Opinion Piece: Talent Transformation for Seamless Access-Driven Drug Development and Commercialization: a Leadership Imperative!
by Anjua Roy and Kome Okposo
As part of Access Forum initiatives in the last couple of years, we have had the privilege of both formal and informal conversations with a broad group of pharmaceutical industry leaders in R&D, medical affairs, commercial and general management. As we welcome the New Year, we present our impressions on the high priority need of ‘Talent Transformation’ as an organizational response to the new commercialization paradigm (from drug conceptualization and early development to launch and beyond) as key to success for Pharma 2.0.
Summary: Proliferation of non-traditional competitors and stakeholders, including non-traditional flow of innovation, and a general perception of inflated cost of healthcare, challenge the legacy model of drug development and commercialization. When innovation is marginal, patient -product fit becomes key to differentiation. Organizations that shape their development and commercialization activities to consistently fulfil their obligation of ensuring continuity of patient access to healthcare innovation, and to serve patients’ needs profitably, will have a competitive edge over others. This is especially true in an era of personalized medicine, evolving clinical algorithms, deeper patient engagement, and artificial intelligence. However, considerations (beyond what is considered traditional market access i.e., price and reimbursement) are seldom incorporated in the innovation process. While this is attributed to several reasons, such as, size of corporation or resources, and shareholder pressure among others, an ability to quickly pivot is essential for success in the new era. When innovation is incremental, ensuring patient -product fit – the key to differentiation and product positioning, needs new kinds of understanding within the organization, along with newer skillsets to incorporate into strategic and tactical plans. Initiating a transformative process boils down to fundamentally enhancing organizational learning to enable quicker decision-making. External world developments are giving a clarion call to the pharma world to modify old ways of working. It is in their best interest to invest in and lead the transformation in their commercial organization, one step at a time.
Elaboration: Fast-paced market dynamics necessitate activities for early development to be patient-access oriented and seamlessly incorporated into an evidence-driven drug development and commercialization plan - one that forms the foundation for medical affairs, marketing and market access activities and meaningful customer engagement. Developing such a seamless plan requires recognition that customers communicate with, influence and reinforce each other in their thinking in a highly interconnected and informed world and that it helps to tell a coherent product story ---- one that makes sense to all stakeholders and helps them achieve their goals, efficiently. While this process needs to be futuristic, it also needs to be nimble in that it can be quickly adapted to changing conditions.
Beginning with business development, decisions need to be robust for selecting and progressing quality assets through the clinical development lifecycle, rather than solely relying on clinical teams to build value through clinical trials over an extended period of time. Proper context for couching decisions is needed. Amidst pressure to get to an approved indication, difficult choices, such as, e.g., being first to market at the cost of replicable and robust therapeutic benefits or moving to an earlier line after preliminary efficacy and safety signals, or choosing target patient segments, or treatment outcomes and thereby finalizing clinical selection criteria, or tentative differential positioning versus the competition etc. often need to be made considering availability of limited data early on. However, such issues that impact patient access are seldom discussed as critical cost and business success drivers. Organizationally, too, these critical decisions are made by a handful of people, and often “on the fly.” Making this process more scientific and participative, however, may be beneficial. Often, no specific department or team has accountability for driving such decisions in early product development that may have a bearing on patient access. Sometimes there may be a program management team early on – however, their remit and focus are the clinical (and / or pre-clinical) studies, and limited competitor clinical data.
Organizations also have numerous processes in place to address the needs of varied customers, all of which acknowledge and deepen structural silos and functional divisions. The current situation, however, calls for a special set of skills (as a formal new department or otherwise) that mesh several disciplines pertinent to maximizing patient access. This must come from in-depth thinking and nimble managerial maneuvers for a constantly changing environment. It is important to assign accountability to designated members of the organization whose sole job is to connect science to decisions that need to be made for true business success – ones that will shape a patient-access orientation across the organization.
Meshing science with patient access considerations systematically for business decisions is key to organizational agility. People are neither trained, nor is the organizational culture built to think about this critical aspect. Often, processes developed by experienced management consultants purport to guide the ‘hows’ for improving innovation yield; however, what may be needed more urgently is a framework that gets to the ‘whats’ for uniform understanding and concerted action oriented towards patient access of new (and largely incremental) innovation.
Success of this framework, however, will be critically dependent on transforming organizational talent into possessing the key skillsets and competencies. Commercial leaders with expert knowledge of drug and evidence development processes, in addition to an astute business acumen, are best poised to serve as catalysts in this process. They must lead this talent transformation to Pharma 2.0 by execution of pilot projects, aligning incentives, purging incompetencies, and facilitating shared organizational learning and goals. In doing so, they will help move organizations towards being more agile, with fewer multi-million-dollar studies, less information clutter, and higher relevance. This will be critical to viability and bottom line and will serve to weed out inefficiencies in medical practice, thus re-establishing the strategic relevance of pharma and making it a genuine partner in the overall delivery of healthcare.
by Anjua Roy and Kome Okposo
As part of Access Forum initiatives in the last couple of years, we have had the privilege of both formal and informal conversations with a broad group of pharmaceutical industry leaders in R&D, medical affairs, commercial and general management. As we welcome the New Year, we present our impressions on the high priority need of ‘Talent Transformation’ as an organizational response to the new commercialization paradigm (from drug conceptualization and early development to launch and beyond) as key to success for Pharma 2.0.
