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SUBJECT MATTER EXPERTS

Thomas S Ingallinera

Thomas Ingallinera, R.Ph., Ph.D.

Vice President, Technical Support

Brian Braxton

Bryan Braxton, Ph.D.

Senior Director, Aseptic R&D

Sundeep Sethia

Sundeep Sethia, Ph.D.

Senior Director, R&D

Veeranna Lolla

Veeranna Lolla, RAC

Head of Regulatory Affairs

Devan Patel

Devan Patel

Senior Director, Project Management

Shafi Shaik

Shafi Shaik

Principal Scientist, Product Development

Vishnu Dwadasi

Vishnu Dwadasi

Head of Project Management Office

Vidhi Desai-Pii

Vidhi Desai

Sales and Marketing Assistant

Brian Sasaki

Brian Sasaki

Senior Director of Business Development

Irina-Prudnikovanew

Irina Prudnikova

Associate Director, R&D

Jay Feldman

Jay Feldman

Head of Information Technology

Sam-Chia

Sam Chia

Director, Aseptic Operations & Plant Manager

Thomas S Ingallinera

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

Dr. Thomas Ingallinera is the Vice President of Technical Support at Pharmaceutics International, Inc (Pii) and one of Pii’s talented subject matter experts whose purpose is to solve problems. Dr. Tom has over 40 years of experience in pharmaceutical development, with an expertise in complex dosage forms. He has advised on product development programs across the continuum, from pre-formulation through commercial production. He 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. Dr. Tom also serves as a member of the Technical Advisory Group for the Bill and Melinda Gates Foundation.

Brian Braxton

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

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

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

Veeranna Lolla, RAC
Head of Regulatory Affairs

Veeranna Lolla, is the Head of Regulatory Affairs at Pii and is also responsible for Change Control, Supplier Qualification, Product Complaints and Annual Product Reviews (APRs).  

Mr. Lolla has over 25 years of experience in the pharmaceutical industry. He 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 a 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).

Devan Patel

Devan Patel.
Senior Director, Project Management

Devan Patel is the Senior Director, Project Management at Pharmaceutics International, Inc (Pii).

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 a 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 art form. 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 an 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 Bachelor 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.

Vishnu Dwadasi

Vishnu Dwadasi
Head of Project Management Office

Vishnu Dwadasi is responsible for all aspects of project management, guiding Pii’s client projects from pre-clinical through full-scale manufacturing for a wide-range of oral-dose and parenteral formulations.

Prior to joining Pii, Vishnu led the R&D and lab informatics focus area within the Life Sciences practice of West Monroe Partners. Before his time at West Monroe Partners, he was a Business Development Director at BioDuro, leading CMC sales for the east coast. He also worked at Catalent Pharma Solutions and held several positions in operations, R&D, project management and business development. Vishnu is an alumni of Catalent’s prestigious Global Operations Leadership and Development (GOLD) program. Vishnu has extensive experience shepherding complex drug development programs from early clinical development to full-scale commercial manufacturing and distribution.

Vishnu earned an MBA from the Fuqua School of Business at Duke University and a B.S. in Health Sciences from Purdue University.

Brian Sasaki

Brian Sasaki
Senior Director of Business Development

Brian Sasaki has over 20 years of experience in the pharmaceutical industry and is responsible for Pii’s business development operations in the Western Region of the United States.

Brian began his career as a bench scientist with Bayer Corporation. His range of experiences include roles with Pfizer, Takeda/Abbott, GE, Lonza, Catalent, and Rapid Micro Biosystems. Throughout his career, he has been at the center of applying innovative thinking to solve some of the industry’s most vexing problems. Working with client drug sponsors and using his extensive skills to help them accomplish their objectives is his passion.

Brian earned his Bachelor of Science in Microbiology, with a Minor in Chemistry, at San Jose State University.

Jay Feldman

Jay Feldman
Head of Information Technology

Jay Feldman is a dynamic technology leader specializing in pharmaceutical information technology and management. His ability to deliver innovative technology solutions to pharmaceutical companies, contract development and manufacturing organizations (CDMOs) and healthcare businesses has consistently enabled better results faster to clients and patients.

Jay’s over 30-years of experience spans positions of ever-increasing responsibility with Catalent Pharma Solutions, Optimer Pharmaceuticals, HighPoint Solutions, and IMS Health.

He earned a Bachelor of Science Degree in Computer Science at Drexel University in Philadelphia, Pennsylvania.

Vidhi Desai-Pii

Vidhi Desai
Sales and Marketing Assistant

Vidhi Desai is the Sales and Marketing Assistant and responsible for facilitating all initial contact between drug developers and Pii, and streamlining the initial stages of every potential drug developer project that comes to the Pii team.

Prior to joining Pii, Vidhi was a Formulation Scientist and Associate Manager at Tergus Pharma. She was also a Teaching Assistant in the Biology Department and Pharmaceutical Analysis Lab, an Assistant Analyst, and a Research Assistant, all at Campbell University.

Vidhi earned a Masters in Pharmaceutical Sciences from Campbell University, a Masters in Pharmacy Quality Assurance from Ganput University, and a Bachelors of Pharmacy from B.S. Patel College of Pharmacy.

Jay Shukla

Jay Shukla
Director of Aseptic Process Quality

Jay Shukla is the Director of Aseptic Process Quality at Pii.  He joined Pii in 2006 and has over 27 years of experience in the pharmaceutical industry.

He has held multiple roles of increasing responsibility in Microbiology and QA while working at Torrent Pharmaceuticals and Cadila Pharmaceuticals. Jay has a thorough understanding of cGMP regulations for Sterile Pharmaceutical Manufacturing including Quality System elements including Investigations, Root Cause Analysis, CAPA, Change Control, SOP’s, Equipment and Process Validations, Annual Product Quality Review, Microbiology, Batch Record Review/Release, Training and Audits.

Jay earned a graduate degree in Microbiology from Gujarat University, India.

Sam-Chia

Samuel Chia
Director Aseptic Manufacturing

Samuel Chia is the Director Aseptic Manufacturing at Pii. Sam joined Pii in 2015 and has over 26 years of experience in the pharmaceutical industry, much of it leading teams supporting the manufacture of a variety of sterile injectable dosage forms.

Sam formerly served as Focused Factory Supervisor & Manager in Ben Venue Laboratories for 10 years. Prior to Ben Venue Laboratories, Sam held positions of increasing responsibility at Cangene Biopharma (formerly known as Chesapeake Biological Laboratories) and Alpharma Inc.

Sam is a graduate of Paddington College in London, UK with a degree in Chemistry / Biochemistry. Sam is also an associate member of the Institute of Science & Technology (London England).

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