Pharma Focus Asia

Shaping the Future of Pharmaceutical Manufacturing

Trends, Technologies and Beyond at ISPE Singapore

International and Regional Bio/Pharma meets online / in-person at Suntec Singapore this month.

Following its biggest gathering post-pandemic, ISPE Singapore Affiliate’s highly anticipated annual meeting reflects the energy and positive growth for the industry in Asia Pacific. Each year, the show provides an extraordinary opportunity for professionals in the bio/pharmaceutical and related industries to gather, learn, and exchange insights on the latest trends and advancements. The Conference runs alongside the sold-out Exhibition, packed with over 90 leading companies offering the spectrum of expertise from aseptic to digital solutions!

Annual Symposium + Main Conference

Now into its 23rd edition, the 3 day event kicks off with an online pre-Conference Symposium on 23 August. This is followed by the Main Conference, held in-person from 24-25 August at Suntec Singapore. True to its mission of ‘Connecting Pharmaceutical Knowledge’, the conference will also be livestreamed and available on-demand for 6 months afterwards.

Under the theme of "Shaping the Future of Pharmaceutical Manufacturing: Trends, Technologies and Beyond," the conference features over 90 distinguished speakers including 12 Keynotes. Spanning global to regional biologics, vaccines and pharmaceutical manufacturers, CDMOs, regulatory authorities and industry leaders, highlights include:

  • Latest updates from 8 Regulatory agencies: EMA, PIC/s, WHO, HSA, ANSM, Philippine FDA, DRAP Pakistan & Malaysia’s NPRA
  • Case study insights from Bio/pharma manufacturers including Pfizer, Amgen, Merck & Co, MSD, Lonza Biologics, Bayer, LOTTE BIOLOGICS, AstraZeneca, Genentech, WuXi Biologics, Moderna, Takeda, Thermo Fisher, GSK and more.

ISPE Singapore Conference & Exhibition

23-25 August | Online & In-person @ Suntec Singapore

Full programme & registration details: www.ispesingapore.org1

Attendance is by registration and open to ISPE Members and non-Members alike. This year, non-Members benefit from 1 year’s ISPE membership included when they register!

This year’s symposium & programme tracks comprise extensive in-depth coverage on digital transformation / pharma 4.0, digital CQV, regulatory & compliance, quality, advanced manufacturing and ATMPs, Annex 1, CCS, GAMP5, sustainability and supply chain amongst others. Extended panel discussions revolve around hot topics, including innovating for speed-to-market, tackling drug shortages, challenges and opportunities working with CDMOs, mRNA vaccines development and beyond.

Regulators & Industry on Drug Shortages

5, yes 5 Keynote speakers open the online Pre-conference Symposium; from both regulatory agencies and industry. Hear from Pfizer, Amgen & Merck and regulators from ANSM/PIC/s & EMA. Coming together in a live Global Panel discussion, they will address ‘Regulatory, Policy & Industry Approach to Combat Drug Shortages’. Diane L Hustead, Executive Director, Regulatory Affairs, Merck & Co, Inc, & Drug Shortage Initiative Team Chair, ISPE, USA will moderate this online session.

Industry Best Practices

Following the plenary, two concurrent tracks focus on A: Industry Best Practice, sponsored by Fedegari and B: Digital Transformation, sponsored by Lachman Consultants.

Keynote speaker, Dr Joerg Block, GMP Compliance Engineering, Bayer AG Pharmaceuticals, Germany will present on ‘Good Engineering Practice: Accelerating Project Delivery‘. Case studies range from HPAPI biomanufacturing, CIP Operation and single-use for mRNA to good engineering practice. Discussion on ‘Applying Good Practices for the Project Life Cycle’ conclude this track.

