Speakers

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Lovisa Afzelius is an origination partner at Flagship Pioneering. A computational scientist by training, she brings to Flagship two decades of leadership experience in emerging biotechs and large pharma companies, and a passion for data-driven drug discovery. Dr Afzelius has served as CEO, co-founder, president, board chairman and executive director in emerging biotech and large pharma companies. She joined Flagship in early 2020, leading innovation as co-founder and founding CEO of Alltrna, Apriori Bio, Metaphore Biotechnologies and Prologue Medicines. Before joining the Flagship ecosystem, Dr Afzelius built and led Pfizer’s systems immunology function and served as executive director of clinical programs. In 2017, she co-founded Elsa.science, a digital health company for which she serves on the board. Dr Afzelius began her career at AstraZeneca and has received numerous accolades for her work, including being named one of the 100 “most influential persons under 40 in Sweden” by the business magazine, Affärsvärlden. In 2022, Dr Afzelius, was named one of the 20 women blazing trails in biopharma Endpoints for her work with companies using AI and machine learning to advance drug development. In 2023, Apriori Bio was named a Technology Pioneer by the World Economic Forum and received an honorable mention for Fast Company’s World Changing Ideas list in the Rapid Response category. Apriori’s co-founder and CEO, including at Apriori. She holds a PhD in computational chemistry from Uppsala University, a Master of Science in integrative pharmacology from Gothenburg University as well as an MBA from MIT.

Vikram Agarwal completed his PhD in Dr David Bartel's lab at the Massachusetts Institute of Technology, where he utilized computational approaches to study the principles of microRNA targeting. He completed his post-doctoral research in Dr Jay Shendure's laboratory at the University of Washington, where he applied deep learning methods and massively parallel reporter assays to investigate the mechanisms of transcriptional gene regulation. Transitioning into industry, Vikram worked at Calico Life Sciences LLC, an Alphabet company whose mission is to better understand the mechanisms underlying human aging. There he applied deep learning methods with Dr David Kelley to better understand transcriptional and post-transcriptional gene regulation as well as its link to human genetics. He is currently the Head of mRNA Platform Design Data Science at the mRNA Center of Excellence at Sanofi, where his team is applying machine learning and deep learning methods towards the design of enhanced mRNA therapeutics.

Ludwig Erik Aguilar, PhD, is a researcher and expert in the field of Biomaterials and Nanotechnology with a profound passion for advancing medical technologies. Growing up in the Philippines, he pursued his BSc in Nursing at Bulacan State University, which laid the foundation for his deep understanding of the healthcare industry. Driven by an insatiable curiosity, Dr Aguilar pursued further education in South Korea, obtaining his MSc and PhD degrees in Bionanosystem Engineering from Jeonbuk National University. Throughout his academic journey, he focused on the design and synthesis of cutting-edge nanobiomaterials, including nanoparticles, nanofibers, and nanocoatings, primarily for drug delivery and medical device applications. His research has been recognized by the scientific community, with over 20 peer-reviewed academic papers and an internationally published scientific textbook titled “Biomaterial Science, Anatomy, and Physiology Aspects.” Leveraging his clinical and biomaterials background, Dr Aguilar possesses invaluable insights into the development of biomaterials that are both safe and highly effective when deployed within the human body. His expertise led him to serve as an Assistant Research Professor at Jeonbuk National University, where he also taught anatomy and physiology at the graduate school of engineering. Currently, Dr Aguilar holds the position of Senior R&D Engineer at Novo Nordisk A/S, where his research is dedicated to revolutionizing drug delivery devices.

Scott Ariagno is Vice President of Engineering and Development Services at EdgeOne Medical and has over 25 years in medical device and combination product design, development and manufacturing. His expertise includes development and global launch of various single-use, disposable medical devices, infusion systems and combination products, strategic/technical development of device platforms and IP development. Throughout his career, he has held management roles in engineering including heading device development and external manufacturing at Shire (now Takeda). Mr Ariagno is a named inventor on over 20 patents and applications. Mr Ariagno has Bachelor of Science in Mechanical Engineering from Bradley University and a Master in Engineering Management from Northwestern University.

Dr Isabelle Aubert works as a Senior Scientist at Sunnybrook Research Institute, Professor and Co-Vice Chair of Wellness, Inclusion, Diversity, and Equity in the Department of Laboratory Medicine and Pathobiology at the Temerty Faculty of Medicine, University of Toronto. She holds a Tier 1 Canada Research Chair in Brain Repair and Regeneration, and she is an elected Fellow of the Canadian Academy of Health Sciences. She obtained her PhD in neurosciences, on brain plasticity in aging and neurodegenerative diseases, at McGill University in the Department of Neurology and Neurosurgery. As a Medical Research Council of Canada fellow, Dr Aubert completed her post-doctoral training on regenerative gene therapies for the brain at the Salk Institute for Biological Studies. Dr Aubert has over 30 years of expertise in regenerative gene therapies for the aging and diseased brain. At Sunnybrook, she leads the Brain Repair Group in evaluating the impact of focused ultrasound and blood-brain barrier modulation for the delivery of therapeutics to the brain, and on the plasticity of molecular, cellular and cognitive systems in animal models. Through collaborative work, Dr Aubert and team members are developing molecular, cellular and gene therapies that can halt neurodegeneration and promote regeneration, particularly when combined with magnetic resonance image-guided focused ultrasound in preclinical models of neurodegenerative disorders, specializing in Alzheimer’s disease.

Annette Bak, Ph.D., MBA leads Advanced Drug Delivery at Astra Zeneca and serves on the Pharmaceutical Sciences leadership team. Advanced Drug Delivery has the mission to transform diverse modalities, small molecules and new modalities alike, into investigational medicines and is a global organization based in Sweden, UK, and US.

Since joining AstraZeneca in 2016, Annette has been instrumental in delivering new modality formulations for clinical studies, notably VEGF mRNA for cardiac regeneration, building intracellular drug delivery capabilities, and sponsoring initiatives on augmenting drug discovery with artificial intelligence. 

Annette previously worked for Amgen and Merck in the US with responsibility for small molecule and peptide formulations, building outsourcing partnerships in China, in licensing and partnership evaluations, and contributing to getting small molecule therapies to the market.

Annette has published more than 40 articles, has more than 35 invited presentations, and serves on the editorial board for the Journal of Pharmaceutical Sciences. She holds several patents for pharmaceutical technologies enabling drug delivery of small molecules and biologics.

A key volunteer in American Association of Pharmaceutical Scientists (AAPS). She is the President for the association and responsible for leading implementation of  the 2021-2025 strategic plan and ensuring that the AAPS communities are thriving. Annette was the 2020 co-recipient of the AAPS Alice E Till Women in Pharmaceutical Science Recognition, honoring women who has made significant contributions to the to the mentorship, advancement, and support of women in the pharmaceutical sciences

Tony Bedford is a Commercial Director at Phillips-Medisize and has been involved in the design and development of medical devices for over 25 years. He is part of a global team developing industry-leading solutions and platforms for drug delivery, digital medicine, and connected health. With a First Class Honours Degree in product design, his broad experience covers everything from innovation and market strategy to clinical research and product launch, with a focus on understanding market, stakeholder and user needs. Prior to joining Phillips-Medisize he held project management and business development roles in the consulting industry, working on a wide range of device programs. He has been specializing in drug delivery devices for a number of years.

