Session Abstract – PMWC 2024 Silicon Valley

Track 2 - January 25 9.00 A.M.-4.30 P.M.


Track Chair:
- William Oh, Mount Sinai

Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support.

Sessions:

  • PMWC 2024 Award Ceremony
    Pioneer Honoree: Atul Butte, UCSF
  • Opening Talk: Pioneering the Next Decade: The Transformative Potential of Real-World Evidence/Data
    - William Oh, Mount Sinai
  • Strategies to Enhance Data Sharing in Medical Research (PANEL)
    Chair: Amar Das, Guardant Health
    - Paul Boutros, UCLA
    - Ziad Obermeyer, UC Berkeley
    - George Sledge, Caris Life Sciences
    - Erica Galvez, Manifest MedEx
  • Data Privacy and Security in RWE/D (PANEL)
    Chair: Deven McGraw, Invitae
    - Christopher Boone, Oracle
    - John Kalafut, Asher Orion Group
    - Susan Stayn, Stanford
    - Jessica Santos, Oracle
  • Using RWD to Accelerate Precision Medicine Product Development
    - Mark Watson, Guardian Research Network
  • Multi-Modal Datasets & RWE/D: Pioneering Tools for Accelerated Biomedical Research (PANEL)
    Chair: Ilyana Rosenberg, Microsoft
    - Charlene Son Rigby, STXBP1 Foundation
    - John Wilbanks, Broad Institute
    - Tristan Naumann, Microsoft
  • Leveraging RWE/D in Lupus: Using RNA Data and Predictive AI to Enhance Patient Care Decisions (PANEL)
    Chair: Amrie Grammer, Ampel Biosolutions
    - Ajay Nirula, Eli Lilly
    - Pete Schafer, Bristol Myers Squibb
  • Accelerating Drug Development Approvals Using RWE/D (PANEL)
    Chair: Mika Newton, xCures
    - Leo Russo, Pfizer
    - Eric Schadt, Pathos AI
    - Ashley Brenton, Optum
    - Nasha Fitter, Invitae
  • CVS Health Real World Evidence – Updates and New Directions in RWE
    Chair: Alexandra Berk, CVS Health
    - Kate Rosenbluth, Cala Health
  • Regulatory Challenges in RWE (PANEL)
    Chair: Susan Winkler, Reagan-Udall Center
    - Mei Sheng Duh, Analysis Group
    - Rachael Fones, IQVIA

 Speaker Profile

MD, CMO, Prostate Cancer Foundation

Biography
William K. Oh, M.D. is Chief Medical Officer at the Prostate Cancer Foundation and Clinical Professor of Medicine at Icahn School of Medicine. He is an internationally recognized medical oncologist with over 25 years of clinical and translational research experience and leadership roles in academia and industry. He has authored more than 350 articles, reviews, books and book chapters related to genitourinary cancers. He has conducted multiple clinical cancer trials and has served in key invited roles for ASCO, ACS, and AUA. He also recently served as Chief Medical Officer for Sema4, a genomics and health intelligence company.


 Speaker Profile

CEO, xCures

Biography
Mika has more than 20 years of commercial strategy and leadership experience in life sciences, with a focus on novel technologies. Over the last 10 years Mika has concentrated on evidence-based medicine and tools to transform healthcare and clinical development. Before joining xCures he was the Chief Commercial Officer of Doctor Evidence, LLC. Prior to Doctor Evidence he was the General Manager of Clinical Development Services at diaDexus, SVP of Client and Market Development at Evidera, VP of Sales and Marketing at Archimedes, and held sales management and sales operations roles at Quintiles, Invitrogen and Tripos.


 Speaker Profile

MD, PhD, Vice President, Real World Evidence, Guardant Health

Biography
Dr. Amar Das has three decades of experience in advancing clinical research through data science and AI. At Guardant Health, he leads a team that generates real world evidence for blood-based testing in precision oncology and cancer screening. Prior to Guardant Health, Dr. Das was on the faculty at Stanford and Dartmouth. As Director of Biomedical Informatics at Dartmouth, he co-founded the Department of Biomedical Data Science, the first department focused on this discipline. Following his career in academia, he served as Director of Healthcare Effectiveness Research at IBM and Director of Real World Data Analytics and Innovation at MerckMSD. Dr. Das has received multiple professional and research awards, and is a Fellow of the American College of Medical Informatics. Dr. Das received his MD and PhD in Biomedical Informatics from Stanford and completed his residency and postdoctoral fellowship in Clinical Epidemiology at ColumbiaNew York Presbyterian.


