Janssen Biotech, Inc.

Dr. Yosef Witdering is a former FDA medical officer, a board-certified psychiatrist, and the co-founder, CEO, and medical director of Taper Clinic.

After working in traditional psychiatry, clinical development at Janssen, and the FDA's division of psychiatry, he became interested in patients who were not improving with standard treatment.

That includes people with difficult-to-recognize medication side effects, people struggling to discontinue psychiatric medications, and people cycling through multiple prescriptions without a long-term plan.

Today, much of his work focuses on helping patients navigate psychiatric medication withdrawal, deprescribing, and complex medication-related problems.

I'm going to dedicate myself to drug safety.

I want to understand the research behind these drugs.

So I end up doing a fellowship at Johnson & Johnson's pharmaceutical branch, Janssen.

And then I go to the FDA because I want to see what is the evidence base supporting these drugs.

Uh, his name is Bill Hite.

Um, so Bill actually went on to quite an illustrious career outside of Yale, uh, when he, he left and went to Rutgers and then got hired by, uh, J&J or Janssen and was leading, um, uh, a lot of their efforts in oncology, uh, and beyond.

Um, but when I was in Bill's lab, um, he, he proposed a really interesting project for me as a, uh, as a PhD thesis project, which was to, um, identify a selective inhibitor of protein kinase C. [lips smack] Um, so, you know, a- and, and his, his hypothesis was that by modulating protein kinase C, you might be able to modulate, um, multidrug resistance.

It was really kind of a, a flyer hypothesis.

Uh, tell the story of Risperdal.

So Johnson & Johnson, um, entered the drug business actually in 1960, when it bought both, uh, Janssen Pharmaceutica, the sort of the named company of this great medicinal chemist, Paul Janssen, and, um, McNeil Laboratories, which made Tylenol.

And Paul Janssen had developed something called Haldol, which was part of the original group of what are now known as antipsychotics.

They originally were known as major tranquilizers.

I've been working in the pharma biotech space for over 20 years now.

Started my career back in Ireland in a large pharma company, in a Janssen & Janssen company, and spent about half of my career there.

and then moved to the US 11 years ago.

So I spent some time in quality control in the bioassay microbiology space.

And it was just a natural transition for me into QA from there while I was back with Janssen.

And sort of throughout my career since then, I've really had exposure to the whole life cycle across the board from preclinical all the way through clinical stage and into commercial as well.

And just a lot of exposure to different modalities too, for monoclonal antibodies, combination products, diagnostics, you know, cell and gene therapy, small molecules.

So I, you know, I worked with them for a bit and then I decided to go back into the lab work, into QC, just to use my science degree and spend some time there in the microbiology lab as an analyst and then a senior analyst in the lab.

And I guess I just had this idea in my head that there was a lot of rigor behind these studies.

Now, after I worked for Janssen, which is the pharmaceutical arm of Johnson & Johnson, so I was doing psychiatric clinical trials there, and then I went to the FDA.

And essentially what I found was that most of the studies supporting the use of these medications are 12 weeks long.

And a study was done by Vinay Prasad who last year he was the chief medical and scientific officer at the FDA.

And that's what I'd love to ask about next, because...

although your professional focus really is on tapering in the taper clinic, my sense is you have some familiarity with what's going on with ketamine.

I mean, you worked at Janssen, which was the company that got S-ketamine or Spravato approved by the FDA.

We're on the verge potentially of FDA approval of psilocybin.