sensing

2:50 pm - 3:00 pm: Cambridge Design Partnership

2:50 pm - 3:00 pm: Kindeva 2:50 pm - 3:00 pm: SHL

3:00 pm - 3:10 pm: Team-Consulting, Ltd

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1:00 pm ENHANZE(R) Drug Delivery Technology: Facilitating Rapid Subcutaneous Administration of Large Volume BiologicsOverview of Halozyme’s ENHANZE subcutaneous administration technology including recent clinical and commercial advancesMichael J. LaBarre, PhD, Senior Vice President, Chief Technical Officer, Halozyme

1:10 pm Advanced biodegradable polymer-based drug delivery systems for the development of long-acting injectables for the treatment of chronic and site-specific diseases With the majority of the drugs currently under development requiring parenteral administration and the growing importance of patient-friendly pharmacological therapies, there is a highly increased interest in long-acting-injectables (LAI) for the treatment of chronic and site-specific diseases. InnoCore owns a versatile portfolio of advanced biodegradable polymeric DDS for the development of LAI for a wide range of drug molecules and diseases. Demonstrating excellent compatibility with protein therapeutics, InnoCore’s SynBiosys technology combines all the features required for microparticle and implant-based LAI for biologics. Its Gamma thermoresponsive hydrogels and LQP liquid polymers provide an excellent platform to develop patient friendly and easy to manufacture LAI liquid formulations for lipophilic drugs. This talk will highlight the unique features of InnoCore’s DDS and their application for the development of unique and competitive LAI.Rob Steendam, PhD, CSO, Innocore

1:20 pm The Nanoprimer: a Nanoparticle Engineered to Improve the Efficacy of Nucleic Acid-Based TherapeuticsIntravenously 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 tissueMatthieu Germain, CEO, Curadigm

1:30 pm Cracking the Code: How Customizable Matrices Deliver on the Promise of Long-Acting InjectablesThis talk will focus around how the company is solving some of the industries most challenging formulation challenges. Pendant is currently developing a new polymer-based platform (like the outdated PLGA, only different and better), which will serve as a product engine with broad utility in multiple therapeutic areas.Shawn Glinter, Founder and CEO, Pendant Biosciences, Inc.

1:40 pm Molded and Extruded Injectable Implants for Long-term Release This talk will review polymer drug delivery materials and processes used in the fabrication of long-acting implant, along with key design considerations. Examples of products in development and potential applications will be shared.Jim Arps, PhD, Director of Pharma Services, ProMed Pharma LLC

2:00 pm Ten Minute Break

Track 1B: Pre-Filled Syringes, Auto-Injectors and SimilarChaired by: Ulrich Bruggemann, Medical Device Strategy and Early Programs, Takeda

2:10 pm The Credence Connect™ Auto-Sensing Injection SystemThe Credence Connect™ Auto-Sensing Injection System incorporates automatic real-time monitoring of critical injection data into a reusable ergonomic finger grip that is applicable to any prefilled syringe. The Connect embeds the digital connectivity into a comfortable grip that enhances the usability of any syringe while measuring and transmitting injection progress in real time. The user receives reminders and instructions on the app and can visualize the injection as it occurs, watching a meter increment as the medication is delivered. The user then receives feedback on whether the injection was completed successfully.John Merhige, Chief Commercial Officer, Credence Medsystems

2:20 pm Gx InnoSafe® – Safety Syringes in Ready-to-Fill ConfigurationIt is everyday life for health care workers to handle blood contaminated injection needles which leads in some cases to a contraction of serious diseases. It is estimated that there are about one million needlestick injuries in Europe every year. In the last decade regulations have been implemented to improve the safety of the healthcare professionals. These regulatory requirements triggered the development of various systems to prevent needlestick injuries. Latest legislative revisions imposed new challenges to be considered in terms of developing new products in this field. With Gx InnoSafe® Gerresheimer aims to address these requirements by offering a custom tailored and ready-to-fill solution for a wide range of applications.Maximilian Vogl, Global Head of Product Management Gx® Solutions, Gerresheimer

2:30 pm Primary Packaging and Injection Systems for Biopharmaceuticals: An Integrated Approach from Design to Final Device AssemblyThe speaker will talk about the how the Stevanato Group has developed or acquired a range of capabilities and services to position itself as an Integrated Solution Provider. In particular, he will highlight lessons learnt in working with Contract Manufacturing of device as well as the importance of partnerships to bring complete solutions to biopharma companies in a shorter period of time with case studies related to auto injector and pen injector. The talk will also include trends in the market related to providing such solutions during Covid-19 and demand continues to increase for device support. Lastly the speaker will briefly highlight wearables and the importance of working on innovative technologies which can enhance patient care while also achieving an affordable total cost of ownership.Steven Kaufman, Vice President of Drug Delivery Systems, Stevanato Group

