Food and Drug Administration The US approval score could bounce back this year, particularly as the FDA said it received fewer applications in and waved through five drugs during that were slated for approval last year. This concession has already prompted accusations that FDA approval standards will be undermined.
Industry must win back public and political trust The past year has seen a number of companies, such as Pharma business plans, Turing, Mylan, Teva and Pfizer, in the dock amid successive waves of negative publicity about pharmaceutical industry practices.
It has to be multichannel With increasingly tight restrictions on face-to-face relationships between pharmaceutical sales teams and healthcare professionals, industry has been taking a much broader view of its sales and marketing strategy.
Can accelerated, conditional or adaptive approval pathways, with surrogate endpoints supplemented by real-world data, function effectively to the real benefit of patients? The trend to speciality drugs rolls on The aforementioned trend towards speciality and rare-disease drugs looks set to continue during Smaller, highly specialised teams will need to drive a seamless launch engine across geographical and functional boundaries through optimal transparency, awareness, knowledge exchange and harmonisation.
Many large-scale chronic diseases, such as diabetes and asthma, are now relatively well controlled. This is despite a marked decline last year in the volume of innovative medicines approved for entry to the key US market.
Given the escalating concerns about drug pricing and affordability already noted, the continuing emphasis on lower-volume, higher cost speciality assets will further raise market-access barriers at launch and from one country to the next.
These concerns centred mainly on drug pricing, exploitation of market monopolies, creative accounting and dubious promotional practices in developing and other markets.
Time will tell, but an industry seeking to win back public and political trust is certainly one of the key pharma trends for Moreover, the launch pipeline for and beyond remains well stocked with speciality therapies addressing anything from rheumatoid arthritis to osteoporosis, non-small cell lung cancer, melanoma, acute myeloid leukaemia, asthma and tardive dyskinesia.
Clearly, some authorities are more inclined to scepticism. However, several countries have already adopted or are trying out regulatory mechanisms to speed progress of innovative drugs to market.
The challenge for industry in will be to think more carefully about what customers really want and need, so that they can deliver the right information and promotions through the right vehicle at the right time as part of a more tailored, smart multichannel strategy.
And even when accelerated approval reflects intense lobbying from affected patients willing to accept a less encouraging risk-benefit equation? It remains to be seen whether all of this will add to costs and discourage inward investment, or could provide the impetus for fresh thinking about how to support and nurture indigenous pharma industries.
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In the EU, there were also signs of a slowdown. The solution may reside in genuine, data- and technology-driven patient centricity, where industry joins with healthcare professionals, payers, regulators and its end-customers in helping to manage the entire disease spectrum. Pharma has much work to do if it is serious about being a genuine partner in healthcare and outcomes.
At company level, that calls for even more intensive focus on efficiency and cost-efficiency. As pressure mounts for the pharmaceutical industry to generate value by addressing truly unmet needs, it will have to face some awkward questions head on.
With populist and nationalist movements on the rise, more member states could follow suit in ditching the EU, seriously destabilising the Union.
According to ZS, US physicians estimate they spend about two full working weeks a year interacting with pharma via digital and other non-personal channels. Mending reputational damage, and heading off further damage down the road, is one of the key challenges facing the pharmaceutical industry.
While the trend towards more cost-effective multichannel marketing accelerates, there is also a risk of overload. In the US the wide-ranging 21st Century Cures Actpassed by Congress in early December, will consolidate the early-approval trend by permitting more reliance on surrogate markers in clinical development.21st & 22nd FebruaryHoliday Inn, Kensington High Street, London UK “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”.
PM ET Wed, 12 Sept Nirmal Mulye, founder of Nostrum Pharmaceuticals, argues the generic drug business has become so bogged down in inefficiencies at the Food and Drug Administration. See more articles like this one in the following categories When it comes to effectiveness of machine learning, more data almost always yields better results—and the healthcare sector is sitting on a data goldmine.
McKinsey estimates that big data and machine learning in pharma and medicine. From pricing concerns, reputational damage control, Trumpian uncertainty, technology convergence to multichannel, we predict the key pharma trends for Cigna is buying massive pharma middleman Express Scripts for $67 billion in a move that changes the industry as we know it.Download