Visionary Panel: CDMOs, Regulatory & Compliance

ISPE President & CEO, Thomas B Hartman will grace ISPE Singapore Affiliate’s annual conference for the first time this month. He will moderate the Opening VISIONARY PANEL: Biotechnology Industry Challenges and Opportunities Working with Contract Development & Manufacturing Organizations (CDMO’s).  Global and regional regulators are well represented, culminating with the in-person ASEAN REGULATORY ROUNDTABLE: How Regional Regulatory Agencies are Adopting Global Standards.

Global & Regional Regulatory Agencies:

Keynote Speakers:

Jacques Morenas, Chair, Training sub-committee, PIC/s & Technical Advisor, Inspection Division, ANSM, France

Andrei Spinei, Manufacturing Team Lead, Inspections Office, Quality and Safety of Medicines Dept, European Medicines Agency, Netherlands

Chong Hock Sia, Director (Quality Assurance) & Senior Consultant (Audit & Licensing), Health Products Regulation Group, Health Sciences Authority, Singapore

Vimal Sachdeva, Senior GxP Inspector, WHO, Switzerland

Jesusa Joyce N. Cirunay, Director IV, FDA Center for Drug Regulation and Research (CDRR), Philippine.

Abdul Mughees Muddassir, Assistant Director to CEO, Drug Regulatory Authority of Pakistan (DRAP)

Dr Noraida Mohamad Zainoor, Deputy Director, Centre of Compliance and Quality Control, National Pharmaceutical Regulatory Agency (NPRA), Malaysia

Manufacturing Trends

On 24th August, Keynote speaker Takashi Kaminagayoshi, Head, Biotherapeutics Process Development, Pharmaceutical Sciences, Takeda Pharmaceutical Co Ltd, Japan will expand on ‘Global Engineering Standards for Biopharma Manufacturing’. Additional highlights include: CDMOs outlook, aseptic filling platform technology and a discussion on ‘Innovating to Gain Speed to Market’.

Held in-person, this track in the Main Conference is sponsored by Yokogawa, which hosts a deep-dive ‘Lunch n’ Learn’ workshop on ‘Digital Transformation Toward Smart Manufacturing’ earlier in the day.

Digital Transformation

This year’s call for presentations yielded a majority under Digital Transformation. Unsurprisingly, given the prevalence and influence of technology in both our work and personal lives. Undoubtedly spurred by necessity during the pandemic, it is significantly impacting and expediting this industry into digitalisation and virtual work practices.

Fundamental to this evolution, ISPE’s GAMP® CoP2  (Community of Practice) has been prolific in disseminating pragmatic guidance on the use of computerised systems in regulated industries without which DT could not happen. Instrumental in this arena is Charlie Wakeham, Global Head of Quality and Compliance, Magentus & Co-Chair, ISPE GAMP Global Steering Committee and Lead, ISPE GAMP CSA Special Interest Group. Her online discussion entitled ‘How does GAMP5 Revision Impact the Industry?’ appears in the ‘Digital Transformation’ track. Held online, presentations such as ‘No-Code GMP Apps: Has Paper Finally Met its Match?’, ‘The Nexus: Data Integrity & Pharma 4.0’, and ‘Digitalisation in Predictive Maintenance’ are discussed.

Charlie will be onsite in Singapore for the launch of the GAMP® South Asia CoP. and lead an interactive workshop on ‘Applying Critical Thinking in Computerised Systems Projects’. Key supporting companies, CAI, NNIT, No deviation and PQE will host an onsite GAMP® Quiz in conjunction with recruitment of members to this new Community of Practice.

The importance of Digital CQV is reflected as a track, sponsored by No deviation. Featuring presentations by experts on ‘Transition & Implementation Strategies for Digitising C&Q’, Digital CPV and a discussion on ‘C&Q Digitalisation’.

Hosted by NNIT on 25 August, the Digital Transformation/Pharma 4.0 theme continues with sessions encompassing innovation, advanced therapies, smart manufacturing, digital twins and sustainability. Keynote speakers Richard Lee, Chief Executive Officer and Member of the Board, LOTTE BIOLOGICS, Korea & Meli Gallup, Director, Global MSAT Commercial Product, Genentech, USA precede a Digital Pharma Discussion tackling ‘Challenges to Digital 'Emancipation' (Freedom)’.