2:40 pm Autoinjectors: Enhancing Therapy by Remote Patient MonitoringA look at how heart rate, ECG and pulse oximetry can improve the digital twin of the patient in the cloud. Attendees will get a tour of the latest technologies available to enrich patient data collection in an efficient way. Marco discusses the challenges in extracting actionable information locally for further storage and analysis at cloud level. He will discuss a reference system architecture and analyse a full data path from patient to cloud.Marco De Angeli, Senior Director, Design, Process and Technology Engineering, Flex

2:50 pm Unpacking Opportunities for Healthcare Packaging InnovationComparing and contrasting healthcare and consumer innovations, Chris and Clare highlight what we can learn from the Consumer sector and how these can be applied to your drug delivery devices, products and packaging portfolio.Chris Houghton, Partner – Brand Innovation and Packaging Leader, Cambridge Design PartnershipClare Beddoes, Senior Medical Innovation and Research Consultant, Cambridge Design Partnership

Track 1A: Injectable Formulation TechnologiesChaired by: Matthew O’Brien, PhD, Drug Delivery and Technical Strategy Lead, Pfizer

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Track 2A: Non-Injectable Technologies

Track 2B: Novel Injectable & Non-Injectable Technologies

Chaired by: Keith Horspool, PhD, VP of External Alternative CMC Development (EACD), Boehringer Ingelheim

Chaired by: Marian Gindy, PhD, Executive Director, Pharmaceutical Sciences, Merck

1:00 pm Oral Targeted Drug Delivery, the Importance of Where and WhenThe benefits of administering drugs at specific times of the day (or night) are well documented, as are the constraints or advantages of drug release at different areas of the GI tract. We will review the advantages of being able to control where and when you release your product, to avoid degradation or enhance efficacy and how to achieve this.Fiona MacDougall, PhD, Development Director, BDD Pharma

1:20 pm Orally-Disintegrating Dosage Forms with Taste-Masked MultiparticulatesThis presentation will cover taste-masking strategies, along with key features and benefits of Adare’s taste-masking technology and proprietary dosage forms. These technologies can be utilized to develop improved, patient-friendly dosage formsSrinivasan Shanmugam, PhD, Senior Director, Pharmaceutical Sciences, Business Support and New Technologies, Adare

1:30 pm Nanoparticle-improved Solutions for Oral Drug Delivery How Nanoform’s Controlled Expansion of Supercritical Solutions (CESS ®) technology can enhance the properties of tablet formulations for oral drug delivery. With 85% of the most sold drugs in the US and Europe being orally administered, innovations in this area promise to dramatically impact the pharma industry.Satu Lakio, PhD, Pharmaceutical Development Manager, Nanoform

1:40 pm Solving the Insoluble Poor water solubility and high melting points are major hurdles in oral formulations leading to low bioavailability. SeraNovo is presenting a new platform, proven to have solved both issues for even the most challenging molecules.Niall Hodgins, Co-Founder and CEO, SeraNovo B.V.

1:10 pm Delivering the Medicine of the Future TodayThe session is an overview of the development of the first ultra-long acting oral dosage form, capable of delivering sustained drug levels over a week. The presentation describes how Lyndra has successfully developed this unique dosage form and is pursuing the technology in clinical programs. Opportunities and challenges ahead will be discussed. Örn Almarsson, PhD, Chief Technology Officer, LyndraRay Knox, Chief Manufacturing Officer, Lyndra

2:10 pm Enabling Reduced Size in Wearable DeliveryBattelle will discuss its novel Chemical Engine (CEng) drive technology tuned for ≥ 5.0ml formulations with the opportunity to create non-linear drive force thereby reducing the device footprint and optimizing form factor. Battelle’s CEng drive also offers superior shelf-life, safety, operating temperature range, and environmental profile when compared to other solutions. Available solutions include drop in engines for existing patch systems (device + container closure) and integrated system options.André LaFreniere, Commercial Sales Director, Medical Device, Drug Delivery & Diagnostic System, Battelle

2:40 pm DelSiTech Silica Matrix: Long-Acting Drug Delivery for Small Molecules and BiologicsDelSiTech Silica Matrix allows long acting controlled release and stabilization of APIs from small molecules to large molecules for injectables and topical delivery.Frederic Dargelas, PhD, MBA, Director, Head of Business Development and Alliance Management, DelSiTech

