Dear Forum Stakeholders,  
 

2022 was a year of remarkable growth for the Forum. Truly a special year because we were able to convene many of our projects in-person. As we get ready to welcome 2023, we want to pause and share some highlights of 2022: 

New Team Members: 
 

Chris Hoffman, PhD IT and Operational Director	Logan Donaldson, MPH Research Associate	Sehyr Khan, BA Research Associate
Mitchell Leus, MPH Research Associate	Shilpa Mitra, MPH Research Associate	Zach Rooney, MSCS Research Associate
Alicia Jellinek Program Financial Analyst	Nayri Alajaji Graduate Student Researcher	Mayland Treat Graduate Student Researcher

HIV Forum Research Grants and Gifts: 
 

• Bill and Melinda Gates Foundation: $1,584,618 to further work on novel trial designs for HIV prevention and conversations related to making new HIV prevention products available to the public.  
   

• Gilead Sciences, Inc.: $1,638,338 to help accelerate HIV PrEP research by strengthening counterfactual incidence estimates using a collaborative approach to combine data from multiple sources, informing future trials and bolstering current ones, while simultaneously leading conversations in responsible and ethical use of trial data and its future implications. 

Publications: 
 

Association between rectal gonorrhoea and HIV incidence in men who have sex with men: a meta-analysis. Sexually Transmitted Infections. December 2021 
 

Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials. Clinical Infectious Diseases. February 2022. 
 

Application of Bayesian methods to accelerate rare disease drug development: scopes and hurdles. Orphanet Journal of Rare Diseases. May 2022. 
 

Immunological biomarker discovery in cure regimens for chronic hepatitis B virus infection. Journal of Hepatology. August 2022. 
 

A systematic review of limiting antigen avidity enzyme immunoassay for detection of recent HIV-1 infection to expand supported applications. Journal of Virus Eradication. September 2022.  
 

Nomenclature of HBV core protein-targeting antivirals. Nature Reviews Gastroenterology & Hepatology. October 2022.  
 

Facilitating next-generation pre-exposure prophylaxis (PrEP) clinical trials using HIV recent infection assays: a consensus statement from the Forum HIV Prevention Trial Design Project. Clinical Pharmacology & Therapeutics. Accepted, in print.  

Projects Launched: 

Data & Analysis Center: to serve the needs of stakeholders in advancing data science for drug development, thus serving patients most of all. 


Ocular Diseases Forum: to advance the regulatory sciences for the treatment of inherited retinal diseases and macular degeneration. Co-chaired by Jim Wang and Claire M. Gelfman.  


Towards Accelerating Strategies for Hepatitis B Elimination: Increasing Vaccination Among Adults in High-Impact Settings Symposium: as part of the Forum’s Policy Series, a symposium for strengthening implementation of adult hepatitis B vaccination was convened on November 1, 2022 in Atlanta, GA. The symposium convened clinicians, industry, health departments, viral hepatitis programming agencies, harm reduction coalitions, and community-based organizations to facilitate dialogue aimed at producing strategies for implementing universal hepatitis B vaccination among US adults aged 19 to 59, in support of April 2022 guidance by the Advisory Committee on Immunization Practices (ACIP). An output of this meeting will be a special issue in the Journal of Virus Eradication.


Expanding Inclusion for Long-Acting HIV Treatment Trials: this meeting convened on November 10th, 2022 in Washington DC discussed the need for approaches to and regulatory considerations for expanding inclusion of patients who will benefit most from LA treatment options. The Forum brought together stakeholders from the US FDA’s Division of Antivirals, NIH Office of AIDS Research, NIH National Institute of Drug Abuse, NIH National Institute of Mental Health, AIDS Clinical Trial Group (ACTG), Merck, ViiV, Gilead, among other academic institutions and patient advocate groups. Outputs of this meeting include a series of recommendations to be released in 2023.  

 

Meetings Convened:  
 

HBV Therapeutic Vaccines Webinar: January 18, 2022 
 

Liver Forum 12: Washington, DC on April 22-23, 2022 
 

HBV Forum 8: London, England on June 21, 2022 
 

AIDS 2022 Satellite Symposium Next Generation PrEP - Science, Policy, Community Impact: Montreal, QC on July 29, 2022  
 

Liver Forum 13: Paris, France on September 7, 2022 
 

TAVI Forum 7: Washington, DC on October 19, 2022 
 

HBV Forum 9: Washington, DC on November 3, 2022 
 

PSC Forum 4: Washington, DC on November 8, 2022 
 

Expanding Inclusion for Long-Acting HIV Treatment Trials Workshop : Washington, DC on November 10, 2022 
 

Forum on the Integration of Observational and Randomized Data (FIORD) Workshop: Washington, DC on November 17-18, 2022 

The Forum thanks you for fruitful collaborations in 2022.
We wish you a happy and healthy holiday season!