Three Phases of Biotech's Development

Even giant pharmaceutical corporations struggle with the lengthy process of developing new pharmaceuticals because biotechnology is such a highly specialized sector. David Johnston of DBJ Consulting LLC explains the three phases of the often-lengthy process of a biotech’s development.

Phase biotic

Phase 1: Discovery

Because there are so many possible paths that the development of a new medicine can take, it can be challenging to decide where to start. According to former CFO David Johnston, this phase of discovery frequently entails:

  • Examining current treatments and their intended and unforeseen outcomes.
  • Further study of an illness to discover strategies to cure or reverse the problem.
  • Testing diverse molecular compounds for potential anti-disease effects.
  • Investigating cutting-edge technologies like genetic engineering.

Following testing, researchers narrow down a lengthy list of prospective chemicals to a select group of candidates that show promise for further investigation.

Phase 2: Research

Preclinical and clinical research are the two phases of developing novel drugs.

Following toxicology testing, the corporation sends the U.S. Food and Drug Administration (FDA) an application for an Investigational New Drug (IND). It would summarize the outcomes of the animal study if one was carried out, as well as the present side effects, future clinical protocols, and other pertinent information.

David Johnston says a study protocol is created for clinical trials, and participants are chosen from among human subjects. Data collection and analysis mark the conclusion of these small-scale experiments.

Phase 3: Review

Once it has gained confidence in the product's efficacy and safety, the corporation files a New Drug Application (NDA) to indicate its intention to release the medication to the public. The NDA includes:

  • Results of clinical trials
  • Labeling and usage instructions
  • Information about abuse and safety
  • Patents
  • Research that is pertinent but carried out outside of the US

The FDA decides whether the NDA is complete. If positive, the review panel takes between 6 and 10 months to decide whether to approve the new product.

The project manager assembles everything for FDA assessment, approval, and determination. The FDA now deems the medication suitable for use by the general public.

The FDA then collaborates with the company to create prescription instructions and recommended practices for using the drug during the "labeling" process.

Ultimately, the FDA might decide that there are more issues worth looking into in addition to those mentioned by the NDA. It might create an advisory group where professionals can present their arguments, and the public could provide feedback.

Financial expert David Johnston cautions that pharmaceutical product advertising is very strictly controlled because companies cannot make false statements in their claims.

With over 30 years of senior financial leadership experience, David Johnston, former CFO, brings a wealth of knowledge to investors. Johnston's most recent position was Chief Financial Officer for Waltham, Massachusetts-based Immunogen, an oncology-focused biotech company. He presently serves as the principal of DBJ Consulting LLC, which offers financial and strategic guidance to startup life science businesses.

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