CATALYZING COLLABORATION BETWEEN INDUSTRY/ ACADEMIA/ LABORATORIES FOR DRUG DISCOVERY AND DEVELOPMENT Sushma Berlia President, Apeejay Stya Group 'International Conference on Translational Pharmacology and 41st

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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
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Traditional model Independent contributions to
society

• Society

Research Publications
Products Services
Grads
University
Industry
Laboratory
Universities, Industry Laboratories continue to
produce their traditional output
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New Model University-Industry - Laboratory
partnershipContd.

• Society

Research Publications
Products Services
New Opportunities
Grads
University
Industry

Joint Research, Hiring Exchange,
Collaboration, Licensing
Laboratory
Ideally Laboratories should be based in/near
universities
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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

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Why these new Demands?

• It is all about
• INNOVATION

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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

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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

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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

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University, Lab.. industry roles in an
innovation system

• .

Funding Source
Industry
Government
Mfr. Market
Product Dev.
Applied research
Basic research
Central Laboratories
Development Division
Industry
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

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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.

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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 RD activities
  of the Industry for funds which helps them to
  sustain their broader research interest

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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 RD
• To access expertise not available in corporate
  laboratories.
• To aid in renewal expansion of a companys
  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

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University Benefits

• Allow universities to gain access to external
  sources of expertise and funding.
• To earn additional resources for the universitys
  educational and research mission severely
  constrained financially.
• To fulfill the universitys 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 mans place.
• To move Discoveries from the Academic Institution
  to the market place

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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 whats expected of you
• Dont be afraid to reach out beyond your own
  areas of expertise
• Deliver more than askedspecific to the industry
• Communicate.Communicate..Communicate

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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
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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

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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.

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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.

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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

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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)

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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

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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

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Commercializing discoveries
Collaborations for Drug development
Contd

• 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.

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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 RD Report, 2008
- Developed countries have RD expenditure of up to 3 of GDP
- Of the 0.8 expenditure in India, public sector- 75, Pvt. sector only 23.
Amount spend on RD 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 RD, 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

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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 worlds best universities

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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 IITs
  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

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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.

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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.

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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 industrys 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

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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

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Ways ahead ..

• Govt need to Formulate Promote Research
  friendly policy
• India's investment in RD 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 RD after giving taxes
  levies, retailers, stockiest distributors.

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Ways ahead ..

• RD 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 RD. This will ensure
  that capital is directed to this important area
  critical for long-term success.
• The weighted deduction for RD presently extended
  to 5 yrs should be for 10 yrs at any given time
  as most RD 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 RD expenses and
  should be recognized accorded the same
  preferential treatment as other forms of RD
  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

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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.

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THANK YOU