Whitney Beysselance Moro joined Evonik as part of the acquisition of the LACTEL® Absorbable Polymers line in 2021. She is currently the Director of Strategic and Technical Marketing for Evonik’s Parenteral Drug Delivery Solutions business. Prior to the acquisition, Dr Moro served as the Director of Scientific and Technical Operations for the Lactel group within DURECT Corporation. In this capacity, she was responsible for managing the analytical testing and development for all LACTEL products, developing and optimizing manufacturing and purification processes for new products (including glucose star polymer), and bridging the gap between technical and customer support for new and existing clients. Dr Moro obtained her PhD in organic medicinal chemistry from the University of Alabama in Birmingham (UAB), USA, which was followed by postdoctoral training at UAB in the discovery of small-molecule antibacterial drugs with activity against novel therapeutic targets for the treatment of biowarfare agents

Sherri Biondi joined AstraZeneca in March 2018 and is Head of Device Development. She is responsible for parenteral drug delivery devices including early stage technology selection, development and late stage scale-up for commercial manufacturing. Currently, her group is developing products such as prefilled syringes, autoinjectors, on-body delivery systems, and pen injectors as well as a range of new technologies to meet the AstraZeneca pipeline needs. Prior to working at AstraZeneca, Dr Biondi was Director of Device Development at Genentech and Director of Product Development at Alexza Pharmaceuticals developing both injection and inhalation products.

Benjamin S Bleier, MD, FACS, is an Associate Professor and the Claire and John Bertucci Chair in Otolaryngology at Harvard Medical School and Massachusetts Eye and Ear. Dr Bleier is the Director of Translational Research, Endoscopic Skull Base Surgery, and Co-Director of the Center for Thyroid Eye Disease and Orbital Surgery. Dr Bleier is an R01 funded surgeon-scientist with 10 patents and over 200 peer-reviewed articles, book chapters, and textbooks. He lectures internationally on endoscopic management of orbit and skull base tumors as well as intranasal drug delivery to the brain. His work has been featured in TIME Magazine, CNN, Forbes, Wired, Popular Science, Boston Globe, Boston Magazine, and Harvard Medicine Magazine.

Ulrich Brüggemann has been working on the development of medical device and diagnostics technologies and products for over 30 years in the US and Germany. After graduation from the University of Applied Sciences, Frankfurt, he worked at Mass General Hospital, Nova Biomedical, Sanofi and has been working for 4 years at Takeda Pharmaceuticals. Over the last 18 years he focused mainly on the development of drug device combination products in various technical and management positions. He recently led initiatives to identify promising innovative technology at academic institutions and entrepreneurial startup companies. In his currently role he is leading early technology feasibility activities and device strategy focusing on rare diseases.

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Stephen T. Buckley, PhD, is Director and Head of Oral Delivery Technologies at Novo Nordisk A/S, Denmark. In addition to his leadership responsibilities, he is responsible at Novo Nordisk for a cross-organizational team of scientific experts tasked with identifying and evaluating novel drug delivery technologies. Dr Buckley holds a degree in pharmacy from Trinity College Dublin (Ireland), and a Ph.D in biopharmaceutics and cell physiology from the same university. During this time, he also worked as a Visiting Fellow at the University of Southern California (USA). Prior to joining Novo Nordisk A/S, Dr Buckley was a Postdoctoral Research Fellow at the University of Southern Denmark (Denmark). He is the recipient of honors and awards from the American Association of Pharmaceutical Scientists (AAPS) and the Scandinavian and German Physiological Societies. He is (co-) author of 25+ articles in peer-reviewed journals (including Science, Science Translational Medicine and Nature Biotechnology), 1 book chapter and 30+ abstracts, and has been invited to give numerous presentations at research institutions, international conferences and workshops.

Gaurav Byagathvalli is a co-inventor of Piezo’s novel microneedle electroporation platform and co-founded Piezo in 2022 to commercialize the technology originally developed at Georgia Tech. Prior to Piezo, he’s served in a variety of roles at Moelis and Company, Capital One, and Elevance Health. He’s a published scientist with a background in vaccine delivery and synthetic biology. He holds a BS in Industrial and Systems Engineering from Georgia Institute of Technology.

Julien Bérard is Business Development Director over Corbion’s PURASORB® portfolio, which includes lactide and glycolide (co-)polymers. He works closely with partners in the creation of medical devices and long-acting pharmaceutical depots, and is intent on continuously improving PURASORB® materials and associated services to better support customers’ development and innovation efforts. Prior to joining Corbion in 2020, Mr Bérard held several positions in product development (injectable microparticles) and business development at DSM in the Netherlands. He obtained his MSc in Chemistry at the ENSCM of Montpellier (France) before earning an MBA at Rotterdam School of Management (the Netherlands).

Dr. Ester Caffarel-Salvador is a multidisciplinary scientist with a background in biotechnology and biochemistry. At the Langer Lab at MIT, she developed a pill to administer insulin orally, which led the MIT Technology Review to recognize her as one of the 35 Innovators Under 35 in 2019.

After working across startups, pharma, and consulting, Dr. Caffarel-Salvador is now an Associate Director of Rare Disease Strategic Innovation at Chiesi USA. She is passionate about advocating on career development for women in science and is an advisor and mentor to various startups and academic programs.

Nick DiFranco, MEM, is the Global Market Manager for Oral Treatments at Lubrizol Life Science Health (LLS Health). In his role, Mr DiFranco coordinates a multi-disciplinary team offering excipients and services for controlled release and solubility enhancement in oral solids and liquids, including Carbopol® and Apinovex™ polymers. Prior to this role, Mr DiFranco held positions as an Applications Scientist and Market Manager at Lubrizol supporting long-acting drug delivery and CDMO services. Mr DiFranco holds a BS in Biomedical Engineering (Biomaterials focus) and a Master of Engineering and Management degree from Case Western Reserve University.

With over 18 years of industry experience, Ryan Doxey is a seasoned, strategic leader in the areas of CMC-Regulatory and Pharmaceutical/Biologics Development. Mr Doxey’s expertise includes Pharmaceutical and Biopharmaceutical Product Development (Formulation | Process | Analytical), US and ROW/Global CMC Regulatory Strategy, Technology Transfer (Pre- and Post-Approval), CDMO/CMO Selection and Management, Program and Portfolio Management, and Clinical Supply Manufacturing, Labeling and Distribution. He has a specialty and passion for identifying, developing, and delivering practical and innovative solutions for complex, non-conventional product formulations and drug delivery systems from concept to pivotal clinical studies. In addition to Mr Doxey’s technical expertise, he also possesses a well-honed quality and business aptitude and has extensive experience in the areas of Technical Operations and Quality Management for manufacturing, release, and distribution of pharmaceutical, biopharmaceutical and combination drug products.

With over 18 years of industry experience, Ryan Doxey is a seasoned, strategic leader in the areas of CMC Regulatory and Pharmaceutical Development and currently, is the Director of Technical Services (CMC, MS&T and Validation functions) at Kymanox, a professional services organization exclusively serving the Life Science Industry. Mr Doxey’s expertise includes Pharmaceutical and Biopharmaceutical Product Development (Formulation | Process | Analytical), Global CMC Regulatory Requirements and Strategy, Technology Transfer (Pre-and Post-Approval), CDMO/CMO Selection and Management, Program and Portfolio Management, and Clinical Supply Manufacturing and Distribution. He has a specialty and passion for identifying, developing, and delivering practical and innovative solutions for complex, non-conventional, product formulations and drug delivery systems throughout a product’s lifecycle.

Jason Durkin is the Vice President of Supply Chain at Windgap Medical having worked in the combination product industry for nearly 30 years. With experience in both injection and inhalation products, Mr Durkin has spent his entire career bringing life changing technologies to patients in need.

