Subject Matter Experts

Thomas Ingallinera, R.Ph., Ph.D.
Vice President, Technical Support

Bio

Bryan Braxton, Ph.D.
Senior Director, Aseptic R&D

Bio

Sundeep Sethia, Ph.D.
Senior Director, R&D

Bio

Veeranna Lolla, RAC
Senior Director, Regulatory Affairs

Bio

Sharada Kolindrekar
Director, Validation & Technical Services

Bio

Devan Patel
Senior Director, Project Management

Bio

Shafi Shaik
Principal Scientist, Product Development

Bio

Thomas Ingallinera, R.Ph., Ph.D.
Vice President, Technical Support

Dr. Tom Ingallinera is Pii’s technical liaison between the Business Development team, Project Management, Operations, and our valued Partners. Tom has over 40 years of experience in pharmaceutical development, with particular expertise in parenteral dosage forms. He has advised on product development programs across the continuum, from pre-formulation through commercial production. Tom has worked at several leading pharmaceutical companies including BioCryst Pharmaceuticals, Parenta Pharmaceuticals, AAI Pharma, Genzyme, Burroughs Welcome, and A.H. Robins. Dr. Ingallinera has a B.S. in Pharmacy with a Ph.D. in Pharmaceutics from Virginia Commonwealth University.


Bryan Braxton, Ph.D.
Senior Director, Aseptic R&D

Bryan Braxton joined Pii in October 2018 as Senior Director of Aseptic R&D. Bryan has 30 years of experience in the pharmaceutical industry.

Bryan held roles of increasing responsibility in sterile products at both Unither, AMRI, Pfizer, Abbott, and Glaxo, in the areas of Formulation Development, Process Transfer, Quality by Design, Technical Services, Contract Services, and Project Management.

Bryan earned a Ph.D. in Pharmaceutical Chemistry from the University of Kansas and is a registered pharmacist.


Sundeep Sethia, Ph.D.
Senior Director, R&D

Dr. Sundeep Sethia joined Pii in September 2018 as Senior Director of Pharmaceutical R&D. He has over 15 years of experience in the pharmaceutical industry.

Dr. Sethia formerly served as the Director of Pharmaceutical R&D at Amneal Pharmaceuticals. Prior to Amneal, he held positions of increasing responsibility at both Teva and Barr Laboratories in R&D. His expertise is in drug development across a broad range of therapeutic areas and dosage forms. He has a proven track record in generic drug development and approvals.

Dr. Sethia received his Ph.D. in Pharmaceutical Sciences from St. John’s University, NY. He earned a Master’s and a Bachelor’s degree in Biotechnology and Pharmacy, respectively from Jadavpur University in India. He has co-authored various peer-reviewed scientific publications and patents/patent applications.


Veeranna Lolla, RAC
Senior Director, Regulatory Affairs

Veeranna Lolla, joined Pii in October 2017 as Senior Director of Regulatory Affairs. He has over 25 years of experience in the pharmaceutical industry.

Mr. Lolla formerly served as Director of Regulatory Affairs at Strides Pharma USA. Prior to Strides, he held positions of increasing responsibilities at Endo Health Solutions and Sun Pharma USA, in the areas of CMC Regulatory Affairs, Technical Services, Manufacturing and Quality Compliance. He filed numerous ANDAs, amendments, supplemental ANDAs and NDAs for a variety of dosage forms, IR and ER Tablets, Capsules, Soft Gelatin Capsules, Sterile Products, Topical Formulations and Transdermal Patches. He has proven track record in filing and winning approvals for first to file and first-time generics.

Mr. Lolla received his Masters in Pharmaceutical Sciences (Pharmaceutics) from Mangalore University, India. He received his RAC certification from the Regulatory Affairs Professional Society (RAPS).


Sharada Kolindrekar
Director, Validation & Technical Services

Sharada Kolindrekar joined Pii in 2011 as a member of the Analytical Research team.

Applying her keen analytical skills and possessing a high attention to detail, Sharada held positions of increasing responsibility over the next 9 years including: Validation Coordinator, Supervisor of Aseptic Validation, and Associate Director of Validation and Tech Services. She assumed her current role in 2019.

In her role as Director, Sharada leads a multi-disciplinary team responsible for commissioning, validation, and technology transfer for Pii’s manufacturing processes including, complex, highly potent parenterals under aseptic conditions, tablets, capsules and softgels. Additionally, she is instrumental in steering activities contributing to Pii’s foundation of quality that includes product risk assessment, cross-contamination risk assessment, qualification, cleaning and process risk assessments.

Before joining Pii, Sharada served as an Automation Specialist for Electronic cGMP Methods and Records for VelQuest Corporation, a provider of automated Procedure Execution Management Systems (PEMS) and before that as a Project Engineer at the National Chemical Laboratory, a research, development, and consulting organization in Pune, India. Sharada received a Bachelors in Chemical Engineering from Visveswaraiah Technological University, Belgaum, India and a Masters in Engineering Management with a concentration in Chemical and Biochemical Engineering from the University of Maryland, Baltimore County.


Devan Patel
Senior Director, Project Management

Devan Patel joined Pii in 2012 as a member of the Project Management team.

Devan has held roles of increasing responsibility in Project Management leading key development and commercial programs for Pii for both the orals and injectables. With his leadership, Pii has built a world-class Project Management Organization (PMO) consistently characterized by superb customer experience. Over the years, Devan has used his knowledge and technical skills to play a vital role for the Operations team, managing key initiatives for the Parenteral/Sterile business unit, including managing the overall scheduling and planning of all Aseptic Operations. His collaborative style when working with cross-functional teams across Pii’s business units and ability to anticipate problems before they occur as raised the role of project management to an artform. Devan delivers a positive, outcomes-focused experience for our client-partners, from initial contact through successful completion of each project.

Devan earned his Bachelors in Cell Biology and Molecular Genetics from the University of Maryland and a M.B.A. from Johns Hopkins University.


Shafi Shaik

Shafi Shaik
Principal Scientist, Product Development

Shafi Shaik joined Pii in 2010 as a member of the Formulation Science team.

In his role as Principal Scientist, Shafi works closely with a multi-disciplinary team responsible for advancing client therapeutic development concepts from pre-formulation to first-in-human trials and beyond. Shafi’s knowledge and experience regarding solid oral dosage forms have delivered extraordinary results for Pii’s clients. His expertise includes: design and development of conventional and controlled solid dosage forms, highly variable drug molecules, and immediate and controlled release formulations.

Additionally, he has been instrumental in filing a number of ANDAs successfully in an extremely short time. His understanding of CMC, process validation, QBD, and the nuances of a variety of processes and equipment capabilities makes him an incredibly valuable asset to the Pii team and its clients.

Before joining Pii, Shafi served as an R&D Manager and Formulation Scientist for Capricorn Pharma Inc. in Frederick, Maryland and a Research Associate at Lamar University in Beaumont, Texas.

Shafi received a Bachelors of Science in Pharmacy from Jawaharlal Nehru Technological University, Hyderabad, India and a Masters of Science in Chemistry from Lamar University, Beaumont, Texas. He also completed advanced course work in Pharmaceutics at the University of Sciences, Philadelphia, Pennsylvania.

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