It used to be canon that to work in drug development, one must be a scientist of some kind. In the last couple of decades we, as an industry, learned that this was true no longer.

The average drug development Subject Matter Expert (SME), regardless of scientific training, had to become almost so technically savvy as to qualify as an IT professional. A similar “Skills of the Future” transition is happening today when it comes to understanding legalese, legal agreement terms, and legal risks. As the work of drug development is 40-60% outsourced, and more than a few small pharma companies operate closer to 99% outsourcing, almost every aspect of drug development involves one or more external sources, all of which is tightly bound by complex legal agreements.

A significant bottleneck

Organizational silos imply that there’s a legal department that will handle all legal matters, without any involvement from the rank and file. Again, in the past, that was true and arguably still is today, however, getting contracts through legal is a significant bottleneck that has the potential to affect every aspect of the organization. In most organizations however, there is little or no quantitative analysis of how contract delays negatively impact achieving business objectives. The thinking goes, “So long as legal is protecting against risk, the business will carry on no matter how long it takes to execute legal agreements.”

The negative business impact of this approach is exacerbated significantly as the product approaches market approval and revenue generation (or lack of) becomes clearly delineated by months and days to submission.

Agile development

Using software development as a metaphor, the traditional “Waterfall” development strategy (i.e., putting large efforts into large user requirements) has been almost universally replaced by “Agile” development. This means breaking the work of software development into small bites, or sprints, which allows for the ability not only to test innovations on a smaller, nimble scale, but also to cast a wider net of development teams and suppliers. Agility as a business concept opens avenues that are otherwise closed in an approach that prioritizes “large” among all other considerations.

An important drug-development skill

Increasingly, drug-development SMEs are starting to recognize the value of confidently navigating legal agreements, embracing legalese as an important drug-development skill, and transforming their legal relationships from helpless dependence to collaborative partnerships.

I have found that understanding legal terms, business risks, benefits, and context is imperative to my ability to get things done.”

“One too many times, I have found myself between legal and an SME stakeholder who wanted to work with a vendor,” says Aditi Khurana, Director of Project Management at Asher Biotherapeutics, who started her drug development career as a state certified Clinical Cytogenetics Scientist. “I have found that understanding legal terms, business risks, benefits, and context is imperative to my ability to get things done.” Which she now has a reputation for. SMEs embracing of legalese doesn’t remove or replace the legal department, but it does make things go smoother and quicker.

“There’s a significant operational efficiency difference between coming to legal with a solid understanding of the business risks they’re most concerned about, versus no understanding at all,” she adds. “Over time, trust is built, and even more efficiencies are gained.”

However, some drug-development SMEs actively avoid legal matters and legalese. “Team members I work with who are otherwise outspoken tend to go very quiet when legal terminology is involved,” says Jennifer Whittaker, Senior Pharmacovigilance Process Director at Roche.

Naturally risk adverse by nature, most drug development SMEs need little reason to become more cautious, which can inadvertently widen the gap between legal and line functions.

 

Jennifer Whittaker, Senior Pharmacovigilance Process Director, Roche, and Clint Craun, Associate Program Director, Transcelerate

 

Navigate through the PVA maze

A stark example of the intersection between drug-development SMEs and legal is the Pharmacovigilance Agreement (PVA) between licensing partners, which dictates the responsibilities for safety data exchanges and reporting between two, or maybe even more, parties.

The volume and variety of alliances have increased significantly in recent years, as pharmaceutical companies push into new markets, technologies, and competitive spaces, and yet patient safety, regulatory, and reporting requirements are immutable. The rising complexity and burden of negotiating and managing safety data exchange prompted TransCelerate BioPharma (Transcelerate) to launch the Transcelerate Pharmacovigilance Agreements Optimization Initiative, which brought together member companies to create referenceable processes and tools designed to enable organizations to efficiently navigate through the PVA maze.

They found an astonishing degree of legalese variation.”

“After scoping the project to outline efficiency goals we analyzed almost 400 PVAs that were provided by 18 of our member companies,” says Clint Craun, Associate Program Director, Transcelerate. They found an astonishing degree of legalese variation. Over 750 PVA term headings, from which the team was able to create a concise table-of-contents template with just 68 unique headings. This was a staggering efficiency gain considering how much time negotiation of even basic terms can consume.

“It’s incredible to hear our member companies and others in the industry say ‘I wish we did this ten years ago’,” says Jeneen Donadeo, Executive Director, Transcelerate, who adds, “We hear that a lot.”

Embrace legalese

Legal terminology is rarely on the top of any scientist or drug developer’s list of interests, and yet it is increasingly vital for any role that involves working with external partners and collaborators, large or small.

By embracing legalese, forging a deeper understanding of business risks, and gaining confidence with respect to legal agreements, SMEs can establish productive relationships with their legal department counterparts, furthering our shared goal of getting safe and efficacious interventions to more patients, sooner.

This article was originally published in NLS magazine No 02 2024, out May 2024

About the Author

Sheila Mahoney-Jewels, MBA, is a Drug Development Cross-Functionalist and Science Writer. She is heavily involved in industry adoption of advanced safety analytics, data science and application of AI and ML to drug development operations.