RAGHU S. PANDURANGI, M.Sc.Ed; Ph.D.

*** ********* ******* ***** *****: piqes1@r.postjobfree.com Cell: 636-***-****

St. Charles, MO 63303 Home: 636-***-****

Analytical, Bio assays, Biomarker Imaging and Diagnosis/Therapy of Cancer

Innovative team leader with 15 years of experience in oncology drug discovery and development, biomarker assays, imaging gene expression, predictive, safety biomarkers (PET, SPECT) for translational medicine and product development. Proven track record of directing and building strong multidisciplinary team (chemists, biologists) for preclinical program, Expertise in targets and mechanism for drugs based on pathways of tumorigenesis. Experience in generating external grants &collaborations.

CORE COMPETENCIES

Gene/Protein expression/Purification Analytical Method Development In Vitro Biology

PET/SPECT/Optical Imaging Impurity Profile, Stability Protocols Cellular Imaging

ELISA/PAGE/PCR/Cloning CMC for IND & NDA DNA/RNA extraction

Biomarker Research Project Management Recombinant Protein Therapeutics

ACHIEVEMENTS:

DANFORTH PLANT SCIENCE CENTER, St Louis: 2009-Present

Increased expression of site directed mutagenic therapeutic protein 10 times higher from e-coli (IPTG) & Pitchia, Proteomic biomarker of diseases, Successfully adapted targeting technology of cancer to plant science. Interdisciplinary research, Result: (One proposal and 2 Papers ( Plos-1 & J. Mol. Biol.) ready for submission in < 12 months).

COVIDIEN PHARMACEUTICALS: St Louis: 2004-2009

Directed “Embedded Therapy” (ET) in record 6 months to meet the bonus objective. Identification, qualification and validation of receptor, pharmacodynamic, genomic & surrogate biomarkers for assessing cancer therapy, Cancer Targets assessment, IP in 3 fields.

Achieved consistent positive evaluation including achievement award for 5 years service.

Established 5 Collaborations resulting in POC, 5 papers, 15 presentations, CMC for generics..

Aseessment of indigenous imaging probes (e.g somatostatin) Vs metabolic (FDG), proliferation (FLT) and cell death imaging “in vivo” Result: Full preclinical evaluation of ET: Go.

SCHERING PHARMACEUTICALS, GERMANY/BERLEX/USA 2000-2004

Developed Aptamer based therapeutic product upto clinical phase 1. Answered FDA and EMEA questions. Pharmacodynamic, safety & predictive biomarkers for translational medicine..

Assembled, written, edited and compiled requirements of EMEA/FDA CMCs for 2 INDs, 1 NDA.

Result: Saved entire preclinical program with new formulations/stability saving millions of dollars.

UNIVERSITY OF MISSOURI: INTERNAL MEDICINE AND CHEMISTRY

Established for the first time radiopharmaceutical (small molecule) synthesis/ imaging program for cancer directed the program. Result: External funds, mentored students and post docs, 1 photo cross linking agent commercialized (PIERCE).

20 years of total scientific leadership (10 industrial + 10 academic, defined objectives for the 6-7 team members of chemistry and biology personnel (direct reports) in targeted drug development. 42 Publications (5 submitted), 59 Oral presentations (31 invited), 15 collaborations, 9 Patent disclosures, 4 Book Chapters, 6 Posters & 1.5 million $ funding.

PROFESSIONAL ACCOMPLISHMENTS

Scientific Writer: Guide Point Research Consultants, NY 2009-Present (http://www.guidepointglobaladvisors.com), Clients: Walker Smith Capital, Biotech companies.

Assessment of targets of cancer with existing technology: report on where do we stand?

Sections of CMC for oncology and cardiology drugs.

Provide consulting research services to business decision makers and leading investors around the world.

Consultant for imaging agents particularly, on Nuclear Medicine products, Contrast Agents (XRCA, MRCA), Radioisotopes, Radiolabeling, Bioconjugation, Cardiology and Oncology related clinical issues, IP, Feasibility, CMC Regulatory issues.

Specific GMP manufacturing of kits issues, Impurity profile based on ICH guidelines, Preclinical and clinical protocols and accelerated stability profile, FDA and EMEA questions on IND and NDA.

DANFORTH PLANT SCIENCE CENTER, St Louis: 2009-Present

• Analytic support for genetically modified crops, antifungal recombinant protein expression from cell culture, Gene cloning and transgene expression in Arabidopsis, Target identification for biotherapeutic proteins using OMICS (proteomics, metabolomics), Assessment of phosphorylation status by proteomics/MS and PET/CT, SDS-PAGE, RT- PCR and ELISA. C14, 3H, 13C/15N proteins.

• Extensively used high-throughput techniques; ELISA, PAGE, PCR and 2D HPLC, Mentored post doctoral fellows. Involved in external grants.

• Impact: Generated novel ideas bridging plant science and medical noninvasive imaging science for external funding (therapeutics).

COVIDIEN (PHARMACEUTICALS & IMAGING), ST. LOUIS, MO, 2004 - 2009

(11 billion $ company with > 41, 000 workforce in 59 countries)

TECHNICAL FELLOW, Project Leader 2008 – 2009

PROJECT; Embedded Therapy: Validation of biomarkers to identify lead drug candidates using bioassays, imaging with SPECT/PET and optical probes for specific biological end point.

• Evaluated proof of concept for Phase 0 on targeted embedded therapy directing chemistry and biology group -Go decision. Imaging gene expression, assess efficacy of cancer treatment through imaging in vivo.

• Optimized pharmacodynamic biomarkers for receptor avid cancer (somatostatin receptor binding peptides, Leukemia peptides, folic acid) for generic clinical endpoint with FACS, ELISA, Hoechst 33342, PI, staining techniques, histology assessment, LC/MS and fluorescence confocal microscopy.

