Welcome
Keynote: Charles Flexner, PI, LEAP
Major accomplishments in 2022.
- Supplement published in CID on December 1, 2022.
- Special thank-you to David Thomas and Susan Swindells (co-editors) and Jane McKenzie-White (editorial organizer).
• Release of the Integrated Compounds Database within the Long-Acting Therapeutics Patents and Licenses Database (LAPaL) website www.LAPaL.ch.
- LAPaL is the brainchild of Lobna Gaayeb (Medicines Patent Pool) and originally funded by UNITAID to focus on intellectual property issues – a “Technologies link” gives you the platforms.
- LEAP created an online compound landscape focused on the drugs themselves with input from Adeni Olagunju (Univ of Liverpool) –
- Compounds link gives you the individual drugs.
- Interactive visualization dashboard shows where the compound is in clinical development (brainchild of A. Olagunju and colleagues at Univ of Liverpool).
- List of all clinical studies for the particular drug and indication of interest.
- Color-coded clinical trials timeline (PI, P2, P3, etc.), including post-marketing studies.
- List of individual studies including a link to the clinicaltrials.gov number, enrollment, and status (complete vs open).
- Global summary of regulatory filings on a map, color-coded according to status of a product or formulation (approved, submitted, withdrawn, or on clinical hold).
- • Other publications.
- Review on LA formulation development and implementation for PrEP; Cost-effectiveness analysis of LA Cabotegravir in LMICs; and Survey of patient preferences for LA formulations for HCV.
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Where we are going in 2023.
- Ongoing collaboration with two large UNITAID programs developing drugs for Phase I studies in HIV, TB, and HCV.
- Publication of the first systematic review of LA/ER ARVs in children, adolescents and pregnant women.
- Expansion of the LAPaL Intellectual Property and Integrated Compounds Databases.
- Add more products, formulations, and indications, and also move into products that are in advanced pre-clinical development.
- Expect increased support for clinical development of new LA formulations for HIV, TB, and viral hepatitis.
- Continued demand for the modelling and simulation core service headed by Andrew Owen at Univ of Liverpool.
- July 1 2023 we will enter year 4 of our 5-year grant. We have started discussions about the possibility of renewal and priorities going forward.
Two important thank-you’s and farewells.
- Terry Blaschke – one of the founding members of our Executive Committee, an important part of this program, and my most important professional role model and mentor.
- He retired last year after several decades as Director of the Division of Clinical Pharmacology at Stanford University and as Founding Director of the Global Clinical Pharmacology Program at the Bill and Melinda Gates Foundation. “We will miss your wisdom, warm smile, and great sense of humor.” We appreciate everything you’ve done for LEAP.
- Daniella Livnat – our founding Program Officer at DAIDS and an important supporter of this program. She has helped align LEAP and DAIDS priorities.
- Daniella’s portfolio has expanded at DAIDS, and she had to resign as our Program Officer last year. Marina Protopopova will take her place – she has been a part of the TB Working Group, she is familiar with the program, and has been a great collaborator.
- Daniella’s portfolio has expanded at DAIDS, and she had to resign as our Program Officer last year. Marina Protopopova will take her place – she has been a part of the TB Working Group, she is familiar with the program, and has been a great collaborator.
Quotes:
“I want to thank all of you for being here, whether you are in person or at home watching virtually. If you are not here in person, I can tell you … It is extremely emotional for all of us to be together in the same room and seeing each other after 3 or 4 years, and I am so glad we have this opportunity to be together again.”
“For decades we have been saying in HIV… why isn’t there one place you can go to know where an individual drug or formulation sits in clinical development, and today we have this for LA formulations.”