DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

** ***** ***** • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

OBJECTIVE

Accomplished, results-oriented professional in analytical/bioanalytical research. Expert in method development, validation,

structural characterization and quantitation of small molecules and large molecules in regulated environment using cutting edge

analytical techniques in support of NDA, IND and ex-US Regulatory filings

IMMIGRATION STATUS

Permanent Resident (Green Card holder)

SUMMARY

• Expertise in bioanalytical/analytical method development and validation in complex matrices

Proficient in sample preparation/purification/concentration/extraction techniques: solid phase extraction

(SPE), liquid-liquid extraction (LLE), protein precipitation, immunoprecipitation. Expertise in developing

automated sample preparation methods using liquid-handling robots to increase efficiency and reduce costs

Demonstrated expertise in state-of-the-art separation technologies in multiple projects using reversed-

phase (RP) liquid chromatography, normal phase (NP), ion exchange chromatography, (IEC), size exclusion

chromatography in complex matrices (whole blood, plasma, biological tissues, Caco-2 cell, CSF, urine, chew

formulations, nutritional bars, vesicular systems)

Expert in qualitative & quantitative analytical techniques such as LC/MS/MS, LC/DAD, LC/UV, GC/MS/MS

mass spectrometry, fluorescence spectrometry to support method development and validation of NCEs,

metabolites, drug intermediates, raw materials under GLP and FDA regulations

Proficient in use of Laboratory Information Management System (LIMS) & Scientific Data Management

System (SDMS)

• Contributed directly to NDA, IND, NDS and other ex-US Regulatory filings for the following Commercial

Products and Clinical/Pre-clinical compounds:

NDA: Fetzima® (levomilnacipran capsules), NamendaXR® (Memantine)- Donepezil FDC combination

Clinical: Cariprazine

Pre-Clinical Toxicology and Pharmacology Studies: RGH-618

WORK HISTORY

• Forest Laboratories, August 2010-Present

Research Scientist, Bioanalytical & Drug Metabolism, 2013 - Present

Associate Research Scientist, Bioanalytical & Drug Metabolism, 2010 - 2012

• Rutgers- The State University of NJ, Research Assistant, Pharmaceutical Science, 2005-2010

• Hamdard University, India, Research Associate, Pharmaceutics, 2001-2003

EDUCATIONAL QUALIFICATIONS

• Ph.D. in Pharmaceutical Science, Ernest Mario School of Pharmacy, Rutgers- The State University of New Jersey,

Piscataway, New Jersey, (2006 -2010).

• Masters in Pharmacy (M. Pharm) (specialization in Pharmaceutics) - Hamdard University, New Delhi, India (2001 to

2003).

• Bachelor of Pharmacy (B.Pharm) - Hamdard University, New Delhi, India (1997 to 2001).

PROFESSIONAL EXPERIENCE

DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

20 Avery Court • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

Page: 2 of 7

Bioanalytical and Drug Metabolism, Forest Research Institute, Forest Labs., NY (2010 –Present)

• Associate Research Scientist to Research Scientist

Project Contributions

Delivered top-line results (method development, validation, sample analysis support, report writing) in regulatory

filing of Forest’s antipsychotic NCE Cariprazine (Phase 3 to NDA filing)

Delivered results in support of bioequivalence study of Forest’s NamendaXR® and donepezil fixed dose

combination (FDC) for treatment of Alzheimer’s disease (505(b)(2) NDA filing) including method development,

validation, sample analysis support

Contributed to method development, validation, sample analysis to support post marketing BE studies for Forest’s

approved drug Viibryd® for treatment of depression (Post marketing studies).

Developed analytical method, performed validation and supported toxicology, pharmacology, pharmacokinetics for

Forest’s preclinical drug candidate, RGH-618. Prepared and reviewed BA data for drug toxicology, pharmacology

metabolism and pharmacokinetics studies. Contributed to IND filing for Forest Labs’ licensed compound RGH 618

for treatment of anxiety. (Preclinical to Phase 2)

Prepared and reviewed BA (method development, validation, sample analysis) data for drug toxicology,

pharmacology metabolism and pharmacokinetics studies. for preclinical drug candidate, AUFR001026

Delivered top class data including method development, validation and sample analysis for Forest’s GK1-399 and 5

related NCEs for preclinical and clinical studies in myriad matrices such as plasma, pancreas and liver (Preclinical-

Phase 2)

Delivered high quality data for post marketing PK studies for Forest’ approved drug Savella® (Post marketing

studies)

Developed analytical method, performed method validation and delivered preclinical and clinical studies data for

