Meeting the global challenge of infectious diseases

The expanding use – and overuse – of antimicrobials in humans, animals, and agriculture in recent years has resulted in a rapidly growing number of bacteria and viruses that have developed resistance to even the most powerful anti-infectives.  Many infectious diseases are increasingly difficult to treat because of the prevalence of drug-resistant strains.  Although the need for new anti-infectives has never been greater, infectious disease (ID) therapies are increasingly difficult and expensive to develop.  To succeed, biopharmaceutical companies need an experienced ID development partner to help steer their products through a complex regulatory environment, challenges in patient and investigator recruiting, and a problematic public health climate – especially for potential new vaccines.

PAREXEL possesses a wealth of experience conducting ID trials, supported by an in-house staff of experts in this highly specialized development field.  Over the past five years, PAREXEL has actively participated in more than 280 ID studies involving nearly 91,000 patients, covering diseases such as HIV/AIDS, hepatitis B and C, pneumonia, skin infections, HPV, and septicemia.  We have particularly broad experience with community- and hospital-acquired pneumonia, HIV, and preventative vaccines.

PAREXEL’s global scope and long-standing ID experience allow us to more efficiently recruit treatment-naïve patients – an increasingly difficult challenge for ID trials.  These worldwide resources also help us accelerate the trial start-up process while maintaining consistent quality standards and best practices at every site.

With the high cost of developing new anti-infectives, no biopharmaceutical company can afford regulatory delays.  For anti-infective products, the regulatory environment is particularly challenging, with complex statistical, clinical, and safety requirements for superiority and non-inferiority trials.  PAREXEL’s long experience in ID product development, combined with our unmatched expertise in global regulatory affairs, gives our clients the ability to meet these challenges – ensuring that your trial designs, regulatory strategies, and submissions will support timely regulatory approvals and avoid unnecessary delays.