Stephen Gianelis, currently the Senior Director of Digital Health Operations at Teva Pharmaceuticals, has cultivated an impressive career in the healthcare technology sector spanning two decades. His expertise, built at companies like Ximedica and Proven Process Medical Devices, ranges from mechanical engineering to digital health technologies. A Northeastern University alumnus with a degree in Mechanical Engineering Technology, Mr Gianelis consistently blends his technical expertise with strategic insights to pioneer innovation in digital health.

Dr Ana Gomes dos Santos currently holds the position of Principal Scientist at the Advanced Drug Delivery Team in AstraZeneca, based in Cambridge, UK, since 2020. Dr Gomes dos Santos earned her PhD in biopharmaceutic sciences from the University of Paris Sud, France (2005), where she focused on the delivery of antisense oligonucleotides for ocular diseases. In her current role, she serves as a strategic lead in development direction and has established the CMC (Chemistry, Manufacturing and Controls) development roadmap by incorporating drug product centricity and end-to-end development thinking, as well as developability guidelines for therapeutic peptides. She is also coordinating the scouting and evaluation of cutting-edge technologies for new modalities delivery, including long acting injectables, intradermal delivery, and oral formulation of macromolecules. Previously, she held a Principal Scientist position at Medimmune/AZ, where she was responsible for the parenteral formulation development of therapeutic peptides from the early discovery phase through clinical trials. With broad knowledge in the biopharmaceutical sector, Dr Gomes dos Santos brought her expertise to more than 20 projects involving various modalities, such as biologics, peptides, and oligonucleotides, from early discovery to clinical development. Furthermore, she fosters purposeful and productive engagement with academics and external businesses (B2B) to enhance capacity in drug delivery innovation through collaborations, publications and mentorship of startup companies.

As a Partner at PA Consulting in the Global Health and Life Sciences Team, Kate Hudson-Farmer leads both early and later stage strategic initiatives, with a strong focus, but not limited to, drug delivery and connected health. Designed to add value and competitiveness to products and services, and enrich the end to end product development offering from PA Consulting.

Dr Stefanie Johns brings over 12 years of comprehensive regulatory experience across medical devices, pharmaceuticals, biologics, and combination products. Stefanie has provided strategic global regulatory guidance from concept through commercialization and life cycle management. Previously, Dr Johns served as Chief Scientific Officer at Hoth Therapeutics where she contributed to the invention and development of several therapeutic drug and diagnostic products. Dr Johns served as Director of Regulatory Affairs at Enable Injections, a device-constituent part developer and manufacturer of large-volume on-body infusion systems. As Scientific and Regulatory Manager at Camargo Pharmaceutical Services, Dr Johns provided strategic guidance on over 20 different drug-device combination product programs spanning therapeutic divisions at CDER and CDRH. Early in her career, Dr Johns assisted with the Integrity of Supply Initiative including members of the FDA and Senate HELP Committee Staff as the Program Manager of Xavier Health Initiatives. Dr Johns, graduated from the University of Cincinnati College of Medicine with a Doctorate degree in Molecular Genetics, Biochemistry, and Microbiology. She graduated from the Wright State University magna cum laude with a Bachelor’s degree in Biological Sciences.

Rasmus Just joined Novo Nordisk in 2022 as Vice President, Device Innovation. In this role he is overall responsible for research and innovation activities to support future delivery solutions. Before Novo Nordisk, Mr Just held various leadership positions within the medical device industry. He has worked within MedTech innovation and development, helping people with intimate healthcare needs, developing a broad range of devices from single use disposables and electro-mechanical durables to implants and surgical instruments. Mr Just holds a MSc in Applied Mechanics and an eMBA in Management of Technology and serves as an external examiner at several universities and research institutions.

Andrew Kroetsch is an Associate Director at Takeda responsible for leading business development for CMC. He represents CMC on due diligence teams with the scope of evaluating external opportunities, and builds teams to conduct confirmatory diligences. The range of his work spans all modalities and therapeutic areas of interest to Takeda. Prior to joining Takeda, Dr Kroetsch was a technical lead in CMC for C> compounds at Sanofi. There he was a drug product leader for key programs in the rare hematology and oncology spaces. He obtained a PhD in Chemical Engineering from the University of Buffalo with a dissertation in antibody engineering, and a BS in Chemical Engineering from the University of Delaware with a thesis studying protein aggregation.

Karsten Lindhardt has more than 20 years of experience from the pharmaceutical industry (the last 12 as an executive). He is the CEO and founder of Biograil developing a drug delivery device for effective oral delivery of biomacromolecules. Mr Lindhardt managed spin off Biograil from Egaletafter securing Seed funding from a strong syndicate of experienced investors. Mr. Lindhardt started to explore this technology with his team when he was CSO of Egalet where he was also part of the executive management team making a successful IPO on NASDAQ NYC. Mr. Lindhardt and the team were responsible for the world’s first injection molded oral product Arymo ER to FDA Approval. Through his career Mr. Lindhardt has worked in various biotech and pharma companies (Egalet, Curalogic, Prosidion, Ferring and Novo Nordisk) and has been involved in API upscaling,formulation development, pre-clinical screening and toxicology, phase 1, 2 and 3 clinical development, NDA, approval and launch, and business development pitching various technologies with great success. He was the main driver of initiating the Category 1 focus group working on behalf of the pharmaceutical industry to improve methodologies to evaluate abuse deterrent technologies and has participated in several FDA hearings as representative for the industry.

For the past 30 years, Vincent Ling, PhD, led successful groups in diverse biotechnology fields including cell devices, protein engineering, biosimilars, stem cell differentiation, checkpoint inhibitors and molecular evolution of antibody scaffolds. He has held leadership positions in large, mid-sized and start-up environments, creating practical biotherapeutics. His current interests lie in novel drug delivery technologies, which includes drug particles, energy guidance and biomaterial scaffolds. At Takeda, Dr Ling currently serves as Senior Director within Search and Evaluation, Business Development, after directorship roles in external innovation and pharmaceutical sciences. Prior to Takeda, Dr Ling was Head of Biological Sciences developing cell therapies for wet AMD at Neurotech. He has held positions including Vice President at Dragonfly Sciences, managing all scientific operations and marketing functions, Director of Molecular Genetics at Adnexus (Compound Therapeutics), and other scientific roles in Discovery Research at Genetics Institute and Wyeth Pharmaceuticals.

Ashoka Madduri is Head of Scientific Strategy and Competitive Intelligence at mRNA Center of Excellence, Sanofi. Before joining Sanofi, he was at Yale Ventures where he enabled multiple early-stage life science startups, providing strategy and intelligence to the portfolio companies. He was a partner at Vestra Associates where he advised biotech companies on corporate strategy, partnerships, and provided competitive intelligence, platform-disease fit analysis. Over the years he has worked in multiple biotech companies and has built expertise in business development & corporate strategy in areas ranging from mRNA, Antisense oligonucleotides, and delivery technologies. He received his MBA from MIT Sloan School of Management, has a PhD in Bio-organic Chemistry from University of Groningen, Netherlands, and performed his post-doctoral research in Immunology at Harvard Medical School.

Bernd Mahlmann, Executive MBA is a Senior Business Development Executive enabling customer-centric transformation and driving growth in the international pharma and medical device industries for more than 15 years. At Ypsomed, Mr Mahlmann has also a particular focus on sustainability topics and facilitating pharma companies to complete their sustainability strategies with zero CO2 emission injection devices such as autoinjectors.

