OSDD is a Council of Scientific and Industrial Research (CSIR), India, led initiative supported by direct funding from Government of India of Rs. 46 Crores (about $12 Mn) with an overall project outlay of $46 Mn. All are welcome to join OSDD. CSIR (www.csir.res.in) is one of the largest publicly funded research organizations in the world and has played a key role in the development of industry in India by providing them with technologies. It holds a wide array of patents in biological, chemical, engineering, physical and environmental sciences. It has been rated by Thomson Reuters as the most innovative high tech academic organization of India in 2010. Tuberculosis (TB) is the first target disease of OSDD due to its high incidence and mortality rates in India and other developing countries. OSDD has decided, based on its encouraging experience on the work done on TB to extent the open source program for malaria. The OSDD model is scalable and applicable to all diseases without market. Launched in September 2008, OSDD has more than 5975 registered partners from more than 130 countries around the world. OSDD is an open innovation platform, where all the ongoing projects and the research results are reported on the web based platform Sysborg2.0 (http//sysborg2.osdd.net). In about two and a half years OSDD has filled up many areas of the drug discovery pipeline and plans to move to development phase in the near future. OSDD works like an assembly chain for drug discovery where anyone can join at any stage of the pipeline The Collaborative Model: OSDD brings in the concept of open innovation and product development partnership concepts on the same platform and its business model is to ensure affordability by mandating that the drugs that come out of the OSDD platform will be made available as generic, thereby using the already established business models of generic industry. At the early stages of discovery, OSDD puts in place a collaborative model with large community participation, but at development stage collaborates with industry/ contract research organizations and other publicly funded organizations.  Partnerships OSDD engages both public-public and public-private partnerships. A large number of partners are actively engaged on OSDD. More than hundred institutions in India and around the world collaborate in this project. Engagement of Private Partners OSDD demonstrated that private partners can be actively engaged in open source approach and that intellectual property issues will not hamper such collaborations of open source projects with private partners. The two molecules discussed above are on a hit to lead phase in collaboration with two different private partners, who are renowned contract research organizations (CROs) based in India. It is also working with M/s TCGA and Premas Biotech in managing a strain repository. Engagement of Pharmaceutical Enterprises Pharmaceutical industry has made enormous contribution to improving healthcare around the world. Many pharma majors have made considerable investment in research on tropical infectious diseases. The Indian division of Astra Zenecca has been working on TB with commendable results. GSK has adopted open innovation principles. Novartis Institute for Tropical Diseases is dedicated to the diseases of the developing world. Johnson and Johnson is undertaking Phase II clinical trials on an anti TB molecule. Eli Lilly has brought considerable strengths to TB research. OSDD community salutes these initiatives and hopes more will follow. OSDD will actively work with the pharmaceutical enterprises interested in working on TB. OSDD is willing to take forward any promising candidates of TB, using its resources, in collaboration with the industry or otherwise as preferred by the industry. The OSDD guiding principle in all such collaboration is affordable healthcare to the developing world. If a drug comes out of such collaboration, it shall be available, non exclusively, like a generic drug, to the developing world. Transparent Project Funding Mechanism The projects of OSDD are executed and funded through a transparent and open process. The procedures of CSIR in awarding of work to industry is followed in partnership fundings. These are open, transparent and merit based evaluation mechanisms. OSDD Open Call OSDD has an ongoing Open Call to the industry for collaborations. Any pharmaceutical enterprise who has promising clinical trial candidates may express their interest in collaborating with OSDD to carry out clinical trials in India. Interested parties may write to Dr. Sarala Balachandran, Scientist CSIR, at sbalachandran@csir.res.in OSDD is also inviting Contract Research Organizations (CROs) who are working in the areas of pre clinical development phase and clinical trials and those who share the OSDD philosophy of affordable healthcare, to express their interest in working on OSDD projects by writing to to Dr. Sarala Balachandran, Scientist CSIR, at sbalachandran@csir.res.in Contract Research Organizations working in other areas of drug discovery and those who share the OSDD philosophy of affordable healthcare, are invited to express their interest in collaborating with OSDD by writing to to Dr. Sarala Balachandran, Scientist CSIR, at sbalachandran@csir.res.in Institutions Academic and research institutions in India and abroad interested in collaborating with OSDD on TB drug discovery may contact Dr. Geetha Vani Rayasam at gvrayasam@csir.res.in Approach to Intellectual Property: OSDD has a scalable and IP neutral business model to make drugs affordable and accessible to the developing world. A key premise of OSDD is that when it comes to health we need to have a balance between health as a right and health as a business. In the case of tropical diseases the market based incentive mechanisms do not operate. Patents as a mechanism to ensure Return on Investment (ROI) from the market fails to play the role it plays as a driver of innovation in the pharma industry. Intellectual Property as a legal system has limited role to play in fostering innovation in tropical diseases. Therefore the OSDD approach to drug discovery and development is IP neutral. Affordability and accessibility remain the core concerns of delivery of drugs for tropical diseases. The only successful market based model ensuring both is the generic drug industry business model where the market competition is driving the prices to affordable levels and makes competitors seek extended market reach ensuring accessibility. The fundamental principle of OSDD is affordable healthcare to the developing world. Anything that is developed in OSDD will be available to the developing world in open source, generic mode, without price monopolies. This means that there will be no market monopoly associated with OSDD drugs, diagnostic or delivery mechanisms. Markets are the key determinants for delivery of drugs. The drugs will be discovered and developed with public funding. Once a drug is approved for use by the regulatory agencies, OSDD will depend on the business model of generic drug industry which made drugs affordable in the developing countries. OSDD developed drugs will be available for any industry player with appropriate manufacturing practices to distribute the drugs to the market. The market competition will ensure accessibility and affordability. OSDD also understands that researchers may be contributing patented inventions to OSDD or there may be cases where the inventors worked in an open source environment