Barb Bailus, PhD
As FAST funded science moves toward clinical trials, it has become essential to add SAB members that are familiar with the process of human clinical trials and FDA regulations. As this need became more apparent, Dr. Allyson Berent reached out to Dr. Lauren Black who had advised Dr. Timothy Yu on the Milasen Batten Disease antisense oligonucleotide drug.
Dr. Black has extensive expertise in drug safety and drug dosage for new therapeutics, having worked at the FDA in new drug development trials. Her expertise and guidance in this area will greatly enhance the ability of promising AS treatments to move through FDA regulations, and into clinical trials. She received her PhD in pharmacology and toxicology from Virginia Commonwealth University School of Medicine. Currently, Dr. Black is a distinguished scientist at Charles River Laboratories where she focuses on accelerated drug development for rare diseases. She attended her first FAST Gala in 2018 and was struck by what an amazing patient community she was able to meet, and their unified goal of planning for a cure. Having been part of the FDA team that evaluated the first set of effective AIDS drugs, she sees parallels in the promise and persistence of the AS field, and expects great progress to occur in the next five years. An area of research that she hopes to see materialize in the next five years is the ability to measure changes in UBE3A protein production in the cerebral spinal fluid without the need for more invasive samples, this sounds sci-fi, but so did no-needle diabetes kits ten years ago.
When not consulting and navigating the FDA red tape, Dr. Black spends time in her pottery studio watched over by her three cats and one dog. When she is feeling slightly more adventurous she takes her teenage children on driving lessons.