Ginny Murnen, Founder and President and Karen Ruffner, Vice President Operations
Promotional review has historically been a challenge. From navigating regulatory and FDA (OPDP) guidance to working through demanding timelines and critical deadlines, promotional materials implementation and more specifically, promotional regulatory committee (PRC) review, for pharmaceutical companies can be quite complex and often very time-consuming. The entire process depends on balancing the collective efforts of various review disciplines, marketing teams, ad agencies, and production (print/ digital) to create promotional materials that are competitive, yet accurate and compliant with the increasing regulatory constraints put forward by OPDP. The process requires bringing together professionals from very different perspectives (marketing, legal, regulatory, medical) in an attempt to agree on what can be said or written about a product. PRC and other key stakeholders are already extremely knowledgeable and well-versed in FDA requirements; however, in many cases, the promotional review is only a portion of an individual’s already packed day job. Stakeholders are often overwhelmed with limited staff, high volume of materials, lack of prioritization, and the need for quick turnaround based on a highly volatile and competitive marketing environment.
With the right partner like RTP, North Carolina-based NuEra Health Alliance—which specializes in marketing promotion and operations for the pharmaceutical, biotech, and medical device industries—companies can lower operating costs without sacrificing compliance or risk and find they have the ability to respond to competitive and governmental requests quickly, if and when needed. A boutique consulting firm, NuEra, can help organizations build more flexible and proactive processes and teams that work together better and can more quickly scale up or scale down depending on the circumstances.
Ginny Murnen, founder and president of NuEra Health Alliance, says, “We work with organizations of all sizes—from startups with few resources to companies that have one or two brands to Fortune 500 firms—and help them streamline promotional advertising, review, and approval.” The organization has a proven track record of helping life sciences companies drive efficiency and reduce the workload on staff that is often overwhelmed with large volumes of material. “Efficient review processes shorten cycle time—which we view as an indicator of efficiency—thus, getting materials to the field and customers more quickly. An efficient promotional review process also allows stakeholders to spend the right time on materials, thereby, fostering rich discussion that leads to compliant pieces that can effectively increase sales,” adds Ginny.
The explosion of digital and social media as a viable marketing channel has made promotional review even more challenging. Never before have businesses had to not only produce and approve content at a faster pace but also be prepared to respond to individual requests, comments, tweets and posts—many of which require promotional review and approval. “This has not only increased the volume of materials requiring approval today but the current FDA guidance includes some grey areas resulting in interesting conversations around the review meeting table,” informs Ginny. The one thing that has, however, remained is the basics of promotional review, which still apply. What is important is taking those basics and turning them into best practices, and this is precisely what NuEra Health specializes in.
Within the marketing operations space, NuEra Health’s focus spans the entire marketing materials management life cycle including agency management, promotion management, PRC review, 2253 filing, production, distribution, and warehousing.
A boutique consulting firm, NuEra assists organizations in ensuring that their promotional pieces adhere to the many requirements from the OPDP/FDA, thus, helping in smooth and timely launch of new products and drugs as well as ongoing throughout the product life cycle
“We have identified seven best practices gathered not only from our more recent client database but also from our real-world working experiences. We have been where most pharma staff have been. We have done the work. We recommend that our clients implement these best practices whenever possible as we believe strongly—and see real evidence— that if you leverage these, you will experience real benefits,” informs Karen Ruffner, vice president operations at NuEra Health Alliance. “However, not every client has the ability or money to implement these practices immediately, so we work to ensure which practices are critical at the time. Not one size fits all. We collaborate with organizations and help identify the specific actions to take to move to a ‘best fit of best practices.’”
For example, with its proprietary rapid assessment process, NuEra enables clients to quickly identify bottlenecks and areas of improvement for a more efficient review process. “We assess your process to eliminate gaps, overlaps, and extra, non-value-add steps in the process. We help clients take complete control of the review process and ensure smooth flow at every stage,” mentions Ginny.
Through the rapid assessment, the firm helps identify the areas and processes that are bottlenecks and address them with quick wins and/or long-term solutions. In addition to the rapid assessment process, NuEra has developed and offers additional tools for clients. One such tool—A Quality Checklist— makes it easier for advertising agencies to submit review-ready content the very first time. This saves the time and money that can be spent on multiple reviews of the same content. By identifying opportunities, quantifying savings, recommending implementation, and tracking approaches, NuEra facilitates improved efficiency of agency spend. “To determine the scope and goals of a project, we help companies define key performance indicators (KPIs), which help gauge the effectiveness of their efforts,” affirms Karen.
Another significant aspect of NuEra is its staff-related services. Organizations are often resource-limited, and to address that problem, NuEra supplements an organization’s current staff with experienced contractors at attractive pricing. NuEra has specialized project managers with years of experience facilitating PRC review and managing large volumes of promotional pieces. They can place experienced pharma content copy editors and experienced reviewers to quickly and transparently fill in gaps. In a recent instance, the firm helped a small pharmaceutical company with a hiring freeze recruit an experienced remote copy editor. “This resource has been critical for the company, especially in today’s unprecedented pandemic situation, as work has continued without a glitch,” asserts Ginny.
In addition, NuEra can complete the 2253 filing requirement for an organization, thus, freeing up internal resources to focus on other tasks. This requirement must be done via electronic common technical document (eCTD) starting January 2021. NuEra can advise companies as they begin to fulfil this important requirement in a timely manner and will have the capability to file via eCTD on behalf of clients by the January deadline.
In a nutshell, for life science companies, accelerating time-to-market requires a review process that is informed, cost-efficient, and risk-averse. With partners like NuEra, this can be achieved effectively. For the road ahead, NuEra is looking to grow in the medical device arena where there continues to be increasing scrutiny and oversight. “We will continue to maximize the efficiency and improve compliance in promotional review for our clients. We are committed to providing high-quality service and deliverables for pharmaceuticals, medical devices, and biotech companies of all sizes by accelerating review and approval of their promotional material,” concludes Ginny.