With more than 25 years of experience in med tech and pharma, Dr Justin Wright currently serves as VP of Device, Packaging, and Process at Gilead, where he is responsible for leading the product system strategy and development activities for Gilead’s portfolio of biologics and small molecules. Before joining Gilead, Dr Wright led enterprise innovation and Connected Health development at Novartis, helped launch, and then led Lilly’s Cambridge Innovation Center, tasked with building Lilly’s next-generation delivery and connected product systems. In prior roles, Dr Wright worked at BD, where he served various roles focused on developing and commercializing drug delivery systems for the biotech, vaccine, and pharmaceutical industries. He began his career at Merck & Company, working in manufacturing, product commercialization, and franchise management. Dr Wright holds a PhD in Bio-Organic chemistry from Clemson University and completed a research fellowship at Harvard Medical School. He is the author of more than 50 patents and publications.

Dr. Alireza Nomani is a Pharmaceutical Scientist with experience in drug and gene delivery using polymeric and lipid nanoparticles (LNP) for cancer therapy, mRNA vaccines, and gene editing. He received his Doctor of Pharmacy in 2003 and earned two PhDs in Pharmaceutical Chemistry and Pharmaceutical Sciences in 2010 and 2021, respectively. Before joining Regeneron and current role in new technology development for biologics delivery, Alireza also experienced two postdoctoral fellowships in non-viral gene therapy and molecular pharmaceutics and worked on projects related to quantitative image analysis, such as quantitative magnetic resonance imaging (qMRI) for theranostics applications. During his more than 15 years of research career, he has also gained extensive experience in macromolecular analytical method development and in-depth characterization of mRNA drug substance, LNPs, protein therapeutics, and long acting injectable manufacturing. Furthermore, his track record of industrial and academic collaborations has resulted in 38+ publications in various reputable journals, such as Science, Biomaterials, Journal of Controlled Release, and US patents.

Strategic leader in multifunctional organizations and biopharmaceuticals with 13+ years experience in sterile injectables; proven track record of leading change utilizing technical knowledge, CDMO experience, customer service expertise, and results oriented approach. Technical transferred over 53 product skus across 14 customers.

Dr Suman Luthra is currently Director in Discovery Pharmaceutical Sciences at Merck Boston site and is responsible for providing strategic and technical leadership at the discovery-development interface to enable the discovery of new drug candidates including small molecules, peptides and biologics. She oversees preclinical drug product development activities that include nomination of candidate for clinical development through developability risk assessment and application of insights to assess and mitigate CMC drug product developability risks. Dr Luthra’s team enables the transition of the right molecules from discovery to clinical formulation development with clinical formulation strategies in place. With 30+ active programs including various modalities and stages of development, she provides scientific oversight and make strategic decisions for acceleration. She is passionate about advancing patient friendly drug delivery solutions of diverse modalities including macrocyclic peptides which is the focus of the panel discussion today.

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.