5th Annual Pharmaceutical Innovation & Manufacturing Strategies Leaders’ Summit, 10-11 February 2015, London

5th Annual Pharmaceutical Innovation & Manufacturing Strategies Leaders’ Summit, 10-11 February 2015, London

I attended and spoke at the 5th Annual Pharmaceutical Innovation & Manufacturing Strategies Leaders’ Summit 2015 in London this past week. Many thanks to Nick Williams and the team at GBX Summits for organising such a great and well attended event.

Presentations I attended were:

Pharmaceutical Supply Chain Segmentation

Birk Vanderweeën, VP Global Supply Chain Systems Processes and Analytics at AstraZeneca

Birk presented on how AstraZeneca have been transforming their supply chains to make them deliver even more value to the organisation.  Using three key supply chain leadership drivers, Velocity, Visibility and Variability (the three Vs), AZ have developed a set of supply chain designs for products at different points in their lifecycle and with specific needs.  By implementing a regional packaging model for much of the portfolio, they have managed to split their supply chain to control complexity upstream of packaging and offer the market variation required downstream.  Their focus is now on driving down inventory and improving lead times.

Pre-competitive Collaboration in the Pharma Industry

David Elder, Director of Externalisation, GSK

David presented on the considerations to be taken when deciding how to collaborate or not depending on the type of drug research and development programme.  He outlined the different types of collaboration opportunities that may exist and the factors to consider (e.g. exclusivity) when exploring a collaboration partner.  Finally, he illustrated these opportunities and factors through a number of specific consortiums, tools and collaborations.

How OPEX can improve Supply Chain

Marco Lupo, Director Operational Excellence, Takeda

Marco presented on how Operational Excellence is organised and undertaken at Takeda.  A central team of Master Black Belts are aligned to each operational business unit and support Black Belts at each of the manufacturing sites.  Marco discussed how operational excellence tools can help improve the end-to-end supply chain and illustrated this through a video of value stream mapping at Takeda.

Starting with the end in mind, QbD and supply chain integration to improve the success of Biopharmaceuticals

Jesus Zurdo, Senior Director, Lonza

Jesus presented on how Quality by Design can help in the development of the product to benefit the resultant supply chain.  He outlined how the process for drug product manufacturing evolves through discovery and development and the challenges that often need to be overcome as the process evolves and responsibility is passed between multiple teams.  The presentation closed with views on how the process can be improved via thinking carefully about the targeted product profile.

Operational Excellence – application and innovation within the Pharmaceutical Manufacturing Industry

Matt Moran, Director, IBEC

Matt presented on the pharmaceutical industry in Ireland and how operational excellence is being used as a key differentiator in maintaining Ireland as a competitive location for manufacturing.  He outlined many of the features of the pharma cluster in Ireland that drive competitiveness over and above the low tax rate.  PharmaChemical Ireland run many networking and best practice activities to help reduce opex and improve manufacturing capabilities.

Outlining the final Step in Operational Excellence

James Mackenzie, Commercial Director, HAPA

James presented on what drives complexity in the pharma industry.  As pharma companies grow, the diversity of their product offering results in complexity in their supply chains.  This complexity drives significant amounts of waste in terms of time, materials and equipment utilisation.  Choosing the right equipment is critical depending on the profile of the product, volume and variability required.  Standardisation of packaging formats to speed line changeovers is a necessary enabler to improve OEE.  Where HAPA can provide value is in increasing the agility of the packaging operation.  Print on-line capability helps reduce material inventory and changeover times.

Containment and Barrier Systems in processing and packaging applications for Pharmaceutical Liquids

Klaus Schreiber, Marketing Sales Manager, Bosch

Klaus outlined the suite of capabilities that Bosch provide for filling and packaging of pharmaceutical liquids.  As well as providing a wide array of equipment, they also provide a range of services to help the definition, design, installation and support of customer solutions.  The growth in oncology and bioprocessing products is resulting in increased demand for containment and barrier systems in manufacturing.  This impacts the design of equipment and facilities to meet both GMP and HSE requirements.

Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.  

Andrew Love, VP Capability Development, Be4ward Ltd

I presented on the capabilities a Pharma company needs to consider to ensure it has a sustainable end-to-end artwork and labelling service.

Integrity of Supply Chains and their risks

Jyrki Syvaeri, Corporate Director Supply Chain Integrity, Boehringer Ingelheim

Jyrki presented on risk management across the supply chain at Boehringer Ingelheim.  Focus is on product with high impact on medical health or commercial value.  Where BI are providing the only healthcare solution or a very high percentage of the healthcare solution where there is a high medical need, they need to have a high ability to maintain supply.  This is assessed through formal risk assessments following ICH9.  The risk assessment then allows BI to decide what contingency plans or solutions need to be applied to different supply chain risks.  Jyrki then discussed some of these solutions.

Quality Systems – business needs, patient requirements and regulatory expectations

Peter Murray, former QA Director, External Supply Chain, GSK

Peter presented on the need for a comprehensive QMS within a pharmaceutical company.  Starting from the legal requirements, regulators will interpret what their expectations are and these will evolve over time as experience grows.  A quality system needs to ensure these requirements are met.  A QMS needs to be appropriate in scope and a live system.  Ideally it should be ahead of the curve.  Peter highlighted a particular challenge is how standards can be maintained where the supply chain is virtual and executed through multiple external partners.

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