Scott Gibson is the Director of Systems Engineering at Amgen with responsibility for combination product development.  Since joining Amgen in 2012 he has held multiple roles directing device innovation and product development.

Scott has more than 30 years of experience in organizational development, medical device development, and combination product development with focus in cardiac rhythm management, diabetes, pain management, and subcutaneous and intravenous therapeutic delivery.  His experience includes start-ups acquired by Medtronic and Boston Scientific. 

Scott studied at California Polytechnic State University, San Luis Obispo, and holds more than 50 US patents. He has served as a member and chair of several industrial advisory boards.

Luis Santos, PhD, is currently the Senior Director of RNA & LNP Product Development at Prime Medicine, where he leads a team of scientists and engineers working on developing mRNA and LNP processes, LNP formulation, and drug product development to bring Prime Editing to patients. He also heads cross-functional and CMC teams. Prior to joining Prime Medicine, he held multiple roles of increasing responsibility in AstraZeneca's Biopharmaceutical Development organization. There, he was a team leader with focus on intracellular delivery, drug delivery technologies for nucleic acid and biologics, and technology strategy. He was responsible for mRNA-LNP development programs and was a CMC team leader for early-stage programs. Before that, Dr Santos led the implementation and development of an artificial antigen-presenting cell platform at NexImmune to enable an adoptive cell therapy pipeline. More broadly, he has contributed to several industrial consortia, has published over 40 articles, and holds several patents in drug delivery, process to manufacture, and enabling the development of nanomedicines.

TBA

Mr Welch has been with PCI, a large, global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions throughout the product lifecycle, since 2022. Prior roles include serving as Chief Technology Officer of Phillips-Medisize, a Molex Company, until December 2021. Phillips-Medisize is a leading, global contract development and manufacturing organization focused on drug delivery devices, combination products, and connected health. Mr Welch led their global pre-production services organization, a team spanning front-end innovation, development, and new product introduction. He was active in the company’s merger and acquisition activity, including leading the search, acquisition, and integration of locations in China and Denmark. Mr Welch received a B.S. in Industrial Engineering from University of Minnesota Duluth.

Christopher Kovalchick, PhD, is the Director of Systems Engineering within the Research Development (R&D) organization for Abbott’s diabetes care business, based in Alameda, California. 

He joined the company in 2023 when Abbott acquired Bigfoot Biomedical and has since played a pivotal role leading the Systems Engineering strategy and execution across Abbott’s FreeStyle Libre portfolio including sensor-based glucose monitoring products, as well as their associated applications and cloud software. 

Dr Kovalchick has spent his career developing connected and combination product technologies within several medical device, drug delivery and pharmaceutical organizations including Becton Dickinson and Eli Lilly. He has led development activities from innovation through commercialization across nearly all aspects of diabetes management including glucose monitoring, algorithm development, and closed-loop/open-loop insulin delivery.

Dr Kovalchick earned his PhD in mechanical engineering and his master’s degree in Aeronautics from the California Institute of  Technology, and his bachelor’s degree in engineering mechanics from the Johns Hopkins University.

Alexander (Alex) Josowitz is currently a member of the New Technologies Team in the Formulation Development Department at Regeneron Pharmaceuticals Inc. His work focuses on new technologies including formulation, drug delivery and device evaluations for biologics. Previously, Alex earned his PhD in Biomedical Engineering at Yale University under Mark Saltzman, where he tackled drug delivery to the brain from multiple angles. He investigated the use of polymeric nanoparticles to allow for sustained release of hydrophobic drugs in the tumor microenvironment, local infusion systems and techniques such as Convection Enhanced Delivery (CED), and combination therapies between alkylators and DNA-repair inhibitors to lower systemic toxicity associated with high clinical doses. This is Alex’s first experience with PODD and he is excited to be introduced to this growing community that brings together cross-functional experts to address drug delivery challenges.

Camilla has ten years’ biotech start-up experience as CEO and COO working exclusively on hydrogel-based medical devices. Originally a veterinary surgeon, she has run veterinary clinical trials and launched the veterinary arm of a biotech company. Following on from this she moved into the human biotech sector where she has been involved in all aspects of start-ups including, R&D, fundraising, regulatory, pre-clinical and clinical trials for medical devices.

