2024 Main Stage Speakers
Every conference has talks. Too many are overlong, underprepared, thinly vetted, and poorly lit. The Gathering will feature a small number of tightly crafted talks, from different perspectives and disciplines – bridging cultures from the clinical to the software worlds.
Here is our current speaker lineup for the 2024 Gathering (more speakers TBA)
Founder & CEO | Empactful Ventures
Topic of Dr. Bronner’s talk: Evaluating Protocols for Useability
Denise has roughly 15 years of organizational thought leadership experience within the global healthcare/tech space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch and storytelling refinement, and identifying business opportunities within the pharma space.
Beyond her professional endeavors, Denise is passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a Bachelor’s degree in Biological Sciences from Wayne State University, a Ph.D. in Microbiology & Immunology from the University of Michigan - Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.
Denise N. Bronner, Ph.D.
Associate Director for Data Science and Artificial Intelligence Policy | FDA
Topic of Dr. Fakhouri’s talk: Where artificial intelligence and regulation meet.
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing medical policy with a focus on data science and the use of Artificial Intelligence (AI) in drug development.
These efforts include overseeing an AI policy group, as well as engaging external stakeholders and advancing the development of regulatory science around the use of AI in drug development. She also contributes to the development of medical policy related to real-world evidence and the use of digital health technologies for medical product development.
Dr. Tala Fakhouri
Principal | HealthX Ventures
Topic of Laura’s Talk: Why Great Ideas Fail
Laura Hilty is a health tech operator turned venture capital investor. After nearly two decades working to improve the healthcare ecosystem, including 14 years in clinical research, she is investing in early-stage health tech companies and helping portfolio companies grow through strategy and board work. Prior to HealthX, she held leadership roles spanning corporate strategy, M&A, product strategy, product management, and partnerships across stages from company start-up to scale through Forte / Advarra and Epic.
Through that time, she launched 7 new software products, helped the company exit, developed corporate strategy, and acquired 6 companies within 18 months, all contributing to the company's $5B valuation.
With clinical research domain expertise combined with experience in Electronic Healthcare Records (EHRs) at Epic, she is passionate about creating new paradigms in healthcare that create impactful and sustainable change. Laura holds a Bachelor’s in Molecular / Cell Biology from Vanderbilt University, is a mentor to start-up entrepreneurs, active in helping improve healthcare in Africa, and spends her free time negotiating with her young daughter or outdoors hiking or kayaking.
Laura Hilty
Global Head, Collaboration and Technology Strategy | Novartis Pharmaceuticals Corp. & Workstream Leader, Digital Data Flow | TransCelerate Biopharma Inc.
Topic of Bill’s Talk: Shipping Containers & Vacuum Cleaners: How better data interoperability can unlock better human trials. (Aka, “to do the cool stuff, we have to do the boring stuff.”)
Bill has over 30 years of industry experience in Life Science R&D spanning subject areas of Cancer Epidemiology, Health Care Cost/Utilization Research, Preclinical Safety, and Clinical Development and Regulatory Affairs. He has led business and information technology functions in Drug Development at Novartis and enterprise transformation projects in data and digital across the pharmaceutical R&D landscape.
For the past 5 years he has also worked for the pharmaceutical consortium, TransCelerate, leading an industry- wide innovation project which aims to drive the efficient, effective, and high-quality delivery of new medicines through the development and adoption of standardized clinical study protocol digitalization solutions.
Bill Illis
R&D Standards Expert | Bayer
Topic of Julius’s talk: How to Unlock Innovation Within Large Pharma
Julius is R&D Data Standards expert at Bayer and leads a team that manages clinical standards and its automation within Bayer Pharma. Julius has over 20 years of experience in the pharmaceutical industry both at pharma and the CRO side.
During his career he worked or held management roles in data management, statistics, statistical programming, standards management and quality management which gives him an unique perspective on processes in clinical development and corresponding standardization and automation opportunities.
