CPHI Expert Industry Panel Members Comment on Future Contingencies for Pharma in Part II of CPHI Industry Report

CPHI Worldwide and CPHI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, has released the second edition of its annual report — with its expert industry panel identifying the market trends set to affect growth and innovation across the industry.

Part I of the report was launched prior to CPHI Worldwide, with a further eight industry expert panel submissions being released in Part II of the report, over 2 days at the show (Tuesday 22nd and Wednesday 23rd October).


The first four articles for Part II of the report indicate that during the next few years, Big Pharma’s business model is shifting from its traditional markets and moving towards the development of niche medicines, companion diagnostics, and perhaps most significantly, towards increased partnerships, both with CMOs and academia. The implication of this is that innovations and IP processes will be coming from outsourced partners, Big Pharma and academia. QbD is seen as being essential to the process of harmonising product and process development, which will accelerate standards, enabling more developed partnerships and strategic uses of outsourcing.


Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers forecasts in his submission that Big Pharma will move towards the development of niche medicines, alongside companion diagnostics for patients with specific genotypes.


Echoing these sentiments, William Botha, Sensei at Interlean, says that as well as a move towards niche medicines, pharma will increasingly diversify towards commodity-based, low margin products- meaning we will see an increased specialisation, particularly amongst small and medium pharma. To achieve this goal, he argues that there will need to be increased connection between product development and manufacturing so that products can move more seamlessly through the development process.


Bikash Chattejee, President and CTO at Pharmatech Associates, argues that two essential developments that will be universally adopted over the next five years are the concepts of QbD and Question-based-Review (QbR). If we are to move towards the harmonization of product and process development cycles, QbD will be essential not only in safeguarding quality but also in reducing the cost of development. However, one area that is forecast for particular change is the application of QbR within the generics drugs industry. For instance, FDA enforcement approaches, it is forecast, will start to look more at baseline characterisation activity, which will reduce the number of GMP transgressions in the medium-term future.


One longer-term change that all experts across the industry panel agree on is the increased collaboration with strategic outsourcing partners and particularly the commercial development of innovations coming out of academia.



Ajaz Hussain, an independent consultant and formerly of the FDAs PAT team, continued: “Academic partnerships such as that between Novartis and MIT will also be increasingly important over the coming years and academia will play significant roles in both technology and policy. This partnership concept will also expand to relationships with suppliers and manufacturers where there is a need for knowledge-based relationships, particularly in the areas of QbD and FDASIA”.



Hussain also believes that manufacturing metrics from CDER will allow regulators to identify data ‘too good to be true’ and decrease non-compliance over the coming years.



Another growing trend is the increased outsourcing across the supply chain and development cycle with industry building symbiotic relationships, commented Bikash Chatterjee. He highlighted that a CMOs ability to provide product development services will be essential to companies moving into emerging markets and smaller start-ups looking to tap into the global marketplace.



Botha however, sees significant risks in too much outsourcing and predicts that lower risk downstream processes such as packaging and logistics will grow, alongside upstream vertical integration of high-risk areas such as APIs: “Outsourcing isn’t always the answer. In some cases it is just abdicating or abrogating responsibility”.



Venugopal expands on these ideas in his contribution, and believes that the ability to handle increasing volumes of data will facilitate partnerships with reduced risks and enable the global implementation of QbD: “Our ability to increase collaboration and knowledge has increased with our ability to manage data. We can now gather and analyse knowledge to an unprecedented degree”. His view is that whilst contracting will increase, this will be more strategic in nature across the global supply chain.

Chris Kilbee - Group Director, Pharma, commented: “The CPHI Pharma Evolution annual report highlights the main industry trends over the next five years, with tighter regulatory controls and processes (e.g. QbD) and diversification of ingredient suppliers featuring prominently in all submissions. Harmonising product and development process partnerships are going to be critical to the success or failure of this- which proves the importance of making strategic partnerships at events such as CPHI”.