Can you outline some of the trends that you’re seeing in the life sciences sector?
Carol Loepere: There has been considerable consolidation in this industry over the past few years, both on the drug side and the device side. We are also seeing a focus on specialisation by disease state or by a particular framework that a company is focused on. That has led to companies deciding an area may not be part of their core mission or core function, and setting up joint ventures to focus on different areas.
There continues to be a focus on start-ups and emerging companies, with maybe one particular product. It may be an orphan drug, or one with a limited projected patient base, but it may grow into having uses for different indications. That’s consistent with the trend of personalised medicine – developing drugs that are right for the right person.
A lot of companies have been acquiring research and development from companies that may be start-ups. Is that something that we’ll continue to see?
CL: In order to have research and development (R&D), especially considering the expiration of patents, you either have to grow it in-house or acquire it. I see a continuing trend to look for start-ups and promising emerging companies. There are certainly a number of different companies in that space and with a lot of the larger pharmaceutical companies having cash on hand to make those acquisitions – I see the trend of acquiring R&D continuing.
We’re also seeing collaborations, where there may be a long-term licensing or co-promoting arrangement which may result in, or lead to, an acquisition. You may have one company focused on the biotech development R&D partnering with one helping on marketing.
What would be a common challenge for this example where you have a biotech and a larger corporate partnering cross-border?
CL: Both companies must be aligned and getting their own value out of the arrangement. For example, the start-up may be looking for additional finance and to use the larger company’s marketing team. It’s also a way for the larger company to see whether there are going to be promising results from clinical trials before making a significant investment.
It’s a good way for two entities to get to know each other, like dating before getting married, to see if they have the same focus and approach to development.
In terms of regional trends, what are you currently observing and in which direction do you expect it to develop?
CL: I think there’s still is a focus on looking to the emerging markets for additional product development – such as Asia markets for manufacturing as well as distribution – and many companies are still looking for expansion in global markets. Where you may have a product that is commercialised in the United States and Europe, there is a trend to expand to global markets that can be done through different types of arrangements. We also see trends where there can be a licensing arrangement where one company will license to another the ability to market a product in a particular region.
Where is the focus on personalised medicine in the United States? There is a feeling that investors feel there is a lack of regulatory certainty in this area. Would you agree?
CL: I think “lack of regulatory certainty” may be a little strong but there are more challenges from a regulatory perspective. It’s a great opportunity but with some potential risks or challenges. The future of medicine is to have the right medicine for the right patient, and the right dose at the right time. You don’t want to be taking a drug that doesn’t work for you, or one that could have a negative effect.
Other challenges included reimbursement and payment. If you have a drug and an accompanying laboratory test, which is often how many of these personalised medicine products proceed, an area of regulatory uncertainty is whether the insurance company or the payer will pay for both the product and the test.
There’s also the issue of what happens when the product is already being commercialised. You may start with a relatively small patient population that’s going to benefit then there could be other symptoms that come to light as you get more people in the sample.
Which types of technology do you think will have a particularly strong impact on the sector and drive it towards personalised medicine?
CL: One area that could have significant technological breakthroughs would be in laboratory-developed testing. A number of the tests that are used along with personalised medicine are laboratory-developed tests, and if there are breakthroughs in making those more efficient or less costly, that could have an impact. There’s a potential to have much greater breakthrough in such tests that will make it easier to be able to determine – at a molecular level – whether somebody could benefit from a particular product.
Is there anything else, such as a specific regulation, holding back advancement in personalised medicine?
CL: Yes. To get approval for certain kinds of products – and to get payment. Here in the United States, to get payment for some of these drugs can take a while, even after you get your FDA approval, to get coverage by payers like Medicare. That is a challenge. Early on in the product approval process – even at the clinical trial stage – it’s important to consider who is going to be the patient population for this drug. You need to think how to position the product for coverage and payment. For example, if you think that the drug may be used for Alzheimer’s, you’re going to want to have a geriatric population in your clinical trial.