Plenary Keynote Presentation & Keynote Sessions
Tuesday, February 16
PLENARY KEYNOTE SESSION
10:55 am FDA Update on COVID-19 Molecular Diagnostic Testing
Timothy Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, FDA
11:15 Sponsored Presentation
Speaker to be Announced
11:20 RADx Tech: A New Paradigm for MedTech Development
Steven Schachter, MD, Professor, Neurology, Harvard Medical School; Chief Academic Officer and RADx Chief, CIMIT
On
April 24, 2020, Congress appropriated $1.5 billion for SARS-CoV-2 testing to the NIH. Within 5 days after the legislation was signed into law, the NIH launched RADx Tech to support the development, production scale-up, and deployment of accurate,
rapid tests across the country. One of the goals of the RADx Tech initiative was to expand capacity so that by December 2020, approximately 2% of the U.S. population (6 million persons) can be tested per day, with more tests ready for rapid deployment
in proportion to national demand. During its first six months, the RADx Tech program evaluated over 700 applications and moved 22 projects into large-scale manufacturing. There are numerous unprecedented aspects of RADx Tech that make it a validated
model for medtech development, as will be detailed in this presentation.
11:40 Sponsored Presentation (Opportunity Available)
11:45 From Influenza, to Ebola to Zika: How a Decade of Experience and Investments Prepared Us to Respond to This Pandemic
Robert A. Johnson, PhD, Influenza Director, Biomedical Advanced R&D Authority, US Department of Health & Human Services
12:05 pm Talk Title to be Announced
Helen Roberts, PhD, President, Seegene Technologies
12:10 Global Public Health Consortium: A Path for Global Biosecurity through Equity and Transparency
W. Ian Lipkin, MD, Director, Center for Infection and Immunity, Columbia University
COVID-19
has exposed our vulnerability to pandemic risk and the urgency of addressing the challenges of climate change, food security, and the viral dissemination of misinformation. New molecular diagnostic platforms, investments in wildlife, domestic animal,
and human microbial surveillance, and the advent of social media tools that mine the world wide web for clues to outbreaks of infectious disease are all proving invaluable in early recognition of threats to public health. However, inequities in the
distribution of resources required for diagnostics and discovery, and lack of trust and transparency remain threats to biosecurity. To address these challenges, we are establishing a global public health consortium comprising of ministries of health
and academic institutions. This collaborative global program will focus on creating an infectious disease epidemiology network and has three main objectives: (1) develop a model realizing and extending the goals of the International Health Regulations
established by the WHO in 2005 by providing inexpensive, rapid tools for diagnosis discovery, and surveillance of infectious diseases, (2) identify and prioritize infectious agents based on pandemic risk, and (3) share data and build the infrastructure
needed to produce, validate and implement drugs and vaccines to reduce morbidity and mortality.
Wednesday, February 17
10:30 am Women in Science
Panel Moderator:
Karen Kaul MD, PhD, Chair, Department of Pathology and Laboratory Medicine; Duckworth Family Chair, NorthShore University HealthSystem; Clinical Professor, Pathology, University of Chicago Pritzker School of Medicine
Panelists:
Janice Chen, PhD, Co-Founder & CTO, Mammoth Biosciences
Malileh Poorfarhani, Director, Digital Health and R&D, Bayer
Theresa L. Whiteside, PhD, Professor, Pathology, Immunology & Otolaryngology, University of Pittsburgh
PLENARY KEYNOTE SESSION
1:20 pm Exploring New Therapies for COVID-19: Focus on AstraZeneca’s Long-Acting Monoclonal Antibody Combination
Mark T. Esser, PhD, Vice President, Microbial Sciences, BioPharma R&D, AstraZeneca
This talk will provide an overview of convalescent plasma and monoclonal antibodies currently in development for treating COVID-19
with a focus on the discovery and development of AstraZeneca's long-acting antibody (LAAB) combination (AZD7442) currently being evaluated for both the prevention and treatment of COVID-19.
1:40 Sponsored Presentation (Opportunity Available)
2:05 Sponsored Presentation (Opportunity Available)
2:10 Developing a COVID Vaccine in Ten Months
Sanjay Gurunathan, MD, Vice President and Head, Global Clinical Department, Sanofi Pasteur
Thursday, February 18
PLENARY KEYNOTE SESSION
11:40 am Turning Science into Medicine: The Power of Collaboration
Mene N. Pangalos, PhD, Executive Vice President Biopharmaceuticals R&D, AstraZeneca
The
rate of change across healthcare is more rapid than ever before and although 2020 has been challenging, it has forced us to think progressively about how we enable and execute the discovery and development of the next wave of life-changing medicines
to patients. Because of the investment we have been making in transformative technologies, digital health solutions, and data science and AI in clinical trial innovation, we have enabled existing trials to continue safely and at speed through remote
data collection from home. Scientists in our labs have rapidly applied their expertise in diagnostics, high-throughput screening and infectious diseases, developing new treatments and preventative approaches to combat the virus. This has shown how
we can adapt quickly, work seamlessly across partners and accelerate the introduction of new ways of working to fast-forward the pace of science. Creating R&D organizations that are integrated and collaborative means we are fit for the future
– whatever that may hold – and it is this strength which allows us to continue transforming science to create the greatest and swiftest impact on the diseases we aim to treat, prevent and in the future even cure.
12:00 pm Keynote Introduction
Rob Fannon, MPH, MBA, General Manager, Biospecimen Solutions, Biospecimens, Precision for Medicine
12:05 Diagnostics at Pfizer: Enabling Precision Medicine
Hakan Sakul, PhD, Vice President and Head, Diagnostics, Pfizer
Many drugs
have been brought to global markets by pharmaceutical companies over the years through the use of Precision Medicine approaches. Even though oncology has been the biggest beneficiary so far, other disease areas are recording progress in development
of such precision medicines. Diagnostics, and in particular companion diagnostics, have been an integral part of such drug development programs. This talk will focus on progress in the use of companion diagnostics in pharma environment with particular
focus on Pfizer programs, our historical approach to diagnostics, its impact on our pharma pipeline, regulatory, policy and commercialization considerations, as well as exploration of new technologies.
12:25 Sponsored Presentation (Opportunity Available)
12:40 Keynote Panel Discussion: Implementing Precision Medicine at Big Pharma
Moderator:
Cecilia Schott, PharmD, MBA, Head, Global Precision Medicine Strategy, Oncology Business Unit, Novartis
Panelists:
Hakan Sakul, PhD, Vice President and Head, Diagnostics, Pfizer
Maria C. M. Orr, PhD, FRSB, Head of Precision Medicine, Biopharmaceuticals, AstraZeneca
Masayuki Kanai, PhD, Director & Global Companion Diagnostics Leader, Clinical Biomarkers & Translational Science, Daiichi Sankyo Inc.
Zhen Su, MD, MBA, Senior Vice President, Head of US & Global Oncology Franchise, EMD Serono, a business of Merck KGaA, Darmstadt, Germany
Rob Fannon, MPH, MBA, General Manager, Biospecimen Solutions, Biospecimens, Precision for Medicine