"Everyone's Risk, Everyone's Benefit": The Keys To Effective Strategic Partnerships

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Whether it be a collaboration between Big Pharma companies, a sponsor and CRO, or a pharma company and a research foundation, partnerships are dependent on the proper alignment of goals, trust, and risk management. As the industry is faced with increasing demand for timely drug research and development, partnerships need to be a balance of equals, and both parties need to be ready to tackle whatever challenges might arise.

Clinical Leader spoke with Mark Scullion, Senior VP, Strategic Resources, from inVentiv Health to learn more about the changes in the industry that are influencing partnership strategies, collaborative drug development, and innovation. 

Anna Rose Welch: How should one approach strategic partnerships, especially to ensure effective risk management?

Mark Scullion: Partnering is an exercise in value creation. To be an effective partner, you have to be able to define value in terms that work, create value against those terms, and prove at the conclusion of a project or initiative that it was successful. That sounds straightforward: define value, create value, prove value. However, in practice, one has to recognize that ‘value’ is a shape-shifting concept, and that ‘partnerships’ are comprised of many different stakeholders whose varying responsibilities and vantage points give them similarly different ideas on what value – and therefore success – looks like.

Mark Scullion, Sr. VP, Strategic Resources, inVentiv Health

Just as value shifts shape, so too does risk according to the needs of a specific partnership. For example, risk assessment will probably include operational delivery risk; resourcing risk; risk of developing success factors that do not adequately measure success; risk of changing internal and external circumstances; risk of failure to adapt to change; and perhaps most classic, the risk that a drive for cost reductions will impact quality.

However, balance is not that simple – you seldom exchange quality for risk. Effective partnerships consider risk a core element of partnership design and planning. These partnerships will include systematic risk assessment at the start of a partnership to map out a course and to identify detailed risk and mitigation plans and period review of changing circumstances — all to ensure that risk and value are at the forefront.

Welch: Are there any new expectations throughout the industry that have led to a redefinition of the criteria used to select a partner?

Scullion: With regard to strategic partnerships – whatever the model – partner accountability remains a key expectation. Traditionally, when biopharmaceutical companies contracted with a CRO on a transactional level, the CRO was given a specific scope of work with very prescriptive guidelines. Now, even in very task-oriented engagements, CROs are increasingly invited to suggest alternatives to the sponsor’s planned approach. In this new environment, functional excellence matters, but should be considered a basic criterion; it is expected that the requisite scale and skill in data management, for example, exists.

Accountability demands something more, and we see it in three parts. First, it is important that a partner can articulate a compelling vision for the future — a vision that materially advances a shared strategy and that leads to the achievement of the strategy. Secondly, it requires a strong cultural fit, comprising a high-degree of personal trust and commitment. Some of this can be accomplished through the process of partner selection and evaluation, some through structuring an agreement in the right way. Short-term “service level agreements” are no longer fit for the new environment. Large-scale partnerships are often among the most visible and business-critical initiatives a sponsor company will undertake, and they impact directly on the success of a function or program. Therefore, bonus and penalty arrangements should reflect shared commitment: everyone’s risk, everyone’s bonus tied to the same key measurements. The importance of these partnerships also means that they are potentially career defining, and that is where personal and cultural fit matter.  There will be challenges; there will be urgent phone calls. Your partner must be someone whom you respect and trust.

Welch: What is the biggest challenge you have run into with a partner in the course of your work together, and how did you approach said challenge?

Scullion: Commonly this sort of question is answered with an example of a company’s challenge, then move on to actions taken and results achieved. These examples matter — it is essential to be able to demonstrate bonafides, a proven ability to match experience with circumstances. However, they reflect an outmoded manner of operating. They represent almost a test: this is our problem, what solutions can you bring to bear? That is no longer the environment in which we work.

Circumstances — regulatory, political, economic, competitive, scientific, operational — are in constant flux, and adaption is more than expected. Our job is no longer to deliver against the scope; it is to anticipate and plan for all of those constantly-changing circumstances; to consult, advise, and mitigate. With one partner, we worked together to develop a systematic risk assessment to be the backbone of their risk-based monitoring program; with another we developed an assessment of geopolitical, operational, and financial risk surrounding their current delivery locations and provided scenarios to achieve a more optimal footprint.

The point is that there are now multiple levels to a partnering relationship, and an effective partner is operating at all of them or is missing the mark.

Welch: What have you found to be the best practices when collaborating to streamline drug development?

Scullion: There are many elements, though in our experience these four are critical to success, especially in a cross-company collaboration:

1. Begin with the end in mind: Do not focus on the provision of resources, but on the future achievement of significant financial or operational objectives that encompass people, processes, technology, and geography.
2. Drive decisions with data: This involves creating the data you need, as well as using the data you have. Benchmarking current performance enables data-driven discussions on the prioritization of finite resources to achieve the desired outcomes. Prioritization should come within a defined and understood ranking schema that balances all critical objectives, such as risk, quality cost, and the frequency at which something occurs. Data will be critical in adjusting your course over time to take account of changing opportunities and circumstances.
3. Innovate for ‘Now’ and for ‘Next’: Many attempts at streamlining projects focus on moving the largest rocks. For example, there are attempts to reduce the development timelines by three months or to lower the cost of clinical monitoring by 30 percent using one initiative or form of technology. A combination of staged investments and big bets on the future will allow for constant progress and the achievement of necessary wins.
4. Manage change: Change is difficult, and not always welcomed. Understanding early who will be affected, when, and in what way will enable engagement of the right leaders across the partnership to bring the right institutional knowledge to bear. It is important to note, too, that leaders are not limited to those with the most-senior titles.

Welch: What are some game changers today that are leading companies to partner up to “think outside the box?”

Scullion: Clinical development remains one of the most regulated industries, but the demands of innovation and change abound. Five or ten years ago, the focus of this conversation might have been on applying Total Quality Management (TQM) principles to clinical monitoring, or lean sigma to data management. However, today, the potential of data, technology, and innovation to impact the patient experience and streamline clinical development is greater than ever and is growing by the day.

Perhaps one of the bigger trends today is an increase in focus on patient centricity to ensure the patient’s experience is at the center of the clinical development process. The development of electronic informed consent has radically improved the patient experience by enhancing the patient’s ability to comprehend the expectations of a study in which they plan to enroll. Electronic informed consent can also reduce the potential for fraud and error and increase the ability of investigators and study coordinators to improve the patient experience.

You can see this focus on patient centricity in the working of CROs and pharma and bio companies, as well, which are currently seeking to improve patient engagement, education, and experience by exploring the potential value of game theory — “serious games”. These methods, which employ similar techniques to those commonly used now by the military and corporate strategists, could potentially increase patient adherence and reduce the cost of patient recruitment and retention by better addressing patients as individuals and responding to their needs.

Finally, some companies have developed proof of concept projects around the potential of semantic analysis of unstructured data, including passive analysis of web content, to increase the quality of signal detection and analysis and to reduce the time and cost of adverse event reporting. Many of these projects are collaborations between large Pharma or service providers with entrepreneurs outside of the industry. As in any industry, there is a drive to hire smart, engaged, creative, and passionate people from whatever background to bring new perspectives to important challenges. There is nothing outside of the range of normal consideration anymore!