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CPhI Worldwide and CPhI Pharma Evolution’’s second annual report released

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CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, 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.

The first four articles for the report indicate that over 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.

Report’s expert highlights
Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers

  • Big pharma to develop niche medicines and associated companion diagnostics
  • Technical advances in design and development to reduce costs- with a more collaborative model between partners and increased outsourcing in development processes
  • Academic partnerships with pharma and CMOs to increase innovation

William Botha, Sensei, Interlean

  • Increased outsourcing to lower risk processes such as packaging and logistics
  • Increased vertical integration when risks are higher (e.g. APIs)
  • Changing pharma business model towards niche products or commodity-based low margin products
  • Regulators to pay increased attention to human factors and staff turnover

Bikash Chatterjee, President and CTO, Pharmatech Associates

  • Pharma to focus on improving drug discovery and development effectiveness
  • CMOs need to develop larger service development offerings
  • Understanding of foreign regulatory requirements, beyond FDA, to become increasingly common
  • FDAs enforcement of QbR in generics to reduce GMP transgressions

Ajaz Hussain, Independent Consultant

  • Continuous manufacturing processes to continue to grow, encouraged by the FDA
  • CDER manufacturing metrics to help regulators identify data that is too good to be true and potential compliance issues
  • Industry to witness more frequent inspections of foreign facilities

Girish Malhotra, President, EPCOT International

  • Pharma to switch to low-cost drugs that have a larger customer base
  • Industry is at risk from possible drug shortages as weaker players in developing countries fail to meet regulatory requirements
  • Minimizing process inefficiencies through PAT and QbD will lead to 20-25% savings of global revenues
  • Continuous processing is forecast to revolutionise manufacturing with reduced costs, increased sustainability and consistently higher product quality
  • Alternatives for APIs include modular technologies in place of continuous processing

Prabir Basu, Independent Consultant and a former Director of NIPTE

  • Regulatory environment needs to change to offer incentives for achieving excellence- presently pharma is focussed on non-compliance
  • FDA should focus resources on regions with a likelihood of failure
  • FDA could learn from ‘trust and verify’-style OHSA Voluntary Protection Program
  • Biggest threat to industry is that most companies get ingredients that are not being inspected
  • cGMP needs to be extending to excipient manufacture.

Emil Ciurczak, Principal at Doramax Consulting

  • Speed of development from lab scale to small scale manufacturing is dramatically accelerating
  • Batch processing may now be a thing of the past
  • In 10-15 years it will be impossible to tell if one is in a generics or branded pharmaceutical facility
  • Generics race will lead to smaller number of larger generics companies
  • Increased collaboration between FDA and EMA, with QbR adoption ensuring generics manufacturers improve process knowledge-base

Hedley Rees, Principal at PharmaFlow

  • Regulation with such a prescriptive approach is not actively targeting mal-intent within the supply chain
  • Regulators should raise the bar for CMC filing at the IND/CTA stage to ensure only the most promising molecules enter the clinic
  • Improvements in in silico and in vitro testing will help to improve predictive capabilities
  • Track and trace under FDASIA to support supply chain improvements but a change in behaviour is needed to truly ensure safety
  • Contract research and manufacturing sector needs to take an active role in innovation and share some of the costs and risks

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 Chatterjee, President and CTO, Pharmatech Associates, argues that two essential developments that will be universally adopted over the next five years are the concepts of Quality by Design (QbD) and Question-based-Review (QbR). If we are to move towards the harmonisation 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 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, UBM Live 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.”

Girish Malhotra, President, EPCOT International suggests that alongside these quality and process issues, pharma is likely to change its business model towards developing lower-cost drugs that have a larger customer base, with big pharma revenues increasingly coming from orphan drugs. However, he also sees risks of an increasingly stringent regulatory environment, with drug shortages envisaged as consolidation occurs amongst weaker players in developing countries.

Prabir Basu, Independent Consultant and former Director of NIPTE, in contrast, sees the greatest threat to the industry coming from uninspected ingredients and argues that it is essential that cGMP be extended to excipient manufacture.

Hedley Rees echoes these thoughts and believes that the current prescriptive approach is not adequately targeting ‘mal-intent in the supply chain’.

One solution, Basu believes, to the regulatory mine field would be for the FDA to implement a ‘trust and verify’-style OHSA Voluntary Protection Program, which would provide flexibility for cGMP sites to make modifications whilst accelerating the implementation of Operational Excellence (OpEx) without fear of shut down. The FDA should also focus its resources on regions with the greatest likelihood of failure.

“Track and trace under FDASIA will also help to drive supply chain improvements but a change in behaviour is also needed to ensure safety. Industry is far too reliant on regulation as an excuse for not taking the initiative,” Hedley Rees, Principal at PharmaFlow notes.

Another major problem, Basu identifies, is that the current regulatory environment does not incentivise achieving excellence and is rather more focused on non-compliance. Girish identified a solution to this and believes that the implementation of PAT and QbD will not only lead to higher standards, but will help remove process inefficiencies- leading to global revenue savings of 20-25 per cent.

Emil Ciurczak, Principal, Doramax Consulting also sees the benefits of these new methodologies and states that in 10-15 years’ time, it will be impossible to tell if a site is generic or a branded pharmaceutical facility.

These improvements in standards will inevitably come at the cost of market consolidation, with a generics race underway ultimately leading to a smaller number of larger generics companies. An essential element to improve standards across generics manufacturing will be the adoption of QbR and ever-closer collaboration between the FDA and EMA.

Another benefit of QbD/PAT is the ability to vary experimental conditions, which should allow development work to progress from laboratory scale to small scale manufacturing more quickly. Rees supported this, adding that supply chain quality should be brought into the equation at the early development stage, with poorly characterised molecules becoming redundant before development work. He also suggests regulators should raise the bar for CMC filing at the IND/CTA stage to help ensure that only the promising molecules enter the clinic.

The final area highlighted by several of the panel members, including Malhotra and Ciurczak, is the potential for continuous processing to revolutionise manufacturing with reduced costs, increased sustainability and constantly higher product quality, with the advent of QbD and PAT producing an enabling environment so that batch processing may be a thing of the past.

Kilbee commented, “The remaining findings from our CPhI Pharma Evolution annual report show that over the next few years stringent regulations and practices such as QbD are prominently shaping the global marketplace. A large number of our experts emphasise QbD in playing an increasingly large role to ensure products are manufactured to consistently high standards of quality that align with all regulatory bodies. But with increased standards does come short-term risks of product shortages, however, in the longer term we can expect huge revenues savings from these techniques, and in as little as 10-years’ time standards at generics and branded sites will be indistinguishable.”

EP News BureauMumbai

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