Collaboration between Industry and Academia – An Opportunity to Drive Efficiency in Research - Craig Conoscenti, Boehringer Ingelheim Pharmaceuticals, Inc

Collaboration between Industry and Academia An Opportunity to Drive Efficiency in Research

Craig S Conoscenti MD FCCPCraig S. Conoscenti, MD, FCCPDirector and Pulmonary Fibrosis Program Area Lead

Respiratory Clinical Development and Medical Affiars

Boehringer Ingelheim Pharmaceuticals

DISCLOSURES

Employee of Boehringer Ingelheim Pharmaceuticals in theEmployee of Boehringer Ingelheim Pharmaceuticals in the position of Director and Pulmonary Fibrosis Program Area Lead,

Respiratory Clinical Development and Medical Affairs

Any views expressed in this presentation represent the personalAny views expressed in this presentation represent the personal opinions of the author and not those of Boehringer Ingelheim

Pharmaceuticals

Academic Industry CollaborationsAcademic Industry Collaborations

• Concept of “pure research”– In the 19th Century the concept of pure research exemplified by the German

Wissenschaft* was identified as “a dedicated scientific pursuit of natural phenomena without seeking any practical application” *any study or science that involves systematic research

• In 1986, Ross (John Hopkins University), commenting on academic and pharmaceutical industry relationships:

Academic scientists have as their goals the acquisition and dissemination of knowledge– Academic scientists have as their goals the acquisition and dissemination of knowledge as full‐time independent ‘scholar scientists’

– Contrasts to the pharmaceutical industry’s goal of profit arising from the full‐time employment of scientists

• With this type of culture still existing in pockets today, there will be hurdles in the collaborative space between industry and academics

Ross, R. Academic research and industry relationships. Clin. Investigat. Med. 9, 269–272 (1986).


• Drug discovery is facing considerable challenges with increasing costs, decreasing productivity and attrition of projects as they progress through the development process

d h h h h• Companies are responding with extensive changes which in many cases are leading to a mixed model for drug discovery with new entrants into the space including university‐based drug discovery groups

• It is accepted that industry has not succeeded in fully realizing the potential of academic research and will require novel and forward‐thinking approachesthinking approaches

DiMasi JA, Hansen RW, Grabowski HG. The Price of Innovation: New Estimates of Drug Development Costs. J Health Econ 2003 Mar;22(2):151‐85Brewer GJ Fundamental problems lie ahead in the drug discovery and commercialization process: restructuring of the pharmaceutical industry and an improved partnership

with academia are required. J Investig Med 54: 291–302Tralau‐Stewart ,CJ. Wyatt CA, Kleyn DE, Ayad A. Drug Discovery: new models for industry –academic partnerships. Drug Discov Today; 14(1);95‐101

Academic Industry CollaborationsAcademic Industry CollaborationsWho really contributes to the making of innovative drugs?

Chin‐Dusting J, Mizrahi J, Jennings G, Fitzgerald D. Finding improved medicines: the role of academic – industrial collaboration. Nature Reviews Drug Discovery 4:892‐7


• Translational medicine is now playing a larger role in bridging the gap from science to development and this serves as an ideal place for collaborations to take place.

• There are many models of collaborations that can be addressed but companies and universities lack a systematic approach for capturing the full potential of such collaborations

• The term ‘open innovation’ was coined by Henry Chesbrough– “how useful knowledge and technology was becoming increasingly widespread,” such g gy g g y p ,

that newly developing technologies and products benefited from integrating knowledge and expertise from multiple sources and began to address the economics of innovation

Melese T, Lin SM, Chang JL, Cohen NH. Open innovation networks between academia and industry: an imperative for breakthrough therapies. Nature Medicine 15 (5) May 2009;502‐7Chesbrough HW. Open Innovation : The new imperative for creating and profiting from technology. Harvard Business School Press Boston MA 2003Chesbrough HW. Open Business Models: How to thrive in the new innovation Landscape. Harvard Business School Press Boston MA 2006


• Since 2008, several pharmaceuticals firms have established collaborations with d i i i i i h h l f l i h b b i dacademic institutions with the goal of closing the gap between basic and

clinical research, utilizing evidence and outcomes based research

• Most collaborations occur ad hoc often being based on personal relationships• Most collaborations occur ad hoc often being based on personal relationships between individuals and it is not uncommon to lose opportunities to leverage existing relationships and broaden the scientific focus

• There needs to be an effective way to classify information into what can be shared openly, confidential but with a confidentiality agreement, not shared

h• Two approaches:– Develop focused collaboration between academia and industry – Develop consortia between academia and industry in precompetitive areas to advance

industry wide science but not the goals of an individual company

Melese T, Lin SM, Chang JL, Cohen NH. Open innovation networks between academia and industry: an imperative for breakthrough therapies. Nature Medicine15 (5) May 2009;502‐7

Melese T, Lin SM, Chang JL, Cohen NH. Open innovation networks between academia and industry: an imperative for breakthrough therapies. Nature Medicine15 (5) May 2009;502‐7


• A major topic in developing collaborations is potential conflict of interest and this will need to i l dd d bl k h d l f b fi i l ll b iprospectively addressed to not block the development of beneficial collaborations.

