Dr Suzanne J Rose, the Executive Director of Research for Stamford Hospital holds an MS and PhD in Biomedical science from Albany Medical College. She was recently inducted into the 2021 class of Fellows of the Association of Clinical Research Professionals (ACRP), a recognition less than 45 members of the clinical research profession hold globally. Fellowship is a mark of distinction and leadership. ACRP recognizes individuals who have made substantial contributions to the association and the clinical research industry.

Her role as Director entails overseeing all clinical trials and managing the research team. Under her guidance, The Office of Research encompasses the Clinical Trials Office, Center for Simulation and Learning and Office of Academic Research. Dr Rose is also an Adjunct Professor for Sacred Heart University Master of Physician Assistant Program and Purdue Global University Undergraduate Health Science Studies.

Dr Rose is an avid speaker at conferences and webinars on various topics including Team Building, Leadership, Principal Investigator Compensation and Clinical Research Coordinator Workload Assessment Tools. In addition, she is a Certified Group Fitness Instructor and Personal Trainer. She enjoys spending time with her husband and two teenage daughters hiking, running, watching movies, and baking.

In her role as Global Head Product Optimization, Dr Beate Bittner drives the development of customer-centric product optimization opportunities across the Roche portfolio. Dr Bittner joined Roche in 1998 and held numerous positions of increasing responsibility including Preclinical DMPK Project Leader, Laboratory Head Preformulation, Clinical Pharmacologist, Clinical Team Leader, Global Development Leader, Global Project Leader, Portfolio Strategy Director, and Product Optimization Franchise Leader. Since 2012 Bittner has been a Lecturer at the Baden- Wuerttemberg Cooperative State University in the field of Personalized Health Care, Developing New Drugs, and Pharmacology. She is trained as a Pharmacist with a PhD in Pharmaceutical Technology & Biopharmaceutics from the University of Marburg, Germany, and holds a Diploma in European Market Access from the Aix-Marseille University, France.

Sherri joined AstraZeneca in 2018 and is Head of Device Development. She is responsible for parenteral drug delivery development including early-stage technology strategy, clinical device 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. A particular focus of her group is understanding user needs and business needs to design the right product for patients and health care providers. Prior to working at Astra Zeneca, Sherri was Director of Device Development at Genentech and Director of Product Development at Alexza Pharmaceuticals developing both injection and inhalation products. 

Sherri earned a PhD in Chemical Engineer from the University of Pennsylvania and a BS in Chemical Engineering from Rensselaer Polytechnic Institute. While in industry she has been active in various academic and industry-based organizations. She has taught several university engineering courses and publishes and presents frequently. 

Supason Wanichwecharungruang, PhD, is a Professor at Chulalongkorn University with over 20 years of experience in drug delivery technology. Dr Wanichwecharungruang received her bachelor’s degree in chemistry from Chulalongkorn University and completed her PhD. In Chemistry at Miami University. She has worked at Chulalongkorn University since graduation. Her previous contributions include 10s technology transfers of innovations from her lab to private sectors and two spin-off companies.

Her specific expertise includes biomaterials, drug carrier design, microneedles, drug and biologics stability, spinoff from technology, and technology transfer

Mandana Borna is currently Scientist II in formulation and drug product development team at Biogen. Mandana and her team lead the drug delivery activities of oligonucleotide product and focus on advancing new technologies to overcome challenges of CNS delivery. She identifies promising brain delivery technologies for application to Biogen’s neurologic pipeline of oligonucleotide drugs, designing feasibility studies, technical assessment as well as leading project partnership. Mandana holds PhD degree in Materials Science & Biomedical Engineering from McGill University, and her research is focused on Biomaterials for drug delivery and cell therapy.

Heinrich Haas has more than 20 years of experience in academic research and industrial pharmaceutical development. After he received his PhD in physical chemistry, Dr Haas researched lipid membranes and organized biomolecular systems. His professional focus is on colloidal/nanoparticulate formulations for targeted drug delivery with therapeutic and diagnostic applications. After joining BioNTech RNA Pharmaceuticals GmbH in 2010, he helped build the formulation development and analytics unit, which develops formulations for delivery of RNA and small molecules.

