Associate Research Scientist-II (Translational Research - PKPD) @ AstraZeneca
Bachelor of Pharmacy (B.Pharm.), Pharmacy, Distinction @
Bapuji Pharmacy College
Highly motivated and exceptionally well organized research scientist with nearly ten years of experience in PKPD. Project organization and management (planning and execution of work as well as modeling). Expert in development of biomarker and receptor occupancy assays to support project progression for various novel targets. In depth expertise in pharmacokinetic evaluation of NCEs/drugs in preclinical animal
Highly motivated and exceptionally well organized research scientist with nearly ten years of experience in PKPD. Project organization and management (planning and execution of work as well as modeling). Expert in development of biomarker and receptor occupancy assays to support project progression for various novel targets. In depth expertise in pharmacokinetic evaluation of NCEs/drugs in preclinical animal species. In depth hands-on knowledge of several modelling and other softwares e.g. Phoenix-WinNonlin (Compartmental and non-compartmental PK models), sigma plot and GraphPad prism. Good understanding of the drug discovery and development process with a proven track record of project leadership and department representation on cross-discipline project teams. Excellent communicator with strong interpersonal skills, with the ability to influence colleagues and teams from a range of disciplines. Writing scientific publications and reports. Looking to improve extrapolation of preclinical PD to allow prediction of clinical efficacy new treatments across a number of therapeutic areas.
Senior Scientist – Quantitative Pharmacology and Pharmacometrics @ Perform systematic review, literature search, keyword optimization, source database and outcome database entry for comparator modeling project.
Active role in the planning, execution and delivery of pharmacokinetic assignments.
Designing and finalizing the Pharmacokinetic Analysis Plan (PKAP) using Clinical Study
Protocols and Study Specifications.
Pharmacokinetic and Pharmacodynamic analysis of clinical data (all phases) and preparation of pharmacokinetic summary tables, and concentration vs. time plots/charts using Phoenix-WinNonlin and/or Sigmaplot software as per the Protocol and Sponsor requirements in Clinical trails.
Interpretation of PK results and preparation of pharmacokinetic content for Clinical Study Reports (CSRs) as per applicable Regulatory/Sponsor requirements.
Perform quality control and quality assurance of PK deliverables as per the client assignment specifications. From January 2015 to October 2015 (10 months) Hyderabad Area, IndiaSenior Pharmacokineticist @ Read and understand the study protocol, PK analysis specifications worksheet and
PK/PD Non compartmental analysis (NCA) of clinical data (plasma, blood, serum, PBMC
and urine) from various phases using Phoenix WinNonlin® 6.3 software as per the specifications.
Generation of tables, figures and summary reports, etc.
Read and thoroughly understands applicable compliance standards such as client
protocol and client’s SOPs. From July 2014 to December 2014 (6 months) Hyderabad Area, IndiaAssociate Research Scientist-II (Translational Research - PKPD) @ PKPD Scientist
Designed, developed and validated biomarker assays for TB and inflammation (measuring various biomarker levels in infected plasma and lung samples using magnetic bead technology and LC-MS/MS).
Participated active role in experimental design, protocol preparation, execution and dose
projection of TB compounds to final efficacy study.
Tested anti-mycobacterial activity of preclinical candidates and their pharmacokinetics in infected animals. Performing PK and PKPD analysis using Phoenix WinNonlin.
Performed several DDI studies for NSAIDS & standard TB drugs in preclinical animal
species infected with Mycobacterium tuberculosis.
Certified to work in a BSL3 facility and trained in handling BSL3 pathogens. Familiar with SOPs and protocols involved in BSL3 in-vitro and in-vivo experimentation. Extensive experience working in the BSL3 laboratories for testing anti-mycobacterial activity of preclinical candidates and their pharmacokinetics in infected animals.
Familiar with animal ethics and CPCSEA guidelines.
Preparation of Sop’s, protocols, posters and reports. Writing manuscripts, project reports, data documentation (ELN, ECM, IBIS & share point), and presentation. From March 2013 to June 2014 (1 year 4 months) Scientist - PKPD (Functional Leader - Receptor Occupancy & Biomarker) @ Screened test compounds from different CNS targets for various disease modifying biomarker assays (betaamyloid 40, 42 & sAPPα).
Screened NCEs for receptor occupancy & other profiling assays in rodents.
Collaborated with both internal and external partners, coordinated and managed research associates and other team members.
Prepared reports, study protocols, presentations and communicated to both internal and external collaborator. From July 2011 to February 2013 (1 year 8 months) Hyderabad Area, IndiaAssociate Scientist - PKPD (Functional Leader - Receptor Occupancy) @ Developed and validated various novel disease modifying ELISA based biomarker assays (interleukins, betaamyloid 40, 42 & sAPP).
Optimized & standardized novel neurochemistry assays. Designed, developed and optimized various disease models in rat/mice using neurotoxins (Alzheimer’s and Parkinsonism disease). From July 2010 to July 2011 (1 year 1 month) Hyderabad Area, IndiaSr. Research Associate - Translational Research Neuroscience (Receptor Occupancy) @ Designed, developed and validated novel brain regional receptor occupancy assay using radio-labeled and non-radio labeled ligands in preclinical animal species.
Planned, designed and conducted stereotaxic surgery, other neurological procedures and carried out in vivo brain microdialysis for measurement of various neurotransmitters and drug concentrations in dialysate samples.
PD analyses of several drugs using WinNonlin and non-compartmental analysis. From July 2009 to June 2010 (1 year) Hyderabad Area, IndiaResearch Associate – PKPD (Neuropharmacokinetics) @ Designed and implemented preclinical neuropharmacokinetic, in vivo brain penetration and brain regional distribution studies in preclinical animal species.
Planned and conducted pharmacokinetic studies in rats, and performed preclinical pharmacokinetic analysis using WinNonlin software.
Prepared SOPs, Protocols and reports. From March 2008 to June 2009 (1 year 4 months) Hyderabad Area, IndiaResearch Assistant @ Performed in vivo pharmacokinetic studies in rodent and non-rodent species and performed preclinical pharmacokinetic analysis using WinNonlin software.
Co-ordinated and performed various toxicokinetic & PK/PD studies.
Established CSF collection technique in rat using stereotaxic apparatus. From March 2007 to February 2008 (1 year) Hyderabad Area, IndiaTrainee Research Assistant @ Performed various cannulation, conducted pharmacokinetic and toxicokinetic and brain penetration studies in rodent and non-rodents. From February 2006 to February 2007 (1 year 1 month) Hyderabad Area, India
Master of Pharmacy, Pharmaceutical science, University Topper @ Rajiv Gandhi University of Health Sciences From 2004 to 2006 Bachelor of Pharmacy (B.Pharm.), Pharmacy, Distinction @ Bapuji Pharmacy College From 1999 to 2004 Ramanatha Saralaya is skilled in: Pharmacokinetics, Receptor Occupancy, In vivo Brain Microdialysis, Neuropharmacokinetic, Pharmacology, Drug Discovery, Assay Development, HPLC, Lifesciences, In Vivo, DMPK, Biomarkers, Pharmaceutical Industry, Molecular Imaging, Drug Delivery
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