We sat down with Robert Yu, CEO of Yuyu Pharma, to ask about his experience working with Bachem on a recent new chemical entity (NCE) project.
Could you give us a short introduction to yourself and the company?
My name is Robert Yu. I’m the CEO of Yuyu Pharma. Yuyu Pharma is a Korean pharmaceutical company founded in 1941 by my grandfather. We are a healthcare company manufacturing medicine, importing medical devices, and manufacturing health supplements. We are focused on CNS, urology, neurology, and ophthalmology, and currently undergoing several new drug discovery programs.
What are some of the challenges you face as a drug product developer?
The challenge is, first, drug discovery is hard. I think that it’s important in order to make less mistakes that you want to work with people that have experience. At Yuyu we are mostly manufacturing generics, so drug discovery is new to us.
We’re very fortunate to have a very interesting molecule, which we believe has potential to be a global blockbuster and help a lot of patients’ need. We just want to make sure that the product is well developed and is available in the market as soon as possible. However, drug discovery there’s a lot of requirements, there’s a lot of work that needs to be done. And because we don’t have that expertise, we rely on an outside experts and advisors.
Bachem has been great in the sense that they have experience developing these molecules from early stage, all the way to commercialization. By working with them, they’ve taught us many things to prepare in order to file, whether it’s your IND with your FDA or whether it’s preparing documentation for CMC. I think that we’ve been able to be quite successful so far and make less mistakes because we work with partners like Bachem who’ve had experience in drug discovery and making new chemical entities.
Why did you choose to work with Bachem?
When we were looking for a partner, we first asked people in the industry, what partners, or what companies are available to help us manufacture this new chemical entity. We’ve asked around, and Bachem was obviously one of the top players.
Next was that I really believe in partnerships and interactions. So when we actually met with the Bachem team, we thought that there was chemistry, partnership chemistry that is. We actually were able to communicate our thoughts and they would understand it correctly. I think the reputation and the chemistry with the team was a big part of our decision to work with Bachem.
Our experience working with Bachem has been amazing in the sense that I’ve heard so many stories about how maybe the FDA comes back to you and asks for additional studies or ask for additional data, and I think that we were scared when we first ventured into drug discovery, that we would encounter that. So it was my goal, whenever I find partners, is to ask if they’ve had experience working with the FDA, because I believe that making less mistakes is a very good idea, and perhaps working with people who’ve actually gone through that experience would be helpful for Yuyu in our drug discovery ventures.
So we were asking around. It was important to understand how much experience a company has had in developing new chemical entities, preparing the documentation for regulatory approval. We were very impressed with Bachem’s resume and experience. So far, I think our experience has been great in sense that we haven’t gotten any requests to update or improve some of our materials and our documentation. That’s very important because drug discovery timing is everything, and we want to make as few mistakes as possible.
How did Bachem help you for this NCE project?
I think Bachem has helped us in various ways, but one of the important things is they were able to create a roadmap for us. We’ve only focused on the molecule per se, but that’s the drug substance and there’s manufacturing the drug product and eventually the commercialization. I think it’s important to understand where you’re heading. I always like to keep the end in mind when I’m doing projects. And because again, Bachem has experience with several commercially successful products, that they were able to provide us with a very efficient roadmap that so far has been very helpful for us in our drug discovery program.
How has the experience been?
I was really impressed with their industry experience and expertise, especially the fact that they’re in multiple sites and we’ve actually worked with multiple people in multiple sites and everybody was very knowledgeable and very efficient in responding to our needs. We were very impressed. We’ve been working with some of their people in Switzerland and the US and in Japan, and everybody has been great in terms of coordinating and providing us feedback as soon as possible.
Working with Bachem definitely feels like a partnership. We are basically talking with them on a constant basis. Their response time is great. If there were specific needs we had, they were doing their best to accommodate. I would say that the team is phenomenal and I’m very happy working with them. I’m definitely considering working with them again if we have any future projects that require their expertise.
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