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 Expert  725216

Expert in Drug Delivery, Formulation Development of NCE's, Preformulation, Stability, Clinical Manufacturing

Available for your Consulting and Expert Witness Needs

California (CA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral solids. For the devices it has encompassed evaluation of device manufacturers in the area of nasal and inhalation devices (nebulizers and dry powder inhalers) She has also been responsible for determining the special features in the devices such as devices being child proof, abuse proof, patient compliant etc. She has worked with device engineers and design engineers to evaluate devices to be optimized for various formulations and in some cases with specialized feature as high viscosity, gels, powders etc.

She has been involved in various dosage forms - conventional such as tablets, capsules, solutions (sterile and non-sterile) and non- conventional such as nasal sprays, gels, powders, controlled drug delivery (biodegradable and silicone polymers); inhalation powders (spray dried) and lactose blends and also nebulizers and ocuserts (polymeric ocular inserts).

She has been involved in various drug delivery methods such as microsphere preparation (solvent evaporation and extraction method); biodegradable and silicone controlled polymers (plastic molding); oral, nasal, ocular and inhalation.

She has been responsible in all aspects of drug development from Discovery to Phase 3 and commercial manufacturing. Lead screening, lead optimization, preclinical studies, non-GMP and GMP tox study support, Manufacturing for clinical trials from PHASE 1 and beyond. Stability, manufacturing, IND and NDA submissions.

She has been responsible for taking the molecules from discovery to drug dosage development through various phases such as for preclinical studies through early clinical trial through commercial presentation. Outsourcing, strategy for various phases and selection of vendors etc.

She has been responsible for various drug formulations from preclinical to clinical and commercial manufacturing.

She has been responsible for conducting stability studies for drug substance and drug product and interpretation of stability data and ICH guidelines.

She has been responsible for working on various investigational drugs in the area of inhalation and oral solids form and developing dosage forms, preformulation characterization and filing IND.

She has been involved in formulation of drugs as nasal sprays, characterization of devices for nasal sprays, stability and manufacturing of solutions for nasal sprays in the area of small molecules and biologicals. She was also responsible for screening and evaluating vendors in the area of characterizing nasal spray plumes etc.

She has been responsible for researching on new chemical entities, new drugs in the area of COPD, respiratory infections, asthma, GI prokinetics such as idiopathic constipation, opiate induced bowel dysfunction etc.

She has been responsible for working on various devices suitable for nasal spray, characterization of spray in terms of surface tension, viscosity, stability etc.


contract manufacturing


drug delivery


dosage form


drug development


drug dosage form development


drug formulation


drug stability


investigational drug


nasal drug delivery


new drug


nasal spray


clinical supply manufacturing

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California;  San Francisco, California;  Sacramento, California;  Oakland, California;  Stockton, California;  Fremont, California;  Modesto, California;  Salinas, California;  Santa Rosa, California;  and Hayward, California.

Often requested
with this expert:

Powders and Tablet Manufacturing
Pharmaceutical Solid Dose Forms
Pharmaceutical and Biopharmaceutical Product Development,...
Chemistry R&D and cGMP Manufacturing, Pharmaceutical...

Year   Degree   Subject   Institution  
1995   Ph.D.   Pharmaceutics   University of Rhode Island, Kingston, RI  
1992   MS   Pharmaceutics   Northeastern University, Boston, MA  
1987   M. Pharm   Pharmaceutics   University of Delhi, Delhi India  
1985   B. Pharma   Pharmacy   University of Delhi, Delhi, India  

Work History:
Years   Employer   Department   Title   Responsibilities

2003 to




Pharmaceutical Sciences


Group Leader


She is responsible for preformulation characterization of lead molecules; molecule developability for progressing to Phase I and beyond; formulating strategy for clinical manufacturing, stability program, selection of vendor for manufacturing.

2000 to 2003


Nektar Therapeutics


Pharmaceutical Sciences


Senior Scientist


She was responsible for formulation feasibility as dry powder inhalation of the new and existing molecules. Screening and selection of proprietary technologies as spray dried powders. Evaluation of devices- inhouse and marketed; screening and evaluation of passive and active inhalers. aerosol method development.

1997 to 2000


Nastech Pharmaceuticals


Pharmaceutical Sciences




She was responsible for formulation of molecules as nasal solutions, gels and powders. Screening and selection of nasal devices. She was also responsible for developing animal models to screen various formulations. She was involved in clinical manufacturing and scale up for commercial manufacturing.

1995 to 1997


West Pharmaceutical Services


Pharmaceutical Sciences


Associate Scientist


She was involved in drug delivery in the area of nasal drug delivery and ocular drug delivery. Ocular drug delivery involved fabrication of ocuserts as silicone polymers and Nasal drug delivery involved proprietary microsphere powders.

Career Accomplishments:

AAPS (Association of Pharmaceutical Scientist)

Publications and Patents Summary

She has 4 patents and a dozen publication and presentations

Consulting Services:
Selected Consulting Examples:
  • She is a member of GLG Council and regularly participates in phone consultations with investors.
Recent Client Requests:
  • Expert oral dosage pharmaceutical tablet formulation excipient compatibility API degradation pathways phase III trials CMC pharmaceutical formulation development expert for consulting on oral dosage tablet formulation development.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Market Research:
She has been involved in non-invasive drug delivery technologies- solids, controlled release delivery, immediate release delivery, powders ( lipid an sugar based); solutions ( oral - sterile and non-sterile)

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Worked with vendors in the area of clinical manufacturing of oral solids ( Aptuit, Catalent, PII, Pharmatek)


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