Julius Kusserow
Director | Muchieast LLC
Topic of Enrique’s talk: Innovation Ecosystems: What teaching spies and bureaucrats can teach clinical research design.
Enrique’s expert power is to apply a design mindset to the challenges that leaders across all sectors face today. He helps organizations build cultures of ideas that breed innovation. From his early career as a practicing architect and industrial designer, he holds simplicity, know-how, and insightfulness as core values. To transform leaders with a vision of work that places imagination at the core of diversity of thought, insightful action, and effective communication, he founded Muchieast LLC, a design and innovation consultancy that partners with companies and individuals committed to a better tomorrow.
Clients have included Sibley Hospital, Humana Inc., MIT Collaborative Initiatives, the Prime Minister’s Office of the U.A.E., and the U.S. Department of State. Previously, Enrique was a Senior Critic at the Rhode Island School of Design, a visiting professor at Brown University and, further back in time—and while still a struggling architecture student—the architectural critic for El Mundo del Siglo XXI, one of Spain’s leading news organizations.
Currently, in addition to his consultancy work, he serves on the faculty of the Federal Executive Institute, bringing his creative expertise to the leadership development journeys of federal executives, managers, and supervisors. Enrique is a fellow of the Royal Society for the Encouragement of Arts, Manufactures and Commerce (RSA) and a keen visual tinkerer who relies on his drawing and diagramming skills to understand and explore ideas and interventions.
Enrique Martínez-González
Chief Technology Officer and Chief Product Officer | Saama
Topic of Lisa’s talk: Human Data & AI: Training our machines better than we trained our grandfathers.
Lisa Moneymaker is the Chief Technology and Product Officer for Saama, an industry leader in AI-supported SaaS products for the clinical development analytics space. Lisa has nearly 25 years of experience as a leader in the pharma, biotech and medical device industry, specializing in delivering complex systems solutions in support of excellence in clinical trial execution.
Prior to joining Saama, Lisa was Senior Vice President of Clinical Operations Technology at Medidata Solutions. In this position, she helped to advance the role of internal sponsor and CRO technology, leading solutions across the RBQM, Centralized Monitoring, CTMS, and Payments space.
Lisa began her career at Accenture and continued as an independent consultant, gaining exposure to information systems across the pharma space. Much of her career was in support of Amgen, developing systems within its global development organization, which gained her exposure and recognition as a subject matter expert within pharma information systems. While at Amgen, she was given leadership roles within TransCelerate Biopharma, driving industry innovation through delivery of the Shared Investigator Platform and the Investigator Registry.
A graduate of University of Southern California, Lisa holds a BS in Biomedical Biochemical Engineering.
Lisa Moneymaker
Senior Vice President, eCOA Strategy | YPrime
Topic of Donna’s talk: Future Proofing Patient-facing Clinical Technology
Donna’s diverse career in healthcare began in nursing and evolved to focus on technologies that support patients in clinical research. With nearly 20 years in the clinical trials space and expertise in patient centricity, improving enrollment success, eCOA, BYOD, and more, Donna is a published author and presents regularly at pharmaceutical industry conferences. In her current leadership role at YPrime, she is the subject matter expert for eCOA, providing strategic direction that drives key partnerships through innovation.
Donna Mongiello, RN, BSN
Director, Localisation Services | YPrime
Topic of Jonathan’s talk: Translation, AI and Diversity Action Plans
As Director of the Localization Services group, Jonathan Norman leads the translation and questionnaire licensing strategies for YPrime’s products and services.
With 7 years of experience in the localization of both paper and electronic COAs, Jonathan has been actively involved in the development of strategies to ensure the quality and accuracy of translated materials for clinical trials. He has a special interest in innovating localization to reduce the burden of translation for study teams, making it easier to include wider reaching and more diverse populations in their trials.
