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2018 Parenteral outlook

corresponding

RICHARD M. JOHNSON
President/CEO, Parenteral Drug Association

Abstract

Richard M. Johnson has been President and CEO of the Parenteral Drug Association in September 2009. He has been an active member of PDA, serving on the SAB (co-chair); Regulatory Affairs Quality Control committee; Sterile/Aseptic Processing Interest Group (chair); Aseptic Processing committee (co-chair); GMP and Glass Defects (Chair) Task Forces. 

In his more than 35 year career in the pharma and medical devices industry, Richard has been a recognized leader with excellent knowledge of US and international regulatory requirements, quality practices, and technical operations, especially in validation, sterilization, aseptic and sterile processing. 

Prior positions include VP of Global Quality Assurance for Fort Dodge Animal Health (a division of Wyeth), Director of the Corporate Quality Center of Excellence for Abbott Laboratories, and both US and International assignments with Alcon Laboratories and Bausch&Lomb


2018 will be an eventful year for parenteral manufacturing, on several fronts: market, manufacturing technology, and regulatory requirements. Parenterals include a wide variety of products: small volume, small molecule products; large volume parenterals; ophthalmic products; vaccines; biological therapies; and a growing number of cell and gene therapies (ATMPs). What they all have in common is that they are required to be sterile, and this requirement, in addition to other safety, efficacy and quality requirements, make this category of products among the most difficult to manufacture.

MARKET
Parenteral products have never been more critical, and both quantity and value are increasing. In large part this is due to the continuing increase in the number of biologic products entering the market. In the last five years the number of biologic product approvals has increased, and account for the majority of the top ten pharmaceuticals in terms of sales. Diseases such as diabetes are on the rise globally, which require more and more patients to have access to parenteral therapies. With the advent of biosimilars being approved in many markets, the ...




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