Forest’s licensed compounds ATL 844 (Dogwood Pharmaceuticals), BC-3781 (Nabriva Therapeutics, Inc.),

Apadeneson (Dogwood Pharmaceuticals), Azimilide (Blue Ash Therapeutics)

Regulatory Filing Contributions (NDA, NDS, IND, ex-US)

Significant contribution to regulatory filing and approval of Fetzima® for USA (NDA) and filing in Canada

(NDS). Significant contribution in preparation of response to FDA queries following NDA filing

Active scientific, technical and regulatory role in bioanalytical submissions for Forest’s Namenda® XR and

donepezil fixed dose combination (FDC) for treatment of Alzheimer’s disease

Delivered high quality data for IND packages of preclinical drug candidates. Prepared and reviewed BA data

for drug toxicology, pharmacology metabolism and pharmacokinetics studies. Wrote BA reports for IND filing

for Forest Labs’ licensed compound RGH 618 for treatment of anxiety.

Bioanalytical Departmental Contributions

Researched and designed bioanalytical methods for NCEs and their metabolites to support toxicology,

pharmacology, pharmacokinetic and bioequivalence studies Performed method development and validation in

myriad matrices e.g. plasma, whole blood, urine, liver, brain and pancreatic tissues, caco-2 assay media in a

GLP and non-GLP environment

Developed and validated drug/drug metabolite high throughput fully automated assays in 96-well format in

GLP and non- GLP environment using LC-MS/MS, GC/MS techniques

Routinely used high throughput automated LC systems such as Shimadzu UPLC (with and without rack-

changer), Shimadzu UFLCXR, Agilent 1200 & 1100 series and undergone training for nanoflow-UPLCs

(Waters Triziac with XevoTQ-S).

Proficient in using bioanalytical industry standard MS/MS instruments (triple-quadruple MS) such as AB

Sciex 5500 with SelexIon technology, AB Sciex Q Trap 5500, AB Sciex 6500, AB Sciex 5000, AB Sciex

4000, AB Sciex 3000

Undergone seminar & training for OrbiTrap, Q-Exactive MS, Q-TOF

DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

20 Avery Court • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

Page: 3 of 7

Expert in using LC/MS/MS softwares such as Analyst 1.4.2, 1.5.2, 1.6.1

Proficient in use of Watson LIMS version 7.4 as Laboratory Information Management System (LIMS)

including hand on sample handling, sample analysis, method validation, generating stability data and

providing data to customers

Proficient in use of NuGenesis® version 6.0 as Scientific Data Management System (SDMS).

Automated the workflow of quantitative analysis of drug candidates and metabolites. Continuously

introduced and implemented automation for all steps in bioanalysis, including method development, batch

setup, sample preparation and analysis, and data processing. Utilized the automatic liquid handlers (Tomtec)

to prepare samples using protein precipitation, solid phase extraction and liquid-liquid extraction.

Performed routine performance qualifications (assisted in Installation and Operational qualification) of

newly installed LC/MS/MS instruments, LCs, software and in-house water systems

Performed routine purity testing of reference standards (isotopic purity and HPLC purity)

Provided helpful feedback in introduction, drafting and implementation of new Standard Operating

Procedures

Made recommendations and suggestions on HPLC and mass spectrometer purchase.

Team work with informatics group and BA in bringing and implementing e-Notebook

Additional expertise in biological sample preparation (from tissues, cell lysates and tumors), protein

purification, enrichment, fractionation techniques and protein enzymatic digestion.

Knowledge of different aspects of ligand binding assay, ADC analysis, SISCAPA technology

Well versed in separation techniques of CE-SDS, SDS-PAGE, Ion Exchange (IEX), HIC, Size Exclusion

(SEC), and RP-HPLC.

Developed and founded the Intra-department Journal Club for discussion of new regulatory guidelines, best

practices, industry trends, new analytical and chromatographic techniques in the field of bioanalysis

Preparation & review of validation and bioanalytical reports for completeness for Quality Assurance/FDA

audits

Preparation & review sample analysis study reports for completeness

Business Development Contributions

Performed extensive due-diligences both in-house and on-site as bioanalytical Forest Lab. representative and

helping Forest in diligently licensing good NCEs

Independently determine experimental design, data evaluation, formulation of relevant and scientifically

based conclusions, and coordinate/present studies with technical groups

Dept. of Pharmaceutical Sc., Ernest Mario Sch. of Pharmacy, Rutgers - The State University of New Jersey (2005 -2010)

• Research Assistant

Dissertation Projects

Human pharmacokinetics and pharmacodynamics of orally administered Quercetin

Development and validation of assay to analyze actives in human biological matrices (plasma, urine

and muscle).

