Accelerating Pharmaceutical Drug Launch: Essential Steps for Success
Bringing a new drug product to market can be challenging – especially during late-stage development, when the focus shifts from product creation to commercial readiness and launch.
This phase is often viewed as one of the most critical milestones in any drug program, representing the culmination of years of research and development. Because timing is crucial, effective and focused launch management becomes essential. Getting it right the first time is vital, as there is so much at stake. However, the traditional launch cycle is frequently hindered by fragmented data, inefficient workflows, regulatory challenges, and siloed teams.
To achieve maximum commercial impact, pharmaceutical companies should establish a clear launch strategy based on proven best practices while allowing flexibility to adapt to changing circumstances. Numerous activities must occur at specific times to exact standards. While it may seem uninspiring, a company must ensure nothing is overlooked. When the launch’s impact varies significantly from country to country, it is often due to inconsistent execution of the launch plan. By utilizing a detailed, step-by-step approach, pharmaceutical launches can be expedited within a defined timeline.
Accelerating product development
The cost of bringing a drug to market has more than doubled in the past decade. This process is not linear and requires collaboration among various functions and stakeholders. An integrated model is essential for enhancing efficiency and speed. The integrated product development plan is a roadmap for aligning goals and activities across research and development. It helps integrate strategies from cross-functional teams, ultimately increasing the chances of success. This plan fosters transparency and allows for early identification of key risks that may impact clinical development.
Organizations need to tackle operational challenges that can slow progress, as many drug development processes such as regulatory compliance, toxicology, and clinical trials are often conducted in silos. This lack of integration can lead to cost overruns and delays. To create a more collaborative environment, organizations should assess their operational models and eliminate unnecessary layers of decision-making. By adopting an integrated approach, teams can work in parallel, improving efficiency and reducing costs. The integrated product development plan will outline strategies and key deliverables for various aspects of development. Ultimately, organizations must also establish the necessary infrastructure to facilitate internal and external collaboration.
Optimize regulatory processes and prepare for launch
80 percent of experts identified regulatory roadblocks and competition as significant factors affecting the success of product launches. A label that provides important and accurate information is essential for a successful launch. However, achieving this can be challenging due to the constantly evolving regulatory landscape. A strong regulatory strategy balancing speed with compliance is necessary to facilitate faster commercial pharmaceutical product launches.
To anticipate potential hurdles, organizations should stay updated on FDA, EMA, and other global regulatory requirements. Simultaneous filings in multiple markets (e.g., FDA, EMA, and PMDA) can significantly reduce launch delays. Regulatory teams should collaborate closely with commercial teams during go-to-market planning. Launch preparation should commence before final decisions regarding a drug's labeling, pricing, and reimbursement.
In some markets, such as the US, UK, and Germany, products are often commercialized almost immediately after receiving approval from regulatory bodies. This leaves companies with little opportunity to adjust their strategies if payers make unexpected decisions. It is crucial to have a structured process for tracking post-approval variations globally. The ICH is coming up with more streamlined guidelines for regulatory approvals with different regulatory authorities, which would reduce effort duplication, cost, and time to product launch.
Develop a robust supply chain
A robust supply chain is critical for successfully launching pharmaceutical products, ensuring timely delivery, regulatory compliance, and product integrity. One of the first steps an organization can take is creating a multi-year supply chain roadmap. This roadmap should provide a comprehensive view of the necessary supply chain capabilities, and the short-term and long-term business decisions required to support commercial operations.
Ideally, this planning should begin two to three years before filing for approval, with key milestones to indicate progress. In the pre-commercial stage, procurement and supplier management commonly report to finance or engineering departments, as purchases primarily serve R&D or indirect expenses and are not typically inventoried or tracked beyond receipt and payment.
However, to effectively support commercial operations, these functions should report to the supply chain team, fostering strong collaboration with the quality team. This collaboration is essential for creating a supply chain that delivers products at the correct cost, time, and quality. Connecting regulatory, quality, and supply chain functions is important to minimize bottlenecks. Proper risk management includes contingency planning, such as identifying potential vulnerabilities, developing emergency response playbooks, and conducting frequent quality and compliance checks.
Adopting Quality by Design (QbD) during manufacturing ensures fewer failures and facilitate timely interventions. Proper documentation of supply chain and tracking systems provides the monitoring needed to identify the source of issues and to recall defective products.
