Development Project

Punit Shah

**** *** ***** ********* *****,, Tallahassee, FL 32301, United States,

Cell: +1-505-***-****, **********@*****.***

Executive Summary

New product identification, patent search and infringement analysis

for development of ANDAs (Para III and IV)

Generation of innovative ideas for development of new formulations and

existing drug for the product life cycle management

Patent drafting to prevent infringement for generics (ANDAs)

Preformulation and compatibility studies (FT-IR, DSC, X-RPD and SEM)

Solublization and stabilization of new chemical entity (NCE) along

with novel peptide

Development of tablets and capsules including pellets, liquid orals,

suspensions, ophthalmics, topical and transdermal formulations

Process optimization, scale-up, technology transfer to process

validation/ commercial batches and stability studies

Handling trouble shooting during technology transfer

Analytical method development and validation (HPLC,

UV-spectrophotometer, spectrofluorometer)

Documentation - preparation of exhibit batch summary reports, product

development reports, cleaning verification reports, Batch

Manufacturing Records (BMR), sampling protocol, validation protocol

and other relevant document for execution of exhibit and validation

batches

Managed a team of 2 people in industry, and undergraduate and graduate

students for their research projects during post-doctoral research

Competent to work well on own initiative and demonstrate high levels

of motivation required to meet deadlines

Professional Experience

Post-Doctoral Research Associate, Florida A&M 2010 -

University, FL, USA Present

Successfully developed a transdermal formulations and HPLC method for

a novel peptide, obtained from marine source (Industry sponsored)

Developed an in vivo model for allergic contact dermatitis and

psoriasis (Industry sponsored)

Filled a patent and communicated a research paper on development and

characterization of surface modified multi-layered nanostructures for

the dermal delivery of 2 drugs

Developed and evaluated nanogel formulations comprising Nanocarriers

Developing nanocarriers for hair follicular delivery

Understanding the wound healing process for chemical and burn wound

using 3D Epiderm Full Thickness (EFT-300 and 400) (Industry

sponsored)

Purchasing and inventory management of raw materials, laboratory

supplies and drug supplies

Tracking project status and co-ordination with collaborators

Identified and managed the potential risks within complex projects in

a timely fashion.

Conducting laboratory experiments and to prepare reports with

conclusions and recommendations.

Mentoring undergraduate/graduate students for the research projects

Post-Doctoral Research Associate, University of New 2008 - 2010

Mexico, NM, USA

Involved in preformulation and biological activity of novel titanium

based anti-cancer drug (NCE) (sponsored by Sandia National

Laboratory)

Developed deuterated glucose formulation for anti-counterfeiting in

commercial formulations

Worked in collaboration on microneedles for skin delivery

Developed Imatinib mesylate topical formulation

Hands on use of confocal fluorescence microscope Plasma analysis of

Sildenafil using HPLC

Supervised and trained undergraduate/graduate students for their

research projects

Research Associate, Lupin Ltd, Pune, India 2008 - 2008

Involved in new product identification (supported by business and

medical group) and patent evaluation for that identified product

Generated innovative ideas for development of new formulations and

existing drug for the product life cycle management

Drafted patents for innovative formulations and to prevent

infringement for generics (ANDAs)

Involved in patent search and Infringement analysis for development

of ANDAs (Para IV)

Project status tracking and co-ordination with attorneys and other

departments like regulatory, analytical, medical and business

Managed a team of 2 people

Scientist, Ajanta Pharma Ltd, Mumbai, India 2003 - 2005

Involved in API sourcing, vendor validation and setting up the

specification for API

Involved in preformulation and compatibility studies (FT-IR, DSC)

Developed formulation of Tablets (Immediate and Extended release),

Capsules, Liquid Orals, Suspensions and Ophthalmics

Prepared pellets using spheronisation technique and coated with

polymer using Glattr fluidized bed coater

Hands on use of powder blending, tray dryer, fluidized bed dryer,

high shear granulator, rotary compression machines and tablet coater

etc.

Involved in process improvement/process optimization, scale-up and

transfer of technology to process validation/commercial batches

Handled trouble shooting during technology transfer of tablet

formulations

Involved in documentation of the research data viz. preparation of

exhibit batch summary reports, product development reports and

cleaning verification reports

Preparation & execution of Batch Manufacturing Records (BMR),

sampling protocol, validation protocol and other relevant document

for execution of exhibit and validation batches

Involved in preparation and execution of stability protocols as per

ICH guidelines for exhibit and developmental batches

Calibration, maintenance and establishing SOPs for equipments

Project status tracking and co-ordination with analytical department

Scaled up 2 ophthalmic dosage forms FIRST TIME in India Training of

new resources for formulation development and technology transfer

process

Educational Qualifications

Ph.D, Pharmacy 2008

The M S University of Baroda, Vadodara, India

Dissertation Title: Development and evaluation of some taste masked

formulations

Summary of Dissertation:

