Request Expert

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.

Expert is a member of multiple consulting networks and regularly participates in phone consultations with investors.