Application of Pharmacogenomics in Drug Development, Regulatory Review and Clinical Practice | Summary and Q&A

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October 26, 2015
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Application of Pharmacogenomics in Drug Development, Regulatory Review and Clinical Practice

TL;DR

Pharmacogenomics plays a crucial role in drug development and clinical practice by considering factors like genetics, age, organ dysfunction, and concomitant medications.

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Key Insights

  • πŸ™ˆ Emerging countries like China, Brazil, India, and Russia have seen a significant increase in pharmacogenomics sales.
  • β˜„οΈ The FDA receives submissions from countries outside the US, especially for orphan drug products, where data can come entirely from other countries.
  • πŸ§‘β€πŸ­ Intrinsic factors (age, genetics, organ dysfunction) and extrinsic factors (concomitant medication) need to be considered in drug submissions.
  • ☠️ Pharmacogenetics plays a crucial role in determining the response to hepatitis C treatments, with different race groups having varying prevalence rates of favorable genotypes.
  • πŸ§‘β€πŸ­ Personalized medicine relies on understanding genetics and other factors to achieve successful drug development.
  • βŒ› Market outlooks and market shares are dynamic, with different countries and regions experiencing shifts over time.
  • πŸ’ Collaboration and sharing of information are essential in the advancement of pharmacogenomics and personalized medicine.
  • πŸ“œ FDA guidance documents and workshops help develop the regulatory framework for personalized medicine.

Transcript

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Questions & Answers

Q: What factors contribute to the market shift towards emerging countries in pharmacogenomics sales?

The market shift towards emerging countries like China, Brazil, India, and Russia is driven by a tremendous increase in sales, reaching billions of dollars. These countries have become significant players in the market, surpassing the US in market share.

Q: How does the FDA handle drug submissions from countries outside the US?

The FDA receives submissions from countries outside the US, particularly for orphan drug products. In some cases, the data for these submissions can be completely from outside the United States, reflecting the global nature of drug development.

Q: What factors need to be considered when evaluating drug submissions?

When evaluating drug submissions, both intrinsic and extrinsic factors are important. Intrinsic factors include age, genetics, organ dysfunction, while extrinsic factors include concomitant medication. The importance of each factor depends on the specific drug, disease, or region where the trials were conducted.

Q: How does pharmacogenetics affect hepatitis C treatment?

Pharmacogenetics plays a crucial role in hepatitis C treatment, particularly regarding the response to interferon alpha treatment. The CC genotype for il-28 B is considered a favorable genotype, making patients more responsive to treatment. Different race groups also have varying prevalence rates of this favorable gene, emphasizing the importance of considering population sensitivity to new treatments.

Summary & Key Takeaways

  • The market outlook for pharmacogenomics shows a shift towards emerging countries like China, Brazil, India, and Russia having a significant increase in sales.

  • The FDA receives submissions from countries outside the US, especially for orphan drug products, where data can come completely from other countries.

  • Intrinsic factors like age, genetics, and organ dysfunction, as well as extrinsic factors like concomitant medication, need to be considered when evaluating drug submissions.

  • Pharmacogenetics, such as the CC genotype for il-28 B, plays a significant role in determining the response to hepatitis C treatments.

  • Personalized medicine relies on understanding genetics and other factors to achieve successful drug development.

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