7 Predictions for Pharma
The following predictions were based on interviews with range of professionals in the pharma and biotech space. To hear from these thought leaders and more go to the Pharma Show Podcast Series.
Prediction 1: New nano approaches to the value chain
My expectations from the pharmaemerging regions in 2011 are that the several pharmaceutical companies of those regions start a pioneering and brand new approach to their value chain: include into their R&D the responsible and intensive use of nanoscience and Nanotechnology. To illustrate my expectations, follow two examples: nanotechnology in Drug Delivery and computer-aided drug design at the nano scale,” said Luis Bastos, Editor-in-Chief at nanogolive.
Prediction 2: Risk-benefit assessment will be king
“Pharmacovigilance is going to move heavily into risk-benefit assessment instead of just pure description of the side-effects we receive. So we will have to do a much more proactive approach to pharmacovigilance, use risk management during our development programme as a tool to develop our development programme, and also to create comprehensive post-authorisation commitments that would give us the information we need to ensure the safe use of the drugs. So, definitely... I believe we are entering a new and exciting era,” said Pilar Carrero, Director of Safety Medical Writing at Novo Nordisk.
Prediction 3: Internal focus on late stage development
“In two to three years, the model of the pharma industry will move more and more towards outsourcing - and due to portfolios attrition the pharma industry will have to find compounds externally. The internal research will decrease more and more to outsource the most risky part for pharma companies which is the preclinical stage. So in the future, pharma companies will focus their activity mainly in late stages of the development and more particularly in late clinical stages, said Sophie Hallakou-Bozec, Research Director and Cofounder of Poxel.
Prediction 4: New biopharmaceuticals manufactured by Single Use systems
“Single-use manufacturing today has been widely applied in clinical batch manufacturing and larger scale manufacturing is still, in many cases just in the adoption mode so in five years we can expect to see many newly approved biopharmaceuticals being manufactured in single-use systems all the way through to final filling and even some of the established drugs as they expand in capacity may transfer over into single-use manufacturing systems,” said Jerry Martin, Senior Vice President for Global scientific affairs at Pall Life Sciences and Chairman of the Board of the Technology Committee for the Bio-Process Systems Alliance.
Prediction 5: Growth expected from freeze-dryers processing on the fly
“I think there has been in the last two decades a growth in the degree of automation, and I’m sure that’s the way it’s going, and people are building new plants, there will be ever increasing degrees of automation of the freeze-drying process. And that’s fine at large-scale, but I think where the most interesting developments are coming are in the application of techniques that enable you to understand the sublimation of your product and such as monitoring the flux rate through the whole process, whether that’s by laser infra-red methods, or whether that’s by other vapour study methods, mass-spectrometry methods.
But I think those will become increasingly commonly used because you’ll fit those on medium-sized freeze-driers, and that will enable people to be able to develop cycles which are – you can use, which will give you more responsive – so that you can adjust your process to meet the… to developing online, on the fly, if you like – to be able to modify cycles to get optimal processing times. And I think that’s probably where the biggest growth will occur over the next ten years, will be the application of those and the benefits that they will bring to shortening cycles in production processes”, said Dr. Paul Matejschuk, Principal Scientist at the National Institute for Biological Standards and Control.
Prediction 6: A higher order of programming in clinical design
“Building in a lot of information about the products going in; the likely benefits of these molecules, and the effects coming out; the benefits to patients; the financial returns to a company. So I think that higher order planning of programme design is one of the most interesting areas that we’ll see explored in the near future,” said Chris Jennison, Professor of Statistics at the University of Bath.
Prediction: 7: Cold Chain and global security practices will align
“Canada is and has been a leader in cold chain management of pharmaceuticals by being one of the first nations to develop a guidance document (Health Canada). With temperature extremes, businesses must develop more robust time and temperature solutions to protect products. Being a close neighbour of the US and addressing the global security issues, Canada will develop its own cargo screening procedures and regulations that will need to be closely aligned with the cold chain guidance document,” said Jim Bacon, Senior Director, Global Demand Planning & Customer Operations, Talecris Biotherapeutics.
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