Finding a New Regulatory Balance in Biopharma

By Admin
Posted 05 / 23 / 2016

When the recent Economist Intelligence Unit survey asked biopharma industry leaders what they thought about the future of their business, many were eager to explore new possibilities – from developing novel therapies to expanding into emerging markets. But they were also concerned about risks, especially regulatory uncertainties. We spoke with Heike Michaelis – Director of the Emprove® Program at brand-name – and she shared her thoughts on the industry’s regulatory needs, what companies sometimes miss about compliance, and why regulatory uncertainty can sometimes be a good thing.

Can you tell me about your role?

I’m leading the Emprove® Program, which helps customers manage regulatory challenges. If you want to be active in this industry, you need to be compliant with regulatory laws. You need to manage your risks. In order to do that, you have a lot of questions for your suppliers. Our program organizes these processes internally in a way that provides our customers with a lot of answers in a structured way. We are educating them and guiding them through the regulatory jungle. We’re not only addressing today’s needs, we’re also anticipating and addressing our customers’ needs for tomorrow.

It’s important that we have smart regulation of the biopharma industry. At the end of the day, there is the patient and it is all about patient safety and supply security. And we as a leader in the industry can play a very active role, not only in addressing our customers’ needs for information, but also in building the future regulatory environment for the industry.

Has this process changed for you over the years?

The Emprove® Program has been introduced 12 years ago for chemical raw and starting materials used in pharmaceutical manufacturing. The degree of regulation for those materials is very mature and regulatory requirements are generally very clear. On the biopharma side, with filters and especially single-use technologies, there’s a definite difference in regulatory maturity. There’s a considerable discrepancy between what the biopharma industry expects and needs, and what information is actually available.

At the same time, the industry is changing from being science-driven to being standard-driven. It’s being reigned in now in order to manage complexity, both on the customer side and on the supplier side. This is a trend we see, and it’s a good time for us to come in with a very structured approach and a lot of answers to the questions that are currently exploding.

In the Economist Intelligence Unit survey, respondents said the most potentially disruptive risk to growth and development was clearly regulatory uncertainty. Do you think the discrepancy you mentioned is one of the reasons behind that?

The discrepancy is certainly one reason. The interesting thing is that the industry isn’t very aware that there is a big regulatory gap. Sometimes you need something, but you don’t know that you need it.

Regulatory topics are not always discussed thoroughly in the industry. Science is sexy, regulatory concerns are not. But if you don’t talk about it, you don’t know what’s needed. The industry sees regulation as mystic, as a threat. But I see it as an opportunity. With a program like the Emprove® program, we can help our customers speed up their processes.

We've seen that companies sometimes make decisions in early development that have negative implications for the future, even years away. How early in development would a company want to take advantage of the Emprove® Program?

It comes back to the level of education of the customer. There are quite a few out there who are not fully aware of the amount of information they need for the materials they use. They work with technical material in early development and are not aware of of the potential effect this has on their journey to commercialization. They miss the point where they should ensure that they have the depth of information required for (bio)pharmaceutical production. And then they face a lot of difficulties once they go into clinic and want to file their drug.

You mentioned how small molecule drugs have become more standardized regarding their regulatory requirements over the years. But now many companies are working on newer products like biosimilars. And then you have novel therapies, which are even newer. What is your sense about regulatory uncertainty when it comes to these treatments?

Biosimilars aren't such a big question anymore. They were five years back, but now regulations are in place, so you know what's required. When it comes to novel therapies, they are very unregulated. This is really emerging technology. Nobody really knows where this is going, and industry is still very much focused on the technology. They haven’t spent the time yet to build regulations around it. Some people see it as a great risk. But again, I see it as a greater chance to not only develop technology in this novel area but also build the regulation along the way


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