Apex Early Phase (AEP) is a specialty division of Apex Innovative Sciences dedicated to meeting the complex needs inherent in early-stage drug development.

With 160 beds in our state-of-the-art CRUs and thought-leader expertise in the design and execution of complex Phase I-IIa/POC trials, AEP offers unique capabilities to accelerate drug development. Harmonized clinical, operational, and scientific processes across sites, including standardized biomarkers, disease models, imaging, and electrophysiologic assessments, enables the seamless execution of trials with the enrollment benefits of bicoastal operations.

Our two sites, CNS Research and Hassman Research Institute (HRI), exemplify operational excellence, providing clinical conduct of the highest quality.

Dedicated to the conduct of early phase clinical pharmacology studies in normal healthy volunteers, special populations, and patient populations across a variety of therapeutic areas, AEP offers a wide spectrum of specialized services and capabilities. We have an unsurpassed track record of assisting our sponsors in de-risking POC Phase II trials as well as providing results that increase the confidence of go/no-go decisions.

Download the AEP fact sheet.

Leadership

Larry Ereshefsky, Pharm.D.
Chief Scientific Officer
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
CNS Research

Dr. Walling, a licensed clinical psychologist, has served as an investigator in over 400 trials, including over 100 Phase I trials. He is a highly sought after KOL in psychiatry and cognition as well as digital device and software technologies. 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, and also provides training to rater training companies for some of the most widely used psychiatric and cognitive rating scales.

Howard Hassman, D.O., AOBFP
Chief Executive Officer, Principal Investigator
Hassman Research Institute

Dr. Hassman, a board-certified family practitioner, has served as an investigator in almost 400 trials, including a wide range of early drug development trials from First-in-Human through Proof-of-concept. He is considered an expert in the field of Psychopharmacology, and has an extensive background in psychodynamic psychotherapy, pain management, and addiction medicine. He provides a broad range of expert consulting services to clients for early drug development, developing creative, de-risked solutions for a variety of clinical programs. Dr. Hassman holds multiple advisory board memberships and has authored numerous articles that have been published in leading scientific journals.

Research Sites

CNS Research
CNS Research is a clinical research organization operating three outpatient clinics in the Los Angeles/Orange County area. The Long Beach location offers a state-of-the-art Clinical Pharmacology Unit with 60 beds as well as a 12-bed Asian Studies unit and a Psychiatric Health Facility.

Hassman Research Institute
HRI is a clinical research organization with inpatient and outpatient facilities in Marlton and Berlin, NJ. 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. The inpatient unit in Berlin has 28 beds.

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)

 

Specialized Studies

  • 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

 

Technology/Capabilities

  • 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

 

Therapeutic Areas

  • 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.
(916) 803-7149
bobbietheodore@apexsci.com