Clinical Trials International

Larry Young
Larry brings over 22 years of global development experience in the pharmaceutical, biotechnology and medical device industry and 10 years of clinical research experience as a pharmacist at Veterans Administration Medical Centers. Prior to joining CTI, Larry was the Executive Director of Clinical Affairs at Inovio Biomedical Corporation where he was responsible for clinical development and regulatory affairs for a combination product in multiple cancer indications. Before joining Inovio, he served as the Director of Project Management and Clinical Operations at Chugai Pharma USA, now a Roche group company. Larry has held various clinical research positions at Depotech, Gensia, Bristol-Myers Squibb and Veterans Administration Cooperative Studies Program. His experience encompasses several major therapeutic areas. Larry earned his BS in pharmacy from North Dakota State University, Fargo, ND and his MBA from New Mexico Highlands University.

Cameron Gall
Cameron brings over 20 years of global development experience in the pharmaceutical, biotechnology, medical device and CRO industry. His most recent work includes field monitoring and auditing covering a wide range of therapeutic areas. Prior to joining CTI, Cameron was the Director of Clinical Operations at Intercool, a medical device company and a Global Project Leader with Chugai Pharma USA working in oncology. He has extensive monitoring and project management experience and recent experience in drug safety. He also has held various clinical positions with Quintiles, Fujisawa Pharmaceuticals and Bristol-Myers Squibb and was involved with research activities with the Veterans Administration Medical Center in San Diego. Cameron earned his BS in zoology from San Diego State University and his MBA degree from Lake Forest Graduate School of Management, Lake Forest, IL.

Melody Anderson
Melody brings over 25 years of global development experience in the pharmaceutical, biotechnology, medical device and CRO industry. Prior to joining CTI, she was responsible for initiating and managing clinical trials in Australia and New Zealand for St. Jude Medical Australia and a director at Clinimetrics-Australia P/L. She has working knowledge of ICH guidelines, ISO 14155, and FDA regulations and has several IND, PLA and NDA submissions. Melody held several director level positions and performed drug development that encompassed a wide range of therapeutic areas. She also held various clinical positions at ICON Clinical Research, Genetronics, La Jolla Pharmaceuticals, Depotech Corporation, Liposome Technology, Xoma Corporation, Syntex Research and Abbott Laboratories. Melody earned her MS degree in Physiology and BS degree in Biology at the University of Illinois, Champaign-Urbana, IL and post-graduate work in Pharmacology at University of Illinois in Chicago, IL.

Richard Hake
Richard brings over 14 years of pharmaceutical development experience in legal affairs, intellectual property, patents, partnerships, joint ventures, mergers, acquisitions, divestments and product commercialization. Prior to joining CTI, he was responsible for international litigation, mergers, acquisitions and divestments with Elan Pharmaceuticals and later with Chugia Pharma USA. Richard has a long history of working on health care issues and serving investors, entrepreneurs, government and corporations. Richard's experience also includes positions with Procter & Gamble Pharmaceuticals and Sterling Winthrop Pharmaceuticals. Richard earned his JD from, Salmon P. Chase College of Law, Highland Heights, KY, PhD in Biophysical Chemistry and MS in Organic Chemistry from University of Rochester, NY and BS in Chemistry from Canisius College, Buffalo, NY.

William D. Mikrut
William has over 18 years of development experience in the pharmaceutical and biotechnology industry in data management and biostatistics. He has provided statistical input and data management support in all phases of development, as well as, pre-IND studies. William has held lead responsibilities in critical communications with the FDA statisticians and international regulatory agencies. He has also provided independent assessment of clinical data for financial groups seeking to invest in biotechnology. William's statistical career includes working in oncology, infectious diseases, gastrointestinal, pain, diabetes, wound healing, neurological diseases, dermatology, and diagnostic imaging. He has been the primary statistical lead for several successful NDA/BLA submissions including 2 oncology, 2 dermatology, 2 diagnostic imaging, and 1 dental anesthetic reversal agent. After an academic biostatistician position at University of Texas Medical Branch, Galveston, TX, William moved into private industry where his work experience included Pharmaco (now PPD), ILEX Oncology (now Genyzme), and Vical prior to founding his consulting company in 2006. He is currently president and founder of Vertex Data Designs, Inc. William earned his M.Sc. in Biometry at the University of Texas Health Science Center, Houston, TX.

Brandon Porter
Brandon brings over 6 years of global development experience in the pharmaceutical, medical device and CRO industry. His primary focus has been regulatory affairs, clinical operations, contracting and finances. His area of expertise is in global start-up activities and institutional contracting. Brandon is currently specializing in early drug development as a Manager of Global Regulatory Affairs with a major pharmaceutical company. His prior experience was with Inovio Biomedical Corporation and Quintiles Incorporated. Brandon earned his JD, MBA, and BA in Environmental Science from the University of Kansas, Lawrence, KS and a Master of Law from the University of San Diego. He has been a licensed California attorney since 2002 and has authored regulatory articles in professional journals for RAPs and DIA.

Jo White
Dr. White has 23 years of clinical & product development experience in the pharmaceutical industry. Her experience is focused in infectious disease, primarily in vaccine development. She has co-authored over 10 INDs, designed and conducted over 50 clinical trials in all phases, filed 6 BLA/MAAs, 1 NDA and licensed 4 vaccines. She's also made significant contributions to several other products now on the market and has small molecule experience in Phase I-III studies with antibiotics, antivirals, and an anti-inflammatory drug. She held sr. management positions at Merck, Aviron (MedImmune/AstraZeneca), North American Vaccine (Baxter), Wyeth (Pfizer), and VGX Pharmaceuticals. Dr. White received her medical degree with honors at Baylor College of Medicine, completed an Internal Medicine program at North Carolina Baptist Hospital, Bowman Gray School of Medicine, and did a fellowship in Infectious Diseases at the National Institutes of Health. She is board certified in Internal Medicine and Infectious Diseases.