Dror Rom, PhD

Chief Executive Officer

Dr. Rom is a biostatistician with over 30 years of experience working in the pharmaceutical industry. Dr. Rom’s career has combined research and clinical data analyses. His research interests focus on statistical methodologies applicable to clinical trials, primarily in the areas of numerical computations, bioequivalence, multiple comparisons, and adaptive designs, which have led to numerous publications including the co-authoring of a SAS book on the subject of multiple comparisons.

Robert Babilon MS, MBA

President

Mr. Babilon has both an MBA from St. Joseph’s University and an MS in Microbiology and Immunology from Temple University. Mr. Babilon’s expertise lies in Regulatory Affairs, Quality Assurance, and Business Development. Over the course of his 35 years in the pharmaceutical industry he has provided numerous strategic product development plans, has supported international clinical development programs and has organized and submitted clinical trial and marketing applications leading to approvals for Dermatology, Analgesia, HIV, Oncology, Gastrointestinal, Neurology, and Cardio-Renal drug and device products. Additionally, Mr. Babilon has participated in numerous FDA meetings and is an established presenter of US FDA Regulations, including annual presentations for Atrium, an international educational facility in Denmark.

Donna Borgnis MS, MS

Chief Operating Officer

Ms. Borgnis has over 25 years’ experience in Quality Assurance and Regulatory Affairs for pharmaceutical, biotech and medical devices. Ms. Borgnis has managed the Clinical and Regulatory/Quality assurance aspects of trials with as many as 200 sites. Ms. Borgnis has experience with NDA and IND eCTD submissions, ESG portal submissions, GMPs, GLPs and GCPs. Ms. Borgnis spent 10 years as a laboratory technician and holds a certification as an MLT. Ms. Borgnis holds a Bachelor of Science degree as well as a Masters’ degrees in Health Sciences and Management/Information Sciences.

Michael Nordsiek

Board Member, Business Advisor and CMC Consultant

Mr. Nordsiek has over 30 years of experience in the pharmaceutical industry with specialization in CMC, manufacturing, formulation and overall product, package and process development, and validation and site transfers. Mr. Nordsiek obtained his BS in Pharmacy from the West Virginia University School of Pharmacy and has participated in or led the global development of products, teams and companies in the therapeutic areas of dermatology, women’s health, respiratory, and cardio-renal health. Mr. Nordsiek specializes in Regulatory Affairs, Project Management, and Quality and Business/Product Development. As a co-founder of several specialty pharmaceutical companies over the last decade, along with his partners, he has successfully secured the funding, products, and personnel necessary to build companies that achieved up to $400 million in yearly revenue.

Matt Hudson, Ph.D.

Vice President, Biostatistics

Dr. Hudson is a biostatistician with nearly 20 years of experience in the pharmaceutical industry, and has provided statistical support to all phases of clinical trials in numerous therapeutic areas. Dr. Hudson has contributed to successful development and approval of many investigational drugs in both the US and Europe. Dr. Hudson has developed an expertise in regulatory guidelines including FDA, EU, ICH, and CDISC. Matt has a PhD in theoretical statistics from Western Michigan University.

Jeff Harbaugh

Vice President, Data Services

Mr. Harbaugh has over 18 years of Data Management and eDC development experience. Mr. Harbaugh has managed data activities for numerous Phase I-IV clinical trials across many therapeutic areas. Mr. Harbaugh has established an Intelligent eCRF design based on CDASH guidance, a user-friendly eDC set-up, and consistently provides high quality SAS data from his Data Management group. Mr. Harbaugh earned a BA/BS degree in Human Biology & Anthropology from Temple University, with honors.

Jack Furst

Vice President, Clinical Research

Mr. Furst has more than 25 years of experience in the biopharmaceutical research industry. He has been responsible for the strategic planning and execution of non-clinical and clinical studies (Phase I through IV) for investigational drugs and medical devices. He has successfully designed and authored numerous clinical study protocols and managed many international and domestic clinical programs. Mr. Furst has authored/published many CSRs, study manuscripts, FDA briefing documents, and NDA/PMA submissions including development and preparation of the ISS, ISE, package inserts, and all other clinical sections of an FDA application. His therapeutic areas of experience include Dermatology, Women’s Health, Respiratory, Allergy/Asthma, and Cardiology. Mr. Furst earned a BS degree in Biology (physiology emphasis) from Penn State University.