TECHNICAL

• Cancer targets evaluation (PARP, Proteosome, EGFR, Receptors).

• Developed blood borne fluorescent biomarkers measured through skin patch for assessing cancer therapy

• Expertise in imaging antibodies, peptides and drugs, SPECT- CT, PET and Optical imaging modalities.

• Involved in developing animal models (LLC in C57BL/6, CT26 WT, Xenograft nude/SCID, transgenic models), biodistribution, histopathology assessment, radiolaigand binding assays.

• Worked with biology people for cell screening (U937, A3 or Jurkat, HT1080, CT26) for in vitro evaluation of biomarkers, Designed, executed in vivo, ex vivo assays using ELISA, FACS.

• Developed intellectual proprietary platform (IP) in new fields.

• Designed analytical method development for insertion efficiency of reporter probes on nanoparticles.

• Initiated and established research contract with Charles River discovery and biomarkers services to validate biomarkers.

PRINCIPLE RESEARCH SCIENTIST; CO-DIRECTOR 2004 - 2008

PROJECT: Apoptosis Imaging, Biomarkers research in oncology and cardiology (Ang II Receptor, TGF- , CTGF, PDI, VEGF, Proteosome).

MANAGERIAL

• Established 5 Collaborations; Scrutinized preclinical data on variety of targets/animal models Result: No Go decision.

• Enhanced the visibility of COVIDIEN through plenary lectures, & workshop presentations.

• Visionary for biomarkers in cardiology projects and embedded therapy oncology projects

• Result: (5 patent disclosures on biomarkers.

TECHNICAL

• Developed new analytical methodology, validation and RT radiolabeling technology.

• Validation of CK-18 biomarkers for differentiating apoptosis and necrosis induced by chemotherapy.

• Identified safety, predictive & and surrogate biomarkers assay development for clinical team.

• Generated cross functional contribution of characterizing radio labeled impurities for “ generic drug” to fulfill IND application, CMC support (currently marketed at $100 million sale).

BERLEX, USA /SCHERING AG BERLIN, GERMANY 2000-2004

(17 Billion $ company with > 100, 000 work force)

PRINCIPLE INVESTIGATOR

PROJECT: Product Development: : DVT Imaging agent, Lung cancer imaging and therapeutic agents and Breast cancer imaging and therapeutic imaging product based on Aptamer (Oligos).

Developed deep vein thrombosis (DVT) imaging product IND & CMC, non-small cell lung cancer imaging agent (IND, EMEA Approval), Aptamer (Oligos) based combined imaging and therapeutic agent (SPECT, PET, IND) from concept level to phase 1 clinical. Small molecule, peptide and protein based therapeutics. Synthesis of bifunctional chelating agents and radiolabeling.

MANAGERIAL

• Successfully taken Aptamer product (breast cancer imaging agent) from bench level to Phase 1 clinical level, GLP, cGMP and ICH guidelines.

• Coordinated with Berlin team and reviewed CMC for IND and NDA. (high visibility).

• Transferred Technology to Berlex (QC, NJ), Berlin (Germany) and France for Tox studies.

TECHNICAL

• Formulated several kits, In vitro assays, analytical method development for peptide and oligo based radiopharmaceuticals.

• Characterized low level peptide impurities and assigned structures and mechanism for impurity profile to answer FDA and EMEA (European) questions.

• Authored SOPs and technical reports to support FDA filings.

• Evaluated bioassays for specificity, sensitivity, linearity, limit of detection, limit of quantification.

• Synthesized standards, batch release tests, set specifications.

• Expertise in HPLC, TLC, UV/IR, NMR, LC-MS/MS, wet chemistry techniques, preparing reports,

• Established stability program, problem solving and complete project management.

• Hands on experience in assay development, assessment and validation (in vitro & in vivo).

UNIVERSITY OF MISSOURI, COLUMBIA, MO 1996-2000

RESEARCH ASSISTANT PROFESSOR, Faculty @ Chemistry Department/Internal Medicine

ADJUNCT ASSISTANT PROFESSOR, Internal Medicine

• Established and directed radiopharmaceuticals @ UMC, External funding, Training post doctoral fellows, Published in JOC, Bioconjugate Chem, Bioorganic Chem, JACS.

UNIVERSITY OF MISSOURI, COLUMBIA, MO 1991-1995

SENIOR ESEARCH ASSOCIATE with Prof. Kuntz & Prof. Wynn Volkert Inventor of “Ceretec” and Quadrimet”, brain imaging and pain palliation agent resp., Department of Radiology.

• Photolabeling of antibodies, Fab fragments, radioimmunoassay, bioactivity measurements (6 Publications), Organic photochemistry, Synthesis of chelating agents, , in vivo imaging, IC-50, ID50).

• WEST VIRGINIA UNIVERSITY/NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND HEALTH RESEARCH ASSOCIATE 1987-1990

• FTIR/Photoacoustics on silicosis and pneumoconiosis. Cytotoxicity Measurements.

EDUCATION

Post Doctoral Research: Nuclear Medicine/Radiopharmaceuticals; Radiology and Internal Medicine, University of Missouri, Columbia. Missouri.

Ph.D. - Chemistry, Indian Institute of Science, India.

M.S. – Organic Chemistry, Mysore University, India.

B.S. - Physics/Chemistry/Mathematics, India.

HONORS

Dr. J. C. Ghosh Gold Medal for the Best Ph.D. Thesis.

A Citation and Award for the Best Paper Published in Journal of Chemical Society, 1989.

5 year Excellency award from Covidien.

PROFESSIONAL ASSOCIATIONS:

ACS, SNIDD, EANM (Europe). (SNM), Associate member of ASNC (2007).

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