Rethinking the Role of Regulatory in Innovation – Part 1


I’ve written several articles about the need to eliminate the misperception that regulatory, legal and compliance professionals are sales suppressors and policemen.   In fact, the professionals I know in these roles can (and do) think outside of the proverbial box to support their business colleagues and achieve critical company objectives that help increase the top and bottom line.

Yet, there is always room for improvement especially since innovation and compliance/risk management are both at the forefront of industry decision-making.  So I’ve asked industry veterans to share their tips on how these functions can be more innovative.

This topic generated much interest from within the industry and there was an overwhelming response from professionals and their commercial colleagues both here and abroad to comment.  Therefore, I will be writing several articles on the subject.

In this article, industry veterans share best practices on how regulatory professionals can be more innovative:

  1. Take Your Regulatory Hat Off
  2. Explain the Why Behind a Decision (Don’t Just Say No)
  3. Keep Creative Juices Flowing
  4. Focus on Building Trust
  5. Walk in Their Shoes

Why is it that some regulatory professionals can think creatively and strategically to drive innovation and others find themselves unable to break out of the ‘it can’t be done because it’s too risky’ mold?

Here’s my perspective:  professionals in regulatory (or compliance, legal and medical) roles must possess cognitive flexibility.  Cognitive flexibility is broadly described as the ability to adjust one’s thinking from old to new situations and to overcome habitual thinking in order to adapt to new scenarios.

Regulatory professionals with cognitive flexibility can simultaneously consider two aspects of an idea or situation at one point in time.  For example, even if FDA guidance is still gray regarding the use of social media, these individuals are able to examine all possibilities for executing a digital tactic in a compliant manner. They understand and are aware of options and alternatives simultaneously within any given situation.

I’ve begun coaching regulatory (as well as legal, compliance and medical) professionals to apply cognitive techniques to enhance their ability to think creatively and strategically.  More on how to help change someone’s mindset will be shared in a future column.

  1. Take Off Your Regulatory Hat

Speaking of mindset, Glenn Byrd, Senior Director, Specialty Care Promotional Regulatory Affairs at AstraZeneca, believes that regulatory professionals must be able to separate from their ‘regulatory self’ instead of staying in their ‘regulatory box.’

“When regulatory professionals embrace their role as an integrated team member, we are vested in the outcome’s success.  It is only then that we can begin to think not just about risks, but about opportunities and how we can achieve them.  We become integrated in the strategic planning and vision of a project – and thus, become part of the solution, thinking broader, bigger, and creatively, while also navigating the risk.”

Stephanie Bova, Head of the EUCAN Digital Accelerator initiative at Takeda Pharmaceuticals, adds that creative thinking among regulatory professionals can drive great ideas.

“I’ve been in review committee sessions where the best idea on our brand strategy came from my regulatory colleague which is a great example of what can happen when we collaborate.  However, for me, the best results come when my regulatory (compliance and legal) colleagues deeply understand what we are doing and why we are doing it.  That’s why we must take them through the patient journey and explain our brand strategy so commercial doesn’t inadvertently limit the value our regulatory colleagues bring to our brands.”

Brian Williams, Sr. Director, U.S. Marketing Lead, Pain Commercial Business Unit at Endo Pharmaceuticals, says that he “really appreciates when regulatory colleagues understand markets and their promotional tactics, and how sales reps think.  When regulatory partners enhance the creative process and provide solutions, our output is quick and effective.”

  1. Explain The Why Behind a Decision (Don’t Just Say No)

Innovative regulatory professionals provide context, detailed examples and their rationales behind decisions because this information can open the door for new solutions to emerge.

“When marketers understand the ‘why’ behind regulatory boundaries, we can provide suggestions or recommendations for consideration to address the concerns,” explains Maria Finlay, Associate Director of Oncology Marketing at Teva. “Then, together, Regulatory and Marketing can determine how to achieve these same goals with meaningful and compliant tactics which align with the strategy.”

