The COVID-19 pandemic has brought a range of unprecedented challenges, ushering the pharmaceutical industry and businesses into a new era of how to approach work in more productive and effective ways. The urgency in creating a vaccine to ameliorate the burdens of the pandemic has highlighted the need for greater efficiency within the drug development process, pushing the boundaries of industry to new limits. The pharmaceutical industry’s ability to successfully create a vaccine without compromising quality and safety while under immense public pressure and real time constraints demonstrated that, under the right circumstances, processes that are sometimes slow and clumsy can in fact be streamlined. Pharmaceutical companies were able to achieve significant accomplishments by incorporating agile strategies in their processes.
Challenges in the industry
The substantial price tag of bringing a drug to market is enough to deter many. Reports from the Tufts Center for the Study of Drug Development puts the cost of bringing a medicine from discovery to pharmacy shelves at $2.6 billion. Reasonably so, some companies are hesitant to invest billions of dollars into a drug that can ultimately fall short of market approval. Getting a drug through market authorization is a highly regulated and lengthy process, requiring companies to conduct rigorously designed and executed clinical trials, maintain frequent contact with regulators about updates and changes, and deliver high quality clinical data.
Due to the increased compliance and regulatory pressure, Medical Affairs teams have emerged within pharma as well-educated subject matter experts and have positioned themselves to often lead launch processes. To address the need for transparency and stronger relationships with stakeholders, companies are introducing holistic business models that shift engagement towards greater patient centricity. Tackling on a new approach of how Medical Affairs can be utilized will aid in the efforts to deliver financial value and combat the high cost of bringing a drug to market.
With the increased use of technology and automation in pharmaceutical processes, pharma has launched products faster than ever before. Those that fail to keep up to speed with the evolving industry may miss out on a competitive edge and risk significant inefficiencies. Adapting Medical Affairs interactions to the changing landscape in a stepwise fashion parallel to the pace of the industry will help to enhance efficiencies and minimize potential hindrances during product launch.
Introducing agile in pharma
The agile process is a multi-faceted concept of approaching work in a manner that brings higher customer value in a shorter frame of time. Agile mindset and values have been used for over 20 years in other sectors, particularly software development. Such practices have effectively revolutionized the way that companies seek to engage with their customers and accelerate towards impressive innovations. Companies such as Cisco and Spotify have applied new agile frameworks and created collaborative teams. As a result of these innovations, the tech giants were able to deliver new systems on schedule, reduce defects, and increase customer satisfaction.
With the urgency to create new treatments for unmet medical needs and the significant resource investment required, implementing agile frameworks in the pharmaceutical industry is a potential key to solving historically slow drug development timelines within a heavily regulated system. Agile is based on the principle of working incrementally in short, iterative cycles within a collaborative environment. These “sprints” expedite development by establishing a set focus, and having the team undergo frequent check-ins and inspections to assess changes that need to be made. Additionally, this fosters a space for co-creation where team members and customers work closely together to deliver the outcomes defined by the group. A prime example of the co-creation process is the “test and learn” approach of research and design, in which a team regularly seeks and incorporates feedback from a range of individuals both within and outside the company. Input is sought from external stakeholders, which can include patients, patient advocacy groups, health care professionals, key opinion leaders, payers, and regulators. The stakeholders are brought along throughout the process so that real and relevant value is delivered to customers and the team remains responsive to the changing market environment.
Pharmaceutical product launches are complex processes, and as with any complicated process, communication is key. Setting the stage for an agile mindset begins with identifying the team’s primary vision. By clearly and openly communicating the team’s goals, members will understand how their responsibilities contribute to the success of the team. Such defined expectations will shorten the process if all recognize their distinct role and accountabilities in delivering product launch. Companies can allocate their resources at the appropriate time to their highest priority goals, eliminating potential areas of waste along the way and resolving issues early in the process.