 Speaker Profile

PMWC PIONEER AWARD
Outstanding contributions to precision medicine include analyzing large-scale biomedical data, uncovering novel insights to improve patient care, and impacting the field through research on big data analysis, drug repurposing, biomarker discovery, patient stratification, and data-driven clinical decision support

MD, PhD, Institute Director and Distinguished Professor, UCSF

Biography
Atul Butte is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and Director of the Bakar Computational Health Sciences Institute at UCSF. Dr. Butte is also the Chief Data Scientist over all 6 academic health centers and 10 hospitals of the University of California Health System, the eighth largest by revenue in the United States. Dr. Butte has been continually funded by NIH for 25 years, is an inventor on 24 patents, and has authored over 300 publications, with research repeatedly featured in the New York Times and Wall Street Journal. Dr. Butte was elected into the National Academy of Medicine in 2015 and was recognized by the Obama Administration as a White House Champion of Change in 2013. Dr. Butte is also a cofounder of three investor backed data driven companies: Personalis (IPO, 2019), medical genome sequencing, Carmenta (acquired by Progenity, 2015), pregnancy complication diagnostics, and NuMedii, finding new drugs using AI.


 Speaker Profile

PhD, Vice President and Head of Global Medical Epidemiology, Pfizer

Biography
Leo J. Russo, has been a practicing epidemiologist for nearly 30 years, with the last 23 in the pharmaceutical industry. He has spent time in big (GSK, JJ, Pfizer) and midsize (Shire) pharma and has brought the best practices from each stop into his current role. Leo leads Pfizer’s Global Medical Epidemiology group within the Worldwide Medical and Safety organization. His academic training began in the field of statistics, in which he holds a Bachelor of Science degree from The Ohio State University. Leo went on to complete his M.S. and PhD degrees in epidemiology at Case Western Reserve School of Medicine. He believes epidemiology is a highly creative field and a catalyst for innovation. It is a mindset and perspective that can be leveraged across many areas such as drug candidate selection, drug safety, machine learning, digital health, clinical trial diversity, health equity, and health systems quality.


 Speaker Profile

PhD, Professor, UCLA

Biography
Paul Boutros did his training at the Universities of Waterloo and Toronto. Research in his laboratory lies at the intersection of clinical questions and big molecular and imaging data. The team focuses on how these diverse pieces of information can be integrated to personalize therapy for cancer patients by using and innovating statistical and machine learning techniques.


 Speaker Profile

RPh, Esq, CEO, Reagan-Udall Foundation

Biography
Susan C. Winckler, RPh, Esq, has 30 years of experience in the FDA and healthcare community and has worked with members of regulated industry across FDAs portfolio; with healthcare professionals, associations, patient organizations, consultants in this community; and other governmental and quasigovernmental organizations. She has served as chief of staff at the agency and in helping the commissioner and FDA navigate routine and emergent situations both domestic and international; leading the Food and Drug Law Institute to speak, write, and convene discussions of food and drug law issues; driving the policy, regulatory, and communications agenda of the American Pharmacists Association, and advising regulated industry (drug, device, biologic, and food companies) and others in the health care sector while at Leavitt Partners, the health care consulting firm founded by former HHS Secretary Michael O. Leavitt. She can be reached at swincklerreaganudall.org


 Speaker Profile

JD, MPH, LLM, Chief Regulatory Officer, Ciitizen

Biography
Deven McGraw is the Chief Regulatory Officer for Ciitizen and was one of the company's original co-founders. She previously was lead for Data Stewardship and Data Sharing at Invitae after its initial acquisition of Ciitizen in 2021 (Ciitizen was divested from Invitae in November 2023). From 2015-17, she directed U.S. health privacy and security as Deputy Director, Health Information Privacy at the HHS Office for Civil Rights and Chief Privacy Officer (Acting) of the Office of the National Coordinator for Health IT. Widely recognized for her expertise in health privacy, she directed the Health Privacy Project at the Center for Democracy Technology for six years and led the privacy and security policy work for the HITECH Health IT Policy Committee, and currently serves on the Health IT Advisory Committee. She also served as the Chief Operating Officer for the National Partnership for Women and Families.