2:50 pm Drug Delivery – MicroneedlesKindeva’s two platforms have been designed to precisely and accurately delivery drugs to the skin, including solid microneedles (solid Microstructured Transdermal System or sMTS) and hollow microneedles (hMTS). In addition to discussing Kindeva’s expertise in inhalation, transdermal, and microneedle drug delivery and drug development capabilities that extend from formulation development through commercial manufacturing, also discussed will be Kindeva’s flexible business models and will work with its partners throughout the entire drug development process.John Vasilakos, PhD, MBA, Global Head of MTS Business Development & Senior Research Immunologist, Kindeva

2:30 pm DSM’s Biodegradable PolyEsterAmide (PEA) PlatformThis presentation highlights application of our biodegradable PolyEsterAmide (PEA) platform to address unmet needs in sustained drug delivery. The differentiating features of the PEA platform enabling delivery for challenging APIs wil be discussed. Presented examples include capability for multi-month sustained release of free amine API (Kinase Inhibitor), peptide (GLP-1 Receptor Agonist), and protein.Lukasz Koroniak,, Business Development Manager, DSM

2:20 pm Building a Global Pharma Leader Through Long-Acting InjectablesMedinCell is a clinical stage pharmaceutical company developing long- acting injectables based on BEPO platform enabling controlled, localized and sustained drug delivery. Independently and in partnership with other pharma or NGOs MedinCell develop a portfolio of best-in-class medicines.Victor Aguilar Lopez, PhD, Partnering Director, EMEA, Medincell


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Track 3A: Connected Delivery Devices, Wearables & Other Novel Devices, Part 1Chaired by: Dhairya Mehta, Head of Drug Delivery, Drug Delivery Devices, Takeda


1:00 pm Addressing the Evolving Needs of Complex or Variable Drug Delivery Regimens: BD Evolve™Faced with a changing healthcare landscape and transition of care out of traditional clinical settings to alternative sites such as patients’ homes, a trend that may be augmented by global coronavirus concerns, delivery technologies that enable patient treatments in home settings are increasingly attractive. Designed as a programmable system capable of continuous, episodic, or delayed subcutaneous delivery of up to 3 mL dose volumes for up to a 3-day wear period, BD Evolve™ on-body injector may facilitate at-home medication delivery.Christian Sandmann, R&D Associate Director, BD Medical

1:20 pm Sterilization Engineering – A Critical Part of Successful Drug Delivery Device DevelopmentSterilization can make or break a combination product – sometimes literally! Using a holistic approach to sterilization mode selection, as well as incorporating sterilization process development early in the development lifecycle, can be a key enabler of successful novel technology commercialization.Shaun Devitt, Vice President, Neuma

1:30 pm A Smarter, Sustainable and Connectable AutoinjectorAn autoinjector that’s small, intuitive and easy to use for patients, yet powerful and flexible for pharmaceutical companies. An autoinjector that’s designed with both sustainability and connectivity in mind from the start. It’s just Smarter.Kevin Deane, Vice President – Front-End Innovation and Connected Health, Phillips-Medisize

1:10 pm The Potential of Connected Add-ons Combined with Successful Patient Engagement Software: Use Cases in the Field of Injectable MedicinesBIOCORP will present his collaborations with successful patient engagement software, and show how, through this partnering approach, connected add-ons can deliver their full potential and benefit all healthcare stakeholders.Arnaud Guillet, Business Development Director, Biocorp

1:40 pm Needle-Free Injections; Why Differentiating Your Drug for Home Health is More Important than EverHome health care and the ability to monitor health remotely has never been as profoundly needed as over the last 6 months during the Covid-19 pandemic. The need for easy-to-use, patient-friendly, home use medical devices is here to stay. Dr. Patrick Anquetil will provide an update on Portal Instruments’ next-generation needle-free injector, including its connectivity features for home health.Patrick Anquetil, PhD, MBA, CEO, Portal Instruments

1:50 pm Wearable Electromechanic Large-Volume Injection Devices. Advantages, Challenges and Opportunities for the FutureWith the increasing pressure to enable home care, Pharma companies face challenges when it comes to providing the right means to enable patients a safe and intuitive option to inject large volumes of drug products without assistance. This is where an advanced technology platform for body-worn devices can make the difference while at the same time protecting patients from potential exposure to infectious disease. This talk explains how Sonceboz defines platform technology and how proven Swiss technology can help patients and pharma companies to tackle future challenges.Tom Mayer, Associate Business Unit Manager, Sonceboz


