“Milky is a very intelligent and hard working individual. I worked with Milky while she was a Safety and Compliance Officer at Wyeth and also while she was a Regulatory Affairs Associate at Pfizer. She is a pleasure to work with, she is a quick learner, very tech-suave. Anyone would be lucky to have Milky on team.”
About
Creating scalable frameworks is vital in regulatory affairs to maximize biopharmaceutical…
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Education
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Women in Leadership
Google (ELVTR)
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Publications
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Meta-analysis to identify and evaluate factors associated with regulatory approval of Orphan Drugs to develop and standardize an algorithm for predicting regulatory success and improve portfolio decision making
See publicationBackground and Purpose of the Study: Developed an algorithm (AODI) for predicting probability of regulatory success (PRS) for new orphan drugs after phase II testing has been conductedwith the objective of providing a tool to improve drug portfolio decision-making.Methods: Examined 132 studies from recent publications (2005 onwards). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Meta-analysis and meta-regressions were used to…
Background and Purpose of the Study: Developed an algorithm (AODI) for predicting probability of regulatory success (PRS) for new orphan drugs after phase II testing has been conductedwith the objective of providing a tool to improve drug portfolio decision-making.Methods: Examined 132 studies from recent publications (2005 onwards). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Meta-analysis and meta-regressions were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors.Results: Found that a simple three-factor model (disease prevalence, clinical trial duration and clinical trial participation) had high specificity for predicting regulatory approval (success).Conclusion:smaller clinical trial participation, shorter clinical trials duration and lower rare disease prevalence were found to be highly associated with the Probability of Regulatory Success (PRS) of orphan drugs.
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Spanish
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English
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French
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Regulatory Affairs Certification Program (RAPS),
Member
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Recommendations received
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