Archana Gangakhedkar

408-***-**** (H)

abg449@r.postjobfree.com

Objective: To procure respectable position in biotech industry.

Summary:

. Certificate holder in Regulatory Affairs from UCSC extn in june-2011.

Gained tremendous knowledge about regulatory, clinical and compliance

of drugs and devices, CAPA GMP, SOP's, FDA inspections etc.

. Prepared documents for mock IND submission in eCTD format.

. Gained tremendous knowledge and rules about clinical trials, GCP, ICF,

CRF etc.

. Proactive and motivated, confident individual with detail oriented

observation and follow through skills.

. In depth knowledge of drug discovery path, from bench to selection of

investigational leads (in vitro and in vivo) to IND candidate.

. Excellent interpretation skills of molecular stability in DMPK,

transporter, Caco, PAMPA and other biological assays.

. Understands and interprets in vivo PK and efficacy of molecules. Solid

understanding of mechanism of action of complex diseases.

. Expertise in using MS Powerpoint, Word, Excel etc and has scientific

writing skills. (reports and Patents)

. Excellent interpersonal and teamwork skills. Valued for ability to

achieve goals and follow through cross functionally with good inter

personnel skills.

. Member of safety committee. Served as department safety coordinator in

coordination with E,H&S.

. Contributed towards scientific writing in published and provisional

patents.

. Expertise in using analytical instruments LCMS, HPLC, NMR etc.

Areas of Expertise:

. Prioritizes projects with good documentation practice. Achieves

accurate results under aggressive timelines and consistently

drives for highest level of quality work.

. Stays abreast of project developments (scientific, legal,

clinical), good time management skills.

. Computer friendly with expertise in power point and other MS

documentation.

. Good organizational, documentation skills.

PROFESSIONAL EXPERIENCE:

XENOPORT Inc CNS company (Santa Clara, CA) Senior Research

Associate 2007-2010 (2001-

2010)

Worked closely and effectively with cross - functional teams

(Discovery biology, DMPK, chemical development, PK, toxicology) for

smooth and effective screening process of target molecules. As a

member of core team committee, was responsible for selection of right

molecule into in vivo and toxicity studies for late stage development

and business collaboration.

. Key synthetic chemist in MS (Multiple Sclerosis) project. Managed

compound supply demands for PK, EAE efficacy studies and GI toxicology

studies which enabled this project to be on fast track development.

. Designed and synthesized prodrugs which significantly reduced toxicity

profile in rats. These prodrugs were then was selected for late stage

development.

. Guided the team in right direction by keeping updated with current

project literature to set appropriate goals for the project saving

significant amount of time and money.

. Assisted in step by step detailed documentation for CRO. Detailed

documentation were written for filing provisional and non provisional

patent documents.

. Designed Prodrug and NCE for MS (multiple sclerosis) and

Schizophrenia with superior bioavailability and improved toxicity

profile.

Research Associate : 2001 to 2007

. Utilized good synthetic organic chemistry skills to independently

develop synthetic routes for target molecules from milligram to

multigram scale. Applied analytical interpretation skills using NMR,

HPLC, MS and IR which helped company build solid SAR (Structure

activity relationship).

. Designed and synthesized proof of concept molecules for various

transporters and its application for prodrug and NCE (new chemical

entity) resulting in establishing standards for various transporter

assays.

. Interpreted stability of produgs in various biological assays

including transporter assay, Caco, PAMPA permeability and further

modified their structure to meet the desired properties resulting in

right molecule design.

. Performed in vivo interpretation of lead compound efficacy in tumor

target models to select the right investigational lead for the

project.

. Synthesized safe & cost effective candidates for several therapeutic

investigational lead molecules saving several thousand dollars

expenditure for a project.

. Synthesized NMDA-agonist prodrug which improved bio-availability in

rats when dosed intracolonic (Schizophrenia).

. Experienced in writing synthetic chemistry portion of provisional and

non provisional patent documents.

. Member of Environment, Health &Safety at Xenoport. Was Department

safety coordinator for medicinal chemistry team.

AFFYMAX, Palo Alto Research Associate

1999-2001

. Enhanced expertise to build chemistry on solid support. Synthesized large

solid phase libraries (monomer and dimer libraries) for 7TM (seven trans-

membrane receptors). These libraries were decoded and analyzed. Hits from

the library were scaled up and purified by HPLC for further studies and

transferred to medicinal chemistry team.

. Was member of safety committee.

. Supervised and trained summer interns.

Dr. REDDY'S RESEARCH FOUNDATION, (Pharmaceutical company ) Hyderabad, INDIA

1994-1998

Senior Chemist 1995-1998

Trainee Chemist 1994-1995

Awards:

Star Award 2009 nomination for fast track project development at Xenoport

Inc.

Star Award 2008 for efficacious prodrug design in Multiple sclerosis.

Star award 2006 for improving bioavailability of NMDA agonist.

EDUCATION:

. MS. Organic Chemistry Osmania University, India

. BS. (Biology, Chemistry, Physics), Osmania University, India.

PATENTS AND PUBLICATIONS:

Poster # 671 at the 26th Congress of the European Committee for the

Treatment and Research in Multiple Sclerosis on October 15th in

Gotenburg Sweden.

Comparison of the Efficacy and Tolerability of a Novel

Methylhydrogenfumarate Prodrug with Dimethylfumarate in Rodent EAE and

GI Irritation Models

Kathleen Gogas, Grace Kim, Bernd Jandeleit, Archana Gangakhedkar,

Thamil Annamalai, Timothy McCullough, Peter Virsik, Mark Gallop, David

Wustrow

XenoPort Inc., 3410 Central Expressway, Santa Clara, CA 95051 USA

Patents:

1. 201******** Prodrugs of Methyl Hydrogen Fumarate, Pharmaceutical

Compositions Thereof, And Methods Of Use 02-25-2010.

2. 200******** Acyloxyalkyl Carbamate Prodrugs Of Alpha Amino Acids,

Methods Of Synthesis And Use 07-30-2009.

3. (WO/2005/117931) GLUT1 Transporters Expressed In Cancer Cells.

4. US Patent 5972955 - Water Soluble C-ring Analogs Of 20(S)-

CAMPTOTHECIN

Papers:

5. Bioorganic and Medicinal Chemisty September 1999, Pages 2013-2020

In vitro cytotoxicity of 5-aminosubstituted 20(S)-camptothecins.

part 1*1 Duvvuri Subrahmanyam, a, V. M. Sarmaa, A. Venkateswarlua,

T. V. R. S. Sastrya, Archana P. Kulakarnia, D. Srinivasa Raob and

K. V. S. R. Krishna Reddyb.

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