The drug deals

We all benefit from new medicines, but getting them to market is expensive. Academia and industry must collaborate better to improve the drug development process.

 
  Long gone are the days when getting drugs into the hands of patients who need them was a simple process.   Internet Archive Book Images/Flickr  (public domain)

Long gone are the days when getting drugs into the hands of patients who need them was a simple process. Internet Archive Book Images/Flickr (public domain)

 

Scientists begin their career with a desire to make a difference. In the world of drug discovery, this means successfully converting their findings from the research and development (R&D) phase to a medication that will benefit patients. This is referred to as bridging the space from the lab bench to bedside. However, the high cost required to get a single drug to market is insurmountable for most universities and small companies. While there is debate over the precise figure, estimates of associated expenses range from $100m to $2.6bn. Putting that in perspective, the entire 2015 budget for the National Health and Medical Research Council, Australia’s peak body for medical research, was $892m.

Many factors contribute to the immense cost of drug development. For a company to provide proof of safety and efficacy, they must conduct large clinical trials and compensate the participants. These trials are designed and overseen by legal, regulatory and medical professionals who must also be paid. Additionally, while universities and R&D departments may discover and flag thousands of potential medicinal molecules, the proportion that makes it to market is extremely low. Even among the medicines that successfully make it through Phase I clinical trials, just 12% will be approved. Although it would be nice to imagine that we could fund an entire drug development program with taxpayer dollars, it would be difficult to claim that this is the most efficient use of government funds.

 
  Bringing a new medication to market is an expensive and prolonged process.   Chris Potter/Flickr  (CC BY 2.0)

Bringing a new medication to market is an expensive and prolonged process. Chris Potter/Flickr (CC BY 2.0)

 

The average lag-time from discovery at the bench to application in the clinic is approximately 17 years; while this may seem inordinately long, it is the norm. A recent example: Clinuvel, a Melbourne-based biotech company, received European Medicines Agency approval for their headline drug Scenesse in 2014. The active ingredient, afamelanotide, was first discovered in 1980 at the University of Arizona and the first clinical trial was performed more than a decade later. A staggering 23 years followed before it was approved for use in the treatment of the orphan condition erythropoietic protoporphyria (EPP). Similarly, the technology behind the Gardasil vaccine was developed in 1990, and FDA approval was granted 16 years later.

In recent years there has been a significant tightening of global pharmaceutical R&D budgets. As Australia lacks a critical mass of large pharmaceutical companies, medical innovation has typically come via small biotech companies spun out of our universities. Typically, venture capital and angel investors initially fund smaller biotech firms. At a later stage, multinational ‘big pharma’ companies may acquire them or license their promising drug in multimillion-dollar deals. Recent Australian biomedical commercialisation success stories include Hatchtech, Fibrotech, Spinifex Pharma, and the Gardasil vaccine.

 
  A scientist carries out research at the International AIDS Vaccine Initiative, an organization that designs and studies HIV vaccine candidates.   IAVI_flickr/Flickr  © 2011 Sokomoto Photography for International AIDS Vaccine Initiative (IAVI)

A scientist carries out research at the International AIDS Vaccine Initiative, an organization that designs and studies HIV vaccine candidates. IAVI_flickr/Flickr © 2011 Sokomoto Photography for International AIDS Vaccine Initiative (IAVI)

 

For an academic discovery to make the transition from bench to market, it requires a certain element of vision, foresight and entrepreneurial acumen. These soft skills are not typically fostered in the academic domain. Most academic scientists work in highly specialised areas and the cutthroat ‘publish or perish’ culture can distract them from considering the potential broader impacts of their research.

Fortunately, the status quo is changing. In 2015, the federal government announced the National Innovation and Science Agenda. As part of this agenda, the Research Engagement for Australia programme aims to convince universities to value commercialisation by measuring university-industry engagement and collaboration. There are also new opportunities for PhD students to undertake industry placement during their studies or to receive mentorship from experienced industry leaders. These types of programs broaden the student’s exposure to career paths in industry and break down some of the traditional academia-industry barriers. This progress is also seen at individual universities, which often have commercialisation and technology transfer offices to help researchers apply for patents, find potential partners, and manage commercial relationships.

 
  Partnering with large pharmaceutical companies enables universities and smaller biotech companies to bring their drug to market.   Jamie/Flickr  (CC BY 2.0)

Partnering with large pharmaceutical companies enables universities and smaller biotech companies to bring their drug to market. Jamie/Flickr (CC BY 2.0)

 

It is also vital to consider the people who will ultimately prescribe and use the medicine or technology: doctors and patients. Considering their needs, expectations and perspectives is critical. To gain insights about these factors, academic researchers should maintain close collaborations with practising clinicians throughout the drug development process. Doctors can liaise with both patients and researchers, and facilitate research by connecting consenting patients with research programs in need of patient samples.

Research teams also benefit from a health professional’s greater understanding of unmet medical needs. Is the medicine user-friendly? Would doctors be likely to prescribe it? Where is the patient population? Are they adequately represented in the clinical studies? The answers to these questions are key to the prescription and reception of any new drug and will be front-of-mind for any commercial partner. By working with doctors and patients early on in the drug development process, researchers will better understand their needs.

 
  Vaccines are critical to public health, and large clinical trials must be carried out to confirm their safety and efficacy.   Blake Patterson/Flickr  (CC BY 2.0)

Vaccines are critical to public health, and large clinical trials must be carried out to confirm their safety and efficacy. Blake Patterson/Flickr (CC BY 2.0)

 

For collaboration between academia and industry to succeed, one must balance and consider expectations of all involved parties. The researchers who perform the work, the principal investigator, the commercial partner, and the academic institution have their own priorities, goals and preconceived notions. Academic researchers often hope for publications in major scientific journals, while the institution may pursue tight control of their intellectual property. Naturally, the commercial partner wants a commercially successful product that provides good returns on their investment. Navigating these competing interests is a skill that academics would do well to hone.

Scientists labour in the hope that their discoveries will one day make a positive impact on society. When the relationship is managed properly, commercial collaboration can help researchers do just that. If we are to achieve the best societal outcomes for Australia, we must encourage an integrated research system where scientists, clinicians, government, and commercial industry engage early and often in the development process. The pursuit of pure science and applied research are not like oil and water: they are miscible if done right.

Edited by Ena Music, Jack Scanlan and Nicola McCaskill, and supported by Michael Vagg.