Day One Recap – October 17, 2018
Organized and presented by the Conference Forum, a life science industry research firm, the 8th annual PODD is all about the latest drug delivery technologies and insights. PODD provides opportunities for pharma and biotech formulators and business development professionals to establish partnerships to help solve delivery challenges and find new partners with the drug delivery industry. The main themes of the 2018 conference were high volume subcutaneous drug delivery, collaboration within the drug delivery space, and digitally-enabled drug delivery systems. See below for day one highlights:
Drug Delivery Approvals and Partnerships Year-in-Review
The first day of PODD began with conference chair, Barbara Lueckel, PhD, Global Business Development Director, Roche Partnering Innovation, Roche, who presented the latest approvals and partnerships within the past year, as well as insights on the current state of the field. Notable trends include a steady rise in the use of cell and gene therapies, a focus on the usage of small molecules, and a rise in partnerships between pharma and drug delivery companies, as well as between drug delivery companies themselves. Advances and approvals in the past year include the first siRNA therapy, the first gene therapy for IRD, the first peptide receptor radionuclide therapy, and the first “digital pill” with an ingestible event marker sensor to track adherence. She ended by highlighting a new partnership between Portal and Takeda creating a subq needle-free injector with an internal feedback system and cloud connectivity.
Fireside Chat with Dr. Robert Langer and Amy Schulman
Robert Langer, PhD, David H. Koch Institute Professor, MIT and Amy Schulman, Co-Founder and CEO, Lyndra and Partner, Polaris Partners joined Dr Lueckel for a fireside chat in which they discussed how an idea gets carried from academic innovation in the lab to a clinic through the drug development process. They stressed the importance of beginning with an integrated approach that looks at aspects such as intellectual property and launch specifics from the beginning, rather than first approaching the science and later dealing with the logistics. Based on her experience, Ms Schulman mentioned that, “the ideal partnership starts with candor, deep collaboration, and mentorship, while being unabashedly yourself.”
Stories from Bioinspiration to Innovation
The first keynote of the conference was from Jeffrey Karp, PhD Professor of Medicine, Harvard Medical School and Director of the Laboratory for Accelerated Medical Innovation, Brigham and Women’s Hospital, who explained his principle of bioinspiration: taking a basic idea from nature and improving on that idea for one’s own purposes, allowing an approach that allows scientists to break out of the conventional mold. He presented clinical examples currently in development, such as using tissue glue from snails as a sealant and using small molecules from gut epithelium to regenerate progenitor cells within the inner ear. He left the audience with the advice to embrace radical simplicity – thinking about all aspects of the development spectrum with an aim for simplicity at all steps.
Pharma’s Perspective on Partnering
The morning continued with a panel moderated by Ronald L Smith, PhD Scientific AVP, Pharmaceutical Sciences, Merck Research Laboratories, that included a variety of different business development and technology assessment professionals, including:
James Cunningham, PhD, Executive Director, Drug Delivery, Allergan
Dan Groszmann, PhD, Principal Engineer, Device Technologies Innovation Center, Amgen
Barbara Lueckel, PhD, Global Business Development Director, Roche Partnering Innovation, Roche
Imran Nasrullah, MS, JD, Director, Strategic Partnering, BD&L, Boehringer Ingelheim Pharmaceuticals
Terry Reed, Director, Business Development, AstraZeneca
The panel discussed the necessity of cross-disciplinary partnering for the future of science and a key way to bring innovations into organizations. After discussing several examples of partnerships within their organizations, the panel concluded that the key to a successful partnership is a champion – a person who can challenge the system and keep the organization energized despite facing obstacles.
High Volume Subcutaneous Drug Delivery
The next panel, moderated by Cindy Atwell, Senior Director, Business Development and Strategy, Halozyme, focused on a hot topic within the field, high volume subcutaneous drug delivery. The panel discussed general trends focused around improving the patient experience through high volume subq, making it more convenient to the patient and less cumbersome and time-consuming. However, there are several challenges to this approach, such as regulatory considerations, device design, and most importantly, determining the value of this technology for the payers and stakeholders. This panel included several interesting insights from:
Nancy Barbour, PhD, VP, Drug Product Science & Technology, BMS
Chris Coletta, PhD, Drug Delivery Technology Expert, Coactuate
Shawn Davis, PhD, Head of Drug Delivery, Medimmune
Robert Epstein, MD, CEO, Epstein Health
Peter Quinn, Platform Leader – Wearable Injection Systems, BD Medical-Pharmaceutical Systems
Johannes Schmidt, PhD, Global Head, Product Optimization, F. Hoffmann-La Roche Ltd
Drug Delivery Pipeline Year in Review
Another year in review was presented by Kurt R Sedo, VP Operations, PharmaCircle, specifically showcasing innovative technologies currently in the pipeline. Kurt began his talk by explaining that injectables are taking over the market, with a focus on the delivery of high volume or viscous biologics, with approximately 45% of current VC funding in the field being directed to injectable companies. There is also significant investigation of rapidly disintegrating formulations within oral delivery and a focus on dry powder inhaler combinations.
