Bioforum, the Forum for EmergingBio's Outsourcing Decisions

Welcome to the Forum for EmergingBio's Outsourcing Decisions!

If you’re reading this post, chances are you work in clinical research and are well aware of the countless challenges that life sciences companies face today. Limited headcount and resources combined with increased pressure to contain costs, accelerate timelines and deliver novel, targeted therapies to market are not new challenges for our industry, but they are intensifying amid the COVID-19 crisis. As the biopharma industry traverses uncharted waters and doubles down on efforts to bring new therapies to market quickly, cost effectively and without affecting quality, the success of strategic partnerships and functional service provider models are more critical than ever before.

But, how can small biotechs and startups successfully navigate the pathway toward finding an outsourcing partner, particularly in a pandemic? Does being “small” limit your options? How big a role should cost, therapeutic expertise and geographic location play when evaluating potential CRO partners? 

When the stakes are even higher from the get-go

The stakes are even higher for small biotechs to get CRO and vendor partnerships right from the outset than for Big Pharma as they simply cannot afford missteps. Avoiding mistakes can be especially difficult for emerging companies that do not have an abundance of in-house expertise and resources available, both for executing clinical trials and for risk management and contingency planning.  

Unexpected “surprises” can be completely out of a company’s control, such as with how COVID-19 has affected certain trial operations. Current and planned clinical trials with traditional site-centric protocols suddenly cannot operate the way they were designed. Due to the social distancing and travel restrictions associated with the pandemic, for example, access to many clinical trial sites is limited for staff, principal investigators (PIs) and, most significantly, patients. Bigger companies have the advantage of being able to invest the time, resources and budgets into adjusting or rethinking their clinical trial design and data collection strategy to deal with these issues. Small biotechs and startups, however, simply do not have the infrastructure and expertise to mirror how big pharma is managing the crisis-all of which means a different approach is required for smaller companies.

Choosing the partner that’s right for you

The core competencies CROs have built over the decades to service large pharma don’t always fit the fast-paced, entrepreneurial world of small biotechs and startups. Emerging companies need more flexibility and expertise on how to chart the fastest, most efficient course through clinical trials, mitigate any unnecessary risk of delays or failure, and increase the likelihood of launch-all just to survive long enough to have the chance to get their novel treatments into the hands of patients who need them most.

If they don’t already outsource, emerging companies must first understand why they are going down this path in the first place and what they are trying to achieve-whether it’s clinical support to help with a study or regulatory work to drive data management. The key is to do your homework upfront. What may work for one small company may not work for another.

And that’s where building relationships with the right partners who understand how emerging biotechs operate and appreciate the entrepreneurial culture of startups is crucial. CROs or service providers that support small biotechs must strike the right balance between following best practices and thinking outside of the box, while ensuring ongoing communication and to stay within the agreed upon budgets.

Leveraging hidden advantages

All that said, the challenges that emerging companies face can also be seen as opportunities. They have fewer decisionmakers and are nimbler than larger companies weighed down by bureaucracy. Additionally, across the industry, there’s a perception that having budget constraints means that one has to give up standardization and consistency in clinical trial execution. While each trial has its own set of unique design aspects, the actual data strategy for each study does not have to be unique and there are numerous ways to bring this strategic thinking into a company’s processes and procedures, without incurring costs. And lastly, having a less rigid business environment creates the freedom to explore new ways of doing things, spurring innovation.

The current environment we find ourselves in with COVID-19 illustrates this point; now, we all must rethink the way we’re conducting clinical trials. Indeed, the recent FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, applies to all entities conducting clinical trials, no matter the size or experience of the organization.

Putting a plan into action

Over the next few months, as we tackle the coronavirus outbreak and its fallout together as a community, we’ll be discussing all of these different challenges and opportunities in bimonthly blogs on Applied Clinical Trials. Planned topics include:

• When to outsource and how to choose the right partners

• Identifying the right balance of oversight when working with a service provider and whether internal staffing investments are necessary

• How to incorporate more standardization and consistency across all trials or study operations

• Determining which services are essential and how to weigh the pros and cons when it comes to making budget decisions

What topics would you like to hear about?

We’re open to evolving these discussion starters based on your input and would love to hear your thoughts, so please reach out and feel free to share ideas. Our goal is to create a forum for knowledge sharing that specifically addresses the needs of the small biotech and startup community.

Looking forward to continuing the EmergingBio conversation soon!

Tanya

Tanya du Plessis VP, Data Strategies and Solutions Bioforum the Data Masters

tanya.duplessis@bioforumgroup.com