Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
Summary
This Fractional Biomeedical R&D Executive is an internationally recognized scientific leader and principal investigator with over 15 years of expertise spanning drug delivery systems, biomedical imaging, biosensors, neuroengineering, and medical device development. Ranked among the world’s top 2% of scientists (Elsevier & Stanford University, 2021–2024), he has authored over 200 peer-reviewed journal articles, delivered 40+ conference presentations, and holds four patented inventions. He has successfully led projects from preclinical development through IND readiness, combining deep technical expertise with regulatory acumen to advance innovative therapeutics and drug-device combination products toward clinical translation.
His multidisciplinary research integrates advanced biomaterials, 3D bioprinting, targeted drug delivery systems, biomedical imaging technologies, biosensing platforms, and neuroengineering applications. This Fractional Biomedical R&D Executive has developed neurotransmitter sensing devices and systems for adaptive neuromodulation, as well as the design and fabrication of nano-electrode arrays for functional electrical impedance tomography (EIT) in the brain, utilizing advanced microfabrication techniques within controlled cleanroom environments. These innovations enable high-resolution neural monitoring, functional brain mapping, and novel neurotherapeutic interventions. Through this integrated approach, he continues to advance precision medicine, neurotherapeutics, and next-generation biomedical technologies.
Highlights
- Design and Fabrication of Nano-Electrode Arrays for Functional Electrical Impedance Tomography (EIT) in the Brain Using Advanced Microfabrication Techniques in Controlled Cleanroom Environments
- Development of Neurotransmitter Sensing Devices and Systems for Adaptive Neuromodulation
- Advanced Drug, Biologic, and Gene Delivery Systems
- Drug-Device Combination Product Development
- Lipid-Modified Magnetic Nanoparticles for Targeted Therapy
- PK/PD, ADME, and PBPK Modeling Expertise
- IND, NDA, BLA Submission Leadership (FDA, EMA, ICH)
- Advanced Biomedical Imaging: MRI, EIT, FUS
- Biosensors and Multiplexed Immunoassay Technologies
- 3D Bioprinting and Regenerative Medicine Applications
- Intellectual Property Development & Patent Strategy
- CMC, GMP, and Quality Compliance in Drug Development
- Strategic Leadership of Cross-Functional R&D Teams
- CRO/CDMO Partnership & Vendor Management
Relevant Accomplishments
- Recognized among the world’s top 2% of scientists (Elsevier & Stanford University, 2021–2024) for exceptional research contributions in biomedical engineering, drug delivery, and medical device development.
- Engineered neurotransmitter sensing devices and systems for adaptive neuromodulation, enabling novel interventions for neurological disorders and real-time neurochemical monitoring.
- Designed and fabricated nano-electrode arrays for functional electrical impedance tomography (EIT) in the brain, leveraging advanced microfabrication techniques in controlled cleanroom environments to achieve high-resolution neural monitoring and functional brain mapping.
- Directed the design, fabrication, and validation of bioresorbable orthopedic implants and advanced biomaterial scaffolds using 3D bioprinting, accelerating innovations in tissue engineering and regenerative medicine.
- Invented and patented electrochemical and optical nanobiosensors for ultra-sensitive detection of biomarkers, pathogens, and neurochemical targets, enhancing diagnostic precision in precision medicine applications.
- Spearheaded the development of injectable lipid-modified magnetic nanoparticle systems for cancer-induced hearing loss and brain oncotherapy, achieving IND readiness and securing over $4 million in competitive grant funding.
- Led comprehensive in vitro, ex vivo, and in vivo toxicology studies supporting regulatory submissions for novel magnetic-based drug delivery systems, advancing them toward clinical translation.
- Developed and validated combination drug-device products by optimizing formulation, stability, and CMC processes, ensuring compliance with FDA, EMA, and ICH regulatory standards.
- Successfully prepared and submitted IND, NDA, and BLA dossiers, leading cross-functional teams to navigate complex regulatory pathways and achieve milestone approvals.
- Managed and optimized collaborations with CROs and CMOs, ensuring successful technology transfer, scale-up, and GMP-compliant manufacturing of drug-device combination products.
- Secured multiple intellectual property filings and invention disclosures, strengthening organizational IP portfolios in nanomedicine, neurotechnology, and drug delivery innovation.
- Served as principal investigator and program lead on multimillion-dollar grants, advancing translational research initiatives with significant impact on global health outcomes.
- Established advanced biomedical imaging capabilities integrating MRI, EIT, and FUS modalities to support theragnostic nanomedicine development and real-time molecular diagnostics.
- Led strategic initiatives to enhance CMC readiness, process characterization, and validation, aligning product development with regulatory expectations and commercial manufacturing requirements.
- Championed multidisciplinary mentorship and leadership, fostering innovation across scientific, regulatory, and engineering teams to drive breakthrough biomedical technologies.
Roles
- Senior Scientist-R&D Manager
- Senior Scientist
- Postdoctoral Researcher-Project Scientist
- Technical Advisor
- Research Scientist
- Postdoctoral Researcher
Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
To apply for this job email your details to haleymmagnani@gmail.com