Extraction of actives from biological matrices through several techniques including solid phase

extraction.

Pharmacokinetic modeling of drugs using Kinetica™ & WinNonlin® softwares.

Knowledge of PK-PD principles including compartmental and non-compartmental modeling

Investigation of novel penetration modifiers as enhancers and retardants

Formulation development of various topical/transdermal formulations.

DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

20 Avery Court • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

Page: 4 of 7

Investigation of mechanism of novel percutaneous permeation enhancers/retardants through in vitro

permeation studies and spectral (IR-FTIR spectroscopy) and thermal analysis (Differential

Scattering Calorimetry).

Tissue engineering skills (including culture of human primary cell lines such as dermal fibroblasts

and keratinocytes)

Proficient in handling of radioactive/chemicals and hazardous agents at Rutgers - The State

University of New Jersey.

Mentored and supervised several undergraduate students toward their honors thesis, senior design

courses and research credits.

Industry Projects

Conducted several research projects with industrial and government collaborators including

Department of Defense (DOD)-US Army Natick Soldier Center, Natick, MA, Polytherapeutics Inc.,

Nuvo Research, Inc., Edko and Nexmed,

Projects involved the analytical/bioanalytical method development for the actives and evaluation

and characterization of formulations and drug delivery systems for oral, topical and transdermal

delivery.

PK modeling of the actives using Kinetica™ & WinNonlin® softwares.

Conducted research project with industrial collaborator Nuvo Research, Inc., that involved the

development and evaluation of formulations for topical and transdermal delivery. Project also

involved analytical method development of the active.

Dept. of Pharmaceutics, Hamdard University, India (2001 - 2003)

• Research Associate

Proniosome based delivery of Cyclosporine A: Formulated Cyclosporin A into a novel delivery system,

proniosomes, consisting of lipid and surfactant vesicles and incorporated proniosomes in transdermal patches and

characterized by animal skin diffusion studies, dissolution testing, electron microscopy and particle size

SKILLS & EXPERTISE

• Analytical/Bioanalytical skills: MS/MS instruments (triple-quadruple MS) such as AB Sciex 5500 with SelexIon

technology, AB Sciex Q Trap 5500, AB Sciex 6500, AB Sciex 5000, AB Sciex 4000, AB Sciex 3000, high throughput

automated LC systems such as Shimadzu UPLC (with and without rack-changer), Shimadzu UFLCXR, Agilent 1200

& 1100 series, Tomtec semi-automatic liquid handlers, HPLC with UV detection, UV spectrophotometer, GC/MS

Varian Tablet Dissolution Equipment USP 1 & 2 methods, Diffusion cells for membrane transport studies, Scintillation

counter: Beckman LS5 Liquid Scintillation Counter

• Chromatography & sample separation/extraction skills: Reversed-phase (RP) columns (Waters’ BEH™ & CSH™

technology, Agilent’s Stable Bond, Kinetex™ pore shell technology), Normal phase (NP), ion exchange

chromatography (IEC), size exclusion chromatography (SEC) columns, Solid Phase extraction techniques in cartridge

and automated 96-well plate format (Waters’ Oasis® HLB, WCX, WAX technology, Biotage’s Evolute®), supported

liquid extraction and supported protein precipitation techniques

• Formulation skills: Proficient at handling Tablet Press (single station), wet granulation, direct compression,

dissolution method development, formulation of topical and transdermal formulations including gels, creams and

ointments

• Preformulation skills: IR-FTIR spectroscopy (Pike technologies with Bruker software), Differential Scanning

Calorimetry (DSC, Mettler Toledo with STARware software), familiarity with Nuclear Magnetic Resonance (NMR,

Varian), Microscopy: Fluorescence Microscopy (Zeiss AxioObserver D1), Amray Scanning Electron Microscopy

DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

20 Avery Court • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

Page: 5 of 7

(SEM), Amray Transmission Electron Microscopy (TEM), particle size characterization (DLS, Beckman Coulter), X-

ray diffraction (X-RD)

• Cell culture skills: Tissue engineering skills (including culture of human primary and secondary cell lines such as

Caco- 2 cells, fibroblasts and keratinocytes), proficient in handling of radioactive/chemicals and hazardous agents

HONORS AND AWARDS

• Awarded Travelship Award at the American Association of Pharmaceutical Scientist, AAPS 2010, New Orleans

conference.

• Awarded best poster at the “New Approaches and Technologies in Oral Drug Delivery” conference organized by the

New Jersey Chapter of the “Controlled Release Society” in June 2008.

