scholarly journals Assessing implementation mechanisms for an international agreement on research and development for health products

2012 ◽  
Vol 90 (11) ◽  
pp. 854-863 ◽  
Author(s):  
Steven Hoffman ◽  
John-Arne Rottingen
2013 ◽  
Vol 16 (2) ◽  
pp. 123
Author(s):  
Basil D Roufogalis ◽  
Arthur D Conigrave ◽  
Emanuel E Strehler

This Special Issue of the Journal of Pharmacy and Pharmaceutical Sciences arises from an inaugural conference on “Mechanism-Based Natural Product Development” held at Whistler Mountain, Canada on September 21-22, 2012. The aim of the conference was to bring together scientists from various disciplines to discuss the development of new therapeutic products from natural medicines based on mechanistic and related scientific studies. It provided an opportunity to explore new directions in natural medicine research and development, with the ultimate objective of leading to greater integration of natural and conventional synthetic pharmaceutical medicines for the health of the community worldwide. The concept for this conference and the Special Issue has come from the growing interest internationally in traditional and natural medicinal health products in recent years. It may, at first, appear surprising that developed countries are re-embracing natural product research and development. There are of course many reasons for this, including growing community interest in natural products providing improved health and wellbeing, the growing difficulty and cost of maintaining a pipeline of effective and, above all, safe new products for chronic diseases in the mainstream pharmaceutical industry, and the knowledge that many of our small drug pharmaceutical medicines have come from plants and other organisms. But as traditional natural product medicines increasingly enter the mainstream, the call for evidence to support their use also grows louder. Essential to the acceptance of natural medicines are the validation of their traditional uses and identification, isolation and structural characterization of their active components, together with the elucidation of their mechanisms of biological action, adverse effects, and identification of their molecular targets. These requirements provide the focus of this Special Issue. Scientific investigation and development of new health products requires the joining together of many disciplines, including chemistry, pharmacology, pharmacognosy and cell and molecular biology, as well as integration with clinical medicine. Natural product medicines are expected to be multi-component and multi-targeted. Are they effective, safe and properly standardized in their existing formulations? Are there opportunities to isolate single active components for standardization and conventional drug discovery and development? Answering these questions requires collaboration between scientific disciplines focused on a common goal. In line with the aims of the conference, the Special Issue has incorporated review and original research articles related to mechanisms of action in a number of therapeutic areas, mostly from invited speakers at the Whistler conference. Other articles were unsolicited submissions to the Journal that satisfy the scope of the issue. Articles range from reports on efforts to work with traditional owners in the appropriate cultural context, to develop new therapeutics based on traditional literature, to discover new medicinal products, to develop new pharmaceuticals based on the isolation of active chemical components, to develop new methods of delivery, and to identify mechanisms of action. The medical 'territory' includes cancer, heart disease, diabetes and related chronic inflammatory diseases, pain pathways, deafness and infertility. Other articles investigate the quality and safety of products by the application of current analytical methods, the potential for interactions of natural products (e.g., cranberry) with pharmaceutical medicines and the variability of a selection of similar natural product medicines with regard to their contents of therapeutically beneficial and marker compounds, as claimed on the product labels. In addition, the issue includes the abstracts of posters that formed an important part of the conference, especially from postgraduate students and postdoctoral fellows. These are included as Proceedings. We are indebted to the scientists who willingly gave their time and resources to attend the Whistler conference and, in many cases, submitted manuscripts for inclusion in this Special Issue. The delegates and contributors came from many places, near and far, to make this inaugural conference on mechanism-based natural product development a success. Such a conference and the subsequent proceedings in the Special issue are not possible without the work of many. We thank the organizing and scientific committee for their support and valuable suggestions. A conference of this scope would not be possible without sponsorship; this includes especially the National Health Products Research Society of Canada, the Canadian Society for Pharmaceutical Sciences and several Universities. Major support, without program or editorial input, was provided by SOHO Flordis International (SFI). We commend them for believing in the quest for clinically proven and research-based products based on an understanding of underlying mechanisms. The support of Purapharm International is also gratefully acknowledged. We would like to dedicate this Special Issue to Professor Allan SY Lau of the University of Hong Kong, who contributed enthusiastically to the organization of the conference and its program, but was ultimately unable to attend due to his untimely passing. Professor Lau was a pioneer in the integration of natural and orthodox medical studies and his inspiration will be greatly missed. Basil D Roufogalis, Arthur D Conigrave and Emanuel E Strehler Co-Guest Editors


F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 116
Author(s):  
Maël Redard-Jacot ◽  
Devy M. Emperador ◽  
Eva Junyent ◽  
Mickey Urdea ◽  
Rich Thayer ◽  
...  

Background: The Portfolio-To-Impact version 2 (P2I v.2) financial forecasting tool estimates funding requirements for development of portfolios of candidate health products (drugs, biologics, vaccines or diagnostics). The assumptions and archetypes relating to diagnostics in P2I v.2 are based on limited data and may not accurately describe research and development costs, timelines and probability of success. This study aimed to revise the P2I v.2 tool by modifying the diagnostic assumptions to improve accuracy of predictions for diagnostic portfolios. Methods: Data from expert interviews and historical information on development of 26 existing diagnostics were used to determine approximate research and development costs, timelines and probability of success for development of diagnostics, and to revise diagnostic archetypes and development phases. To compare the revised tool with P2I v.2, data on 27 candidates from the Foundation for Innovative New Diagnostics (FIND) tuberculosis and pandemic preparedness portfolios were input into both versions. Results: The number of diagnostic archetypes increased from two in P2I v.2 to three in the revised tool. Total estimated costs to move the 27 candidates along the pipeline to launch were US$641.62 million with P2I v.2 and US$274.00 million with the revised model. The number of expected launches was 21.65 over five years with P2I v.2 and 11.48 over eight years with the revised model. Development timelines were extended and probability of success was lower with the revised model compared with P2I v.2. Conclusions: Outputs from the revised tool were in line with expert experience, suggesting that the proposed revisions improve the accuracy of the tool for estimating research and development costs, timelines and probability of success relating to diagnostic portfolios. Additional improvements to the tool could include further refinement of archetypes, incorporation of a measure of potential public health impact, and addition of a commercialization phase for diagnostics.


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