Open Forum 4: Key Issues in Drug Development

16 Aug 2010
by Working Group

This article originally appeared on Citizen News Service. Click here to read the original post.

by Shobha Shukla

Open Forum 4
Open Forum 4

The Open Forum 4 on key issues in tuberculosis (TB) drug development is all set to begin in Addis Ababa, Ethiopia (18-19 August 2010). This Open Forum 4, will raise and address key issues in TB drug development, with a special focus on regulatory affairs. The Forum will include sessions on the current global TB drug development portfolio, key issues in the critical path to TB drug registration, designing pivotal trials, conducting registration trials in high TB burden countries, challenges in TB drug development for resistant disease and developing regimens containing multiple novel agents.

These meetings will bring together regulators, TB drug developers and other interested stakeholders, such as TB care providers, public health policy-makers, and community advocates from industrialized as well as from high burden countries. Open Forum 4 will have a special focus on Africa and the regulatory challenges it faces.

TB has remained a public health challenge from ancient times. Hippocrates, the famous Greek physician, identified TB as a widespread and highly fatal disease in 460 BC. At that time, no one knew how TB was caused and no one knew how to treat it. It spread uncontrollably, killing most of its victims, irrespective of their social class. Pharaoh Tutankhamen, poet Keats, author George Orwell, composer Chopin, Peshwa Madhavrao 1, Princess Amelia-daughter of King George III, Kamala Nehru—wife of India’s first Prime Minister are some of the upper class who succumbed to TB.

Twenty-five centuries later, TB is still spreading and still killing nearly 5,000 people every day, or 1.8 million in 2008 alone. The World Health Organization (WHO) estimates that two billion people are infected with the TB bacteria. While some people with this latent infection will never develop active TB, five to 10 percent of carriers will become sick in their lifetime. Once active, TB attacks the respiratory system and other organs, destroying body tissue. The disease is contagious, spreading through the air by coughing, sneezing, or spitting. An estimated nine million new active cases develop each year.

It is second only to HIV as the leading infectious killer of adults worldwide. Nearly 170,000 children die from TB each year. Most of the TB patients belong to Asian and African countries.

The social and economic costs of TB are enormous, particularly because the incidence of TB is concentrated in adults between the ages of 15 and 54, who are the primary wage earners. The combination of the enormous burden of TB as well as the inconsistent availability of cost-effective interventions, make TB one of the highest priorities for action in international health.

In view of the seriousness of the problem, WHO in 1993 declared TB as a global emergency.

The current 40 years old regimen of treatment, takes too long to administer (at least 6-9 months to treat simple/ drug susceptible TB), and requires too many pills – an average of 130 doses, each consisting of four medicines (known as first-line drugs): isoniazid, ethambutol, pyrazinamide and rifampin.. Those who do not complete their treatment may develop drug-resistant strains that may take up to two years to treat with second-line drugs, or become untreatable with any existing antibiotics.

So, the need of the hour is to fuel development of new treatment methods, to make the treatment of this dreaded disease simpler and more effective.

Since the 1950s, researchers have known that TB treatment must be delivered in multi drug regimens (combination therapy) to prevent it from becoming resistant.

But in TB drug development drugs are developed individually and independently. This conventional paradigm for TB drug development means that individual drug candidates are developed separately and substituted/ added, one at a time, into existing combination therapies.

Each substitution studied in clinical trials takes approximately 6 years to complete. So, a novel four-drug regimen would require a quarter century of development. With more than 9 million new cases of TB each year, this is too long a wait for those suffering from the disease.

The Critical Path to TB Regimens (CPTR) Initiative is a cross sector initiative, which purports to reduce the amount of time needed to register novel regimens for tuberculosis and drug-resistant tuberculosis from decades to years.

CPTR members include the world’s leading pharmaceutical developers, global regulatory agencies, and civil society organizations, which are working together to speed up new TB drug regimens to the patients need them urgently.

CPTR has the potential to shorten development time to 6 years. Under this initiative, a diverse group of drug developers will allow their compounds to be tested in combination to find the best regimen, regardless of sponsor. This collaboration is a testament to a “patient-first” commitment from all parties and the realization that it will take many organizations working in partnership to stop TB’s devastating global effect. This is not a path which one can tread alone.

The CPTR initiative also seeks to advance the regulatory science that will allow for the most efficient, accurate, and robust evaluation and application of these new testing models as well as address issues related to the lack of clinical trial capacity and funding.

It is hoped that the CPTR Initiative will help in achieving these Millennium Development Goals, by bringing relief to millions of TB/HIV sufferers worldwide.

Shobha Shukla
Citizen News Service (CNS)

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