Step Pharma Strengthens Clinical Development Team Ahead of First in Human Studies

On May 10, 2022 Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective oral treatment of cancer, reported that it has strengthened its clinical development team with the appointment of Dr. Brian Schwartz as Chief Medical Officer and Dr. Maureen Higgins as Vice President and Head of Clinical Operations, as it continues to advance STP938, its lead CTPS1 inhibitor, towards clinical studies in haematological malignancies (Press release, Step Pharma, MAY 10, 2022, View Source [SID1234614004]).

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Dr. Brian Schwartz brings more than 25 years of experience in drug development in the pharmaceutical and biotechnology industries, in areas including oncology, haematology and rare diseases. Dr. Schwartz previously served for twelve years at ArQule, where he was Chief Medical Officer and Head of Research and Development and led clinical development of the BTK inhibitor ARQ 531 before the company’s $2.7 billion acquisition by Merck in 2020. His previous roles also include CMO and Senior Vice President, Clinical and Regulatory Affairs at Ziopharm, where he oversaw the development of new cancer drugs. Earlier in his career, he held leadership roles at Bayer Healthcare and Leo Laboratories. Alongside his role at Step Pharma, Brian will continue to act as a consultant to other biotech companies, and also serve on the boards of Mereo BioPharma, Enlivex, Cyclacel Pharmaceuticals and Infinity Pharmaceuticals.

Dr. Schwartz, who practiced medicine prior to his career in the biopharmaceutical industry, holds a medical degree from the University of Pretoria, South Africa, and completed a fellowship at the University of Toronto, Canada.

Dr. Maureen Higgins has 30 years of experience in clinical research in project management, clinical operations, and business development within both the pharmaceutical and CRO sectors. Dr. Higgins was previously VP for Project Management at Precision for Medicine. Prior to that, she served as Director for Project Management at Chiltern Oncology, overseeing studies and leading project managers in the conduct and delivery of early phase oncology studies, and as Project Director at PRA Health Sciences, UK, where she project-managed early- and late-phase oncology, and neurology studies. She was also Director for Business Development at CroMedica and an Internal Business Consultant at Quintiles, where she also served as Head of Operations in South Africa.

Dr. Higgins holds a B.Sc. in Biology from Bristol Polytechnic, a Ph.D. in Molecular Developmental Genetics from the University of Edinburgh, where she also completed her post-doctoral fellowship in Molecular Biology and an MBA from Strathclyde Graduate Business School.

Andrew Parker, Chief Executive Officer of Step Pharma, commented: "On the eve of Step Pharma progressing into the clinic with STP938, we are delighted to have made such strong clinical operations appointments in Brian and Maureen. Step Pharma are the world leaders in CTPS1 inhibition, a novel approach that we believe could allow us to selectively target cancer cells, not only in our core focus of haematological cancers but in a combination setting in solid tumours as well."

Dr. Brian Schwartz, Chief Medical Officer, commented: "Researchers have been trying to target pyrimidine synthesis for decades to treat cancer without success, but with Step Pharma’s CTPS1 approach I believe we have the breakthrough. I am delighted to be joining such an experienced team at this pivotal time for the company."

Dr. Higgins, VP, Head of Clinical Operations, commented: "Step Pharma is the world leader in CTPS1 research and with its strong scientific heritage, outstanding team and high-quality investors has the clear recipe for success. I am excited to support the company take the next important clinical step in its development."