Drug Development to Marketing

Bringing a drug to market is no cheap task. The cost of discovering, developing, testing and launching a drug to be well over $1 billion. Drug companies can recoup that with a blockbuster drugs. Meantime, industry spending on research is leveling off. Venture capitalists who might have provided funding in the past for early-stage projects have also drawn back. There are far fewer firms that are investing in life sciences, and because of a lack of exits, they've been focusing more on late stage than on early stage investments.

Translating Research into Medical Treatments

The pharmaceutical industry is now looking to the early stages of research for innovation to fuel its denuded pipelines. Translational research needs to tap into this demand; universities present their capabilities and provide channels for pharma to access and work with academics.

Chasing "translational science", the kind of discoveries that will produce medical products, treatments and services for patients, is in fashion. Translational science is about being relevant and keeping the discoveries flowing to advance human health. Translational medicine can be defined in terms of promoting multidisciplinary interactions between science and medicine to enhance disease research and drug development.

Clearly there's been a shift from basic research to translational research. The basic science researchers probed the underlying mechanisms of disease, leaving the work of drug development to industry. Now, though, the federal government is shifting dollars to translational science, and it's a shift industry is happy to see. At a time when companies are feeling pressured to reduce their research budgets, they're doing it by relying on academic centers to get this work done.

We help to bridge the "translational gap" that still separates the world of scientific medical research from applications in the clinic. The aim is to ensure biomedical research is translated faster, and more efficiently, into products for clinical application, like novel drugs, vaccines and diagnostics. With this cooperation it is thus hoped to turn huge progress made in the field of biomedical research, now into medical innovations with substantial benefits for patients.

A Better Framework for Medicine

We are calling to create stronger mechanisms and structures for translational medicine. We need a better framework for translating biological research into new drugs and treatments. It’s essential to collaborate and share best practice.

There has never been a more pressing need to establish robust systems for translating rich seams of basic research into the clinic, providing improvements in patient care and generating innovative commercial products. This presents an opportunity, since it is possible to draw on the wealth of existing best practice and the evidence base of what works – and what does not. This can be a long, drawn-out and expensive process and technology transfer and commercialization systems need to provide support.

We encourage dialogue between academics and industry, discuss university research agendas with companies, and build a strong interface populated with technology transfer and commercialization professionals.

Providing an Essential Platform

We think of translational research and drug discovery as a one-way street. It all starts with the identification of a molecular mechanism and later on eventually leading to a drug that can specifically target a component. As the R&D process can be time and cost-intensive at the best of times, it is vital to look at the whole drug life cycle, from molecular discovery and target selection, to clinical development and approval. In short, the right development strategy could prove less than fruitful, if early discovery efforts are not strengthened.

We strategically aim to improve outcomes in translational medicine, by challenging current paradigms of therapeutic and diagnostic product development. We provide an essential platform for pharma professionals to learn, network and make crucial strategic decisions and connections. By facilitating vital affiliations and innovation, we offer the tools you need to make the future count. We focus on the multiple facets of drug discovery and development, partnerships and lessons learned, all at forefront of technology, research and strategy. We help in therapeutic drug discovery, development, formulation and commercialization.

We encompass current and emerging challenges in the biopharmaceutical industry and strategies for drug development. We review the requirements of various medical advances in terms of innovative strategic approaches to deliver advances to patients, and the contrasting requirements for effective translation in commercial companies and health services. We aim to integrate across scientific, medical and socio-economic disciplines. Additional information at Biomedical Research to Translational Medicine and Personalized Medicine: Clinical Translational from Bench-to-Bedside.

Invention to Healthcare
Drug development is an expensive, long and high-risk business taking 10-15 years and is associated with a high attrition rate. It is driven by medical need, disease prevalence and the likelihood of success.

Drug candidate selection is an iterative process between chemistry, biology and computational scientists, refining the molecular properties until a compound suitable for advancing to human is found. Typically, about one in thousands of synthesized compounds is ever selected for progression to the clinic. Approximately only 1 in 10 drugs that start the clinical phase will make it to the market.

The pharmacology and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures, followed by the drug testing in animals to assess its safety, carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Phase IV studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
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