How Regulatory can Best Work With Sales & Marketing: Execs From Terumo, Abbvie, Endo and Helen of Troy Provide their Wisdom

Our panel of experts:

Rajesh S. Kasbekar- Global Vice President, Regulatory & Clinical Affairs Helen of Troy, Health & Home Inc.

Robert K. Lally Global Vice President Regulatory Affairs -Terumo Aortic

Andrew Storey – Head, Regulatory Affairs, Western Europe and Canada- AbbVie

Harris Rotman – Vice President, Regulatory Affairs – Endo Pharmaceuticals


In your experience, how does regulatory affairs affairs best work with marketing and sales?  Can you give an example of a partnership that had a strong result?

ANDREW STOREY: It is critical that regulatory affairs understand the commercial business and also helps commercial partners understand the regulatory environment and challenges and opportunities.  Only through mutual understanding can true synergy be achieved. There needs to be strong alignment early in the development process on what the key drivers for an asset will be and what the strategy is to achieve them. An example of this is gaining crystal clear alignment on what the commercial priorities are for a new label, and then aligning on the strategies.

HARRIS ROTMAN: Regulatory always works best with marketing and sales when open communication and trust are generated between the groups.  Sales/marketing have to reveal their desires and intentions and regulatory has to resist the urge to just say “no” and always pick the most conservative path (instead, when regulatory tries to find compliant, alternate pathways when challenges occur, great results can present themselves).  We recently partnered with commercial in designing the packaging on cartons and containers for one of our newer products.  Regulatory kept an open mind on the designs commercial wanted to use and commercial worked with regulatory to modify artwork when we continually received feedback from FDA.  At the end of the day, it was successful and both groups took ownership of the final product.

RAJESH KASBEKAR: For regulatory affairs and marketing/sales to work best, three key items must be well managed: a good understanding of the business and product strategy, the organizational culture and effective use of risk management.

First, a good understanding of business and product strategy is key in ensuring that regulatory and marketing are willing to make departmental tradeoffs in favor of higher goals. It is very important to understand what your source of competitive advantage is: major product innovation at a higher price point, or a me-too product at a lower price point with speed to market. In the consumer marketplace, there is also “consumer perception” based on the packaging and industrial design of the product. Both regulatory and marketing must take ownership for the success of the product and not for their specific disciplines or departments. The silos then disappear and the teams resolve their constraints to work as one.

Second, in terms of organizational culture, aspects such as commitment to regulatory and safety, accountability, all styles produce results, be here now, and a forgiving risk-taking mindset are simple concepts but play a huge role in amplifying productivity within the organization.

Third, effective use of risk management tools can hugely facilitate decision making.  The regulatory and marketing constraints need to be managed using an effective risk-management tool for deliberate, carefully considered decisions to get a successful product to market.

ROBERT LALLY: Regulatory affairs is an integral part of corporate strategy from product inception through to obsoletion. With marketing it is essential for RA to be fully aware of what the intended indications are for the proposed devices, how that fits with the market place (and with potential predicates/competitors) and into which geographies it is intended. In a previous employment my RA team were engaged with a new device from the get-go, realized it would be an incremental product for US but a breakthrough opportunity for Japan, we liaised with the Japan regulator from inception, addressed all their test requirements (essentially variants on US testing) kept them informed of developments – net result was shaving at least 2 and probably 3 years off the Japan launch timelines.

With sales, RA needs to keep ahead of promotional materials, physician (and sales team) training on products, keep aware of clinical evolution and feedback as seen by the hands-on sales teams. As regulatory requirements change over time these become a burden on the manufacturer but also present an opportunity to communicate the enhancement of the devices to the user groups.

In a previous employment we initiated product management teams with RA, QA, R&D, Clinical, Sales and Marketing and became aware of growing off-label use of a long- established device for an indication that had become critical for the physicians and that other comparative devices were not best suited for. Following bench testing and evaluation of the physician clinical papers on this off-label use, we secured full regulatory approval and were thus able to further, almost exclusively, promote the device for that specific indication.

How does regulatory impact the commercial side of the business?  Can you give an example of a regulatory strategy and how it contributed to revenue?

ROTMAN: When R&D and commercial functions communicate well and truly listen to one another, the business always benefits.  I think it is dangerous for regulatory groups to be siloed from the rest of the organization.  When I worked for very large organizations that had hundreds of regulators, the regulatory strategists were rated on drug approvals and not necessarily on how well the eventual labeling could be used in promotion as a different regulatory group handled those aspects.  I believe regulatory should partner with commercial and clinical groups to plan at the very beginning of a development program the types of studies that will be needed to create the best labeling and promotional claims by the time drug approval occurs.  If regulatory can be honest as to promotional prospects early on with the commercial groups, clinical programs can be course-corrected or key FDA meetings can be planned to drive consensus with the Agency well in advance of a product launch.

