Praveen Mididoddi Email & Phone Number

Alameda, California, Us

Responsible for managing Exelixis’s world class global drug product manufacturing operations for commercial products. Oversee Exelixis’s commercial CMOs to ensure that the highest level of operational excellence is applied to all manufacturing operations.

Lead oral solid dosage development activities by working with CMOs. Specific activities include overseeing pre-formulation activities such as physico-chemical characterizations, formulation activities such as manufacture of clinical supplies, stability assessments, planning for Registration batches, scout for alternate suppliers by sending RFPs etc.

Princeton, Nj, Us

Primary responsibilities include R&D formulation development, tech transfer and scale up activities related to NMEs. Specific areas of focus are immediate release, extended release and delayed release of tablets and capsules. Achieved corporate and department goals by managing and overseeing activities at CDMOs and Contract Manufacturing Organizations (CMOs).

Princeton, Nj, Us

Princeton, Nj, Us

The overall goal of being an independent consultant was to partner with pharmaceutical companies and assist them in diverse areas. Specific areas of interest include reducing costs and increasing profits using methodologies such as Statistical Data Analysis, Continuous Process Improvement and Lean Six Sigma. Assisted a company with the launch of their injection product by coming up with a statistical sampling plan justification for their validation batches; provided guidance on the validation strategy for their new product launch. Assisted another CRO with an in vitro strategy to establish therapeutic equivalence. Also worked for a company in New Jersey (Appco Pharmaceuticals), oversaw their tech transfer activities, manufacture of clinical supplies and validation of commercial manufacturing and packaging activities. As an Operations Project Manager for another company (Virtus Pharmaceuticals), ensured that activities at CMOs met the required timelines and were within budget. Worked simultaneously with companies in United States, China, India and Europe.

Canonsburg, Pennsylvania, Us

Part of Technical Services team and major areas of focus were Process Validation (New Product Launches) and addressing technical challenges related to marketed products (oral solids and powders). Oversaw the manufacture of engineering batches and addressed technical investigations by doing a thorough root cause analysis. Implemented Corrective and Preventive Actions (CAPAs) and helped address communications from the FDA. Completed Lean Six Sigma Green Belt Training and applied the concepts of Lean and Statistical Data Analysis to various projects. Played an active role in implementing Continued Process Verification (CPV).

King Of Prussia, Pa, Us

Developed new pharmaceutical products using proprietary SoluMatrix reformulation platform that can make nano-sized particles. Specific focus was on improving the performance of approved drugs and new molecules using dry nano milling technology. Used the technology to reduce the particle size of the API and applied roller compaction process (dry granulation) to prepare solid dosage forms such as tablets. Malvern Mastersizer was used to analyze the particle size of reduced API (wet dispersion method) and Dynamic Vapor Sorption (DVS) was used to analyze the surface area of powders. Small scale studies were done at the R&D site in King of Prussia using the QbD approach, whereas scale up was done at CMOs contracted by iCeutica. Short and long term stability studies were also performed on the reduced powders.

Basel, Basel-Stadt, Ch

Developed high quality affordable medicines (generics) to seek FDA approval through 505(j) pathway (ANDA). Specific responsibilities included R&D work at the East Hanover site and tech transfer and scale up at the GMP manufacturing site. Activities included wet granulation, direct compression, tableting, aqueous and solvent coating of tablets and soft gelatin capsules. Interacted with professionals from various functional areas such as Analytical, Regulatory, Legal, Business Development, Clinical etc., and successfully developed medications that met the FDA bioequivalence criteria - 90% confidence interval limits 80-125%.

Boston, Ma, Us

Taught two core courses (Pharmaceutics I and Pharmaceutics II) and an elective (Applied Pharmaceutics) to Doctor of Pharmacy (Pharm.D) students. Focus was on scientific concepts related to the drug development process, solid dosage forms such as powders, tablets and capsules, semi solid dosage forms such as ointments, creams, gels and suppositories, liquid dosage forms such as solution and disperse systems and sterile dosage forms such as parenterals. Also taught students formulation of the above mentioned dosage forms.

Worked on developing immediate release and controlled-release oral solid dosage forms (multi layered tablets) and also on bioadhesive technologies that were designed to increase residence time of dosage forms within the gastrointestinal tract thereby enhancing bioavailability.

Brentford, Middlesex, Gb

Investigated the effect of penetration enhancers on transnail drug delivery using technologies such as Atomic Force Microscopy.

Ph.D., Pharmaceutics

Bachelor’S Degree, Pharmacy

Education record