Strategic R&amp;D transactions in personalized drug development

Makino, Tomohiro; Lim, Yeongjoo; Kodama, Kota

doi:10.1016/j.drudis.2018.03.009

Cited by 11 publications

(6 citation statements)

References 19 publications

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“…Originally, the pharmaceutical industry comprised vertically integrated organizations, in which adjusting several different types of specialized knowledge and compiling a myriad of research was both necessary and important in creating novel types of drugs [41]. However, the trends of open innovations have expanded to several other industries and, thus, we observe the current, horizontally collaborative modes between pharmaceutical firms and start-ups [42,43].…”

Section: Discussionmentioning

confidence: 92%

Trends of Business-to-Business Transactions to Develop Innovative Cancer Drugs

et al. 2020

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A key concept in the pharmaceutical industry is open innovation, in which pharmaceutical companies contribute to human health and adapt to a changing business environment by acquiring external knowledge. As successful drug discoveries and developments have become challenging, pharmaceutical companies must proactively pursue the open innovation of new drugs through various inter-firm partnerships to be more sustainable. This study aims to interpret the trend of inter-firm partnerships in the development of cancer drugs and to evaluate their effectiveness by examining inter-firm transactions related to cancer drugs approved by the US Food and Drug Administration (FDA). It is a novel approach to exercise this on each product instead of at the company level. The findings revealed that the number of inter-firm transactions in the oncology field has increased over the past 20 years. Furthermore, the annual number of transactions related to biologics has surpassed that of small molecules since 2015 and has been primarily driven by three PD-(L)1 inhibitors: Keytruda, Opdivo, and Tecentriq. Moreover, the average number of inter-firm transactions related to biologics is significantly higher than that of small molecules in total, in alliances, and in financing, suggesting that inter-firm transactions for biologic cancer drugs actively occur through various means. Additionally, a positive and significant correlation exists between the number of transactions and the average number of approved indications for biologics, but not for small molecules. These results suggest that the observed trend of active inter-firm transactions is key in increasing the probability of success in cancer drug research and development. This could provide a potential breakthrough in this industry for the successful development of innovative drug candidates to address unmet medical needs. Further study is necessary to confirm the applicability of this paradigm in broader drug discoveries and development.

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Section: Discussionmentioning

confidence: 92%

Trends of Business-to-Business Transactions to Develop Innovative Cancer Drugs

et al. 2020

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“…The difference in organizational interests can affect one's motivation to facilitate innovation and even its consequences. As a case of collaborative development of cancer drugs, Makino et al 2018 argued in their quantitative research that there was a positive correlation between the number of alliances (i.e., R&D licensing, marketing licensing, etc.) and a number of patents relating to CDx [90].…”

Section: Recommendations For a Better Clinical Sequencing In Oncologymentioning

confidence: 99%

“…As a case of collaborative development of cancer drugs, Makino et al 2018 argued in their quantitative research that there was a positive correlation between the number of alliances (i.e., R&D licensing, marketing licensing, etc.) and a number of patents relating to CDx [90]. This implies that a challenge for MSK-IMPACT is to promote collaborative opportunities with external counterparts for drug development activities.…”

Section: Recommendations For a Better Clinical Sequencing In Oncologymentioning

confidence: 99%

Regulations, Open Data and Healthcare Innovation: A Case of MSK-IMPACT and Its Implications for Better Cancer Care

Jibiki

Nishimura

Sengoku

et al. 2021

Cancers

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This study investigated a case of Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT), a tumor profiling test approved by the U.S. Food and Drug Administration (FDA) in 2017, to examine what factors would contribute to healthcare innovation. First, we set the following three parameters to observe cases: (i) the FDA regulatory reforms, (ii) early application of new technologies, such as next-generation sequencing (NGS), to both research and clinical settings, and (iii) accumulation of open data. Then, we performed a comparative analysis of MSK-IMPACT with FoundationOne CDx and Oncomine Dx Target Test, both of which were FDA-approved tumor profiling tests launched in 2017. As a result, we found that MSK-IMPACT secures neutrality as a non-profit organization, achieves the active incorporation of basic research results, and performs superiorly in clinical operations, such as patient enrollment. On the contrary, we confirmed that FoundationOne CDx was the most prominent case in terms of the number of new drugs and expanded indications approved in which the FDA’s expedited approval programs were considerably utilized. Consequently, to uncover the full potential of MSK-IMPACT, it is suggested that more intersectoral collaborative activities between various healthcare stakeholders, in particular, pharmaceutical companies, for driving clinical development must be carried out based on an organizational framework that facilitates collaboration.

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“…Thus, companies in the pharmaceutical industry have strived to enhance sustainability by adopting various strategic approaches, such as pursing globalized or region-oriented business models [ 5 , 6 ], selective therapeutic areas in R&D, optimizing R&D productivity [ 7 ], and open innovation, including external collaboration and interorganizational transactions [ 8 , 9 , 10 , 11 ]. In particular, the importance of external collaboration in R&D has been disseminated and many pharmaceutical companies have pursued interorganizational transactions and established open innovation platforms to acquire external knowledge and pipelines across organizations [ 8 , 10 , 11 , 12 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Dynamic Collaborations for the Development of Immune Checkpoint Blockade Agents

Djurian

Makino

Lim

et al. 2021

JPM

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We studied the overview of drug discovery and development to understand the recent trends and potential success factors of interorganizational collaboration by reviewing 1204 transactions performed until 2019 for 107 anticancer drugs approved by the US Food and Drug Administration (FDA) from 1999 to 2018. Immune checkpoint blockade was found to be a significantly active area in interorganizational transactions, especially the number of alliances, compared with other mechanisms of action of small molecules and biologics for cancer treatment. Furthermore, the analysis of pembrolizumab and nivolumab showed that the number of approved indications for these two drugs has been rapidly expanding since their first approval in 2014. Examination of the acquisitions and alliances regarding pembrolizumab and nivolumab showed that many combination partners were developed by US-based biotechnology or start-up companies, the majority of which were biologics. These findings suggest that immune checkpoint blockade is a paradigm for cancer treatment, resulting in huge product sales and continuous indication expansion. Additionally, interorganizational collaboration, especially trial collaboration, is a strategic approach for the development of immune checkpoint blockade agents. The translation of these empirical practices to new drug candidates is expected for the research and development of innovative drugs in the future.

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Strategic R&D transactions in personalized drug development

Cited by 11 publications

References 19 publications

Trends of Business-to-Business Transactions to Develop Innovative Cancer Drugs

Trends of Business-to-Business Transactions to Develop Innovative Cancer Drugs

Regulations, Open Data and Healthcare Innovation: A Case of MSK-IMPACT and Its Implications for Better Cancer Care

Dynamic Collaborations for the Development of Immune Checkpoint Blockade Agents

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