Managing Innovation to Maximize Value Along the Discovery‐Translation‐Application Continuum

Abstract

Success in pharmaceutical development led to a record 51 drug approved in the past year, surpassing every previous year since 1950. Technology innovation enabled identification and exploitation of increasingly precise disease targets ensuring a next generation diagnostic and therapeutic products for patient management. The expanding biopharmaceutical portfolio stands however in contradistinction to the unsustainable costs that reflect remarkable challenges of clinical development programs. This annual Therapeutic Innovations issue juxtaposes advances in translating molecular breakthroughs into transformative therapies with essential considerations for lowering attrition and improving the cost-effectiveness of the drug development paradigm. Realizing the discovery-translation-application continuum mandates a congruent approval, adoption and access triad.

Health Care Evolves From Reactive to Proactive

“…Biological discovery, associated with advances in enabling technologies, has transformed healthcare management paradigms for patients and populations . This transformation reflects logarithmic expansion of our molecular, technological, and engineering enterprises, driven by investments from the public and private sectors .…”

“…This, in part, reflects a healthcare delivery system that places a priority on reimbursing for the treatment of chronic illness rather than preventing disease in the first place . In that context, advancing molecular and regenerative approaches, in conjunction with enabling informatics and omic technologies, offers unique opportunities to evolve preventive strategies that promote healthy aging and longitudinal wellness across the continuum from inception to senescence …”

“…These considerations underscore the importance of maintaining a focus on preventive approaches that complement therapeutic interventions, as our mechanistic armamentarium evolves from discoveries of the biological bases of health and disease . Although molecular innovation has been impressive, the translation of those discovery‐based insights into preventive therapies for individual patients, which are scalable to populations, must remain a priority . Emerging clinical paradigms should maximize the impact of discovery innovations by facilitating their translation into novel preventive algorithms to maintain longitudinal health and wellness, at all points along the developmental continuum.…”

Process Improvement for Maximized Therapeutic Innovation Outcome

“…When considering therapeutic innovation, we naturally focus on biological discovery and the associated advances in technology, which have revolutionized clinical management paradigms and the delivery of care to patients and populations . This evolution reflects the exponential growth in bioinnovation propelled by public–private partnership investment in generating platforms for solutions to health and disease that benefit communities, now and in the future . This scientific revolution drives the development of increasingly precise solutions, leveraging insights in molecular mechanisms within a systems context underlying pathophysiology, which offers biologically based targets for novel therapies, enhance the ability to find cures, and restrict adverse events .…”

“…Indeed, the increasing toolbox of cutting‐edge platforms has produced unprecedented opportunities to individualize and indeed optimize drugs, devices, and their delivery that can be best aligned across the spectrum of diseases, communities, and geographies to reach global populations in need . The biotechnology and pharmaceutical industry, in turn, has translated these biological advances into new preventive, diagnostic, and treatment approaches that are evolving health and the care of patients and their diseases in ways that were only imagined a decade earlier . The developing framework established by biologically targeted biomarker, device, and therapeutic paradigms alters the one‐size‐fits‐all method to managing patients into individualized health solutions .…”