Thomas von Erlach, PhD co-founded Vivtex and joined as its Chief Scientific Officer when Vivtex was formed as a MIT spin-off in 2018. Prior to that he led the interdisciplinary efforts around gastrointestinal model systems for oral drug delivery applications at the Laboratory of Prof. Robert Langer and Prof. Giovanni Traverso at MIT. Dr von Erlach obtained his PhD from Imperial College London in Bioengineering and a BSc and MSc in Biochemistry and Biotechnology from ETH Zurich in Switzerland. His research interest include advanced in vitro models for drug development, oral drug delivery and gastrointestinal pharmacology. His work is published in several high impact journals such as Nature Materials, Nature Biomedical Engineering, and Nature Communications.

Jerry obtained his Ph.D. at the University of Utah and was an NIH fellow at Harvard University before starting his industrial career at Pfizer Central Research. Prior to joining Amgen in 2006, Jerry was Sr. Director of Process Development at Merck Research Laboratories, where he led several PST level cross-functional teams. In August 2013, Jerry joined the Amgen Full Potential Initiative and led the AFP#3 team, Redesign Process Development through Business Case and into Implementation planning. In August 2014, Jerry became VP CMC Lifecycle Management within the Process Development organization where he managed the support for the commercial products and their lifecycle management activities, as well as the early development portfolio. His team was responsible for organizing and planning all drug delivery activities including drug substance manufacture, product formulation and drug delivery technologies including medical devices. During that timeframe, Amgen launched 10 new products for which this team was responsible for all CMC activities. In May 2018, Jerry was promoted to Sr. Vice President, Process Development, where he now serves both the Operations and R&D Organizations.

Marcie is currently the Chief Medical Officer at Tectonic Therapeutic, Watertown MA. She has over 18 years of experience in drug development across all stages of clinical drug development from translational/early development through post approval and across multiple modalities including small molecules, siRNA and biologics. She was named one of the 2023 Top Women in BioPharma by Endpoints News. Prior to joining Tectonic, she was VP and Head of Clinical Development for the Immunology/Inflammation Therapeutic Area at Regeneron Pharmaceuticals. In that role she led the clinical development of Dupixent® through over nine Phase 3 trial initiations and multiple regulatory approvals globally, including approvals for adult and pediatric asthma, pediatric AD, chronic rhinosinusitis with nasal polyps. She was instrumental in the pivotal study design and its execution supporting the recent approval in eosinophilic esophagitis and design of COPD studies. Over her career, which has included time at Merck and Alnylam and EMD Serono, she has built and led clinical development and cross functional groups across a range of therapeutic areas including respiratory, inflammation, bone, anemia and metabolic and rare diseases. Prior to entry into drug development, Marcie held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Program. She holds an AB from Princeton University and a MD/ MS from Washington University, St. Louis and completed her internal medicine and pulmonary fellowship training at Harvard Medical School affiliated hospitals.

Susan P Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Ms Landis led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI), the largest academic research institute in the world. While at Duke, Ms Landis established and led the DCRI Research Communications & Engagement group and created ResearchTogether™, a model for championing patient engagement at every phase in clinical research trials and studies. With her team, she ushered in a unique method for returning results to trial participants and established the first-ever Engagement Protocol™ model. Ms Landis also served as a team member on commercial-funded interventional and outcome studies and several large government-funded trials, including the Environmental Influences on Child Health Outcomes program (ECHO), the ABC Science Collaborative, and RADx-UP. Prior to joining Duke, Ms Landis worked at Quintiles (now IQVIA) as an executive for the company’s Patient Engagement division. She also managed the company’s branding initiatives and thought leadership program and served as a corporate communications business partner for the company’s business units that represented more than $5 billion and 30,000 employees.

Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information for patient communities. Through opportunities working with healthcare organizations on content strategy, writing, speaking, clinical trial development, and sharing the patient experience, she aims to affect the healthcare landscape by raising awareness of rare diseases, promoting self-advocacy to patients, and valuable insights to organizations. More of her work and experiences can be found at www.ellabalasa.com.

Tyler Bye oversees the strategic deployment of solutions tailored for each indication and personalized to each site’s individual needs. With 15 years of clinical research experience, Mr Bye implements best practices and lessons learned across therapeutic areas and indications that resonate with the target patient profile. Previously, he has worked directly with patients as part of a comprehensive cancer center and has developed and implemented global protocols from a sponsor perspective.