 Speaker Profile

PhD, Group Vice President, Research Services, Life Sciences, Oracle

Biography
Christopher P. Boone, PhD is an accomplished global executive, strategist, social scientist, and data technologist with a passion for reinventing and transforming healthcare and life sciences companies utilizing enterprise data analytics capabilities to drive value creation. Chris has a career long history as a dynamic, innovative thought leader and a public voice on the power of real world evidence, health informatics, and enterprise data analytics, and its ability to radically transform the global health care system into a learning health care system.


 Speaker Profile

PhD, CSO, Pathos AI

Biography
Eric Schadt is a well known American scientist who is recognized for his work in the fields of genomics, integrative biology, and personalized medicine. He has helped build and found companies to advance driving precision medicine into the standard of care, including founding roles at Sema4 (now GeneDx) and Sage Bionetworks, and leadership roles at Rosetta Inpharmatics, Merck, and Pacific Biosciences. Currenly, Schadt is helping build Pathos, an information driven precision oncology company, and also maintains a faculty role at the Icahn School of Medicine at Mount Sinai, where he previously led the Department of Genetics and Genomic Sciences and founded the Icahn Institute for Genomics and Multiscale Biology. Schadt has published over 500 scientific papers (hindex = 148 and has received numerous awards for his contributions to the field of genomics, including several appearances on the Reuters "most influential scientists" list.


 Speaker Profile

JD, Deputy General Counsel for Research and Medicine, Stanford

Biography
Susan Stayn is Deputy General Counsel for Research and Medicine at Stanford University and Stanford Medicine. She supports Stanford's research and innovation, health care, and education missions. She has broad background in health care regulatory work, privacy and data sharing, life sciences and translational research, and impactful collaborations across industry, government, institutes, and foundations. Before joining Stanford, she was senior counsel at Mass General Brigham and practiced with an international law firm.


 Speaker Profile

PhD, VP RWE & Genomics, Optum

Biography
Dr. Ashley Brenton is the Vice President of Real World Evidence and Genomics for Optum Life Sciences. In this role, she is responsible for leading data strategy, product development, business development and operations for genomics. Ashley bridges the gap between clinical genomics and product development to leverage the wealth of Optum data into commercial datasets and strategic alliances to drive precision medicine initiatives. Prior to joining Optum, Dr. Brenton was the Chief Science Officer at Mycroft Bioanalytics, where she led corporate valuation and sales strategy of the intellectual property portfolio, including the world's largest Clinicogenomic biobank in chronic pain. Previously, Dr. Brenton developed and commercialized a number of precision medicine tests and algorithms while building Clinicogenomic datasets. Ashley is an accomplished athlete, completing the Ironman twice and a number of ultramarathons, and competing in CrossFit competitions. She lives in Washington state with her husband and two daughters.


 Speaker Profile

MD, PhD, Institute Director and Distinguished Professor, UCSF

Biography
Atul Butte is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and Director of the Bakar Computational Health Sciences Institute at UCSF. Dr. Butte is also the Chief Data Scientist over all 6 academic health centers and 10 hospitals of the University of California Health System, the eighth largest by revenue in the United States. Dr. Butte has been continually funded by NIH for 25 years, is an inventor on 24 patents, and has authored over 300 publications, with research repeatedly featured in the New York Times and Wall Street Journal. Dr. Butte was elected into the National Academy of Medicine in 2015 and was recognized by the Obama Administration as a White House Champion of Change in 2013. Dr. Butte is also a cofounder of three investor backed data driven companies: Personalis (IPO, 2019), medical genome sequencing, Carmenta (acquired by Progenity, 2015), pregnancy complication diagnostics, and NuMedii, finding new drugs using AI.


 Speaker Profile

MD, Executive Vice President and Chief Medical Officer, Caris Life Sciences

Biography
George W. Sledge, Jr., M.D. oversees Caris Life Sciences medical affairs, research, and medical education, including oversight and leadership for the Caris Precision Oncology Alliance and Caris global team of Medical Science Liaisons. Prior to joining Caris, Dr. Sledge was Professor of Medicine at the Stanford University School of Medicine where he served as a member of the Division of Oncology. He was most recently codirector of the Stanford Cancer Institutes Cancer Therapeutics Program and served from 20132020 as Chief of the Division of Oncology. Trained in Internal Medicine and Medical Oncology, Dr. Sledge has devoted his professional career to understanding the biology and improving the treatment of breast cancer. He is active as both a laboratory and clinical researcher, with more than 390 scientific publications.


