1. CATALYZING COLLABORATION BETWEEN INDUSTRY/ ACADEMIA/ LABORATORIES FOR DRUG DISCOVERY AND DEVELOPMENT Sushma Berlia President, Apeejay Stya Group 'International Conference on Translational Pharmacology and 41st Annual Conference of Indian Pharmacological Society'. 20th December, 2008, AIIMS
The basic Issue is about how to catalyze the collaborations between Industry, Academia and Laboratories?

2. Traditional model: Independent contributions to society
Research
Publications
Products
Services
Grads
To start with this is the Traditional Model where each University/Academia, Industry and Laboratory are contributing independently to the economy, society.
University
Laboratory
Industry
Universities, Industry & Laboratories continue to produce their traditional output

3. New Model: University-Industry - Laboratory partnership Contd….
Society
Research
Publications
Grads
New
Opportunities
Products
Services
This is the new model whereby University/Labs/Industry collaborate in joint research, hiring & Exchange, Licensing etc & contribute to the society, economy in different ways.
This new model because of the new Demands.
University
Industry
Joint Research, Hiring & Exchange,
Collaboration, Licensing
Laboratory
Ideally Laboratories should be based in/near universities

4. New Models: University-Industry - Laboratory partnership
Through real-time relationship and direct technology transfer-
University, Laboratory and industry together will produce new opportunities, such as new Products, new ventures & new industries
Government (central & State) for positive cooperation to take place -
provide stable environment & encouragement, and
protect the interest of the people
Government also provides important Science & Tech. funding
New models because of new demands.

5. INNOVATION It is all about Why these new Demands?
From where have these new demands emerged.
Need for innovation

6. Innovation – attributes
The process leading from the discovery or invention of a new idea or technology to its practical implementation (often via commercialization)
Early stage (basic research): typically without a practical implementation (product) in mind
Late Stage (development): driven by technology and cost demand of a real-world application
Usually, different stakeholders are involved at different stages
Innovation consists of these attributes. Each stage have to be looked at in its own manner as – we have said that different stakeholders are involved at different stages- at some stage academia is involved and at some stage industry and Labs may be more involved. Now the Question is why Innovation at all Necessary?....

7. Why Innovation?
Innovation is critically important for any advanced country
Now: an era of rapid, revolutionary technology progress and new markets (Knowledge Economy)
Industry faces ever more severe economic conditions
New world wide competition,
more knowledgeable customers require
Efficiency,
Sophisticated planning, and
Current financial meltdown
How to bring about innovation? In order to bring about innovation we need to look at what would be the best systems which help to contribute towards a knowledge society. We have seen the traditional model earlier. Keeping in view the new model we saw the new demands. These new Demands lead to Innovation. Now in this innovative system we have to look at what would be the nature of demands?

8. Nature of Demands?
Quicker, more flexible response by Universities & Laboratories to Industry needs
More practical output from Universities & Laboratories: Intellectual Property, ventures
Better knowledge acquisition by companies from Universities & Laboratories
Identify and develop new business ideas more rapidly
Keeping in view the nature of the demands requiring innovations, the new models for the differing roles of the universities, Labs and Industries need to be examined

9. University, Lab.. & industry roles in an innovation system
Funding Source
Industry
Government
Mfr. & Market
Product Dev.
Applied research
Basic research
Central Laboratories
Industry
Development Division
University
Tech
Transfer
Implementation Organisation
Natural division of Labour
Basic research: govt. funds, university conduct
Product development: industry funds, industry conduct
Transition in innovation system at Applied Research stage
Both industry and govt. fund applied research
All university, Laboratory & industry conduct
Technology (knowledge) transfer
Internal to industry: from research lab to development groups
From University - Laboratory - Industry and vice versa
In order to have an innovative system and keeping in view the nature of demands this is the kind of role we envisage for university, Labs & Industry. Their roles cannot be envisaged in vaccum but rather keeping in view industries and universities expectations.

10. Industry Needs and Expectations
Large industrial houses have the resources to invest in technology development but Academic participation is often needed in minor technological innovation
Medium & small scale industry, often depend on support in the areas of
Design process, improvement and machinery performance
Rely on process to yield a product which already exist
Problem solving accounting to Product testing and Production enhancement in terms of quantity & quality
Ancillary facility to medium and large scale industries.
In its interaction with the academia
industry's expected time frames are immediate
investment is directed towards efforts that promise result- oriented solutions.

