Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 12, Num. 2, 2002, pp. 33-34

Australasian Biotechnology, Vol. 12 No. 2, 2002, pp. 33-34

CLINICAL STUDIES

WHAT YOU DON'T KNOW WILL HURT YOU! AUSTRALIAN BIOTECH - 'IN THE KNOW' WITH CLINICAL TRIALS?

Karen Woolley and Mark Woolley

ProScribe Medical Communications, 18 Shipyard Circuit, Noosaville Qld 4566. Email: kw@proscribe.com.au

Code Number: au02013

Clinical research is the most expensive and longest phase of drug development. A loss of one million dollars (US) is incurred for every day of delay in developing a successful drug. Therefore, clinical trials must be conducted efficiently to optimise drug development. Data from the US, however, indicates that timelines for clinical trials of biopharmaceuticals have become progressively worse. In contrast, the timelines for clinical trials of new chemical entities have become progressively better. While relatively few Australian biotechnology companies have advanced compounds to the clinical trial stage, companies will need to develop strategies to ensure clinical trials are conducted efficiently. Australian biotech companies need to focus on planning, processes, people and partners and may benefit from lessons learned by large pharmaceutical companies ('Big Pharma').

One million dollars (US) lost per day

If you (or your investors) don't want your biotech company to lose one million dollars (US) per day, you had better make sure that your clinical trials are conducted efficiently. If your drug is going to be a success story in the global marketplace, every day lost in drug development will cost your company at least one million dollars (US) (Maloff, 1999). Clinical trials are the most expensive and longest phase of the drug development pathway (Mathieu, 2001). If you don't have a strategy for an efficient clinical trial program, be prepared to lose money, a lot of money.

Compared to Big Pharma, biotech companies have been heading in the wrong direction when it comes to conducting efficient clinical trials (Figure 1). Poorly designed and managed clinical trials can cause major setbacks in taking the drug to the market. These setbacks delay patients from accessing much needed treatment and unnecessarily inflate drug development costs. Big Pharma finally realised the true cost of inefficient clinical trials. In the mid-90's, a wave of 'time-compression initiatives swept through Big Pharma, with each company developing new strategies to inject greater efficiency into their clinical trial processes.

No data are currently available on clinical trial timelines for Australian biotechnology companies (in fact, the first survey of clinical trial efficiency in Australia is being conducted this year*). Relatively few Australian biotech companies have advanced to this critical stage of drug development, with the majority focusing on intellectual property and venture capital. This is understandable but, ultimately, if your medical biotech product does not work in humans, you have nd biotech product. Australian biotech companies that like to plan for high-cost activities will need to understand the key success factors that drive efficient clinical research. There is still time for Australian biotech to play leapfrog. Based on valuable information gained from Big Pharma initiatives, Australian biotech companies would be well served to focus on the four 'Ps':

1. Planning: investing sufficient time upfront to ensure efficiency "from protocol to publication"; haste will make waste if planning is sacrificed.
2. Processes: with approximately 120 processes required for the 'average' clinical trial and the need to comply with ICH-GCP (the FDA's human subject protection standard for accepting clinical studies for review), streamlined and documented processes fall in the 'must have' category.
3. People: watch out for those who profess to know about clinical trials! A medical, nursing or science degree does not buy you clinical trial expertise. Question candidates about relevant clinical trial metrics - if you want performance, check performance. Clinical trial expertise gained from Big Pharma could be desirable (if performance metrics are sound i.e. don't employ the people that could not drive efficiency for Big Pharma...)
4. Partners: depending on your business strategy, you will need to partner with hospitals, private practice, CROs, SMOs. Performance-based contracts with partners should be based on relevant, current Australian/international benchmarks*. Whether you in-source or out-source your clinical trials, you will need to be an informed decision-maker to ensure efficiency in your clinical trial program.

As more Australian biotech companies advance through the drug development pathway, increased focus will be placed upon the demands and challenges of clinical research. The conferences, meetings, seminars and publications that serve the Australian biotech community should provide educational support in this area. Without knowledge and expertise in clinical research, Australian biotech companies could well be throwing away more than one million dollars a day...

References:

• Maloff, B. (1999) Partnering for success -Performance measurements for sponsors, contract research organizations and the site management organizations. Drug Information Journal 33, 655-661.
• Mathieu, M.P. (2001) Statistics on Drug Development (Section 3) in: Pharmaceutical R&D Statistical Sourcebook. PAREXEL International Corporation.

* The First Australian Clinical Trial Survey (FACTS) is being sponsored by the Australian Pharmaceutical Manufacturers Association and the Association of Regulatory and Clinical Scientists. FACTS is being conducted for the Australian clinical research industry by ProScribe. For further information on FACTS, please contact Dr Karen Woolley (kwl41proscribe.com.au; 61 75455 6330; www.proscribe.com.au).

Copyright 2002 - AusBiotech

The following images related to this document are available:

Photo images