10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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Partnership opportunities in drug delivery

october 8 - 9 • Virtual

ANNUAL

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

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10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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Srini Sridharan, PhD, Head, Materials Science & Engineering, BMS

Anand Subramony, PhD, Vice President, External Innovation & Novel Technologies, AstraZeneca

11:15 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 & Evaluation

Ferring PharmaceuticalsJanet Halliday, PhD, Associate VP, Ferring Controlled Therapeutics & External Technology

11:45 amThe 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

12:10 pmLunch Break

1:00 pm - 3:00 pmDrug Delivery Technology PresentationsChocie Between 3 Tracks

DAY ONE - THURSDAY, OCTOBER 8TH, 2020

9:00 amA Year in Review and PODD WelcomeBarbara Lueckel, PhD, Global Head of Research Technologies Partnering,Roche Pharma Partnering

9:30 amAnnual Keynote Fireside DiscussionRobert Langer, PhD, David H. Koch Institute Professor, MITHosted withRon Cohen, MD, Founder, President and CEO, Acorda Therapeutics

9:50 amIndustry CEO Keynote on the Story of Inbrija®Ron Cohen, MD, Founder, President and CEO, Acorda TherapeuticsHosted with Robert Langer, PhD, David H. Koch Institute Professor, MIT

10:10 amScientific KeynoteSangeeta Bhatia, MD, PhD ohn J. and Dorothy Wilson Professor of Engineering; Director, Laboratory for Multiscale Regenerative Technologies, MIT

10:30 amMorning Break

10:45 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 drug delivery partnering, addressing questions such as:

• Is there more emphasis on “product enabling” or “product enhancing” technologies?

• How often are drugs in development modified to make them more stable for long-acting delivery?

• What is the ratio of internal technology development vs external partnering to access novel delivery technology?

• What are the key drivers for considering drug delivery technologies in life cycle management?

• Does patient advocacy play a role in motivating pharma companies to incorporate a delivery technology in the final marketed product?

• What role do Brand Managers play when considering a delivery technology for life cycle management?

Q&A with the audience

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

Johannes Schmidt, PhD, Global Head Product Optimization, Roche

10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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Track 1A: Injectable Formulation Technologies

Companies will present technologies to improve the formulation and delivery of injectable drugs. Examples of technologies presented: sustained release microspheres, nanoparticles, and enabling technologies for high volume drugs.

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

Presenting Companies:HalozymeOakwood LabsInnocore

Companies will present injectable drug delivery devices including pre-filled syringes, novel vial and syringe systems, pens and auto-injectors.

Chaired by:Ulrich Bruggemann, Head, Academics and Innovation, Global Medical Devices, Takeda

Presenting Companies:Credence MedsystemsGerresheimerSMC LtdStevanato Group

Track 2A: Non-Injectable Technologies

Companies will present non-injectable/non-invasive delivery technologies such as oral, mucosal, transdermal, ophthalmic, and pulmonary technologies. Examples of technologies presented: oral modified release systems, mucoadhesive dosage forms, and nanoparticles.

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

Presenting Companies:BDD PharmaHarro Hofliger

Companies will present a range of novel formulation technologies such as those offering site-specific delivery, extended release and improved solubility. Examples of technologies presented: bioerodible implants, transdermal systems, and ophthalmic technologies.

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

Presenting Companies:Battelle

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

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

Chaired by:Dhairya Mehta, Head, Connected and Software Medical Devices, Takeda

Presenting Companies:BD MedicalBIOCORPCambridge Design Partnership – unclear participationEnable InjectionsNeumaPhillips-MedisizePortal InstrumentsSonceboz

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

Chaired by:Courtney Nicholas, Manager, Combination Product New Technologies Management, Regeneron Pharmaceuticals

Presenting Companies:Sensile MedicalSorrel MedicalKey TechCommon SensingXimedica

Track 1B: Pre-Filled Syringes, Auto-Injectors and Similar

Track 2B: Novel Injectable & Non-Injectable Technologies

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

3:00 pmPartnering Meetings and Virtual Group Meetings Begin

5:30 pmDay One Concludes

10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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DAY TWO - FRIDAY OCTOBER 9TH, 2020

8:45 amChair’s Opening RemarksShawn Davis, PhD, Head of Drug Delivery, Biopharmaceuticals Development, AstraZeneca

9:00 amIndustry Fireside ChatMahesh Chaubal, PhD, Vice President, R&D, Baxter

9:30 amPatient Panel: Understanding the Patient Perspective on Treating Chronic Illness and Self-Injecting TherapeuticsNitika Chopra, a patient with psoriasis and psoriatic arthritis

Megan Starshak, an inflammatory bowel disease (IBD) patient

9:50 amMorning Break

10:15 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, Pfizer

11:00 amIndustry Fireside ChatJerry Murry, PhD, Senior VP, Process Development, Amgen

11:45 amPartnering Meetings

12:30 pmLunch Break

1:00 pmChoice Between 2 Tracks

Track A: Device & Injectable Panels

Track B: Formulation Panels

1:00 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:Manuel Sanchez-Felix, PhD, Sr Fellow, Novel Delivery Technologies Group, Novartis

Advait Badkar, PhD, Senior Director, Novel Delivery Technologies, BioTherapeutics, Pfizer

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

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

Renee Tannenbaum, PharmD, MBA, CSAP, Vice President, Global Alliances, Halozyme Therapeutics

1:00 pmLong-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

Nima Akhavein, PhD, Director, Drug Product Strategy, ViiV Healthcare

René Holm, PhD, Head and Scientific Director, Liquids & Parenterals, Janssen

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

Hongwen Rivers, PhD, Director, Protein Delivery, Abbvie

Choice Between 2 Tracks

10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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Track A: Device & Injectable Panels

Track B: Formulation Panels

1:30 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 by:Paul Upham, Head, Smart Devices, Genentech/RochePanelists:Beate Bittner, PhD, Product Optimization Franchise Leader, RocheKevin Deane, VP, Front-End Innovation and Connected Health, Phillips-Medisize

1:30 pmOral Protein & Peptide Delivery: Achieving Clinical Success and Exploring New Opportunities

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

2:00 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 PFSNatasha Bolick, MBA, Associate Director, Parenteral Sciences Center of Excellence, BD Technologies & InnovationDarin Zehrung, Global Program Leader, PATH

Additional speakers TBA

2:00 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:Maria-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

Choice Between 2 Tracks

10TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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Afternoon Plenary Sessions: Focus on Next Generation Therapies

2:30 pmAdvancing RNAi Therapeutics: the success and learnings from Onpattro® and Alnylam’s platform delivery technologies

Muthiah (Mano) Manoharan, PhD, Senior Vice President of Drug Innovation Chemistry, Alnylam Pharmaceuticals, Inc

2:50 pmUnlocking 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).

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

Gabriele Proetzel, PhD, Director, Neuroscience External Research, Takeda

Gregory Stewart, PhD, Senior VP, Vector Delivery and Optimization, Axovant Gene Therapies

Additional speakers TBA

3:20 pmClosing Remarks

3:20 pm - 4:30 pmPartnering Meetings

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