A Streamlined Pathway to Drug Approval

LARA C. PULLEN | June 26, 2019

article image
Randomized, placebo-controlled clinical trials have long been the gold standard for drug approval. Patients are assigned to either drug or placebo and the comparison between the two groups can provide meaningful data to allow the Food and Drug Association (FDA), pharmaceutical companies, physicians, and patients to understand whether the perceived drug effect (or safety signal) results from the drug or is the result of the placebo effect. While this approach to drug approval is undoubtedly good and often best, is it optimal for all patients? Specifically, is it optimal for children (and families) who have a rare debilitating disease that lacks reasonable treatment options?

Spotlight

TCP Group

TCP Homecare is one of the largest providers of 'direct to patient' services in the healthcare sector in Ireland. The company provides 'nurse-led' solutions to a range of services all delivered at the patient's home. TCP Logistics offers a unique supply chain solution in Irish healthcare. The company provides a quality driven, cold chain and ambient logistic service for pharmaceutical products requiring distribution direct to patient or pharmachy

OTHER ARTICLES

The Future of Pharma Beyond Blockbusters

Article | March 17, 2020

We’ve all heard the saying “treat the patient, not the disease”, and this couldn’t be truer in today’s ever-changing pharmaceutical landscape. We are living in a time of revolution – advancements in genomics and technology are improving our ability to develop precise drugs and targeted therapies, rather than focusing on a one size fits all approach. Each individual’s genetic makeup is slightly different from everyone else’s,

Read More

Merck’s Patient-Centric Clinical Trial Recruiting

Article | March 4, 2020

Everyone in pharma knows that product success depends on the results of clinical trials — but we don’t usually hear from the people who are involved in running them. Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed how Merck is overcoming the barriers to clinical trial recruitment by adopting a patient-centric process — a model that affects their trials top to bottom, from design through implementation. Each of the panel members manages clinical trials, serving as the main point of interaction with the Clinical Research Associates (CRAs) on research requirements, goals, and resources, including recruiting and retention.

Read More

As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | April 17, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

Read More

Artificial intelligence in pharma: utilising a valuable resource

Article | March 11, 2020

The pharmaceutical industry is set to greatly benefit from the use of artificial intelligence (AI), due to its wide range of applications. Sydney Tierney discusses how machine learning can enhance marketing, manufacturing and drug trials. Artificial intelligence (AI) can be applied to nearly every aspect of the pharmaceutical and healthcare industry, to enhance data processing. Adopting the technology will reveal the astonishing potential of the healthcare sector, with success rates flying higher than ever before – especially in the research and development of crucial, life-changing drugs.

Read More

Spotlight

TCP Group

TCP Homecare is one of the largest providers of 'direct to patient' services in the healthcare sector in Ireland. The company provides 'nurse-led' solutions to a range of services all delivered at the patient's home. TCP Logistics offers a unique supply chain solution in Irish healthcare. The company provides a quality driven, cold chain and ambient logistic service for pharmaceutical products requiring distribution direct to patient or pharmachy

Events