Prior to joining YPrime earlier this year, Jonathan served in multiple positions of increasing responsibility at RWS Regulated Industries. Jonathan began as a Linguistic Validation (LV) Project Manager in 2016, directly guiding study teams through their COA translations processes. As Director of LV Quality & Purchasing, he oversaw the organization's approach to ensuring the quality of translated deliverables and the effective purchasing of services from freelance linguists, all in line with industry standards.
Throughout his career, Jonathan has built strong relationships with eCOA providers, pharma sponsors and questionnaire copyright holders, often serving as a trusted SME for localization best practices in the COA industry.
Jonathan Norman
Senior Director, Head, Global Site Engagement | GSK
Topic of Laura’s talk: Reducing Friction in Clinical Research
Laura is a high-engagement high-ownership leader passionate about eliminating preventable pain and working and living out of a place of freedom. She has built expertise in her more than 20 years in clinical operations and now has a never-ending well of energy for working together in iterative and transformational ways to remove friction and deliver trials faster with our collective sanity intact.
Her career began in bench science where she fell in love with the immune system, but since then she has held a variety of complementary biotech and pharma roles leading cross functional teams in highly diversified therapeutic areas. After establishing her foundation, she focused on clinical trial optimization and strategic site alliances, including building a Study Start-Up unit, leading US and global investigator-centered innovation pilots, building tailored strategic partnership models with diverse institutions, and launching a bi-directional site feedback program to drive sustainable and effective collaboration and performance. She is currently the Head of Global Site Engagement at GSK and enjoys partnering with teams to unlock the power focused, intentional effort to accelerate clinical trials, transform the site and patient experience, and integrate innovation in drug development.
Outside of her professional pursuits, she is deeply committed to her San Francisco church community, and finds deep fulfillment in serving as part of a vibrant recovery ministry focused on helping individuals find freedom and healing. These experiences have profoundly shaped her perspective and enrich her work, allowing her to bring a compassionate, holistic approach to everything she does.
Laura O’Donnell
Partnerships Lead | Sano Genetics
Topic of Lindsey’s talk: What Death Might Teach Us About Better Research: Lessons from a Clinical Research Professional & Momatologist.
Lindsey Wahlstrom-Edwards has spent the past decade helping to create space for participant voices in medical research. In 2023, life caught up with her profession when her daughter, Rona, was diagnosed with a rare disease and died from complications from treatment.
As her daughter’s stem cell donor, Lindsey participated in four clinical trials in three months along with her child. Her experience as a rare caregiver led her to question much of what she thought she knew to be true about her work, and she has since begun challenging how we think about outcomes and define success.
Lindsey currently leads partnerships for Sano Genetics, and previously worked in research at Antidote Technologies and at Columbia University. She spent the first 10 years of her career teaching individuals around the globe how to write Entertainment-Education soap operas. Lindsey holds an MPH from Columbia University and bachelor degrees (BA/BS) from Boston University.
Lindsey Wahlstrom-Edwards
On Stage Hosts
SVP of Site-Sponsor Innovation | Advarra
Christine Senn, PhD is the SVP of Site-Sponsor Innovation at Advarra, a global company offering services and technology solutions to safeguard trial participants and enable collaboration across all industry domains. She has worked in clinical research since 2005, starting at the University of Vermont then spent 16 years building the site network that became Centricity Research, where she served in various business roles across strategic growth initiatives, project planning and execution, and continuous process improvement.
Christine has a PhD in psychology and master’s degrees in clinical psychology and advertising and public relations. She was the 2023 Chair of the Association of Clinical Research Professionals (ACRP), is an ACRP Fellow, and is double certified as a Certified Clinical Research Coordinator (CCRC) and Certified Principal Investigator (CPI).
Christine Senn
CEO | Lokavant
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley.
Rohit Nambisan
Main Stage Talks From Past Gatherings
Watch all the main stage talks from 2022 and 2023.
2024 Registration is Open!
Use the following form to nominate yourself or someone else.
If you have already been nominated and invited, please check your inbox for your special registration link and register ASAP. One of the defining features of the Gathering is that there are only 150 attendees that are invited for the full event.