Solid dispersion, CD complexation and microencapsulation techniques

used for bitterness masking of antimalarials

Characterized taste masked drug using FT-IR, DSC, XRPD and SEM

Analytical method developed including HPLC, UV-spectrophotometer,

spectrofluorometer

Statistical approaches used for optimization of microparticles

Developed an in vitro model, Mini-column, to avoid bias of human

volunteers in taste evaluation

Masters of Science, Pharmacy 2003

Mumbai University, India

Dissertation Title: Development and evaluation of anti-fungal

formulations prepared from herbal extract

Bachelor of Science, Pharmacy 2001

University of Pune, India

Accomplishments

. Outstanding Team of the Year for 2003 & 04, Ajanta Pharma Ltd.,

2004 - Awarded for outstanding achievement of a performance

objective, department and company goal

. Visiting Research Scholar at University of Turin, Italy

. Qualified GATE (Graduate Aptitude Test in Engineering) - 2001,

conducted by Indian Institute of Technology (IIT), Kanpur

. Invited speaker at University of New Mexico, Albuquerque, NM

Honors

Reviewer for scientific journals & meetings

Journal of Pharmaceutical Sciences

Journal of Pharmacy and Pharmaceutical Sciences

AAPS PharmSciTech

Drug Development and Industrial Pharmacy

PDA Journal of Pharmaceutical Sciences & Technology

Asian Journal of Pharmaceutics

Paper presentations at the 2009-2011 AAPS Annual Meeting and

Exposition

Computer Skills

. Scientific applications: Design of Expert (DOE, Stat-Ease Inc), JMP

(SAS institute Inc), Sigma-Stat, Sigma Plot, End note, ChemOffice,

Prism

. MS Office Applications: Microsoft power point, Word, Excel, Lotus

Notes

Affiliations

American Association of Pharmaceutical Scientists

Indian Pharmaceutical Association

Publications

Patents:

Filed provisional US patent application entitled "Surface modified

multi-layered nanostructures for dermal delivery" in 2010

Selected Publications (Total - 17)

1. Effect of oleic acid surface modification of bilayered polymeric

nanoparticles on topical delivery. Journal of Controlled Release,

submitted

2. Stable isotope-labeled excipients for drug product identification

and counterfeit detection. Drug Development and Industrial Pharmacy,

2011, 37(1): 88-92.

3. Palatable reconstitutable dry suspension of artemether for

flexible pediatric dosing using cyclodextrin inclusion complexation.

Pharmaceutical Development and Technology, 2010, 15(3): 276-285.

4. Influence of chitosan cross linking on bitterness of mefloquine

hydrochloride microparticles using central composite design. Journal

of Pharmaceutical Sciences, 2009, 98(2): 690-703.

5. Development and evaluation of primaquine phosphate taste masked

rapid disintegrating tablet. Journal of Pharmacy and Pharmacology,

2008; 60(10): 1279-85.

6. Formulation and evaluation of taste masked oral reconstitutable

suspension of primaquine phosphate. AAPS PharmSciTech, 2008; 9(3):

1025-30.

7. Development and evaluation of artemether palatable rapid

disintegrating tablet with improved dissolution. AAPS PharmSciTech,

2008; 9(2): 494-500.

Selected Presentations (Total - 28)

1. In Vivo Efficacy of Cell Penetrating Peptide Modified

Nanocarriers to Treat Topical Inflammation. AAPS Annual Meeting &

Exposition, Washington DC, October, 2011.

2. Transport of spantide II and ketoprofen across the skin by

surface modified nanostructured lipid carriers. AAPS Annual Meeting

& Exposition, Washington DC, October, 2011.

3. Effect of oleic acid modified poly-(lactide-glycolic

acid)-chitosan nanoparticles on skin permeation of ibuprofen. AAPS

Annual Meeting & Exposition, Washington DC, October, 2011.

4. Nanogel system for enhanced pecutaneous delivery of spantide II

and ketoprofen. AAPS Annual Meeting & Exposition, Washington DC,

October, 2011.

5. Use of Epiderm Full Thickness (EFT) Skin Cultures as an in vitro

model for wound healing. SOT 50th Annual Meeting, 6th-10th March,

2011.

6. In vivo studies of cell penetrating peptide coated lipid

nanocarriers for skin-targeted drug delivery. 2010 Biomedical

Nanoscience Initiative of University of Miami ("BioNIUM"), 9th and

10th December 2010. 2nd prize winner

7. Stable isotope-labeled excipients for drug product identification

and counterfeit detection. AAPS Annual Meeting & Exposition, New

Orleans, 14th - 19th November, 2010.

8. In vivo permeation of cell penetrating peptide modified lipid

Nanoparticles formulations in rat skin. Third Annual Joint Student

Research Forum and FAMU Graduate Feeder Conference, Florida A&M

University, September 30th, 2010, Tallahassee, FL. 3rd prize winner

References

Available on request.

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