AI in Pharma: Clinical Development

Greg has been at Merck since 2015, and is now Associate VP in Clinical Research, and Head of Clinical Imaging and Pathology. With his team of radiologists, pathologists, and research scientists, he oversees endpoint assessments in ~250 clinical trials in oncology, neuroscience, immunology, cardiovascular, infectious, and metabolic diseases. He also leads teams conducting research in artificial intelligence, tumor growth kinetics, novel response criteria, and other innovative approaches to clinical trial imaging. Prior to Merck, he was a senior medical director and head of oncology imaging at a global CRO, and before that in academia. He participates and has held leadership positions in QIBA, PINTAD, CDISC, RECIST, Project Data Sphere, and other industry and academic collaborations. His clinical training was in diagnostic radiology, along with a PhD and postdoctoral research in neuroscience, and business training in finance.

Nirmal Keshava is the Vice-President of Data Science and Innovation at Cerevel Therapeutics, where he leads efforts introducing novel data-centric approaches and technologies into all parts of the drug discovery and development continuum.  Previously he was the Head of Artificial Intelligence at BioXcel Therapeutics and a Senior Principal Informatics Scientist at AstraZeneca.  Preceding his career in the pharmaceutical industry, he spent 15 years leading government and industry-sponsored research at MIT Lincoln Laboratory and the Charles Stark Draper Laboratory.  Before that he worked as a telecommunications system engineer at Bell Communications Research.  He received his B.S. and Ph.D. in electrical engineering, respectively, from UCLA and Carnegie Mellon University.  He has been recognized by IEEE, NSF, and NAE.

Alex Aronov is Executive Director and Head of Data Science at Vertex Pharmaceuticals, a function he co-founded in 2017 to address data-centric problems across the entire business through application of advanced analytics and machine learning. 

Previously, Alex led the Discovery Informatics team at Vertex, with responsibility for HTS content and enrichment, the global chemogenomics initiative, as well as the company’s toxicogenomics efforts. He started his career as a computer-aided drug design scientist and was involved in projects in oncology, inflammation, rare diseases, and antivirals. 

Alex serves on the Drug Discovery for the Nervous System committee at the Center for Scientific Review/NIH and is a board member for MIT delta v entrepreneurship bootcamp at the MIT Martin Trust Center. He is an author of over 30 peer-reviewed manuscripts and an inventor on over 40 international patent applications. He holds a PhD in Chemistry from the University of Washington and an MBA from MIT Sloan School of Management, and completed postdoctoral training at the University of California, San Francisco School of Pharmacy.

Youssef Idelcaid is an applied mathematics engineer by training, he is the head of Data Science, Commercial, Medical & Government  affairs at Genentech, renowned for his pioneering work in leveraging machine learning to tackle complex health equity and customer engagement challenges. 

With a proven track record of success across various industries, Youssef Idelcaid has held key positions at Levi Strauss & Co as the global head of AI and director of digital products, where he created the company’s first AI-powered Live Streaming Demand platform. 

Youssef Idelcaid’s career began in the food industry, where he served as a data analyst at Danone before joining L’Oreal Research & Innovation as a scientific computing manager, later becoming the brand’s director of technology incubator in the US. At L’Oreal, Youssef Idelcaid led the development of the company’s first ML-powered formulation assistant for chemists and initiated with other scientists L’Oreal’s connected and augmented beauty initiatives.

Ronak Kadakia, heads Data Science Digital Health Clinical Trial acceleration and transformation for multiple Therapeutic areas. She leads a team that spearheads data driven analytics and transformation to power trial recruitment and execution acceleration with best-in-industry Data Science AI/ML methods, approaches, insights, and innovation.

A 15+ years veteran in clinical trial landscape at Janssen R&D, Ronak has in-depth understanding of real world and clinical operations data, and AI/ML allowing her to lead various applications of them, across research and development. Having had the privilege of working with a variety of J&J sectors and Janssen functions she has successfully brought about process optimizations, increased business efficiencies, accelerated decision making within and across Therapeutic Areas and indications. Ronak has been instrumental in successfully leading the clinical trial feasibility analytics, enrollment modelling and advancing, thus enabling 100+ site recommendations for Janssen R&D. She has been a pioneer in designing and launching first of its kind centralized end to end Feasibility Site Intelligence hub and Site Engagement Hub. Both of which collectively allowed for rapid visibility into site selection process and reduction of site burden with a help of a well-defined Site engagement strategy. Additionally, she has been a key leader in driving data science pathway and data driven insights using multi-modal data and AI/ML approaches for Inflammatory Bowel Disease, Factor XIa, Rare Diseases, Pulmonary Hypertension among several other programs.

Laszlo Vasko’s career in leading technology enabled innovation in drug development spans over
twenty years having worked at Wyeth, AstraZeneca, and now Janssen Pharmaceuticals.
Throughout this career, Laszlo seized opportunities to engage drug development leaders in improving
the delivery of new medicines across clinical development program and trial design, clinical
information science, regulatory, and clinical operations. Laszlo’s current responsibilities, as Product
Group Leader for Therapeutic Area Enabling Innovation, are enabling Advanced Therapies such as
CAR-T, innovation in workflow and decision enablement, as well as continuing to pioneer Research in
Clinical Care – ways to leverage healthcare platforms for clinical trial execution.
A passion for understanding R&D challenges inspired Laszlo to complete a second Master’s of
Science degree, in Clinical Research Operations Management at Drexel University’s College of
Medicine. With degrees in computer science, information science, and clinical operations
management, he brings forth a blend of technical and functional expertise, combined with business
change management skills.
Laszlo lives in Harvard, MA and outside of work he’s active in the aviation community as private pilot.