11. Academia Expectations
Academia shows interest normally in problem solving that are intellectually challenging
Academia interest lies in
Technology development initiatives.
Methods related to process & design improvement
Work towards creation of knowledge in specialized areas.
Multidimensionality of a problem leading to explore a variety of options to arrive at a solution which is time consuming
In academia, time frame of an academician is governed by research guidance and teaching assignment
Academicians are oriented towards R&D activities of the Industry for funds which helps them to sustain their broader research interest
With these expectations in mind the collaboration envisaged have to be benefit each in other world a win-win situation.
Now let us see how collaboration translates into benefits for Industry & for Academia

12. Industry Benefits
Opportunity to leverage research resources to gain access to external sources of expertise in a cost – effective fashion.
Academic knowledge base to improve industrial cost, quality and competitive dimensions, reducing dependence on foreign know-how and expenditure on internal R&D
To access expertise not available in corporate laboratories.
To aid in renewal & expansion of a company’s technology.
To gain access to students as potential employees.
To use the university as a means of facilitating the expansion of external contacts for the industrial laboratory.
To expand pre-competitive research, both with universities and with other companies,
To leverage internal research capabilities, and
To grow its business by using the results of the academia

13. University Benefits
Allow universities to gain access to external sources of expertise and funding.
To earn additional resources for the university’s educational and research mission severely constrained financially.
To fulfill the university’s service mission.
To broaden the experience of students & faculty.
To identify significant, interesting and relevant problems.
To enhance regional economic and social development.
To increase employment opportunities for students.
To move Results of fundamental research from the laboratories to the common man’s place.
To move Discoveries from the Academic Institution to the market place
In order for these benefits to flow we have to find out the ways and means for catalyzing the interactions.

14. Means for catalyzing interaction
Understand, define shared & distinct goals & expectations of each party
Identify potential conflict of each party
Define deliverables and anticipated timelines
Unequal expectations can cause significant frustration if not clarified
Establish upfront the use of the data (publication, patents)
Know what your intentions and expectations are - Be clear as to how the results can be used
Focus on relationship - Every interaction is the basis for a long-term relationship
Deliver what you promised
Be certain what’s expected of you
Don’t be afraid to reach out beyond your own areas of expertise
Deliver more than asked……specific to the industry
Communicate…….Communicate……..Communicate
In order to promote and catalyze this type of interaction which obviously is not taking place we need to consider first of all what are the kind of collaboration models which are possible.

15. Collaborations: Collaborative & Licensing
Mechanisms through which universities, Laboratories and Industries can work together
Sponsored research: Companies directly funding university research.
Collaborative research: encouraged through partial govt. Funding.
Consortia: Groups of companies and universities engaged in various research efforts of common Group interest.
Technology licensing: Licensing of university patents (stemming from govt. funded research) to Companies for commercialization.
Start-up companies: Involving university faculty, obtain licensing agreements to access University technologies.
Exchange of research materials: To expedite the performance of research & accomplished through material transfer agreements.
Collaborations
Licensing

16. Some other forms of collaborations……..
Universities employing practicing professionals from industry as part-time guest faculty and/or constituting a Research Chair
Offering short-term courses for professionals in industry,
Visiting researchers from industry in the University, Laboratory taking up specific industry problems
Cross lecturing/ hiring/deputizing/ training
Summer trainings/project for UG/PG students and research scholars in industry
Sponsored projects to academia including research fellowships or Post-doctoral fellowships on topics of their interests
Industry mentors for Ph.D students
Industry encouraging their personnel to take up projects in Academia which are of interests to their employers
Membership in Industry affiliate programmes & Research Labs
Use of Industry researchers of university & research Labs
Let us see what are some of the inhibiting factors both for Industry and academia in the process of collaboration.

17. Inhibiting Factors – For Industry
Insensitivity to and lack of awareness of the resource potential of the academia
a blind, herd-like obsession with
expensive, high-profile professional consultants,
easy availability of foreign know-how,
compulsions of existing technical collaboration agreements,
bad experience of earlier interactions with academia,
anxiety to keep problems and breakthroughs confidential for
fear of losing the competitive edge.