Mark Gaydos, Vice President & Head, US Specialty Care, North America & Global Regulatory Affairs, Sanofi emphasizes the importance of not simply defaulting to, ‘No.’

“It is Regulatory’s job to protect the public health through compliance with FDA requirements while working with commercial colleagues to meet business objectives. And while we must always operate within the current regulatory parameters, this does not justify saying, ‘No,’ without providing explanations and options to the extent possible.”

For example, explanations are needed for certain broad ‘subjective’ words that can’t simply stand on their own – for example, off-label, outside the regulations, violative.

“Being in a regulatory role which includes Compliance is definitely not about just saying “no” which is actually the easiest part, states Bruno Falcone, Healthcare Compliance Director, Global Compliance, Takeda.  “Of course being the gatekeeper is part of the job, but it is only a piece. To be effective and add real value in a regulatory role, the professional needs to partner with the other functions and get to know the business profoundly. Once that happens, the regulatory professional becomes much more than a subject-matter expert but a specialist on the company`s business as a whole, and this is the first step to become innovative, creative and protect the company`s reputation at the same time.”

Tracy Rockney, JD, Co-Founder & Managing Partner of OneSource Regulatory offers another way to educate commercial teams. “Regulatory team members should proactively benchmark against competitors in the industry in a different way – instead of looking at “did they get a letter for XYZ tactic”, benchmark on innovative initiatives that were successfully implemented with an assessment of how the regulatory parameters were met.”

  1. Keep Creativity Juices Flowing

Regarding the importance creativity plays in the role of Regulatory, Lynette Hopkinson, Vice President of Global Commercial Regulatory Affairs at Vertex Pharmaceuticals, states: “Creativity is key when you are building out a team of regulatory product communication specialists to support the business.  Having the ability to come up with new ideas or options in advance of review committee meetings, or better yet in the meetings, is invaluable from a resource perspective as the team struggles to swiftly find a path forward. Being creative can also mean appropriately challenging current thinking on marketing practices or easily connecting to and leveraging previous experiences on other brands.”

  1. Focus on Creating Trust

According to Falcone, “Rather than focusing on what is not allowed, regulatory professionals should focus on what is allowed and build personal relationships with the various stakeholders based on trust. Regulatory professionals need to be passionate, very good listeners and communicators, assertive, pragmatic, solution-oriented and always explain the rationale behind their recommendations. Those are the key requirements for regulatory professionals to be able to find the right balance between innovation and compliance”.

Kathryn Stripling, Executive Director at AstraZeneca, agrees and explains that, “cultivating a collaborative tone and approach to review meetings is key to building respect and trust, breaking down barriers and overcoming the “us versus them” attitude that is so prevalent in the industry.  A close-minded approach and negative tone will prolong the review process and make everyone’s job more difficult.”

Stripling encourages her team to approach review meetings with an open mind and to ask questions.  “You have to understand the business objectives before you can provide compliant, creative solutions.  Successful teams understand that creativity thrives in environments that are grounded in mutual respect and trust.”

  1. Walk in their Shoes

And we must remember to ‘walk in the shoes’ of both the patients and the regulatory experts. Regarding the patients we serve, Rockney reminds us, “I have always encouraged my regulatory team members go sit behind the glass on consumer/patient journey research, hearing and learning from the patients and/or their caregivers themselves – with the expectation that they come back to the office with the mindset that it is now their job to find a way to create better and compliant ways to communicate to and help patients and their caregivers.”

When I spoke with Lisa Drucker, Senior Director, Regulatory Affairs, Celgene, about her perspective on innovative regulatory professionals, we came full circle as she addressed the points made in this article.

“Regulatory professionals must walk in their commercial partners’ shoes to be able to provide innovative ideas that address the needs of the business.  Go on field rides with sales reps. Learn as much as you can about what members of the commercial team face every day.  Address their business objectives and strategies.  Speak their language.  Demonstrate your commitment to understanding the business.  When Regulatory embraces what’s important to business partners, and remains open to understanding their needs, we can more effectively help our company accomplish its business goals in a creative and compliant fashion.”