Advanced Manufacturing / ATMPs

Rounding off the Main Conference, the Advanced Manufacturing/ATMPs track opens with a Keynote by Dr Jerry Yang, CTO & Head of TechOps, Fosun Kite Biotechnology Co Ltd, China. This is complemented by talks on QdD, multimodal ATMP facilities etc are discussions on ‘Reliability in Continuous Manufacturing’ and ‘Key Strategies in Supply Chain Resiliency’.

View all Speakers & the full Symposium/ Conference Programme on www.ispesingapore.org3

Over the 3 days, spanning from aseptic / sterile, single-use, multi-modal, flexible or continuous manufacturing and more, speakers will share their experience alongside the latest updates and developments.

Whether in-person or virtually, the ISPE Singapore Annual Meeting offers a great opportunity to network with peers, engage in meaningful discussions, and explore innovative solutions in the pharmaceutical landscape.

On-Site Exclusives Open to all: Free Workshops & ‘Power Hour’ Talks

Taking place alongside the main conference and exclusively for all who join in-person, 22 open-access satellite workshops will further facilitate knowledge sharing among attendees. Each hour-long session provides in-depth coverage on a wide range of topics, complementing and adding to the conference. Each led by industry subject matter experts, workshops are open to both conference attendees and visitors.

Concurrently, this year’s expanded exhibition showcases the largest gathering of leading product, technology and service providers. Visitors may also attend the ‘Power Hour’ programme of 32 talks held daily at participating exhibitors’ stands. The schedule of workshops, Power Hour talks and associated onsite events can be viewed on the event site www.ispesingapore.org4

Outreach & Networking Opportunities

ISE’s community of volunteers reaches across manufacturing industry professionals, with student engagement to executive mentoring programmes. The Singapore affiliate encourages students and Emerging Leaders locally and from the region, with the Hackathon competition held online, resulting onsite with final presentations. Results are announced during Pharmanite on 24th August.

Women in Pharma are well represented, gathering for a Roundtable Lunch discussion on multiple topics, each table featuring an inspiring host. This takes place on 25th August, with the Emerging Leaders Networking reception providing an informal celebration to conclude the event.

Pre-event Commissioning & Qualification Training & Site Tours

ISPE Commissioning and Qualification Training Course – 22 & 23 August 2023

For the first time in this region, ISPE Global training offers participants an accessible and affordable onsite course on:

Science and Risk-based Commissioning and Qualification - Applying the ISPE Baseline Guide, Volume-5, Second Edition: Commissioning and Qualification (T40)

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

Registration & details can be found at www.ispesingapore.org to Schneider Electric Singapore’s Innovation Hub & Merck’s M Lab™ Collaboration Center provide a great opportunity to view state-of-the-art facilities and experience technology hands-on.

Last year’s ISPE Singapore affiliate Conference & Exhibition drew a record 1,300+ participants, with returning regional delegates and visitors expected to boost this year’s attendance.

With a packed schedule of events lined up, the stage is set to maximise learning and collaboration among regulatory agencies, manufacturers, and technology and service providers. The committee appreciates the support from the community and looks forward to welcoming the industry to Singapore this August!

Exclusive Offer for readers:

Register for the Symposium/Conference with discount code PHARM10 to save an extra 10% off prevailing rates.

ABOUT ISPE

The International Society for Pharmaceutical Engineering is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. www.ispe.org

ISPE Singapore Affiliate since 2000 has over 300 Active Members and over 3,000 supporters predominantly in Singapore and the region.

References:

1 http://www.ispesingapore.org/
2 https://cop.ispe.org/forums/community-home?CommunityKey=ed72d220-cd9e-4ba9-87c2-a4b3623e5ca5
3 http://www.ispesingapore.org/
4 http://www.ispesingapore.org/

--Issue 52--

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