18. Inhibiting Factors – For Academia
Apathy towards applied research and extension
reluctance to leave the comfort zone of pure teaching;
inadequate marketing of its strengths to industry;
lack of a critical mass of experts and specialized technical infrastructure;
overspecialized loyalties and reluctance to collaborate in inter-disciplinary problem-solving;
unhelpful, restrictive internal policies and procedures
discouraging or frustrating academicians' attempts to collaborate with industry.
Let us see what are some of the key parameters derived from various successful collaborations models

19. Best practices - Key parameters for of Successful Partnership
Universities seek partnership if actively supported by faculty
Straightforward & transparent structure for corporate arrangements that defines acceptable parameters for
confidentiality, handling of intellectual property, financing (especially indirect costs) & conflict resolution should be in place
Scientific projects supported by industry have clear objectives, timelines and milestones
Acceptance of the notion of industry sponsorship in the academic department leadership, such that there is not a stigma associated with faculty working with industry
On the industry side there is a internal expert of the proposed work having support of sr. management and who is-
responsible for fostering collaboration and ensuring deliverables are actually of interest and have future in the company
Collaborations is of sufficient duration-chance for personal connection & mutual trust to be established by all the parties involved
Let us see live example of Silicon Valley – collaborations which have benefited not only those involved but the economy & the nation as a whole.

20. Best Practices: Silicon Valley-Stanford Model
Earlier - universities considered as Ivory towers where
Learning, academic endeavors pursued in isolation from practical personal needs or economic development
More concerned about the implications of industrial involvement with academic freedom
The situation changed in 1995 with the leadership and vision of Frederick Terman and realised
Industry-Academia-Research interaction imparting relevant knowledge and contributing to sustainable knowledge
Cooperation started at small university grew to become Silicon Valley of California by design of people with vision
Business creation through collaboration involving
students, faculty, institution and industry (recruiting top scholars creating constructive & productive collaborations between Stanford & Local companied)

21. Best Practices: Silicon Valley-Stanford Model Contd…
University supporting the continued development of technology & their relationship
The Univ. park (1962) opened 42 companies employing 12,000 people
Today as many as 100 ‘Stanford start-ups’ in Silicon valley contribute more than $65 billion to the economy
Concept of business creation in Academia is pervasive-
interest in entrepreneurship across Univ. enhanced with targeted teaching, research & outreach programmes involving various disciplines

22. Collaborations for Drug development
Opportunities for enhanced collaborations
Develop mechanisms that facilitate learning from failed drug targets
Create collaborative system to enable the sharing of toxicology date across the industry and govt.
Establish joint models for biomarker validation
Set up a consortium to analyze and learn from failed clinical trails
Identify and propose to govt. new regulatory incentive policies for small market drugs
Develop model agreements for sharing information now restricted as intellectual property or proprietary
To increase the pool of shared knowledge
Stimulate collaborative R & D across the sector, and
Enable learning from failures at every stage of drug development

23. Commercializing discoveries
Collaborations for Drug development Contd…
Commercializing discoveries
Financial return on industry investment in academia & Research through both licensing and funding of basic research can be similar to that on investment in their own internal research programs.
most "innovative" drugs found that almost half were directly derived from non industry sources (that is, universities, government labs and research hospitals) (1990 study by Maxwell and Eckhardt)
Further, the development of many pharmaceutical blockbusters followed a common path in which discoveries made from federally funded basic research conducted in academia were translated into drugs by pharmaceutical and biotechnology companies.
Examples include cholesterol-lowering drugs (such as the statins), nuclear hormone receptor modulators and protein therapeutics (such as Epogen (erythropoietin)).
Industry increasingly interested in investing in research performed in academic settings as a complement to its own research efforts.
Accordingly, the number and types of arrangements between Academic, Research and industrial partners has proliferated.
Now we can talk of where we are and what are the inhibiting factors for such as low research output and further in the catalyzing of the interaction particularly in India.

