Janet R. Rea, MSPH, Senior Vice President, Research & Development at Atossa Therapeutics, a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet needs joins eHealth Radio and the Health News Channel.
Listen to interview with host Eric Michaels & guest Janet R. Rea discuss the following:
Janet, with over 35 years of experience bringing landmark treatments like LEUKINE® and FLU-BLOK® from clinical development to commercialization, you have a deep public health and scientific perspective on drug development. From an R&D leadership standpoint, what drew you to this chapter at Atossa, and how does your background shape your vision for the company’s expansion into rare diseases?Over the past several months, Atossa has made an aggressive, synchronized push into the orphan disease space securing back-to-back FDA Rare Pediatric Disease designations for Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS), while simultaneously appointing a dedicated Medical Director for Rare Diseases. Why is now the optimal moment for Atossa to rapidly scale this multi-pronged, rare disease strategy alongside your established breast oncology programs?The company’s lead product candidate is (Z)-endoxifen. For those unfamiliar with the compound, how does Atossa’s proprietary oral formulation differ from traditional treatments like tamoxifen, particularly regarding its safety profile, and mechanisms like PKC inhibition?The FDA has granted (Z)-endoxifen both Orphan Drug and Rare Pediatric Disease (RPD) designations for DMD. How do these specific designations alter Atossa’s clinical and regulatory strategy?
The regulatory landscape for orphan drugs is transforming rapidly, especially with the FDA's new Rare Disease Innovation Hub and accelerated approval frameworks. How are these new federal guidelines changing the way biotech companies design clinical trials and talk to regulators?Given your prior leadership role at AVI BioPharma (now Sarepta Therapeutics), a pioneer in Duchenne Muscular Dystrophy, and your background teaching biomedical regulatory affairs, how does that specific rare-disease experience inform your scientific and clinical strategy as Atossa advances (Z)-endoxifen for DMD and McCune-Albright Syndrome?As you look toward the next 12 to 18 months, what is the primary clinical milestone or breakthrough that you are most excited to deliver to patients and shareholders?Janet R. Rea, MSPH brings over 35 years of industry leadership experience in clinical development through commercialization in biologics and small molecules, with focus on oncology, infectious diseases, orphan and rare-diseases. A Washington native, she obtained her B.S. degree in Microbiology from the University of Washington and was conferred a Master of Science of Public Health from the same institution.
Prior to rejoining Atossa, she was an independent consultant to biopharmaceutical companies. She has held senior leadership positions with AVM Biopharma, Poniard Pharmaceuticals, AVI BioPharma (Sarepta), Protein Sciences (Glaxo), and Atossa Therapeutics, playing key roles in the approval of Immunex’s initial product, LEUKINE® and Sanofi’s rDNA influenza vaccine, FLU-BLOK®.
Rea has lectured at both Shoreline Community College and the University of Washington for the Biomedical Regulatory Affairs Certificate and Master’s Program, where she also served as a part-time Assistant Clinical Professor.
Website: atossatherapeutics.com
Facebook: facebook.com/atossageneticsinc
Linkedin: linkedin.com/company/atossatherapeutics
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