Welcome to the 2023 Biotechnology Conference

Jun 26, 2023 9:00am ‐ Jun 26, 2023 9:20am

Ireland - Enabling Biotech Innovation and Future Success

Jun 26, 2023 9:20am ‐ Jun 26, 2023 9:45am

Patient Access Through Innovation

Jun 26, 2023 9:45am ‐ Jun 26, 2023 10:10am

The talk will provide an overview of key initiatives in EU to facilitate the use of advanced manufacturing methods and recent experiences.

Future Biotech Portfolio: Challenges in Translating Biotech Innovation into Viable Therapeutics

Jun 26, 2023 10:10am ‐ Jun 26, 2023 10:35am

Over the last few decades, we have seen incredible innovation in different types of therapeutic modalities. Cell and Gene therapies encompass many diverse approaches. Added to that are Live Biological Products (Microbiome) and increasingly complex combination approaches. The challenges facing biopharmaceutical manufacturing groups is how to translate this landscape into processes and supply chains that can support product registration and commercial supply.

Keys to Realising the Full Potential of Advanced Therapies

Jun 26, 2023 11:00am ‐ Jun 26, 2023 11:25am

As the advanced therapies landscape continues to evolve, with the ever increasing number of new cell and gene therapy products being evaluated along with anticipated regulatory approvals on the rise, how can we enhance delivery of these transformational treatments to patients? Cynthia will discuss various levers, each critical to success, including process, technology, people, systems and infrastructure.

Our journey from MANUfacturing to SMARTfacturing!

Jun 26, 2023 11:25am ‐ Jun 26, 2023 11:50am

Smart manufacturing capabilities in biotechnology and Life Science industries are revolutionizing the way products are developed, manufactured, controlled, and supplied to customers. By harnessing the power of advanced data analytics, Artificial Intelligence, Industrial Internet of Things and Automation, Smart Manufacturing enables companies to streamline and optimize their manufacturing processes, reduce costs, speed up Time to Market while continuously ensuring high-quality products and services and an increasing the impact on our shared sustainability goals. In this presentation Michelangelo will talk about Merck’s vision, ambition, approach, and roadmap from ManuFacturing to SmartFacturing including tangible use cases and their respective benefit.

The Importance of Manufacturing in the Development of Advanced Therapies

Jun 26, 2023 11:50am ‐ Jun 26, 2023 12:15pm

Gene therapy offers tremendous promise for the treatment of both rare and common diseases. Despite initial successes, growth of the field has been slower than predicted. By leveraging characteristics that products have in common whenever possible, by intensely focusing on manufacturing, by maximally employing expedited development pathways, and by fostering international collaboration, FDA hopes to accelerate the pace of bringing advances to the benefit of patients.

PFAS REACH Restriction – A Potential EU Ban on Use of Fluoropolymers

Jun 26, 2023 12:15pm ‐ Jun 26, 2023 12:30pm

The European Chemicals Agency (ECHA) is proposing a REACH Restriction, or a ban on the manufacture, placing on the market, and use of per- and polyfluoroalkyl substances (PFAS) potentially as early as 2027. These so-called ‘forever chemicals’ are substances of concern, due to persistence in the environment. At least 10,000 substances including fluoropolymers fall within scope of the Restriction, making it the most complex ever proposed in the EU.

There are multiple applications of fluoropolymer containing plant, equipment, consumables in pharmaceutical manufacturing. For example, PFA (Perfluoroalkoxy alkanes) are chemically inert, stable and of very high purity which means they are used extensively in biomanufacturing processes. Other types of fluoropolymers provide corrosion protection against aggressive process solutions, for this reason extensive PTFE (polytetrafluoroethylene) lined pipework and components are found in chemical synthesis facilities. Pharmaceutical sector use of fluoropolymers in process installations, equipment and consumables is not listed nor evaluated in the proposed Restriction. During a six-month public consultation period, which opened on March 22nd stakeholders must engage and provide supporting evidence for derogations.

The briefing will give you an overview of the proposed REACH restriction regulatory process highlighting the critical urgency for the sector to mobilise to seek relief from the proposed ban on the use of fluoropolymers. This is a call for action, as EU manufacturing facilities would not be able to function without fluoropolymers and if these facilities are global suppliers of APIs (active pharmaceutical ingredients), supply chains of medicines will be put at risk.

Message from the Programme Chair

Jun 26, 2023 12:30pm ‐ Jun 26, 2023 12:40pm

The Digital Conundrum

Jun 26, 2023 1:30pm ‐ Jun 26, 2023 2:00pm

In today’s world, data and digital tools can be transformative for industries and organisations with digital threads of data that span the product lifecycle and beyond traditional organisation boundaries. BioPhorum’s Digital Technology Roadmap sets out the challenges and identifies the key enablers for organisations to tackle to unlock the potential of digital. Members of both the Technology Roadmapping group and the IT group share examples of where they are collaborating, and concrete examples of solutioning that is scalable. These solutions enable progress for the industry as a whole, encompassing considerations for all aspects of development from raw material to product, for the future of the industry.