24. Research constraints in India
India lags behind in spending on research and development work as well as number of scientific researchers
Country
No. of people in R & D*
% of science and engg. Students**
R & D Expenditure % of GDP
% of funding from Industry***
% of funding from Govt.***
% of funding from other***
HDI rank
Japan
5085 20
3.1 77 16 7 11 US
4700 19
2.7
63.1
31.2
5.7 10
Russia
3415 40
1.2 29 63 8 62
S. Korea
2979 41
2.5 75 22 3 28
China
633 25 70 5 85
Brazil
324
1.0 -
India
156
0.8 23
74.7
2.3
127
Apart from that the numbers of doctoral degrees awarded in science & engineering in India it is a
little over 6500 doctorates, compared to 9000 in China and in the US.
As far as published research is concerned
India stands at the 13th position in terms of the number of papers published;
It ranks 21 in terms of number of citations with citations per paper being as low as 3.17 (119 rank out of 149 countries) compared to in case of the US.
The US has the largest share of papers and also the citations.
Even smaller countries like the Netherlands and Switzerland have large citation and publication counts as compared to India.
Patents - Patenting is an important measure of innovation. Number of PCT applications filed by a country is a good measure of the innovative capacity of a country.
Patents from India has been very low compared even to china while those from other countries have increase substantially. The number of patents approved as a proportion of application made has improved minimally but not really in drug discovery.
All these have impacted the countries development. Country has suffered by separating scientific research and education in its institutions
*Researchers per million of population, ** In tertiary education, Source- UNDP, *** Global R&D Report, 2008
- Developed countries have R&D expenditure of up to 3% of GDP
- Of the 0.8% expenditure in India, public sector- 75%, Pvt. sector only 23%.
Amount spend on R&D in India Rs. 19,200mill US$ whereas US , China-72,014, Japan 106,854, Russia- 16,838, Korea 24,869
Out of the total expenditure on R&D, percentage spent on Higher edu. Inst. is very low in India 2.9% as compared to 16.8% in US, 10.1% china, 13.9% Japan & 17.1% Germany

25. Collaborative research in India – the missing link
In every country that has a significant scientific presence, fundamental research takes place in universities that handle UG & PG teaching
In India Research Institutions/laboratories were created independent of the university system
Country has suffered by separating scientific research & education in its institutions
We have universities that teach science at UG & PG levels and separate national laboratories that carry out research at doctoral and post-doctoral level
No interaction between the two- having twin negative impact
It kept students from best scientist, and
Kept the scientist away from the best students
Over the year both declined in quality – students in India has missed the opportunity to be taught by top scientist & interact with PhDs
The research labs failed in their basic mandate of acting as a liaison between the academic and industrial/societal worlds
Attempt to bring education and research together, the way it happens in world’s best universities
Initiatives in India & Roadblocks that needs to be overcomed.

26. Initiatives in India
In India there are instances of this linkages, however they take place in discrete pockets, and are not widely prevalent
And some sporadic efforts have come up
Institutes such as the IIS, Bangalore & the IIT’s and some prominent institutes have ongoing research engagements with companies in various industries on a one-one basis.
IIT Kharagpur and the TeNet (Telecommunications and Computer Networks) group of IIT Chennai are arguably the earliest to have deployed the consortium model.
TIFAC- providing technology linked business opportunities(Lab/Indy.)
National Entrepreneurship Network (NEN) to develop the next generation of high growth entrepreneurship in India
IISER devoted to science education and research
NFSE to oversee and funds research & new fellowship
CSIRs Open Source Drug Discovery' (OSDD) programme
NIPER centre of excellence for advanced studies & research in pharmaceutical sciences
As it has been already discussed
CSIR has launched a unique collaborative programme to discover drugs for infectious diseases common to the developing countries. The 'Open Source Drug Discovery' (OSDD) programme, launched by CSIR, aims to build a consortium of global researchers and bypass the patent regime, which makes drugs expensive, because the normal process of drug discovery, through the patent regime, has not worked very well for diseases in our part of the world
Inspired by open source movements like Linux and the human genome sequencing project, OSDD seeks to expand resources for research manifold by allowing collaboration among voluntary researchers.
Laboratory experiments during this process will be carried at CSIR-sponsored centres.

27. National Institute of Pharmaceutical Education & Research (NIPER)
Institute of National Importance engaged in
teaching & research
Promoting collaborative research with Industry
Some Key features
Research programmes & interacting with industry
Availability of Pilot plant for processing bulk drugs & natural products
Facilities for scale up studies for bulk pharmaceuticals
Process for licensing of APIs
Preformulations studies of new molecular entities
Biotechnology unit to create awareness in pharmaceutical bio-tech
Distinctiveness
Research & training in advanced areas of genomics, proteomics, computational drug discovery techniques including bioinformatics, QSAR, Molecular Docking, pharmacophore mapping, chemoinformatics, computational ADME / Toxicity prediction methods, pharmaceutical informatics and medical informatics.
Focus on practical applications of computer aided target identification, validation and drug-design,
Centre different from other academic canters where the focus is either on theoretical studies or on development of bioinformatic methods or on chemoinformatic methods.

