2021 Archived Content

COVID-19 Vaccines & Biotherapeutics

February 17 - 18, 2021 ALL TIMES EST

In response to the urgent need for vaccines and biotherapeutics for the novel coronavirus, Cambridge Healthtech Institute is adding a new meeting dedicated to COVID-19 vaccine development, repurposing of existing therapeutics for COVID-19, and developing new biotherapeutics and antibodies, as well as unraveling the mechanisms of the novel coronavirus and identifying new targets. The COVID-19 Vaccines & Biotherapeutics meeting will present a comprehensive update on the global efforts, clinical trials, research programs, and case studies from industry and academia.

Wednesday, February 17

COVID-19 VACCINES: EMERGING TECHNOLOGIES AND ACCELERATED DEVELOPMENT

3:00 pm

Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Antiscience

Peter Hotez, MD, PhD, FASTMH, FAAP, Dean, National School of Tropical Medicine; Professor, Departments of Pediatrics, Molecular Virology & Microbiology; Co-Head, Section of Pediatric Tropical Medicine; Health Policy Scholar, Baylor College of Medicine

A look at modern 21st century forces – war, political collapse, climate change, urbanization, anti-science, leading to a return of neglected and vaccine-preventable diseases. My lecture will address my time as US Science Envoy in the White House and US State Department.

3:20 pm

COVID-19 Vaccine Development

Dan Barouch, MD, PhD, William Bosworth Castle Professor of Medicine, Harvard Medical School, Ragon Institute of MGH, MIT, and Harvard; Director, Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
Erica Dawson, PhD, Chief Technical Officer, InDevR

Learn about our new VaxArray Coronavirus Kits that provide quantitative analysis in 30 minutes of hands on time. It helps you get quantitative data from <10uL of serum for 9 different multiplexed pandemic and endemic coronavirus proteins. Provided in a streamlined format without customization or reagent preparation.

3:50 pm Sponsored Presentation (Opportunity Available)
4:00 pm

Accelerated Development of a Self-Assembling T Cell-Based Vaccine for COVID-19

Mark Poznansky, MD, PhD, Associate Professor, Medicine, Vaccine and Immunotherapy Center, Massachusetts General Hospital

The VIC team is working with its academic collaborators and Voltron Therapeutics to develop a new vaccine for the SARS-CoV-2 virus. The vaccine has two components that can be manufactured rapidly: the core protein activates the immune system, is stable and can be stockpiled; antigen-targeting peptides unique to the SARS-CoV-2 virus that can be rapidly generated and direct the anti-viral immune response. This vaccine has entered into preclinical trials.

4:20 pm

Skin Targeted Vaccines for COVID-19

Louis D. Falo, Jr., MD, PhD, Chairman, Department of Dermatology, University of Pittsburgh School of Medicine; Professor, Department of Bioengineering, University of Pittsburgh Swanson School of Engineering

Rapid development and deployment of an effective COVID-19 vaccine is critical to limit the devastating consequences of infection by this emerging pathogen, and several vaccine strategies are currently being developed.  The skin is a rational target for vaccine delivery. It contains a rich population of antigen presenting and immune accessory cells capable of inducing a proinflammatory microenvironment favoring the induction of potent and durable adaptive immunity. Here we summarize potential advantages of skin-targeted immunization and our efforts to develop a skin-targeted subunit protein vaccine using a dissolvable microneedle array delivery platform.

4:40 pm

Protein and Newcastle Disease Virus-Based COVID-19 Vaccines

Adolfo Garcia-Sastre, PhD, Professor & Director, Global Health & Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai

We have investigated the immunogenicity and ability to induce protective immune responses of several SARS-CoV-2 spike constructs, either as recombinant proteins in combination with adjuvants or expressed from a Newcastle Disease Virus (NDV) vector. Mutations associated with increasing spike stability are also associated with increased immunogenicity in mice. Moreover, NDV viruses expressing a stabilized spike protein that gets incorporated into the NDV viral envelope induce robust protective immunity against SARS-CoV-2.

