ISPE Singapore Affiliate Conference and Exhibition – 2022 Highlights
The ISPE Singapore Affiliate 2022 Conference and Exhibition is a WRAP! I was fortunate to chair both the pre-conference symposium opening plenary and the ‘Post Pandemic Transformation’ track.
Paul A. Gustafson
The opening plenary (17 August, online) began with Regulatory Keynote from Paul Gustafson, GMP Inspection Supervisor, Health Canada & Chairperson, PIC/S. Paul delivered a powerful message on how the harmonisation efforts of PIC/S are improving both time to market and patient safety. The long-awaited EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products was also discussed, which will take effect next year. By taking advantage of the new ICH Q9 and C10 guidelines, Annex 1 will update the industry for quality management systems. Additionally, Annex 1 harmonizes with the WHO and PIC/S scheme for sterile drug manufacturing.
The next track session on ‘Future Proofing Hybrid Inspections’ by Jenny Hantzinikolas, (Director, Inspection Section, Manufacturing Quality Branch, Australian Department of Health (TGA), provided an insightful look into how regulators have had to pivot to an online model seemingly overnight. While the pandemic did bring on a rush of innovation, as Jenny pointed out, even when going back to the office, some of the benefits from the online model can remain. In the future, we can expect a blended model that takes the personal touch of in-person inspections with the efficiency of a hybrid model.
No stranger to ISPE Singapore, Bob Tribe (Asia Pacific Regulatory Affairs Advisor, ISPE) hosted the ‘Global Regulatory Panel: International Collaboration & Reliance’ with Paul, Jenny, Dr. Joey Gouws (Team Lead, Inspection Services Prequalification Unit (PQT), World Health Organisation (WHO), Switzerland) and Chong Hock Sia (Director (Quality Assurance) & Senior Consultant (Audit & Licensing), Health Products Regulation Group, Health Sciences Authority, Singapore). In a continuation from Paul’s talk on international collaboration, the panellists echoed the renewed spirit of partnership both at the regulatory and manufacturing level. This co-operation is also facilitated through the use of digital tools and a joint effort in the name of patient safety.
The last session of the opening plenary on ‘Stakeholder Collaboration: The Race to Market, Achieving Accelerated Scalability & Quality’ was chaired by Dr. Georg Singewald (Global Head MSAT & Engineering, Roche/Genentech, Switzerland; Asia Liaison & International Board Director, ISPE). The panel comprised of Dr. Oliver Schläfli, (SVP, Head of Global Quality, Lonza, Switzerland), Dr. Ganapathy Mohan (Executive Director, External Advocacy and Strategies, Merck & Co & ICH Q13 EWG, USA), and Kristian Kinscher (Partner, McKinsey, Germany). This session highlighted key insights on how manufacturers may utilize both existing and new technology to maintain patient safety while ramping up production. Reflecting the previous regulatory panel, no longer can organizations work in silos but with the global networks to develop best practices.
Following the online pre-conference Symposium, the Main Conference returned in-person at Suntec Singapore and was livestreamed online from 18-19 August.
During the ‘Post Pandemic Transformation’ track, Dr. Songpong Deechongkit (Managing Director, Siam Bioscience Co., Ltd, Thailand) identified vaccine collaboration models that helped deliver medicine on time safely. Partnering with key stakeholders throughout the supply chain, in this instance, AstraZeneca, improved both time to market and vaccine reliability.
In ‘ASEAN Manufacturing for the Future: Addressing Sterile Manufacturing with Global CDMO’, Selva G (General Manager, Thermo Fisher Scientific, Singapore) detailed strategies for COVID, critical therapeutic medicines, and future pandemic planning. One key takeaway is that technology and digital systems are cornerstones to this strategy. Organizations now must be fast and flexible in their approaches to keep up with market demands.
Concluding the track was a collaboration panel on ‘Industry - Regulator - External CMO/CDMO’ moderated by Vee Revithi (Senior Consultant to Pharmaceutical Regulatory Authorities on GMP, GDP; Greece) with panellists Vivian J. Arencibia (Vice President, Global Quality Systems & Compliance, Moderna, International Board Director & Co-Chair, Women in Pharma, ISPE, USA), Do Tuan Dat (President, Vabiotech, Vietnam) and Dr. Songpon. This examined the changing relationships and new ways to collaborate to expedite supply of medicines to patients. The hybrid approach for on-site and online methods reinforced the advice given by the regulatory panel. The best way going forward will be to use a combination of both going forward.