clinical development strategy

The American Society of Clinical Oncology’s (ASCO) annual meeting is fast approaching, scheduled for May 31st to June 4th in breezy Chicago.  One of the many to present data this year is Advaxis, a biotechnology company that develops cancer and infectious disease...

Melanoma is the deadliest form of skin cancer.  Although the World Health Organization estimates that melanoma accounts for only 5% of skin cancer cases — or 132,000 annual cases globally — it accounts for 75% of skin cancer deaths.  However, compared with...

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion...

Although marketing and market access functions may not support a developing drug until Phase 2 or even later, companies need to coordinate between several different teams as products move through different development stages beginning in the pre-clinical stage....

Pharmaceutical companies may not take the Hippocratic Oath, but, through dedicated pharmacovigilance programs, companies ensure that drug safety remains a top priority among their medical affairs responsibilities.  Within companies’ medical affairs teams, evaluating...

Many companies have launched successful exploratory and investigative clinical trials targeting oncology.  Clinicaltrials.gov lists 24,710 active cancer trials during the past 10 years.  Specifically, 1,763 non-small cell lung cancer trials were conducted over...

If you’re looking for reasons to expedite drug research and approval processes, you need look no further than oncology departments in hospitals around the country.  The need in these facilities for cutting-edge therapies is critical, and doctors are performing...

When planning Phase 1 trials, there are many high profile cost-drivers — from patient recruitment to CRO contracting.  For many therapeutic areas, these functions will require the most money and time on the part of the clinical trial team.  However, for the...

The pharmaceutical industry is feverishly searching for the next big drug to replace lost revenue from patent expirations on major blockbuster medicines.  Drugs with more than $30 billion in annual revenue lost patent protection in the last two years.  Patent...

As exciting a field as companion diagnostics (CDx) is, few, if any, people would argue that such tests are necessary for every compound.  Most companies recognize the time and resource sacrifices that CDx requires, and only focus such tasks on certain therapeutic...