LIVE NEWS: CPHI North America

CDMO Insights at CPHI North America

“After approval, don’t miss out – plan change the order early for accelerated paths’

A postal admission Change the order is often necessary, but innovators should plan and prepare for this pre-approval. Planning in conjunction with outsourcing partners helps ensure that only a small study is required – not a new full clinical trial.

In a keynote session at CPHI North America, Stephanie Gaulding, Executive Director of Regulatory Compliance at Pharmatech Associates, urges innovators to take a close look at the frameworks they agree to and work with an experienced advisor to address future product development challenges reduce clinical phases.

The drug pipeline contains an increasing number of rare disease indications and rare diseases with smaller batch volumes and accelerated treatment pathways – which together mean that both innovators and CDMO have a greatly reduced time to work on optimal treatment pathways. Gaulding explains that preparation for this work begins after approval before signing with a CDMO, as this framework will be invaluable for future improvements.

“With a compressed timeline, it’s very likely that further refinement will be required after approval, but innovators need to accept this as part of the strategy and possibly run parallel programs in later development – one for approval and one for post-approval process improvements. For this to work smoothly, a good communication and governance framework is essential so that the drug sponsor and outsourcing partner know what the issues are and what post-approval remedial actions are planned.” said Gaulding.

The goal of the planning process is to ensure that any future change order can be fulfilled in the shortest possible time — ideally in just 30-45 days — and one approach to mitigating risk, Gaulding says, is to focus on one or two markets initially, rather than focusing on to adopt a multi-market entry-level model.

“They want to plan for change and minimize future complexity. So if you have expedited routes in multiple markets and they classify a single post-approval change differently, the situation becomes more difficult to execute post-approval. Nothing is insurmountable when you plan it sequentially, but the innovator often needs to have detailed plans up to a year after approval to outline the manufacturing improvements to get a fully optimized process – whether it’s improving yield or impurity profiles or reduction of the cycle time” said Gaulding.

When questions arise, the drug sponsor needs to be able to work with its partner to get the data quickly to respond to regulatory inquiries. Therefore, setting up the framework and incorporating it into agreements is crucial.

CPHI North America, the ONLY end-to-end pharma event in America, welcomed thousands of attendees and hundreds of companies at the Pennsylvania Convention Center this week (May 17-19, 2022). Additionally, the online learning and networking SMART event will run throughout May (9-27), with on-demand sessions available.


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About CPHI

CPHI drives growth and innovation at every step of the global pharmaceutical supply chain, from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPHI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global marketplace. CPHI hosts events in Europe, Korea, China, India, Japan, Southeast Asia, North America, and the Middle East and Africa. Cooperation with ICSE for contract services; P-MEC for machines, systems & technology; InnoPack for pharmaceutical packaging; bioLIVE for Biopharma; and finished dosage formulation for every aspect of the finished dosage supply chain. CPHI offers an online buyers and suppliers directory at

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CPhI Japan (April 20-22, 2022 at Big Sight Exhibition Center – Tokyo, Japan); CPhI North America (May 17-19, 2022 at the Pennsylvania Convention Center, USA), Pharmapack Europe (May 18-19, 2022 at Paris Expo, Porte de Versailles – Hall 7.2, Paris); CPhI & P-MEC China (June 21-23, 2021 at SNIEC – Shanghai, China); CPhI South East Asia (19-21 Oct 2022 at IMPACT, Thailand); CPhI, ICSE, P-MEC, FDF, InnoPack Worldwide, BioProduction (November 1-3, 2022 at Messe Frankfurt, Frankfurt); CPhI & P-MEC India (29 Nov – 1 NovSt December 2022 at India Expo Mart, Greater Noida, Delhi NCR – Delhi, India)

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