Report on Innovation in Drug Discovery and Development

胜利者

The United Statesshould set a goal of doubling the output of innovative new medicines that meetcritical public health needs over the next 10 to 15 years, while continuing toincrease drug safety, a presidentially appointed council of experts advised ina report released today. The council recommends a number of actions involvingindustry, academia, and the Federal Government.

While basicbiomedical sciences have seen stunning progress in past decades, challengesremain in translating those scientific advances into practical solutions,according to the report—Propelling Innovation in Drug Discovery,Development, and Evaluation—produced by the President’s Council of Advisorson Science and Technology (PCAST). Thereport assesses the reasons for that long-term trend.

To support innovationand accelerate the development of new therapies, the report makes a number ofdetailed recommendations aimed at bolstering the discovery and development ofnew therapeutic compounds; optimizing processes used by the Food and DrugAdministration (FDA) to evaluate the safety and efficacy of candidate drugs;enhancing long-term monitoring of approved medicines; and enhancing publicunderstanding about the benefits and risks of medicines.

“With improvedcollaboration among all the participants in the drug development ecosystem andoptimization of drug-evaluation pathways, American researchers and companiesshould be able to accelerate the development of safe and effective drugs whilealso strengthening the U.S. economy,” said Eric Lander, who co-chairs PCAST.

The report notesthat heart disease and stroke remain leading causes of mortality, many commoncancers are still incurable unless they are caught in the earliest stages, andthe vast majority of rare diseases lack effective therapies altogether. Infectiousdiseases, including those caused by antibiotic-resistant bacteria and viruseswith pandemic potential, pose a constant threat of large-scale mortality. Andtreatments for psychiatric diseases, which impose a tremendous burden onsociety, are frustratingly limited in their efficacy, as are treatments forneurodegenerative diseases such as Alzheimer’s.

All three majorcomponents of the drug development ecosystem—basic biomedical research inuniversities and research institutes, clinical research in hospitals, and drugdiscovery and development in the biopharmaceutical industry—are facing growingchallenges as the time, complexity, and cost of developing drugs have gone up,the report states. The rate of new-drug applications submitted by industry tothe FDA, as well as new drug approvals, has remained relatively constant for 20years. In an encouraging sign, however, the FDA approved 35 new medicines inthe past year—among the highest totals in the past decade.

The report concludesthere are two critical needs related to drug discovery and development thatmust be addressed to advance innovation:

(1) Scientists need better methodologiesand tools for translating basic biological insights into validated therapeutictargets and leads—a gap in the drug discovery and development pipeline thatacademic scientists often view as “too applied” and pharmaceutical companiesoften eschew as “too basic” to justify private investment.

(2) Pharmaceutical developers andregulators need to incorporate new efficiencies into clinical trials ofcandidate medicines—complex and costly human studies that today constitutefully 40 percent of the biopharmaceutical industry’s R&D budget.

To achieve some ofthe report’s broader goals, PCAST recommends the creation of a public-private“Partnership to Accelerate Therapeutics,” involving representatives from thebio-pharmaceutical industry; the academic biomedical research and ethicscommunity; physician societies and pharmacists; patient-focused researchfoundations and advocacy groups; healthcare providers and insurers; and theFederal Government. The Partnership would help identify and plan collaborativeactions to speed drug development while balancing competing stakeholderinterests and minimizing duplication of efforts.

In addition, thereport concludes that the return on investment in certain disease domains maybe too low to justify their pursuit by companies, even though the potentialbenefits for public health in these domains may be large. It recommends thatthe Department of Health and Human Services commission a study to assesspotential mechanisms to encourage companies to tackle important medicalchallenges that may be financially unattractive.

“There is atremendous need for new antibiotics, for example, but the potential marketshare for such medicines is typically small and their duration of use istypically short,” said PCAST member Christine Cassel, a physician who—withLander and PCAST members Ed Penhoet and Rick Levin—oversaw a group of 30outside experts who helped inform PCAST in its work.

大才子

全英文，看不懂，是不是得移动到外语翻译区啊
努力向楼主学习英文

胜利者

大才子 发表于 2012-10-9 19:18
全英文，看不懂，是不是得移动到外语翻译区啊
努力向楼主学习英文

是否移动听版主们的。
斑竹们太谦虚

yongge

悲哀，看不懂，能否翻译一下