Alliance Early Phase (AEP) combines thought-leader expertise in conducting complex Phase 0-IIa trials across a range of patient and healthy populations.
We provide single- and two-site solutions for efficient study conduct, assuring a harmonized approach to the clinical and scientific aspects of the trial.
Download the AEP fact sheet.
Download a presentation about AEP.
Larry Ereshefsky, Pharm.D.
CSO, Early Phase Development
Hassman Research Institute and CNS Network
Dr. Ereshefsky is an internationally recognized thought leader in clinical translational central nervous system research with a proven track record in designing Phase I/IIA and clinical pharmacology studies. He is a leader in the application of translational drug development tools, and in the use of signal detection strategies to minimize placebo response. He is a retired Regents Professor of Pharmacy, Psychiatry, and Pharmacology from The University of Texas/UT Health Science Center. Subsequently, he was the VP, Principal Clinical Pharmacologist, and Global CNS Leader for Early Phase at PAREXEL.
David Walling, Ph.D.
CEO, Principal Investigator
Dr. Walling, a licensed clinical psychologist, has participated as a lead or co-investigator in hundreds of Phase I-IV clinical studies, with many focusing on schizophrenia, an indication for which he has KOL status. He has extensive experience advising leading pharmaceutical sponsors in many ways including the creation of drug development plans, design and analysis of clinical trials, and preparation for interactions with regulatory agencies. He has authored dozens of articles on psychiatric indications that have been published in leading scientific journals.
Howard Hassman, D.O.
CSO, Principal Investigator
Hassman Research Institute
Dr. Hassman, a Board-Certified Family Practitioner, has vast knowledge of clinical research with over 30 years of experience in the field. He is considered an expert in the field of Psychopharmacology, and has an extensive background in psychodynamic psychotherapy, pain management, and addiction medicine. Dr. Hassman holds multiple advisory board memberships, and has published numerous articles on psychiatric indications.
CNS Network is a clinical research group operating three outpatient clinics in the Los Angeles/Orange County area. The Long Beach facility oﬀers a dedicated state-of-the-art Clinical Pharmacology Unit (CPU) with 60 beds, and a 30-bed Joint Commission-accredited inpatient Psychiatric Health Facility (PHF).
Hassman Research Institute
Hassman Research Institute is a clinical research site located on a large campus in Berlin, NJ. Its Early Phase Unit can house up to 40 subjects. Two separate wings provide the controlled environment needed to accommodate separate patient populations as well as translational studies.
Our Principal Investigators have conducted over 500 early phase trials including:
- First-In-Man (FIM)
- Single ascending dose (SAD) and Multiple ascending dose (MAD)
- Adaptive Designs
- Proof of Concept (POC)
- Drug to Drug Interaction (DDI)
- Pharmacokinetics and Pharmacodynamics
- Bioequivalence and Bioavailability
Our KOLs have consulted on:
- Program design
- PK/PD modeling
- Clinical drug development plans informed by animal behavioral markers
- Safety signals
- Protocol feasibility
- Vendor selection
We have expertise in designing and conducting studies incorporating experimental medicine strategies as well as translational drug development tools supporting neurocircuitry/biomarker based (RDoC) strategies, including:
- CSF collection
- Quantitative electroencephalogram (QEEG)
- Event related potential recording (ERP)
- Polysomnography (PSG)
- Positron emission tomography (PET)
- fMRI, sMRI
- QTc, TQTc, cardiac monitoring
- Cognitive and behavioral paradigms
- Healthy Volunteers: Including sub-populations of Asian, elderly, post-menopausal females, tobacco users
- Psychiatry: ADHD, Anxiety, Bipolar, Depression, PTSD, Schizophrenia
- Neurology: Alzheimer’s, Multiple Sclerosis, Parkinson’s, Post-Stroke, Sleep Disorders
- Pain: Acute/Chronic, Fibromyalgia, Osteoarthritis, Migraine, Pain models such as UV and capsaicin
- Human Abuse Liability: Addictions, Exploratory assessments, Definitive HAL testing
- Asian Studies: Bridging to Japanese, Chinese, and other Asian populations
- Impairment: Cognitive Dysfunction, Validated Driving Simulation studies
- General Medical: Dermatology, Endocrinology, Gastrointestinal, Metabolic Disorders, and more
- Immunology: Allergies, Asthma, Psoriasis
For more information or to further discuss your study needs please contact:
Bobbie Theodore, M.S.
Alliance Executive Director
(o) (916) 939-6696
(c) (916) 803-7149