Edward Ramos, Ph.D., is Chief Scientific Officer at CareEvolution and Co-founder of the Digital
Trials Center and Director of Digital Clinical Trials at Scripps Research. Dr. Ramos’ work is based
on the growing need to rethink clinical research studies by leveraging digital health
technologies and embracing decentralized, “site-less” approaches, which can promote broad
participation without sacrificing robust data collection. Ed’s leadership role focuses on
overseeing implementation of digital research studies in a variety of research contexts including
infectious disease, maternal health, sleep medicine, and precision nutrition (where he serves as
the primary investigator). Ed prioritizes efforts to address health disparities and to enhance
participation in a diverse, equitable, and inclusive manner. Prior to this dual role, Ed served in
the federal government for nearly 15 years. There, he led independent research projects and
has been coordinating and administering large-scale national research efforts. His expertise
spans population genomics, bioinformatics, mobile health, and digital clinical trials. In his
previous positions serving in various capacities at the National Institutes of Health (NIH), Ed
oversaw and managed portfolios that focused on innovative and groundbreaking initiatives
aimed at improving public health. Most recently, Ed was Team Lead for the Participant Center
of the All of Us Research Program, an ambitious program launched by NIH inviting one million
people across the U.S. to help build one of the most diverse health databases in history, which
could help in the development of better treatments and ways to prevent different diseases. Ed
began his federal service as a legislative fellow and legislative assistant, advising then-U.S.
Senator Barack Obama on health and science policy. He received his Ph.D. in molecular
biotechnology from the University of Washington with his thesis work carried out at the Fred
Hutchinson Cancer Research Center.

Nishtha Jain is a strategic, innovative, and futuristic leader with 13+ years of global information technology experience in driving strategic business partnerships, digital technology and platform transformation and innovation in biopharma with past employers – Biogen and GlaxoSmithKline. Experienced in wide range of industry verticals ranging from Healthcare IT, Consulting, Biotech, Pharmaceutical and Vaccine industry– R&D Clinical, R&D Quality, Drug Development, Regulatory, Manufacturing, Medical and Commercial. Trusted adviser to executive leadership seeking to solve highly complex enterprise business challenges in fast-paced, rapidly changing, and challenging environments.

Nishtha is currently Head of Innovation and Digital Technology at Takeda Pharmaceuticals where her role expands across Global R&D Quality in driving digital and data initiatives from concept to execution leveraging emerging technologies and design principles. She has a strong passion for not only for applying emerging and digital technologies in improving patient healthcare but also for diversity and inclusion initiatives. She is currently member of Chief and serves as President for Healthcare Businesswomen’s Association’s (HBA) Mid- Atlantic chapter.

Gary pursues the use of emerging technology to provide new and more efficient capabilities to enhance clinical trial management. This includes development of new design software through to more recent advancements with AI capabilities where his team has developed several micro-products and micro-services that can be plugged in and used by any SaaS solution.

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Tomasz Adamusiak MD Ph.D. is a Chief Scientist for Clinical Quality and Data Science at MITRE. He leads a multi-disciplinary group driving high-impact contributions to private and public sectors in clinical and genomic data science. Before MITRE, Tomasz was the Head of Data Science in the Pfizer Innovation Research (PfIRe) Lab. His team was responsible for developing novel digital endpoints, designing decentralized approaches for clinical trials, and applying AI/machine learning methods to generate novel insights from clinical data. Tomasz served in leadership and advisory roles in the American Medical Informatics Association, the SNOMED International, and the Epic Research Data Network.

Qinghua serves currently the Head of “Data and Statistical Science” in Kite Pharma, a Gilead Company. This is a group of data scientists and Statisticians who provide advanced statistical methods, programming and modeling and simulation for clinical studies, translational research, real world evidence generation and data dashboards. Qinghua holds Ph.D. (2005) and M.S. (2002) in Biostatistics from University of Wisconsin-Madison, and has early 20 years of data and statistical research experiences and comprehensive industry experiences (top companies including Merck, Genentech and Gilead) across various stages of drug discovery and development (from research, preclinical, translational science to all phases of clinical trials). He is author/co-author of many peer-reviewed, high-profile indexed publications (including Nature, PNAS, Science of Translational Medicine) and a regular speaker in many data science/statistics conferences.

Amin leads Data Science and Real-world evidence (RWE) for key Neuroscience programs, working closely with the broader JRD Data Science Team to integrate data science expertise into drug development. Amin uses his clinical, data science and strategic leadership skills to drive the development and implementation of creative data science solutions to accelerate clinical development.

He’s previously worked at a mix of academic and consulting organizations specializing in RWE generation and Patient-Centric Research across various therapeutic areas including the use of machine learning techniques within the electronic medical records for patient identification, diagnostic aids, and RCT emulation in RWD.

Sharon Chen is currently the CEO of AlphaLife Sciences. She oversees the company’s
business operation including business and product strategies, talent acquisition,
financing, and public relations.
Prior to joining AlphaLife Sciences, she was the head of Verily China (Alphabet’s life
science arm) and the Engineering Site Lead of Google Shanghai. She began her Google
career as a software engineer at the headquarter in the Bay Area since 2005 and
advanced positions to head of Google Engineering Shanghai Site. Prior to Google and
Verily, Sharon held tech lead positions at Experian and Brocade.
Sharon has been working in the tech field for more than 20 years. She has received her
B.S. degree major in Automation from Shanghai Jiaotong University and a M.S degree
major in Computer Science from Texas A&M University.