WEDNESDAY, JANUARY 27, 2021 - Biotherapeutics Part One: Neutralizing Antibodies and Convalescent Plasma Workshop Session Three
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WEDNESDAY, JANUARY 27, 2021
Biotherapeutics Part One: Neutralizing Antibodies and
Convalescent Plasma
Workshop Session Three
Scientific Organizing Committee:
John (JR) Dobbins, Eli Lilly and Company
Taro Fujimori, AbbVie Bioresearch Center, Inc.
Carol Krantz, Seagen Inc.
Ewa Marszal, CBER, FDA
Kenneth Miller, AstraZeneca
Emily Shacter, ThinkFDA LLC
Zahra Shahrokh, ZDev Consulting
Marjorie Shapiro, CDER, FDA
John Stults, Genentech, a Member of the Roche Group
Therapies to treat and prevent coronavirus disease 2019 (COVID-19) are a global health priority. There is
an urgent need to identify neutralizing antibodies (nAbs) that specifically target severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) and many efforts are underway. This session focuses on the
development of nAbs for the treatment and prophylaxis of COVID-19, which also may aid in vaccine
design. It also draws on lessons learned from the development of nAb therapeutics to other emerging
infectious viral diseases such as the Ebola virus disease.
nAbs may be identified by isolating antibodies or B cells directly from patients during the course of
illness/recovery, by display technologies using patients as the source of B cells, or by immunizing animals
with virus or other forms of viral antigens. A first step in developing nAbs from COVID-19 survivors is
identifying those that confer strong protection against SARS-CoV-2. Several groups have selected nAbs
that bind to the viral spike protein, which facilitates entry into host cells by binding to the angiotensin-
converting enzyme 2 (ACE2) receptor. Current approaches to developing nAbs include the development
of mAb and mAb cocktails, and hyper immune SARS-CoV-2 specific globulins. Candidate selection and
product development timelines were compressed for the earliest of these products, which entered clinical
studies by the summer of 2020, with many more being studied by the end of 2020. By the time of the
WCBP 2021 meeting, some may have Emergency Use Authorization.WEDNESDAY, JANUARY 27 continued
NOTE: All times are Eastern Standard Time (EST).
08:30 – 09:00 Sign-in to Virtual Platform
Biotherapeutics Part One: Neutralizing Antibodies and
Convalescent Plasma
Workshop Session Three
Session Chairs: Kenneth Miller, AstraZeneca, Zahra Shahrokh, ZDev Consulting and
Marjorie Shapiro, CDER, FDA
09:00 – 09:05 Introduction
09:05 – 09:30 The Coronavirus Immunotherapy Consortium (CoVIC) – A Broad
Collaboration for Antibodies Against SARS-CoV-2
Erica Ollman-Saphire, La Jolla Institute, La Jolla, CA United States
09:30 – 09:55 Production of Anti-SARS-CoV-2 Hyperimmune Globulin from Convalescent
Plasma
Todd Willis, Grifols, Raleigh, NC United States
09:55 – 10:20 Regulatory Perspectives and Learnings from the Accelerated Development of
a Neutralizing Monoclonal Antibody for COVID-19
John (JR) Dobbins, Eli Lilly and Company, Indianapolis, IN United States
10:20 – 10:45 How Platform Technologies Tested by Ebola Enabled the Development of
COVID-19 Neutralizing Antibody Cocktail at Pandemic Speed
Hanne Bak, Regeneron Pharmaceuticals, Inc., Tarrytown, NY United States
10:45 – 11:15 Technical Seminar
Solving Analytical Challenges in Protein, Vaccine and Gene Therapy
Sponsored by SCIEX
10:45 – 11:30 Virtual Networking Break – Visit Exhibits in East / State Exhibit Hall A
Visit Exhibits in East / State Exhibit Hall B
Visit Exhibits in East / State Exhibit Hall CWEDNESDAY, JANUARY 27 continued
11:30 – 12:45 Panel Discussion – Question and Answers
Hanne Bak, Regeneron Pharmaceuticals, Inc.
