The Safety Pharmacology Society salary survey.

INTRODUCTION: Safety pharmacology is a growing discipline with scientists broadly distributed across international geographical regions. This electronic salary survey is the first to be distributed amongst the entire Safety Pharmacology Society (SPS) membership. An electronic survey was sent to all members of the Society. Categorical survey questions assessed membership employment types, annual incomes, and professional certifications, along with other associated career attributes. METHODS: This survey was distributed to the SPS membership that is comprised of safety pharmacologists, toxicologists and pharmacologists working globally in the pharmaceutical industry, at contract research organizations (CRO), regulatory agencies, and academia or within the technology provider industry. The survey was open for responses from December 2015 to March 2016. RESULTS: The survey response rate was 28% (129/453). North America (68%) was the region with the largest number of respondents followed by Europe (28%). A preponderance of respondents (77%) had 12years of industry experience or more. 52% of responders earned annually between $40,000 and $120,000. As expected, salary was generally positively correlated with the number of years of experience in the industry or the educational background but there was no correlation between salary and the number of employee's directly supervised. The median salary was higher for male vs female respondents, but so was median age, indicative of no gender 'salary gap'. DISCUSSION: Our 2016 SPS salary survey results showcased significant diversity regarding factors that can influence salary compensation within this discipline. These data provided insights into the complex global job market trends. They also revealed the level of scientific specialization embedded within the organization, presently uniquely positioned to support the dynamic career paths of current and future safety pharmacologists.

Does targeted, disease-specific public research funding influence pharmaceutical innovation?

Public funding for biomedical research is often justified as a means to encourage development of more (and better) treatments for disease. However, few studies have investigated the relationship between these expenditures and downstream pharmaceutical innovation. In particular, although recent analyses have shown a clear contribution of federally funded research to drug development, there exists little evidence to suggest that increasing targeted public research funding for any specific disease will result in increased development of drugs to treat that disease. This paper evaluates the impact of changes in the allocation of U. S. National Institutes of Health (NIH) extramural research grant funding across diseases on the number of drugs entering clinical testing to treat those diseases, using new longitudinal data on NIH extramural research grants awarded by disease for years 1975 through 2006. Results from a variety of distributed lag models indicate that a sustained 10 percent increase in targeted, disease-specific NIH funding yields approximately a 4. 5 percent increase in the number of related drugs entering clinical testing (phase I trials) after a lag of up to 12 years, reflecting the continuing influence of NIH funding on discovery and testing of new molecular entities. In contrast, we do not see evidence that increases in NIH extramural grant funding for research focused on specific diseases will increase the number of related treatments investigated in the more expensive, late-stage (phase III) trials.

How do the top 12 pharmaceutical companies operate safety pharmacology?

INTRODUCTION: How does safety pharmacology operate in large pharmaceutical companies today? By understanding our current position, can we prepare safety pharmacology to successfully navigate the complex process of drug discovery and development? METHODS: A short anonymous survey was conducted, by invitation, to safety pharmacology representatives of the top 12 pharmaceutical companies, as defined by 2009 revenue figures. A series of multiple choice questions was designed to explore group size, accountabilities, roles and responsibilities of group members, outsourcing policy and publication record. RESULTS: A 92% response rate was obtained. Six out of 11 companies have 10 to 30 full time equivalents in safety pharmacology, who hold similar roles and responsibilities; although the majority of members are not qualified at PhD level or equivalent. Accountabilities were similar across companies and all groups have accountability for core battery in vivo studies and problem solving activities but differences do exist for example with in vitro safety screening and pharmacodynamic/pharmokinetic modeling (PK/PD). The majority of companies outsource less than 25% of studies, with in vitro profiling being the most commonly outsourced activity. Finally, safety pharmacology groups are publishing 1 to 4 articles each year. CONCLUSION: This short survey has highlighted areas of similarity and differences in the way large pharmaceutical companies operate safety pharmacology.

Natural products drug discovery: accelerating the clinical candidate development using reverse pharmacology approaches.

The pharmaceutical industry is facing serious challenges as the drug discovery process is becoming extremely expensive, riskier and critically inefficient. A significant shift from single to multi targeted drugs especially for polygenic syndromes is being witnessed. Strategic options based on natural product drug discovery, ethnopharmacology and traditional medicines are re-emerging to offer good base as an attractive discovery engine. Approaches based on reverse pharmacology may offer efficient development platforms for herbal formulations. Relevant case studies from India and other countries where such approaches have expedited the drug discovery and development process by reducing time and economizing investments with better safety are discussed.

Reconsidering Japan's underperformance in pharmaceuticals: evidence from Japan's anticancer drug sector.

Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.

One target-multiple indications: a call for an integrated common mechanisms strategy.

Ever-increasing research and development costs are putting constant pressure on the pharmaceutical industry to improve their efficiency. Efforts to increase the output of the research pipeline have yielded limited success. Traditionally, maximization of the value of a drug is attempted through life-cycle management, which is initiated late in development, or when the drug is already on the market. Validated targets can be exploited further through development of a follow-up drug, which may offer advantages regarding safety or convenience. In this article, we propose to systematically evaluate the full therapeutic potential of a drug target, proprietary chemical lead structure, or drug candidate as broad and as early as possible and we call this the 'common mechanism' approach.

A cost-effectiveness approach to the qualification and acceptance of biomarkers.

The flow of new medicines to patients depends on the development of new biomarkers and their correct interpretation, yet there are no widely accepted and practically applicable criteria that facilitate adequate biomarker qualification. As a result, case-by-case qualifications are based on subjective assessments that do not lead to optimal decisions for patients, which have contributed to the 'stagnation' in drug productivity identified by the FDA. An alternative is to qualify biomarkers in terms of cost effectiveness using a set of principles that enable the evaluation of biomarkers even with incomplete knowledge. This approach could minimize harm to patients, improve access to medicines and reduce healthcare costs.

Drug Discovery and Development Asia-Pacific Conference 2005. Strategies and case studies of successful alliances, licensing and outsourcing partnerships.

Delegates gathered at the conference to hear speakers presenting talks from a business and strategic viewpoint. This report highlights selected presentations relating to promotional alliances, globalization of R and D and successful collaborations.

Issues affecting the growth of independent prescribing.

AIM: To investigate factors that have influenced A&E departments, minor injury units (MIUs) and walk-in centres (WICs) on whether or not to send nurse practitioners on extended nurse prescribing courses. Also, to examine the extent to which nurses who have completed an extended course are independently prescribing in their everyday practice. METHOD: A pilot study was undertaken in 20 randomly selected units, and following minor changes the main study was carried out by sending a questionnaire with a stamped addressed envelope to all nurse managers in 307 units. The response rate was 62 per cent (n=192). RESULTS: The study found that 71 per cent (n=20) of WICs, 30 per cent (n=33) of A&E departments and 20 per cent (n=11) of MIUs have sent nurses on extended nurse prescribing courses. The most striking result was that 44 per cent (n=28) of nurses were still not prescribing even after completing the course. Patient Group Directions (PGDs) are the most common method for nurse practitioners to obtain medication for patients and 81 per cent (n=52) of nurses who have completed the course would continue to work under PGDs to supplement the formulary. CONCLUSION: It was surprising and worrying to find that less than half (n=28, 44 per cent) of nurse prescribers do not prescribe after completing the course. The reasons for this are unclear but could include: inappropriate selection of staff and problems accessing prescription pads, lack of peer supervision and inadequate knowledge of pharmacology. More studies are needed to understand the reasons and to help ensure government targets on increasing the numbers of nurse prescribers are met.