Drug Delivery Technology Tracks
After the general sessions, the conference split into three main tracks that focus on drug delivery devices, injectable technologies, and non-injectable technologies.
Track 1: Injectable Formulations & Device Technologies
This track included presentations on technologies that are aimed to improve the formulation and delivery of injectable drugs. The first half of the track was moderated by Michael Cucolo, Director of Business Development, BMS, and the second half was moderated by Nima Akhavein, PhD, Associate Fellow and Scientific Leader, GSK. Presentations included:
Enable Injections: on-body delivery devices that enable self-administration of high volume and high viscosity therapeutics.
Innocore Pharmaceuticals: a biodegradable polymer platform for development of long-acting injectable sustained release formulations for biological therapeutics.
Halozyme Therapeutics: ENHANZE® technology that enables optimization of subcutaneous drug delivery and facilitates translating intravenous compounds to subcutaneous.
Evonik Corporation: “product-by-process” scale up, the criticality of process parameters, and other considerations when it comes to developing complex parenteral devices.
Datwyler: innovations within the manufacturing of parenteral packaging components that aims to reduce defects.
Cureport: a liposomal-based drug delivery technology to improve pharmacokinetics and reduces toxicity, by replacing the pre-existing lipid extrusion process.
InnoMedica: a novel liposome platform that affects biodistribution, ameliorating therapeutic effects and reducing side effects within oncology and neurology.
Adocia: a polymer technology that optimizes solubility and stability of biomolecules, addressing formulation and administration challenges.
Serina Therapeutics: a non-immunogenic polymer that provides continues drug delivery for small molecule and proteins via subcutaneous delivery.
DelSiTech: a biodegradable silica matrix for extended release of biologics, focusing on peptide and protein delivery.
Gerresheimer Regensburg GmbH: small batch product to speed product for small and niche products, such as laser drilling of transparent medical materials.
Nanexa: a platform that covers drug particles with extremely thin shells of slowly dissolving inorganic materials, enabling parenteral depots with low frequency and high drug loads.
Interface Biologics: an intravitreal drug delivery system to release a constant low dose of dexamethasone without the use of a carrier polymer.
Ocular Therapeutix: intracameral and intravitreal hydrogel inserts with sustained release for up to 90 days.
Congruence Medical Solutions: an ocular-specific injector with a microliter dosing system that integrates with standard pre-fillable syringes.
Track 2: Non-Injectable Technologies: Oral, Mucosal, Transdermal, Ophthalmic, and Pulmonary
This track included presentations on technologies for a variety of alternative routes of administration, such as oral, mucosal, transdermal, ophthalmic, and pulmonary. The first half of the track was moderated by Manuel Sanchez-Felix, PhD, Senior Fellow, Novel Delivery Technologies / Chemical and Pharmaceutical Profiling, Novartis Institute for BioMedical Research, and the second half was moderated by Ann L Daugherty, PhD, Senior Manager, Drug Delivery, Genentech. Presentations included:
leon-nanodrugs GmbH: a continuous nanoprecipitation technology platform for a variety of different APIs that addresses the key issue of poor water solubility.
Adare Pharmaceuticals: technologies to improve the targeted biopharmaceutical performance of controlled release formulations.
Aquestive Therapeutics: oral soluble films (lingual, sublingual, and buccal) with rapid disintegration and high bioavailability.
Recro Gainsville: technical formulation differences between immediate release and modified release solid oral formulations, and how to address the a change between the two.
BDD Pharma: an erosion-based controlled release technology that provides controlled drug release at a pre-defined time with no release of drug prior to a pulse.
Lyndra: long-acting oral pills demonstrating gastric residence with delivery for up to a week, reducing dose frequency and improving patient compliance.
Matinas BioPharma: a lipid nano-crystal technology to encapsulate biologics, improving safety, tolerability, toxicity, and bioavailability.
Ileo Science: an oral nanotechnology platform that layers bile salts around the API to promote absorption via the distal small intestine, with delivery to the lymphatic system.
Pharmaero: an aqueous droplet inhaler for large volume products that has a lung deposition up to 5 times higher than a jet nebulizer.
