MedAdNews VOL. 28, NO. 8 • AUGUST 2009 Written and submitted by Darius Naigamwalla, Kuyler Doyle, and Michael Turner of Campbell Alliance Top 10 launch challenges and how to manage them A s a majority of product managers will take part in only one or two major launches during their careers, many do not have a wealth of personal launch experience to draw upon when preparing for the daunting job at hand. Brand managers will face 10 major challenges during the course of planning and executing a product launch. Some challenges are external, while others are internal to the organization. By becoming familiar with the critical challenges, product managers can take necessary steps to plan accordingly and be better equipped to prevent or manage issues effectively, thereby increasing the prospects of a successful launch. Challenge 1: Increased regulatory uncertainty The Food and Drug Administration Amendments Act (FDAAA) of 2007 ushered in increased regulatory authority for drug safety enhancement, including requirements for label changes, post-marketing studies, and a Risk Evaluation and Mitigation Strategy. Although an increased focus on safety is a positive development, it can also make it more difficult to get products through regulatory hurdles. The increased regulatory responsibilities have burdened the existing FDA staff and led to numerous approval delays as the agency struggled to meet its Prescription Drug User Fee Act (PDUFA) goals in 2008. A lengthened regulatory approval process delays launch and leads to costly setbacks for companies; smaller companies, with more limited cash on hand (a major factor given today’s uncertain economic climate), can be particularly affected by these delays. To minimize surprises and facilitate adherence to timelines, brand managers should proactively maintain open lines of communication with regulatory officials. Pre-submission interactions with regulatory authorities can assist in adequate preparation for the application process and can help evade oversights that cause delays. Brand managers should coordinate cross-functional teams to anticipate questions from regulatory authorities and prepare for advisory committees and label negotiations to minimize turnaround time by conducting “mock FDA review” meetings with regulatory experts and key opinion leader panels. Risk management processes should also be developed early in the application process, as creation and negotiation of these programs could require a considerable amount of time when deemed necessary. Challenge 2: Increased competition In many therapeutic areas, multiple products have flooded the market. A crowded market poses additional challenges as it is considerably more difficult to enter and successfully gain share. If the differentiating attributes of the product are not clearly communicated and a sustainable, credible, and compelling positioning not established in the physician’s mind, market penetration will likely be low and lead to a disappointing launch. When entering into any market, especially a crowded one, brand managers need to work with the development team to ensure the design of clinical trials will result in data that adequately differentiates the product from its competitors. If the standard of care will be difficult to replace, either niche populations should be sought to avoid direct competition, or, depending on the risk tolerance of the organization, headto-head safety and efficacy trials can be conducted to clearly demonstrate improvements. Brand managers must also identify the best means of reaching patients to effectively communicate the competitive advantages of their products and differentiate them from existing therapies. As various proposals are debated regarding increased regulation of direct-toconsumer (DTC) advertising – and in parallel, pharma companies debate whether or not an acceptable ROI can still be realized with this route – brand managers must come up with novel means to convey their messages to consumers. In addition to the traditional Web-based approaches, including disease-state education and branded Websites, companies need to try alternative approaches (i.e., partnering with advocacy organizations and other patient foundations) to reach the target consumer. Challenge 3: Decreasing access to physicians With increased perceptions that pharmaceutical sales representatives are providing limited value to physicians and potentially even corrupting the integrity of the healthcare system, access of sales representatives to physicians has become more restricted. Some practices, hospitals, health systems, and academic medical institutions have gone so far as to ban sales representative visits altogether. In addition, busier practices simply have less available time for a sales visit and are thereby limiting access to pharmaceutical company sales personnel. Execution of an effective launch strategy is clearly dependent on the successful relay of core messaging regarding the product to stakeholders. As such, the restricted access to physicians can be problematic to an accelerated uptake of a drug. To address this issue, the launch team must first ensure that all personnel who are representing the company – sales reps, medical science liaisons, clinical research specialists, etc. – understand the needs and sensitivities of target