28. Collaborative Research at NIPER an example
Ranbaxy Labs has entered into a collaboration with NIPER & DST as the tripartite agreement on
Computer Aided Drug Design & Synthesis of novel small molecules as potential anti-asthma agents
Ranbaxy & DST to fund NIPER, to synthesis small molecules as anti-asthma drugs
Ranbaxy to screen these molecules & identify candidates for further development.
Morepen Labs collaborative research with NIPER
in medicinal chemistry in the areas of lead identification, lead   validation and lead optimization.
established combinatorial chemistry laboratories and HTS facility to undertake contract   research program.
IND - Swift Laboratories Ltd collaborative research with NIPER
for development of new processes
developed and filed joint patent in the therapeutic segment of anti-thrombotics.
It would generate revenues from `Proprietary Prescription Products.'
Pharmaceutical research is highly complex & interdisciplinary in nature,
Interfacing with academia to establish global leadership, as well as to expedite the process.
This programme will strengthen the interaction of the Institute with industrial houses & promote industry-academia interaction in the country, which is the need of the day.

29. Ways ahead for Scalability
Clear lesson from successful partnership is that there must be
Effort to accommodate the specific cultural needs that exist in Industry, academia & research environment
Mutual respect and understanding of each others’ priorities & goals
Funding is best distributed in the competitive grant-oriented fashion
Academia & Labs accommodating industry’s need to capture proprietary intellectual property that can eventually be commercialized
Developing long term joint research plans
Research labs, Institutions and start up companies in close proximity
With an increased mutual understanding and respect for the priorities within both institutions and well defined & transparent research collaborations it should be possible
Leverage public investment in basic science in to discoveries having impact on public health
As career defining basic science discoveries more academic researchers will set their sight on innovations
Keeping this in view What are the initiatives which are already in place and what needs to be done for the future

30. Ways ahead ……..
Industry in India feels the absence of great universities including MIT & Stanford in the neighborhood; and,
The academics in institutions of excellence equally miss the genuine interests of big companies like Eli Lilly & Pfizer in partnering with these institutions.
In effect, need to start the work at both the ends.
Creation of the Research Initiative, the specific funding of universities to develop dedicated research programs and emergence of institutes, Univ. at national laboratories that focus on the development of younger scientists in this field.
This combines the extensive resources and expertise found in the national lab system with the many strengths inherent in true academic research/process.
The continuation of these successful arrangements and the active development of more joint efforts are needed to provide the best environment to achieve the desired goals

31. Ways ahead ……..
Govt need to Formulate & Promote Research friendly policy
India's investment in R&D remains far below the level required for a country aspiring to emerge as an economic & knowledge superpower. (Planning Commission )
The prices of Pharma products in India are among the lowest in the world and
have gone up only marginally by just 1-2 per cent per year,
much lower than the rate of inflation, and this holds true for over 80 per cent of the medicines.
The drug price control regime does not reward innovation or research, which is a high risk activity
For every rupee spent on the medicine by the consumer, a manufacturer is left with a marginal amount to spend on R&D after giving taxes & levies, retailers, stockiest & distributors.
It may be noted that for every rupee spent on the medicine by a consumer, a manufacturer gets only 35% of the MRP, since approx % goes to the taxes and levies.
Another 18-29% goes to the retailer as his margin and approx. 8-10% goes to the stockiest and 5% to the distributer.
Even out of this share of 35-40%, inputs account for more than 75%, so manufacturer is left with a marginal amount.
How could companies spend the money on R&D if the govt. does not give grants.
There should be strategies for new initiatives, Priorities, challenges and obstacles
Strategies to solve the problems
Clear cut road map for the future- More effective methods to solve them

32. Ways ahead ……..
R&D in pharmaceutical is expensive and time consuming with long gestation periods and uncertain outcomes. Therefore, fiscal incentives and grants are a must and need to be scaled up for companies to spend on R&D. This will ensure that capital is directed to this important area critical for long-term success.
The weighted deduction for R&D presently extended to 5 yrs should be for 10 yrs at any given time as most R&D decisions are based on 7-10 yrs window
Expenses incurred on clinical trials, bioequivalence studies, regulatory approvals and patent filings, made outside India (necessitated by regulation) are legitimate R&D expenses and should be recognized & accorded the same preferential treatment as other forms of R&D expenditure by the government.
tax benefits to Industry & encourage Pvt. Sector investment
Funding to be open to Pvt. Sector
Research funding with open ended provisions to allow benefits of commercializing the product

33. Ways ahead ……..
True collaborations and collaborative efforts between universities, labs & Industries provide the
greatest potential contribution towards realizing the educational goals in specific field &
meeting industry expectation for the benefit of the nation at large.

34. THANK YOU