Atossa Therapeutics Names Janet R. Rea, MSPH, as Senior Vice President, R&D to Accelerate (Z)-Endoxifen Toward Key Regulatory Milestones
Atossa Therapeutics (NASDAQ:ATOS) has appointed Janet R. Rea, MSPH as Senior Vice President, R&D. This strategic hire brings over 20 years of clinical development and regulatory expertise to accelerate the development of (Z)-endoxifen, the company's lead product candidate for breast cancer treatment and prevention.
Ms. Rea, who previously served at Atossa, returns with significant experience in securing regulatory approvals, including her role in the approval of FluBlok® at Protein Sciences. Her prior work at Atossa involved securing regulatory clearance for (Z)-endoxifen clinical studies in Australia, the US, and Sweden.
In her new role, Ms. Rea will focus on upcoming FDA submissions and defining the pathway to commercialization for (Z)-endoxifen across multiple indications.
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Insights
Atossa's hiring of Janet Rea signals progression toward regulatory submissions for (Z)-endoxifen with her proven track record of drug approvals.
Atossa Therapeutics' appointment of Janet Rea as Senior VP of R&D represents a strategic enhancement to their executive team at a critical juncture in their development pipeline. Ms. Rea's return to Atossa brings valuable continuity, as she previously secured regulatory clearances for the company's (Z)-endoxifen clinical studies across three countries - work described as the "cornerstone" of their breast cancer programs.
Her track record includes notable regulatory successes that directly align with Atossa's current needs. She played a key role in securing approval for FluBlok® and obtained IND clearance for what later became Exondys 51 - demonstrating her ability to successfully navigate complex regulatory pathways through to commercialization.
The creation of this new position specifically focused on late-stage development signals an organizational shift toward commercialization preparation. The press release explicitly mentions "upcoming FDA submissions" and "defining pathway to commercialization" for (Z)-endoxifen, indicating the company is transitioning from earlier clinical stages toward regulatory review processes.
The company's reference to addressing "multiple indications" with (Z)-endoxifen suggests Atossa is pursuing a multi-pronged development strategy that could potentially expand their market opportunity. CEO Steven Quay's statement about being "laser-focused on bringing our lead product candidate, (Z)-endoxifen, to market" further emphasizes the company's commitment to advancing this specific asset through regulatory channels.
This executive addition reflects deliberate strengthening of Atossa's regulatory expertise precisely when needed for upcoming FDA interactions - a typically positive development for clinical-stage biopharmaceutical companies approaching key regulatory milestones.
Veteran development leader with successful regulatory approvals record returns to lead late-stage clinical and regulatory programs to address multiple unmet clinical needs
Ms. Rea most recently served as a consultant to a variety of biopharmaceutical companies. She has held senior development leadership roles for AVM Biotechnology (COO, SVP), Atossa Therapeutics, TPI Therapeutics, and Protein Sciences (now Glaxo), where she played a key role leading to the approval of FluBlok®, an innovative rDNA egg-free influenza vaccine. She was also an Assistant Professor at the University of
"Janet's extensive experience in strategic regulatory and clinical development pathways, particularly in getting programs successfully through approval processes, aligns perfectly with our mission to bring transformative treatments," said Dr. Steven Quay, Atossa Therapeutics Chief Executive Officer. "We are laser-focused on bringing our lead product candidate, (Z)-endoxifen, to market to address the large clinical need across multiple indications. Janet combines approval-path experience with hands-on execution – exactly what we need to propel our programs forward."
For over 20 years, Ms. Rea has built an impressive career with leadership positions in the clinical development and execution of regulatory strategies. She has directed cross-functional teams, led regulatory submissions in the US and internationally, and managed comprehensive clinical development programs including in oncology, biopharmaceuticals, as well as viral and cardiovascular diseases. Her expertise in aligning clinical strategy with regulatory and commercial goals are supportive to Atossa's growth.
"Atossa is at an exciting inflection point. I am thrilled to rejoin the team advancing promising (Z)-endoxifen therapies to market," said Ms. Rea.
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The Company's lead product candidate, (Z)-endoxifen, is a highly potent SERM/D designed for use across the breast cancer spectrum, including risk-reduction, and treatment in the neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit atossatherapeutics.com.
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SOURCE Atossa Therapeutics Inc
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