Traditionally pharma has often operated in siloed functions. In contrast, the agile approach encourages a collaborative and cross functional approach. A successful launch requires input from a number of internal functional groups, as well as the various external stakeholders. Ongoing communication and information sharing to the team throughout the planning process will preemptively address challenges and bottlenecks and allow teams to adapt accordingly, thus expediting the overall process. Pharma has largely been conservative in adopting agile values and methodologies, perhaps due to the highly regulated environment and long cycle time in bringing treatments to market. However, a hybrid Agile Pharma model has been recently developed by PharmAgile co-founders Glen Pearce and Michael Harries, and has been successful across 10 global launches, which challenges the more traditional approaches.
How agile might work for Medical Affairs
Medical Affairs plays an important role in disease education, data generation and dissemination, and insight gathering as a product prepares for launch and once it is commercially available. At the core of this functional area is scientific engagement, and with the new shifts in digitization and a virtual work environment, Medical Affairs professionals need to modify both the forums and forms of their interactions. Medical Affairs needs to refocus their approach towards customer-centric engagement and approach HCPs, payers, professional societies, and patient advocacy groups in ways that meet the needs of each group. Initiating early engagement and co-creation principles with the individuals in these various groups will enable the company to receive feedback early in the planning processes that can help shape tactics. This added layer of insight enables companies to effectively incorporate changes and reflect the current scientific environment as they formulate their scientific and communication plans in preparation for launch. By refocusing efforts on better engaging with others, companies can have greater clarity from the external stakeholder perspective. Working closely with external stakeholder groups provides feedback on research questions, trial design, and data interpretation to tailor the product’s launch. Implementing input from these groups can also promote innovation within the company by suggesting novel endpoints, areas of unmet need, or drug delivery ideas. Key to all of these potential outcomes is an agile and closely connected Medical Affairs organization, where field and office-based colleagues quickly and efficiently pass information to one another and throughout the organization and can modify tactics as the insights dictate.
The strong relationships that Medical Affairs holds with KOLs are another asset that can be leveraged in launch planning. Involving HCPs and KOLs early in the process can help build impactful scientific communications and publication plans, and identify key areas for disease state or product education, and suggest areas for post-registrational research. Again, bringing these experts’ voices into the planning conversations early and accurately is another example of how Medical Affairs can ensure agile working.
Through the combined agile methods, drug companies can collaboratively strategize in preparation for launch and maximize the team’s fullest potential in a dynamic manner.
A Medical Affairs launch excellence certification program
Traditionally Medical Affairs professionals have been scientific subject matter experts. The rapidly changing pharma landscape is dictating now more than ever they must also lead people, projects and launches in an Agile way. By incorporating agile habits in the drug development process, teams can bring important medicines to patients more quickly. The Medical Affairs Launch Excellence certification program is an e-learning professional certification program offered through the Accreditation Council of Medical Affairs (ACMA) that brings a new perspective on applying agile methodology to expedite drug development. Through the program, learners are introduced to a range of models that highlight how Medical Affairs teams can work together in new ways to solve problems related to product launch and meet today’s demand in the industry. The course also addresses foundational Agile leadership capabilities and enables participants to confidently lead major medical projects and teams in addition to product launches.
What this means for the future
With the rapidly changing environment of the pharmaceutical industry, finding modern day solutions while using inefficient methods of approaching work does not unlock a company’s full potential. As the COVID-19 pandemic has highlighted, today’s workforce requires greater efficiency and rapid adaptation, and companies need to be more adept at developing responsive mindsets that increase productivity. Incorporating workforce agility and increased communication within the launch process are fundamental in allowing pharma to operate more efficiently with greater cross-functional involvement and more rapid outcomes.
Better, faster launch planning delivers high-quality product launches in less time, allowing more rapid access to important medicines, as well as organizational value. With the development of potentially curative therapies for debilitating diseases, getting these treatments to patients quickly has never been more important. Patients who gain access to such treatments will ultimately lead healthier lives and reap the benefits of agility, which is our common goal.