David A. Zarling, Dyadic Global Group

A global unmet need exists for affordable, safe and effective recombinant antigen viral vaccines or therapeutic monoclonal antibodies for SARS-CoV-2 and variants causing COVID-19 disease. Plans are presented using genetically engineered thermophilic filamentous fungus C1-cells for protective Antigen Vaccine and Monoclonal Antibody production in greater amounts and in shorter times, outperforming mammalian-, insect- or yeast-cell commercial product production.

5:30 pm PANEL DISCUSSION:

Moderated Q&A

Panel Moderator:
Armen M. Donabedian, PhD, Scientific Technical Advisor and Chief, Vaccine Development, Division of Influenza and Emerging Infectious Disease, BARDA
Panelists:
Louis D. Falo, Jr., MD, PhD, Chairman, Department of Dermatology, University of Pittsburgh School of Medicine; Professor, Department of Bioengineering, University of Pittsburgh Swanson School of Engineering
Adolfo Garcia-Sastre, PhD, Professor & Director, Global Health & Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai
Sanjay Gurunathan, MD, Vice President and Head, Global Clinical Department, Sanofi Pasteur
Mark Poznansky, MD, PhD, Associate Professor, Medicine, Vaccine and Immunotherapy Center, Massachusetts General Hospital
Erica Dawson, PhD, Chief Technical Officer, InDevR
David A. Zarling, Dyadic Global Group
6:00 pm Close of Day

Thursday, February 18

DEVELOPMENT AND REPURPOSING OF BIOTHERAPEUTICS FOR COVID-19

8:00 am

Remdesivir for the Treatment of COVID-19

Tomas Cihlar, PhD, Vice President, Virology, Gilead

Remdesivir is a prodrug of adenosine nucleotide analog with a broad-spectrum antiviral activity against multiple RNA viruses including coronaviruses. It is also active against SARS-CoV-2 both in vitro and in animal models. In several randomized clinical trials, remdesivir has demonstrated efficacy in hospitalized COVID-19 patients by significantly reducing disease progression and accelerating time to recovery. In October 2020, remdesivir was approved by FDA as the first treatment for COVID-19.

8:20 am

COVID-19 Therapeutic Discovery with Supercomputing

Jeremy C. Smith, PhD, Governor's Chair and Director, University of Tennessee/Oak Ridge National Laboratory Center for Molecular Biophysics

We have established a supercomputer-driven pipeline for in silico drug discovery for Covid-19 and beyond. Using the Summit supercomputer at the Oak Ridge National Laboratory, more than 1 ms of enhanced sampling MD simulation can be generated per day and it is possible to perform exhaustive docking of one billion compounds in under 24 hours. A number of screened compounds have been experimentally validated in assays and live viral tests.

8:40 am Sponsored Presentation (Opportunity Available)
9:00 am

The I-SPY COVID Platform Trial: Accelerating Therapeutics for Severe COVID-19

D. Clark Files, MD, Associate Professor, Pulmonary and Critical Care Medicine, Wake Forest School of Medicine

This talk will discuss the rationale and design of the I-SPY COVID Platform Trial, a trial designed to rapidly evaluate phase 2 therapeutics for severe COVID-19.

9:20 am Session Break - View Our Virtual Exhibit Hall

COVID-19 ANTIBODY THERAPIES

9:40 am

Human Monoclonal Antibodies for SARS-CoV-2

James E. Crowe Jr., MD, Ann Scott Carell Chair & Professor & Director, Vaccine Center, Vanderbilt University Medical Center

Neutralizing antibodies appear to be the principal mechanism of immunity to resistance to SARS-CoV-2 infection and disease. We will discuss the genetic, molecular and structural basis of human monoclonal antibody-mediated neutralization of the virus.