Exicure: a topically applied antisense molecule for gene regulation, with feasible clinical results in mouse models using a topical anti-IL17R.
QPharma AB: specialty controlled-release polymeric devices, including vaginal rings, intrauterine systems, and subdermal implants.
Intract Pharma: a platform that allows conversion of injectable antibody therapeutics into oral pills, with targeted delivery to the proximal colon using entering coating technology.
4P Therapeutics: transdermal technologies that incorporate a taste aversion technology to deter opioid abuse with fentanyl patches.
Harro Hofliger Verpackungsmaschinen GmbH: focusing on interactions between the device, formulation and filling technology for dry powder inhalation formulation.
Daré Bioscience: a non-hormonal vaginal ring for pregnancy prevention, as well as an intravaginal ring technology for sustained drug delivery over time.
Track 3: Device Technologies
This track included presentations on novel delivery devices, such as needle-free delivery devices, auto injectors, and digital health technologies. The first half of the track was moderated by Ulrich Bruggemann, Head Academics and Innovation, Global Medical Devices Development, Sanofi, and the second half was moderated by Mathias Romacker, Senior Director, Device Strategy, Pfizer. Presentations included:
BD Medical: a pre-filled manual injector that addresses current patients’ desire for a higher level of manual control and sophistication.
Bespak: a nasal delivery device that be customized to suit application-specific patient populations and needs.
Credence MedSystems: a dual chamber reconstitution syringe for lyophilized drug products that enable injection of biologics at home.
Cambridge Design Partnership: a research platform that turns user insights and unmet needs into a user-centered design to transform the patient’s ecosystem.
BIOCORP: considerations in making digital delivery devices successful, by looking at all stakeholders, including pharma, the payers, and patients.
Sensile Medical: a rotary piston pump that delivers small volume increments precisely and consistently over time, increasing dose accuracy.
Phillips-Medisize: creating a low-cost connectivity technology platform that will integrate higher volume drug delivery devices.
Portal Instruments: a needle-free injector that automatically collects injection data and offers immediate patient support.
Vernay in partnership with Quantex: a driver platform for micro pumps that feature Bluetooth connectivity and a web portal to gather infusion data.
Common Sensing: a removable cap that allows monitoring of disposable injector pens, allowing adherence and ease to the patient.
Altaviz: an autoinjector that enables the injection of high viscosity formulations in a short period of time.
Cureport: a liposomal-based drug delivery technology to improve pharmacokinetics and reduces toxicity, by replacing the pre-existing lipid extrusion process.
Sorrel Medical: a wearable drug delivery system that efficiently delivers large volume and high visocity drugs.
Ypsomed: a push-on-skin autoinjector with Bluetooth-based wireless tracking of injection and adherence.
Battelle: a controllable-force autoinjector technology that employs a single spring to deliver fluids with reduced insertion impact force.
Ichor Medical: a delivery system that use electrical fields to increase nucleic acid delivery efficiency up to 1,000-fold as compared to conventional injection.
The first day of PODD also included partnering meeting through out the day a rich exhibit hall of a wide range of drug delivery technologies and concluded with a networking reception.
Day Two Recap – October 18, 2018
Organized and presented by the Conference Forum, a life science industry research firm, the 8th annual PODD is all about the latest drug delivery technologies and insights, while providing opportunities for pharma and biotech formulators and business development professionals to establish partnerships to help solve delivery challenges and find new partners with the drug delivery industry. The main themes of the 2018 conference were high volume subcutaneous drug delivery, collaboration within the drug delivery space, and digitally-enabled drug delivery systems. See below for day two highlights:
Industry Keynote: Harnessing the Digital Exhaust
The featured industry keynote at PODD was given by Justin M. Wright, PhD, Global Head of Innovation, Novartis. In his keynote, Dr Wright analyzed the current state of the business pharma model and the need to shift to focusing on the consumer experience. Dr Wright advocated for new metrics to quantify this experience, such as trust, friction to value, and transparency. He explained how these values should guide the future of digital health and drug delivery, “When we think about patients receiving medication, it’s a very intimate moment between us and them. As we build these systems for patients, are we taking the patients’ preferences into account? It’s not a one-size-fits-all approach.” Dr Wright concluded by describing how the traditional axis of “outcomes” is now replaced with “engagement and experience,” and that the next steps for the field are to improve access for all instead of creating disparities.
