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Despite numerous and efficacious therapies and treatments being readily available in the pharmaceutical supply chain, there has been for some time a critical need for new drugs, especially since viral strain outbreaks from the COVID-19 pandemic and more recently the monkey pox virus.
However the ability to quickly develop and deploy medications has been challenging primarily because the drug development life cycle is typically drawn-out and convoluted, taking up to 15 years for a drug to be approved and marketed.
The drug development process in itself is beset with numerous challenges, such as elucidation of effective drug targets, declining market approval market success rates, increasing development costs and reimbursement pressures.
It is therefore imperative that biotechnology and pharmaceutical entities combine forces to champion the drug life cycle and accelerate the approval process yet still deliver on safe and effective medicines.
Unlike other consumer goods, the prescription drug market has the added complexity of two product life cycles – pre-approval and post-approval by the relevant regulatory authority. For the pre-approval life cycle, basically there are five stages in its life cycle pertaining to a drug development process. Firstly understanding the disease process enables a design of a new medical or molecular entity to halt or harness the effects of the disease and then assessing this molecular entity and sometimes structural analogs thereof to find potential beneficial effects in preclinical models which can be in silico, in vitro, in vivo or any combination of the three for certain diseases – the so-called discovery process. The second stage is preclinical research, which includes in vitro and in vivo testing and animal testing to answer basic questions about safety. Then at the third stage, clinical research begins whereby the sponsor files for an investigatory new drug application and if approved enters into phase I, whereby a new drug’s safety and dose range in about 20-100 healthy volunteers is tested. These phase I pharmacokinetic studies investigate how a drug is absorbed, distributed, metabolized and excreted by the human body. In phase II studies the effectiveness of the drug in approximately 100 to 300 patients is investigated lasting from several months up to two years. A secondary purpose of the phase II studies is to ascertain therapeutic dose level and dosing frequency with the study design being often randomized and double blinded to prevent any unscientific influence on the study results. Phase III studies undertaken at multiple centres with several hundred to several thousand patients providing a continued generation of data on a drug’s safety and efficacy. As in phase II, most phase III studies are randomized and blinded. The phase III trials provide the bulk of data needed for the package insert and labeling of a medicine, after being approved by the regional regulatory authority. A drug in this phase can be under investigation for several years and perhaps become one of the 25-30 percent candidates that pass all three clinical trial phases.
The fourth stage of the process is for the drug candidate to undergo review as a New Drug Application which may be approved or rejected with the regional advisory committee providing feedback on the outcome. If approved, finally the registered drug enters post-market drug safety monitoring whereby the regulatory authority reviews pharmacovigilance reporting of problems with the registered medicine and at this stage can add cautions to the dosage or usage information, as well as other measures regarding serious adverse events.
At this juncture, the approved drug undergoes lifecycle stages akin to what other conventional products go through – introduction, growth, maturity and decline. However in comparison to the life cycle of conventional products, there are still further challenges which actually complicate this post-approval drug lifecycle. The registered medicine when at the introductory stage is just fresh on the market from regulatory approval which may entail it is protected by market exclusivity owing to its patent or trademark status. Then at the growth stage, it will begin to enjoy a revenue surge from new patient awareness and buy-in. At the mature stage the drug product will be reaping the rewards of brand recognition and competitiveness over other therapeutic class medicines. Finally at the decline stage it is likely to have reached patent expiry with lower cost generics gaining ground.
With the many lengthy stages of a prescription drug lifecycle, the pharmaceutical sector faces a plethora of both drug development and post-approval challenges, chiefly of a cost and time containment nature. Moreover, owing to many diseases having an unknown pathophysiology or yet to be discovered target receptor or disease pathway, then there is the added challenge of finding a newly efficacious yet safe drug.
A further major challenge in the drug lifecycle is increasing costs and pressure on pricing, despite adaptive designs and big data alleviating the pressure on this issue somewhat. In contrast public-private partnerships which may offer specific opportunities e.g. market access, equally however pose distinct challenges, e.g. health equality pressures on pricing.
There are five best practices to alleviate operational costs and improve cycle time in drug research and development as follows:
Overall, the drug development cycle is intricate and multifarious, yet important. The goal at the R&D stage is for researchers to determine if a drug is safe and effective as a treatment for certain disorders. However it is equally vital that biotechnology and pharmaceutical companies come together with specialist service providers to consider the root causes and trends that bring on these various challenges in order to overcome and circumvent them so as to introduce beneficial medicines into the supply chain in a more cost effective manner.
i3 Consult can give a critical appraisal of your pre-approval or post-approval product and its life cycle market performance against its competitors in the same therapeutic class and advise on the corrective action necessary. To find out more contact: email@example.com