At Novartis, Jennifer Yip’s mission is to find novel approaches to leveraging data and technology to design better clinical trials, accelerate patient recruitment, drive patient engagement, and re-imagine clinical trial data collection and management for the US Medical Affairs organization. Before joining Novartis, Ms Yip held global clinical and commercial digital innovation roles at other big pharma and led global product marketing in eClinical, healthcare, and ad tech technology organizations.

Bryan Cobb is a PR Medical Science Director and the Healthcare Delivery Innovation & Collaborations Lead at Genentech, U.S. Medical Affairs. Dr Cobb is focused on bringing novel biomarkers (digital and traditional) as well as innovative healthcare delivery tools into clinical trials and clinical practice with the goal of improving disease identification, patient treatment, and a patient’s overall quality of life.

Dr Cobb obtained a PhD in Medical Genetics at the University of Alabama at Birmingham and completed an American Board of Medical Genetics post-doctoral fellowship at NIH (National Human Genome Research Institute). He is a board-certified diplomate of the American College of Medical Genetics & Genomics.

Dr Cobb has held several roles at Roche, including Lead for the GE Healthcare partnership for Acute Care, Head of Medical Affairs for Roche, Director for Roche’s Molecular Centers of Excellence, and has over 15 years of experience across therapeutic areas (infectious diseases, genetics, neuroscience and oncology). He has published in key scientific journals, is a scientific reviewer for journals such as the Journal of Clinical Microbiology, and has served on several international scientific committees and working groups.

Leslie Addy has over 10 years of experience in the biotechnology industry. He is currently Director of Development Operations Innovation and Decentralized Clinical Trials at Amgen where he is driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies and services. Mr Addy spent a majority of his working life in Information Systems and Digital Health and has a proven track record of identifying, testing and bringing new solutions to scale, in close collaboration with internal and external stakeholders. He has a Bachelor’s Degree in Computer Science and Mathematics and an MBA from the University of Southern California (USC).

Ardy Arianpour is CEO & Co-Founder of SEQSTER the leading healthcare technology company that puts the patient at the center of all their health data for more efficient clinical trials and improved healthcare outcomes for life science enterprises. With over 20 years of experience driving innovation in life sciences and digital health, Mr Arianpour is a visionary health tech executive. Before founding SEQSTER, he successfully launched numerous clinical and consumer-based genetic tests while serving as CCO of Pathway Genomics. Additionally, he held the position of SVP of Ambry Genetics, which was sold to Konica in 2017 for $1 Billion.

Mr Arianpour played a crucial role in the landmark SCOTUS decision that eliminated gene patents, expanding access to genetic testing. The launch of BRCA testing, in particular, significantly benefited patients and their family members nationwide.

Mr Arianpour received his BS in Biological Sciences from UC Irvine and an MBA from Marshall Goldsmith School of Management. He was a Medical, Marketing, and Media’s (MM&M) Top 40 Healthcare Transformer and San Diego Business Journal 40 under 40. Mr Arianpour is on the Digital Health Advisory Board of UCSD and Faculty for NextMed.Health.

Hila Barak, PhD, joined Gilead in 2021 as the Head of Oncology Clinical Science and Chief of Staff. Dr Barak serves as a key business partner to the Oncology Therapeutic Area Head and is immersed in strategic and operational elements for Gilead’s Oncology, leading and driving large projects, providing insight and access to the organizational strategy and direction.  Furthermore, she is directly responsible for building, managing, and mentoring a high-performance clinical science team to support clinical development programs across the Oncology Therapeutic Areas.

Dr Barak obtained her PhD from the Technion Institute in Israel and completed her post-doctoral fellowship at Washington University School of Medicine in St. Louis, where she performed distinguished research in the field of stem cells and renal development. After joining the pharmaceutical industry, she held a variety of roles in Regulatory Affairs, Global Medical Affairs and Clinical Science in multiple therapeutic areas as well as leadership roles, in leading strategic and operational projects for Clinical Oncology within R&D organization and provided strategic input for future clinical development of products in the pipeline. In her last role, Dr Barak served as the Global Clinical Lead for the MORPHEUS Combination Platform at Roche-Genentech, where she effectively led the overall strategy of more than 40 novel combinations tested across 10 solid tumor indications. In addition, she led several innovation initiatives to bring transformative treatment to patients with unmet medical need, including utilization of Artificial Intelligence tools to explore combination development and patient enrollment.  

Dr Barak is passionate about bringing transformative treatment to patients with cancer. 

Kimberly Barnholt has spent over 20 years in the healthcare industry in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.