The Pediatric Patient Perspective
Following the patient focused precedent set by Dr Wright; PODD brought a patient advocate to give the patient perspective on drug delivery. Cornell Stamoran, PhD, VP of Corporate Strategy and Government Affairs, Catalent Pharma Solutions sat down with Alex Rinaudo, Patient Advocate, who has a 5 year old son with type 1 diabetes. Alex explained his daily routine for caring for his son, as well as challenges surrounding his son’s care experience, such as managing different types of technology, caregiver handoffs, and overall tracking of sugar and insulin levels. Alex advocated that, “Small changes that smooth out the patient experience may not seem super exciting to developers, but they make a huge difference in the caregiver experience.” He believes understanding how to improve drug design for patients begins with an understanding of the patients themselves.
Digital Health: Paradox or Paragon?
The first panel of the day, moderated by Dhairya Mehta, Director, eHealth & Connectivity, Medical Device & Combination Products, Shire, discussed the hot topic of digital health, as well as implementation challenges and strategic approaches to execution. Dhairya was joined by these panelists:
Supriya Lagu, PhD, Director, Digital Health Technology, Biogen
Cliff Lee, Head of Digital Health, Flex Digital Health
Paul Upham, Senior Principal, Smart Device Technology Center, Roche/Genentech
Neil Williams, Director Front-End Innovation, Head of Connected Health, Medicom Innovation Partner Ltd, a Phillips-Medisize Company
The panelists discussed how some of their respective companies are working with behavioral scientists to explore the patient experience and find ways , understanding that there is a need for ways to motivate patients to continue usage. One perspective from the panel was the idea that the healthcare providers themselves should be creating apps, rather than pharma and device companies bringing apps to patients. Dr Lagu left the audience with a thought-provoking quote, “We need to understand and map the patient journey and then find the gaps, rather than trying to replicate many solutions.”
Maximizing the Value of Collaboration for Novel Device Design
Next was a presentation by two industry professionals who laid out their guidelines for successful collaborations. Doug Boyd, PE, PMP Manager, Medical Devices and Health Analytics, Battelle and Gary Henniger, Senior Director Global Device R&D Operations, Teva gave the audience actionable points for collaboration, such as maintaining a potential partner database across disciplines, highlighting clear objectives within the RFP, and engaging all levels from project leads to senior management. Mr Boyd and Mr Henniger explained that the very foundational level, the key for a successful partnership is a culture fit between the two organizations.
8th Annual Company Spotlights
In this annual session, four leading pharmaceutical companies are invited to discuss their current needs, scouting interests, and partnership philosophies.
Advait Badkar, PhD, Senior Director, Novel Delivery Technologies, BioTherapeutics, Pfizer explained that Pfizer’s pipeline is currently focused on small molecules and biologics, a shift from the prior focus on only small molecules. Pfizer is currently investigating a patient-focused drug delivery approach that focuses on portfolio-level choices that will make the greatest impact for customers.
Grégoire Schwach, PhD, Head of Drug Delivery, F. Hoffmann-La Roche Ltd discussed the collaborative work happening between PTDE (Roche, Europe) and gRED (Genentech, USA), with a current focus on biologic development. Current investigations include a long-acting delivery system for age-related macular degeneration and viscosity reduction technology for overcoming subq volume limitations.
Srini Sridharan, PhD, Head, Materials Science & Engineering, Bristol-Myers Squibb mentioned BMS’ primary focus areas as oncology, cardiovascular, immunoscience, and fibrotic diseases. He stated that BMS is currently investigating customized delivery technologies like orals and injectables suited for their needs, and are currently looking for long-term collaborative relationships within the space.
Simon Todd, Science and Innovation Lead, AstraZeneca elaborated on the role of AstraZeneca’s Innovation Strategy and External Liaison (ISEL) team to support their pipeline to increase value contribution and presented a new device to deliver their Symbicort product that features Bluetooth connectivity and a smartphone app. AstraZeneca is currently looking for partnerships in autoimmunity, infection, and neuroscience.
DDS Technology Soapbox @ PODD
A highlight of the PODD conference is the DDS Technology Soapbox, where several start-up entrepreneurs, inventors, licensing officers, and university researchers have five minutes to present their cutting-edge technologies, innovations, and ideas. This year’s Soapbox was moderated by Patrick Lim Soo, PhD, Senior Principal Scientist, Novel Delivery Technologies, Pfizer.
Presenting companies included:
Cam Med LLC (Larry Alberts, Co-Founder and CEO) – an electrochemical, small patch pump, Evopump, with multiple reservoirs for different medications that enables improvements in cost, efficiency, and control.
Cinti Medical (Alex Wasson, CEO) – a novel injection device, SureMix, that includes automated mixing of lyophilized drugs, eliminating the challenges patients and caregivers face in preparing and administering solutions.
