The Science of Alignment

The concept of alignment for partnering and/ or collaborating to advance like-minded research appears, on the surface, evident to most individuals working in the scientific community. However, beneath this obvious axiom is a level of complexity that too often creates a show-stopping conundrum, wherein perceived individual needs outweigh or overshadow the common good sought from pursuing the partnership or collaboration. The key to resolving this conundrum is proper alignment of stakeholders and resources.

Shawnmarie Mayrand-Chung, Immunologist

The ‘ultimate’ objective

Do more, better, and faster research! Scientific researchers have always generally acknowledged the importance of collaboration and sharing of scientific findings to advance scientific innovation. Whether at the level of discovery, development or product testing, the common motivation among stakeholders involved in such activity, be it academic, government, industry, or private researchers, is to minimise cost and time while maximising scientific expertise and outcomes. This ‘win-win’ mentality across research groups provides the backbone for

Finding ways to bring the scientific community together more frequently and easily to solve larger goals that go beyond the interests of the individual participants would be not only beneficial but essential if we wish to effectively tackle the increasingly complex sustainability goals facing the world.

a collaborative advancement whereby additional incentives are provided to one or more stakeholder groups. The benefits of research partnerships and collaborations in the life sciences have been demonstrated by the successes of public-private partnerships (PPPs) such as The Biomarker Consortium (BC) , Accelerating Medicines Partnership (AMP) and The Critical Path Institute (CPI) . Although the success of these PPPs can be largely attributed to their pre-competitive nature and/or opensource design, the value of the partnership itself should not be undervalued. In addition to achieving their individual scientific research goals, these PPPs serve as positive examples of how different stakeholders can align to reach concurrently a common objective.

For the last two decades, we have seen a proliferation of scientific research partnerships, and an expansion of collaboration. The drivers for these partnerships include the need for: proprietary tools, leveraging of scientific expertise and knowledge, and access to data or samples, for example. Traditionalstructured partnerships have for the most part been conservative in their design, being narrowly crafted and with a finite endpoint. In such partnerships, each stakeholder participates in a shared research effort chiefly to advance each participant’s individual benefit. Finding ways to bring the scientific community together more frequently and easily to solve larger goals that go beyond the interests of the individual participants would be not only beneficial but essential if we wish to effectively tackle the increasingly complex sustainability goals facing the world, such as hunger, health and wellbeing, affordable and clean energy, and climate control.

The conundrum

The scientific research community has long suffered from the tendency to work in silos, whereby ideas, data and discoveries are held confidentially by the research organisation. In some cases, even within the same research organisation, there is a propensity to keep such information from being shared broadly within that organisation. Regardless of the stakeholder group – e.g. government, academia, industry, private organisations (not-for-profit or for profit), the historical tendency has been to “hold close” these pieces of information or risk missing an opportunity for publication and/or funding. This inherent fear that personal opportunities may be lost by sharing information, be it data or scientific knowledge, has played a major role in the inefficiency of medical research and the unaffordability of medical device and drugs. Although the potential promise of scientific alignment, intellectually, makes sense to most researchers as most recently demonstrated by the heroic efforts to develop COVID-19 vaccines, the reluctancy to work collaboratively remains pervasive in the scientific community. The reality is that stakeholders are not always able to either successfully come together for numerous reasons, including failure to identify amongst potential stakeholder partners suitable complementary resources held by others and mis-matching needs of stakeholders. Even when they can match up needs, they may not be able to successfully work together to achieve the desired outcome. The inability to align these factors ultimately results in missed opportunities and inefficient and more costly research.

The science of alignment: Making research collaborations work

Although the last two decades have shown that it is possible to achieve a “win-win” through PPPs and research collaborations, generating more such opportunities for scientific research to be done more efficiently, effectively, and affordably remains unfulfilled. There are several key elements required to achieve the alignment needed for a successful scientific partnership or collaboration. In addition to reaching the ultimate shared outcome, it is also critical that all stakeholders reach their individual desired benefits. For both the overarching and specific individually desired outcomes to be achieved, there are core aspects of the formation of the partnership or collaboration that must be considered and realised. Importantly, the relationship amongst stakeholders must be structured and memorialised in a concrete way. The hallmarks of a successful relationship also include the following steps: 1. Identify prospective partners with resources that complementarily align with there sources brought by the other prospective partners. 2. Cross-check that the needs of the prospective partners align with the expected outcome(s) of the partnership/collaboration to ensure adequate incentives exist for the participants to fully contribute the expected resources toward the partnership/collaboration; and 3. Once suitable partners are identified, align stakeholders to reach agreement on clear policies and robust procedures to carefully define and document the engagement.

By following these steps, the benefits include: · Transparency – building trust to assure cooperation and full participation in the collaboration · Confidentiality – protecting stakeholder intellectual property interests · Accountability – assuring appropriate governance

The stakeholders: Know and understand your partner’s needs

A critical part of assuring a successful partnership or collaboration is to appreciate what each stakeholder (1) brings to the table and (2) needs to take away from the table. This entails understanding your partners and aligning on both the primary shared benefit(s) – e.g. “the sweet spot”, and all secondary benefits that accrue to individual shareholders. Secondary agendas or goals cannot be overlooked, because often they must also be achieved to justify the stakeholder’s participation in a partnership. The misalignment on a seemingly minor issue can easily become the reason for a failed or less successful collaboration.