• Awarded Outstanding Reviewer for Pharmaceutical Research Journal for 2011

• Awarded Junior Research Fellowship by University Grants Commission, India.

• All-India rank in Top 1% in the Graduate Aptitude Test in Engineering, 2001 with 98.59 percentile ( Scholarship

award for M. Pharm. program).

PROFESSIONAL AFFILIATIONS

• AAPS (American Association of Pharmaceutical Scientists)

• CRS (Controlled Release Society)

• American Chemical Society (ACS)

• American Society for Mass Spectrometry (ASMS)

• Canadian LC-MS group

SCIENTIFIC TRAINING

• 8th WRIB Workshop on Recent Issues in Bioanalysis, Universal City, CA, 2014

• Applied Pharmaceutical Analysis Meeting, Baltimore, MD 2012

• AB Sciex Advanced LC/MS & On-site training, NY, 2011

• AAPS Annual Meeting, Atlanta, GA; 2008

• CRS Annual Meeting, New York, 2008

• AAPS Annual Meeting, San Diego, CA; 2007

REVIEW PANEL OF SCIENTIFIC JOURNALS AND COMMITTEES

• American Association of Pharmaceutical Scientist Annual Meeting Abstract Screening Committee APQ

section, Sub-chair 2014-2015 (biological matrices)

• Pharmaceutical Research

• The Journal of Pharmaceutical Science

• The Journal of Pharmacy and Pharmacology

• Drug Development and Industrial Pharmacy

• The European Journal of Pharmaceutical Science

• The Journal of Agricultural and Food Chemistry

• The Journal of Chromatography A

• AAPS PharmSciTech

• AAPS Annual Meeting Abstract Screening Committee APQ and PDD sections 2006-2013

DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

20 Avery Court • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

Page: 6 of 7

PUBLICATIONS

• Peer-Reviewed Articles and Book Chapters

1. Kaushik, D. O’Fallon, K., Clarkson, D., Dunne, C.P., Conca, K.R. and Michniak-Kohn, B. Comparison of

quercetin Pharmacokinetics following Oral Supplementation in Humans, Journal of Food Science 2012

October 24 DOI: 10.1111/j.1750-3841.2012.02934.x

2. O’Fallon, K.S., Kaushik, D., Michniak-Kohn, B.B., Dunne, C.P., and Clarkson, D., Effect of Quercetin

Supplementation on Response to Eccentric Exercise, International Journal of Sports Nutrition and Exercise

Metabolism. 2012 Jul 4. [Epub ahead of print]

3. Ganio, M.S., Armstrong, L.E., Johnson, E.C., Klau, J.F., Ballard, K.D., Michniak-Kohn, B., Kaushik, D.,

Maresh, C.M. Effect of quercetin supplementation on maximal oxygen uptake in men and women. J Sport

Sci, 2010, 6, 1-8.

4. Kaushik, D., Costache, A. and Michniak-Kohn, B. Percutaneous permeation modifiers and formulation

effects, Int J Pharm, 2010, 386(1-2), 42-51

5. Kaushik, D. and Michniak-Kohn, B. Percutaneous permeation modifiers and formulation effects: thermal

and spectral effects. AAPS PharmScitech, June 2010.

6. Kilfoyle, B.E., Kaushik, D., Terebetski, J.L., Bose, S., Michniak-Kohn, B., Skin Delivery and Effects of

Quercetin and Curcumin, In: Formulating Cosmetics with Natural Ingredients edited by Nava Dayan and

Lambros Kromidas, John Wiley & Sons, Inc., 2010,

7. Kaushik, D., Kilfoyle, B., Thakur, R., Michniak-Kohn, B., Microneedles - minimally invasive transdermal

delivery technology. Minimally invasive transdermal delivery technology. Elsevier/William Andrew

Publishing, 2009.

8. Kaushik, D., Kyodenieus, A., Rai, V., Michniak-Kohn, B., ‘Pharmaceutical Sciences and Biotechnology

Patents’in the Controlled Release Society Newsletter, 2009, Vol 26, Issue 1 2009.

9. Batheja, B., Kaushik, D., Kyodonieus, A., Michniak, B.., “Transdermal Patent Watch” in the Controlled

Release Society (CRS) newsletters CRS Vol 25, Issue 2 2008

10. Kaushik, D., Batheja, P., Kilfoyle, B., Rai, V., Michniak, B., Percutaneous permeation modifiers:

enhancement versus retardation, Expert Opin Drug Deliv, 2008; 5 (5), p: 517-529.

