www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Grand Rounds: Some Perspectives on Data Science and Coronaviruses
June 9, 2022


Activity Coordinators:
Madison Hanson (Madison.Hanson@fda.hhs.gov),  Rokhsareh Shahidzadeh (rokhsareh.shahidzadeh@fda.hhs.gov),  Sharron Watson (Sharron.Watson@fda.hhs.gov)
Series Description

The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.


Lecture Description
This lecture will present some perspectives, illustrated with recent COVID-19 experience and examples, on how in silico modelling and data science techniques could strengthen nonclinical (in vitro and animal) models for existing and emerging coronaviral diseases. Four peer-reviewed case studies will be reviewed briefly: 1. Could alignment-free approaches complement traditional phylogenetic analysis of coronavirus variants? 2. Why big data on viral genome sequences are less useful without metadata? 3. Could we predict if certain hosts are likely susceptible to infection by an emerging coronavirus variant? 4. Can AlphaFold2 artificial intelligence predictions of protein structure aid our understanding of viral antigens?
References
  • Supporting pandemic response using genomics and bioinformatics: A case study on the emergent SARS‐CoV‐2 outbreak, https://doi.org/10.1111/tbed.13588
  • Interoperable medical data: the missing link for understanding COVID‐19, https://doi.org/10.1111/tbed.13892
  • But Mouse, you are not alone: On some severe acute respiratory syndrome coronavirus 2 variants infecting mice, https://doi.org/10.1093/ilar/ilab031
  • Highly thermotolerant SARS-CoV-2 vaccine elicits neutralising antibodies against Delta and Omicron in mice, https://doi.org/10.3390/v14040800
Series Objectives
  • Discuss the research conducted at the FDA
  • Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
  • Examine how coronavirology can benefit from alignment free kmer approach and dimensionality reduction methods.
  • Explain the potential of big data on GISAID and other platforms by overcoming metadata barriers.
  • Discuss the value of bringing together in silico, in vitro, in vivo and in situ data on coronavirus mutations to predict susceptibility of target hosts.
  • Discuss the benefits and current limitations of novel AI tools such as AlphaFold2 in coronaviral protein structure prediction and countermeasure development.
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
Agenda

Lecture 1 June 9, 2022
Time Topic Speaker
9:00 - 10:00 AM EDT Some Perspectives on Data Science and Coronaviruses Seshadri Vasan, DPhil(Oxon)
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-006-L04-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Vasan, Seshadri, DPhil(Oxon), Honorary Professor, University of York - nothing to disclose

Planning Committee
  • Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
  • Pfundt, Tiffany, PharmD, Senior Advisor, HHS/ASPR - nothing to disclose
  • Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team
  • Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
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