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DEVELOPING INNOVATIVE PRESCRIPTION AND NON-PRESCRIPTION TOPICAL PRODUCTS

Disruptive Innovation
in Life Sciences

What We Do

PHD Biosciences (PHD) is a privately held clinical stage product discovery and development company that is focused on the development of prescription and non-prescription topical products.  The PHD pipeline is complimented by revenue from non-dilutive grants that total more than $13.5 million since 2011. These include: several Small Business Innovation Research (SBIR) grants, along with grants from New York State and philanthropic foundations.   

Clinical Stage Topical Prescription Drug Programs in Clinical Trials

Awards Won Since 2011

Million in Non-Dilutive Funding

Our Team

Our team comprises experts with experience in drug development, operations, business development, regulatory affairs, planning, finance, and drug product registration.

Steven Isaacman, Ph.D.

CHIEF EXECUTIVE OFFICER

Dr. Isaacman founded PHD Biosciences in 2008, and currently serves as the Chief Executive Officer (CEO) where he manages the preclinical and clinical therapeutic programs. He is an expert in the development and commercialization of topical and systemic drug products; has been responsible for the invention and management of collaborative efforts that have led to the commercialization of several globally distributed drug- and non-drug products; and since 2011 has been the Principal Investigator on 19 of PHD’s grants. He is also a Visiting Scholar in the Chemistry department at New York University. He received his Ph.D. in organic chemistry from New York University, and M.S. and B.S. degrees in chemistry and biochemistry from Stony Brook University.

Andrew Mahon, Ph.D.

CHIEF SCIENTIFIC OFFICER

Dr. Mahon is the Chief Scientific Officer (CSO) at PHD Biosciences. With over 16 years of experience in medicinal chemistry and chemical biology, he manages drug development and basic research within the company. He is directly involved in experimental design, and implementation and works closely with the CEO to manage corporate strategy. He has also been instrumental in raising over $10M in funding to accelerate the translational development of the preclinical and clinical stage assets that constitute the company’s pipeline. 

Michael Isaacman, Ph.D.

DIRECTOR R&D

Dr. Michael J. Isaacman is Director of Research at PHD Biosciences, and manages programs to develop novel topical products for drug and non-drug applications. He is a polymer chemist by training, and received his Ph.D. from the University of California, Santa Barbara where his research focused on the synthesis and self-assembling dynamics of silicone-based amphiphilic block co-polymers. Michael is an expert in polymer chemistry and has pioneered novel methodologies for the design & fabrication of moieties for use in drug delivery and over-the-counter drug products Michael has 12 years of experience in the fields of natural product synthesis, polymer synthesis, nanoparticle self-assembly, and topical drug delivery.

Michael Szarek, Ph.D.

REGULATORY AFFAIRS
Dr. Szarek leads Regulatory Affairs, is the company’s representative to FDA, and maintains open INDs. He has been involved in the design, conduct, and analysis of numerous cardiovascular and oncology clinical trials. This includes SPARCL, a landmark study where 4,731 patients with a history of cerebrovascular disease were treated with atorvastatin or placebo and followed for the occurrence of cardiovascular events. He is currently a member of the Executive Steering Committee of the Odyssey Outcomes Study, which is comparing the effect of alirocumab with placebo on the occurrence of cardiovascular events in 18,000 patients who have experienced an acute coronary syndrome (ACS) event prior to randomization. He has also served on Data Monitoring Committees for Phase 3 studies, and has written protocols, analysis plans, Committee charters, and study reports for multiple studies in various therapeutic areas across all stages of clinical development. In his prior and current positions in regulatory affairs, he has also been responsible for initial IND submissions and amendments to open INDs.

Eric Rowinsky, M.D.