Prioritize market access, HCP, and patient engagement
Many experts agree that payer activation and reimbursement challenges significantly impact a product's launch. Timely coverage ensures products reach patients, as delays can hinder healthcare provider adoption. To overcome these challenges, integrating access strategies early in the launch plan and collaborating with medical affairs and commercial teams to create a compelling value narrative based on clinical, economic, and real-world evidence is crucial.
Understanding payer priorities enables teams to anticipate and proactively address obstacles. Clear, data-driven justifications for a product’s price are vital for securing favorable coverage. Medical affairs plays a key role in generating real-world evidence. Effective engagement with healthcare professionals is also crucial. Independent medical education platforms and a strong digital marketing strategy can enhance communication, especially in limited in-person interactions.
Furthermore, patient engagement is essential for successful launches. Companies that focus on patient-centered approaches and offer personalized support can improve treatment adherence and health outcomes while gathering valuable data for reimbursement decisions. Ultimately, aligning drug development with patient needs fosters trust and positive engagement.
Planning must be tailored to different regions. In the U.S., a complex multi-payer system affects therapy uptake, while many international markets have more streamlined access, relying on national or sub-national bodies for pricing and reimbursement. The U.S. has strict regulations on healthcare provider interactions, particularly regarding promotional activities, limiting engagement. In contrast, some countries have more flexible guidelines. The U.S. leads in using technology for patient engagement through digital platforms and remote monitoring. Initiatives like the Partnership for Patients focus on improving engagement and reducing hospital-acquired conditions. Meanwhile, many countries are adopting patient-centered care models that respect patients' preferences and involve them in decision-making.
Financial planning with a phased budget
Financial support is crucial in successfully launching a pharmaceutical product, encompassing budgeting, forecasting, resource allocation, and financial risk management. It is financially prudent to tie investments to specific milestones, such as positive outcomes from pivotal clinical studies or responses to competitive actions. In the years before launch, uncertainty often influences initial spending levels. However, as robust clinical data becomes available and marketing strategies are finalized, investment increases as prospects improve.
Pharmaceutical companies face balancing risks and opportunities, requiring access to reliable market intelligence. Brand teams must navigate unpredictable factors, such as expedited FDA approvals, while avoiding overspending on products that may face delays or fail approval. Companies should reallocate resources from existing brands to maximize commercial potential to support new product launches. Capturing early market opportunities is critical, necessitating effective marketing strategies and close monitoring of uptake post-launch, allowing for timely adjustments to enhance success in a competitive landscape.
Form an agile team with an iterative mindset
To achieve faster product launches, companies often form a specialized team known as a “company within a company.” This approach grants launch teams the authority and agility to prioritize patient outcomes and brand success. They can focus on key strategic issues without being hindered by extensive checklists. Dedicated launch task forces with defined roles and efficient communication can adapt quickly to challenges.
Teams must deliver insights rapidly while refining their research and developing new hypotheses through an iterative problem-solving framework. Pre-launch activities ensure products resonate with prescribers and meet market expectations. Continuous iteration during product development is vital for understanding market dynamics, packaging, pricing, and safety feedback from the FDA.
Teams should also be ready to respond to unexpected market changes and gather last-minute feedback from target prescribers. Successful launches often show early progress indicators, such as collaboration and enthusiasm within the organization and the medical community. Regular cross-functional workshops involving key decision-makers can help develop scenarios, agree on immediate actions, and anticipate competitor responses. Simulation workshops can replicate real-life decision-making, allowing teams to analyze potential challenges. This phased approach enables timely corrective measures and encourages sustainable long-term growth, contrasting with traditional aggressive launch methods.
Listen to the market for feedback
For 85 percent of pharmaceutical product launches, a drug's path is established within the first six months. Establishing strong feedback loops refines strategies and adapts to market dynamics. Post-launch monitoring is critical in the first few months, leading up to patent expiration. During this time, the field force plays a vital role in gathering feedback from conversations with HCPs, KOLs, and other significant stakeholders.
As the volume of observations increases, an insights management platform integrates and analyzes various feedback sources. This comprehensive view allows teams to better understand the strategy's impact on the market. By centralizing these insights within one integrated platform, teams can identify patterns, address stakeholder concerns, and continuously improve their plan to align with market needs.
Efficacy and awareness are two of the most important KPIs often determining success for life science brands. These two attributes play a crucial role in shaping a product's brand. While efficacy is a foundational element that influences how a brand is perceived, the communication and marketing efforts made by brand and market insight professionals also significantly impact this perception. New technologies, such as AI, machine learning, and other real-time automation tools, analytics, and online workflows, show great potential for adding agility and efficiency to product launches.
