This document discusses opportunities for collaboration between academia and industry to drive efficiency in research. It notes that while academia traditionally focused on pure research and industry on profit, drug discovery now requires a mixed model with contributions from both. Effective collaborations could help address challenges like rising costs and project attrition. However, differences in culture and goals can hamper partnerships. The document recommends developing focused projects and consortia, addressing intellectual property and conflicts of interest upfront, and managing collaborations strategically like an investment portfolio to maximize their potential for innovation.

1. Collaboration between Industry and Academia
An Opportunity to Drive Efficiency in Research
Craig S Conoscenti MD FCCPCraig S. Conoscenti, MD, FCCP
Director and Pulmonary Fibrosis Program Area Lead
Respiratory Clinical Development and Medical Affiars
Boehringer Ingelheim Pharmaceuticals

2. 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

3. 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).

4. Academic Industry CollaborationsAcademic Industry Collaborations
• 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):151‐85
Brewer 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: 291–302
Tralau‐Stewart ,CJ. Wyatt CA, Kleyn DE, Ayad A. Drug Discovery: new models for industry –academic partnerships. Drug Discov Today; 14(1);95‐101

5. Academic Industry CollaborationsAcademic Industry Collaborations
Who 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

6. Academic Industry CollaborationsAcademic Industry Collaborations
• 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;502‐7
Chesbrough HW. Open Innovation : The new imperative for creating and profiting from technology. Harvard Business School Press Boston MA 2003
Chesbrough HW. Open Business Models: How to thrive in the new innovation Landscape. Harvard Business School Press Boston MA 2006

7. Academic Industry CollaborationsAcademic Industry Collaborations
• 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 Medicine
15 (5) May 2009;502‐7

8. 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;502‐7

9. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

10. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

11. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

12. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

13. Academic Industry CollaborationsAcademic Industry Collaborations
• 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 y
change value

14. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

15. Academic Industry CollaborationsAcademic Industry Collaborations
• 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 p
or 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

16. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

17. Academic Industry CollaborationsAcademic Industry Collaborations

18. Academic Industry CollaborationsAcademic Industry Collaborations

19. Academic Industry CollaborationsAcademic Industry Collaborations
• 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 2006
Heller, M.A. & Eisenberg, R.S. Science 280, 698–701 (1998).

20. Academic Industry CollaborationsAcademic Industry Collaborations
• 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

21. Academic Industry CollaborationsAcademic Industry Collaborations
• 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)

22. Academic Industry CollaborationsAcademic Industry Collaborations
• 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 y
help advance scientific knowledge surrounding specific diseases