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DB for Module 2: Discovery Trials and Development No unread replies. No replies. Question 1) Who is in charge of discovery and pre-clinical development? Question 2) What is the enterprise value of “Drug Trials Snapshot”? (meaning: why would a company review Drug Trials Snapshot?) Go back to the US FDA's “Drug Trials Snapshot” and select a drug of interest. Question 3) What drug or biologic did you select, and why? Question 4) What does your drug or biologic do for patients? (hint: this is about the patient, the patient's family, the patient's friends-- it is not necessarily about the science or regurgitating the indication) I added all resources.You can check questions and look which one you will need it .If you have any question let me know. Please do not forget citation
Date Posted: 06/07/2022
Category: Biology
Due Date: 08/07/2022
Willing to Pay: $25.00
Due Date: 08/07/2022
Willing to Pay: $25.00
Instruction
FDA Resources: * Overview: Discovery and and Development: https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-development (Links to an external site.) * Overview: Pre-Clinical Research: https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research (Links to an external site.) * FDA Guidances to Broaden Cancer Clinical Trial Eligibility (2 different articles on same story-- good to see what was covered and additional links from the two articles): * RAPS: "FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility," March 12, 2019 by Zachary Brennan: https://www.raps.org/news-and-articles/news-articles/2019/3/fda-unveils-5-guidances-on-broadening-cancer-clini (Links to an external site.) * CenterWatch: "FDA Guidances Recommend Broadened Eligibility, New Strategies for Trials," March 18, 2019 by Bill Meyers (includes links to the FDA Guidances for quick view): https://www.centerwatch.com/articles/12376-fda-guidances-recommend-broadened-eligibility-new-strategies-for-trials (Links to an external site.) Inherent risks of drug development (biotechnology or pharmaceutical): * BioSpace: "Reports: Odds of Getting Drugs to Market Range from 6% to 40%" April 30, 2019 by Mark Terry: https://www.biospace.com/article/never-tell-me-the-odds-what-are-the-chances-of-drugs-getting-to-market-/ (Links to an external site.) * Perspective: Why do it when the risks of failure are so high? https://www.forbes.com/sites/brucebooth/2017/11/17/painful-truth-successful-failure-of-a-biotech-startup/#6decc2f5d025 (Links to an external site.) Research: * Please go to the US FDA Drug Trials Snapshot page: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots (Links to an external site.) and review 1 drug or biologic of interest. (I recommend a diagnostic or therapeutic; Drugs and Biologics will be mixed in together-- you do not have to search specifically for a Biologic). Be prepared to discuss in class. Remember to view all drugs and biologics through the eyes of the patient.
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