Staying connected and responsive to customers fosters loyalty and enhances long-term relationships. Regular account reviews and monthly forums with district sales managers facilitate discussions between managers and their sales teams to generate insights and share knowledge.
Leverage and collaborate with partners
It is important to acknowledge that all launch scenarios are complex and challenging. Due to which, many pharmaceutical organizations seek expert launch experience to develop new skills and enhance their performance under pressure. This need is particularly significant during first-time launches, where a company cannot rely on past experiences to guide the launch team's actions. Joint ventures or co-commercialization agreements can help distribute financial risks and reduce upfront investments. Additionally, leveraging an established partner’s sales network can increase geographic reach and market segmentation. Partnering with patient advocacy groups, payers, or digital health platforms further enhances the collection of real-world evidence and improves patient adherence.
To achieve "launch competence," pharmaceutical and biotech companies with limited launch experience can benefit from collaborating with seasoned professionals. The launch management process begins with the customer’s product launch plan. This phase allows both parties to outline the organizational structure and the requirements and expectations for bringing the product to market. Because large teams from various departments, such as quality control, demand management, and supply chain management are involved, clearly defining each team member's roles and responsibilities is crucial. This clarity is essential for both the filling partner and the customer teams.
Working with partners who bring the relevant expertise and commit to bringing those experts into the launch is imperative. This is a challenge for small and emerging biotechs seeking to compete with “big pharma”, not the largest pharmaceutical organizations.
Leverage data and technology
For organizations seeking transformative approaches, enabling technology can be a crucial differentiator. Automation, AI, and machine learning are revolutionizing how biopharmaceutical companies support all phases of the development process and convert data into actionable knowledge.
Companies should adopt AI-driven tools for regulatory document generation, compliance checks, and submission tracking to expedite the clinical trial process. Organizations should leverage AI and ML technology to forecast demand fluctuations and simulate supply chain risks. Technology capabilities like IoT and blockchain can also enhance transparency across suppliers, manufacturers, and distributors.
Omnichannel orchestration for personalized marketing can be achieved through coordinated communication and AI-driven segmentation during the launch phase. Instead of a "one size fits all" approach, use dynamic content tailored to HCP profiles, specialties, locations, and behaviors. Employ Rep 2.0 models that blend human interaction with smart automation to optimize touchpoints based on HCP responsiveness. Utilize AI and machine learning to identify high-value early adopters and launch patient onboarding platforms alongside complex specialty drugs. Integrate call planning apps and CRM dashboards with AI-recommended next-best actions that update daily based on HCP behavior. Create launch microsites and virtual advisory boards to enhance engagement around the therapy or disease state.
Pharmaceutical companies must upgrade their infrastructure and security to ensure business continuity and increase their reliance on technology to automate and accelerate these processes. By doing so, they can effectively leverage data for more informed decisions. A helpful guideline is to begin designing and developing your launch infrastructure about 24 months before you expect to receive FDA approval. This timeframe may vary based on the specific circumstances of your brand.
Zensar’s fundamental point of differentiation is our “fit” with our clients, as we are “big enough to matter but small enough to care”. Launch partners with global brand recognition often run the same playbook and lack innovation, or their talent is spread too thin, thereby jeopardizing the goal at hand – to deliver much-needed products and therapies to those in need to improve and even save their lives. Zensar provides a comprehensive suite of capabilities to accelerate the commercial launch, ensuring a seamless transition from pre-launch to full commercialization. Our subject matter experts offer the proper guidance and expertise in discovery, clinical development, regulatory support, and launch enablement. Our data management team understands that true business transformation requires more than just implementing technology; it involves delivering actionable data ahead of your competition to ensure faster and better outcomes for healthcare professionals and patients. Our marketing technology (Martech) and agency services enable you to execute a data-driven, omnichannel launch strategy, leveraging the right marketing automation and analytical insights.
We specialize in translating strategy into execution by developing strategic brand messaging, content creation, and localization. Additionally, we provide market research and competitive intelligence to deliver real-time insights. We have extensive experience implementing customer relationship management systems for leading pharmaceutical organizations and possess deep expertise in Veeva Commercial Cloud, Veeva Development Cloud, and Salesforce Life Sciences Cloud.
Successful launches depend on a robust program management framework with strategic governance and oversight. Our program management office enabled by CommandBridge™ services, orchestrates every aspect of your data, technology, and operations ecosystem, allowing your organization to focus less on IT and more on serving customers and patients. With Zensar as your partner, you can confidently navigate the complexities of a pharmaceutical launch, turning innovative science into market-ready solutions that improve lives worldwide.
