CATALYZING COLLABORATION BETWEEN INDUSTRY/ CATALYZING COLLABORATION BETWEEN INDUSTRY/ ACADEMIA/ LABORATORIES FOR DRUG DISCOVERY ACADEMIA/ LABORATORIES FOR DRUG DISCOVERY

AND DEVELOPMENTAND DEVELOPMENT

Sushma BerliaSushma Berlia

President, Apeejay Stya Group President, Apeejay Stya Group

'International Conference on Translational Pharmacology and 'International Conference on Translational Pharmacology and 41st Annual Conference of Indian Pharmacological Society'.41st Annual Conference of Indian Pharmacological Society'.

2020thth December, 2008, AIIMS December, 2008, AIIMS

Traditional model:Traditional model: Independent contributions to societyIndependent contributions to society

SocietySociety

Research Publications

Products Services

Grads

UniversityUniversity LaboratoryLaboratory IndustryIndustry

Universities, Industry & Laboratories continue to produce their traditional outputtraditional output

New Model:New Model: University-Industry - Laboratory partnershipUniversity-Industry - Laboratory partnershipContd….Contd….

SocietySociety

Research Publications

Products Services

New Opportunities

Grads

UniversityUniversity IndustryIndustryJoint Research, Hiring & Exchange,

Collaboration, Licensing

LaboratoryLaboratory

Ideally Laboratories should be based in/near universities

• Through real-time relationship and direct technology transfer-

– University, Laboratory and industry together will produce new opportunities, such as new Products, new Products, new venturesnew ventures & new industries new industries

• GovernmentGovernment (central & State) for positive cooperation to take place -

– provide stable environmentstable environment & encouragement, encouragement, and

– protect the interest of the peopleinterest of the people

• Government also provides important Science & Tech. Science & Tech. fundingfunding

New Models: University-Industry - Laboratory partnershipNew Models: University-Industry - Laboratory partnership

Why these new Demands?Why these new Demands?

It is all aboutIt is all about

INNOVATIONINNOVATION

Innovation – Innovation – attributesattributes

• The process leading from the discovery or inventiondiscovery or invention of a new idea or technology to its practical implementationpractical implementation (often via commercialization)

• Early stage (basic research):Early stage (basic research): typically without a practical implementation (product) in mind

• Late Stage (development):Late Stage (development): driven by technology and cost demand of a real-world application

• Usually, different stakeholders are involved at different different stakeholders are involved at different stagesstages

Why Innovation?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

• 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

Nature of Demands?Nature of Demands?

University, Lab.. & industry roles in an innovation system University, Lab.. & industry roles in an innovation system

• Natural division of LabourNatural division of Labour– Basic research: govt. funds, university conduct– Product development: industry funds, industry conduct

• Transition in innovation system at Applied Research stageTransition in innovation system at Applied Research stage– Both industry and govt. fund applied research– All university, Laboratory & industry conduct

• Technology (knowledge) transferTechnology (knowledge) transfer– Internal to industry: from research lab to development groups – From University - Laboratory - Industry and vice versa

UniversityUniversity

..

IndustryIndustry

GovernmentGovernmentIndustryIndustry

Implementation OrganisationImplementation Organisation

Funding SourceFunding Source

Mfr. & Market Product Dev. Applied research Basic research

Tech Transfer

Development DivisionDevelopment Division Central LaboratoriesCentral Laboratories

Industry Needs and ExpectationsIndustry 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.

Academia ExpectationsAcademia 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 BenefitsIndustry 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 BenefitsUniversity 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 interactionMeans 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

Collaborations: Collaborations: Collaborative & LicensingCollaborative & 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.

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Some other forms of collaborations……..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 IndustryInhibiting 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.

• 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.

Inhibiting Factors – For AcademiaInhibiting Factors – For Academia

Best practices - Best practices - Key parameters for of Successful PartnershipKey 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: Best Practices: Silicon Valley-Stanford ModelSilicon 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 visiondesign 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)

• 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

Best Practices: Best Practices: Silicon Valley-Stanford Model Silicon Valley-Stanford Model Contd…

Collaborations for Drug developmentCollaborations for Drug developmentOpportunities 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

Commercializing discoveriesCommercializing 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.

Collaborations for Drug developmentCollaborations for Drug development Contd…Contd…

Research constraints in IndiaResearch constraints in India

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

JapanJapan 5085 20 3.1 77 16 7 11

USUS 4700 19 2.7 63.1 31.2 5.7 10

RussiaRussia 3415 40 1.2 29 63 8 62

S. KoreaS. Korea 2979 41 2.5 75 22 3 28

ChinaChina 633 25 1.2 70 25 5 85

BrazilBrazil 324 40 1.0 - - - 63

IndiaIndia 156 20 0.8 23 74.7 2.3 127

India lags behind in spending on research and development work as well as number of scientific researchers

**Researchers per million of population, ** , ** In tertiary education, Source- UNDP, *** Global R&D Report, 2008 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-public sector- 75%, Pvt. sectorPvt. 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 linkCollaborative 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 IndiaInitiatives 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 IITIIS, 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 IIT Kharagpur and the TeNet (Telecommunications and Computer Networks) group of IITNetworks) group of IIT Chennai are arguably the earliest to have deployed the consortium model.

– TIFAC-TIFAC- providing technology linked business opportunities(Lab/Indy.)

– National Entrepreneurship Network (NEN)National Entrepreneurship Network (NEN) to develop the next generation of high growth entrepreneurship in India

– IISERIISER devoted to science education and research

– NFSENFSE to oversee and funds research & new fellowship

– CSIRs CSIRs Open Source Drug Discovery' (OSDD) programme

– NIPER NIPER centre of excellence for advanced studies & research in pharmaceutical sciences

National Institute of Pharmaceutical Education & Research National Institute of Pharmaceutical Education & Research (NIPER) (NIPER) • Institute of National Importance engaged in Institute of National Importance engaged in

– teaching & research– Promoting collaborative research with Industry

• Some Key features 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

DistinctivenessDistinctiveness• 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 exampleCollaborative 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.

• 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 for ScalabilityWays ahead for Scalability

Ways aheadWays 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 aheadWays ahead ……..

Govt need to Formulate & Promote Research friendly policyGovt 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 aheadWays 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

• 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.

Ways aheadWays ahead ……..

THANK YOUTHANK YOU