Apex Early Phase (AEP) is a partnership offering unique capabilities to accelerate drug development. With thought-leader expertise in the design and execution of complex Phase I-IIa/POC trials, AEP provides single- and two-site solutions for efficient study conduct, ensuring a harmonized and synergistic approach to the clinical and scientific aspects of the trial. Biomarkers, imaging, and electrophysiologic assessments are standardized across sites.
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Larry Ereshefsky, Pharm.D.
CSO, Early Phase Development
Hassman Research Institute and CNS Research
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.
Chief Executive Officer, 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., AOBFP
Chief Scientific Officer, 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 has participated as a lead or co-investigator in hundreds of Phase I-IV clinical studies. 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 authored numerous articles on psychiatric indications that have been published in leading psychiatric journals.
CNS Research 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 with 60 beds as well as a new Asian inpatient unit and a Psychiatric Health Facility.
Hassman Research Institute
Hassman Research Institute is a clinical research organization with locations in Marlton and Berlin, NJ. In addition to outpatient facilities, Marlton is home to its state-of-the-art 60-bed Inpatient Unit which provides an array of services that are critical to the successful completion of complex studies.
Knowledge & Experience
Our KOLs have supported pharma with:
- Clinical drug development planning
- Clinical trials methodologies
- PK/PD modeling
- Experimental medicine strategies
- Development, validation, and application of biomarkers
- Vendor selection (Imaging, Electrophysiologic, cognitive sciences)
- First-In-Man (FIM), Single ascending dose (SAD) and Multiple ascending dose (MAD)
- Translational and experimental medicine studies
- Adaptive and umbrella designs
- Elderly and patient populations
- Asian sensitivity and bridging in Japanese, Chinese, and Korean first-generation subjects
- PK/PD relationships with QEEG/ERP, fMRI/PET
- QTc, TQTc, cardiac monitoring
- 505(b)(2) program strategies
- Biologics and biosimilars
- Bioequivalence/Drug-Drug Interaction (DDI)/Food Effect
- Digital device and software technologies
- Orphan indications
- Imaging – PET, MRI, fMRI, MRS, MRE, FibroScan
- Electrophysiology – EEG, PSG, and QEEG / ERP
- Pain models in HNVs and patients
- Digital Therapies – health devices, software, and applications
- Safety – capnography, pulse ox, continuous safety EEGs, telemetry, biomarkers
- Cognitive and behavioral assessments, including impairment of function
- Driving Simulators
- CSF collection
- 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
- Internal Medicine: Endocrinology, Gastrointestinal, Immunology, Pulmonology, NASH/NAFLD, and more
- Dermatology: Alopecia, Psoriasis, Acne, Atopic Dermatitis, Rosacea, Aesthetics
For more information or to further discuss your study needs please contact:
Bobbie Theodore, M.S.
Alliance Executive Director