Matt McCawley has sixteen years of experience as a Mechanical Engineer, nine of which have been spent designing Pico-cylinders and Gas-powered drug and implant delivery medical device platforms. He currently holds nine patents, two related to the development of Pico-cylinders. He is a graduate of Cal Poly Pomona with a BS in Mechanical Engineering.

Sukanya Murali is a Technical Services Manager at BD Medical-Pharmaceutical Systems. In this role, she serves as a key technical contact for some of BD’s top pharma customers in the vaccine and biologics therapeutic areas, supporting them in their drug-device combination product development and commercialization. In addition, she serves as a key scientific liaison in bringing innovative technologies and solutions to pharma’s drug delivery needs, such as deep cold storage, novel biologics and vaccines, traceability, and sustainability. Sukanya has several years of experience in the healthcare, medical devices and advanced materials industries and brings a diverse background in drug delivery, specialty polymers, connected devices, sustainability, and other related disciplines. Sukanya holds a PhD in Materials Science and Engineering and a Master’s in Chemical Engineering.

Courtney Nicholas Sutton is an Associate Director in Device Development at AstraZeneca where she leads device programs at various stages of maturity and is responsible for leading the technology development strategy. Prior to joining AZ, she led the Combination Product New Technology team at Regeneron. Dr Nicholas Sutton holds a Bachelor’s of Science in Biomedical Engineering from Rensselaer Polytechnic Institute.

Jessica Placido-Weber is a Toxicologist on the Medical and Scientific Affairs team in Pharmaceutical Systems at BD. She is responsible for leading the ISO 10993 biocompatibility strategy for wearable injectors, reviewing, and interpreting biological and chemical study reports, and conducting toxicological risk assessments. In addition, she prepares biological evaluation plans and reports, as per the ISO 10993 guidelines. She previously held a role as a Contracting Toxicologist with Ethicon, where she authored biological evaluation reports to capture changes mandated by European Union (EU) Medical Device Regulation (MDR). Dr. Placido-Weber has also worked as a Toxicologist in the personal care products and cosmetics industry, as well as a Forensic Toxicologist. She has extensive knowledge in the areas of Extractables, analytical testing strategies, and risk assessment, and is working towards her national certification under the American Board of Toxicology.

Dr Sanyogitta (Sanya) Puri is currently Senior Director & Head of Non-viral Delivery with the RNA & GT organization at Novo Nordisk. She leads a global department with multidisciplinary teams across Denmark and Boston, that are accountable for a portfolio of nucleic acid therapeutics with novel delivery systems within Novo Nordisk. Prior to this role, Dr Puri was Director of the Advanced Drug Delivery team, AstraZeneca Cambridge, UK, where she led a team of multidisciplinary drug delivery, formulation and clinical development scientists. Over her 10+ years & industrial career, Dr Puri has worked on design and development of oligonucleotide, peptide, mRNA and targeted nanomedicine products across oncology, cardiovascular, respiratory and rare disease areas. Dr Puri holds a degree in Pharmacy from India and PhD in Nanoparticle drug delivery from Nottingham University, UK. Dr Puri is known for being passionate about innovative drug delivery and has a track record of preclinical to clinical translation of novel medicines through both internal capability build and external partnerships.

John Quackenbush is Professor of Computational Biology and Bioinformatics and Chair of the Department of Biostatistics at the Harvard TH Chan School of Public Health and Professor at the Dana-Farber Cancer Institute. John’s PhD was in Theoretical Physics but a fellowship to work on the Human Genome Project led him through the Salk Institute, Stanford University, and The Institute for Genomic Research (TIGR), before joining Harvard in 2005. Dr Quackenbush’s research uses massive data to probe how many small effects combine to influence our health and risk of disease. His published work has more than 89,000 citations and among his honors are recognition in 2013 as a White House Open Science Champion of Change and election in 2022 to the National Academy of Medicine. In 2012 he founded Genospace, a precision medicine software company that was sold to Hospital Corporation of America in 2017.

Karthik Raman is the CEO of Persist AI, a company that seeks to use AI-driven automation to develop long acting injectables 50% faster. He holds a PhD in Bioengineering from the University of Utah, focused on drug delivery to the brain. Previously, he developed automation for synthetic biology at Zymergen and machine learning for phenotypic screening at Recursion.

Dr Veena Rao, PhD, is President and Chief Business Office at Portal Instruments. As a distinguished leader and innovator in the fields of medical device, pharma, biotech and digital health, she plays a pivotal role in spearheading Portal’s development and partnership initiatives and steering its short and long-term commercial strategy. Dr Rao brings a wealth of experience from her prior role as Chief Commercial Officer and Head of Corporate Development & Strategy at Beta Bionics, where she demonstrated her expertise in product launches and building successful commercial organizations. Prior to that, with over a decade of valuable contributions at Eli Lilly, including serving as Vice President of External Innovation in the Lilly Device, Delivery and Digital Health groups, she possesses an in-depth understanding of the pharmaceutical and device industries. Dr Rao holds a PhD in Chemical Engineering from Stanford University and an MBA from the University of Virginia Darden School of Business.

Darren Reid is Director of the Synthetics Enabling Technologies group in Pre-Pivotal Drug Product Technologies at Amgen and is responsible for synthetics Dev-Molecule Assessment and form selection, end-to-end solid state process support, and synthetics formulation development for preclinical and parenteral FIH studies. Before joining Amgen, Dr Reid received his PhD in physical organic chemistry from McMaster University and held Postdoctoral positions at the University of Calgary and Pfizer, developing approaches to assess oxidative stability.  He has co-authored 30 external articles, reviews, and book chapters, and several patents/applications, including for the LUMAKRAS(R) commercial form. His research interests include drug stability, developability assessment, and formulation strategies. Dr Reid is a founding steering committee member for Lhasa Ltd’s Zeneth drug degradation prediction program and an active member of ACS and AAPS.

Daniel Reker is a tenure-track Assistant Professor in the Department of Biomedical Engineering at Duke University and a Duke Science and Technology Fellow. He holds a BSc with honors in Computer Science and a MSc with honors in Computational Biology and Bioinformatics. He received his PhD from the Institute of Pharmaceutical Sciences at ETH Zurich and conducted his postdoctoral work in drug delivery as a SNF Postdoctoral Fellow with Bob Langer and Giovanni Traverso at MIT. Daniel has been named Forbes 30 under 30 in Science and Healthcare and has this year been recognized both as a National Institute of Biomedical Imaging and Bioengineering “Trailblazer” and as a National Institute of General Medical Sciences “Outstanding Investigator”. At Duke, he has built an integrated experimental and computational laboratory to conduct active machine learning campaigns with applications in drug discovery and drug delivery.

Philipp Richard has been with Ypsomed since 2009 in various roles in product and key account management with pharma companies to develop and bring to market innovative self-injection systems. He studied electrical engineering at the Federal Institute of Technology in Lausanne, Switzerland. Before joining the world of medical devices, he has worked in the area of contactless bearing technology for high-speed turbomachines. Since 2011, his main focus has been on defining platform-based product offerings and on implementing customized injection devices with a growing base of pharma customers. As key account manager, he has managed the transition from project to market supply including ramp-up with several autoinjector customers. Ypsomed Delivery Systems continues to focus on the development and manufacture of next generation pens, autoinjectors, patch injectors, smart device technologies and therapy management services.

Prior to joining MedinCell in 2008, Dr Christophe Roberge earned his PhD in polymer science from the Institut National de la Recherche Scientifique in Montreal, QC and held the position of Technical Director in a medical device company based in Montreal. He has been involved in many projects at MedinCell, aimed at designing long-acting formulations - based on the proprietary BEPO technology platform - for a wide variety of pharmaceutical active compounds, from the proof of concept phase to more advanced development steps. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™ (BEPO technology is licensed to Teva under the name SteadyTeq™).

