1. Introduction
As we emerge from COVID-19, we reflect upon the impact of long-term changes to healthcare and specifically the bio / pharmaceutical industry. In the race to deliver medicines and treatments amidst global lockdowns, what strategies, operations and practices enabled or hindered our response? How rigorous, agile and prepared are our processes and technologies to equip us for future pandemics?
2. BioPharma growth in Asia
BioPharma growth forecasts for Asia remains upbeat, with growth within the Asia Pacific region anticipated to hit high single digits to low double digits year on year. Post-pandemic, the development of COVID-19 therapeutics and vaccines continues to be a key driver for mRNA technologies. Digital transformation and increased management of external providers, such as CDMOs, continue to be of focus.
Meanwhile, methods of pharmaceutical regulatory inspection are in flux, as regulatory bodies implement hybrid inspections. These trends lend a highly dynamic backdrop for the growth conditions of BioPharma in Asia.
3. Role of ISPE for BioPharma growth
Against this rapidly evolving environment, the International Society for Pharmaceutical Engineering (ISPE) continues its mission, to connect knowledge from various parties, including regulators, subject matter experts, and key decision- makers.
As a non-profit organisation with over 40 years of industry leadership, the ISPE is well positioned to progress in key strategic focus areas. These include manufacturing, innovation, supply chain excellence, operational excellence, regulatory and compliance.
4. How ISPE provides insights on BioPharma growth
From digital transformation efforts, to navigating regulatory inspections post- pandemic, and to BioPharma-specific growth strategies, ISPE and its relevant stakeholders continue to provide valuable insights on key contributing factors in BioPharma growth.
In Asia, ISPE Singapore Affiliate’s annual conference is well positioned to offer unique and high-level learning and networking opportunities. This year's theme should be no surprise: “Collaboration | Transformation | Digitalization”.
Delivered as a hybrid event, whether onsite in Singapore or online, expect more quality, breadth and depth of knowledge, insights and expertise alongside in-person and virtual networking options. Understanding ever-pressing demands on time, all Symposium and Conference content is provided on-demand for 6 months post-event.
The affiliate’s last onsite, in-person event in 2019 attracted a record 1000+ participants, while online editions in 2020-2021 grew to over 980 attendees. This strong presence of pharmaceutical manufacturers was supported in equal measure by regulators, EPCM, and various other stakeholders and service providers.
As above, industry support by itself is a testament to the quality. After the prolonged hiatus, the event promises better, newer, and more value-packed beyond three-days. The team welcomes online and onsite participants and is confident that the event will generate great learning value for attendees.
Conference highlights
Wednesday 17 August | Pre-Conference Symposium | ONLINE
The 2022 ISPE Singapore Affiliate Conference and Exhibition kicks off with a pre-conference Symposium, delivered online only. The opening plenary addresses global regulatory and industry concerns, including the key themes:
Collaboration | Transformation | Digitalization
Keynote and senior regional regulatory agency speakers include:
- Paul Gustafson, GMP Inspection Supervisor, Health Canada & Chairperson, PIC/S
- Dr Joey Gouws, Team Lead, Inspection Services Prequalification Unit (PQT), World Health Organisation (WHO), Switzerland
- Jenny Hantzinikolas, Director, Inspection Section, Manufacturing Quality Branch, Australian Department of Health (TGA); Australia
- Chong Hock Sia, Director (Quality Assurance) & Senior Consultant (Audit & Licensing), Health Products Regulation Group, Health Sciences Authority, Singapore
Discussions revolve around ‘future-proofing’ hybrid inspections, international regulatory collaboration & reliance. These will be followed by a Stakeholder Collaboration Panel comprising:
- Dr Georg Singewald, Global Head MSAT & Engineering, Roche/Genentech, Switzerland; Asia Liaison & International Board Director, ISPE (Moderator)
- 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
- Kristian Kinscher, Partner, McKinsey, Germany
‘Ask The Expert’ Live Q&A sessions ensue, with 2 afternoon tracks on ‘Quality’ & ‘ATMPs, Aseptic Processing & Annex 1’
Thursday 18 & Friday 19 August | Main Conference
Onsite @ Suntec Singapore | Livestreamed online
TRACKS:
- Post Pandemic Transformation
- Regulatory & Compliance
- Digital Transformation
- Paperless CQV
- Scaleability, Speed & Flexible Manufacturing
- Advanced Manufacturing
Exclusive Onsite Workshops offer a deeper dive into pressing topics, accompanied by the Exhibition and ‘Power Hour’ talks which are open to visitors.
For more details & registration: www.ispesingapore.org