Consegna Pharma (Larry Zana, President and CEO) – a predictive modeling algorithm to develop long-acting injectables and predict both in vitro and in vivo activity.
Wyss Institute (Frank Bobe, PhD, Entrepreneur-in-Residence) – using microfluidic emulsion drop template to tune release kinetics for biologic drugs, enabling a higher precision of dosage.
Better Sense (Shanglin Yang, Founder) – using blockchain, ioT and AI to integrate methodology for home infusion prescription, monitoring, and adherence.
Massachusetts General Hospital (Ganesh Shankar, PhD, Attending Neurosurgeon) – operative genotyping for rapid molecular characterization of glioma, OperaGen, and using microparticle therapy targeted towards the same mutations.
SiNON Therapeutics (Afreen Allam, Founder and CEO) – a molecular platform, Carbon Dot, that acts as a trojan horse to cross the blood-brain barrier using passive diffusion, reducing dosage required.
Disruptive New Models for Advancing Drug Delivery
Rosemarie Truman, Founder and CEO, The Center for Advancing Innovation was joined by a panel consisting of Eric Elenko, PhD, Chief of Research and Strategy, PureTech Health, Kristen C Kosofsky, Senior Managing Director, Life Sciences, Hercules Capital, Scott E Weiner, MBA, Partner, Pappas Capital who discussed game-changing models of commercialization that can accelerate the development of early stage drug delivery technologies. The panel provided the key insight of finding a demonstrated, commercial value for the platform and maximizing that value to ensure that promising breakthrough technology does not hit a wall within the economics of the healthcare system.
Delivering mRNA Drugs and Vaccines
Investigating a promising alternative to conventional drug delivery approaches was a panel focusing on mRNA design and delivery as both a drug and a vaccine. The panel emphasized the advantages of using mRNA as personalized cancer vaccines, such as scalability and repeat dosage without driving a response to the vaccine. The panelists all agreed that the biggest selling point of mRNA is rapid design and optimization. They mentioned that several collaborations are booming within the oncology discovery space surrounding mRNA, but there are considerations with CMC that must be looked at as the space grows.
The panel featured:
Moderator: Marian Gindy, PhD, Executive Director, Discovery Pharmaceutical Sciences, Merck
Örn Almarsson, PhD, Head of Formulations, Moderna Therapeutics
Danilo Casimiro, PhD, VP & Head, External R&D and Vaccine Platforms, Sanofi
Christian W Mandl, PhD, Chair / Co-founder, Scientific Advisory Board / Tiba Biotech
Jinjun Shi, PhD, Associate Professor / Faculty Member, Harvard Medical School / Center for Nanomedicine at Brigham and Women’s Hospital
Sybil Williams, PhD, Senior Principal Scientist, Personalized Cancer Vaccines Biology Lead, Merck
Innovations and Advances in Protein and Peptide Drug Delivery
The final panel of the conference turned everyone’s attention to the latest in protein and peptide delivery. The majority of the panel was spent looking at big-picture trends within the space and how to move forward. The key takeaway was to look first at patient insights before creating a new drug delivery paradigm and the necessity to integrate patient opinion as early as possible in the manufacturing possible. At the end of the day, efficacy and safety are the highest value drivers for payers, so that must be taken into account as well.
This panel, moderated by Ann L Daugherty, PhD, Senior Manager, Drug Delivery, Genentech, featured:
Mark Currie, PhD, SVP, Chief Scientific Officer, and President of R&D, Ironwood Pharmaceuticals
Mohamed E H ElSayed, PhD, Research Fellow, BioTDR Formulation & Delivery, Eli Lilly and Company
Adam Mezo, PhD, Senior Director, Head of Molecular Design, Ferring Research Institute, Inc
Douglas P Nesta, PhD, Sr. Director, Biopharmaceutical Product Sciences, GSK
Julia Rashba-Step, PhD, VP, Research & Development and Alliance Management, Phosphorex
The Role of Digital Biomarkers in the Future of Drug Delivery
The final presentation of the conference Christopher Kovalchick, PhD, Chief Engineer, Drug Delivery & Devices R&D Innovation, Eli Lilly and Company, who elucidated on the role of digital biomarkers and the need to create composite biomarkers that involved intrinsic and external factors to get a deeper perspective over disease management and overall wellness, as compared to simply direct physiological metrics. Christopher advocated that contextualized composite data will cause a shift from disease management to prevention and on the large scale, population health.
For information on either participating or attending the 9th annual PODD event, please email us at firstname.lastname@example.org or call 646-350-2580.