Secretome Therapeutics Names Dr. Marshelle Smith Warren as New Chief Medical Officer
Secretome Therapeutics, a pioneering clinical-stage biotechnology company dedicated to advancing therapies derived from neonatal cardiac progenitor cells (nCPCs), is pleased to announce the appointment of Marshelle Smith Warren, MD, as its new Chief Medical Officer (CMO). Dr. Warren, a distinguished pharmaceutical executive with an extensive career spanning over two decades, brings a wealth of expertise in clinical development, translational medicine, and regulatory strategy. Her career has spanned multiple therapeutic areas, including cell therapy, immunology, cardiovascular diseases, and rare disorders, making her an invaluable addition to the Secretome Therapeutics leadership team.
Dr. Warren’s appointment comes at a critical time in the company’s growth as Secretome Therapeutics continues to advance its innovative therapies designed to address unmet medical needs in the cardiovascular and rare disease spaces. With the company’s pipeline featuring STM-01, a promising clinical candidate in the field of heart failure, Dr. Warren’s leadership will be instrumental in shaping the trajectory of ongoing clinical trials and upcoming pivotal studies for this and other key programs.
A Distinguished Career in Biotechnology
Dr. Warren’s most recent role as Chief Medical Officer at SQZ Biotechnologies marked a significant chapter in her career. In this capacity, she led the successful development of the company’s first-in-human cell therapy programs, which culminated in the acquisition of SQZ Biotechnologies by STEMCELL Technologies in 2024. Dr. Warren’s leadership was pivotal in navigating the complex landscape of cell therapy, ensuring that the company’s novel therapies received the necessary regulatory approvals and progressed through clinical trials efficiently. Her tenure at SQZ Biotechnologies underscored her ability to guide early-stage companies from innovation to clinical validation and eventual acquisition, a testament to her strategic foresight and deep understanding of biotechnology.
Prior to her time at SQZ Biotechnologies, Dr. Warren held key senior clinical development roles at Atara Biotherapeutics, where she played a pivotal role in the strategy and development of allogeneic T-cell therapies. At Atara, she helped lead the company’s efforts in advancing cutting-edge immunotherapies for various cancers and autoimmune diseases, including overseeing the execution of Investigational New Drug (IND) applications and New Drug Applications (NDA).
Dr. Warren’s vast experience also includes tenures at pharmaceutical giants Gilead Sciences and Amgen, two companies renowned for their leadership in the development of groundbreaking therapies across multiple therapeutic areas. During her time at these companies, Dr. Warren led the successful submission of numerous INDs, NDAs, and Biologics License Applications (BLAs), contributing to multiple regulatory approvals by the FDA and European Medicines Agency (EMEA). These approvals led to the launch of innovative therapies, generating collective revenues exceeding $100 billion and solidifying Dr. Warren’s reputation as a transformative leader in the pharmaceutical industry.
Throughout her illustrious career, Dr. Warren has been instrumental in the successful execution of numerous initial public offerings (IPOs), corporate acquisitions, and strategic mergers. These achievements underscore her exceptional ability to navigate the intersection of clinical development and corporate strategy, ensuring that innovative biotechnology companies not only bring new therapies to market but also achieve long-term success in an ever-evolving industry.
Strengthening Leadership at Secretome Therapeutics
As Secretome Therapeutics progresses through its ongoing clinical trials and prepares to enter late-stage development, Dr. Warren’s leadership will play a key role in driving the company’s clinical strategy and advancing its promising therapeutic candidates. According to Vinny Jindal, President and CEO of Secretome Therapeutics, “We are delighted to welcome Marshelle as our Chief Medical Officer. Her world-class expertise in cell-based therapies and her proven leadership history are invaluable as we execute ongoing clinical trials for STM-01 and as we design potentially pivotal studies in orphan forms of heart failure. Importantly, her depth of experience strengthens Secretome’s management team meaningfully as the company matures towards late-stage clinical studies and beyond.”