yet would like to file patents. OSDD will encourage such patenting only for ensuring attribution to the inventors and for proving the non-obviousness of the research. In cases where OSDD inventions are covered by patents, it will be used to ensure: i. Affordability and accessibility, by ensuring that the drugs are licensed non exclusively, utilizing open competition in the market, removing the monopolistic nature of IP for access in developing countries; ii. For ensuring quality control of downstream drug manufacturing, by licensing to only those entities who employs quality processes; iii. That the subsequent innovations which follows on the existing patent developed in open source also in open source through its viral clauses. At no circumstances will OSDD hamper further research on any of its patents by any group anywhere as these patents will be available with an open source license which enables further research. While OSDD approach to research and development is IP neutral, it shall respect the intellectual property of others. There may be situations where OSDD may have to enter into collaborations with industry partners who works on the IP based model. In such situations the OSDD approach shall be to ensure that research on tropical diseases progress and result in drugs and that such drugs are available like a generic drug in the developing world. OSDD will honour the IP of its partners and will work with those partners who are IP holders but align with its vision of affordable healthcare to the developing world. Attribution and Authorship When a community collaborates, it does so with some basic rules that governs such collaboration. These rules are laid out in the OSDD license which all community members signs in when they join the Sysborg portal. OSDD license treats the entire information available on the portal as ‘protected collective information’. It mandates common ownership of the data and research results, sharing of such data, contribute back of improvements to the protected collective information. Such Protected Collective Information is held on behalf of OSDD community by CSIR as a trustee holder with legal powers and authority for legal action. A cornerstone of any scientific investigation is attribution. OSDD ensures that all contributions made on OSDD are attributed to the concerned. Intellectual Property, in addition to its other roles, plays a role in attribution (of authorship, invention, etc). Therefore in an open source scientific environment of drug discovery for tropical diseases IP could have a limited role to ensure attribution. Therefore if individual researchers would like to patent their inventions for this purpose, they are welcome to do so, but will need to provide worldwide royalty free non exclusive license to OSDD to work further. OSDD will take forward such molecules in the drug discovery pipeline and make it available without IP encumbrances. Thus IP may play a limited role but within the premises of affordability and accessibility. Since the inception of OSDD in September 2008, a large number of activities have been initiated with several results being produced and some of these have been already published. OSDD encourages the Principal Investigators (PI) to publish their results in peer reviewed publications. OSDD Consortium, in keeping with the spirit of collaboration, has further reiterated the following policy for authorship of various papers for further clarification.
For example, if P1, P2, P3,...Pn are the PIs of the OSDD Consortium; S1,S2, S3,...Sn are the student researchers participating in the project, then the following authorship pattern may be followed: S1,S2... P1,P2, OSDD Consortium, Corresponding PI(s).
OSDD Approach to Clinical Trials One area where doubt has been expressed around the world is on how open source could work in clinical trials. A study conducted by London School of Economics surveying major pharmaceutical industry involved in drug discovery revealed that none of the research based pharmaceutical enterprises are willing to invest in risky clinical trials for neglected diseases, particularly as these trials conducted in the developed world are expensive. This is not a desirable situation as the pipeline of drug candidates will remain dry in tropical diseases. OSDD model believes that the alternative is publicly funded clinical trials involving public institutions where infrastructural and other capacity has to be built up for conduct of trials. OSDD understands that introducing more TB drugs in the market which is an absolute necessity will be possible only if it offers to conduct clinical trials of molecules developed by it or developed by others on the condition that it holds the rights to the drug in developing countries so that the drugs are available like generic in developing countries. With the good will OSDD has generated and the participation of public funded institutions the cost of trials can be brought down considerably on the open source platform. The countries with disease burden have a special responsibility to solve the problem. India has high disease burden and a cost advantage but infrastructure necessary for the conduct of trials in TB may have to be built up. OSDD will demonstrate the applicability of this model in the case of TB. This approach is disease and country neutral (any developing country) and can be scaled up. The experience of CSIR in conducting clinical trials is a guiding point. Two important points govern the principles under which clinical will be conducted under the CSIR/OSDD umbrella but with the Open source concept. The main features guiding success: - The clinical trials under OSDD program will be conducted with substantial partnership from publicly funded hospitals. Additional expertise will be sought from private pharma in the country as well as experts from large international pharma who are committed to helping in the progress of molecules in the neglected disease arena. In order to ensure that appropriate processes and documentation required for clinical trials and during the conduct of it are maintained to internationally acceptable standards, the clinical trials will need be conducted in collaboration with CRO’s or industry partners with experience in the field. -Private pharma will be inducted as a stake holder very early in the process of conducting clinical trials. The arrangements with the different stakeholders ensure that the drug will be made available to the generic industry in India for manufacture which in turn ensures ‘affordable pricing’. In all cases where clinical trials are conducted by OSDD, the data will be available in the open and high standards will be adhered to. Thus, OSDD has a clear alternative approach for the expensive clinical trials conducted in secrecy and at high cost. OSDD approach is that clinical trials for tropical diseases have to be de risked by investing public sector funds and involving public institutions in the countries where disease occurs. This will bring down the cost of clinical trials. OSDD ensures that clinical trial data, sans personal details, is made public so that community inputs are available while conducting clinical trials and for later designing of new trials. OSDD will also make the commitment that these trials will be conducted following all national regulations, following the best ethical practices in a transparent manner and will be monitored by an independent group appointed by the OSDD. |
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