Posts

2019 ISPE European Conference: Key Takeaways

/in /by

Last week BPE attended the sold out 2019 ISPE European Conference in the Clayton Hotel, Burlington Road, Dublin where over 700 industry professionals attended over the few days. The key theme for this years event was “Driving and Leveraging Innovation for Pharma”.  Below we have gathered some of the key takeaways from number of  industry speakers who shared their insights at the conference:

Speaker: Pam Cheng, Executive Vice President – Global Operations & IT, Astra Zeneca.

Key takeaways:

  • New demands on innovation as health systems worldwide increase their scrutiny on value to address rising costs
  • Investment in new digital solutions to solve research, development and access challenges and drive differentiation in the market
  • Breakthroughs in digital and technology are redefining society and the practice of medicines
  • AstraZenca global operations is shaping the factory of the future-3D printing of tablets in the future , Predictive and prescriptive analytics , Digital twins – get to a robust process much faster / accelerate the design of new drug’s process, Voice-directed technology – changeover with headset – operator will be guided through the procedure – clear instructions, fewer errors  and Connected drones – to inspect the facilities

Speaker: Chris Chen, CEO, WuXi Biologics.

Key takeaways:

Building Biologics Facilities of the Future in Ireland.

  • Flexible – can handle fed-batch, concentrate fed-bath, or perfusion processes and can handle low-titer and high-titer process
  • State-of-the-art – leverage best disposables and stainless steel, high automated, and PAT and data analytics incorporating Industry 4.0
  • Modular – not to scale up but scale out
  • Cost competitive – enable penetration of biosimilars and biologics in emerging countries

 

Speaker: Olivier Loeillot, General Manager BioProcess, GE Healthcare Life Sciences

Key takeaways:

  • More agility and efficiency in manufacturing
  • Optimal process for fragmenting markets
  • Supply chain has to be robust

Industry Challenges:

  • Capex Investment: Considerable investment is required while a molecules likelihood of success is still low
  • Time to market: It takes 12 years on average for a drug to go from concept to market
  • Small batch sizes:Small batch sizes are more common, driven biosimiliar production, personalized medicine and higher MAB titter

 

Speaker: Brendan O’Callaghan, SVP & Global Head Biologics Platform, Sanofi.

Key takeaways:

  • Multi-targeting molecules
  • In-house developing model (formerly nearly only external partner for biologics)
  • Investing in internal capacity & capabilities
  • Expanding capacity through strategic partnerships (selected partner, gives flexibility, the opportunity to scale-up)
  • Preparing the future through innovative technology platforms (next generation of biologics, integrated continuous manufacturing – with small reactors – reduction in footprint – fully paperless)

 

Speaker: Thomas Wozniewski, Global Head of Operations Takeda, Shire

Key takeaways:

4 major industry trends:

  • Trend #1: Changing technologies
  • Trend #2: Drug product & device combination
  • Trend #3: Changes in the regulatory framework result in shorter development time – fast track approvals.  Reduced development time through fast track/priority review designation. Trend to personalized medicines reduces approval timelines but reduces scale from one batch for may patient down to one batch per patient
  • Trend #4: Environmental sustainability matters!

 

BPE is actively welcoming new clients and projects and would be delighted to discuss how we can help you with any of the above. View our similar 2019 trends post here To arrange a call back at your convenience or to organise a meeting click here