Patty Leuchten is Founder/CEO of Diligent Pharma, a tech-enabled service firm focused on quality and compliance. With 30+ years of experience in clinical trials, Patty is a leading authority on global clinical outsourcing, strategic alliances, and driving change in clinical trial execution. At Diligent, Patty is transforming the current approach to identifying/qualifying clinical trial vendors to drive time savings and efficiency while ensuring quality and compliance. Diligent’s platform can shave 100+ days off the vendor qualification process, providing the potential to accelerate clinical trial start-up timelines. Prior to Diligent, Patty founded The Avoca Group, a firm focused on driving improvements in clinical trial execution. Avoca was the first organization in the industry to launch an industry-wide collaborative focused on quality - the Avoca Quality Consortium (AQC). Patty is a frequent speaker and writer on topics surrounding clinical outsourcing, innovation in life sciences, and quality/risk management in clinical trial execution.

Ken Olovich serves as the Executive Director of Sourcing, Procurement, and Finance for the Chorus Division at Eli Lilly. With a background as a pharmacist from Purdue University and an MBA in Finance, he brings over 32 years of experience to his role at Eli Lilly. In addition to his long-standing career at the company, Ken has remained actively involved in various areas of pharmacy practice. He has been married for 33 years and is the proud father of three children: a daughter who is a Doctor of Physical Therapy, a son who holds a master’s degree in Marine Biology, and a daughter currently pursuing a nursing degree. Outside of his professional life, Ken is a dedicated athlete, an avid pickleball player, and continues to actively pitch in a 55+ baseball league.

Joe O’Rourke serves as the Head of Commercial Development for Walgreens RWE Clinical Trials as the Head of Commercial Development. He brings 20 years of experience in the clinical trials space and has a passion for increasing patient access and diversity to clinical trials. 

Joe’s history involves growing clinical trial companies, recruiting patients, and conducting clinical trials in a leading academic medical center. Prior to Walgreens, Joe served as Vice President of Business Development at WCG Clinical. Over the course of 7 years, he was responsible for the growth of strategic partnerships, clinical trial enabling technologies, growth of endpoint solutions in CNS diseases, as well as the commercial integration of several acquisitions by WCG. 

Prior to WCG, Joe spent 8 years recruiting patients at Acurian (now a part of PPD/Thermo Fisher Scientific) where he spent 4 years in operational delivery in a variety of roles and 4 years in business development. Joe personally delivered and oversaw more than 100 patient recruitment campaigns and helped to accelerate to market blockbuster new medicines in Diabetes and COPD. He also specialized in early digital patient recruitment from 2009-2011. In Joe’s last 4 years there, he was a Business Development leader supporting Acurian’s growth and account management within the large biopharma market segment. 

Joe started his early career as a research assistant at Johns Hopkins, performing metabolic research in wound healing as well as exercise science. Joe has a MBA from Villanova University and a Bachelors in Kinesiology from West Chester University.

Dr Kantor is a scientist, entrepreneur, and company builder with over 10 years of experience in the genetic medicines field. He is Senior Vice President and leads Business and Corporate Development at ReCode. Previously, Dr Kantor served as an entrepreneur in residence at Oxford Science Enterprises, where he led company creation efforts and financings for several Oxford spinouts. Prior to Oxford, Dr Kantor was an investment banker with Evercore Partners and a management consultant at Headland Strategy, advising on corporate strategy, M&A, and ECM transactions. Dr Kantor has co-founded multiple companies in the fields of gene editing and RNA biology. In recognition of his technology developments, he was recognized in 2023 Forbes 30 under 30 in Science and Health Care. Dr Kantor graduated from Duke University summa cum laude with a B.S. in bioengineering and finance and received his PhD in Clinical Neuroscience from Oxford University, where he was a Rhodes Scholar.

Yoshiyuki Nakagawa, PhD, is an Assistant Manager at Asahi Kasei Corporation. He brings six years of academic research experience in biomaterials (2012-2018), during which time he also served as a Japan Society for the Promotion of Science (JSPS) Research Fellow from 2016 to 2018. Having earned his PhD degree from The University of Tokyo in 2018, he transitioned to a pivotal role in the development and commercialization of an innovative pharma excipient: hyaluronic acid nanogel, Sonanos™, at Asahi Kasei. Leveraging his background in Biomaterials, Polymer Science, and Chemical Engineering, he is passionate about driving advancements in drug delivery technologies.