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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

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

Brian Sasaki

Brian Sasaki

Senior Director of Business Development

Jay Feldman

Jay Feldman

Head of Information Technology

Vidhi Desai-Pii

Vidhi Desai

Sales and Marketing Assistant

Irina-Prudnikovanew

Irina Prudnikova

Associate Director, R&D

Sam-Chia

Sam Chia

Director, Aseptic Operations & Plant Manager

Koshy George

Koshy George

Associate Director of the Manufacturing, Science and Technology

Peng Zhang

Peng Zhang

Senior Formulation Scientist, R&D Aseptic Formulation

Dylan Amig_final

Dylan Amig

Head of Manufacturing and Packaging

Roberto Almodóvar Febles

Roberto Almodóvar Febles

Head of Aseptic Operations

Eric Coutinho

Eric Coutinho

Manager, Research and Development

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.

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.

Irina-Prudnikovanew

Irina Prudnikova
Associate Director, Analytical Research & Development (R&D)

Irina leads the Analytical R&D team at Pii, responsible for developing chemical test methods, providing support for formulation development, and validating all methods before transferring them to Quality Control. The work of the Analytical R&D team is critical to enabling technology transfer for drug developer clients and streamlining the scaling of drug production. She has experience in supporting the development of a variety of medicines for orphan diseases, oncology, and nervous system disorders. Irina is often the catalyst that helps to transform a development candidate, be it a small or large molecule, into a viable drug formulation that improves, and even saves, the lives of patients.

Irina earned a Master of Science in Chemistry with a focus in Analytical Chemistry from Lomonosov Moscow State University.

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).

Koshy George

Koshy George
Associate Director of the Manufacturing, Science and Technology

Koshy George is Associate Director of the Manufacturing, Science and Technology at Pii. He began working for Pii in 2003, setting up the Validation/Qualifications and Technology Transfer department as a group leader within the Formulation Development and Operations Departments. Mr. George has successfully performed numerous product tech transfers (site change, pilot-scale development, commercial scale), validated, and launched multiple New Drug Applications (orphan drugs, hormones, potent, DEA-schedule drugs, veterinary chewable tablets, tablet in tablet and softgels) and Generic Abbreviated New Drug Applications (tablet, hardgel capsule, softgel capsules, nanosuspension, solution, lotions, creams, and ointments) throughout his tenure at Pii.

Mr. George has more than 25 years of experience in Oral Dosage Formulation Development, Quality Compliance/Assurance, Manufacturing Science & Technology, Product Life Cycle Management, Process and cleaning validation, CSV, Calibrations, Tech Transfer, and Packaging with DSCSA emphasis. He has dual Graduate degrees: a Master of Science in Pharmaceutical Sciences and a Master of Science in Biotechnology from the University of Maryland, Baltimore County. He holds certifications from the National Institute of Health (NIH) in Clinical Pharmacology and in Clinical Research and is affiliated with the International Society for Pharmaceutical Engineering and American Association of Pharmaceutical Scientists, through memberships and mentorship programs.

Peng Zhang

Peng Zhang
Senior Formulation Scientist, R&D Aseptic Formulation

Peng Zhang is a Senior Formulation Scientist, Aseptic Research & Development at Pharmaceutical International, Inc. (PII), serving at the company since 2011. She received her PhD in Chemistry and Biochemistry from the University of Maryland, Baltimore County (UMBC) and MD from Beijing Medical University. Dr. Zhang has led the formulation development, and formulation process development for more than a dozen of aseptic products in the past two years, including at least five IND or NDA submissions. Dr. Zhang is also an expert in analytical method development and validation. She has participated in 50-plus ANDA fillings of different dosage forms and five approved genetic drug launches. She has strong research experience and broad background in drug discovery, especially in the area of anticancer, antivirus and addiction treatments.

Dylan Amig_final

Dylan Amig
Head of Manufacturing and Packaging

Dylan Amig is the Head of Manufacturing and Packaging for orals, solids, and non-sterile liquids. Dylan’s leadership has grown in increasing responsibility where he leads and supports strong Manufacturing Science & Technology (MS&T), Manufacturing, and Primary/Secondary Packaging teams. Dylan practically grew up at Pii, starting as a Manufacturing Technician for solid dose production in 1999 while still in high school. Mentored by Pii’s founder and former CEO, Dr. Syed Abidi, Dylan went on to hold a variety of positions at Pii, including Production Supervisor; Senior Supervisor, Manufacturing; and Senior Manager, Manufacturing. Throughout those years, Dylan cemented himself as an integral part of Pii’s growth, successfully working on programs from early stages of development and seeing them through to commercialization – having been an integral part of commercializing over 30 programs.

Roberto Almodóvar Febles

Roberto Almodóvar Febles
Head of Aseptic Operations

Roberto Almodóvar Febles brings more than 15 years of progressive experience in manufacturing management, organizational development, process improvement/development technical support, and quality assurance experience to his role as Head of Aseptic Operations at Pii.  Prior to joining Pii, he supported programs at many world-class pharmaceutical companies, including Baxter Healthcare, Amgen, iPR Pharmaceuticals (the CMO for AstraZeneca), and Mylan. He earned one Bachelor of Science in Chemistry and one in Chemical Engineering, as well as a minor in Environmental Engineering from the University of Puerto Rico, Mayagüez Campus. Mr. Febles has experience in Lean Six Sigma, Tech Transfer, Gap Analysis and Risk Assessment, Project Management, and Warning Letter Remediation, as well as extensive knowledge of regulatory stanards. He also attained an Executive Master degree in Business Administration from the Interamerican University of Puerto Rico, Cupey Campus.

Eric Coutinho

Eric Coutinho
Manager, Research and Development

Mr. Coutinho joined Pharmaceutics International Inc. in 2004 as a Formulation Chemist in Softgel R&D, and is currently Manager, Research and Development responsible for Softgel/Liquids formulation/development, technology transfer, and scale-up. In addition to Softgel dosage form, he has worked with Hard Gelatin Capsules, Oral Solutions, Oral Suspensions, Powder for Reconstitution, and Inclusion Complex Formulations. Additionally, he has overseen Pii’s first Nanosuspension and Suppository projects, the former has a patent pending. His in-depth understanding and technical know-how to develop new products, scale up, and bring them into the market. Mr. Coutinho received his Bachelor of Science in Chemistry from University of Bombay and his Master of Science in Engineering Management from University of Maryland, Baltimore County. He also earned his certificate in Biochemical Regulatory Engineering from UMBC, and has taken additional courses GMP, Regulatory issues, Facility design, and Quality engineering and management.

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