Chaline S. Brown, Pharm.D., Director of Clinical Affairs - Dr. Brown is a clinical pharmacologist with over ten years of experience in the pharmaceutical industry focusing on pharmacogenetics and clinical drug development. Among her areas of therapeutic focus are oncology, HIV, pain/inflammation, infectious disease, neurologic disease, dermatology, and hyperlipidemia. Dr. Brown has broad exposure to and understanding of the multiple disciplines critical to the drug development process: clinical, statistical, regulatory, preclinical and marketing. In her extensive project and program management roles, she has coordinated multi-disciplinary teams to perform strategic program assessments and preparation of data packages for submission to the FDA. Some specific experience includes project management, clinical development and laboratory discovery of pharmaceuticals and biologics at OXO Chemie Inc, and Tularik, Inc. She also served as a research assistant at MD Anderson Cancer Center. Her Bachelor of Science degree in Molecular Biology was granted by the University of Texas in Austin. She received her Pharm. D. Degree from University of California, San Francisco and completed a research fellowship conducting pharmacogenetics clinical studies.

Jean Siegel, Ph.D., Director of Medical Writing - Dr. Siegel has over 25 years of experience in the pharmaceutical industry. Prior to focusing on medical writing she worked in regulatory affairs in a pharmaceutical firm and in international management of clinical trials in a large contract research organization. She has extensive experience in writing pre-IND submissions, INDs, NDAs/BLAs/CTDs, Investigator Brochures, clinical trial protocols, clinical study reports, and other regulatory documents for pharmaceutical and biotechnology firms, as well as experience with eCTDs. Therapeutic areas include analgesic/anti-inflammatory, anti-infective, antiviral, cancer, cardiovascular, dermatologic, ophthalmic, and respiratory therapies. Dr. Siegel serves on the GZP Board of Directors.

Duane B. Lakings, Ph.D., Toxicology / Pharmacology - Dr. Lakings has over 30 years of experience in conducting and reporting results from drug discovery, developability assessment, and drug development experiments and for the past 20 years has been involved in selecting and managing nonclinical research studies outsourced to CROs. He received a Ph.D. in bioanalytical chemistry and has held scientific and managerial positions at pharmaceutical and biotechnology companies and CROs. His responsibilities have included designing and conducting bioanalytical chemistry, pharmacokinetic, drug metabolism, and drug delivery experiments in animal models and in humans and in directing and collaborating with other scientists in the various disciples required for successful drug development. Dr. Lakings has authored 43 publications, 11 commissioned reports, 6 book chapters, and over 200 company-specific technical reports and has written the nonclinical sections for INDs, yearly updates, and marketing applications. Thus, he has experience in the design and implementation of research studies necessary for the characterization and development of drug candidates and in scientific document preparation to support regulatory submissions. Recent clients have included both pharmaceutical and biotechnology firms where assistance has been provided in designing experiments and evaluating results from animal and human studies on NCEs and macromolecules in a variety of disease areas, including CNS, cardiovascular, oncology, virology (AIDS), metabolic diseases, infectious diseases, and dermatology.

Stephan D. Glenn, Ph.D., RAC, Clinical / Regulatory - Dr. Glenn has more than 20 years industry experience managing integrated drug development teams including research and development, clinical research (directing 3 international Phase 3 clinical trials) and regulatory development. Dr. Glenn served on the research staff of the University of Texas MD Anderson Cancer Center for 6 years, before joining industry. Dr. Glenn is experienced in development of small molecules and biologics (CDER and CBER negotiations) for drugs with oncology, HIV, wound healing, tocolysis, diabetes, and autoimmune diseases indications. Dr. Glenn’s oncology clinical research experience includes design and execution of trials in the therapeutic indications of non-Hodgkin’s lymphoma, non-small cell lung, breast, pancreatic, ovarian, gastric, colorectal, and prostate cancer. Dr. Glenn developed the pharmaceutical monoclonal antibody cancer therapeutics program that culminated in the lymphoma therapeutic Bexxar and 10 patents in Nuclear Medicine, therapeutic and pharmaceutical manufacturing technologies, including patents that were successfully defended resulted in payment of $20 MM plus royalties for infringement.

Mark H. Bradshaw, Ph.D., Data Management / Biostatistics - After earning his Ph.D. in Biometrics and Psychometrics from the Johns Hopkins University in 1979, Dr. Bradshaw began his pharmaceutical development career at Glaxo managing statisticians, SAS programmers and data managers in drug development. He subsequently managed the same functional areas for Syntex (later to become a part of Roche), adding IT responsibilities as well. For the past 15 years Dr. Bradshaw has held executive roles in three of the largest global CROs, leading up to 450 staff in 15 countries, engaged in clinical development services along with IT support and clinical trial software development. He has worked and lived for extended periods in UK, Europe and Asia, and has developed data management and clinical monitoring partnerships with companies in India, Singapore and Australia. He is now working as an independent consultant in clinical development and IT areas broadly related to global clinical trials.

Kim A. Donohue, Manager of Regulatory Affairs - Ms. Donohue received her business degree from Saddleback College. She has more than 15 years of regulatory experience in a number of large and small firms, including Allergan Inc., IOLAB Pharmaceuticals, a division of Johnson and Johnson, ISTA Pharmaceuticals, and currently Ground Zero Pharmaceuticals.

Jacque K. King, Manager of Administrative Affairs - Ms. King provides Ground Zero Pharmaceutical's clients with organizational services for their FDA submissions and is responsible for maintenance of the company's central files and office management. She has over ten years in management, most recently for an international retail firm. She holds an AA degree in Creative Arts, which she earned from Pacific Coast College.

Michele F. Smith, Manager of Marketing Affairs - Ms. Smith manages early contact with clients providing the necessary materials and /or communications needed Ms. Smith is also responsible for maintenance of the company’s central electronic storage and intranet communications. Additionally, she provides Ground Zero Pharmaceutical’s clients with organizational services for their FDA submissions. She has over ten years of experience as a Medical Assistant during which she worked for a clinic that provided a series of clinical services. More recently she has worked as an Office Manager for a financial firm, then as a Paralegal for a law firm that specialized in Family Law. She holds an AA degree in Medical Assisting, which she earned from Orange Coast Community College.