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Track 3B: Connected Delivery Devices, Wearables & Other Novel Devices, Part 2Chaired by: Courtney Nicholas, Senior Device Engineer, AstraZeneca


2:10 pm Connectivity, Devices and Upcoming NeedsDrug Delivery Devices, connectivity and production need a wide range of different capabilities.We are presenting different kind of micro pump technologies and discussing the upcoming need of connectivity. Do we know what is the need behind connectivity considering different requirements? Do we have the requirements from the pharma and biotech companies and how to integrate a Software Eco-System for Drug Delivery Devices? After the launch of the product, many different stakeholders need the additional learning curve: data management, cloud, cyber security Amir Tahric, Director Sales, Sensile MedicalDavid Christen, Head Software Development, Sensile Medical

2:20 pm De-risking Clinical Readiness with Sorrel’s Wearable Drug Delivery PlatformMike Ratigan, Sorrel Medical’s CCO, will speak about how the Sorrel wearable drug delivery platform can be used to de-risk the development process and shorten timelines to clinical and commercial readiness. Leveraging the platform design approach and using both vial and cartridge based devices, ensures fast time to market with Sorrel’s pre-filled and pre-loaded device configurations.Michael Ratigan, Chief Commercial Officer, Sorrel Medical

2:30 pm De-Risk Battery Requirements for Small, Connected Drug Delivery DevicesThis talk outlines a clever, rapid approach we took to evaluate which batteries and configurations would work for the intended use for a connected drug delivery device. This talk will help demonstrate how to balance both use and technical requirements to arrive at the optimal product architecture.Mariano Mumpower, Sr. Mechanical Engineer, Key Tech

2:40 pm The Gocap Platform for Diabetes Smart Pen Cap DevelopmentLearn about the development and growth platform for Common Sensing’s smart replacement cap for diabetes pen injectors. Gocap can easily be part of an integrated solution that provides data for analysis, predictive analytics, and AI machine learning. Smart devices and integrated systems designed to enable and empower patients, providers, and payers.Kevin Schmid, CEO, Common Sensing

2:50 pm Delivering the Next Generation of Connected Therapeutics for Digital HealthcareAs a global leader in advanced drug automated device technology, SHL Medical has transformed how patients self-administer treatments for their complex chronic conditions. Capitalizing on digital health movements across the biopharma space, an opportunity is present to create new advancements in how medications are administered, and where care is delivered. In this presentation SHL Medical will unveil its strategy and associated technology investments to create a new generation of connected therapeutics for chronic disease management.Jamie Gould, MHA, Manager of Business Development, SHLRamin Rafiei, Ph.D, Director of Digital Healthcare, SHL

3:00 pm So you’re Developing a New Therapy… 4 Steps to Selecting the ‘Right’ Device to Deliver itHow do you decide which of the many device technologies on the market or in development, will be optimum for your therapy? This session explores the four steps we suggest to take early in the process to ensure you’re on the path to selecting the ‘right’ device for you: Align the team on objectives, Define your requirements, Explore the full range of suitable device technologies, Assess the technologies.Charlotte Harris, Head of Front End Innovation, Team-Consulting, Ltd

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3:10 pmTen Minute BreakPODD Day one main program concludes. For those of you who registered for the Zoom interactive meetings please reference your zoom link. Otherwise, partnering meetings continue through Meeting Mojo until 7:00pm EST.

3:20 pmZoom Small Group Interactive Discussion ChoicesThe concluding afternoon of day one will be dedicated to 30-minute small group discussion choices. These interactive discussions are first come, first served and have limited capacity. Registration is required in advance. Registered PODD attendees may choose one discussion group per time slot to attend live.

Connecting Drug Delivery to Healthcare Systems – What are We Trying to Achieve?We are seeing more connected drug systems gain regulatory approval and launch successfully into the market. For the most part, current systems remain proprietary, supporting patients on particular drug therapies and providing basic analytical data regarding drug usage. More and more, pharmaceutical companies are looking to integrate these emerging systems with provider systems, particularly Electronic Medical Records. But to what end?

In this interactive discussion we will:

• Define the additional value-add services that could be provided to patients (and other stakeholders) through the integration to other healthcare systems such as pharmacies, EMR, etc.

