JAGADEESH S. RAO

• Clinical Drug Development for Phase-1 and Phase-2
• CMC: I have led the CMC team, and CMC preparation and submission to the FDA
• I engaged in oral drug formulation, validation, batch production, and stability testing as per the FDA regulations.
• I engaged in AP1 production and validation using various methods.
• Provided technical leadership of small molecule drug development from the preclinical stage to the FDA-regulated investigational drug under the cGMP environment
• Drug substance and drug product validation from production to product development
• Pharmacokinetics and Pharmacodynamics: Designed PK and PD studies for Phase I and 2 clinical trials and interpreted results (CMAX, TMAX and half- life) based on the influence of p450 enzyme polymorphisms
• Identifying and reporting Drug-drug interaction and adverse events due to investigational drug treatments
• Author/review/approve technical documents (SOPs, protocols, reports, risk assessments, specifications, etc.) for the clinical protocol, CMC document, annual report, investigational brochure, and CSR documents
• Preclinical toxicology: designed preclinical toxicity of the drug before commercialization in two different animal species
• Test evaluated under GLP: Drug dosing selection, validation of drug potency test, Ame’s test-mutagenesis, toxicokinetic- PK& PD -3-6 months single species study in rats, reproductive teratogenicity and fetotoxicity studies, immunogenicity, general toxicity on tissues, Hematological and blood biochemical parameters evaluation against drug toxicity
• Carcinogenicity studies, Chronic two specifies chronic toxicity was designed
• Biomarkers: Led the team in the identification of biomarkers and surrogate markers for neurodegenerative and neuropsychiatric symptoms in Alzheimer’s patients and incorporated them into the clinical trials
• Mechanism of action: Identified potential mechanism of action for investigational drug based on proof of concept
• Genotyping: Genetic CYP2c9 influence on investigational drug on PK and PD effects
• Some of the sophisticated tests for the clinical studies were identified and contracted out to the CRO and managed their activities as per GLP and FDA regulations
• CGMP environment: Provided technical support for the establishment of CFR-211-GMP facility for the production of investigational drugs
• Managed effectively for project timelines/scheduling and lead engagement with internal and external partners, including external contract development/testing laboratories for Phase- 1 trial
• Identified intellectual properties of natural compounds for treating CNS disorders and filed six patent applications with the USPTO
• I am engaged in designing pharmacogenetics studies and interpreting human genotyping clinical trial results
• Managed the CROs for Phase 1 and 2 clinical trials
• Extensive knowledge of FDA-regulated compliance and regulations related to new drugs
• Experience in biostatistics and its application in utilizing clinical trials.

• Maintained project quality, including design, execution, data summarization and interpretation, and report preparation and review by GLP and applicable regulations
• Conception of LDH assay and caspase assay kits
• Development of assay kits for apoptosis and protein assays
• Quality control and validation
• Manufacturing
• Marketing
• Developed and executed protocols/studies to support product development from initial feasibility to final product verification/validation, using chemistry, biochemistry, and microbiology principles, particularly LIGAND binding studies, enzyme kinetics, inorganic and organic chemistry principles, and disinfection chemistry, in new product and assay development.
• Formed and reviewed written information to provide current product support
• Supervise biochemistry or microbiology laboratories
• Quality control and equipment validation
• Delivered guidance and work direction to junior-level research scientists
• Ensured awareness of the advances and needs in enzymatic chemistry, sterilization and disinfection, microbiology, and biocompatibility, and keeping with current trends
• Developed new ideas and applications through journals, patents, scientific reviews, and scientific meetings.

· Create and implement departmental strategies for NIH grant applications.

· evaluated the complex HIV, SIV, addiction, genetic, epigenetic, economics, biochemistry, behavioral, and pharmacological multi-million-dollarresearch proposals and managed the recruitment of a highly elite group of review panels and delivered the summary statements of the grant applications after the peer-review.

· Overseeing the complex peer-review process for NIDA’s grant applications involving HIV prevention, pathology, epidemiology, substance abuse, and comorbid issues.

· I engaged in grant and policy administration.

· Identify, develop, and implement best NIH practice processes across the organization to ensure efficiency in operations that deliver the best possible fair review to all the applicants.

· Managed post-peer-review meeting duties by NIH policies.

Excellent direct experience with (IMPAC II, eRA Commons, QVR, RIMS, Pub Med, NIH Reviewer Support Site, NIDA, SRP Access databases, NIH Reporter, numerous macros, and writing summary statements.

· Lead and participate in peer-review meetings and submit review meeting applications, scoring, and conclusions to NIH grant applicants.

· Participated and contributed to the development of FOA.

· Identify, develop, and implement best NIH practice processes across the organization to ensure efficiency in operations that deliver the best possible fair review to all the applicants.

