Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence

AAPS PharmSciTech, Mar 2019

Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology. For example, progress has been made via modeling and simulation of pharmacokinetic and pharmacodynamic relationships in the more effective use of “End of Phase 2” regulatory meetings for a New Drug Application (NDA). Facilitating utility of prior “Chemistry, Manufacturing, and Controls” (CMC) knowledge to accelerate new drug development and regulatory review process is also a topic of significant interest. This paper focuses on facilitating the utility of prior pharmaceutical formulation knowledge to accelerate drug product development and regulatory review of generic and biosimilar products. This knowledge is described as New Prior Knowledge (NPK) because research is often needed to fill ontological (i.e., the domain of connectivity between concepts and phenomena), epistemological (i.e., distinguishing knowledge or justified belief from the opinion), and methodological gaps in information derived a decade or so ago. The corporate economic advantages of such knowledge are derived, in part, when significant portions remain a trade secret. The proposed NPK seeks to generate knowledge about critical aspects of pharmaceutical quality and failure modes to place it in the public domain and to facilitate accelerated and more confident development and regulatory review of generic products. The paradoxical combination of “new” and “prior knowledge” is chosen deliberately to highlight both a distinction from proprietary and trade secret information and to acknowledge certain historical dogmas inherent in the current practices. Considerations for operationalizing NPK are also summarized.

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Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence

AAPS PharmSciTech April 2019, 20:140 | Cite as Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence AuthorsAuthors and affiliations Ajaz S. HussainVadim J. GurvichKenneth Morris Open Access White Paper Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model First Online: 12 March 2019 3 Shares 945 Downloads Part of the following topical collections:Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model Abstract Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology. For example, progress has been made via modeling and simulation of pharmacokinetic and pharmacodynamic relationships in the more effective use of “End of Phase 2” regulatory meetings for a New Drug Application (NDA). Facilitating utility of prior “Chemistry, Manufacturing, and Controls” (CMC) knowledge to accelerate new drug development and regulatory review process is also a topic of significant interest. This paper focuses on facilitating the utility of prior pharmaceutical formulation knowledge to accelerate drug product development and regulatory review of generic and biosimilar products. This knowledge is described as New Prior Knowledge (NPK) because research is often needed to fill ontological (i.e., the domain of connectivity between concepts and phenomena), epistemological (i.e., distinguishing knowledge or justified belief from the opinion), and methodological gaps in information derived a decade or so ago. The corporate economic advantages of such knowledge are derived, in part, when significant portions remain a trade secret. The proposed NPK seeks to generate knowledge about critical aspects of pharmaceutical quality and failure modes to place it in the public domain and to facilitate accelerated and more confident development and regulatory review of generic products. The paradoxical combination of “new” and “prior knowledge” is chosen deliberately to highlight both a distinction from proprietary and trade secret information and to acknowledge certain historical dogmas inherent in the current practices. Considerations for operationalizing NPK are also summarized. KEY WORDSnew prior knowledge generic drug prices mometasone furoate enoxaparin levothyroxine  Guest Editors: Ajaz S. Hussain, Kenneth Morris, and Vadim J. Gurvich INTRODUCTION The current AAPS PharmSciTech Theme Issue, “Team Science and Education for Pharmaceuticals: the NIPTE Model,” highlights various US FDA-sponsored research projects conducted at the National Institute for Pharmaceutical Technology and Education (NIPTE). NIPTE is a unique 501(c)(1)(3) non-profit academic organization fostering multi-university collaboration to fill critical gaps in pharmaceutical technology research and education. An unmet critical societal need that NIPTE seeks to address is ensuring the availability of affordable medicines with a high assurance of quality (1). This paper discusses how information generated via collaborative public research can be transformed into the valuable knowledge needed to address the unmet need of availability of affordable medicines with the high level of assurance expected by the American public. Increased competition through the availability of generic and biosimilar medicines is the preferred way to improve the affordability of, and access to, medicines in the USA. This competitive mechanism relies on prior knowledge to reduce the cost of development and regulatory approval, as well as the cost of goods while improving manufacturing efficiency and reducing the need for detailing and marketing. Thus, pharmaceutical “new prior knowledge,” or NPK, can significantly improve the reliability and efficiency of this process and increase the speed to market for generic drugs (2). PHARMACEUTICAL “NEW PRIOR KNOWLEDGE” (NPK) The paradoxical combination of “new” and “prior knowledge” is intended to distinguish NPK from traditional and proprietary pharmaceutical “prior knowledge.” Critically, it is also intended to draw attention to the paradoxical state of collective inattention to the root cause of challenges to the availability of affordable medicines with a high assurance of quality. As the ancient adage goes, “nothing new under the Sun.” Science builds on prior knowledge. Balancing policy incentives (e.g., intellectual property, data and market exclusivity) for generation of new knowledge and encouraging the availability, diffusion, and reuse of prior knowledge can have a significant impact on the rate of economic growth and development. The use of prior knowledge is integral to new drug development. For example, objective, quantitative, and generalizable knowledge is the basis for clinical pharmacology considerations in Phase II clinical trials. However, the bulk of the prior knowledge available to generic sponsors is on the molecule itself (...truncated)


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Ajaz S. Hussain, Vadim J. Gurvich, Kenneth Morris. Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence, AAPS PharmSciTech, 2019, pp. 140, Volume 20, Issue 3, DOI: 10.1208/s12249-019-1347-6