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 Biopharmaceutical Alliances glossary & taxonomy
Evolving Terminologies for Emerging Technologies
Comments? Questions? Revisions?
Mary Chitty MSLS
mchitty@healthtech.com
Last revised March 18, 2019



Related glossaries include Business of biopharmaceuticals, Financial, Intellectual property & legal, Research

alliance management:  Strategic Alliance Management Congress  May 13-15, 2019 Philadelphia, PA Program | The approval of new therapies increasingly relies on an ecosystem of strategic partnerships during various stages of the development pipeline. Successfully managing these partnerships has become a critical component to the underlying success of each partner and the biopharma industry. As the quantity and complexity of deals increase, alliance teams have rapidly evolved, developing innovative strategies, systematic approaches and best practices to maximize value, and to leverage strategic partnerships above and beyond the deal.
Strategic Alliance Management Congress

Strategic Management Congress Europe 2018 Dec 3-5, Lisbon Portugal As the biopharmaceutical industry continues to rely on alliances and collaboration with external organizations to access innovation and obtain market access, internal teams are often confronted with the increasing complexities of systematically and effectively managing partnerships throughout their lifecycle. The function and organizational capability of Alliance Management is now recognized as a critical means to ensure the successful execution of any strategic partnership, acting as a central driver of value, while alleviating aggravations, and meeting alliance goals.

alliance strategies:
As the first decade of the 21st century comes to an end, the pharmaceutical industry is facing a major revenue downturn.  The contributing factors are the expiration of patents on a number of blockbuster drugs and the stagnant productivity of R&D.  As a consequence generics are expected to seriously erode revenues and the introduction of new proprietary drugs is not adequate.  The once insular pharmaceutical industry has been forced to look outside beyond its walls for drug pipeline candidates.  The result has been an almost expediential growth of the past decade in the number and value of strategic alliances. Insight Pharma Reports Strategic Alliances: Synergistic Path to Value Creation 2010

alliances: Agreements between two or more companies to cooperate in some way. Originally a military and legal term for treaties between sovereign states, could be offensive, defensive or both. Narrower terms: alliance networks, emerging company alliances, strategic alliances.

collaboration:  Collaboration can be horizontal (a group of small companies), vertical (suppliers and customers), sectoral (same industry sector) or lateral (complementary but different sectors). From the Latin, meaning to work with. 
Related terms: alliances, alliance networks, competitor collaboration, consortium
, joint venture, partnering, research joint venture, strategic alliance, technology transfer, technology web; Intellectual property & legal anti- trust

collaborations FDA: FDA is interested in partnering with the stakeholders to further its public health mission. By leveraging resources and expertise, through appropriate mechanisms, FDA can effectively collaborate to address critical public health needs and bridge scientific gaps, thereby stimulating innovation in the products we regulate. Collaborations with FDA can be formalized through multiple mechanisms including Cooperative Research and Development Agreements (CRADAs), memoranda of understanding (MOUs), contracts, cooperative agreements, or through other public-private partnership mechanisms. FDA will give preference to ideas and proposals that will enhance the delivery of mission-related FDA functions and that do not require funding from the FDA. Partnerships: Enhancing science through collaborations with the FDA  https://www.fda.gov/AboutFDA/Partnerships Collaborations/default.htm

competitive advantage:  The quest for competitive advantage often inspires executives to imitate the strategies of the most successful companies. Interestingly, however, precisely opposite factors are considered sources of competitive advantage at different points in time. ... Clayton Christensen, a leading thinker on disruptive technologies, alerts managers to the imperative of understanding the context that supports a particular competitive advantage. He explains why, for example, pharmaceutical companies' current focus on ever larger mergers is moving them in exactly the wrong direction at exactly the wrong time. C Christensen, Past and Future of Competitive Advantage, Sloan Management Review, 42 (2): 105-109, Winter 2001 http://teaching.up.edu/BUS580/bps/Christensen,%202001,%20Past%20and%20future%20of%20comp%20advantage.pdf

competitor collaboration: Intended to explain how the agencies analyze certain anti- trust issues raised by cooperation among competitors.  Antitrust Guidelines for Collaborations among Competitors, Federal Trade Commission, Dept. of Justice, April, 2000. http://www.ftc.gov/os/2000/04/ftcdojguidelines.pdf  Related terms: Research  pre-competitive R&D, RJV Research joint venture

consortium, consortia: A consortium is typically a loose, long- term alliance between competitors in a given industry. Research and development consortia are a specific type of consortia that focus on basic research and sometimes applied research, rather than downstream activities such as production.  While joint ventures and licensing partnerships are relatively traditional forms of inter-firm collaboration, R&D consortia are new to the scene.  Under the National Cooperative Research Act (NCRA) of 1984, these sorts of industry- based consortia became immune to anti- trust legislation in the United States.  The NCRA emphasizes the pre- competitive aspect of R & D ... To date, no U.S. consortium has been prosecuted under any anti- trust legislation.  The collaboration of competitors in early phases of the innovation process can yield great advances for the entire industry involved in the consortia.  "Collaboration between Firms in Information Technology" Chris Rigatuso, Takeshi Tachi, Dennis Sylvester, Mark Soper; Strategic Computing and Communications  Technology course *, Department of  Electrical Engineering and Computer Sciences, Univ. of California- Berkeley, US, Spring 1997   Related terms:  technology consortia; Intellectual property & legal  anti- trust 