John (JR) Dobbins, Eli Lilly and Company
Xianghong (Emily) Jing, CDER, FDA
David Johnson, GigaGen
Lynne Krummen, Vir Biotechnology
Erica Ollman-Saphire, La Jolla Institute
Dorothy Scott, CBER, FDA
Todd Willis, Grifols
12:45 – 14:30 Virtual Networking Break – Visit the Promenade Foyer Lounge
13:15 – 14:30
Virtual Roundtables
Group A
14:30 Adjourn Day ThreeWEDNESDAY, JANUARY 27 continued
Biotherapeutics Part One: Neutralizing Antibodies and
Convalescent Plasma
Panel Discussion
Panel Members:
Hanne Bak, Regeneron Pharmaceuticals, Inc.
John (JR) Dobbins, Eli Lilly and Company
Xianghong (Emily) Jing, CDER, FDA
David Johnson, GigaGen
Lynne Krummen, Vir Biotechnology
Erica Ollman-Saphire, La Jolla Institute
Dorothy Scott, CBER, FDA
Todd Willis, Grifols
The challenges and advantages of different nAb therapies under development will be discussed during the
panel discussion and the following questions will help to guide the discussion:
• The antibody response against SARS-CoV-2 in patients is reported to have low levels of somatic
hypermutation and use recurrent VH-VL pairs. This is similar to other viruses suggesting the naïve
human repertoire is often sufficiently diverse to respond effectively to many pathogens. How to
choose a candidate with regard to epitope binding, specificity and affinity?
• What are appropriate potency assays to demonstrate virus neutralization? What are the
expectations of the Health Authorities?
• Mechanisms of action other than virus neutralization – should mAbs include antibody effector
functions or should they be engineered to abrogate effector function? Is there a risk for antibody-
enhancement of infection with mAbs and hyper IVIG?
• Given the new UK and South Africa variants, and other variants to come, are hyperimmune
globulins or mAb cocktails a better approach?
• The compression of timelines for rapid development of products to quickly enter clinical trials.
How to assess the risk of postponing certain aspects of product development, manufacturing and
testing until later during clinical development?
• How did your organization adapt to regulating/manufacturing products for the treatment of
COVID-19?
• What are specific challenges for the manufacture and testing of mAb cocktails?
• What if the product works – can you meet the demand?
• What changes in ways of working in your organizations do you think will continue after the public
health emergency is over?WEDNESDAY, JANUARY 27 continued
Virtual Roundtables
GROUP A
Floor 1 - Tables 1-7
Table 1: Linking CQAs, Clinical Outcomes, and Attribute-based Specs for Fast to Approval Therapies
Table 2: Cell and Gene Therapy Products - Manufacturing Control Strategy and CQAs
Table 3: Host Cell Proteins – Identification, Strategies, Successes and Challenges
Table 4: Quality Risk Management for Cross-Contamination in Multi Product Facilities
Table 5: Trace Metals - Challenges and Controls in Raw Materials and Fermentation Media
Table 6: Manufacturing, Characterization and Testing for Bispecific Antibody
Table 7: Extractable and Leachable Studies: Best Practices, Case Studies, and Regulatory Update
Floor 2 - Tables 8-14
Table 8: Reference Standards: Common Practices and Challenges
Table 9: Technical Transfer of Analytical Procedures - Best Practices, Pitfalls and Regulatory
Considerations
Table 10: Practical Experiences with In-use Stability / Compatibility Testing (API)
Table 11: Forced Degradation Studies - Best Practices. What, When, How, Where and Why?
Table 12: Low Endotoxin Recovery (LER)
Table 13: ICHQ12 Regulatory Tools and Enablers: Lessons Learned
Table 14: Comparability Concepts and Case Studies
Floor 3 - Tables 15-20
Table 15: Digital Concepts to Accelerate Development Work / AI and Big Data
Table 16: Surfactants: Control, Use, and Characterization
Table 17: Next Generation Control Strategies: QTPP Definition and Implementation, CQA Definition
and Setting Specifications Beyond Clinical Experience
Table 18: Design of Stability Studies for Accelerated Product Development
Table 19: Streamlining Shipping Qualifications / Transportation Validation
Table 20: Continuous Manufacturing - RTRT, PAT, Modular ManufacturingYou can also read
