Why 90% of clinical drug developments fail ...
.. and how to improve it?
This week I would like to share the publication by Duxin Sun as shared by pharmaexcipients.com earlier this week. I believe it is a very important topic and question how to improve the outcome of the pharmaceutical development. During this week's ExciPerience we had different speeches on AI, predictive modeling and In-Silico development tools which thanks to big data show much better correlations today than some years ago. I am curious to see what is coming next.
Ninety percent of clinical drug development fails despite implementation of many successful strategies, which raised the question whether certain aspects in target validation and drug optimization are overlooked? Current drug optimization overly emphasizes potency/specificity using structure?activity-relationship (SAR) but overlooks tissue exposure/selectivity in disease/normal tissues using structure?tissue exposure/selectivity–relationship (STR), which may mislead the drug candidate selection and impact the balance of clinical dose/efficacy/toxicity. We propose structure?tissue exposure/selectivity–activity relationship (STAR) to improve drug optimization, which classifies drug candidates based on drug’s potency/selectivity, tissue exposure/selectivity, and required dose for balancing clinical efficacy/toxicity. Class I drugs have high specificity/potency and high tissue exposure/selectivity, which needs low dose to achieve superior clinical efficacy/safety with high success rate. Class II drugs have high specificity/potency and low tissue exposure/selectivity, which requires high dose to achieve clinical efficacy with high toxicity and needs to be cautiously evaluated. Class III drugs have relatively low (adequate) specificity/potency but high tissue exposure/selectivity, which requires low dose to achieve clinical efficacy with manageable toxicity but are often overlooked. Class IV drugs have low specificity/potency and low tissue exposure/selectivity, which achieves inadequate efficacy/safety, and should be terminated early. STAR may improve drug optimization and clinical studies for the success of clinical drug development.
领英推荐
Why 90% of clinical drug development fails?
Drug discovery and development is a long, costly, and high-risk process that takes over 10–15 years with an average cost of over $1–2 billion for each new drug to be approved for clinical use1 . For any pharmaceutical company or academic institution, it is a big achievement to advance a drug candidate to phase I clinical trial after drug candidates are rigorously optimized at preclinical stage. However, nine out of ten drug candidates after they have entered clinical studies would fail during phase I, II, III clinical trials and drug approval. It is also worth noting that the 90% failure rate is for the drug candidates that are already advanced to phase I clinical trial, which does not include the drug candidates in the preclinical stages. If drug candidates in the preclinical stage are also counted, the failure rate of drug discovery/development is even higher than 90%.
Executive, Nano Drug Delivery
2 年We don't need a successful strategy we need a scientific approach, not observational clinical studies, you expect a worm killer to kill the virus? Do you expect a cardiovascular drug have some sort of miraculous effect on the immune system or the virus? What we first and before everything else need is pharmaceutical chemistry receptor-drug bond,something that changes the physiology in the right direction, we need mechanism if there is no mechanism for the drug to act you can't expect ?? an anti-malaria hydroxychloroquine ?? or Ivermectin ?? or gastrointestinal drug famotidine ?? to become antiviral or immunepotentiating The problem is a lousy approach that you can justify anything for anything just to sell drugs can anybody show me how Prozac is an antidepressant? Is there any receptor for depression? Just working on a neurotransmitter doesn't mean anything It's like expecting a man gets pregnant, if there is no mechanism 4 pregnancy in a man how could we expect that?? How could we expect a worm killer act or does anything on a virus?
Director, Contract Pharmacal Corporation India Private Limited
2 年Thanks for sharing
Go-to Transformation & Exponential Growth Expert/Mentor- Asia/Europe/MENA
2 年Very interesting reading! Thanks for sharing. Perhaps somewhat theoretical (and very time consuming to calculate) but would be interesting to also estimate the amount of lost revenue and profits of such delays. Not to mention the impact of patients too waiting for a particular therapy
Independent Pharmaceuticals Professional
2 年Hi Philippe, thank you for posting this article. Hope to see you soon! All the best, Marco
helping optimize your cell culture | cryopreservation | high viral vector titres | cell expansion | CTGrade interleukins | pharmaceutical raw materials I LAL reagents
2 年Great article