Dr Andrew Stelzer is a business development expert in the biotechnology and pharmaceutical industries. Most recently, he supported NewCo formation and translational efforts at The Salk Institute for Biological Studies. Prior to Salk, Dr Stelzer developed the partnering strategy for InSphero, a Swiss biotechnology company spun out of ETH Zurich, and co-founded Nymirum, a private venture backed biotechnology company, spun out of the University of Michigan. He holds a Ph.D. in Biophysics and Chemical Biology from the University of Michigan and a B.S. in Chemistry from the University of Toledo.

Ruben Rodriguez, PhD is an accomplished pharmaceutical research and development leader who brings a wealth of experience in oncology and cell therapy. He has served as the Global Head of Research at InstilBio where he oversaw tumor-infiltrating lymphocytes research efforts and helped drive regulatory milestones. He started his career at Kite Pharma where he developed multiple novel CAR-T constructs and led key collaborations.

Dr Rodriguez earned his PhD in Neurobiology and Molecular Biology at the Hospital Clinic in Barcelona and later conducted his postdoctoral studies at Salk Institute for Biological Studies, advancing the fields of neurobiology and stem cell biology respectively. Contact info to date:

Jie Tang is a Principal Scientist at Phosphorex with over 10 years of combined academic and industrial experience in the development of lipid and polymer-based drug delivery systems. Her work has led to more than 40 peer-reviewed publications in top- tier journals and has contributed to three patents in the field.

Prior to joining Phosphorex, Jie managed a variety of projects and led a team at University of Michigan, focusing on the development of sustained and controlled long- acting contraceptives. She earned her B.S. and Ph.D. degrees from West China School of Pharmacy, Sichuan University, and completed her postdoctoral research at University of Michigan.

Hazel Doydum is a visionary leader in digital transformation within the pharmaceutical industry. With extensive and broad experience across Information Technology, Reimbursement, Digital Marketing, Marketing & Sales Operations, Learning & Development, and Clinical Operations, she has consistently driven innovation and process efficiency through automation in each of her roles. Currently, Hazel leads a team at GSK focusing on the large-scale integration of digital health technologies and decentralized trial components within the Global Clinical Operations portfolio. An early adopter of technology, Hazel is based in Pennsylvania and finds joy in camping and exploring the outdoors.

Ashley is the Vice President, Product Lead at Advarra. In this role, Ashley collaborates with current partners and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Ashley has over 20 years of expertise in site activation, clinical operations, data management, and clinical strategy.

Dr Edel Mullen is the Director of Pivotal Biologics Drug Product Technologies at Amgen, holding a PhD in Biochemistry and an MBA from UMass Amherst, plus a Lean Six Sigma Black Belt. With expertise in process development, regulatory affairs, and external manufacturing, she has led numerous projects on process optimization and formulation changes. Dr Mullen is an expert in regulatory affairs for clinical trials and a strategic consultant for approvals. She is dedicated to aligning strategies with organizational goals to drive innovation and deliver advanced therapeutics to patients.

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.