Piotr Bryla, Ph.D., Honored for Excellence in Pharmaceutical Drug Development

    SNOHOMISH, WA, February 04, 2015 /24-7PressRelease/ -- Piotr Bryla, Ph.D., and President of Bryla CMC-Reg Consulting, LLC, has been recognized by Worldwide Branding for showing dedication, leadership and excellence in pharmaceutical drug development.

With a quarter century of industry experience, Dr. Bryla is a seasoned, professional expert in directing clinical and commercial CMC development and operations for global pharmaceutical and biotech companies, as well as worldwide external manufacturing and research organizations. His strength is in pharmaceutical drug development and global CMC regulatory affair (drug substance and drug product) from discovery through commercial launch for small molecular weight, semisynthetic, and monoclonal antibody therapeutics.

Dr. Bryla's duties in his current role are both staggering and impressive. He is preparing CMC electronic regulatory submissions following recent ICH/FDA module 2/3 guidelines, QbD and QbR platforms. Also, he is developing global CMC regulatory affair strategies, and serving as liaison with FDA, EMA and other regulatory authorities. He manages worldwide contract development and the manufacturing network, analytical development and validation, formulation development of highly insoluble compounds and monoclonal antibodies, aseptic and non-aseptic manufacturing processes, upstream and downstream production of BDS, Fill/Finish and other manufacturing drug product operations, tech transfer, process improvement and scale up, supply chain including packaging, labeling and distribution. Finally, he is providing CMC project management, quality control, and preformulation services through partnerships with external state-of-the art lab TeraCrystal.

Also the author of more than 20 scientific publications in scientific literature, as well as numerous internal reports, posters and presentations, Dr. Bryla has previously held positions of increasing responsibility. He was vice president of manufacturing and process development at Lux Biosciences and held CMC management positions at Omeros Corporation, IPM, Barrier Therapeutics, Forest Laboratory, Bayer Corporation, and Hoffmann-LaRoche.

Dr. Bryla has worked on various pharmaceutical dosage platforms for diverse therapeutic areas, including tablets, hard and soft gelatin capsules, topical formulations, vaginal silicone devices, sterile ocular silicone implants, sterile ophthalmic drops, SC and IV injectables and proprietary PharmacoSurgery platforms. He also utilized technologies like micelles systems, spray drying, hot melt extrusion, nano-milling and self-emulsifying drug delivery systems (SEDDS) for highly insoluble compounds to enable in vitro and in vivo drug release.

This distinguished work has brought Dr. Bryla numerous honors, including a Quality Excellence and an Above and Beyond award from the Bayer Corporation and recognition awards from Barrier Therapeutics and Lux Biosciences.

In the future, Dr. Bryla intends to experience continued success and growth in his career. His professional tenure in big, medium, and small pharmaceutical/biotech companies has taken his experience to a new consultancy level. He also intends to continue his charitable work for the hungry and animal rescue.

Dr. Bryla became involved in his profession because he loves drug discovery and pharmaceutical drug development. He is a dedicated pharma/biotech CMC drug developer, and is skilled at working with products from Conception to Marketed Brands. He has worked to create a reputation as a passionate, agile and independent administrator by advancing quality medicine through successful approval. His success comes from his hard work, experience, and education. He completed his post-doctoral fellowship in the pharmaceutical chemistry department at Rutgers University in New Jersey, and received a Ph.D. in pharmaceutical sciences, with honors (1989), and a Master of Science in pharmacy and pharmaceutical analysis (1979), both from the Academy of Medicine, in Lublin, Poland. He was named an Outstanding Graduate Student and MS Manuscript, both in 1979.

Bryla CMC-Reg Consulting, LLC, is a drug product development and CMC regulatory affair consultancy that provides research, spanning many aspects of solid state chemistry and crystal engineering, manufacturing, tech transfer, commercial planning, supply chain, formulation, pre-formulation, analytical development, discovery, and quality system.

About Worldwide Branding
For over 15 years, Worldwide Branding has been the leading, one-stop-shop, personal branding company, both in the United States and abroad. From writing professional biographies and press releases, to creating and driving traffic to personal websites, our team of branding experts tailor each product specifically for our clients needs. We are dedicated to empowering our 600,000 clients with effective branding tools to help them achieve success. From healthcare to finance to education and law, our constituents represent every major industry and occupation, at all career levels.

An international company, we provide our members with access to members in over 52 countries including, the United States, Canada, Australia, the United Kingdom, France, The Netherlands, Germany, Ireland, Spain, Switzerland, South Africa, Belgium, Mexico, Italy, Brazil, Sweden and The United Arab Emirates, just to name a few.

For more information, please visit http://www.worldwidebranding.com.

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