• Identify external systems that a pharma company might look to access when thinking about the value propositions they could bring to market

• Specifically consider potential interaction with various EMR systems; what data can we provide and how might that be utilized, and what data could we retrieve that would be supportive to new value propositions

Moderated by:Kevin Deane, VP, Front-End Innovation and Connected Health, Phillips-Medisize

Development and Commercialization of SC Biologics: Regulatory Landscape and Case Study Examples The ENHANZE® drug delivery technology is clinically and commercially proven to facilitate subcutaneous administration. Learn more about the technology, how it can support the development of your SC formulations, the evolving regulatory landscape and case studies on recently approved products.Moderated by:Michael LaBarre SVP, Chief Technical Officer, Halozyme

Small is powerful – the BIG Opportunities for Nano-Sized ParticlesNanoparticles represent significant opportunities to both optimise and enable new drug delivery routes and applications. By harnessing innovative nanotechnologies we can transform patients’ lives and enable safer, more targeted and efficacious therapies. In this Zoom roundtable, we will delve into the wealth of possibilities for nanotechnology in Pharma.Moderated by:Niklas Sandler, PhD, Chief Technology Officer, Nanoform

3:50 pmFive Minute Transition Time

3:55 pmEmbarking on your Connected Combination Product Journey: Top 3 ConsiderationsPlease join digital health thought leaders from BrightInsight, Teva, and Scripps to discuss key topics that biopharma execs should be contemplating as they embark on their connected combination product journey. Some companies are still unsure of whether to connect their combination products and how exactly to go about doing that. Key areas we’ll dive into during this 30-minute session:

• How do you determine if you want to connect your combination product? What are the key benefits of why you would want to connect your product?

• How do you think through your regulatory roadmap for connected combination products? How do you future-proof your regulatory roadmap?

• What is the value for patients and clinicians? How do you ensure your product integrates seamlessly to the broader ecosystem, such as Electronic Health Records?

Moderated by:Paul Schultz, Sr Director of Commercial Development, BrightInsightDonald Jones, Chief Digital Officer, Scripps Research Translational Institute

Challenges and Progress with Tumor Targeting TechnologiesIn this roundtable, we’ll talk about the challenges associated with tumor targeting, as well as the varying degrees of success related to different delivery technologies and strategies for NCEs. Since many technologies are being explored but nothing has to come to fruition, let’s discuss why that is the case. Will we ever achieve tumor targeting and avoid other side effects, or will it remain only exploratory phase?Moderated by:Sudhakar Garad, PhD, Global Head of Pharmaceutical and Chemical Profiling, Novartis Institutes for Biomedical Research

EACD: A “Biotech within Pharma X-Team” – Changing Paradigms for Working ExternallyIn this roundtable, we will review formation of External Alternative CMC Development that uses the X-team concept (Ancona & Bresman, 2007) to solicit inputs/practices from diverse external sources, combined with a matrix of nimble virtual resources, to advance alternative scenarios and new technologies for future-looking CMC development. We will also discuss an initiative for incentivizing drug delivery partnerships to determine the best way forward.Moderated by:Keith Horspool, PhD, VP, External Alternative CMC Development, Boehringer Ingelheim

4:25 pmDay One ConcludesPartnering Meetings Continue to 7:00pm EST on the Meeting Mojo Platform

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DAY TWO - FRIDAY OCTOBER 9TH, 20208:30 amPODD Virtual Platform OpensThis is an opportunity to explore the platform, reach out to fellow attendees and visit the Drug Delivery Technology and Service companies.Partnering Meetings will also be taking place during this time on the Meeting Mojo platform.

Co-ModeratorValerie Bowling, Co-Moderator, PODD8:55 amChair’s Opening RemarksShawn Davis, PhD, Head of Drug Delivery, Biopharmaceuticals Development, AstraZeneca

Industry Fireside Chat9:15 amWhile drug delivery technologies are traditionally used to enable delivery of new complex molecules, they also carry significant value for generic companies. Drug delivery technologies can help generic companies create differentiated products, or generic equivalents of complex formulations. In this chat we will discuss some case studies to demonstrate how Baxter has utilized drug delivery technologies to create a portfolio of differentiated products. We will also discuss our view on internal technology development versus partnerships to balance development costs, probability of success, and speed to market.

