Helen Pentikis, PhD

Helen S Pentikis, PhD
Areas of expertise: Pharmacokinetics, Clinical Pharmacology, Regulatory Strategy

Dr. Helen Pentikis has over 32 years of experience in the development of new drugs and therapeutics. She has participated in more than 75 FDA regulatory meetings, representing scientific interests in pharmacology/toxicology, clinical pharmacology, biopharmaceutics, and regulatory strategy. Dr. Pentikis has authored more than 80 abstracts/publications and has been involved in more than 200 clinical studies in adult and pediatric patients, including Phase 1-3 studies, with a concentration in anti-infectives, anti-parasitics, women’s health products, CNS, oncology, and oncology supportive care.

Dr. Pentikis co-founded SAJE Consulting in 2008 and has provided pharmacokinetic, clinical pharmacology, and nonclinical toxicology consulting services to small and mid-sized pharmaceutical companies. Dr. Pentikis has designed nonclinical and clinical pharmacology programs that represent a variety of dosage forms including intravenous, oral, intramuscular, transdermal, and topical.

Dr Pentikis has served as a reviewer at the FDA in the Office of Clinical Pharmacology. During her tenure at the FDA in the Neuropharmacology Division, she provided scientific expertise as a member of multi-disciplinary scientific teams engaged in review, evaluation, and in making recommendations regarding the approvability of regulatory submission. Most recently, Dr. Pentikis was the CSO and co-founder of Zero Point Five Therapeutics. She has led the development of a single dose therapy for intestinal parasites, from manufacturing through to clinical development. The drug is currently being evaluated in a multi-national clinical trial. She has also served as CSO and Co-Founder of Symbiomix Therapeutics, a venture-backed company that was sold to Lupin Pharmaceuticals, Inc., in 2017, after achieving NDA approval for Solosec™. Prior to Symbiomix, Dr. Pentikis served as Head, Clinical Pharmacology at AkaRx Inc., with oversight for all clinical pharmacology activities and management for the company’s lead oncology product. Dr. Pentikis’ work and position on the senior management team was instrumental in the $300M acquisition of AkaRx. Her other experiences include senior level positions at global CRO (ICON plc) and Sanofi-Aventis.

Dr. Pentikis received a B.S. in Biology from Wake Forest University, a Ph.D. in Pharmacology and Toxicology from the University of Maryland where her research interests included modulation of EEG effects of opioid agonists with endogenous opioid peptides. She completed a Pharmacokinetics Fellowship at the FDA where she gained expertise in pharmacometrics and the regulatory approval process. She serves as a grant reviewer for the Maryland Innovation Initiative and evaluates drug development proposals from emerging biopharmaceutical companies. She serves as a board member for Metrum Research Group and Redivivus Therapeutics where she provides scientific and entrepreneurial support for company management.

In addition to her scientific interests, Dr. Pentikis serves the community as an Executive Board Member of the Saint Demetrios Greek Orthodox Church and a mentor for pharmacy students at the University of Notre Dame in Maryland. She consistently supports The American Hellenic Educational Progressive Association, the Downtown Baltimore Family Alliance, the Hampden Family Center, the Susan G. Komen Foundation, and volunteers on the Brewers Hill Neighborhood Association in Baltimore.