 Speaker Profile

PhD, Chief Scientific Officer, RWE, CVS Health

Biography
Alexa Berk is Chief Scientific Officer for RWE at CVS Health Clinical Trial Services, where she provides scientific leadership and oversees Data Science for CVS Health CTS. Most recently, Alexa was Medical Affairs Director for Digital Health and Data at Invitae, a leading medical genetics company. Alexa has a history of over 20 years in the health research space including roles at Memorial Sloan Kettering Cancer Center, Novartis Oncology, and top consulting and startup companies focused on RWE. Alexa is a frequent speaker and published author on the topic of high quality real world data and best practices in patient centered research methods, particularly in oncology and rare disease.


 Speaker Profile

CEO, Manifest MedEx

Biography
Erica Galvez is the chief executive officer of Manifest MedEx, California’s largest nonprofit health information organization. She has extensive experience in health information exchange and interoperability and has been with Manifest MedEx since 2017, previously serving as Chief Operating Officer, Chief Strategy Officer, and Chief of Staff. Prior to joining MX, she led the HIE work for Aledade, with ACOs spanning 15 states and accounting for more than $1.5B in annual health care spending. Prior to Aledade, she led the Office of the National Coordinator for Health IT’s (ONC’s) Interoperability Portfolio. She also served as one of the directors of ONC’s State HIE Program and as program manager for AHIMA’s State-Level HIE Consensus Project. Manifest MedEx is an integral part of California’s health data infrastructure, combining and delivering crucial health information for more than 38 million Californians across 125+ hospitals, 13 health plans, and over 1,800 providers.


 Speaker Profile

M.D., Ph.D., Chief Medical Officer, Guardian Research Network

Biography
As a surgical pathologist and NIH-supported scientist in brain tumor biology, Mark brings a range of experiences as a researcher in biology, clinical development and executive leadership, especially with drugs and biologics requiring biomarkers and companion diagnostics. As a thought leader, Mark has mapped the murine whole genome and positionally cloned the gene that spawned an entire field of immune cell regulation. He also cloned the microorchidia gene, a transgene insertion knockout phenotype that defined a new category of DNA and chromosome maintenance genes. Mark also brings GRN Partners and clients his dynamic experience with EMR and IT systems, including pathology databases, laboratory information systems, clinical trial management systems, imaging systems for radiology and others.


 Speaker Profile

PhD, COO/CSO, AMPEL BioSolutions

Biography
Dr. Grammer is an internationally recognized scientist and successful entrepreneur, having founded and managed AMPEL successfully for over 5 years. Dr. Grammer was elected to the class of 2021 for SIBF (Society of International Business Fellows), an organization of 1,400 individuals in 45 countries worldwide. She was also awarded a Virginia SBIG grant for AMPEL's first investment round. She is a second term board member of Virginia Bio. Before cofounding AMPEL in 2013, Dr. Grammer spent over 20+ years in genomics and managed more than 15 National Institute of Health (NIH) scientific teams and a highly productive NIH laboratory. Dr. Grammer received multiple awards for her team's work comparing genes expressed in patients compared with healthy individuals, including the prestigious NIH Director's Award as well as mentoring awards from the American Association of Immunologists. She has published over 75 articles on her scientific research.


 Speaker Profile

MD, PhD, Senior Vice President, Immunology, Eli Lilly

Biography
Ajay Nirula is Sr. Vice President, Immunology for Lilly Research Laboratories based at the Lilly Biotechnology Center in San Diego. Ajay joined Lilly in 2015 and is responsible for discovery research and early phase clinical development in immunology for the company. He also served as the medical leader for Lilly’s work during the COVID pandemic that led to emergency authorization for multiple therapeutic neutralizing antibodies. Prior to joining Lilly, Ajay held leadership positions at Amgen and Biogen Idec and was involved in several research programs and regulatory filings spanning diseases such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, psoriasis, and vasculitis. Ajay earned his undergraduate degree in molecular biology from UC Berkeley, his MD from UCLA School of Medicine, and his PhD from the University of Texas Southwestern Medical School. He subsequently joined the faculty in the Division of Rheumatology at UCSF Medical Center. He has published extensively in the scientific literature in journals such as New England Journal of Medicine, JAMA, and Nature Immunology.