Mahesh Chaubal, PhD, Vice President, R&D, Baxter Hosted with:

Barbara Lueckel, PhD, Global Head of Research Technologies Partnering, tRoche Pharma Partnering

9:40 amPatient Panel: Understanding the Patient Perspective on Treating Chronic Illness and Self-Injecting TherapeuticsThree patients, representing three different chronic conditions and three different infusion / injection regimens, will share their experiences in this interactive panel discussion. Topics will include making decisions about which therapy to pursue, acknowledging the importance of self-image as a key experiential factor, and exploring the expectations and challenges of medication delivery itself. The patients will also share thoughts on what features or changes they’d like to see in next-generation delivery devices.Moderated by:Matthew Jordan, Partner and Healthcare Pratice Lead, ArtefactPanelists:Nitika Chopra, Psoriasis and Psoriatic Arthritis Patient AdvocateMegan Starshak, Inflammatory Bowel Disease (IBD) Patient Advocate10:15 amVisit the Technology & More SectionThis 10 minute session is allotted to visit the Technology & More section of the virtual platform. Meet a wide range of delivery companies and more. When you meet the different companies through the platform and click, “register interest”, PODD will donate $1 to the Juvenile Diabetes Cure Alliance. It is a convenient way to meet lots of companies and fund raise all in one! 10:25 amTen Minute Break10:35 amDrug Delivery and COVID-19: Front Line PerspectivesLessons to take forward on facing drug delivery challenges in this COVID era.Cornell Stamoran, PhD, Founder & Co-Chair, Catalent Applied Drug Delivery Institute Sudhakar Garad, PhD, Global Head of Pharmaceutical and Chemical Profiling, Novartis Institutes for Biomedical Research

Industry Fireside Chat11:00 amIndustry Veteran Fireside Chat with Amgen’s Jerry Murry with AstraZeneca’s Shawn Davis on Current Trends Related to Innovation in the Pharmaceutical IndustryIn this fireside chat with industry veteran Jerry Murry, we will hear his views on current trends related to innovation in the pharmaceutical industry, including sub-sectors such as drug delivery and digital health. Specific topics to be addressed:• The impact of COVID-19 on the industry and Amgen’s response• The role of patient centricity and the evolving point of view on its

relevance• The impact of new modalities in healthcare and in the industry• Approaches to sustainability that also support patient’s needs• Internal and external innovation: understanding Amgen’s position

• Jerry Murry, PhD, Senior VP, Process Development, Amgen

Hosted with:

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

11:30 am10th Annual DDS Soapbox Session Sponsored by PfizerThis session features five minute quick-fire presentations on cutting edge technologies and inventions. The session is open to early stage start-ups, inventors, entrepreneurs and University researchers and licensing officers. Many thanks to Pfizer for supporting the DDS Soapbox session.Chaired by:Patrick Lim Soo, PhD, Senior Principal Scientist, Novel Delivery Technologies, PfizerThe Future of Male ContraceptionContraline is a venture-backed, clinical-stage medical device company that is making breakthrough advancements in the field of reproductive health. The company’s lead product is Adam, a long-acting and reversible contraceptive for men that consists of implanting a biocompatible hydrogel into the vas deferens.Greg Grover, PhD, Chief Technology Officer, ContralineDelivery of Whole Monoclonal Antibodies to Intracellular Cancer TargetsLeveraging patented Multifunctional Polymeric Nanocapsules (MPN) administered intravenously to target tumor and metastatic cells, cross the cell membrane and escape endosomal capture.Olivier Jarry, MSc, MBA, CEO, Libera BioPatches over Pokes – Enabling Passive Transdermal Delivery of Small Molecules and Biologics A discussion on the current state of transdermal technology, and presentation of data from Avro’s transdermal systems, demonstrating passive delivery of non-ideal small molecules and biologics and fundamentally expanding the scope of drugs that may be eligible as transdermal patches. Shak Lakhani, CEO and Co-Founder, Avro Life ScienceEscape the Cold Chain with Elarex PT120 FormulationPreclinical in vivo evidence for stabilization of complex biologics at +40C will be presented. Elarex is seeking opportunities to apply this technology to Protein Therapeutics and Antibody Drugs.Robert DeWitte, PhD, Co-founder and CEO, Elarex, IncDelivery of Gene Therapy and Gene Editing with Polymer Nanoparticle GenEdit develops novel gene therapies based on non-viral and non-lipid based delivery. The company’s patented polymer nanoparticle (PNP) technology delivers a wide range of payloads, including RNA, DNA, protein, and/or ribonucleic acid-protein complexes. Our NanoGalaxy™ library of PNPs allows optimization of tissue- and cell-specific targeting.Hyo Min Park, Co-founder and CTO, Genedit

12:00 pmLunch and Partnering Meetings

12:45 pmChoice Between 2 Tracks

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Choice Between 2 Tracks AGENDA

