By Dan Schell
Nigel Darby, general manager for biotechnologies and chief technical officer at GE Healthcare Life Sciences, comments in this exclusive interview with Life Science Leader on some of the key issues affecting life science executives.
The push for reduced cost, improved quality, and increased access to healthcare. How can healthcare providers, governments, and institutions work to reduce cost and improve efficiencies in healthcare as the burden of chronic disease in the developed world grows and the challenges of infectious diseases and poverty in the developing world continue their devastating impact on people’s lives? How can technology and innovation be harnessed to improve quality in healthcare outcomes, for example, by reducing medical errors?
At a time when the pace of medical advances is rapid, how do we afford to implement the many treatment innovations becoming available, and at the same time manage consumers’ expectations of entitlement to them? How can basic healthcare be made available to the millions that today live without it?
The current financial crisis will have an unbalanced effect on global health, with differing impacts in developed and developing economies. In developed economies, the global recession threatens declines in overall health due to increases in unemployment, the numbers of under- or noninsured, and the potential increase in the long-term effects of poor diets as consumers opt for cheaper and higher-fat, less nutritious foods. For the developing world’s poor, the effect of the global recession will be more immediate. Some estimate that the number of extreme poor, those living on less that $1.25 per day, could rise by as many as 200 million people, with a magnification of the attendant health consequences.
Globally, governments and healthcare providers should be looking at more efficient spending of healthcare investments, with increased focus on prevention, disease-focused programs, early diagnosis and treatment, and innovative financing. President Obama’s pledge to work collaboratively to reduce healthcare costs and extend coverage in the United States is perhaps the highest-profile recognition that the current situation in many countries is not sustainable.
How Life Sciences Companies Can Overcome These Issues
For the life sciences industry and for biopharma in particular, the cost, quality, and access equation is equally relevant. With traditional big pharma consolidating somewhat, as we have seen in the past year, as well as cutting costs as core blockbuster drugs near the end of their patents, the pressure on R&D departments to deliver more with less has likely never been higher. Outsourcing of many of the routine procedures and services will be a growing and necessary trend that should be aimed at enabling research scientists to focus on improving productivity in their core areas of expertise. Many questions are being posed about the ability of big pharma to innovate, and beyond the outsourcing of the routine, there is a growing tendency to drive innovation by in-licensing or alliances with smaller biotech and life sciences businesses.
Regulatory scrutiny of the biopharm industry is increasing the focus on quality around the world. Productivity demands for operational excellence and growth in outsourcing of production and research to contract manufacturing and research organizations places increased demands on GMP and facility validation. With the growing interest globally in generics and biosimilars, this will be a continuing trend. Getting validation wrong, for example, can cost millions in lost time and even adverse publicity. Manufacturers need an efficient and effective approach to ensuring compliance of facilities, processes, and equipment.
Access to drugs and biopharmaceuticals and their means of production have truly globalized in the last decade. Recent events have served as a stark and real warning; governments around the world will be looking for solutions to the threat of pandemic disease and bioterrorism, as well as addressing the less dramatic, but equally important gap between capacity and demand for vaccines against some of the world’s biggest killer diseases. In rapidly developing economies, such as Brazil, China, India, and Russia there is an enormous drive to develop domestic pharmaceutical manufacturing capacity as these nations seek to become more self-sufficient.
We have seen the advent of disposable and single-use manufacturing technologies, driving flexibility, efficiencies, and reduced lead times in vaccines and biopharmaceutical production. Smaller production runs of niche biopharmaceuticals are thus becoming more economically viable, as are the prospects for CMOs to address multiple products in a single facility. Even personalized medicines, such as cancer vaccines or cell therapies, are now becoming a reality.
With more than 190 monoclonal antibody (mAb) projects in the clinical pipeline, according to a recent PhRMA report, manufacturers must decide on the scale of future mAb production and what technologies will be required. Efficient lower-scale production approaches with increased flexibility and multiproduct manufacturing capability are required, and single-use, ready-to-use solutions can already provide this flexibility.
The challenge for vaccine manufacturers is how to address safety, scale-up, and regulatory issues within tightening budgets. As developing world populations continue to grow, so will demand for access to vaccines. Advancements such as micro carriers, single-use components, and improved analytical technologies will support manufacturers in overcoming these challenges. However, an industry worth (U.S.) $10 billion will need integrated solutions, from research to manufacturing, to improve the total economics of production and ensure preparedness for rapid scale-up, reliability, and security of supply.
In drug discovery, high-throughput technologies and a plethora of biological information are opening the doors to more rapid development of innovative drugs, yet attrition in the later phases is still high and results in costly failures. Rational design methods, often relying on biophysical assays and computational chemistry, are increasingly being used alongside or instead of traditional high-throughput screening (HTS). Approaches based on fragment screening with NMR (nuclear magnetic resonance) or biosensors combined with structure-based design, show increasing success and are moving the industry away from mass screening of diverse chemical libraries to information-rich design approaches based on smaller targeted chemical libraries. These approaches are being complemented by advances in cellular imaging technology and systems biology allowing rapid analysis of how drugs work and potential ‘off target’ and toxic effects to be uncovered at an early stage. Combined with the promise of stem cell biology delivering better models for studying toxicity and mechanism of action, these technologies should help reduce clinical trial attrition by identifying at an early stage the safety and efficacy issues that result in so many clinical trial failures.
Finally, we are seeing credible signs of the emergence of true personalized medicine. There are now numerous instances where treatment options are selected on the basis of genetic or other biomarkers, for example susceptibility to particular cancers or which patients will benefit from a particular medicine. These are important tools to cost-effective management of healthcare resources and are increasingly being used to segment clinical trial populations to improve outcomes.
Trends Affecting Life Sciences
The pressures of the current economic climate and the shortage of credit are causing difficulties for many small biotech companies. In particular, this funding crisis poses a serious threat to the pipeline of innovation in life sciences. Fortunately, we have seen moves to increase funding for government and academic research through fiscal stimulus packages, and economies such as China and India continue to slowly grow. Major pharma companies are also making large investments in biotechnology. Even potentially longer-term opportunities such as cell therapy and siRNA (small interfering ribonucleic acid) are receiving attention from major pharma companies, indicating that despite difficult economic times, the appetite for therapeutic innovation remains.
Healthcare providers around the world are exerting price pressure on pharma companies. The increasing trend towards health technology assessments is forcing the development of innovative approaches to pricing and the demonstration of therapeutic value. Better collaboration between diagnostics companies (identifying and validating biomarkers) and pharma companies is helping to better prove the efficacy of drug candidates early in the drug development process, improve selection of appropriate populations for clinical trials, and proving efficacy on a per-patient basis to assure payors of cost benefits.
The life sciences industry has become global with a focus on diseases afflicting masses in developing countries as well as the healthcare issues of developed countries. If scientific and industrial progress can be smart, following best practice and maximizing return on investment, the future, despite the temporary gray clouds, is bright.