CRO Catalent Pharma Solutions has joined the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), a consortium of companies involved in the development, manufacture, and marketing of OINDPs, whose mission is “to advance scientifically driven approaches to enhancing product quality of inhaled and intranasal drug products.” Other IPAC-RS members include 3M, AstraZenaca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mannkind Corporation, Merck, Novartis, Pfizer, Teva, and Vectura.
IPAC-RS Chair Jackie Schumacher (Pfizer) commented, “We are delighted to welcome Catalent into the Consortium. Catalent’s work in the orally inhaled and nasal drug field, combined with its interest in contributing constructively to IPAC-RS’ strategic initiatives, will be an asset to the Consortium. Catalent shares IPAC-RS’ goal of advancing consensus-based, scientifically driven standards and regulations for orally inhaled and nasal drug products, and facilitating the availability of high-quality, safe, and efficacious drug products to patients. Catalent’s decision to join IPAC-RS also highlights the recent strategic Consortium goal of encouraging a broader and diverse number of companies that develop, manufacture or market orally inhaled and nasal drug products to join IPAC-RS. This engagement occurs at a time when the Consortium is expanding the scope of its initiatives beyond developed markets and focusing on advances in emerging markets.”
Catalent VP of Pulmonary and Nasal Development Dean McKinney explains the decision to join the consortium: “We have a strong history in inhalation built around our talented team of scientists, who have experience gained from supporting numerous inhaled products and dosage forms available on the market today. It is this talent and experience we hope to share with the industry at large for the advancement of patient treatments through active participation in IPAC-RS.”
With Catalent acknowledging IPAC-RS as “the leading resource and advocate of OINDP industry,” McKinney adds, “Catalent looks forward to this opportunity to assist in shaping the business and regulatory environment through collaborative workshops, expert roundtables, training classes and working groups aimed at tackling technical issues.”
Read the Catalent press release.