• Intellectual property (IP) rights pose a challenge to allowing the growth of collaborative partnerships that support true innovationp p pp

– If IP terms are too broad then this will hinder academic participation

– If IP terms reach into the future to include future research once collaboration ends it will restrict future collaborations

• The differences between the academic and industry cultures, values, and norms could be substantial

– A company typically defines the goals, objectives, and timelines for industry scientists and in academia typically the goals, objectives, and timelines are scientist defined

– Very important to address this to provide opportunities for investigators from academia and industry to have overlapping goalsoverlapping goals


• A source of considerable tension could be budget and staffing– Academic researchers seek and obtain multiple sources of funding

– Companies typically need to balance short‐term commitments to meet quarter‐to‐quarter business demands and constraints

• Academic community needs to think of new ways to scope, frame, and describe proposed projects to align with corporate budgeting

– The expertise the company can offer is often overlooked and this can lead to access to technology resources and staff such as biostatisticians

– This can advance projects and be factored into the budget


• Academic Medical Centers– Pharmaceutical companies often rely on clinical research organizations

(CROs) to manage clinical studies

– Rarely are academic medical centers thought of as being able to provide much of this support

– Early phase studies and assessment of methodology requires understanding the science and AMCs are often positioned to do this

– AMCs often have interdisciplinary research institutes that mirror the small, therapeutic area–focused R&D units in pharmaceutical companies


• Research networks are now being developed to be able to maximize impact of research at academic centers and the value of new products developed by industry

• Research networks will allow collaborative teams to work together to identify innovation gaps in the development of new therapies and who is best positioned to contribute value

• There are several ways to maximize the potential of these networks– Recognize the value of the collaboration– Manage the industry academic collaboration like and investment portfolio– Adopt more reasonable approaches to sharing information– Create new innovation models


• Recognizing the value of the collaborationRecognizing the value of the collaboration– There should be a strategic approach to attempt to limit failures

that occur during development and can be very costly

– There is a need to fill knowledge gaps and increase the knowledge of the basis for disease development and the response of individual patients to new therapies and collaborations may address this best

– It is very important to identify the value of each partners assets and how the potential outcomes of the collaborations may p ychange value


• Managing the collaborations as an investment portfolioa ag g e co abo a o s as a es e po o o– Many collaborations are based on knowledge of previous

collaborations with individuals or groups in a therapeutic area

Si i di id l f l hi i id l– Since many individuals may transfer or leave this is not ideal

– Future work should build on current and previous work and cross those boundaries

– Have a formal way to document collaborations and make this visible to others to further the activity

To accomplish this goal it is best to look at the collaboration as– To accomplish this goal it is best to look at the collaboration as an investment portfolio requiring critical evaluation of everyone's work


• Managing the collaborations as an investment portfolioa ag g e co abo a o s as a es e po o o– When looked at as an investment portfolio it is possible to

• Eliminate redundancy across therapeutic areas by looking at synergies in projects

• This allows for a master agreement or master service agreement that is then applicable across therapeutic areas g pp por functions

• For the academic side it also allows for multiple departments to have access to industry scientists and for thedepartments to have access to industry scientists and for the industry it allows access to academic scientists


• Managing the collaborations as an investment portfolioa ag g e co abo a o s as a es e po o o– Master service agreements are an important part of

collaborations in many instances

I ddi i li i h h l ll– In addition to streamlining the process, they also allow a secure interface to be developed allowing for sharing of information

– This approach fosters the an innovative outlook on activities




• Adopt a new attitude about sharing of informationdop a e a ude abou s a g o o a o– Companies rely on patents to protect the returns on their

investment and patent nearly all

Thi bl k i i b h h bili l bl k– This blocks competition but has the ability to also block innovation across collaborations

– Many companies do separate out information into proprietary and non proprietary so that non proprietary information can be used across collaborations

– Proprietary is often further broken down to safeguardedProprietary is often further broken down to safeguarded information and that which can be shared across the collaboration

Chesbrough HW. Open Business Models: How to thrive in the new innovation Landscape. Harvard Business School Press Boston MA 2006Heller, M.A. & Eisenberg, R.S. Science 280, 698–701 (1998).


• Creation of new innovation modelsea o o e o a o ode s– When there are multiple members of a collaboration on specific

projects, it is possible to develop alliances between other industry partners and academic institutions for pre competitiveindustry partners and academic institutions for pre competitive research that would allow for a more organized and complete process.

– The standard academic industry collaboration could maintain the partnership for those things not considered pre competitive

Chesbrough HW. Open Business Models: How to thrive in the new innovation Landscape. Harvard Business School Press Boston MA 2006


• Creation of new innovation modelsea o o e o a o ode s– There are several examples of alliances in the past several years

• RNAi Consortium: establishing principles to enable the scientific community to probe the functions of mouse and human genescommunity to probe the functions of mouse and human genes

• Biomarkers Consortium: goals include developing and validating biomarkers to be used in detection, diagnosing, and treating disease

• Diabetes Genetic Initiative: the goal was to identify genetic connectionsDiabetes Genetic Initiative: the goal was to identify genetic connections between Type 2 DM and cardiovascular risk factors

Blow, N. Nat. Meth. 5, 361–368 (2008)Altar, C.A. Clin. Pharmacol. Ther. 83, 361–364 (2008)Saxena, R. Science 316, 1331–1336 (2007)


• Industry‐academic collaborations will have a key role in the development of new therapies and treatments

• Both the academic institutions and industry have the same goal in mind and that is to help improve the care of patientsmind and that is to help improve the care of patients

• There needs to be an approach that takes the interests of both sides into account

• It is best to be treated as a portfolio to enhance synergy across therapeutic areas

• Continued development of alliances for precompetitive activity will p p p yhelp advance scientific knowledge surrounding specific diseases