CROs in a Global State of Mind - Pharmaceutical Technology

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CROs in a Global State of Mind
CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry through a combination of acquisitions, partnerships, and select investments. The author examines these activities as well as the partnership strategies of CROs with academia to broaden their scope.

Pharmaceutical Technology

Sidebar: Partnerships in drug development in China: AstraZeneca and WuXi AppTec

Biopharmaceutical/pharmaceutical companies partner with CROs in emerging markets for various reasons. Access to large pools of patients or targeted patient populations important to the development of a particular drug and potentially lower costs comparative to Western-based CROs are some common reasons. As emerging markets, however, become increasingly important in the revenue position of the major companies, partnering with domestically domiciled contract services providers also provide biopharmaceutical/pharmaceutical companies a way to access local markets.

The use of such partnerships as a vehicle for pharmaceutical/biopharmaceutical companies to access local markets is evident in a recent partnership between MedImmune, the biologics arm of AstraZeneca, and the China-based CRO WuXi AppTec, to advance a biologic-based drug being developed by AstraZeneca.

In September 2012, MedImmune and WuXi AppTec formed a joint venture in China to develop and commercialize MEDI5117, a novel biologic for autoimmune and inflammatory diseases. Under the agreement, MedImmune is providing technical and development expertise, and WuXi AppTec is providing local regulatory, manufacturing, preclinical, and clinical-trial support. When undertaking clinical-trial development in China, the government requires local manufacture of medicines that have not been approved in other markets. The joint venture will control the development of MEDI5117 for autoimmune and inflammatory diseases in China, and the two companies will have equal ownership in the joint venture. AstraZeneca/MedImmune will have the option to acquire the full rights to commercialize MEDI5117; otherwise, the joint venture will have the right to commercialize the product. WuXi AppTec will earn revenue based on services provided to the joint venture. MedImmune will receive various milestone payments as the program progresses.

MEDI5117 is a fully human monoclonal antibody that depletes IL-6 and bears MedImmune's proprietary half-life extending mutation (known as the "YTE" technology) designed to give a long duration of action. IL-6 is known to be an important mediator in the production of inflammation and pain in a variety of disease states. MEDI5117 is currently in Phase I in the US and Europe. In China, a local investigational new drug application will be filed for MEDI5117, and following that process, Phase I trials will be initiated.

Sidebar: CROs form public–private partnerships to advance clinical research

Public–private partnerships are increasingly an important piece of the drug-development paradigm. These alliances provide value for CROs in helping to secure patients for clinical research, and the research entity, private or public, in advancing clinical research. Several CROs recently have announced such partnerships.

In January 2013, Covance formed a five-year exclusive agreement with the Royal Liverpool and Broadgreen University Hospitals NHS Trust for early clinical research. The Royal Liverpool and Broadgreen University Hospitals NHS Trust is one of the largest and busiest hospital trusts in northern England, with an annual budget exceeding 400 million ($631 million). Earlier in 2012, Covance, the French National Institute of Health and Medical Research's (Inserm) subsidiary Inserm Transfert SA, and the seed-investment company Inserm Transfert Initiative formed a multiyear scientific collaboration agreement for R&D. Under terms of the agreement, Covance will conduct discovery and early-development studies, using its capabilities, including those at its facilities in Porcheville, France, and Alnwick, United Kingdom, for projects managed by Inserm Transfert, the knowledge-transfer company of Inserm, and preclinical studies for start-ups within Inserm Transfert Initiative's portfolio. These Inserm Transfert Initiative companies will also gain access to the scientific, operational, and program-management expertise from Covance.

In September 2012, the CRO -Pharmaceutical Product Development (PPD) and the Global Allergy and Asthma European Network e.V. (GA2 LEN) formed a strategic alliance in which GA2 LEN will provide PPD access to the network's allergy and asthma experts and to more than 100 allergy and asthma sites in Europe. GA2 LEN is a multidisciplinary research network addressing all aspects of allergic diseases with a view to reducing the burden of allergy and asthma.

In return, the alliance will enable GA2 LEN to increase the amount of research it conducts in allergic diseases,as well as provide the network with earlier access to new medical therapies to help accelerate their development. PPD and GA2 LEN will work to reduce allergy and asthma study start-up times, increase the number of patients recruited for clinical trials, and ensure the availability of resources and training to increase the number of physicians and support staff conducting research.

In early 2012, PPD also formed a alliance with the Scottish government through NHS Research Scotland, part of the United Kingdom's National Health Service (NHS), to increase the amount of clinical research conducted in Scotland. PPD will work closely with the major health boards across Scotland to further reduce study start-up times, streamline regulatory approval processes, increase the number of patients recruited for clinical trials, and ensure the availability of resources and training to increase the number of physicians and support staff conducting research. The initiative covers a broad range of Phase I-III trials across multiple therapeutic areas, as well as biosimilar and post-approval studies.

Quintiles also formed a strategic partnership in Scotland with four teaching health boards in Aberdeen, Dundee, Edinburgh, and Glasgow as part of its prime site program, which engages researchers and investigators in clinical research. The partnership builds on Quintiles' experience in working with NHS Scotland's four university-based academic research centers in Aberdeen, Dundee, Edinburgh, and Glasgow. As part of the partnership, Quintiles will introduce technology that uses electronic health records to improve health outcomes.


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