LALLY: A typical example is where a new device is being developed. Long term, the device will have an extensive indication supported by extensive clinical data and bench testing data and be marketed across global geographies. For a breakthrough device many countries have a very slow regulatory approval system (China) whereas others (EU, USA and Japan) have established expeditious pathways where the device has strong potential to improve patient outcomes. It is the role of RA to explore the optimal pathways for the device, work at a corporate level to secure strong relationships with those regulatory agencies and with local key opinion leaders to present the best case for approvals.

KASBEKAR:  The regulatory function is more like the defensive specialist in a football game. There are numerous studies showing that football games are won more because of defense than offense. In human physiology, there are cells that regulate cell function and play a key role in wound healing.  In financial portfolio management, it is well known that portfolio return is optimized through risk management-based regulatory function than getting a great return.

A regulatory strategy can contribute to revenue, but also depends on operational effectiveness based on the risk profile of the products as well as organizational strengths.  Regulatory strategy in an organization with complex high risk products or innovative products may focus more on creating barrier to entry, while strategy in an organization with lower risk products may focus on process agility and speed to market in order to create the competitive advantage. Regulatory strategy in startup organizations with no brand recognition may focus on product innovation and aggressive regulatory paths to market, while the strategy in organizations with a strong brand name may focus more on a conservative regulatory pathway and culture.

Regulatory strategy contributing to revenue is based on the least burdensome pathway for new or expanded intended use or indications. Viagra became a blockbuster drug after the indications for use for the drug were expanded to include inducing erections in addition to the original indication of treating chest pain or high blood pressure. Another example is use of a minimalistic regulatory strategy by making cosmetic changes in the product for additional incremental revenue. Both have been effective used for major revenue generation.

What impact has the Covid-19 pandemic had on regulatory and how you work with marketing and sales?

LALLY: My RA teams are primarily based in UK and USA though we strongly rely on our corporate RA colleagues around the world for their local submissions and liaison with local regulators. All have been impacted by Covid-19 to some extent. We have a strong corporate value of “It is not about I can’t do it because… our world is about I can do it if…” Most of the RA teams have adopted a work from home approach which has really challenged many in how we modify our home environment to encompass work related equipment, processes and appropriate disciplines even when their children and other family members are also ostensibly home-based. Their work also requires extensive interaction with the R&D, clinical, quality and sales and marketing teams which 10 years ago may not have been achievable, but with today’s technologies we have been able to adapt to a new way of interacting and I am proud to say my RA teams are achieving minimal disruption to the business RA plans.  By primarily working from home the teams are also minimizing the congestion in the facility space thus enabling social distancing of those whose roles require them to be at the facility.

KASBEKAR:  Covid-19 has had a major impact on product development cycles. It has extended product release life cycles for some products and reduced it for others. 

For example, it has hugely affected clinical recruitment, creating tremendous uncertainty in terms of product life cycle. It has affected manufacturing due to social distancing and use of PPE. It has reorganized resource utilization at regulatory agencies, who are now more focused on Covid-related products, resulting in increased premarket approval times for non-Covid products.

On the other hand, it has also created opportunity for specific medical devices classified as personal protective equipment, by eliminating regulatory requirements altogether. For example, regulatory requirements for devices such as masks, ventilators and thermometers have been considerably curtailed.

All these have impacted regulatory and have resulted in conversations with marketing to take a fresh look at product and business strategy. It has resulted in changes in inventory management such as increased inventories, opportunistic Covid-related product focus, and creative ways of conducting clinicals, to name a few.

STOREY: While the business has been able to be fully sustained, unfortunately, many health authorities have had to divert resources to Covid-19 therapies and vaccines, which has led to delays in reviews of some products.  These delays need to be mitigated as best as possible and clearly communicated to commercial partners to ensure plans to get the products to patients in need are adjusted and optimized.

ROTMAN: Covid-19 has had a dramatic impact on our entire company, including modifying how regulatory works with marketing and sales.  As sales representatives were unable to meet live with doctors and their staff, we had to work together to come up with virtual ways for sales calls to occur.  The challenge, of course, is that the regulations governing advertising and promotion did not change during this pandemic.  We also had to determine how our sales, marketing, and medical staff would engage in discussions with healthcare providers during virtual congresses that took the place of live venues.  By partnering with sales and marketing (and our compliance and legal groups) we provided guidance on how regulatorily-compliant sales detailing could occur using virtual meeting tools.  It has been a challenge, but we have been very successful so far and have now used these new ways to successfully interact with healthcare providers.

