LitCovid-sentences  

PMC:7536913 / 8683-12631 JSONTXT 9 Projects

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Id Subject Object Predicate Lexical cue
T59 0-78 Sentence denotes ADVANCE MORE RISK‐BASED REGULATORY DECISIONS TO ADDRESS OTHER SERIOUS DISEASES
T60 79-287 Sentence denotes In order to rapidly accelerate the development and manufacturing scale‐up of COVID‐19 therapeutics, industry and regulators continue to partner in quick fashion to adopt fit‐for‐purpose regulatory strategies.
T61 288-503 Sentence denotes Similar to how we take such exceptional action for COVID‐19 patients, we need to advance regulatory policy for patients with life‐limiting autoimmune conditions, late‐stage heart failure, or other serious illnesses.
T62 504-745 Sentence denotes Such life‐threatening diseases will continue long after COVID‐19 is managed, and it will be important not to revert to previous practices and to emerge from the current situation with enduring solutions for the benefit of patients, globally.
T63 746-946 Sentence denotes This objective will challenge each stakeholder to implement processes that enable regulators to prioritize and focus on the most important, unmet needs with the most substantial public health impacts.
T64 948-987 Sentence denotes Innovative clinical evidence generation
T65 988-1205 Sentence denotes The pandemic has underscored the premium for speed of success and the acceptability by regulators of the use of innovative trial strategies with a quantitative decision‐making framework to support regulatory approval.
T66 1206-1497 Sentence denotes We have seen the benefit of streamlining trial protocols and embracing novel trial designs such as platform approaches to simultaneously test multiple assets in the clinic, using historical data for predictive analyses, or borrowing information on placebo/standard of care from other trials.
T67 1498-1670 Sentence denotes 10 These mechanisms, together with use of real‐world data on external controls and adaptive clinical designs are not new and are increasingly well understood and accepted.
T68 1671-1745 Sentence denotes They should be leveraged where similar benefit/ risk considerations apply.
T69 1747-1789 Sentence denotes Risk‐based preclinical safety requirements
T70 1790-2114 Sentence denotes The global support for drug and vaccine development, including streamlining nonclinical requirements, has allowed candidates, such as severe acute respiratory syndrome coronavirus 2 (SARS‐CoV2) antibodies, to move quickly into the clinic to most efficiently determine if the experimental treatment is effective for patients.
T71 2115-2332 Sentence denotes The practice of deferring or eliminating certain preclinical studies while there is a degree of uncertainty in the experimental candidate for specific life‐threatening illnesses with no effective treatment is not new.
T72 2333-2481 Sentence denotes ICH S9 Guideline “Nonclinical Evaluation for Anticancer Pharmaceuticals” provides for such regulatory flexibility for advanced oncology indications.
T73 2482-2640 Sentence denotes We encourage regulators to apply this approach to other life‐threatening illnesses across therapeutic areas, and to model a global harmonized approach as ICH.
T74 2641-2815 Sentence denotes The benefits to society could be significant—by reducing the need to use animals, modernize drug development, and potentially make new therapies available to patients faster.
T75 2817-2864 Sentence denotes Fit for purpose and risk‐based CMC requirements
T76 2865-2997 Sentence denotes As preclinical and clinical phases are streamlined, chemistry and manufacturing controls (CMC) data must equally be fit for purpose.
T77 2998-3242 Sentence denotes In order to rapidly accelerate the development and manufacturing scale‐up of COVID‐19 treatments and vaccines, regulators have employed risk‐based decisions to defer certain CMC requirements to later stages of development or even post approval.
T78 3243-3435 Sentence denotes There are long‐standing challenges to accelerating manufacturing aspects under expedited programs, and the COVID‐19 experience further emphasizes the need for analogous regulatory flexibility.
T79 3436-3577 Sentence denotes For instance, using judgment‐based clinically meaningful specifications or deferring longer‐term stability data until the postmarket setting.
T80 3578-3948 Sentence denotes Moreover, allowing companies to report more postapproval changes within their quality system (vs. submitting for regulatory approval) would allow for more manufacturing flexibility and ability to react to supply challenges globally more quickly, as outlined in ICH Q12 Guideline “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Development.”