A fundamental problem in healthcare R&D is that the development of new products is very expensive: failures and delays are frequent and each one is costly. In fact, the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms (1). In addition, finding the right pricing and reimbursement strategy has become increasingly difficult on a global level. Bottomline: not every launch is as successful as it could be if there is no overarching product strategy.
Another example for potential failure in late stage development can include underestimated activities such as proper raw material onboarding and qualification, especially in case of ATMPs (Advanced therapy medicinal products) such as cell and gene therapy products. Companies must work with their suppliers and regulators to qualify each raw material (reagents, excipients, buffers, single-use plastics or primary containers) to assess source, purity, identity, safety, and suitability in a given application (2). ProDeMaCon LLC has recently worked with several clients in the field and has supported them to build a process for this assessment from the ground up.
If you are still looking for the optimal strategy for your product or portfolio or simply want your project to get back on track, ProDeMaCon LLC can provide strategic and executional advice, given its unique setup:
(1) J.W. Scannell et al.: Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews Drug Discovery 11, 191-200 ( 2012)
(2) J. Solomon et al.: Current perspectives on the use of ancillary materials for the manufacture of cellular therapies. Cytotherapy 18, 1-12 (2016)
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