Navigating the FDA Approval Process

Interview with Doctor Sara Zacknoen, M.D. about Navigating the FDA Approval Process for New Cancer Drugs

“Cancer can take away all of my physical abilities. It cannot touch my mind, it cannot touch my heart, and it cannot touch my soul.” – Jim Valvano

In this interview with Doctor Sara Zaknoen, M.D., we discuss a bit about Sara’s background and experience and navigating the Food & Drug Administration (FDA) approval process for new cancer drugs. Sara is a medical doctor that specializes in oncology and hematology. Sara has spent the bulk of her career looking for cures to various forms of cancer, blood diseases, and immune system diseases. Sara spent 18 years working for both large pharmaceutical companies and small biotech companies, including leadership roles at Schering-Plough and Novartis. Sara has served as the chief medical officer of two successful biotech startups. Sara is an expert on the FDA approval process for new cancer drugs, and has tons of experience in how to design and manage clinical trials for new cancer drugs. Sara is now an independent consultant working with both large and small biotech companies that are developing new drugs for various forms of cancer and blood disease.

The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective gives a simplified summary of the steps in a drug review process which includes:

  1. Preclinical (animal) testing.  This phase also includes a lot of chemistry and lab work to develop a “compound”.
  2. An Investigational New Drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
  3. Phase 1 studies (typically involve 20 to 80 people).  The focus is on toxicity (does the drug make you sick, and if so at what dosages).
  4. Phase 2 studies (typically involve a few dozen to about 300 people).  The focus is still on toxicity, but also on efficacy (does the drug help solve the problem).
  5. Phase 3 studies (typically involve several hundred to about 3,000 people).  This is an expanded look at toxicity and efficacy in a larger population with other parameters being considered, like combination with other drugs, and different types of patients.
  6. The pre-NDA period, just before a New Drug Application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
  7. Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
  8. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
  9. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.
  10. The FDA reviews information that goes on a drug’s professional labeling (information on how to use the drug).
  11. The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
  12. FDA reviewers will approve the application or issue a complete response letter.

According to MedicineNet.com, it takes an average of 12 years from the invention of a new drug to market in the United States.  Navigating through the FDA approval process is not a simple task, and Doctor Sara Zacknoen is an experienced navigator.

In cancer you are dealing with life and death.  You are dealing with patients that are very upset.  You are dealing with families that are very upset.  As a medical doctor, Sara says that 85 percent of the role is dealing with people, and only 15 percent is about the science.  All I know is it must be very difficult, and Sara is really good at what she does.

I hope you find this interview as interesting and informative as I did.  Please let me know your thoughts!

Patrick Henry Entropic

This is Patrick Henry, the CEO of QuestFusion, with The Real Deal…What Matters.

This article originally appeared in The Consulting Masters.

Patrick Henry
Written by

Patrick Henry, CEO of QuestFusion, former CEO of Entropic Communications, entrepreneur, executive, father, and freelance blogger living the luxury and active lifestyle in San Diego.

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