Michael Roe is the Senior Director of Device Development & Industrialization at kaléo Inc. A seasoned expert in combination products, he had a 27-year career at Eli Lilly and Company, where he helped launch their first prefilled injector in 1998. Mr Roe had subsequently led Lilly’s reusable device programs and developed cartridge/device specifications and compatibility testing before joining kaléo in 2017. At kaléo, Mr Roe leads the Device and Drug Development Team and is responsible for design controls for all kaléo products, including the Naloxone Auto-injector launched for the Department of Defense in 2022 and the current reconstitution AI in development for the military. Since 2006, he has served as an expert and convener on the ISO committees responsible for the safety of injection devices.

With over two decades of experience, Patrick Ruane has significantly advanced sustained release drug delivery systems across various medical fields such as Cardiovascular, Ophthalmology, Gastrointestinal, and more. His expertise is notable in achieving controlled, prolonged release of Active Pharmaceutical Ingredients from biodegradable platforms, benefiting drug-device combination products. Holding key roles at major pharmaceutical companies like Allay Therapeutics, Chrono Therapeutics and CV Ingenuity, he has played an integral part in enhancing patient care and outcomes through his innovations. Additionally, as a skilled physical-organic photochemist, Dr Ruane has contributed to academic and patent literature through his publications. His educational background from prominent institutions like Trinity College Dublin, University College Dublin and others laid the groundwork for his research, particularly his work at The Ohio State University that led to a commercial product for pathogen inactivation in blood products. His expertise successfully bridges scientific research and real-world application, underlining his dedication to scientific advancement.

Gail Ryan is the Director of Pharmaceutical Transformation at Point32Health.  Point32Health, a health services company serving over 2.2 million lives in the New England area, is the parent company of two legacy organizations, Harvard Pilgrim Health Care and Tufts Health Plan. Dr Ryan earned her BS and her PharmD from the Massachusetts College of Pharmacy and Health Scieånces, and she has almost 20 years of managed care experience with proficiency in clinical pharmacy, medical policy, trend analysis, cost management initiatives, new and emerging technologies, and innovative payment models.

Dr Lyndon Salins is the Technical Application Manager for Biomolecule/Liquid Formulation with MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany. He is responsible for technical GTM activities including introduction of the company's innovative portfolio of excipients. He is also the global business lead for the Viscosity Reduction Platform.

Dr Salins has held roles in antibody drug conjugate targeted therapeutics advancing programs through early and late-stage development with commercialization. His prior roles also included positions in organizational leadership, analytical development, and quality.

Dr Salins received his PhD in Bioanalytical Chemistry from the University of Kentucky.

Dr Seth Salpeter has deep experience in developing and bringing new biotechnologies to market. Currently he serves as Co-Founder and CEO of ImmunyX Pharma, a biotech focused on developing immuno-modulatory therapies for chronic diseases and as Co-Founder and CTO at Curesponse, a precision cancer medicine company. Prior to that he was Chief Scientist and VP Business Development at Sight Diagnostics. Dr Salpeter holds a PhD in Biochemistry from the Hebrew University and performed post-doctoral studies at the Institute for Drug Research, the Hebrew University School of Pharmacy.

Ronak Savla is Director, Strategic Ventures at Catalent Pharma Solutions. In his role, Dr Savla is responsible for expanding and nurturing the company’s strategic partnerships with life science venture capital firms, biotechnology incubators, consulting firms, and academic technology transfer offices. Dr Savla also manages the Catalent’s fund-of-funds representing the company’s limited partnership positions. 

Previously, Dr Savla led the Medical Affairs and Competitive Intelligence functions at a biotechnology company harnessing the innate immune system to develop novel therapeutics. Dr Savla supported the commercial launch of a novel agent for a rare leukemia and was responsible for all aspects of Medical Affairs including medical information, medical education, medical science liaisons, investigator-sponsored clinical trials, Phase 4 post-marketing safety study, and KOL engagement. Dr Savla also built the Competitive Intelligence and New Product Planning function to drive business decisions regarding asset prioritization and indication selection. Outside of his professional role, Dr Savla is an Angel Investor with the HealthTech Capital group focused on funding and mentoring startups to disrupt healthcare delivery.

Dr Savla is also an Adjunct Associate Professor within the Department of Pharmacy Practice at Rutgers University. Dr Savla has a PharmD and PhD from Rutgers University and a MBA from Johns Hopkins University – Carey Business School.

Manuel Sanchez-Felix, PhD, is a Senior Fellow with the Chemical and Pharmaceutical Profiling (CPP) group at the Novartis Institutes for BioMedical Research in Cambridge, MA. He is a scientific leader with over 20 years of experience in drug discovery and development where he co-invented and contributed to the successful development and launch of various pharmaceutical products.  

At Novartis, Dr Sanchez-Felix leads a cross-functional group from Discovery and Development that is responsible for the evaluation and implementation of external Novel Delivery Technologies. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Dr Sanchez-Felix was at Eli Lilly & Company for 20 years. His area of expertise includes Biopharmaceutics, drug delivery and patient-centered formulation design. Areas of drug discovery where he has developed products include CNS, infectious diseases (specifically TB, Malaria and Rheumatic fever), oncology, bone regeneration, and diabetes. 

Dr Sanchez-Felix received his B.Sc. Honors degree and Ph.D in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he has joined the Advisory Board of both the Biomedical Programs at Middlesex Community College and Northeastern University who have a program supporting students from minority communities. 

Samantha (Sammy) Sarett is a Senior Director in the Genetic Medicine department at Eli Lilly. In her graduate research at Vanderbilt University, she designed effective and varied strategies for delivery of nucleic acid drugs. She built upon this foundation in postdoctoral work at AbbVie formulating diverse nanoparticle carriers before joining biotech Exicure. Since then, Dr Sarett has concentrated on design and evaluation of approaches to achieve central nervous system (CNS) delivery of nucleic acids. In her current research at Eli Lilly, she focuses on driving innovative and meaningful advances in the challenging and high-impact CNS delivery space.

Theresa Scheuble is Head of Enterprise Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.

Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.

Paul Schultz has over fifteen years of experience in biopharma, medtech and digital health. As an accomplished and successful entrepreneur, he is passionate about solving challenging healthcare problems with large market opportunities and novel solutions. Mr Schultz has a demonstrated track record of closing large enterprise multi-year partnerships with top-30 pharma while driving significant upside value.

Amin Sedighiamiri is Associate Director, Device Development at AstraZeneca, where he is leading cross-functional product teams to develop and bring injectable drug-device combination products to market. Additionally, he spearheads the evaluation and implementation of innovative technologies aimed at improving drug delivery and the overall patient experience. His expertise extends to the integration of digital solutions for injectable biologics, ensuring the seamless convergence of technology and the administration of biologics. Before joining AstraZeneca, Dr Sedighiamiri worked in Delivery, Device and Connected Solutions organization of Eli Lilly and Company, where he led design and development of connected solutions for various drug delivery devices. Additionally, he serves as a board member at the Society of Plastics Engineers – Medical Plastics Division, dedicated to facilitating the exchange of technical insights among the scientific and engineering community pertaining to medical applications utilizing plastics and polymers. Dr Sedighiamiri holds BSc, MSc and PhD in Mechanical Engineering and over 12 years of experience in product innovation and commercialization across multiple industry segments.

