David Nierengarten, Ph.D., is Managing Director and Head of Healthcare Equity Research at Wedbush Securities. He is a senior biotechnology equity analyst with Wedbush Securities, mainly covering development-stage therapeutic companies. He began his career on the financial side of biotechnology at a venture capital firm that focused on early-stage therapeutic and medical device companies.
Additionally, prior to joining Wedbush, Dr. Nierengarten gained experience on the other side of that equation, working in a clinical-stage, venture-backed biotechnology company, in business development and clinical trial operations. He received his bachelor’s degree in biochemistry from the University of Wisconsin-Madison and his Ph.D. in molecular and cell biology from the University of California-Berkeley. In this 2,974 word interview exclusive to the Wall Street Transcript, Dr. Nierengarten reveals the top picks from Wedbush in this high growth sector.
Here is an excerpt from this fascinating interview:
“TWST: Does the clinical trial process and the FDA review of some of these gene technology companies look very different from their brothers and sisters in biotech and pharma in general, or have you been noticing different hurdles that they have to jump through, including far greater considerations? If so, what might those differences be?
Dr. Nierengarten: I am actually not sure if it is really more difficult or less difficult, but the main difference I see is that there is definitely a greater focus by the FDA on manufacturing and quality control for very good reasons. These viruses are notoriously challenging to manufacture consistently.
A lot of them have been transferred from the benchtop almost directly from an academic setting into the clinic into a more corporatized drug development setting, and that is not the easiest thing in the world either.
These are intrinsically difficult to manufacture, and then, you take an unrefined academic process and start to refine it. The FDA is rightfully concerned with maintaining quality and good clinical practices there.
That is one difference between the making of small molecule drugs that chemists have been doing for a couple of hundred years now and where gene therapy is now.”
To get more detail on the top picks from Dr. Nierengarten, read the entire 2,974 word interview in the Wall Street Transcript.