What “disconnects” have you seen between regulatory and marketing and/or sales?  What strategies have you used to overcome them?

STOREY: In the past, disconnects happened when commercial was not consulted early enough.  When commercial would come to the table with requests late in the game, it was hard to deliver.  Building an agile governance structure is key to ensuring effective communication and alignment.

ROTMAN: Trust has to be built between the groups and if it is lost, it is hard to regain.  Regulatory has to trust that marketing and sales will be thorough about their intentions and reasons for doing things.  The commercial groups have to trust that regulatory will really hear them and truly try to find solutions to challenging issues.  One strategy I use often is to start off all conversations by first stating what I think the other group wants and also stating what I think they are afraid of and what my biases might be.  I think many people appreciate this approach; it initiates conversations off in a good way (much better than arguing the regulatory position right off the bat).

LALLY: In my current employment the organization is effectively designed to avoid disconnects and all functions operate as a single team. In some older previous employments I have seen RA viewed as the Sales Prevention department and the department of unavoidable overhead – areas where RA presented problems were not involved directly with the business, were not engaged early on in product development, but these were all readily addressed through effective communication, working together in sharing the issues and RA focusing on solutions rather than problems. Adopting a product management strategy has been an effective method for pulling all different perspectives into a common view of what is best for the business and provided cross functional integration.

KASBEKAR:  The major disconnects I have seen between regulatory and marketing have been when the leaders of these functions do not clearly understand the other function’s requirements.

The regulatory requirements include following state-of-the-art standards and regulations, producing good quality documentation, and releasing safe and effective products or product changes. Sales and marketing requirements include customer obsession based on product aesthetics, timely delivery, product quality and customer service. Coupled with these two departmental constraints is the program management function or department that has requirements related to deliverables, budget, time and cost. 

The strategies I have used or have seen being used effectively are enhanced communication to clearly define the product strategy and how it fits with the business strategy, and then finding creative ways to find tradeoffs to these regulatory and marketing constraints using risk management principles.

In your experience, how effective have post-market surveillance communications been to marketing and sales?

ROTMAN: Very effective.  We maintain active lines of communication with our marketing and sales business partners and as we receive FDA or pharmacovigilance safety/labeling changes we work with all teams in the company to implement them.  It’s not about commercial groups influencing safety outcomes, which would never happen, but it is about partnering in an efficient way to determine how promotional materials may need to be updated as we learn more about our products in the post- marketing environment.

LALLY: By issuing mandates to address an issue – totally ineffective. By working closely with your colleagues in sales and marketing, understanding what they do and what needs to be done and collaborating on creating the optimal communication – highly effective. RA is typically an engineering/legal/clinical language, whereas sales and marketing are clinician/commercial languages – the same words can mean different things to the various recipients. One key to these communications is, even if they have a negative message, find the positive aspect without losing the key message.

KASBEKAR:  Post-marketing surveillance and its associated communications play a huge role in not only managing liability but also improving future product development. These communications can be done through formal channels such as management review, supplier review or informal channels at the core team level.

New regulations now require more enhanced post-market surveillance, as well as having a well-functioning post-market surveillance program. Well-structured communication is critical to the survival and thriving of an organization.

An awareness of these post-market communications by the sales and marketing function can also result in better customer relationships and conduct of regulatory audits in a more effective manner. It also leads to a better understanding of the organization’s product standing in the competitive landscape. Not having an effective post-market communication process (especially with involvement of sales and marketing) can lead to decreased market share and more waste through more expensive corrections or removals in the field. For organizations with major brand presence, it could even be harmful to their reputation.

STOREY: It is very important to ensure that all post-market information is shared expeditiously with the commercial team to ensure that they have the most up to date information and are able to answer questions posed to them effectively.

How have you measured regulatory success in your company beyond approvals?

STOREY: Beyond getting an approval, other metrics that are key are the time to approval, the degree to which the approved label contains the information deemed key by the company, and the health of the partnership with external stakeholders such as health authorities, to name a few.  Being a strong partner with internal stakeholders is key in achieving all of these.

ROTMAN: Maintaining excellent relations with FDA and health authorities around the world is a primary goal.  Ensuring that we help our company navigate through regulatory challenges compliantly and creatively is also something we strive for.  When the company constantly comes to the regulatory affairs department for help and advice and wants feedback from its members, it feels like the department is truly providing value.