stakeholders, including physicians, nurses, office managers, and billing managers. More importantly, company representatives must deliver and maximize the “value add” with each interaction. To achieve this objective, company representatives must be thoroughly trained on the customer situation, the market landscape within the disease state of interest, product risks and benefits, and how the product compares with competitors in order to relay valuable information that can benefit the practicing physician. With restricted access, brand managers must also work to find alternate touch points for reaching the physician and distribute the key messages through multiple channels, including speaker programs, Websites, direct mail, and more modern “e-detailing” approaches. Challenge 4: Increased payer scrutiny Payers can clearly have a decisive impact on the commercial performance of a product. Little could be more disappointing than adequate commercial preparation for product launch that is tainted by poor uptake due to unforeseen market access challenges. Recently, this hurdle has become more difficult to clear as payers become increasingly discriminating in their reimbursement practices. 2 Although spending on healthcare typically continues to increase during economic contractions, the growth of prescription drug sales has recently slowed significantly. The trend toward reduced prescription spending is due largely to payer pressure toward increased use of low-cost generic drugs, and further includes the heavy discounts on generics found at chain stores. These trends could make it more challenging for a new branded drug to enter into an existing market and gain significant market share unless compelling evidence exists to differentiate it from lower cost offerings. To adequately prepare for launch, brand managers must work to ensure that the groundwork for a strong access and reimbursement strategy is laid early and key data requirements are embedded in the overall development plan. Sound value propositions must be fully developed and effectively communicated. As payers are relying on more information to make formulary decisions, a product value dossier should be developed that details the pharmacoeconomics, quality of life, and outcomes information related to the drug and to justify the price established. Challenge 5: The sub-optimal label Heightened competition is creating the need to significantly differentiate new entrants in the market. As such, proper design of clinical studies is fundamental to launch success. Commercial managers are sometimes given a product data package that is sub-optimal in its ability to provide data that differentiates the product at launch. If the development process was primarily focused on securing regulatory approval with less emphasis on creating clear competitive advantages, then the product’s commercial viability may be compromised. To avoid this situation, companies must involve commercial decisionmakers throughout the development process to ensure that the data generation process is designed to demonstrate competitive advantages that will enhance uptake by all stakeholders – patients, physicians, and payers. Otherwise, launch managers may be stuck trying to make lemonade out of rotten lemons. Of course, it is possible that the competitive landscape changed significantly since the beginning of clinical trials. In this case, differentiation studies, including the possibility of Phase IIIb and Phase IV programs, should be considered to distinguish the product in current market conditions. Challenge 6: Cross-functional collaboration With involvement of many stakeholders – both internal and external – planning a successful launch is a daunting task. With a global launch, some decisions (e.g., sales force size or fulfillment solutions) must be made on a regional level, adding to the complexity. The first step in ensuring cross-functional collaboration is to clearly identify and actively communicate the brand strategy throughout the entire organization. The strategy needs to include the proposed positioning (the space in a physician’s mind that we want to occupy), the branded message platform (how we are going to differentiate the product and occupy that space) and the critical success factors/strategic imperatives (the 3 to 5 items we absolutely must accomplish for launch to be successful). Once the strategy has been defined, the next step is to create a solid crossfunctional launch plan to translate the strategy into reality. Key components of the launch plan include: • Identification of sub-teams and key work streams • Determination of key deliverables • Definition of timelines for each deliverable • Assignment of individual accountability • Identification and characterization of interdependencies Following the development of the launch plan, it is essential to ensure that it is broadly shared across the organization so team members MedAdNews, August 2009 clearly understand the overall picture and their individual roles and responsibilities. In the absence of a clearly defined cohesive launch plan, teams will plan and execute their duties under their own timeframes and expectations. This can lead to confusion or unfortunate delays when teams do not deliver key required deliverables within needed timelines. Challenge 7: Implementation