Summary: Proliferation of non-traditional competitors and stakeholders, including non-traditional flow of innovation, and a general perception of inflated cost of healthcare, challenge the legacy model of drug development and commercialization. When innovation is marginal, patient -product fit becomes key to differentiation. Organizations that shape their development and commercialization activities to consistently fulfil their obligation of ensuring continuity of patient access to healthcare innovation, and to serve patients’ needs profitably, will have a competitive edge over others. This is especially true in an era of personalized medicine, evolving clinical algorithms, deeper patient engagement, and artificial intelligence. However, considerations (beyond what is considered traditional market access i.e., price and reimbursement) are seldom incorporated in the innovation process. While this is attributed to several reasons, such as, size of corporation or resources, and shareholder pressure among others, an ability to quickly pivot is essential for success in the new era. When innovation is incremental, ensuring patient -product fit – the key to differentiation and product positioning, needs new kinds of understanding within the organization, along with newer skillsets to incorporate into strategic and tactical plans. Initiating a transformative process boils down to fundamentally enhancing organizational learning to enable quicker decision-making. External world developments are giving a clarion call to the pharma world to modify old ways of working. It is in their best interest to invest in and lead the transformation in their commercial organization, one step at a time.
Elaboration: Fast-paced market dynamics necessitate activities for early development to be patient-access oriented and seamlessly incorporated into an evidence-driven drug development and commercialization plan - one that forms the foundation for medical affairs, marketing and market access activities and meaningful customer engagement. Developing such a seamless plan requires recognition that customers communicate with, influence and reinforce each other in their thinking in a highly interconnected and informed world and that it helps to tell a coherent product story ---- one that makes sense to all stakeholders and helps them achieve their goals, efficiently. While this process needs to be futuristic, it also needs to be nimble in that it can be quickly adapted to changing conditions.
Beginning with business development, decisions need to be robust for selecting and progressing quality assets through the clinical development lifecycle, rather than solely relying on clinical teams to build value through clinical trials over an extended period of time. Proper context for couching decisions is needed. Amidst pressure to get to an approved indication, difficult choices, such as, e.g., being first to market at the cost of replicable and robust therapeutic benefits or moving to an earlier line after preliminary efficacy and safety signals, or choosing target patient segments, or treatment outcomes and thereby finalizing clinical selection criteria, or tentative differential positioning versus the competition etc. often need to be made considering availability of limited data early on. However, such issues that impact patient access are seldom discussed as critical cost and business success drivers. Organizationally, too, these critical decisions are made by a handful of people, and often “on the fly.” Making this process more scientific and participative, however, may be beneficial. Often, no specific department or team has accountability for driving such decisions in early product development that may have a bearing on patient access. Sometimes there may be a program management team early on – however, their remit and focus are the clinical (and / or pre-clinical) studies, and limited competitor clinical data.
Organizations also have numerous processes in place to address the needs of varied customers, all of which acknowledge and deepen structural silos and functional divisions. The current situation, however, calls for a special set of skills (as a formal new department or otherwise) that mesh several disciplines pertinent to maximizing patient access. This must come from in-depth thinking and nimble managerial maneuvers for a constantly changing environment. It is important to assign accountability to designated members of the organization whose sole job is to connect science to decisions that need to be made for true business success – ones that will shape a patient-access orientation across the organization.
Meshing science with patient access considerations systematically for business decisions is key to organizational agility. People are neither trained, nor is the organizational culture built to think about this critical aspect. Often, processes developed by experienced management consultants purport to guide the ‘hows’ for improving innovation yield; however, what may be needed more urgently is a framework that gets to the ‘whats’ for uniform understanding and concerted action oriented towards patient access of new (and largely incremental) innovation.
Success of this framework, however, will be critically dependent on transforming organizational talent into possessing the key skillsets and competencies. Commercial leaders with expert knowledge of drug and evidence development processes, in addition to an astute business acumen, are best poised to serve as catalysts in this process. They must lead this talent transformation to Pharma 2.0 by execution of pilot projects, aligning incentives, purging incompetencies, and facilitating shared organizational learning and goals. In doing so, they will help move organizations towards being more agile, with fewer multi-million-dollar studies, less information clutter, and higher relevance. This will be critical to viability and bottom line and will serve to weed out inefficiencies in medical practice, thus re-establishing the strategic relevance of pharma and making it a genuine partner in the overall delivery of healthcare.
