Rakesh Bhat

Provide expert oversight to current scientific and manufacturing matters. Serve as the Scientific liaison to key clients and stakeholders. Render efficient support to product development. Strategically constructed cost-effective plan to decrease operating costs and elevate flexibility/productivity through remarkable outsourcing efforts for different products. Collaboratively working with internal stakeholders to negotiating and re-negotiating contracts with suppliers and vendors.

As an Adjunct faculty at Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, I had the the opportunity to carry forward independent basic and translations research. 1. Constructed in-vitro COVID-19 Drug discovery screening program. 2. Generated insect (Sf9) stable cell line for expression of SARS-CoV-2 RdRp complex. 3. Worked on generation of non-infectious SARS-CoV-2 replicon system for drug screening. 4. Developed a one tube buffer system to store and analyze infectious samples by (sq-RT-PCR). 5. Initiated and executed multidisciplinary molecular & Cell Line Engineering projects for the development of engineered in vitro model systems. 6. Planed, organized, assigned and budgeted the research and collaborative projects. 7. Supervised overall recruitment and training of key positions for the laboratory. 8. Initiated, established and maintained academic and non-academic research collaborations. Also applied my passion for research and share my rich academic and industrial experience by mentoring and creating a supportive environment for trainees to attain full research potential.

API is a not-for-profit organization that works in collaboration with the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences as well as research and post-secondary institutions across Canada. API provides translational teams, infrastructure, and industry framework, unlocking the potential of innovative science within post-secondary institutions and building a thriving Canadian health innovation ecosystem. Essential Job Duties: • Headed science operations by driving development of novel drug molecules for brain related diseases using small molecule drug discovery program. • Commissioned and headed the laboratory science unit of Applied Pharmaceutical Innovation (API). • Lead cross-functional teams responsible for R&D, product development, analytical method development and supply-chain management. • Supervised high-caliber projects that optimized product and process development. • Oversaw non-clinical analytical and bio-analytical services (Cardiac Safety Pharmacology, bio-distribution, toxicity, Bioanalysis, PK/PD) • Partnered with internal subject matter experts, external academic groups, industry leaders and CROs to advance translational science capabilities at API. • Headed and supervised overall recruitment and training of key positions for R&D and early phase-manufacturing. • Interacted with biology, medicinal chemistry, discovery research, project management and business teams, to address key development questions. • Designed experiments, analyzing the results and provided subject matter expertise. • Did literature reviews, made project reports, wrote manuscript & grant and performed budgeting for the Laboratory Science unit. • Coordinated third party due diligence with specialty pharmaceutical company interested in partnering technology. • Motivated CEO and collaborators with valuable data and aggressive timelines.

Pioneered new technologies in preparation for the next-generation bio-pharmaceuticals. Commissioned and headed the laboratory Science division of the organization. Sourced and implemented ways to improve product manufacturing while maintaining minimal cost of goods. Initiated and executed new technology initiatives and identified key methods for developing new product prototypes. Built relationships with key stakeholders, vendors, suppliers and CRO’s. Managed collaborative efforts to evaluate 3rd party CMO/CRO for outsource manufacture and testing of lead product, lipids, plasmids, small molecules, as well as other critical research components.

Developed and co-invented novel adult human cardiomyocyte cell line (hMYO), stably over-expressing hERG (the human Ether-à-go-go-Related Gene) for cardiac safety assessment. Developed small molecule drug database for cardiac safety profile computational screening. Initiated and setup in-vitro cardiac safety profiling services for academic and non-academic clients using automated patch clamp. Supported business development activities like budgeting, competitive market research, product landscape, and analyzed business opportunities.

