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
Traditional model: Independent contributions to society
Society
Research
Publications
University
Grads
Laboratory
Products
Services
Industry
Universities, Industry & Laboratories continue to produce
their traditional output
New Model: University-Industry - Laboratory partnership
Contd….
Society
Research
Publications
Grads
New
Opportunities
University
Products
Services
Industry
Joint Research, Hiring & Exchange,
Collaboration, Licensing
Laboratory
Ideally Laboratories should be based in/near universities
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
Why these new Demands?
It is all about
INNOVATION
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
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
conditions
ever
more
severe
economic
– New world wide competition,
– more knowledgeable customers require
• Efficiency,
• Sophisticated planning, and
• Current financial meltdown
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
University, Lab.. & industry roles in an innovation system
.
Funding
Source
Industry
Mfr. & Market
Industry
Government
Product Dev.
Applied research
Development Division
Basic research
Central Laboratories
University
Implementation Organisation
Tech
Transfer
• 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
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 resultoriented solutions.
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
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
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
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 longterm 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
Collaborations: Collaborative & Licensing
• Mechanisms through which universities, Laboratories
and Industries can work together
– Sponsored research: Companies directly funding university
Collaborations
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
Licensing
(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.
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
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
confidential for
problems
and
– fear of losing the competitive edge.
breakthroughs
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.
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
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
involvement with academic freedom
of
industrial
• 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)
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
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
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.
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
1.2
70
25
5
85
Brazil
324
40
1.0
-
-
-
63
India
156
20
0.8
23
74.7
2.3
127
*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-284584, 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
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
• 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
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.
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
lead validation and lead optimization.
of
lead
identification,
– 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 antithrombotics.
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
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
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.
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
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
benefit of the nation at large.
for
the
THANK YOU