Track A: Device & Injectable Panels

Track B: Formulation Panels

12:45 pm Unlocking the Potential of Gene Delivery SystemsGene therapies have the potential to cure disease or deliver long-term benefits to patients via a single-dose. In order to successfully deliver a gene therapeutic to the desired target, it is essential to have a safe and efficient delivery system. Numerous delivery vehicles are being explored such as viral and non-viral vectors, exosomes, liposomes, nanoparticles and novel biomaterials. Our panelists will discuss progress of these technologies and which demonstrate the greatest potential for long term success, and why (ease of manufacture, COGs, regulatory factors).Moderated by:Shawn Davis, PhD, Head of Drug Delivery, Biopharmaceuticals Development, AstraZenecaPanelists:PJ Anand, Founder, President and CEO, Alcyone Lifesciences, Inc.Joshua Horvath, PhD , Director, Device and Packaging Development, GenentechGabriele Proetzel, PhD, Director, Neuroscience External Research, TakedaGregory Stewart, PhD, Senior VP, Vector Delivery and Optimization, Axovant Gene Therapies

12:45 pm Long-Acting Injectables: Therapeutic Needs and Strategic ConsiderationsLong-acting injectables can increase efficacy and enhance compliance therefore a valuable option for treating chronic diseases. While many therapies can benefit from a long-acting formulation, there are therapeutic-specific requirements as well as strategic considerations that play a role in selecting the appropriate technology. Our expert panelists will render their opinion on needs and goals of long-acting formulations for multiple therapeutic categories such as HIV/infectious diseases, ophthalmic disease, autoimmune disorders, psychiatric disorders and pain management.• Ideal dosing/duration of delivery and rationale• Technology requirements (dose or volume minimum, reducing burst

release, removability or stopping drug delivery); small molecule vs. biologics

• Unmet needs with current formulations – what problems can a long-acting formulation solve?

• Cost considerations and expected value to patient and healthcare providers

Moderated by: Christopher A. Rhodes, PhD, President and CEO, Drug Delivery ExpertsPanelists:Nima Akhavein, PhD, Director, Drug Product Strategy, ViiV HealthcareRené Holm, PhD, Head and Scientific Director, Liquids & Parenterals, JanssenMatthew O’Brien, PhD, Drug Delivery and Technical Strategy Lead, PfizerHongwen Rivers, PhD, Director, Protein Delivery, Abbvie

1:15 pmTargeting the BBB: Innovations Making Progress in the Treatment of CNS DisordersA majority of available CNS therapeutics are symptomatic treatments, but a number of promising therapeutics are in development which aim to target and cure a disease. A key challenge however, is getting a sufficient dose across the BBB, using an efficient delivery system. In this session, leaders in the field will discuss progress being made with various approaches for effectively treating CNS disorders. The panel will also highlight clinical successes.Moderated by: Ann L. Daugherty, PhD, Senior Manager, Drug Delivery, GenentechPanelists:Mandana Borna, PhD, Scientist II, ASO Drug Product Delivery, BiogenMaria-Jesus Blanco, PhD, Senior Director, Medicinal Chemistry, Sage TherapeuticsNadine Ruderisch, PhD, Sr. Scientist II, Foundational Neuroscience Center, AbbvieDanica Stanimirovic, MD, PhD, Director, Translational Bioscience Department, Human Health Therapeutics Portfolio, National Research Council of Canada

1:15 pmKey Issues in Subcutaneous Drug Development & Delivery – Focus Areas of the Subcutaneous Drug Development & Delivery ConsortiumThe Subcutaneous Drug Development & Delivery Consortium seeks to address issues associated with subcutaneous drug development and delivery in a pre-competitive manner with the ultimate goal of transforming patient care and improving patient outcomes. Consortium members will discuss 8 critical development issues facing the industry today, how they are collaboratively working to address these issues, and how interested supporters can get involved.Moderated by:Renee Tannenbaum, PharmD, MBA, CSAP, Vice President of Global Partnering, Halozyme TherapeuticsPanelists:

Manuel Sanchez-Felix, PhD, Sr Fellow, Novel Delivery Technologies Group, Novartis

Dave Collins, PhD, Senior Research Fellow, Delivery Devices & Connected Solutions, Eli Lilly

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

Sachin Mittal, PhD, Executive Director, Merck

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



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Afternoon Plenary Sessions: Focus on Next Generation Therapies

