Catalent Announces New Organisation to Speed New Products to Market

Catalent Pharma Solutions has announced that Sharon Johnson, Senior Vice President, Global Quality & Regulatory Affairs, is to head up Catalent’s newly formed Quality, Product Development & Regulatory Affairs organisation, established to further build upon Catalent’s leadership in new product development, regulatory excellence, reliable supply and quality.

One of the key functions of the new organisation will be to focus further on partnering with customers as part of Catalent’s New Product Introduction Excellence programme. An important factor in Catalent’s revenue and growth strategy, the programme has expanded at a rate of more than 70% over the past 3 years, from 59 new product launches globally in 2012, to 97 in 2013, and 175 in 2014.

“The overall goal of the Quality, Product Development & Regulatory Affairs organisation will be to drive excellence and reliability across all of the products that we make and deliver,” explained Johnson. “Our customer promise is not only to provide a reliable supply of their current, ongoing products, but to deliver new products with the same rigorous commitment to excellence. Bringing together these two functions into one team will tighten collaboration and the partnerships across the organisation which are needed to bring more new, innovative and life-saving products to market quicker.”

Ms Johnson will oversee a global function that includes more than 1500 scientists, quality professionals and regulatory affairs experts. Catalent’s 300 R&D scientists work across 20 global development teams to develop up to 500 new products at any one time. Catalent’s Quality and Regulatory Affairs teams have helped the company gain accreditation by over 30 global agencies, to supply more than 7000 products to in excess of 1000 customers. These products are delivered to over 80 countries, with Catalent maintaining a 100% success rate on new Pre-Approval Inspections (PAIs), and a regulatory inspections outcome rate that is two times better than the industry average.

Prior to assuming her new responsibilities, Ms Johnson had served as Catalent’s Senior Vice President, Global Quality & Regulatory Affairs since 2009, having overseen the roll-out of Catalent’s Global Quality Management system to over 20 global sites. Ms Johnson has more than 3 years of experience in the pharmaceutical industry, including API and multiple dosages forms, from discovery and launch of NCEs and life cycle management. Prior to joining Catalent, Ms Johnson served as Vice President of Quality for GE Healthcare’s Medical Diagnostic Division, having previously worked in roles of increasing responsibility for Baxter Healthcare and Sanofi Aventis.