Hassan Choudhury, PhD, discusses the benefits of a well-defined early-stage strategy and why you need to evolve your processes from the preclinical stage of development onward to increase the likelihood of success for launch and the current and future portfolio.
Scientific advances have spurred on major changes across the biopharmaceutical industry in recent years, accelerating the speed and complexity of therapy and portfolio development. These innovations include the growing range of biomarkers, diagnostics, novel modes of action, delivery mechanisms, and subsequent combinations—all of which have driven complexity in the external environment and a need for internal consideration of the challenges this complexity presents.
Additionally, landscapes are more quickly becoming more competitive, with regulatory and clinical mechanisms established to enable faster development. This is fueled in part by a greater ability to focus on more targeted patient populations, meeting high unmet needs, which can then lead to accelerated regulatory approval.
As a result, external stakeholders (regulators, payers, clinicians, patients, etc) are facing an ambiguous treatment paradigm in which it is challenging to determine the optimal treatment sequence for patients. Here, biomarkers are playing an important role in guiding treatment selection or alteration (eg, stopping, switching, or escalation).
However, they are also adding a new element of complexity for all internal stakeholders (marketing, medical, market access, clinical, regulatory, etc) and external stakeholders to navigate.
The expectations of these external stakeholders have also become higher as they navigate the following challenges:
- The advent of greater clinical goals and expectations (eg, symptom management vs disease modification vs curative)
- Greater variation in clinical endpoint utility (eg, predictive and surrogate endpoints)
- The increased importance of endpoints and patient reported outcomes for assessing efficacy beyond traditional clinical efficacy measures
- The increased importance of real-world evidence plans for assessing effectiveness that cannot be addressed in clinical trials
Teams are feeling greater pressure to tell complex stories simply and to highlight the value of these therapies to stakeholders at every stage of development. There is also a greater need to consider services beyond the asset ranging from delivery device to companion diagnostics and apps, which in some cases are as important as the asset itself. This point is best illustrated by treatments affecting muscular or neurological conditions in which physical and mental rehabilitation can significantly improve outcomes beyond treatment alone.
These challenges have culminated in a new landscape for manufacturers in which organizational structure, pipelines, and portfolios often are not fully optimized, hindering current and future success across the organization.
The age-old debate of nature vs nurture can also be applied to therapies developed. While some assets have a greater propensity for success due to their fundamental characteristics and advances over prior therapies, it takes more than this to ensure launch success. No matter how brilliant the therapy may seem in theory, if it is poorly developed and the landscape is inadequately planned for, it can still underperform—and the question arises: Could more have been achieved if we’d considered our commercial development plan earlier?
There is an essential need to solve more complex new challenges and drive long-term value generation by introducing deeper commercial thinking earlier in the development journey. Decisions made at the preclinical stages will have a lasting impact on the launch trajectory and could diminish the value of the future pipeline. Companies that do not shift their thinking at the earliest phases will fail to keep up with the changing landscape.