10:00 am

SARS-CoV-2 Neutralizing Antibodies for the Treatment of COVID-19

Ajay Nirula, MD, PhD, Vice President, Immunology, Lilly Research Laboratories

Bamlanivimab (also known as LY3819253 or LY-CoV555) and etesevimab (also known as LY3832479 or LY-CoV016), are potent anti-spike neutralizing monoclonal antibodies derived from two separate convalescent COVID-19 patients. Results will be presented from the BLAZE-1 clinical trial, which have served as the basis for the emergency authorization for bamlanivimab in the United States for treatment of patients with mild to moderate COVID-19 at high risk of progression to severe disease.

Rea Dabelic, PhD, Manager, Infectious Disease Segment Marketing, 10X Genomics

The ongoing coronavirus outbreak has taken hundreds of thousands of lives, and the number of infections is growing daily. In this presentation we will discuss the utility of single cell technologies to advance infectious disease research, with a focus on experimental workflows that accelerate antibody discovery and validation.

Bo Barnhart, Ph.D., Scientific Director, AbCellera

In three weeks, AbCellera discovered, characterized and selected hundreds of antibodies against SARS-CoV-2 from one of the first U.S. patients to recover from COVID-19. AbCellera’s technology stack combines AI-assisted high-throughput single B cell screening with immune repertoire profiling of natural immune responses. Bioinformatic analysis of the resulting panels of antibodies allowed for the rapid characterization of neutralizing antibodies and the identification of therapeutic lead candidates including bamlanivimab.

11:00 am PANEL DISCUSSION:

Moderated Q&A

Panel Moderator:
Mark T. Esser, PhD, Vice President, Microbial Sciences, BioPharma R&D, AstraZeneca
Panelists:
Tomas Cihlar, PhD, Vice President, Virology, Gilead
James E. Crowe Jr., MD, Ann Scott Carell Chair & Professor & Director, Vaccine Center, Vanderbilt University Medical Center
D. Clark Files, MD, Associate Professor, Pulmonary and Critical Care Medicine, Wake Forest School of Medicine
Ajay Nirula, MD, PhD, Vice President, Immunology, Lilly Research Laboratories
Jeremy C. Smith, PhD, Governor's Chair and Director, University of Tennessee/Oak Ridge National Laboratory Center for Molecular Biophysics
Rea Dabelic, PhD, Manager, Infectious Disease Segment Marketing, 10X Genomics
Bo Barnhart, Ph.D., Scientific Director, AbCellera
11:25 am Session Break - View Our Virtual Exhibit Hall

PLENARY KEYNOTE SESSION: PRECISION MEDICINE AT BIG PHARMA

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.

Rob Fannon, MPH, MBA, General Manager, Biospecimen Solutions, Biospecimens, Precision for Medicine
 
 
12:05 pm

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 pm Sponsored Presentation (Opportunity Available)
12:40 pm KEYNOTE PANEL DISCUSSION:

Implementing Precision Medicine at Big Pharma

Panel 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 Global Oncology Franchise, EMD Serono, a business of Merck KGaA, Darmstadt, Germany
Rob Fannon, MPH, MBA, General Manager, Biospecimen Solutions, Biospecimens, Precision for Medicine
1:25 pm Session Break - View Our Virtual Exhibit Hall

COVID-19 DRUG DISCOVERY: UNRAVELING THE BIOLOGY, MECHANISMS AND TARGETS

2:30 pm Sponsored Presentation (Opportunity Available)
2:50 pm

Confronting the COVID-19 Pandemic with Supercomputing, Explainable-AI and Systems Biology

Daniel A. Jacobson, PhD, Chief Scientist, Computational Systems Biology, Oak Ridge National Laboratory

Using a Systems Biology approach, we are integrating genomic, transcriptomic, proteomic, environmental and molecular structure information to provide a holistic understanding of the COVID-19 pandemic. A range of methods are being used in a supercomputing environment in order to better understand the pathogenesis of COVID-19. This comprehensive analysis reveals that a Bradykinin Storm is an underlying mechanism for much of the symptomatology observed in COVID-19 patients.

3:10 pm Close of Conference





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