Mohd. Saleem Bhat, PhD

. Leading nonclinical safety toxicology efforts, Toxicity Risk assessment, Exposure modeling, ADME/DMPK profiling strategies of Therapeutics, Devices, and Drug-Device combination products using QSAR, NAM and in vivo models . Developing the Study protocols for IND, BLA, CTA and NDA-enabling GLP or nonGLP T studies . Oversight of collaborative network across four Testing facilities, CRO and CDMO companies to deliver integrated nonclinical and clinical trial monitoring services. • Conceptualize, design, and lead the screening, optimization, and validation of Molecular Diagnostic Tests and Biomarker Assays (genomics, proteomics) . Perform Toxicokinetics and Pharmacokinetics data analysis of chemicals, aerosols, drugs, and biologics. Write Regulatory acceptable Toxicology modules (2.4, 2.6).

Study Direction of IND-enabling regulatory DMPK, PKPD and Toxicokinetics studies. Directed +75 GLP and non-GLP early drug development studies across species, enhancing safety evaluations and product readiness. Actively led client interactions, addressed issues and regulatory audits, ensuring program excellence and external visibility Communicated to Clients; Managed Client meetings, Participated in sponsor regulatory inspections SME in Clinical trial models such as Primate and canine for drug discovery. Expert in Writing and Reviewing Technical Reports, Study Reports, and Protocols Expert in VEEVA-Vault, Documentum, Debra, Stacy, eNote, eSchedule, CDT platforms

-Writing RNAi Therapy, Drug Development, Toxicity testing, and Personnel Training protocols - Designing studies for testing RNAi and small molecule therapy for drug-resistant cancer.

• Operated In Vitro Toxicology testing (chemical leaching, Cytotoxicity, DNA chromosomal damage, Mutagenicity, Transporter binding, target binding and reporter assay) Projects. Executed wet-bench studies for chemical and bioanalysis . Managed ICH GLP compliant training for staff. Supervised an R&D business alliance with Tempus Inc. ($1.5M) focused on Diagnostic Test integration . Developed SR medical device in Vivo studies. Supported on the Genomics program for identifying Toxicity bio-responder genes . Presented data critical to Urology device and therapeutic toxicology at Conferences and seminars • Developed biomarker strategies and directed teams to integrate these into the therapeutic area's priorities.

- Product preclinical testing as per GLP guidelines: Executed projects developing novel drugs, gene therapy, and immunotherapies; led Biocompatibility, Toxicity, and Pharmacokinetic studies -Project Management: Leading, managing, and administering Federal-funded (NIH, and DOD ) programs -Product Commercialization: Translated bench discoveries to Patents for product commercialization -Communication skills: Writing, reviewing, and editing grant proposals and manuscripts; > 100 published articles; authored two patent applications - Collaboration: Established cross-functional research collaborations with national and global institutions - Professional Training: Trained staff members the technical knowhow and study execution

Developed a research project to translate discoveries from prostate physiology into a new therapy for prostate cancer leading which ultimately led to a Patent and promotion to next level of Associate Scientist (equivalent to Research Assistant Professor).