Working Collaboratively: Using Co-operation to Boost Pipelines

As drugs, devices and other healthcare products become more innovative and complex, and as development costs increase, working collaboratively becomes more important. By working with collaborators, companies can: [1]

·        Avoid duplication of research

·        Access resources such as technologies, platforms and equipment

·        Access people with specific expertise, such as regulatory skills and research experience

·        Source early-stage innovation or late-stage products for the market

·        Share costs, data and results

·        Move through development more quickly, efficiently and cost-effectively

As an example of the power of collaboration, by working together in ‘Project Light Speed’, Pfizer and BioNTech developed a successful COVID-19 vaccine in just nine months. The vaccine was based on BioNTech’s messenger RNA (mRNA) technology, which the two companies were originally developing for a flu vaccine. The R&D teams worked together on a number of vaccine candidates, while Pfizer created a manufacturing process in parallel. The manufacturing process was supported by collaborations with a number of contract manufacturing organisations (CMOs). [2]

The main types of partnerships and collaborations are: [3]

·        Mergers and acquisitions

·        R&D collaborations

·        In- and out-licensing agreements

·        Outsourcing agreements

·        Industry-academia collaborations and spinouts

·        Public-private partnerships

Mergers and acquisitions

Mergers and acquisitions (M&As) allow companies to access pipelines and technologies, particularly in areas of unmet medical need, as well as to share costs and knowledge. Similar sized companies may merge to pool resources and save costs through economies of scale.

During 2023, the top ten M&A deals totalled $115.8 billion, increasing from $65 billion in 2022. The largest was Pfizer’s merger with Seagen, a cancer biotech. The agreement was worth around $43 billion, and gave Pfizer access to Seagen’s antibody-drug conjugate (ADC) technology. [4, 5]

Companies need to be aware that M&A deals can negatively affect early-stage innovation as a result of a decrease in R&D expenditure and a loss of expertise. [6] Understanding this risk should be part of the M&A process.

R&D collaborations

R&D collaborations, including joint ventures and co-development agreements, allow companies to pool resources and reduce risk. Despite the country’s success in innovative drug research there has been a decline in creating drug discovery startups in Japan. To meet this need, in April 2024, Takeda Pharmaceutical, Astellas Pharma and Sumitomo Mitsui Banking signed a $3.9 million deal to create a joint venture that will incubate early drug discovery programs (mostly Japanese) and create potential therapeutics. [7]

Co-development agreements allow larger companies to access early- and mid-stage products to increase their pipelines. They also mean that smaller companies can receive funding for future R&D as well as get support and gain expertise as they take products through development. The larger company may have the option to acquire the assets later in development. In December 2023, SystImmune and Bristol Myers Squibb signed a deal for the EGFRxHER3 bispecific ADC, BL-B01D1, currently in a Phase I trial for the treatment of non-small cell lung cancer (NSCLC). SystImmune will retain rights in mainland China and BMS will have exclusive rights in the rest of the world. BMS’ goal for the agreement is to strengthen its oncology pipeline. [8]

In a more unusual deal in July 2023, Flagship Pioneering and Pfizer agreed to both invest $50 million upfront in order to co-develop 10 single-asset programs based on Flagship’s ecosystem of more than 40 human health companies and multiple biotechnology platforms. Pfizer will fund each program and retains the right to acquire the assets. The aim is to meet unmet needs in Pfizer’s core strategic areas of interest. [9]

In- and out-licensing

In- and out-licensing allows in-licensees to fill gaps in early- and late-stage pipelines and find drugs to market, and out-licensees to find homes for programs that are out of scope or that they don’t have the expertise or resources to get to market.

Indivior signed an agreement with Alar Pharmaceuticals in October 2023, granting Indivior exclusive rights to develop, manufacture and commercialise Alar Pharmaceuticals’ portfolio of long-acting injectable formulations that release a prodrug of buprenorphine. Alar will receive $10 million upfront, a $5 million option payment, and potential milestone payments. [10]

Outsourcing agreements

Outsourcing research, development and manufacturing functions allows companies to be more flexible and streamlined, and access specialist resources such as biologics and cell/gene therapy development and manufacturing technologies and facilities. Partnerships can cover preclinical and clinical stage research, development and formulation, manufacturing, sales and marketing. [11]

Companies can also outsource regulatory functions; the market for this is expected to rise from $7 billion in 2022 to $15 billion in 2032. The trend is to contract out around half of the work. [12]

Industry-academia collaborations and spinouts

Relationships between academia and industry are an important and growing part of the drug development process. As an example, in the UK there were over 16,000 publications between 2006 and 2015 where the pharma industry and academia collaborated together. [13]

Large biopharma companies have the funding and experience to develop drugs through clinical trials and the approval process, and the resources for national and international sales and marketing, but they don’t always have all the early-stage projects in their pipelines that they need. Universities and research institutions are home to world-class researchers who specialise in basic and applied research, but they don’t have the opportunities to be able to access funding and commercialise their cutting-edge research and innovation. Research institutions, especially those linked with hospitals, may also have links with healthcare professionals, patient advocacy groups and pools of patients for clinical trials. Working together supports both parts of the collaboration. [14]

Another form of academia-industry interaction includes apprenticeships, undergraduate placements, PhD studentships and post-doctoral researcher awards. The relationships and networks created by these early-career opportunities can promote collaborations over the long-term. [15]