Allen Horhota, PhD, is the Senior Director, Head of Delivery Sciences at Orna Therapeutics, leading their efforts to bring oRNA to new, therapeutically meaningful tissues and cell types. Dr Horhota is a classically trained nucleic acid chemist and enzymologist with over ten years in industry focused on nanoparticle development. Dr Horhota earned his Ph.D. in Chemistry at Boston College, followed by a Post Doc at The Scripps Research Institute, specializing in simplified nucleic acid backbones, their chemical synthesis, and enzymatic processing. He is an author on multiple papers and patents spanning the nucleic acid, nanoparticle targeting, polymeric, and lipid nanoparticle delivery of RNA fields.

Before joining Orna, Dr Horhota was an Associate Director and founding member of Moderna’s Delivery Innovation group, focusing on novel materials and processes for effective mRNA delivery across the polymer and lipid nanoparticle spaces. Before Moderna, Dr Horhota held various scientific and leadership roles at BIND Therapeutics. At BIND, he focused on novel approaches to active nanoparticle targeting and nanoparticle processing techniques to enable small molecule and nucleic acid payloads. Dr Horhota has contributed to multiple clinical and commercial nanoparticle programs at Moderna and BIND therapeutics throughout his career.

David Cirelli is a Senior Director in Pfizer Inc.’s Analytical Research and Development department located in Andover, MA where he leads a group responsible for development and validation of biological and impurity assays for Pfizer’s biotherapeutics and vaccine portfolio.  More recently, Mr Cirelli led the COVID-19 mRNA vaccine (COMIRNATY) analytical team responsible for technical strategy, method development, validation and transfer, product and process characterization, and quality control. Mr Cirelli earned his MS in Quality Assurance & Regulatory Affairs from Temple University, School of Pharmacy and his Bachelor’s degrees in Biology and Exercise Sciences from Gettysburg College.

Paul Rohlfing is Executive Director, Global Regulatory Affairs CMC, Pfizer, accountable for development and implementation of Global Regulatory CMC strategies for initial registration and post-approval maintenance for vaccines and other biologics including more than 9 development programs and 10 licensed products. These include three BLA approvals between June and August 2021 including the mRNA COVID-19 vaccine Comirnaty®, and 20-valent pneumococcal conjugate vaccine PREVNAR 20™. In previous roles, Mr Rohlfing was accountable for developing production process improvements and new applications of technology, as well as transferring technology into production facilities in the US and Europe.  These have included processes for production of the Prevenar 13 Pneumococcal Conjugate vaccine and other vaccines in Pfizer’s historical portfolio and early large-scale application of flexible containers to storage of biologic drug substances. Prior to his current focus on vaccines, he has had a broad  range of experiences over more than 25 years with Pfizer and its predecessor companies, including responsibilities for validation, process troubleshooting, production management, training, and quality assurance; working on both biological and classical pharmaceutical platforms.  Prior to joining Pfizer, Mr Rohlfing worked with Novartis and Allergan. He holds a BS Chemical Engineering degree from the University of Nebraska—Lincoln.

Dr. Stephen T. Buckley is Vice President of Advanced Drug Delivery at Novo Nordisk A/S with responsibilities spanning global sites in both greater Copenhagen (Denmark) and Boston (USA). 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. During his time at Novo Nordisk, Stephen has contributed to development of multiple marketed drug products, including semaglutide, oral semaglutide, faster aspart and insulin icodec. He 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 30+ articles in peer-reviewed journals (including Science, Science Translational Medicine and Nature Biotechnology), and has been invited to give numerous presentations at research institutions, international conferences and workshops.

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.

Chris Wahl, MD, MBA is Vice President of Strategy and Operations at Progenity, Inc. in San Diego, California. He has spent over 16 years in the pharmaceutical and biotech industries covering small molecules, biologics, combination products, devices and diagnostics. At Progenity, Dr Wahl leads a cross functional group that is responsible for the development of multiple drug device combination products. For the last 5 years he has focused on the development of ingestible medical devices for the oral delivery of therapeutics.

He joined Progenity following Chief Operation Officer positions at two companies that developed the underlying technologies that are the focus of Progenity’s ingestible device platforms. In previous roles at McKinsey & Company and Merck, Dr Wahl has worked on product strategy, development and commercialization, sales and marketing, patient compliance and organizational structure. In addition to his current focus on gastrointestinal diseases, Dr Wahl has experience in oncology and cardiometabolic, neurologic, infectious and rheumatic diseases. Dr Wahl is an inventor on over 150 US and international patents and patent applications and holds an MD and an MBA from McGill University.