CORDIS Community Research and Development Information Service: An important source on EU [European Union] R&D programmes and relevant matters ... distributed: via the CORDIS World Wide Web service, which includes access to the CORDIS databases. http://www.cordis.lu/en/home.html

CRADA Cooperative Research and Development Agreement: Cooperative Research and Development Agreements (CRADAs) provide an exciting opportunity for NIH investigators to join with their colleagues from industry and academia in the joint pursuit of common research goals. Government scientists can leverage their own research resources, as well as serve the larger mission of NIH, to facilitate the development and commercialization of health-care pharmaceuticals and products. Companies also can leverage their own R&D efforts while collaborating in state-of-the-art NIH research. The purpose of a CRADA is to make Government facilities, intellectual property, and expertise available for collaborative interactions to further the development of scientific and technological knowledge into useful, marketable products. Each NIH institute has a Technology Development Coordinator (TDC) who should be consulted at an early stage of collaboration by the company and the NIH investigator to assist in identifying and developing the proper documents and obtaining the required approvals. NIH Office of Intramural Research, Tech Transfer https://www.ott.nih.gov/policy/cradas

discovery rights: Selling only research findings in the agreement while keeping rights to all the knowledge that is uncovered along the way. (Millennium Pharmaceuticals has been cited as an example of this model.)

expectations management: http://www.forbes.com/sites/85broads/2013/07/22/the-top-five-tips-for-managing-client-expectations/ Related term: collaboration auctions

extension of agreement: Agreement coming out of a previous association, may depend upon the achievement of specific milestones.

joint venture: An association formed for a specific purpose (and duration) between two or more parties. Originally a real estate term, now use much more widely. Unlike most partnerships, a joint venture anticipates eventual termination of the arrangement. Related terms: NCRPA definition of  "joint venture", pre- competitive R&D, RJV Research joint venture.

keiretsu: The framework of relationships in postwar Japan's big banks and big firms... About Economics http://economics.about.com/library/glossary/bldef-keiretsu-system.htm 

NCRPA National Cooperative Research and Production Act: 1993 amendment to the National Cooperative Research Act (NCRA), encouraging corporations to engage in joint ventures for purposes of research and development and/or production.  https://en.wikipedia.org/wiki/National_Cooperative_Research_and_Production_Act

partnership:: http://smallbusiness.chron.com/differences-between-limited-partnerships-joint-ventures-23202.html

pre-competitive R&D, Research Joint Venture RJV: Research pharmaceutical

SBIR Small Business Innovation Research: A highly competitive [US] program that encourages small business to explore their technological potential and provides the incentive to profit from its commercialization. http://www.sbir.gov/ 

STTR Small Business Technology Transfer: The Small Business Technology Transfer (STTR) is another program that expands funding opportunities in the federal innovation research and development (R&D) arena. Central to the program is expansion of the public/private sector partnership to include the joint venture opportunities for small businesses and nonprofit research institutions. The unique feature of the STTR program is the requirement for the small business to formally collaborate with a research institution in Phase I and Phase II. STTR's most important role is to bridge the gap between performance of basic science and commercialization of resulting innovations.  https://www.sbir.gov/about/about-sttr

strategic alliances: Strategic partnerships come in many forms, ranging from precompetitive R&D consortia and co-production and co-marketing partnerships to cross-licensing and cross-equity agreements that do not result in a separate entity and equity joint ventures that do result in the creation of new legal entities. Archived Working Paper Number 13: The Development of Strategic Alliances in Canadian Industries: A Micro Analysis by Sunder Magun, Applied International Economics, October 1996  https://www.ic.gc.ca/eic/site/eas-aes.nsf/eng/ra01186.html

May refer to a joint venture, partnership or an alliance network.  Strategic implies that one (or each) companies have something unique to bring to the agreement. (Not all alliances are as strategic as their participants initially hoped for.) May well involve more than two entities.

TRAs Technology Research Associations: Japanese groups working through MITI (now METI).

technology consortia: The era of companies doing everything in- house has passed. Collaboration of competitors in the early phases of the innovation process can result in great benefits for the entire industry.  In the US pre- competitive R&D consortia have flourished since passage of the National Cooperative Research Act (NCRA) in 1984. Japan had Technology Research Associations (TRAs)  even earlier.  The development of standards by consortia can play a useful role in emerging and disruptive technologies.  Consortia can share R&D costs and risks, particularly when existing technologies are in flux.  They can work against short product life cycles requiring high frequency of innovations. But new and truly disruptive technologies are a potential minefield.  Shared and complementary visions, governance, finance, communication and trust can be difficult to maintain. Intellectual property rights can be problematic.  

technology service agreement: Often refers to information technology, including agreements to maintain, service, customize and update information technology.

Alliance resources
Insight Pharma Reports Strategic Alliances: Synergistic Path to Value Creation 2010 As the first decade of the 21st century comes to an end, the pharmaceutical industry is facing a major revenue downturn.  The contributing factors are the expiration of patents on a number of blockbuster drugs and the stagnant productivity of R&D.  As a consequence generics are expected to seriously erode revenues and the introduction of new proprietary drugs is not adequate.  The once insular pharmaceutical industry has been forced to look outside beyond its walls for drug pipeline candidates.  The result has been an almost expediential growth of the past decade in the number and value of strategic alliances. 

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