Developing and using digital biomarkers

We’ve lined up a group of experts to examine the current state of the art in creating digital biomarkers for use in clinical trials. Mobile sensors have been transforming the kind of data that can be gathered in a clinical trial. We’ll look at where the field is at — and where we’re headed — in transforming what can be accomplished in a clinical trial, with a special look at the regulatory environment governing this technology.

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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.

Chris Benko
intro speaker

Chris Benko

Chief Executive Officer, Koneksa

Chris Benko has twenty years of experience in the pharmaceutical industry, including implementing the operating model for the translational medicine functions of Merck Research Labs. He subsequently held executive roles spanning the company’s research and commercial divisions, as well as positions at the corporate level as head of global talent management. Chris launched Koneksa as an entrepreneur in residence with Merck’s corporate venture capital fund before establishing Koneksa as an independent company.

Eric Perakslis

Eric Perakslis PhD

Chief Scientific and Technology Officer, Duke Clinical Research Institute

As a Rubenstein Fellow, Perakslis developed and led cross-campus collaborations to position Duke Health as a global leader in data science applications and training. Eric is now the Chief Science & Digital Officer at the Duke Clinical Research Institute.

Christian Gossens

Christian Gossens

Head of Digital Markers, Roche

Christian is leading the Digital Biomarkers department in Roche’s Research and Early Development Informatics (pREDi) organization - a bridge between digital technology and science.

Over the last decade he had a particular focus on driving technology innovation in clinical trials. His teams were pioneering the creative adoption of Digital media and mobile devices to translate patient and investigator recruitment and engagement tactics into the digital age. A particular focus since 2014 became the development of clinically meaningful digital biomarkers to modernize clinical endpoints starting in the Neurosciences. A computational biochemist (EPFL, Lausanne), chemical engineer (ECPM, Strasbourg) and MBA (CDI, Paris) by training, he started his career in a leading management consultancy.

Christian joined Roche as a director in the Emerging Technology team in Group Research to identify strategic, game changing trends in the pharma Omics & Digital Health space and to develop strategies to act on those. Now he is implementing them.

Sandeep Menon

Sandeep Menon

Senior Vice President and Head of Early Clinical Development (ECD), Pfizer

Sandeep Menon is Senior Vice President and Head of Early Clinical Development (ECD) at Pfizer Inc. Partnering with key stakeholders across therapeutic areas, the ECD group works to ensure scientific rigor, quantitative decision-making, innovation, and operational excellence across Pfizer’s portfolio. Sandeep leads a multi-functional global team of experts in clinical study execution, biostatistics and bioinformatics, clinical pharmacology, precision medicine, digital medicine, translational imaging and early scientific planning, and operations. He is internationally known for his technical expertise, especially in the areas of adaptive designs, translational biomarkers, multi-regional trials, and small populations.

Sandeep joined Pfizer in 2010 and has held several positions of increasing responsibility. Prior to joining Pfizer, he held late-phase leadership roles at Biogen Idec and Aptiv Solutions (now ICON).

Sandeep is an elected fellow of the American Statistical Association, was recently awarded the Young Scientist Award by the International Indian Statistical Association and was the recipient of the Statistical Excellence in the Pharmaceutical Industry Award by the Royal Statistical Society, UK. Sandeep received his medical degree from Bangalore (Karnataka) University, India, and later completed his Master’s degree in Epidemiology and Biostatistics and Ph.D. in Biostatistics at Boston University and research assistantship at Harvard Clinical Research Institute. He holds adjunct faculty positions at Boston University School of Public Health, Tufts University School of Medicine, and the Indian Institute of Management (IIM). He has received several awards for academic, teaching and research excellence.

John Carroll

John Carroll

Founder & Editor, Endpoints News

John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 17 years. Aside from his daily industry coverage for FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.