Public-private partnerships

Public-private partnerships are agreements between governments and private sector organisations. In the UK, Pfizer has set up collaborative projects with the National Health Service (NHS) to support patient care. Examples include an agreement between Guys & St Thomas’ NHS Trust (GSTT), Kings College London and Pfizer Oncology to create a service model evaluating delivery of cancer care at GSTT, or a project with LloydsPharmacy to deliver an enhanced Pneumococcal vaccination service. [16]

The challenges

Working in collaboration can bring challenges. Academic institutions, startups and smaller biotechs can have very different organisational structures to bigger pharmaceutical companies. For example, a small biotech is more likely to be flexible, agile and comfortable with risk, whereas a larger company may have a slower decision-making process, an inflexible hierarchy, and a lower tolerance for risk. All individuals involved in an agreement, particularly a merger or acquisition, need to ensure that communication is open and clear. [17]

References

1.         Blog post: How to drive collaboration and innovation in pharma R&D. Starmind. Last accessed: 25 April 2024. Available from: https://www.starmind.ai/blog/pharmaceutical-research-and-development-collaboration.

2.         Silver, K. Shot of a Lifetime: How Pfizer and BioNTech Developed and Manufactured a COVID-19 Vaccine in Record Time. Last accessed: 24 September 2024. Available from: https://www.pfizer.com/news/articles/shot_of_a_lifetime_how_pfizer_and_biontech_developed_and_manufactured_a_covid_19_vaccine_in_record_time.

3.         Pakale, J., Collaborations and Partnerships in the Pharmaceutical Industry: Enhancing Innovation and Market Access. LinkedIn, 21 August 2023. Available from: https://www.linkedin.com/pulse/collaborations-partnerships-pharmaceutical-industry-enhancing-pakale/.

4.         Anderson, M., Pharma mergers and acquisitions are on the upswing. Healthcare Brew, 26 February 2024. Available from: https://www.healthcare-brew.com/stories/2024/02/23/pharma-m-and-a-are-on-the-upswing.

5.         Sagonowsky, E., et al., The top 10 biopharma M&A deals of 2023. 5 February 2024. Available from: https://www.fiercepharma.com/special-reports/top-10-biopharma-ma-deals-2023.

6.         Ornaghi, C. Mergers and innovation in the Pharmaceutical Industry. University of Southampton. Last accessed: 20 February 2024. Available from: https://www.southampton.ac.uk/research/highlights/mergers-innovation-in-the-pharmaceutical-industry.

7.         Fidler, B., Pharmas form joint venture to jumpstart Japanese drug research. BiopharmaDive, 22 April 2024. Available from: https://www.biopharmadive.com/news/takeda-astellas-sumitomo-joint-venture-japan-biotech-startups-drug-research/713818/.

8.         Press release: SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1. Bristol Myers Squibb. Last accessed: 11 December 2023. Available from: https://news.bms.com/news/details/2023/SystImmune-and-Bristol-Myers-Squibb-Announce-a-Global-Strategic-Collaboration-Agreement-for-the-Development-and-Commercialization-of-BL-B01D1/default.aspx.

9.         Press release: Flagship Pioneering and Pfizer Partner to Accelerate Development of Innovative Medicines Targeting Unmet Needs. Pfizer. Last accessed: 18 July 2023. Available from: https://www.pfizer.com/news/press-release/press-release-detail/flagship-pioneering-and-pfizer-partner-accelerate.

10.       Press release: Indivior Enters an Exclusive Licensing Agreement with Alar Pharmaceuticals. Indivior. Last accessed: 11 October 2023. Available from: https://www.indivior.com/en/media/press-releases/Indivior-Enters-an-Exclusive-Licensing-Agreement-with-Alar-Pharmaceuticals.

11.       Wright, T., 2024: Trends Shaping the Future of Pharma. Contract Pharma, 2 January 2024. Available from: https://www.contractpharma.com/contents/view_editorials/2024-02-01/2024-trends-shaping-the-future-of-pharma/.

12.       Peachey, C., Outsourcing regulatory activities in pharma. European Pharmaceutical Review, 3 January 2024. Available from: https://www.europeanpharmaceuticalreview.com/article/188483/outsourcing-regulatory-activities-in-pharma/.

13.       Links between industry & academia. ABPI. Last accessed: 23 September 2024 2024. Available from: https://www.abpi.org.uk/partnerships/links-between-industry-academia/.

14.       The Collaboration Between Industry and Academia in Drug Development. Last accessed: 15 August 2024. Available from: https://blog.drugbank.com/the-collaboration-between-industry-and-academia-in-drug-development/.

15.       New survey shows collaboration between pharmaceutical industry and UK academia is growing. ABPI. Last accessed: 30 September 2022. Available from: https://www.abpi.org.uk/media/news/2022/september/new-survey-shows-collaboration-between-pharmaceutical-industry-and-uk-academia-is-growing/.

16.       Collaborative Working. Pfizer. Last accessed: August 2024. Available from: https://www.pfizer.co.uk/partnerships/working-with-nhs-and-other-healthcare-organisations/collaborative-working.

17.       Bridging the Gap: Collaborations Between Pharma and Biotech. Laboratorios Rubió. Last accessed: 25 September 2024 2024. Available from: https://www.laboratoriosrubio.com/en/pharma-biotech/.