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Issue 25 ― Flexibility in Phase I Study Timing
The structure of an early phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase 1 do not have to be conducted before Phase 2 commences. Conversely, some studies that are typically done in Phase 2 can be advanced into a Phase 1 combined protocol to have access to key data earlier in the program. Early Phase 1 studies have become increasingly complex, in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and help solidify the overall plan around sound data.
Partnering with a CRO team that has the knowledge and experience to design each program according to the sponsors’ needs, considering flexibility to perform specific analyses early (in Phase 1) or later (Phase 2 and beyond) is ideal. Experts will incorporate and analyze early signals that point to specialized analyses being included or waived, and the development pathway is structured to maximize efficient timelines and budget.
CHAPTERS:
- 0:08 ― Section 1: Introduction
- 1:30 ― Section 2: Timing of Early and Clinical Pharmacology Studies
- 4:01 ― Section 3: Development Program Optimization
- 7:52 ― Section 4: Scenarios
- 16:31 ― Section 5: Summary
About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
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By The Altascientist
5
33 ratings
The structure of an early phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase 1 do not have to be conducted before Phase 2 commences. Conversely, some studies that are typically done in Phase 2 can be advanced into a Phase 1 combined protocol to have access to key data earlier in the program. Early Phase 1 studies have become increasingly complex, in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and help solidify the overall plan around sound data.
Partnering with a CRO team that has the knowledge and experience to design each program according to the sponsors’ needs, considering flexibility to perform specific analyses early (in Phase 1) or later (Phase 2 and beyond) is ideal. Experts will incorporate and analyze early signals that point to specialized analyses being included or waived, and the development pathway is structured to maximize efficient timelines and budget.
CHAPTERS:
- 0:08 ― Section 1: Introduction
- 1:30 ― Section 2: Timing of Early and Clinical Pharmacology Studies
- 4:01 ― Section 3: Development Program Optimization
- 7:52 ― Section 4: Scenarios
- 16:31 ― Section 5: Summary
About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.