Lopa Bakrania’s full-circle journey into regulatory affairs

Lopa Bakrania is a RAPS member who currently works as the executive director, head of CMC regulatory affairs at Biohaven Pharmaceuticals. She joined us at RAPS Euro Convergence 2023 to talk about her path into regulatory, her experience in Amsterdam at RAPS Euro Convergence and more.

How did you get into regulatory affairs?

So, I have a story that I’m very passionate about because it started off with me making the drug. I got my PhD in organic chemistry and then went to work at Bristol Myers Squibb, and one of the first things I did was develop the drug for migraines, and I was part of the patent that actually made the drug.

But at that time, Bristol Meyers Squibb sold the asset to another company. After working in drug development and doing process chemistry for a long time, I moved to the CMC regulatory and technical space because I felt that as a scientist, whenever the questions came from the different health authorities, they always came to the technical team. But the aspect that I really loved was the merge between the technical and the regulatory side, and I thought I had a lot to contribute in that area, and I really enjoyed the interactions we had with the health authorities.

Then after that, I moved to CMC regulatory, and then a few years went by and about a year and a half ago Biohaven Pharmaceuticals comes back and says, “You know, that drug that that BMS sold, the patent that you were on? Well, we want to market this drug. Do you want to come be the regulatory head and actually globalize this?”

And I thought, what an amazing way to transition. Not only did I make that drug, but now I can be in a completely different role and be part of the team that gets this drug approved by different health authorities. So, I joined Biohaven. I’m the head of the CMC regulatory group there now, and we were able to get this drug approved by the FDA, by EMA, and eventually, Pfizer bought it out because they had better access to trying to get this to many more patients.

So, I'm really proud of the fact that now many patients with migraines will get Nurtec, or Vydura in the case of EU, and it's now even being globalized. That's my journey to how I got into regulatory affairs.

Why did you decide to attend RAPS Euro Convergence?

Recently I realized some of the challenges being in the United States that I face is trying to really understand the EU aspects around the decision making of running clinical trials and regulatory affairs strategy there. I decided to come to RAPS Euro Convergence to learn more about EU regulatory strategy.

One of the things that I've enjoyed so far is that it's very diverse. It's got a really good group of people from different backgrounds. One of the things that I want to learn about is medical devices and also orphan drug status and EU regulations. And I've already met several people. People are very sort of down to earth. You can easily approach them, talk to them, even the health authority representatives that are here from EMA and CHMP, they make it very easy to talk to them.

I think one of the values I see is you actually get to meet with some of the health authority regulators, but you also get to meet with the companies that are based in the EU and get their perspective on the challenges that they face when it comes to getting their products approved or running clinical trials there.

And so, you do get to learn a lot about the European strategy from the SME side and from the actual regulatory, like regulator, side.

Why are you a RAPS member?

Even though I’ve done CMC regulatory for a very long time, I actually only recently became involved in RAPS and it was because I wanted to learn more about biologics and I saw that there a workshop being held in Maryland about the ins and outs of biologics, drug development and getting it approved. And it said it was conducted by RAPS. And so, I said, okay, I'll try and attend that. And I did, and that's how I became a member of RAPS.

I have my PhD, and everything that I do is very CMC-focused. I want to expand and learn more outside of CMC into the clinical space. I decided that I was going to take the RAPS course and actually become RAC-certified so that I could learn more about things outside of CMC.

I think that if you are someone who works with health authorities globally on a regular basis or you're part of decision making when it comes to how a drug gets to a patient, the exposure you get by being part of RAPS is actually pretty valuable.

Learn more about the benefits of RAPS membership today.

Why do you think the regulatory profession is important?

I think the regulatory affairs profession is extremely important because it's the bridge to how you ensure good quality, safety and efficacy of every product that we make and ensuring at the end of the day that patients are first and centric at every decision you're making.