Kurt Sedo is Vice President of Operations at PharmaCircle, a leading provider of authoritative information, global insight, and expert analysis on the pharmaceutical, biotech, drug delivery technology and device, and animal health industries. Mr Sedo received his B.S. in Chemistry and Mathematics from the University of Wisconsin Stevens Point in 1992. Prior to joining PharmaCircle in 2003, Mr Sedo held various positions within Pharmaceutical Sciences and Analytical Development at Searle/Pharmacia.

Dr Srinivasan Shanmugam has more than 20 years of experience in designing and development of conventional, NDDS/alternate, advanced/modified drug delivery systems, and pharmaceutical platform technologies for oral and other routes of administration. His expertise includes stability, solubility/dissolution, permeability, and bioavailability enhancement techniques/technologies for challenging drugs. Additionally, Dr Shanmugam has published numerous research articles, holds multiple patents, and is a reviewer/editorial member of various prestigious journals. In his current position, Dr Shanmugam is involved in the development and expansion of Adare's pharmaceutical technology portfolio and facilitates product development and co-development opportunities.

Michael Sherman is a Venture Partner at RA Ventures. Prior to joining RAVen, Dr Sherman was the Executive Vice President and CMO at Point32Health, formed by the merger of Harvard Pilgrim Health Care and Tufts Health Plan. Prior to Point32Health, Dr Sherman served as CMO of Harvard Pilgrim Health Care, the Corporate Medical Director at Humana and also served as Vice President of Network and Consumer Solutions for UnitedHealth Groups subsidiary Ingenix (now part of Optum). Dr Sherman has also previously held the position of Vice President and General Manager at Thomson Medstat (now part of IBM Watson Health), as well as held management roles at Immusol, a San Diego-based biotechnology company, HealthAllies, an organization created to provide discretionary medical benefits to the cash-pay market, and Da Vita, a national provider of dialysis services. Before pursuing an MBA at Harvard Business School, Dr Sherman received his MD from Yale and practiced as a cardiac anesthesiologist. He also holds a BA in Anthropology and Natural Sciences and an MS in Biomedical Anthropology from the University of Pennsylvania. Dr Sherman is chair of the Board of Managers of the Harvard Pilgrim Health Care Institute. He holds additional board appointments with several well-respected nonprofit organizations, including the Institute for Clinical and Economic Review (ICER), the Personalized Medicine Coalition, the Harvard Business School Healthcare Initiative, NEHI (Network for Excellence in Health Innovation), and the Massachusetts Rare Disease Advisory Council.

Gautam Shetty is the founder and CEO of Congruence Medical Solutions, LLC. With a career spanning ~18 years in the drug delivery space, Dr Shetty is passionate about advancing device technologies to address unmet and hard-to-solve problems in injectable drug delivery. He has authored numerous patents in the injectable drug delivery device space covering ocular drug delivery systems, novel delivery systems, pen injectors, patch pumps and autoinjectors. Previously, Gautam was General Manager of Novel Drug Delivery Systems business unit at Unilife Corporation. Prior to that, Dr Shetty was with Becton Dickinson & Co. (BD). Dr Shetty holds a PhD in Biomedical Engineering from Case Western Reserve University.

Tycho Speaker trained in Physical Chemistry at UC Santa Cruz before embarking on most of a decade in semiconductor manufacturing engineering. Following that career, he pivoted back to his family trade of pharmacy and medicinal chemistry, founding Capsulent to commercialize a novel microencapsulation chemistry in a classic garage startup venture. Capsulent produces a range of custom encapsulates for use across a variety of industries, including for topical delivery formulations as well as sustained release and even delivery inhibition applications for repellents and sunscreen agents. In addition, he worked at TransDerm to develop topical platforms for small molecule and siRNA therapeutics for rare skin disorders, which led to his development of a dissolvable microneedle technology. TransDerm was acquired in 2019 by Allergan, which subsequently was acquired by AbbVie, and he was Director of Drug Delivery and Biomaterials as well as site lead for the Santa Cruz Drug Delivery and Combination Products team until September of this year. Mr Speaker remains active in the microneedle and drug delivery space and maintains his role as CEO of Capsulent while actively working with other companies in a variety of industries.

Colin Spencer is a project manager and the head of the technology transfer group at Oakwood Laboratories. At Oakwood, he has worked on a variety of technology transfer projects, leading the transfer of both commercial and developmental products into Oakwood's FDA approved, GMP, aseptic manufacturing facility. Colin also has experience at Oakwood working on long-acting injectable products, working both on the initial feasibility of new products and the scale-up and large-scale manufacturing of clinical materials. His other roles include leading the process improvements initiative at Oakwood, investigating new technologies that can further enhance Oakwood's development and manufacturing capabilities.

Alina Su is the founder and CEO of NovaXS Biotech. Prior to NovaXS, Dr Su served as researcher at UC Berkeley QB3 Laboratory under rejuvenation pioneer, Professor Irina Conboy. Her extensive experience in drug-device combination and drug delivery efficacy set up the foundation of the science at NovaXS. Dr Su is currently a PhD student at Harvard Medical School.

Kanika Suri is dedicated to developing and advancing creative, efficacious, and patient-compliant therapies to alleviate patients from debilitating conditions. With a strong focus on overcoming barriers to drug delivery for oral, topical, and parenteral routes of administration, she has established herself to lead the CMC development of pipeline drug products at Takeda. Leveraging her experience in research and development, Dr Suri brings a unique perspective to devising patient-centric pragmatic solutions. She is pursuing a PhD in Bioengineering and holds a Master's in Chemical Engineering from Carnegie Mellon University. Dr Suri's passion for ideation and her staunch advocacy for Women in STEM further underscore her commitment to driving excellence in the field.

Dr Shankar Swaminathan is an associate director at Astellas Institute of Regenerative Medicine leading drug product development and technical transfer activities for multiple preclinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer-based drug delivery formulations for cancer nanomedicine. 

Soon after his PhD, he joined the pharmaceutical industry to work on drug eluting long-acting combination products. He later went on to complete his postdoctoral training in ophthalmic drug product development at the College of Medicine at University of Tennessee health science center, where he focused on creating new treatment approaches for debilitating eye diseases. As a young investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan led CMC activities for multiple products/INDs submitted for approvals to various agencies.

He has about 15 years of combined industry and academic experience and has successfully overseen product development from early-stage discovery through late-stage submissions and validation. He is currently supporting multiple cell therapy projects, including immuno-oncology modality from development through GMP technical transfer and manufacturing. He is vastly experienced in aseptic drug product development, quality-by-design, advanced drug delivery, cryopreservation technology, CTM campaign execution and management, fill-finish, modified release solid orals and ocular drug delivery. He is an editorial board member in Scientific Reports and serves as a reviewer for over 20 peer-reviewed journals. He has published 15+ peer reviewed publications, commentaries and blogs.

As a Senior Staff Engineer for Research and Development at Enable Injections, Aaron Swick is focused on leading the connected healthcare program, collaborating with partners to determine the needs of the next generation of the enFuse technology. With 15 years of experience in medical device and healthcare innovation, Mr Swick uses research, strategy, and design to develop products that enhance the patient and provider experience. He earned his MSE and BSE in Biomedical Engineering from the University of Michigan.

Amir Tabaian is a Senior Combination Product Development Engineer at Pfizer. At Pfizer, he has worked on a variety of combination products including auto-injectors, prefilled syringes, and convenience kits. His current role is in the Biotherapeutics Pharmaceutical Research and Development organization and executes device development from conceptualization through initial production registration. Mr Tabaian’s current focus is on vaccine projects. Prior to Pfizer, Amir worked for a startup researching kinase inhibitors design and discovery. Mr Tabaian holds a bachelor’s degree in biomedical engineering from the University of Virginia.