 Speaker Profile

PhD, Scientific Vice President, Bristol Myers Squibb

Biography
Peter Schafer leads a team responsible for translational medicine for the late clinical pipeline in Immunology, Cardiovascular, and Neurology. In addition to designing and implementing biomarker plans for late stage trials, his team also includes laboratory scientists who conduct experiments to understand patient subsets, biomarkers of response resistance, and mechanisms of action for rational combinations and identification of novel targets. Peter joined Bristol Myers Squibb from Celgene where for 20 years he had led the Drug Discovery Biology group and helped to build the Translational Development group focused on Hematology and Immunology. He is co-inventor of apremilast (Otezla), now approved for psoriasis, psoriatic arthritis, and Behçets Disease. His teams helped uncover the mechanism of action of the IMiDs compounds lenalidomide (Revlimid) and pomalidomide (Pomalyst), and iberdomide in SLE. In 2018 he co founded the PROLIFIC prognostic lung fibrosis consortium, and since 2020 he has been CoChair of the LRA Lupus Nexus Steering Committee.


 Speaker Profile

Principal Product Manager, Microsoft Health Futures

Biography
Ilyana Rosenberg is a product leader driving innovation in the field of precision medicine. She currently works within the Biomedical Platforms Genomics Team at Microsoft to enable customers to complete biomedical research at scale and across consortia. Prior to her work at Microsoft, Ilyana led a product to market that automated medical coding and was part of a founding product team that built a biomedical research platform to accelerate scientific discovery. Ilyana focuses on the intersection between technology and healthcare, and her impact spans across the revenue cycle of hospitals, the payer provider space, and the life sciences.


Talk
This session will explore the latest tools and techniques for leveraging multimodal datasets and realworld evidence (RWE) to accelerate biomedical research. The panel will discuss their experiences in working with large and complex datasets, as well as the challenges and opportunities associated with using RWE in research.


 Speaker Profile

Ph.D., Principal Researcher, Microsoft Health Futures

Biography
Tristan Naumann is a Principal Researcher in the Real World Evidence (RWE) group at Microsoft Researchs Health Futures. His research focuses on problems at the intersection of machine learning (ML) and health, specifically exploring relationships in complex, unstructured health data using techniques from natural language processing (NLP) and unsupervised learning. He values supporting the broader ML community through academic service and has served as a General Chair, and a variety of other roles, for NeurIPS, AHLI Conference on Health, Inference, and Learning (CHIL), and Machine Learning for Health (ML4H).


Talk
Advancing Health at the Speed of AI
The dream of precision health is to develop a continuous learning system where new health information is instantly incorporated to optimize care delivery and accelerate biomedical discovery. I'll present our research progress on advancing generative AI for precision health, spanning biomedical large language models, multimodal learning, and causal discovery.


 Speaker Profile

Head of Product at the Data Sciences Platform, Broad Inst.

Biography
John Wilbanks is an accomplished data scientist and a leading voice in the field of medical data sharing. As the Head of Product at the Data Sciences Platform at the Broad Institute, where he leads efforts to develop innovative data science solutions for biomedical research. Prior to joining the Broad Institute, John was the Chief Commons Officer at Sage Bionetworks, where he worked to develop open-source tools for sharing medical data and promoting collaborative research.Throughout his career, John has been a passionate advocate for open science and data sharing. He has served in leadership positions at a number of organizations dedicated to advancing scientific research, including the World Wide Web Consortium, the Science Commons, and the Creative Commons. John has also served as a fellow at the Ewing Marion Kauffman Foundation and as a Senior Fellow at the Kauffman Foundation's entrepreneurship center.


 Speaker Profile

ScD, Managing Principal and Chief Epidemiologist, Analysis Group

Biography
Dr. Duh specializes in real world evidence (RWE) generation for product registration, postapproval safety studies, and health economics and outcomes research of pharmaceuticals, vaccines, and regenerative biotherapeutics. She has led multiple projects for NME approvals and product label expansion applications to the US Food and Drug Administration and European Medicines Agency, as well as health technology assessment. Her extensive research has appeared in over 280 peer reviewed publications. Dr. Duh is also an adjunct in the biostatistics department at the Harvard T.H. Chan School of Public Health. She served as a chairperson of drug safety and epidemiology for the Drug Information Association (DIA) and was an adjunct assistant professor of pharmacoeconomics and pharmacoepidemiology at Massachusetts College of Pharmacy and Allied Health Sciences. Dr. Duh was appointed to an expert panel convened by the Foundation for the National Institutes of Health's Observational Medical Outcomes Partnership (OMOP).


