What is OSDD

OSDD - NKN ; An introduction

OSDD is a CSIR led team India Consortium with global partnership with a vision to provide affordable healthcare to the developing world by providing a global platform where the best minds can collaborate & collectively endeavor to solve the complex problems associated with discovering novel therapies for neglected tropical diseases like Malaria, Tuberculosis, Leshmaniasis, etc.OSDD is a translational platform for drug discovery, bringing together informaticians, wet lab scientists, contract research organizations, clinicians, hospitals and others who are willing to adhere to the affordable healthcare philosophy. It is a concept to collaboratively aggregate the biological, genetic and chemical information available to scientists in order to use it to hasten the discovery of drugs. This will provide a unique opportunity for scientists, doctors, technocrats, students and others with diverse expertise to work for a common cause. The success of Open Source models in Information Technology (For e.g., Web Technology, The Linux Operating System) and Biotechnology (For e.g., Human Genome Sequencing) sectors highlights the urgent need to initiate a similar model in healthcare, i.e., an Open Source model for Drug Discovery.

Council of Scientific and Industrial Research (www.csir.res.in) India is one of the largest publicly funded research organizations in the world. CSIR has played a key role in the development of industry in India by providing them with technologies. In particular, it has been one of the key drivers of Indian pharmaceutical industry. OSDD is supported by direct funding from Government of India of Rs. 46 Crores (about $12 Mn) with an overall project outlay of about $46 Mn.

The OSDD consortium launched in September 2008 has more than 7300 registered users from more than 130 countries around the world, and has emerged as the largest collaborative effort in drug discovery. Launched on the three cardinal principals of Collaborate, Discover & Share, it is a community driven open innovation platform to address the unmet need of research and development of drugs for diseases that affect the developing world. It's objective is affordable health care.

All are welcome to join OSDD.

OSDD Philosophy

The motto of OSDD is “affordable health care for all”. OSDD applies the open source philosophy, ‘many eyeballs makes the bug shallow’ to the science of drug discovery. The principles of open innovation through open collaboration and sharing underlies OSDD approaches.

OSDD understands that the reason for failure to get adequate research investments to the tropical infectious diseases is the absence of a market which ensures return on investment for the industry. These diseases mostly affect the poor and therefore lack an appreciable market. Affordability and Accessibility of drugs to the affected population is at the core of OSDD philosophy.

OSDD aims to bring the best minds to drug discovery through open innovation and best partners with experience of drug development through product development partnerships. OSDD is an open innovation platform, where all the projects and the research results are reported on the web based platform Sysborg 2.0 (http//sysborg2.osdd.net). The drug development for tropical diseases carried out in those countries with diseases situs, in collaboration with the best minds of the world will make the research and development less expensive, compared to the traditional approaches followed in the industry. To ensure affordability, the drugs that come out of the OSDD platform will be made available like a generic drug, without Intellectual Property encumbrances. OSDD thus relies on the already established business models of generic industry for delivery of drugs.

The Collaborative Model

OSDD is a collaborative effort that comprises of researchers, students and organizations across the world. The OSDD is a large community comprise more than 7300 registered users of the portal from 130 countries. 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.

Transparent Project Funding Mechanism

The projects of OSDD are executed and funded through a transparent and open process.Investigators who require funds for scientific projects which add value to TB drug discovery and development are required to upload their project proposals on Sysborg 2.0 portal. Projects are funded through open peer review that takes place on the portal. The procedures adopted by CSIR in awarding of work to industry, is followed in partnership funding. These are open, transparent and merit based evaluation mechanisms.

OSDD Approach to Clinical Trials

A study conducted by London School of Economics surveying major pharmaceutical industry involved in drug discovery revealed that most of the research based pharmaceutical enterprises are not willing to invest in risky clinical trials for neglected diseases, particularly as these trials conducted in the developed world are expensive. In this background, the pipeline of drug candidates will remain dry in tropical diseases.

OSDD model believes that the governments and public funded institutions in the countries with high burden of disease has a responsibility to contribute to the drug development. OSDD alternative is to conduct publicly funded clinical trials involving public institutions. These trials will have to be conducted with internationally accepted standards. Infrastructural and other capacity may have to be built up for conduct of trials, but there are countries like India where such facility already exists in many diseases.OSDD will carry out its clinical trials with the participation of public funded institutions. The cost of trials can therefore be brought down considerably on the open source platform. CSIR has brought many drugs to the market after clinical trials. The experience of CSIR in conducting clinical trials is a guiding point.

Two important points govern the principles under which clinical trials will be conducted under the CSIR/OSDD umbrella but with the Open Source concept. The main features guiding success:

Appropriate processes and documentation required for clinical trials and during the conduct of it, are maintained to internationally acceptable standards, in collaboration with CRO’s or industry partners with experience in the field.

Private pharma will be inducted as a stake holder in the process of conducting clinical trials. The arrangements with the different stakeholders will be with the understanding that the drug will be made available to the generic industry 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 de risks clinical trials for tropical diseases by investing public 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.

OSDD Approach to Intellectual Property

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 fail to play the role it plays as a driver of innovation in the pharma industry. In the absence of a market size that attracts the interests of the pharmaceutical industry, Intellectual Property (IP) Rights 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 follow on the existing patent remain openly accessible through the OSDD community 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 those drugs are available like a generic drug to the developing world. OSDD will honor 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.

In the cases where data that is used in the paper or in the execution of the project, has been generated by the OSDD Community, the OSDD Consortia needs to be given authorship

When the OSDD Consortium is given authorship, it should be before the Corresponding author(s).

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).

There may be projects where the Chief Mentor has actively contributed and merits authorship. In such cases, his express consent should be taken to include him as an author.

If there are specific and significant contributions of individual students or Principal Investigators of the OSDD Community they need to be given authorship.

As there are a large number of projects being pursued under OSDD, it is likely that there will be many publications. To avoid duplication and to ensure that the micro attribution system has been followed, the manuscript should be submitted to the OSDD portal prior to sending the publication.