LALLY: Yes, RA is about securing approvals – and maintaining them as necessary. But it is about developing the RA team members to think about the business, about their colleagues and how we communicate to the cross-functional teams what is required now and what will be required for the future. How best do we predict the future, by influencing and shaping it? We do this by communicating with all involved in our business both internally and in external media – trade associations, industry groups, clinician groups and regulatory authorities.

KASBEKAR:  Regulatory has a key role to play in the success of the organization as their defensive coordinator. The regulatory function has different roles to play beyond premarket approvals. This is best characterized in terms of certain key metrics that should be defined in every organization. These key metrics should be connected to the objectives, goals, strategies and measures at the tactical level.  Some examples of these metrics include the maturity of the quality management system, the pre-market development, and the post-market surveillance system, as well as the clinical validation process. These are some of the metrics one can use to measure success.

Can you relate any incidents in which coordination between marketing/sales and regulatory were well-handled?  Can you give an example of the result?

ROTMAN: Recently we received approval for one of our products and regulatory and marketing/sales coordinated on a daily basis months before the PDUFA date.  By maintaining constant lines of communication we could “pre-approve” promotional pieces and place them in a holding pattern as regulatory proceeded with labeling discussions with FDA.  The regulatory strategists in my group would update the regulatory advertising/promotion review staff as the draft package insert was modified in real time.  In this way, Important Safety Information for fair balance and other launch promotional pieces could be developed in advance of the approval date and modified as needed as the FDA review proceeded.  By the time we received our approval, much of the review and preparation work had been completed by sales, marketing, and the copy clearance reviewers (regulatory, medical, and legal) and the meetings that occurred to finalize the promotional pieces were not as burdensome as they would have been without the constant touchpoints we had.  And we did this during Covid-19 when we were all working remotely.

STOREY: Given strong partnerships, communication and structured processes for gaining alignment, it is possible to manage issues effectively.  When something unexpected comes up, such as an unexpected clinical trial outcome or a new safety signal, we can use the foundation of partnership to work through these issues in an agile and effective manner.

KASBEKAR: An understanding of the product and business strategy, organizational culture that is committed to safety and regulatory, awareness of the cost of quality, as well as application of risk management techniques are the hallmarks of good coordination between marketing/sales and regulatory functions. In organizations and companies that had these skill sets, I have seen several incidents where this coordination is well handled. A specific example that comes to mind is a product that became a huge global success for us. A clear product vision, an early collaboration between marketing and regulatory counterparts from each region of the world, and effective risk management were evident clearly in the complete life cycle of the product development process at every stage.


RAJESH S. KASBEKAR Global Vice President, Regulatory & Clinical Affairs Helen of Troy, Health & Home Inc.

Rajesh has been Global VP for Kaz and Helen of Troy, Health & Home for 11 years. He is responsible for product safety, regulatory, product liability, sustainability, and quality system activities around the globe, including the US, EU, Canada, and the Asia Pacific. Previously, he was a Regulatory­­­­­­ Manager for Hologic, Inc. and RA/QA Leader for GE. He has also published several peer-reviewed articles and white papers, and has patents pending.

ROBERT K. LALLY Global Vice President, Regulatory Affairs Terumo Aortic 

Rob holds MBA, BSc, C.Eng, and MIMechE degrees. He comes from a mechanical engineering background in petrochemical and risk management industries. Rob has spent the last 30 years in medical device quality and regulatory affairs. He established the first Notified Body in Europe for the Medical Devices Directive, and then led regulatory departments for a number of device industry leaders worldwide. Based in USA since 2004, Rob has extensive experience with regulators in USA, EU, Japan, China, India and Latin America.

HARRIS ROTMAN Vice President, Regulatory Affairs Endo Pharmaceuticals Inc. 

Harris was previously VP in Global Regulatory Affairs for both Indivior and Shire. At Sanofi Aventis, he served as Associate Director, Regulatory Development. Before that, he was Regulatory Coordinator for Wyeth Pharmaceuticals.

ENDO PHARMACEUTICALS INC., an Endo company, develops and markets high-value, quality branded pharmaceutical products for patients in need. Endo Pharmaceuticals’ specialty portfolio includes products for urology, men’s health, orthopedics and endocrinology.

HARRIS ROTMAN Vice President, Regulatory Affairs Endo Pharmaceuticals Inc. 

Harris was previously VP in Global Regulatory Affairs for both Indivior and Shire. At Sanofi Aventis, he served as Associate Director, Regulatory Development. Before that, he was Regulatory Coordinator for Wyeth Pharmaceuticals.

ENDO PHARMACEUTICALS INC., an Endo company, develops and markets high-value, quality branded pharmaceutical products for patients in need. Endo Pharmaceuticals’ specialty portfolio includes products for urology, men’s health, orthopedics and endocrinology.

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