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Regulatory Strategy — Insights from an Expert

In today’s highly competitive environment, even a short delay in getting either a drug or medical device on the market can result in significant losses for life sciences companies in terms of market share and generated revenue. What’s the key to success? Obtaining timely marketing approval from regulators. During an interview with Ashton Tweed, President and Principal Consultant of Keystone Regulatory Services Bill McLain shares his insight and some regulatory strategy advice for pharmaceutical and medical device companies.

When Should Organizations Solicit Regulatory Input?
“As soon as an organization has an idea of the type of product they want to market – even in the early stages of product development – they should solicit some form of regulatory input,” answers McLain. “It’s never soon enough.”

In the very early stages of product development, for example, life sciences companies should engage with regulatory affairs to request product designation. For borderline products this will solicit a formal response from the FDA regarding jurisdiction. McLain advises that life sciences companies should get regulatory professionals involved from the beginning stages of product development – whether it involves having regulatory staff within the organization or hiring a consulting firm.

Having good regulatory input and implementing a plan that takes into account all regulatory aspects in product development is important – especially as the general strategy is developed. For example, will manufacturing of a product be done onsite or outsourced? This will impact the investment and fundraising needed, McLain points out, as well as the regulatory staff requirements down the line.

When Is the Right Time to Transition to Full-Time Regulatory Help?
The answer to that question depends on the scale, size, and scope of what an organization is asking the regulatory staff to do, explains McLain. So for a small company with a relatively low regulatory overhead that is working with a Class I or simple Class II product, when to enroll the services of full-time regulatory professionals may be primarily a cash-flow issue. In other words, can the company afford the cost of a permanent, in-house regulatory staff? Or is hiring interim regulatory employees or a consulting firm a more economically feasible solution?

For pharmaceutical companies, however, the regulatory overhead will usually be high from the start, involving multimillion-dollar studies that require volumes of documentation. So when hiring regulatory help, pharmaceutical companies need to consider their exit strategy and how to best deliver value to their shareholders. If a company only wants to spin off an IP, McLain exemplifies, bringing a permanent, in-house regulatory staff onboard may not make sense. But if the company plans on manufacturing the product after approval, however, having the same regulatory staff “in the trenches all along” is valuable.

“There’s not a one-size-fits-all answer to the question of regulatory staffing,” says McLain. In addition to depending on the type of product being developed, he summarizes, the answer is also tied to an organization’s exit strategy.

Advice for Managing an Outsourced Regulatory Team
Because outsourcing regulatory affairs is a growing trend in the life sciences industry, learning how to best manage an outsourced regulatory staff is a challenge faced by more and more medical device and pharmaceutical firms today. When it comes to regulatory strategy, there are many ways to get the same thing done, McLain observes, and usually none is necessarily the wrong way. “Based on my personal experience,” he describes, “when you get three or four regulatory people involved, you get five or six opinions on everything.”

So how do life sciences companies that hire a number of outsourced regulatory staff deal with this challenge? “Establish a strong chain of command,” McLain advises. Designate who is making the final decision, who is responsible for carrying out the tasks, who is responsible for compiling the data, and so on. Due to the strong-willed and opinionated nature of the people who tend to gravitate toward the regulatory profession, says McLain, it’s important that all individuals operating in a large team understand their roles.

By building an effective regulatory team that establishes consistent communications with regulatory agencies from the start, life sciences organizations can help save both time and money as they drive their development and marketing goals forward.

Ashton Tweed would like to thank Bill McLain and Keystone Regulatory Services for this interview. If your company needs help in the area of regulatory affairs and quality systems, contact the Ashton Tweed Life Sciences Executive Talent Bank, which can supply that assistance either on an interim or a permanent basis. Alternatively, we’d also like to hear from those who are regulatory affairs or quality systems specialists looking for interim or permanent opportunities. In either case, please email or call us at 610-725-0290. Ashton Tweed is pleased to continue to present insightful articles of interest to the industry.