chaos Once the plan has been constructed and launch team members are aware of their roles, responsibilities, deliverables, and timelines, they must also be properly managed. Proper launch team management requires well-executed coordination and communication between all functional groups and stakeholders to identify and proactively address issues before they become crises; the responsibility for facilitating this falls on the brand team. Brand managers can keep everyone on track and moving the launch plan forward by establishing a launch process that encourages cross-functional collaboration and communication. This should be accomplished through regular interactions where cross-functional stakeholders are brought together for status updates. During these meetings, sub-team leaders are requested to provide an update on key completed and ongoing activities, discuss any issues they have encountered, and identify critical decisions/ inputs needed. Web-based project management tools are frequently used to share required key deliverables and track project progress in real time. In between these regularly scheduled launch team meetings, sub-teams should have sufficient time to make progress before being required to report back to the launch team. In the absence of a clearly defined launch management process, teams will be unable to react nimbly to launch issues as they emerge and will transition into a reactive mode of “fighting fires” on a daily basis rather than focusing on the right deliverables at the right time. Challenge 8: Senior management interference Clearly, a successful launch is vital to the company and will attract the attention of senior management. However well-intentioned, senior management can become a process hindrance when they micromanage as a result of not being kept properly informed of progress, or when they are not confident in their team’s ability to succeed. When senior management “gets into the weeds” and starts questioning decisions made by the team, launch progress can easily stall as team members feel their contributions are not being valued or endorsed. To avoid the “assistance” of senior management, brand managers must provide a clear and logical plan of action up front to senior managers. Appropriate buy-in from senior management for the plan must be secured early. Once senior management has endorsed the plan, the brand team needs to provide regular “flash reports,” which update management on the progress made and identify the key issues/ decisions requiring senior management involvement. Conducting regularly scheduled updates allows senior management to feel they “own” the launch and maintain confidence that the plan is on track. Challenge 9: Resource constraints Large companies – both pharma and biotech – have been implementing layoffs as a result of the challenging market landscape that we find ourselves in. Given the recent economic climate and an increase in M&A activities, managers are being asked to do more with less. The key to offsetting resource limitations and “doing more with less” is to increase efficiency in launch preparation. By carefully mapping out the launch plan, the brand manager can minimize unnecessary redundancies. Smart investments in technological advances, such as Web-based tools for CRM and e-detailing, should also be used to reduce workload on personnel and streamline processes. Innovative programs should also be evaluated and selectively piloted within the launch window. Launch management software packages can help facilitate the mapping of work streams and keep track of accountability. Challenge 10: Allocating the budget appropriately A solid launch plan needs a carefully considered budget. Unfortunately there is no “one-size-fits-all” approach to the amount of money needed for a successful launch and how it should be allocated. Several conditions surrounding the launch need to be considered when making those decisions. A key driver in determining budget allocation is the competitive landscape. For example, the spend and allocation required for a novel first-in-class drug addressing a major unmet medical need with significant “buzz” is likely to be quite different than a “me too” product entering a crowded market with expectations of capturing 5% to 7% market share. Additionally, the organization needs to look closely at the requirements for commercialization. For instance, the field force costs required to launch a primary care product will be significantly greater than a specialty product. Proper budgeting and allocation of resources can have a major impact on the success at launch. If the budget is too low for the market conditions or if allocations are incorrectly dispersed, then market penetration will suffer greatly as will launch revenue. Editor’s note: This is one of an occasional series of guest columns. Darius Naigamwalla is senior VP and global practice area lead, brand management practice, Campbell Alliance. Kuyler Doyle, is principal consultant, thought leadership, Campbell Alliance. Michael Turner is VP, brand management practice, Campbell Alliance. Campbell Alliance (campbellalliance.com) is a management consulting firm specializing in the pharmaceutical and biotech industry. Reprinted with permission from MedAdNews, August 2009. Copyright 2009 by Canon IMM, Inc. All rights reserved.