Sakura Taneichi is a R&D scientist of NOF CORPORATION. She has been developing LNP formulations. She has made contributions to the development of mRNA-LNP platform using proprietary ionizable lipids.

Sarah Tao, PhD, is the Senior Director of External Innovation for Biologics within Sanofi Partnering since July 2021.  In this role, she is responsible for identifying and evaluating external technologies that align with Sanofi’s strategy for Biologics-based therapies. Dr Tao joined Sanofi in 2017 with successive roles as Technology Lead for Biologics Research, and then Global External Technology and Innovation Lead for Large Molecules Research. Prior to Sanofi, Dr Tao was a Senior Manager of New Technologies at  CooperVision leading external research programs on advanced ophthalmic devices; and was also a Senior Member of the Technical Staff in the MEMS Design Group at Draper Laboratory leading programs in inner ear and ocular drug delivery. She received her Ph.D. in Biomedical Engineering from Boston University with a research focus on MEMS-based devices for oral drug delivery.  Dr Tao has received numerous accolades for her contributions to the field of drug delivery, including the Controlled Release Society Eurand Grand Prize.  

An expert in clinical pharmacology and a Fellow with the American Association of Pharmaceutical Scientists, Dr Tracy holds three patents related to drug delivery systems and has published over 100 scientific manuscripts, fifteen book chapters and three books. Dr Tracy’s expertise is in drug metabolism, pharmacokinetics and pharmacogenetics, as well as the larger field of clinical pharmacology and he has conducted numerous clinical trials. Prior to his current work, he served as CEO of Aprecia Pharmaceuticals, a 3D printing pharmaceutical company.

Dr Tracy has served as a consultant to the pharmaceutical industry since 2003. In addition, he completed a sabbatical at Boehringer-Ingelheim in Ridgefield, CT in 2007. Contributions have ranged from individual compound/product consultations to a multi-year consultancy with a company for all products under development. He has also served as a company subject matter expert, designing experiments, negotiating with CROs for completion of work, analyzing the generated data, generating reports and then designing additional in vitro and in vivo studies. With respect to regulatory contributions, he has assisted with pre-IND and IND submissions and has served as a representative at FDA meetings. Clients have ranged from large, multi-national pharmaceutical companies to smaller companies of 50-300 employees, as well as startups.

Dr Tracy received his bachelor’s degree in pharmacy from Ohio Northern University, his PhD in clinical pharmacy from Purdue University, and completed a postdoctoral fellowship in clinical pharmacology at Indiana University.

Mark Tunkel is Global Category Director, Services at Nemera leads the strategy for contract development and combination product services linked to commercial manufacturing capability. He was previously a partner at Insight Product Development, which was acquired by Nemera in 2019 and became Insight by Nemera. With more than 20 years of global business development experience and a deep understanding of the marketplace challenges and trends affecting the pharma industry, Mr Tunkel has advised many of the world’s leading companies on their product development and innovation strategies for drug delivery and medical devices.

Dr Siva Vaka is a Director of Formulation R&D, specialty product division at Amneal Pharmaceuticals. He obtained his PhD in Pharmaceutics & Drug Delivery from the University of Mississippi. After graduating, he worked at Kashiv Pharmaceuticals LLC, for about 8 years in R&D, focusing on 505(b)(2) programs. He developed GRANDE® (advanced gastric retention system) and KRONOTEC® (advanced osmotic oral drug delivery system) proprietary technology platforms for controlled drug delivery of challenging compounds that significantly improve efficacy, tolerability and compliance. He has authored 25+ research articles in peer-reviewed international journals, 2 book chapters and is an inventor on over 15 patents.

Thomas von Erlach, PhD co-founded Vivtex and joined as its Chief Scientific Officer when Vivtex was formed as a MIT spin-off in 2018. Prior to that he led the interdisciplinary efforts around gastrointestinal model systems for oral drug delivery applications at the Laboratory of Prof. Robert Langer and Prof. Giovanni Traverso at MIT. Dr von Erlach obtained his PhD from Imperial College London in Bioengineering and a BSc and MSc in Biochemistry and Biotechnology from ETH Zurich in Switzerland. His research interest include advanced in vitro models for drug development, oral drug delivery and gastrointestinal pharmacology. His work is published in several high impact journals such as Nature Materials, Nature Biomedical Engineering, and Nature Communications.

Daniel Waites serves as the Director of Research and Development at Enable Injections, leading the innovative programs and future development of the enFuse, from reconstitution to connected healthcare. Mr Waites has over 18 years of experience in medical device development, and currently supports all due diligence processes and feasibility programs with potential and current partners. Mr Waites holds a Bachelor of Science in Mechanical Engineering from the University of Cincinnati and is a licensed PE.

Dr Per Walday is the CEO of EXACT Therapeutics since June 2022, a listed clinical stage biopharmaceutical company developing a unique platform technology for ultrasound-based drug delivery. He has extensive experience spanning from research to commercialization of in vivo diagnostics, therapeutics and medical devices globally, including drug-device combinations within the field of oncology. As CEO of biotech organizations, Dr Walday has built effective organizations progressing drug delivery platform technologies into pipelines of assets, including late-stage clinical programs through FDA and EMA regulatory paths. Prior to this, he spent almost two decades in different positions within Nycomed Imaging, Amersham Health and GE Healthcare, spanning a range of positions, including Global Head Project Management, with responsibility for all development programs of new pharmaceutical products. These included R&D efforts within the field of ultrasound and microbubbles which paved the way for what would become years later EXACT Therapeutics Acoustic Cluster Therapy (ACT®). Dr Walday has an MSc in biology and a PhD in neurophysiology.

Jessica Walsh, the founder and CEO of Rx Bandz, is a seasoned entrepreneur with decades of experience in the development and implementation of game-changing technologies.

Her leadership led to the creation of a portfolio of patents, including MiniJect—the world's smallest auto-injector, setting new standards in size, performance, and durability. This versatile drug delivery platform is designed to administer a wide range of injectable medications and increase patient compliance.

Supported by a world-class team that shares her mission to save lives, Rx Bandz is leading the shift in emergency auto-injectors and advancements that redefine our perception of these critical medical devices. Rx Bandz is currently licensing its device to pharmaceutical companies, making their innovative drug delivery platform available to increase patient compliance and help save lives around the world. 

As interim CEO and one of three SpheroFill co-founders, Dr Paul Weinberger is a nationally recognized airway reconstruction surgeon, scientist, and healthcare leader. In addition to his leadership role at SpheroFill, he is the Medical Director of Specialty Physicians at Deaconess Clinic in Evansville, Indiana. His undergraduate training was at Georgia State and Emory University, followed by medical school at the Medical College of Georgia and subsequent residency and fellowship training programs at Georgia Health Sciences University, Yale University, and the Royal National Throat Nose and Ear Hospital and University College of London. His peer-reviewed scientific publications have been cited in more than 10,000 unique journal articles, and he is named inventor of 6 awarded patents. He has received numerous national awards, including the Fanconi Award from the American Head and Neck Society, the Farr Award from Yale School of Medicine, and the National Leadership Award from the American Medical Association.

David Westberg, CEO at Nanexa since 2015, has many years of experience in the pharmaceutical industry, including roles at Pharmacia, Pharmacia-UpJohn and Orexo. He has worked as a global project manager for development projects and was Head of Product Development (Pharmaceutical and Analytical Development) at Pharmacia amongst many other roles. Mr Westberg was also the main project manager who was responsible for taking two major Orexo products (Edluar and Zubsolv) from the early development phase through formulation development and clinical studies and onto registration and market approval with the FDA in the US.

