Planning and executing highly performant pharmaceutical rollouts

As I sat down with Ava O’Keefe, a Senior Marketing Technology Consultant at Slalom, she walked me through her experience running a go-to-market (GTM) program for a pharmaceutical company awaiting FDA approval. With over 10 years of marketing and operations expertise as a Martech consultant, Ava has worked on numerous large-scale projects, but her most recent project stood out as highly complex, high-stakes, and under tight deadlines.

Ava’s role entailed coordinating multiple teams on the Marketing, Web, Analytics, and IT departments to deliver a comprehensive GTM plan within 72 hours of FDA approval.  “We had to plan down to the minute from receiving approval, accounting for multiple scenarios, including the time of day we receive approval, weekends, and upcoming holidays.” she emphasized.

The plan was sweeping in scope and included website development and optimization, demand generation programs, revenue systems, as well as internal training programs and sales plays. The team created launch materials for both healthcare providers (HCPs) and patients, and tracked the rollout with media planning, KPIs and reporting dashboards.

From a Martech perspective, what was unique about this project was the need for rigorous testing and Quality Assurance (QA) processes to ensure compliance with FDA regulations. “Strategy is key in this kind of rollout,” she advised. “Step back and map out your timings, approvals, and development schedules before diving in.” That will save your team significant time on revisions. “One key learning early on in the project was that we ended up overworking when we shouldn’t have,” Ava noted.

“Step back and map out your timings, approvals, and development schedules before diving in.”

Planning for and around the uncertainty of when FDA approval would occur proved to be a significant challenge for Ava and the teams. “You can’t predict with certainty when the approval will come through,” she noted. To address this, her team practiced dry runs for several weeks, refining processes and adjusting as needed. To mitigate potential delays or setbacks, Ava’s team established a robust backup system. Each key task had a primary person responsible, supplemented by secondary and tertiary teams to ensure timely delivery in the event someone was absent or unavailable. Ava emphasized that having backup plans in place allowed the team to adapt quickly to changes or unexpected events.

Quality assurance played a critical role given the nature of the highly regulated pharmaceuticals industry. “In pharmaceuticals, QA is much more stringent,” Ava noted. “In a regulated space, every detail matters. You need to ensure that all your messaging, branding, and digital assets are accurate and compliant with regulatory requirements. Every piece of communication, including internal sales plays and communications, must meet FDA regulations.” Ava noted that this differs significantly from typical consumer content, where regulatory requirements are less rigorous.

“In a regulated space, every detail matters. You need to ensure that all your messaging, branding, and digital assets are accurate and compliant with regulatory requirements.”

While specific results were not disclosed, Ava indicated the launch was successful, with all elements of the GTM plan delivered on time and within budget. The specific KPIs tracked included both enterprise and function-level metrics to assess the overall success of the launch in alignment with our team’s strategic objectives. These KPIs spanned various levels, including awareness, engagement, action, and maintenance, with a focus on digital performance. Within the first two weeks of launch, company met its key performance indicators (KPIs) for both awareness and engagement.

The product was released to the market and made available to fulfill orders within the first week of approval, as well as the drug being well-received in the medical community on launch. Furthermore, a co-pay program for patients showed promising results, allowing patients to receive the long-awaited treatment in a short amount of time post-approval.

Reflecting on the project, Ava emphasized the importance of careful planning, establishing rigorous QA processes, and planning for flexibility in responding to changing circumstances. For others preparing GTM launch plans, she advises building redundancy into team structures, practicing dry runs to test processes, and ensuring that all stakeholders are aligned with regulatory requirements.

As our conversation drew to a close, it was clear that managing a pharmaceutical GTM program is a high-stress, high-stakes program that requires meticulous planning, technical expertise, and a deep understanding of regulatory environments. Ava’s insights offer valuable lessons for marketers and technologists navigating this complex space.

Key Advice from Ava’s Experience with an FDA Launch:

• Plan for uncertainty: In regulated industries like pharmaceuticals, plan around uncertain approval timing by practicing dry-runs, refining processes, and adjusting as needed.
• Establish robust backup systems: Ensure timely delivery of key tasks by establishing primary, secondary, and tertiary teams to mitigate potential delays or setbacks.
• Rigorous QA is critical: In regulated environments, every detail matters; ensure all messaging, branding, and digital assets are accurate and compliant with regulatory requirements.
• Build redundancy into team structures: Establish backup plans for each key task to adapt quickly to changes or unexpected events.
• Practice dry runs to test processes: Refine processes and adjust as needed to ensure seamless execution on launch day.
• Ensure stakeholder alignment: Align all stakeholders, including Marketing, Web, IT, analytics, leadership, and legal teams, detailing regulatory requirements to avoid costly mistakes.
• Track key performance indicators (KPIs): Define and establish clear KPIs for both HCPs and patients throughout their lifecycles prior to the launch, ensuring that data and reporting mechanisms are in place to effectively measure the success of the GTM launch plan.

Ava O'Keefe is a Senior Marketing Technology Consultant at Slalom. She has over 10 years of marketing and operations experience serving Fortune 500 companies. She is a 3x Marketo Certified Expert and holds Eloqua B2B Masters and Luminary titles.

Slalom is a global consulting firm that helps people and organizations dream bigger, move faster, and build better tomorrows for all.