Expert Industry Annual Report: Part i
CPhI panel members call for a radical shift in pharma's model to reduce manufacturing cost and increase innovation
Expert panel warns 'IPR is stifling innovation'; predicts that a 'process-centric approach will achieve global revenue savings of 20 to 25%', with 'green chemistry set to help drive manufacturing cost reductions'
Part I report highlights
Vijay Shah Executive Director & COO of Piramal Enterprises
· Green chemistry will be valued at $100 billion by 2020, offering $65 billion in savings and improving the ROI for the industry.
· Government must simplify regulation and create regulatory incentives to increase the adoption of green technologies.
· Technologies such as catalysis, flow chemistry, and parallel screening will revolutionise process research, by creating efficiencies and cost savings.
· In the future green chemistry methodologies will be ingrained into the R&D stage. Green Chemistry by Design (GCbD) will be taken up by the leading CRAMs industry players to help drive efficiency savings.
Dilip Shah CEO at Vision Consulting
Innovation and IPR:
· IPR (Intellectual Property Right) which was initially a tool to encourage innovation is now stifling it as it is creating 'legal monopolies' globally- the danger is that without change, over the next five years, pharmaceuticals will continue to increase in price but only demonstrate limited increases in efficacy.
· IPR positions in the USA will weaken over the next 10 years as the government recognizes what is in the interest of big pharma is not always in the interest of the USA.
· Strong IPR are preventing new technologies from disseminating to less developed and developing countries despite the TRIPS agreement. This will be an increasingly debilitating factor over the next five years.
· In order to promote growth, governments in developing and less developed countries must balance IPR with needs of public health.
· Coordination, not harmonisation, in IPR is necessary; distinctions must be made between developed countries and developing and less developed countries, acknowledging that the global optimal level of protection requires an international coordination, not harmonisation.
· Proponents of strong IPR in all countries fail to recognise the benefits experienced by industrialised countries of adopting a weaker IPR protection in earlier stages of their development.
Girish Malhotra President EPCOT International
Quality By Design:
· The pharma industry will have to move away from the regulation-centric approach towards a process-centric approach.
· Global revenue savings of 20-25% will be achieved with the implementation of Quality by Design (QbD), which will lead to optimum process efficiencies, high-quality product and lower costs.
· A 20-30% increase in the pharma customer base is possible with a shift to a process-centric model such as QbD, bringing the pharma customer base to 70% of the global population.
· Quality by Analysis is the cause of innovation paralysis in pharma's manufacturing technologies and business practice.
Amsterdam, 23 September 2014: CPhI Worldwide, part of UBM Live's Pharmaceutical Portfolio, today announces the findings of part one of its second annual report. Three World-renowned experts –Vijay Shah Executive Director & COO of Piramal Enterprises, Dilip Shah CEO of Vision Consulting and Girish Malhotra President of EPCOT International – each forecast their predictions for the industry, advocating radical changes that will revolutionise production processes and profits.
Ideas to help make development and manufacturing more efficient, along with new technologies like green chemistry were identified by our experts as solutions that will reduce costs and improve current manufacturing processes and environmental impact.
A major point of convergence in theme across their three perspectives is that pharma, in its present form, needs an evolutionary approach to remain sustainable in the longer term and open up access to drugs to more of the World's population. Girish Malhotra argues that for too long the industry has relied on selling its drugs entirely to the developed world and has, as such, not been actively focused on delivering increased process innovations that would bring cost savings and increased profits, whilst opening up new markets in the developing world. Similarly, Dilip Shah believes that the current model of strictly implementing IPR in all markets has perversely resulted in diluting innovation across the industry. Dilip believes reducing onerous IPR requirements in developing economies - challenges he argues developed economies did not have to face at a similar stage in their development - can increase innovation. In contrast, Malhotra believes QbD and a 'process centric' approach need to be embedded within the manufacturing and development process from concept right the way through commercialisation- as this would provide an environment where new innovations were encouraged and continually sought.
Dilip added, "the danger is that without change over the next five years pharmaceuticals will continue to increase in price, but only demonstrate limited increases in efficacy". He is advocating a globally coordinated approach whereby there is a clear differentiation between developed and developing countries- with the latter taking a looser approach to IPR implementation.
Similarly Malhotra states that the current regulatory centric approach actively discourages innovation. However, he envisages manufacturing process savings could be as high 20-25% globally and would therefore open up new markets if the industry is willing to evolve. Universal adoption of Quality by Design (QbD), would optimise process efficiencies, improving product quality whilst simultaneously lowering costs- meaning that ultimately pharma will deliver more revenue by selling to more of the world's population.
In keeping with a more sustainable and global approach to drugs manufacture Piramal's Vijay Shah prophesied green chemistry as another new method set to reduce costs and his research indicates this sector will grow rapidly to reach a value of $100bn by 2020. Moreover, he is imploring Governments globally to support this by reducing regulation and increasing incentives. Already he has envisaged a new global standard, which he has coined 'Green Chemistry by Design' (GCbD) and should be ingrained within the R&D stage. CRAMS providers will over the next few years begin to implement this process to drive efficiency savings, which if fully delivered by all types of manufacturers would save the industry $65 billion by 2020.
"Already we are seeing big pharma looking increasingly to explore greener ways of working and the manufacturing process is a natural progression of this trend. Technologies such as catalysis, flow chemistry, and parallel screening are revolutionising process research, by creating efficiencies and cost savings" commented Vijay Shah.
CPhI will release the full annual report findings, which include seven additional expert articles, at CPhI Worldwide 2014, taking place from 7th-9th October at Paris Nord Villepinte- France.
Chris Kilbee, Group Director Pharma at CPhI: "This year CPhI Worldwide celebrates 25 years as the leading pharma industry conference and our panel of experts are instrumental in helping achieve a brighter future for the industry. Not only have they foreseen structural changes that will increase profits, but also changes that will open up increased access to drugs and help make the industry and its processes become far more sustainable and efficient. The full findings of the CPhI annual report will be announced during the Worldwide show (6-9th October) in Paris and is a yet further example of how CPhI as a company is actively providing content, industry insights as well as building the essential business relationships to sustain the industry. The pharma community increasingly uses CPhI as its go to resource for both helping them achieve new business wins, and now, examining business insights holistically to see how the sector is changing and growing. "
For full copies of each article and the overall report, please visit:http://www.cphi.com/europe/
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, Korea, China, India, Japan, Southeast Asia, Istanbul, Russia and South America and co-locates with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com.
For more information visit: www.cphi.com
The UBM Live annual schedule of Pharmaceutical events also includes; CPhI, ICSE Korea (2-3 September, 2014 at the COEX- Seoul, South Korea); CPhI, ICSE, P-MEC and InnoPack Worldwide (7-9 October 2014, Paris Nord Villepinte- France); CPhI and P-MEC India (2-4 December, 2014 at the Bombay Exhibition Centre- Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan (22-24 April, 2015 at the Big Sight Exhibition Centre- Tokyo). CPhI Russia and IPhEB (27-29 April, 2015 at the VVC, Pavilion Nr 75, Moscow Russia); CPhI, P-MEC and Innopack South East Asia (26-28 May, 2015 at the Jakarta International Expo- Jakarta, Indonesia); CPhI Istanbul (3-5 June, 2015, at the Lutfi Kirdar Convention and Exhibition Centre- Turkey); CPhI, Hi and Fi, ICSE, P-MEC, BioPh and LabWorld China (23-25 June, 2014 at SNIEC- Shanghai, China)
About UBM Live
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