• Executed multiple research projects over 7 years, in molecular/cellular biology, virology, protein biochemistry, drug discovery, vaccine development, and HTS assay development. • Discovered and co-invented immunogenic peptides for IL28B (Interferon Lambda) protein, using molecular modelling, bioinformatics, and biochemistry techniques. • Designed Hepatitis C Virus B- cell and T- cell epitopes for HCV vaccine development. • Planned, designed and executed plasmid DNA vaccine clinical trial (pre-clinical) against 2014 Porcine epidemic diarrhea virus (PEDv). • Cloned, purified and characterized IL28B /hERG/ PEDv-Spike protein. • Developed high throughput molecular and biochemical assays for IL28B, hERG and HCV. • Studied molecular viral Etiology of Multiple sclerosis, inflammatory bowel disease and cryptogenic hepatitis using Next-Generation sequencing, biochemical methods and basic bioinformatics. • Assisted in the development of drug-induced NASH experimental mouse model • Provided support and coordination in the preparation and filing of patents and legal documents.

Phase II Clinical study of drug X as a preventive treatment for lowering blood concentration of low-density lipoprotein cholesterol (LDL-C) in patients with normal and elevated concentrations of LDL-C. • Develop and write trial protocols, locate and assess the feasibility of sites • Identified Potential investigators • Designed case report forms • Preparing randomization schedules for blinded studies • Drafting and reviewing informed consent documents and patient information sheets

• Identified, characterized and quantified human endogenous retroviruses - HERV-W and HERV-K, in neuronal diseases, i.e., multiple sclerosis and HIV. • Performed neuronal toxicity using human primary fetal brain cell lines i.e, Neurons, astrocytes, and microglia. • Used microarray, NGS and bioinformatics tools to analyze and characterize miRNA profiling in multiple sclerosis, neuroAIDS, hepatitis C virus and ctrl patient brain samples. • Used miRNA & shRNA for gene regulation in immortalized brain cell lines. • Designed and used different viral and lentiviral vectors to stably overexpress proteins in primary and immortalized human brain cell culture(s), (Astrocytes and neurons). • Worked on experimental autoimmune encephalomyelitis (EAE) mouse model for multiple sclerosis. • Designed, performed and analyzed molecular, neuropathological and neurobehavioral studies in EAE & HIV-vpr mediated pathogenesis experimental mouse models. • Worked and maintained BSL2 and BSL3 biohazard containment facilities. • Supervised and trained junior team members and managed laboratory daily work.

• Carried out computational redesign of protein-small molecule interactions interphases using Rosetta package. • Have expressed the wild type and several mutants of engrailed homeodomain (EnHD), which were computationally redesigned to gain more information about the protein – small molecule binding interactions. • Applied strong research, analytical and problem-solving skills, as a part of team, to successfully develop a proteomics-based approached for large-scale discovery of naturally processed determinants derived from Vaccinia virus • Supervised and trained graduate students to master experimental design, planning, execution, data analysis and interpretation. • Developed and conducted research studies in the laboratory which lead to scientific manuscripts for publication. • Attended workshops, national and international scientific meetings and seminars.

• Worked on upstream and downstream processing of recombinant erythropoietin (rhEPO) from CHO cells. • Communicated with production team to provide QC details and develop effective plan for addressing quality issues. • Documented all QC issues in database with recommended modifications to address issues. • Performed quarterly testing and optimization analysis on QC equipments to ensure correct operational performance and results. • Experienced of cGMP, GLP, FDA and ICH guidelines. • Assisted in product development, regulatory requirements and technology transfer. • Assisted un developing QC documents, QC audits, QC policies, SOP’s, method validation studies, equipment qualifications and technical documents. • Supervised, mentored and trained junior team members.

• Successfully introduced new product line across a sales territory. • Responsible for pre and post- sales support including on site customer product demonstrations, presenting company's product line through seminars and workshops. • Provided feedback to the sales manager on current and emerging market opportunities. • Build positive relationships with clients, vendors, and management to enhancing the distribution and availability of products in retail outlets. • Responsible for collecting, consolidating, and evaluating field requirements. • Reporting to senior managers on client needs, service delivery issues, and any competitive threats. • Maintaining a high personal level of companies and competitor product knowledge.