 Speaker Profile

PhD, Co-President, Founder & CSO, Cala Health

Biography
Kate Rosenbluth, PhD is the Co-President, Founder and Chief Scientific Officer at Cala Health, a bioelectronic medicines company merging innovations in neuroscience and technology. She also holds an Adjunct Faculty appointment of the Department of Medicine at Stanford University, and has authored more than 60 patents and peer-reviewed publications. Previously, she developed cutting-edge neurotherapies with Brainlab, Autonomic Technologies, and Genentech. She completed postdoctoral fellowships in UCSF neurosurgery and Stanford Biodesign, and a PhD in Bioengineering at UC Berkeley and UCSF. She currently serves on the Board of Directors of Cala Health and CloudCath.


Talk


 Speaker Profile

Government & Public Affairs Director and Strategic Advisor, Diversity in Clinical Trials, IQVIA

Biography
In her role with IQVIA, Fones engages with trade associations, advocacy groups and policymakers to identify opportunities to advance the clinical research ecosystem. Fones has been an active participant on numerous Clinical Trial Diversity Inclusion (CTDI) initiatives over the past eight years, including as founding Chair of the Association of CROs (ACRO) DI Committee and an original member of the Multi-Regional Clinical Trials (MRCT) Center DEI workgroup since 2017. For IQVIA, Fones leverages insights from external engagement with advocacy groups, policymakers and regulators to inform IQVIAs CTDI Initiative, coach functional SMEs on implementation, and support biopharma customers with creating FDA Diversity Plans. Her insights were featured in the 2022 IQVIA Institute Report she co-authored, Advancing Diversity in Clinical Development through Cross-Stakeholder Commitment and Action Prior to joining IQVIA (then Quintiles), Fones worked in policy advocacy for BCBS of Florida and as Executive Director of the Health Care Quality Alliance.


 Speaker Profile

MBA, President & Co-Founder, Global Genes/ STXBP1

Biography
Charlene Son Rigby has spent her career building organizations at the intersection of data, technology, and life sciences. Charlene was previously Chief Business Officer at Fabric Genomics and held executive roles at enterprise software and genomics companies, including Oracle and Doubletwist. She started her career in neuroscience research at Roche. When Charlenes daughter was diagnosed with a rare genetic disease, she cofounded the STXBP1 Foundation. Charlene is also CEO of Global Genes, a onprofit organization dedicated to eliminating the burdens and challenges of rare diseases for patients and families globally. She is committed to finding a cure for her daughter's disorder. Charlene's unplanned connection between her personal life and profession has helped push forward the search for a cure for her daughter and kids like her, and given her work deeper meaning.


 Speaker Profile

Global Compliance and Quality Director, Oracle

Biography
Jessica is expert opinion leader in healthcare compliance, privacy, ethics, regulations, data governance, pharmacovigilance and quality management. Experienced statistician, analyst and methodologist. As a global executive, Jessica provides oversight and support across global offices in regulation, ethics and compliance, and responsible for directing strategic frameworks regarding compliance, privacy and quality management in clinical, Real World Research and commercial activities. Jessica gained her reputation through her publications and professional committee work in the industry including ISPOR, MAPS, and IRBs. Jessica is a frequent speaker and contributor in major conferences, also a rowing coach in Cambridge.


 Speaker Profile

PhD, Co-Founder & CEO, Asher Orion Group

Biography
Dr. Kalafut advises on AIML topics ranging from product management to market strategy with a healthcare application. Additionally, he works with HCOs to develop AI strategies, AI Governance and best practices, through deployment and monitoring of purchased and built AIML solutions. He is the principal or co inventor on 43 US patents and 12 pending applications. Many of his inventions are used across nuclear medicine and radiological agent delivery, diagnostic interventional cardiology devices, and patient monitoring systems. Before founding Asher Orion, John was Chief Scientist of Informatics Research at GE Healthcare. His stewardship of an AIenabled, diagnostic pathway solution led to their first Breakthrough Designation. He led the architecture of platforms and applications co created by GE Healthcare and its clinical partners at health systems, including Mass General Brigham and Boston Children’s Hospital. John contributed to the UK's National Consortium of Intelligent Medical Imaging (NCIMI) and was a coPrincipal Investigator on Digital Pathology and Diagnostic (DART).


 Speaker Profile

Co-Founder and Chief Business Officer, Ciitizen

Biography
Nasha Fitter is a leader in the rare disease space through her work on utilizing real world evidence to accelerate treatments. She is also the mother of a child with the rare neurological condition, FOXG1 Syndrome, and co-founded and leads the FOXG1 Research Foundation. Nasha serves on the board for the ACMG Foundation for Genetic and Genomic Medicine and has an MBA from the Harvard Business School.


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