Dr Ashley Williams is the Director of Research and Development. He has over 15 years of experience studying the molecular biology and genetics of Escherichia coli. His research has spanned a spectrum of diverse fields that recent research has revealed are remarkably intertwined, including DNA damage and repair, cell cycle control, host-pathogen interactions, immune DNA sensing, and systemic inflammatory responses. Before joining SiVEC Biotechnologies, Dr Williams studied aging and aging-related diseases at the CECAD Research Center at the University of Cologne in Cologne, Germany. Dr Williams received his Bachelor of Science and PhD in Microbiology from Indiana University and completed post-doctoral fellowships at Harvard University and the University of Southern California.

Cindy W Wu, PhD, is a Director in Drug Delivery and Biomaterials at Abbvie Inc. During her 10 plus year tenure with Abbvie (previously Allergan), Dr Wu has specialized in developing biological delivery products for therapeutic areas including eye care, urology, and medical aesthetics. Currently, she is leading the research and development of biologics delivery platforms and driving the translation of technologies to create innovative products. Dr Wu also acts as the CMC team lead to advance research projects to development. Before joining Abbvie, Dr Wu was a Senior Scientist in Drug Delivery at Amgen, where she was responsible for developing pharmaceutical products based on parenteral and local controlled release technology. Dr Wu earned her PhD in Chemical Engineering from Northwestern University and has authored more than 20 research papers, book chapters, and patents.

Haiming Wu is the Head of New Device Technology Research and Innovation at Sanofi responsible for early-stage device technology development and innovation to meet emerging medical device needs of Sanofi portfolio. He started his career in the technology sector with HP and Texas Instruments and has since transitioned to medical device design and technology development. Over the years, he has developed expertise on a variety of drug delivery devices working at Baxter, BD and Biogen before joining Sanofi, and produced over 20 patents many of which have turned into commercial products. Direct CNS drug delivery to by-pass blood-brain barrier has been a major focus of his research and development efforts to enable and optimize delivery of new therapeutic modalities such as Antisense Oligonucleotides and Gene Therapies for neurological disorders. Other targeted drug delivery and IV infusion innovation are also major areas of his recent focus. He holds an MS degree from Boston University and an MBA from Babson College.

Dr Brandon Wustman is a seasoned R&D executive with experience throughout his nearly 20-year career across many phases of R&D including discovery, clinical development, and the launch of new therapeutic platforms.

Prior to joining ReCode Therapeutics (and its predecessor, TranscripTx) in 2015, he had positions of increasing responsibility, including senior director, Preclinical Biology, at Amicus Therapeutics from 2002 to 2014. At Amicus, Dr Wustman established a new lab focused on protein therapeutic discovery and production. He was also instrumental in leading the discovery and preclinical development of pharmacological chaperones used alone and in combination with enzyme replacement therapies for seven different preclinical programs. Dr Wustman received his BS and PhD from Michigan Technological University. He was an Alexandar Humboldt Fellow at the University of Cologne, Germany and a postdoctoral fellow at New York University from 2000 to 2002. Dr Wustman has published more than 20 peer-reviewed scientific articles and is also the inventor on nine issued US patents.

Yuhong Zeng received her PhD in Analytical Chemistry in 2006 from the University of Kansas (KU). She then had her postdoctoral training followed by holding a Research Associate position at the Macromolecule and Vaccine Stabilization Center at KU. In 2011, she joined the formulation group at Alcon/Novartis and worked on both early- and late-stage antibody drug product development for ophthalmic use. Between 2016-2018, she worked at Vaxess Technologies and led formulation efforts in development of microneedle patches for vaccine delivery. In 2018, she joined ReForm Biologics, now Comera Life Sciences, working on technologies and pipeline development that transform essential biopharmaceutics from IV to SQ delivery.

Prior to joining Hopewell Therapeutics as Chief Scientific Officer in 2022, Dr Kate Zhang served as VP of Biological Development at Editas Medicine, where she led the cross functional teams employing breakthrough CRISPR-based in vivo and ex vivo gene editing technology, bringing AAV gene therapy in ophthalmology and autologous cell therapies in hematology from program inception to three successful IND submissions.

Previously, Dr Zhang was the Senior Director of Global R&D Platforms and Global Pharmaceutical Development at Genzyme and Sanofi. As the portfolio head of global translational science, she was responsible for rare genetic diseases and contributed to the approval and commercialization of Cerezyme, Fabrazyme, Myozyme/Lumizyme, Thyrogen, Cerdelga, Lemtrada and Zenpozyme.

Dr Zhang began her career as a postdoctoral fellow at the National Heart, Lung and Blood Institute at NIH. She has co-authored more than 70 peer-reviewed scientific articles and co-invented multiple issued U.S. patents. She received her BS from Tsinghua University, China, her MSc from the Chinese Academy of Science and her PhD from Queen’s University, Canada.

With formal training in polymers, Dr Ke Zhang is devoting his career to facilitating the marriage of synthetic polymers and nucleic acids. His prized inventions include several forms of DNA-polymer amphiphiles, conjugates, and nanoparticles, which are being geared towards materials science and cancer treatment. Dr Zhang is currently a Professor of Chemistry at Northeastern University and a recent entrepreneur overseeing the commercialization of his technology through pacDNA LLC, where he is the interim CEO. Prior to his current position, Dr Zhang was a postdoctoral fellow at Northwestern University and a doctoral student at Washington University in St Louis.

Liping Zhou, PhD, is currently a senior director at AstraZeneca Boston R&D center. She is heading the new modality formulation development and delivery science team, developing preclinical and clinical formulations and supporting AstraZeneca internal pipeline projects as well as external collaborations. Dr Zhou has 20 years of post-PhD technical and managerial experience in research and development functions in the biotechnology/pharmaceutical industry. She has diversified expertise especially in pre-formulation, formulation development and drug delivery technologies focusing on peptides, nucleic acids and small molecule drug candidates. She has been actively involved in preclinical and clinical programs, life-cycle management and due diligence projects in multiple therapeutical areas as well as efficiently and strategically managing external collaborations in the US, Europe and Asia. Dr Zhou’s previous employment includes but not limited to Novartis, Ipsen, and Ra Pharmaceuticals (now UCB). She co-authored more than 20 scientific publications in the leading biomedical journals and book chapters.

Dr Zhou received her Ph.D. degree in Chemistry from University of Connecticut and her bachelor’s degree from Peking University.

Marianne Ølholm is Senior Vice President at Novo Nordisk with the responsibility for research and development of devices and delivery solutions across the entire Novo Nordisk portfolio. Dr Ølholm has extensive R&D and leadership experience from various roles in Novo Nordisk over the last 25 years, mainly in Denmark but also has international leadership experience from establishing an organization in the research centre in Beijing. In her previous experience within development, Dr Ølholm has successfully driven projects in the obesity clinical development pipeline, first as Project Vice President with responsibility for specific projects, and later as Corporate Project Vice President with responsibility for the obesity and NASH development portfolio. Dr Ølholm is originally trained as a DVM with a PhD within in vivo pharmacology as well as a DMSc and has published several articles in international, peer-reviewed journals. She has also authored numerous abstracts and serves as an ad hoc reviewer for several scientific publications. Since 2021, Dr Ølholm has headed up the device and delivery solution area and ensured a clear strategic direction and efficient execution of the extensive portfolio in Novo Nordisk.