Bruce McClenathan, MD, FACP, FAAAAI
Executive Director, Medical Affairs
Government & Public Health Services
The know-how, experience, and relationships to successfully execute clinical trials on time
Why Allucent?
It’s simple, really. We have the track record and expertise to lead you through the requirements of government-funded and public health research. We collaborate with and support leading public health agencies worldwide including:
- Biomedical Advanced Research and Development Authority (BARDA)
- Centers for Disease Control and Prevention (CDC)
- National Institutes of Health (NIH)
- U.S. Department of Defense (DoD)
While also successfully supporting clinical trials for non-government (NGOs) and nonprofit organizations, we’re well-informed in Federal Acquisition Regulations (FAR), Defense Federal Acquisition Regulation (DFAR), Health and Human Services Acquisition Regulation (HHSAR), and International Traffic in Arms Regulations (ITAR). We identify the regulations applicable to your study or research program and support compliance.
PRE-AWARD CONSULTING
Allucent provides flexible, global solutions that streamline clinical safety operations at the study or portfolio level in a pharmacovigilance partnership model. Leveraging the latest technology advancements in combination with deep expertise, enhances pharmacovigilance efficiency, providing high quality, complete safety oversight.
- Risk management
- Patient recruitment
- Budgeting
- Regulatory strategy
- Feasibility assessment
Therapeutic Expertise
Our scientists, through their collective expertise working for big pharma, government and regulatory agencies, and academia have demonstrated proficiency in most therapeutic areas. They come well-prepared:
- Efficient trial design
- Regulatory insight
- Unparalleled understanding of disease and treatment landscape
- High success rates
INFRASTRUCTURE AND RESOURCES
Allucent is built to support small and mid-sized biotechs. This approach begins and ends with the scientists we recruit and retain who have vast experience and demonstrated therapeutic expertise at all levels of clinical trial management: from our project managers to CRAs, from biostatisticians to medical writers; and regulatory affairs specialist to the principal investigator.
Government Contracts Overview
BARDA CLINICAL STUDIES NETWORK
Allucent assists BARDA by conducting phase 1-4 clinical trials to advance research and development, manufacturing, and procurement of medical countermeasures (MCMs) that protect against health security threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, pandemic influenza, COVID-19, and emerging and re-emerging infectious diseases.
Allucent has supported the following BARDA trials:
- Project NextGen – Phase IIb COVID-19 Clinical Trial
- Project NextGen – Home Focus Decentralized Observational Trial
- SABER – Phase I Trial
- Specimen Collection Observational Trial for COVID-19
BARDA DECENTRALIZED CLINICAL OPERATIONS AND HEALTHCARE RESEARCH
Allucent was recently selected by BARDA for its new Decentralized Clinical Operations for Healthcare and Research (D-COHRe) initiative.
DEPARTMENT OF DEFENSE/JOINT PROGRAM EXECUTIVE OFFICE
Allucent supports multiple programs at the Department of Defense to advance the development of medical countermeasures (MCM) and protect soldiers from existing and emerging infectious diseases. Our support includes providing full service COVID-19 clinical trial services at various military sites in the United States, and biometric services to support the clinical evaluation of Orthopoxvirus countermeasure(s).
- Noise-Induced Hearing Loss Trials
- Operation Warp Speed – Phase III COVID-19 Trials
- Operation Warp Speed – VIRAMP Trial
- Office of Regulatory Affairs – TPOXX Trial
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
We support NINDS mission to advance the treatment of neurological disorders and stroke. We recently completed consulting services to support the NINDS’ HEAL Program and other NIH neuroscience-focused drug discovery and development programs to improve non-addictive therapies to treat pain.
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
We support NINDS mission to advance the treatment of neurological disorders and stroke. We recently completed consulting services to support the NINDS’ HEAL Program and other NIH neuroscience-focused drug discovery and development programs to improve non-addictive therapies to treat pain.
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
Allucent supports NIAID on multiple long-term programs which includes preclinical and clinical trial support for the development and evaluation of vaccines and therapeutic candidates. Our services include regulatory consulting for non-clinical activities and clinical trial support for Phase I-IV trials of bacterial, viral, parasitic, and fungal countermeasures to prevent and treat infectious diseases and toxins in people of all ages and risk categories.
- NIAID Early Phase Clinical Trials Unit (EPCTU) Program
- NIAID Preclinical Services for Biopharmaceutical Product Development Program
Meet Your A-Team
At Allucent, we’re your trusted partner for navigating the complexities of drug development. With unparalleled expertise and a global perspective, our diverse team of pharmacology experts is here to guide your study to success.
- More than 25 years experience
- Lead medical affairs physician and scientific advisor for Allucent’s Government and Public Health Services portfolio
- Previously served 20+ years as clinician and researcher with the DoD
- Task Order or Site Principal Investigator on multiple clinical trials (Phase 1-4) and research studies
Elissa Thomas, LPN, CCRC, PMP
Project Director Clinical Project Management
- 32 years experience in oversight of FDA regulated clinical trials
- 15 years operated federally funded grants and contracts at military installations
- Associate Director Research Management at The Geneva Foundation
- Oversight of all research activities for central and western regions
- DoD Innovation Award and Joint Meritorious Unit Award
Donna Campbell, AS
Executive Director, Portfolio Management and Clinical Project Management
- 25 years in clinical research
- Strong background clinical operations, project management, and client engagement
- Extensive experience in infectious disease and vaccine studies
- Led several US Government contracts, including BARDA Clinical Studies Network and NIAID/DMID Early Phase Clinical Trial Unit
Related Topics
Additional Resources
News
Allucent Receives BARDA-Funded Project NextGen Award to Support a COVID-19 Vaccine Decentralized Clinical Trial
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News
Allucent Awarded 5-Year BARDA Agreement Aimed at Enhancing and Accelerating Decentralized Clinical Trials for Medical Countermeasure Development
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White Paper
Advancing Cancer Vaccines to the Forefront of Immunotherapy
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