Overview of Capabilities

For many of the drug development companies engaged in HIV/AIDS drug development, AIDS Research Alliance (ARA) is known as a leading clinical research site with a proven track record for rapid patient enrollment, even for hard-to-reach groups such as treatment-naïve patients and reliable data collection.

As a nonprofit organization, ARA contains study costs while ensuring the seamless implementation of clinical studies. It is uniquely positioned to meet the needs of HIV/AIDS drug development companies.  Prompt study implementation, enrollment and completion without compromising data integrity are core competencies at ARA.

For development-stage companies engaged in HIV and AIDS-related drug development, ARA is a full-service contract research organization.  Our services have grown to include critical path-to-market analysis, pre-clinical consulting and strategy, clinical protocol design and writing, case report form (CRF) design, regulatory affairs, data management, bio-statistical design/analysis and study report writing.

Clinical Trials Expertise

Phase I-IV
First-in-Man Studies
Pharmacokinetics
Drug Interaction Studies
In-Patient Studies
Neurological Studies

Project Management and Support Services

Regulatory Affairs
Pre-Clinical Development
Study Design & Protocol Writing
CRF Design and Development
Data Management
Biostatistics

Stephen Brown, MD, Medical Director
Dr. Brown has been Medical Director at ARA since 1997 and oversees all clinical activities at ARA.  During his tenure he has been site Principal Investigator for 52 clinical trials relating to HIV infection. During his leadership ARA became the first non-profit organization to in-license a drug from NIH, and has established close ties to other scientists in the HIV research field such as Drs. Jerome Zack, Judith Currier, Ian McGowan and Peter Anton of the UCLA Center for Prevention Research.

Highlights of Dr. Brown's curriculum vitae include:

• Received M.D., Hahnemann University Medical School in Brussels, Belgium.
• Research fellowship in Neurobehavioral Research, HIV Neurobehavioral Research Center at UC San Diego, under Drs. Igor Grant, Allen McCutchan, and Hamp Atkinson.
• Managed clinical trials on drug interventions for cognitive impairment for HIV infected subjects (NIMH and Industry sponsored), HIV Neurobehavioral Research Center at UC San Diego.
• Served on Institutional Review Board at UCSD
• Regulatory certification (RACS) from the Regulatory Affairs Professional Society (RAPS).
• Certified Principal Investigator from the Academy of Pharmaceutical Physicians.
• Currently holds a staff position at Tarzana Treatment Center, a provider of drug and alcohol treatment programs, as well as primary care, HIV services and testing.
• Principal Investigator in an NIH-funded award for the development of a new anti-HIV drug targeting viral reservoirs (NSC623310). Co-Investigator in a UARP-CARC grant investigating the effects of prostratin on decreasing HIV viral reservoirs in gut mucosa (CCO2LA001)
• Co-Investigator in a grant for the development of rectal microbicides (U19-1U19AI0614).
• Member, The Society for Clinical Trials, The Drug Information Association, The American Academy of Pharmaceutical Physicians, The Safety Evaluation Committee for Merck HIV vaccine program.

Marjan Hezareh, Ph.D., Scientific Director
Dr. Hezareh has been ARA’s Scientific Director since 2001.  Working in the field of HIV since 1996, she has extensive experience in HIV pathogenesis and immunology.  Dr. Hezareh supervises the activity of ARA’s Scientific Advisory Board (SAC), designs projects in collaboration with our scientific partners, prepares research updates and grants, and oversees ARA’s two BL-2 laboratories.  Dr. Hezareh’s accomplishments include:

• Received Ph.D., University of Geneva, Switzerland.
• Post-doctoral fellowships at University of San Diego, California and Scripps Research Institute in La Jolla under the direction of Drs. Celsea Spina and Dennis Burton.
• Principal and Co- Investigator in several studies, including the Merck Phase I study of a HIV vaccine candidate (Co-PI) and a Phase I study evaluating the efficacy of a potentially new HIV phenotypic test (PI).

Michele Vertucci, R.N., PA-C, Clinical Trials Coordinator/Manager
Michele Vertucci joined ARA in 1998 and was promoted to Clinical Trials Manager in 2004, after participating in over 50 clinical trials at ARA. Before joining ARA, Ms. Vertucci gained many years of experience at Kaiser Hospital, St. Joseph’s Hospital and in private practice.

• Received B.S. in Biology, Marquette University.
• Obtained Associate Degree in Nursing, College of Marin.
• Obtained national certification and license, Physician Assistant from University of Southern California.
• Member, the American Academy of Physician Assistants, the Association of Clinical Research Professionals and the California Academy of Physician Assistants.

Corie Castro, Clinical Research Assistant
Corie Castro has worked at AIDS Research Alliance since 1994 as a Senior Research Assistant.  He is a clinical trials participant's cheerful first contact at A . Corie developed significant private practice experience before joining AIDS Research Alliance where he divides his time between patient in-take, regulatory concerns and specimen processing.

• Received B.S. in Medical Technology, De Ocampo Memorial College, Philippines

Erica Yang, Clinical Research Assistant

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