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Transformative approaches to clinical development: Scaling adoption across the industry

Transformative approaches to drug development - including adaptive trial design, enhanced segmentation of disease and patient populations, master protocols, RWE applications, and simulating protocol feasibility—have the potential to dramatically improve R&D efficiency and the quality of evidence generated, and to accelerate the drug development process. Importantly, these approaches can improve the patient experience.

Hear from a panel that will discuss:
  • Where the industry is in applying and scaling transformative approaches
  • The capabilities and investments companies should make to expand their adoption
  • Lessons learned in applying transformative approaches – what is working and what is not

Find out how the life sciences industry can move to systematic adoption to benefit patients.

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David Scholfield

David Scholfield

Head of Clinical Sciences, Pfizer

Having obtained a BSc in Human Physiology from the University of London David graduated in medicine from Guys and St Thomas’ Hospitals. He undertook postgraduate training in surgery and obtained his Fellowship of the Royal College of Surgeons of England in 1998. Joining the Pfizer Experimental Medicine group in Sandwich in 2002 David initially worked on biomarker development and early stage assets before taking on clinical lead responsibilities in early and late stage clinical development.

In 2011 David was made the UK clinical site head and in 2016 was appointed as the clinical group head for Europe. Prior to his current role David was the head of the Clinical Sciences group within Clinical Development and Operations. In 2019 he was appointed as Head of Clinical. This global group supports the clinical execution of trials across the late stage portfolio. In addition the group partners closely with internal and external stakeholders to drive continuous improvement and clinical innovation.

Murray A. Abramson

Murray A. Abramson MD, MPH

SVP Clinical Innovation, Medical Sciences, Tempus Labs, Inc.

Murray Abramson received his M.D. from Duke University School of Medicine and his M.P.H. in epidemiology from UNC. After completing his house staff training, fellowship and chief residency, he was appointed as a faculty member at Duke. In 1999, he transitioned to the pharmaceutical industry and spent 12+ years at Merck and almost nine years at Biogen, a neurosciences biopharmaceutical company. Dr. Abramson had served as vice president and head of Global Clinical Operations where he led a 180-person team responsible for the strategic planning and operational execution of all Biogen clinical trials. Most recently, Murray joined a biotech start-up, Tempus Labs, as senior vice president of clinical innovation. He looks to transform drug development and clinical practice through the use of multi-omics and A.I. Throughout his career, Murray has authored several publications including articles published in The Lancet and The New England Journal of Medicine.

Greg Friberg

Greg Friberg M.D.

VP, TA Head for Oncology, Amgen

Greg received his A.B. degree in biochemistry from Middlebury College and M.D. from New York Medical College. He completed his residency training in Internal Medicine at Dartmouth-Hitchcock Medical Center and his fellowship training in Hematology and Oncology at The University of Chicago Hospitals. As part of his training, he graduated from the University of Chicago Health Sciences Department Clinical Research Training Program specializing in clinical trial design and analysis. He joined the faculty of the University of Chicago thereafter joining the Phase I, Gastrointestinal, and Gynecologic oncology teams where he served as the PI for multiple early phase clinical studies. He published multiple research papers and reviews, and he was an active member of ASCO, the CALGB, and the GOG.

Greg joined Amgen in 2006 as an Associate Medical Director in Oncology Early Development. He served as the team lead for multiple early and mid-stage programs, shepherding molecules though IND filings, into initial human studies, and onto later development. Greg took over as group leader in 2011 and served for 3 years as Therapeutic Area Head, Oncology Early Development and later for 4 months as Early Development Head overseeing (Oncology, Inflammation, Neuroscience, and General Medicine/Bone). Starting in 2014, Greg served as the interim co-TA head for the Hematology / Oncology TA. In 2016 he served as the Global Product General Manager (GPGM) for the early hematology BiTE portfolio.

In 2017 Greg assumed the role of vice president and Therapeutic Area Head, Hematology / Oncology Global Development. In addition, in 2019 Greg assumed the TA Head responsibilities for the Bone franchise.

Najat Khan

Najat Khan

R&D Chief Data Science Officer and Global Head Strategy and Operations, Janssen

Najat Khan, Ph.D., is the Chief Data Science Officer and Global Head of R&D Strategy & Operations at Janssen Research & Development. As the Chief Data Science Officer, she is responsible for the overall Data Science strategy and vision for Janssen R&D and ensuring a seamless integration of Science and Data Science as we execute on high value programs for our pipeline. She is continually advancing critical Data Science foundations, including creating a best-in-class R&D data science organization by selecting the highest priority questions to pursue across Discovery and Development, fueled by data and platforms that allow the execution and deployment at scale. She has also built a strong and growing team of bilingual Data Science talent fluent in both Data Science and Science while also being a key catalyst in strategically curating our external partnerships to accelerate on-going efforts and expand our access to relevant real-world data. As the Global Head of R&D Strategy & Operations, Najat shapes the Janssen R&D strategic vision and operationalizes across multiple high priority areas to ensure Janssen R&D continues to deliver on transformational medicines for patients. Najat has more than 10 years of global healthcare experience in pharmaceutical, biotechnology, business and academia. Prior to joining Janssen, she was a Senior Principal at The Boston Consulting Group (BCG) where she led and executed multiple strategic initiatives across research, commercial, business and clinical development, mergers and acquisitions and operations. Najat received her B.A. in Chemistry with a minor in Economics from Colgate University and her Ph.D. in Organic Chemistry from the University of Pennsylvania.

Amy Cheung
moderator

Amy Cheung

Principal, Deloitte Consulting LLP

Amy Cheung is a Principal in Deloitte Consulting’s Life Sciences practice specializing in R&D. Amy has over 18 years’ consulting experience in the pharmaceutical industry. She worked for Merck as a researcher in chemistry prior to receiving her MBA. At Deloitte, she worked with clients to improve productivity and accelerate development; design and implement new R&D operating models, governance and organizational structures. Amy’s most recent experiences include development of digital strategies to enable remote clinical trials, implementation of a clinical sample management strategy to enable biomarker research, design an enterprise-wide RWE capability to enable end to end evidence generation, large scale implementation of clinical and regulatory systems and delivery of intelligent robotics and cognitive solutions for clinical processes. She recently co-authored a paper around transformative approaches to drug development in order to bring new therapies to patients faster.