While the ‘common good’ is easy to identify, and the benefit of sharing cost, time and resources easy to understand, appreciating the specific expectations that have driven a stakeholder to want to enter a partnership or collaboration is much more challenging. More often than not, fail to stakeholders to imagine and to take into account all the factors and needs that their future partners must achieve and/or consider before agreeing to collaborate. This is particularly true in the life sciences where many of the traditional barriers still exist. Some of the factors and needs of each type of stakeholder is described below:

Academia: Historically, academic researchers and entities have not focused on the commercialisation of their scientific research. As such, there has been a long-standing symbiotic relationship with industry. However, over the last two decades, with the evolution and maturation of partnerships and collaborative research, this paradigm has shifted. Today, academic researchers not only desire to be a supporting element of the commercialisation – they also expect to be involved and compensated accordingly for this stage of development. The academia-government relationship has traditionally been one of ‘money-matters’. Because much of academic research is funded by government entities the with the ‘publish or perish’ mentality a strong role. Government-funded research is often also supplemented by private funding – which is again dependent on the researcher being able to demonstrate value in their respective field of research. Government: The benefits for governments to support PPPs is probably the easiest to appreciate as their mandate is to use their resources to advance science for improving the health of society. More specifically, by participating in PPPs in science, technology, and innovation (STI) they are poised to (1) be more responsive and proactive in developing policies that support the rapid advancements

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in science, technology, and innovation and (2) address urgent social and global challenges, such as future pandemics or other health crisis. Governments can use PPPs to mitigate risk of failures, reap the benefits of cost-sharing, and harvest useful insights regarding how to plan for future societal challenges and crisis.

Industry: Collaboration with industry stakeholders affords academic scientists money and access to tools and innovative technology, which are not always available. In return, industry gains access to cutting edge scientific knowledge and early innovations. Additionally, industryacademia partnerships can lead to the development of new markets, as well as helping to solve global health problems, such as developing COVID-19 vaccines. While these research partnerships are often fruitful, partnering with industry can often be viewed as undesirable for reasons surrounding conflict of interest. This is especially true for companies that fall within the definition of a ‘prohibited source’ by government entities. The optics of working alongside a company that has been deemed to have or perceived to have motives that are contrary or misaligned to those of the public health officials, whether grounded in proof or not, can be a deterrent to academic researchers and or non-profit organisations. The need to consider both actual and optical conflict of interest is thus a must when considering a partnership with industry.

Not-for-profit and non-government organisations (NFP & NGOs): These stakeholders hold an important position in the formation of PPPs because of their ability to serve as a neutral entity among government, industry, and academic stakeholders. Because both industry and academic institutions (that are receiving government funds) must respect their status as a potential ‘prohibited source’ for government engagement, a neutral entity is often used to prevent conflict of interests. NFP & NGOs can also bring together unlikely partners, i.e. multiple industry partners, by creating a unique collaboration structure that protects all needs of all individual stakeholders. NP & NGOs can align stakeholder groups with like-minded interests in ways to harness the valuable outputs of collaboration, while simultaneously protecting against far reaching policies such as anti trust policies.

Policies & Procedures – Defining the bright yellow lines

It has been demonstrated that without clear policies and robust procedures to create ‘checks & balances’, all scientific partnerships, collaborations and alliance run a very high risk of failure. Furthermore, even when the bedrock of such engagements is carefully defined and documented there is often missed opportunity. This is particularly true when different stakeholder groups are working together – e.g. academia and industry, government, and industry, nonprofit and academia.

It is essential that that all research collaborations establish the following policies and procedures to ensure that that all stakeholders are aligned with these key aspects of the collaboration. • Conflict of Interest Policy • Confidentiality Policy • Publication Policy • Intellectual Property Policy • Data Sharing Policy • Anti trust Policy & Guidelines (if one or more of the stakeholders are from industry) • Grant Award Policy & Guidelines (if awarding funds is part of the collaboration)

When there is misalignment of one or more if these elements, the entire collaborative entity is in jeopardy of failure.

The Future of Scientific Collaboration – Broader tangible benefits

During this time of heightened awareness about the importance of taking steps towards a sustainable future to protect the planet and to protect humanity’s future, we should take stock of the applicability of the principles and factors discussed here as integral element to fostering partnerships and collaboration in sectors beyond just scientific research. Many of the shortcomings and failures of partnerships and collaborations outside scientific research can be traced to many of the same issued discussed here. This article will hopefully provoke an even deeper consideration of how stakeholders, in general, currently engage with each other, and foster dialogue around whether improved stakeholder alignment could support advancing the environmental, social, and governance (ESG) principles that have become increasingly important to today’s society.

These principles discussed here for the successful formation and execution of scientific collaboration holds the potential to catalyse addressing broader societal challenges, including for example, within just the life sciences sector, protecting human rights in the supply chain, environmental sustainability, improved drug access, and better and more affordable drug pricing. Thinking beyond just the purely research aspects of innovating new medicines, stakeholders will need to consider collaborative new models that agilely tackle the significant and increasingly complex global challenges confronting the world today.

Mayrand-Chung, a PhD-trained Immunologist who also holds a J.D. specialising in intellectual property and negotiations. She held director-level positions within government, industry, non-profit organisations, and academia. Her expertise and passion is in the areas of stakeholder alignment, strategic partnerships and collaborations, regulatory and health policy, scientific engagement, and innovation.

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