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SUBJECT MATTER EXPERTS

Travis.Webb

Travis Webb

Chief Science Officer

Devan Patel, Director, Project Management

Devan Patel

Vice President of Client Services

Brian Braxton PhD Senior Director Aseptic R&D

Bryan Braxton, Ph.D.

Senior Director, Aseptic R&D

Sundeep Sethia PhD Senior Director R&D

Sundeep Sethia, Ph.D.

Head of R&D

Shafi Shaik

Shafi Shaik

Principal Scientist, Product Development

Irina Prudnikova new

Irina Prudnikova

Associate Director, R&D

Koshy George

Koshy George

Associate Director, Manufacturing, Science and Technology

Peng Zhang

Peng Zhang, Ph.D., MD

Principal Scientist

Dylan Amig

Dylan Amig

Head of Manufacturing and Packaging

Rahul Mehta

Rahul Mehta, MSc

Associate Director, Analytical R&D

Fei Cai photo

Fei Cai

Senior Scientist, Formulations R&D

Alex Borodin

Alex Borodin, DBA

Senior Director of Supply Chain

Travis.Webb

Travis Webb
Chief Science Officer

Travis Webb comes to Pii with over 17 years of experience in both analytical and formulation contract development across multiple dosage forms including injectables, liquid pulmonary, oral solids and liquids, and topical drug products. During his career he has developed over 20 approved drug generic and NDA drug products and helped bring numerous INDs to various clinical stages. Travis also has extensive experience with QBD and pediatric drug product development for both the U.S. and Europe, supporting IND/NDA filings and communicating with regulatory agencies.
Travis holds an M.S. in Pharmaceutical Chemistry from the University of Florida and a B.S in Biochemistry from Troy University.

Devan Patel, Director, Project Management

Devan Patel
Vice President of Client Services

Devan Patel, who joined Pii in 2012, is Vice President of Client Services where oversees Pii’s Business Operations functions. He previously served as Pii’s Senior Director, Project Management since 2012. In that role, Devan played a key role in Pii’s development and commercial programs for 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.

Brian Braxton PhD Senior Director Aseptic R&D

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 PhD Senior Director R&D

Sundeep Sethia, Ph.D.
Vice President, 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.

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 coursework in Pharmaceutics at the University of Sciences, Philadelphia, Pennsylvania.

Irina Prudnikova new

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 customers 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.

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 soft gels) and Generic Abbreviated New Drug Applications (tablet, hardgel capsule, soft gel 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, Ph.D., MD
Principal Scientist

Peng Zhang is a Principal 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 R&D activities for aseptic products since 2019, including early formulation development, process development, technology transfer, and submission support of IND, NDA, and ANDA, etc. 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 several approved genetic drug launches. She has strong research experience and broad background in drug discovery, especially in anticancer, antivirus and addiction treatments.

Dylan Amig

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.

Rahul Mehta

Rahul Mehta, MSc
Associate Director, Analytical R&D

Rahul Mehta joined Pii in November 2022 as an Associate Director, Analytical R&D. He leads the Analytical method validation team. Rahul has more than 20 years of experience in the pharmaceutical industry. Rahul previously served at Zydus Cadila Healthcare Limited, Lupin Limited, Pfizer Pharmaceuticals India, and Amneal Pharmaceuticals (India/US) with increasing responsibilities. He has expertise in analytical method development and method validation/verification/transfer activities while providing analytical CMC support for regulatory filing and approval. He has a good understanding of, and exposure to, regulatory requirements for phase-appropriate NDA and ANDA submissions. He also has experience in both drug substance and drug product development analytical support for generic and branded products of various therapeutics. Rahul received his Bachelor’s and Master’s degrees in chemistry from Sardar Patel University, India.

Fei Cai photo

Fei Cai
Senior Scientist, Formulations R&D

Fei Cai joined Pii in September 2022 as Senior Scientist of Formulation R&D. Fei has 16 years of experience in formulation R&D in the pharmaceutical industry. He held formulation roles of increasing responsibility in solid oral, soft gel, and sterile products at Prinston Pharmaceutical, ThermoFisher (Patheon), Impax, Endo, and Amneal, in the areas of formulation development, process development, tech transfer, regulatory filing, FDA inspection, product launch, and contract services. Fei earned a Master’s degree in Chemistry from Princeton University.

Alex Borodin

Alex Borodin, DBA
Senior Director of Supply Chain

Alex Borodin joined the Pii in February 2023 as a Head of Supply Chain Management. He leads the team in scheduling, materials planning, procurement, batch records creation, and materials sampling, transportation, and warehousing. He previously held supply chain leadership roles at Catalent Gene Therapy, Balchem, and Kerry Ingredients. Alex holds a doctorate degree from Colorado Technical University with a concentration in Supply Chain Management, MBA, from Keller Graduate School of Management, and Bachelor of Science degrees in Industrial Management and Accounting from Purdue University. He is also a certified Management Accountant, Supply Chain Professional, and Project Management Professional. Alex enjoys sharing his professional experiences by teaching supply chain and operations management courses at Colorado Technical University.

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