2:20 pmConnected Drug Delivery Devices: Potential to Facilitate Disease Management in the Home SettingConnected drug delivery devices are increasingly being developed to support patient supervision and counseling in the home setting. Features may include dosing reminders, adherence trackers, tools for patient education, and patient diaries to collect patient-reported outcomes, as well as monitoring tools with interfaces between patients and health care professionals (HCPs). There is an initial evidence for a higher adherence to treatment and better outcomes among patients who use the electronic tools. Key barriers to the broader adoption of connected devices include data privacy laws that may prevent data sharing with HCPs in some countries, as well as the need to demonstrate that the tools are consistently used and generate a high-quality and reproducible database. If these challenges can be addressed in a way that is agreeable to all stakeholders, it is expected that the future value of connected devices will be to 1) facilitate and improve patient involvement in disease management in a flexible care setting, 2) enable early treatment decisions, and 3) complement value-based reimbursement models. Beate Bittner, PhD, Product Optimization Franchise Leader, Roche

2:40 pmConnected Health Devices: Key Success Factors & Lessons LearnedMore connected devices are launched every year: smart pill bottles, digital inhalers, connected auto-injectors, smart insulin pens, etc. Designed to improve patient engagement, increase adherence, and facilitate better communication among patients and health care providers, it is critically important to understand how well they are achieving these goals. Our panel of experts will discuss various digital products and technologies, share lessons learned and considerations for future products.

• Overview of peer-reviewed literature: what is and what isn’t working

• Product Development:• How did you choose features/functions?• What are the challenges in proving scientific and technical

validity of digital tools?• Are there technologies that deliver most of their value in clinical

trials but not in the commercial environment?• Commercial Products:• How important is it to understand the overall digital strategy of

a brand into which a technology must fit?• Evidence of increased patient adherence? Other important or

unexpected findings?• How have you approached support and lifecycle management

of your digital tools?Moderated byPaul Upham, Head, Smart Devices, Genentech/RochePanelists:Matthew Clemente, MBA, Vice President, Device Development, Device R&D, Novo NordiskKevin Deane, VP, Front-End Innovation and Connected Health, Phillips-MedisizeMark Milton-Edwards, MBA, Head of Health Solutions – Digital Health, Teva Pharmaceuticals Paul Schultz, Sr Director of Commercial Development, BrightInsight

3:15 pmBig Pharma’s Transition to Connected Health in 2020The Apple of the Pharma Industry is in the room and they don’t even know it! Based on insights from an anonymous Industry wide survey being conducted by EdgeOne Medical some surprising and not so surprising insights on how well Pharma is transitioning to connected drug delivery in 2020 will be shared.Jim McGough, Co-founder, EdgeOne Medical Inc.

3:35 pm Closing Remarks & Partnering Meetings ContinuePartnering Meetings Continue to 6:00pm EST

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Track A: Device & Injectable Panels Track B: Formulation Panels

1:45 pmOpportunities for Next Generation Injectable DevicesThis panel will discuss development and commercial opportunities associated with emerging technologies such as microneedle arrays, advanced needle technology, intradermal devices, and wearable injectors.• Dosing capacities and flexibility, potential for higher volume delivery• Pros and cons of intradermal and subcutaneous injectors• Ideal therapeutic targets: vaccines, autoimmune diseases, biologics• Value proposition and costs vs traditional PFSModerated by:Dhairya Mehta, Head of Drug Delivery, Drug Delivery Devices, TakedaPanelists:Uri Baruch, Head of Drug Delivery, Cambridge Design PartnershipNatasha Bolick, MBA, Associate Director, Parenteral Sciences Center of Excellence, BD Technologies & InnovationMatt Burke, PhD, Executive Director & Head of Pharmaceutical Sciences, Radius Health, Inc.Darin Zehrung, Global Program Leader, PATH

1:45 pmOral Protein & Peptide Delivery: Achieving Clinical Success and Exploring New OpportunitiesWith injectable delivery being the primary administration route for most proteins and peptides, there are vast opportunities to convert these drugs into more patient-friendly oral dosage forms. Though technical barriers are significant, innovative drug delivery strategies are being employed to deliver clinically-successful oral products, such as Rybelsus (oral semaglutide). Our panelists will discuss some of the latest advances and strategies in this space, as well as future outlook for oral proteins and peptides.Moderated by:Aktham Aburub, PhD, Research Fellow, Eli LillyPanelists:Annette Bak, PhD, Head of Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZenecaStephen T. Buckley, PhD, Director, Discovery ADME, Novo NordiskRandall Mrsny, PhD, Chief Scientific Officer, Applied Molecular TransportMargaret Faul, PhD, VP Drug Product Technologies, Amgen

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