CHIEF MEDICAL OFFICER
Dr. Rowinsky is a world-renowned expert on the development and registration of therapeutics with approximately 25 years of experience in the academic sector and biopharmaceutical industry. He has focused on the comprehensive development and registration of novel oncology therapeutics since his seminal clinical and preclinical studies of paclitaxel. These initial studies were the foundation for the ultimate approval of the first blockbuster drug in cancer, and registration in cancers of the ovary, lung, head and neck, and breast in the early 1990s. He has played a major role in development strategies leading to the worldwide registration of paclitaxel, docetaxel, irinotecan, topotecan, erlotinib, gefitinib, panitumumab, temsirolimus, and trabectedin, amongst others. He previously served as the Head of Research and Development and Chief Medical Officer at Stemline Therapeutics Inc., during which time, he was integrally involved with raising approximately $160 Million and a public offering, which launched its principal therapeutic cancer stem cell targeting assets into various worldwide pivotal clinical trials..

Scott Spector

CLINICAL OPERATIONS
Mr. Spector is an accomplished clinical development executive with 20 years of pharmaceutical product development experience. He was previously the European President of Siro Clinpharm, an emerging market CRO with a strong emphasis on the CEE and India. His career in clinical development started at Quintiles Transnational, where he was instrumental in leading the growth of the company’s European operations. Scott served as the President of Quintiles France and Spain and was also the global operations head of the CNS and Anti-Infectives business units. Following a 10-year career at Quintiles, he became President of CAC Oncology, an early pioneer in oncology contract research services and drug development consulting. Upon the sale of CAC Oncology to AAIPharma, he became President of a newly created entity called AAI Oncology. He holds a BS/BA in Finance from Boston University and a Professional Certificate in Genetics and Genomics from Stanford University.

Recent News

May 2021– PHD Biosciences wins a Phase I SBIR from the National Cancer Institute to further the clinical development of a first in class, biocompatible and  environmentally friendly long-wear sunscreen.  The sunscreen is designed to be water resistant for 80 minutes and satisfy emerging / existing environmental regulations in places like Hawaii and Key West, FL.

September 2020 – PHD Biosciences has acquired the exclusive global rights from Washington University (WU; St. Louis, MO) to develop a topical immunotherapy to treat actinic keratoses (AK) and prevent skin cancer.  The topical immunotherapy prescription drug product being developed by PHD uses a combination of calcipotriol (CPO) and 5-fluorouracil (5-FU) to activate CD4+ T cell immunity to clear AKs and block cancer development and recurrence.  The ongoing work at PHD builds upon a successfully completed randomized double-blind study in 130 AK patients and an unpublished open-label study which demonstrated the safety and efficacy of the same combination of CPO and 5-FU to clear AKs and prevent skin cancer for 3 years.1,2 The exceptional results are also supported by clinical studies from independent groups.3-5

  1. Cunningham TJ, Tabacchi M, Eliane JP, et al. Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest. 2017;127(1):106-116.
  2. Rosenberg AR, Tabacchi M, Ngo KH, et al. Skin cancer precursor immunotherapy for squamous cell carcinoma prevention. JCI Insight. 2019;4(6).
  3. Moore AY. Short-contact topical calcipotriene foam and fluorouracil 1% cream after cryotherapy for actinic keratosis. 2019.2.         
  4. Moore AY Nguyen M Moore S. Cyclic calcipotriene 0.005% foam and 1% 5-fluorouracil cream after cryotherapy in treatment of hyperkeratotic actinic keratosis: A retrospective study. J Am Acad Dermatol. 2020.3.         
  5. Teresa Sarandeses Diez M Caral Vanaclocha I Lemaitre S Gónzález Candial M. Topical treatment with calcipotriol combined with 5-fluorouracil for premalignant periocular lesions. J Fr Ophtalmol. 202144(1):e27-e29.

July 2020 – PHD Biosciences has won a $2 million Direct Phase II SBIR award from the National Cancer Institute to accelerate the translational development of new types of sunscreens, designed to mitigate the risk of skin cancer.

PHD BIOSCIENCES

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