Dr. Warren’s experience in navigating the regulatory landscape and her deep understanding of cell-based therapies align perfectly with Secretome Therapeutics’ mission to develop groundbreaking treatments for patients with serious heart conditions and rare diseases. Her appointment marks a significant milestone for the company as it continues to build momentum in the field of regenerative medicine.
Expertise in Translational Medicine and Regulatory Strategy
Dr. Warren is a recognized leader in translational medicine, the field focused on translating scientific discoveries into viable treatments. Her ability to bridge the gap between cutting-edge research and clinical practice has been demonstrated throughout her career. At Secretome Therapeutics, she will leverage her expertise to oversee the company’s ongoing clinical trials and ensure that its therapies are positioned for success in the global marketplace.
In addition to her clinical development expertise, Dr. Warren has extensive experience in regulatory strategy, having guided multiple drug candidates through the complex approval process. Her track record of securing FDA and EMEA approvals will be crucial as Secretome Therapeutics seeks to bring its novel therapies to market. Dr. Warren’s guidance will help ensure that the company’s regulatory submissions are thorough, timely, and successful, positioning its therapies for approval in key markets.
A Commitment to Advancing Innovative Therapies
Dr. Warren’s passion for advancing innovative therapies is matched only by her commitment to improving patient outcomes. She is excited about the opportunity to join Secretome Therapeutics and to lead the company’s clinical development efforts. “I am excited to join the talented team at Secretome Therapeutics,” said Dr. Warren. “The company’s pioneering platform technology offers tremendous potential, and I look forward to leading our clinical development efforts and advancing groundbreaking therapies for patients facing serious health challenges.”
Dr. Warren’s career path has consistently reflected her dedication to improving the lives of patients through the development of novel and transformative therapies. At Secretome Therapeutics, she will continue this mission, with a particular focus on advancing cell-based therapies for patients suffering from heart failure and rare diseases, two areas that have long been underserved by conventional treatments.
Educational Background and Clinical Expertise
Dr. Warren’s educational background and clinical expertise further underscore her qualifications as Chief Medical Officer at Secretome Therapeutics. She earned her medical degree from the University of Nebraska Medical Center, followed by a fellowship in Clinical Immunology at the National Jewish Center for Immunology. In addition, she holds a Bachelor of Science in Biology from Baylor University. Dr. Warren is board-certified in Internal Medicine and Clinical Immunology, credentials that complement her extensive experience in the pharmaceutical and biotechnology industries.
With her medical training and clinical background, Dr. Warren is uniquely equipped to oversee the design and execution of clinical trials that test the safety and efficacy of Secretome Therapeutics’ therapies. Her deep understanding of immunology and cell biology will be instrumental in advancing the company’s regenerative medicine platform, which leverages neonatal cardiac progenitor cells (nCPCs) to develop novel treatments for heart failure and other cardiovascular conditions.
As Secretome Therapeutics continues to push the boundaries of innovation in regenerative medicine, the company is poised for significant advancements in the field of heart failure and rare diseases. With Dr. Warren’s leadership, the company is well-positioned to navigate the complex challenges of clinical development and regulatory approval, while advancing therapies that have the potential to transform the lives of patients around the world.
With a talented team in place and a promising pipeline of therapies in development, Secretome Therapeutics is on a trajectory to become a leader in the biotechnology industry, with a focus on harnessing the power of cell-based therapies to address some of the most pressing unmet needs in medicine today.
The appointment of Marshelle Smith Warren, MD, as Chief Medical Officer at Secretome Therapeutics represents a significant step forward for the company as it advances its cutting-edge therapies in the fields of cardiovascular disease and rare conditions. Dr. Warren’s extensive experience in clinical development, regulatory strategy, and leadership in biotechnology will play a key role in the company’s future success, ensuring that its innovative therapies reach patients who need them most. With her at the helm of clinical development, Secretome Therapeutics is well-positioned to bring transformative therapies to market and to make a meaningful impact in the lives of patients worldwide.