Grant proposals conducted the peer-review grant process:

· Identification of Gene Variants for Addiction-Related Traits by Next-Gene Sequencing in Model Organisms Selectively Bred for Addiction Traits (UH2/UH3) (5 different time intervals)

· Exploratory Studies of Smoking Cessation Interventions for People with Schizophrenia (R21/R33) (4 different time intervals)

· NIDA Research "Center of Excellence" Grant Program (P50) (1 time)

(involving tobacco epidemiology and clinical trials)

· conducted peer-review meetings for the SBIR grant applications and supervised as a Scientific Review Officer.

· Principal Investigator

• Designed and conducted research on neurotoxicity using endotoxin, bipolar disorder, Alzheimer’s disease, schizophrenia, and AIDS pathologies, as well as aging.
• ·Planned and established animal models for bipolar disorder and identified novel pathological epigenetic signatures for bipolar disorder and Alzheimer’s disease.
• ·Designed and conducted in vitro and in-vivo research on glutamate neurotoxicity, viral proteins, and bacterial toxins and their mitigations.
• ·identified the biomechanical and pathophysiological mechanisms underlying chemical and toxin-induced brain injury.
• conducted basic behavioral science research, interpretation, and data analysis.
• Neurotoxicity mitigation strategies -
• analyzed B and T cells using flow cytometry.
• Scientific Software: SPSS, Sigma Plot, SysStat, Molecular Device Enzyme Kinetic Software, LIGAND, Non-linear.

·

Administrative work:

• · I served as an Associate Editor for BMC Neuroscience, the Journal of Alzheimer's Disease and as an adhoc reviewer for several international journals (Journal of Alzheimer’s Disease, Journal of Neurochemistry, Biological Psychiatry, Affective Disorder, Plos One).
• · Serving as a Member of the Animal Care and Use Committee(ACUC) of the NIA/NICHD of NIH
• · Oversees and manages the research activities of over five PhD scientists and technical staff.
• · identified gaps in existing scientific knowledge and provided recommendations for future research efforts in written reports for the intramural research program (Board of Scientific Councilor’s summary report).
• · Write reports, evaluations, summary statements, or correspondence as a part of the peer review process for many high-impact journals and Alzheimer’s Society grant applications.
• · Coordinated discussions aimed at resolving technical issues within the scientific community.
• · provided guidance or interpreted regulations and funding policies for the Alzheimer’s Society.
• Advised grantees or fellows during the preparation of applications or proposals and guided on program issues related to external funding to the Alzheimer’s Society (Advisory reviewer).

· Organized and co-chaired a symposium at the American College of Neuropsychopharmacology (ACNP) Annual Meeting. 2009 in Florida.

• · Budget Management:
• · Monitor and approver of lab expenditures for the Brain Physiology and Metabolism Section, NIA.

· Managing the two grant budgets from the Office of Dietary Supplements (ODS) and appraising the predoctoral fellow’s performance.

Advisory Committee

• Grant Reviewer for Alzheimer’s Association (ALZ.ORG)
• · NIH Research Festival Judging
• · At the 2009 American College of Neuropsychopharmacology Meeting, I organized a mini-symposium.

• · Revealed a novel mechanism for mood-stabilizers (lithium, carbamazepine, lamotrigine), and antidepressants (fluoxetine and imipramine).
• · identified biomarkers for bipolar disorder (arachidonic acid cascade markers, apoptosis).
• · Docosahexaenoic acid (DHA) has been linked to a new biological action: brain-derived neurotrophic factor.
• · identified and characterized animal models for bipolar disorder.

Teaching: I supervised and mentored the research activities of over 3 graduate students.

Pharmaceutical Research and Development, Spring House, PA

· Identified a novel mechanism of action for CNS drugs.

· Played a key role in developing in-vitro and in-vivo models to characterize the efficacy of novel CNS and anti-cancerous drugs.

· Developed high throughput screening for CNS drugs using cell-based and enzyme kinetic-based formats.

· Outstanding ability to analyze, gather, write, evaluate, and produce detailed reports on critical projects.

· Involved in adopting and analyzing pharmacokinetics and pharmacodynamics for CNS drug profiles.

· Collaborated with chemists in a drug discovery group to identify new drug targets for epilepsy and other CNS drugs.

· Excellent hands-on experience in various analytical methods and using various analytical software for HTS.

· Involved in data analysis, evaluating, and then developing viable solutions for integration into the market.

· Involved in drug candidate selection, biomarker development, and proof of concept study design.

· I engaged in reviewing technical and scientific reports, resolving technical issues related to pre-clinical and clinical drug development, and administering and completing pre-clinical projects.

· Involved in the preparation of IND and patent applications.