11. Thakur, R., Batheja, P., Kaushik, D., Michniak, B., Structural and Biochemical Changes in Aging Skin and

their Implications on Skin Permeability Barrier, in: Skin Aging Handbook: An Integrated Approach to

Biochemistry and Product Development, Nava Dayan (Ed.), William Andrew Publishing, 2008.

12. Batheja, P., Kaushik, D., Longsheng, Hu., Michniak, B., Transdermal Iontophoresis, Drug Delivery, 2007;

touch briefings.

13. Kaushik, D., Mishra, P.R. and Talegaonkar, S. “Provesicles as surrogate carrier for improved drug delivery”

in: Progress in Controlled and Novel Drug Delivery Systems (N. K. Jain Ed.), CBS Publications, New Delhi,

2004.

14. Cheuvront SN, Ely BR, Kenefick RW, Michniak-Kohn BB, Rood JC, Sawka MN.No effect of nutritional

adenosine receptor antagonists on exercise performance in the heat., Am J Physiol Regul Integr Comp

Physiol. 2009 Feb;296(2):R394-401 (my contribution represented by my advisor and Principal Investigator

for the grant Bozena Michniak-Kohn)

15. Kaushik D. Investigation of Novel Penetration Modifiers as Enhancers and Retardants & Human

Pharmacokinetics and Pharmacodynamics of Orally Administered Quercetin. Ph.D. dissertation 2010

16. Kaushik D. Proniosomal Based Delivery of Cyclosporine A. M.Pharm dissertation 2003.

• Selected abstracts, presentations and posters

1. Kaushik, D., O’Fallon, K., Clarkson, P., Michniak-Kohn, B. Plasma levels of quercetin following oral

administration. Controlled Release Society, CRS annual meeting 2008, New York City, NY.

DIKSHA KAUSHIK

Home: Relocating to Georgia, USA

20 Avery Court • Nesconset • New York - 11767 • USA (current address)

Phone: 609-***-**** (Cell) • 706-***-**** (Home)

Email: acflwz@r.postjobfree.com

Page: 7 of 7

2. Rahman, AK., Rahman, A., Kaushik, D., Michniak-Kohn, B., Terahertz study of transdermal drug delivery,

oral presentation, ACS, 41 st Mid –Atlantic Regional Meeting, (MARM) 2010, Delaware.

3. Kaushik, D., O’Fallon, K., Clarkson, P., Michniak-Kohn, B. Liquid Chromatography-Ultraviolet

Spectroscopy assay for determination of unconjugated quercetin in human plasma and urine samples,

Rutgers Pharmaceutical Conference, 2007\

4. Kaushik, D. O’Fallon, K., Clarkson, P., Dunne CP, Conca K and Michniak-Kohn, B. Absorption of total

quercetin following oral administration of three quercetin formulations in human subjects. AAPS annual

meeting 2010, New Orleans, LA.

5. Kaushik D, Formulation effects on activity of iminosulfurane and laurocapram based penetration modifiers,

New Jersey Center for Biomaterials, Center for Dermal Research symposium April, 2013

6. Kaushik, D. and Michniak-Kohn, B. Investigation of novel laurocapram and iminosulfurane based

percutaneous penetration modifiers. AAPS annual meeting 2010, New Orleans, LA.

7. Kaushik, D. and Michniak-Kohn, B. Investigation of percutaneous permeation behavior of steroidal drugs

in presence of laurocapram derived retardants, AAPS annual meeting 2009, Los Angeles, CA.

8. Kaushik, D., Costache, A.D., Michniak-Kohn, B., Modeling, solubility and partitioning of percutaneous

penetration modifiers, AAPS annual meeting 2008, Atlanta, GA.

9. Kaushik, D., Gao, J., Chapman, J., Michniak-Kohn, B., Effect of electric current on permeation profile of

model compound DEET in presence of chemical retardants. AAPS annual meeting 2008, Atlanta, GA.

10. Kaushik, D., Michniak-Kohn, B., Vehicle-enhancer and vehicle-retardant effects on percutaneous

permeation of DEET. AAPS annual meeting, 2007, San Deigo, CA.

11. Thakur, R., Kaushik, D., Shah, K., Michniak, B., Formulation of a hydrogel-based system for transdermal

delivery of NSAIDs, AAPS annual meeting 2006, San Antonio, TX.

12. Poustchi, Y, Kaushik, D., Michniak-Kohn, B., Effect of Solvent Systems on Skin Delivery of DEET in

Presence of Penetration Modifiers 2nd Annual Skin Workshop Controlled Release Society-NJ Rutgers

Student Chapter

REFERENCES: Available upon request

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