Andreja is the Head of the Process Analytics Development department at Sartorius BIA Separations. She leads a team focused on advanced chromatographic solutions, involving the development of innovative chromatographic analytical methods for analyzing biological molecules, including viruses, pDNA, mRNA, and LNPs. Throughout her career with biotech companies, she has gained extensive experience in protein chemistry, including characterisation of biosimilars and biologics. She holds a Master of Science in Biochemistry from the University of Ljubljana, Slovenia.

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Ana Cadete is a CMC Leader at the mRNA Center of Excellence at Sanofi, where she leads the strategy and manufacturing of mRNA vaccines. With a background in pharmaceutical sciences and nanomedicine, Ana has dedicated her career to developing novel drug delivery systems. Ana holds a PhD in Nanomedicine and Pharmaceutical Innovation and completed her postdoctoral research at the Langer Lab at MIT. From 2017 to 2022, she worked as a formulation scientist at Moderna, developing CFTR mRNA lipid nanoparticles.

Beyond her scientific career, Ana is passionate about leadership and mentorship. She is the founder of The Non-Conformist Scientist, a nonprofit organization dedicated to elevating scientists' careers and inspiring the next generation of female scientists to become leaders.

Chris Riley is a leader on the Strategic Insights team at H1, specializing in addressing clients' unique needs across the pharmaceutical product lifecycle. In his role, Chris serves as a key liaison between clients and product teams, ensuring that H1’s clinical offerings leverage the latest advancements in AI and DE&I performance data to drive more diverse and effective clinical trials.

With over 15 years of scientific expertise, Chris now focuses on bringing clinical solutions to market that promote equitable patient access to trials, spanning areas such as protocol optimization, site selection, and principal investigator identification.

Chris holds a Bachelor of Science in Biochemistry from the College of Charleston and a PhD in Biochemistry from the University of Texas at Austin.

Breck’s 30-year career spans a variety of roles in consumer, industrial, and life science product development. He has served in engineering, project management, engineering leadership and client advocacy roles in over 100 projects. A core tenant of his approach is understanding and meeting both the end-users’ and clients’ wants and needs. He shares his expertise in product planning, realization, operational leadership, and commercial strategizing in his role at Battelle and as an advisor to specific startups within the innovation and accelerator communities.

Breck’s current objectives include building a deep understanding of the implantable drug delivery device space, and in facilitating partnerships between the pharmaceutical industry and suitable development partners.

Dr. Janelle A. Sabo is a recognized leader in drug development, clinical research, and product delivery.  Her unique background has driven a strong patient focus and desire to find innovative ways to deliver new therapies faster to patients and the global medical community.

Janelle is currently Senior Vice President of Clinical Capabilities at Eli Lilly and Company. Her organization encompasses over 1500 employees across the globe delivering over 500 clinical trials. Clinical Capabilities is responsible for the delivery of clinical studies, including investigator engagement, trial capabilities, clinical labs and systems, clinical trial material, ancillaries and related supply planning/delivery, clinical development systems, clinical research services, clinical innovation and digital health.

Janelle started her career in clinical development and has held key leadership roles across clinical development, chemistry manufacturing and controls, portfolio management and led drug development and brand teams from early discovery to launch. In each role, Dr. Sabo has driven innovative designs, delivery and transformation leading to accelerated drug development and savings over a $1 billion dollars. As an example, she transformed the clinical supply chain to be end to end resulting in 15-20% faster cycle times and a savings of over $200M. During the COVID-19 pandemic, Janelle led the COVID-19 Therapeutics Platform which delivered multiple neutralizing antibodies in under 12 months from discovery to market and utilized novel approaches for clinical and commercial delivery. 

Dr. Sabo recipient of multiple awards at Eli Lilly and in the industry.  She has been named to the Global Product Development President’s Council, twice honored with the Lilly Research Laboratories President’s award, selected as the University of Missouri Pharmaceutical Industry Alumni of the Year and the Pharma We Work for Health award. She has served on dean’s advisory boards, including Butler University and UMKC Dean’s Advisory Board. Janelle holds a Doctorate of Pharmacy from the University of Missouri, Global Executive MBA from Georgetown University, and a Global Executive MBA from ESADE- Barcelona, Spain.

Dr. Sabo is a guest lecturer at several universities and colleges of pharmacy on drug development an has spoken at conferences within the pharmaceutical industry and was the keynote graduation speaker for the UMKC School of Pharmacy. To connect with her, visit @  https://www.linkedin.com/in/janelle-sabo-16248114 .

Dr. Yngve Mikkelsen is an experienced physician, health economist, and biotechnology executive with over 25 years of leadership in pharma, medtech, and translational R&D. He currently serves as Chief Medical Officer at AlgiPharma, where he leads the company’s clinical, regulatory, and partnering strategy for novel alginate oligosaccharide technologies. Dr. Mikkelsen previously held senior roles at Pfizer, Biogen, Akershus University Hospital, and the Norwegian Medical Association, successfully leading multiple regulatory programs through the FDA and EMA. His work focuses on advancing non-injectable delivery of complex therapeutics, including peptides and lipid nanoparticles, via mucosal and oral routes. Yngve also holds a Doctor of Business Administration from Cranfield University, an MSc in Health Economics from the London School of Economics, and an Applied Data Science certificate from MIT. He is a regular contributor at ISPOR and serves on the expert review panel of the Norwegian Research Council.

Charles has more than 30 years experience in the drug delivery industry. He has been employed as a Project Leader for the last five years at Chiesi, an Italian family owned pharmaceutical company with a turnover of ~€3.5bn. Chiesi is a leader in respiratory medicines and has an expanding range of rare disease products which utilize a range of delivery technologies. Charles is working on a range of projects requiring the administration of small molecules, peptides and proteins.

Much of Charles’ career has focused on novel injectable technologies. Following an engineering degree and PhD, Charles joined PowderJect Pharmaceuticals and saw it grow from 4 to >1,000 employees. He then founded and was CEO of Glide Pharma for 12 years before working as an independent consultant with a portfolio of companies which were either developing a proprietary drug delivery technology or were selecting a delivery technology for their novel compound.

Chris Cooper is a Device Engineering Lead at Gilead Sciences, where he supports the development of long-acting injectable drug delivery systems for HIV prevention. He specializes in design control, combination product development, and supplier collaboration. Prior to Gilead, Chris led the technical development of a fully customized on-body delivery system for subcutaneous administration of a biologic oncology therapy, learning key insights into the use of wearable systems for extended drug delivery. Earlier in his career, he supported commercial biologics manufacturing at Bristol Myers Squibb, contributing to the launch and lifecycle management of immuno-oncology therapies. Chris holds an M.Eng. in Bioengineering from UC Berkeley and a B.S. in Chemical Engineering from UCLA. He brings a multidisciplinary background in drug-device development and is passionate about advancing patient-centered delivery technologies and enabling patient access to breakthrough therapies.

After starting her career in New Jersey at Merck as a Research Biologist, Karen Lowitz changed direction and moved into Regulatory Affairs. In 2009, she relocated to beautiful Colorado where she joined Sandoz with responsibility for generic drug regulatory submissions. Most of her professional time in CO was with Terumo BCT supporting blood collection and cell processing devices, which provided opportunities to manage a team and travel to Japan, Northern Ireland, Vietnam, and India to support combination product manufacturing. In 2023, she joined Biogen to work on a Phase 3 clinical therapy to be presented in multiple drug/device combinations. In 2025, sunny California became her home, and she continues to support the complex program for which Biogen plans to commercialize. Global regulation of combination products is ever evolving, which is why it is exciting to work in this space.