CBI Scene Blog

While it's an issue that's not limited to the pharmaceutical industry, miscommunication between the "doers" - those actually performing clinical trials - and the "planners," who set and monitor the budget, is particularly prominent. While research and development in a non-pharmaceutical business can often be put on indefinite hold while funding is secured, clinical trials don't share that luxury. Variables such as timing, resources, and the ability to make adjustments if obstacles arise are freedoms all crucial to a given trial's success. This means, in turn, that "holding" isn't really a viable option. So how can the behind-the-scenes program teams work in tandem with those on the front lines?

To say that global reporting requirements are constantly changing is something of an understatement, particularly as new markets around the world continue to emerge. As a result, many industry professionals are concerned about their own ability to keep up with and be aware of all new compliance requirements around the world - even if their businesses are based primarily within the United States.

Comprehensive risk assessments always seem to make it onto a to-do list, but end up being considerably more difficult to take off of that same list. They take time, effort, and resources - the trinity of what runs competitive businesses in the pharmaceutical industry. It can be tempting to keep pushing them off, involving yourself in another one of the endless checkboxes to take care of - but that's a very bad idea. The very nature of risk assessments is to prevent that looming, nasty, "what if" that could derail your projects or dismantle your clinical trials. It's finding the leak before the pipe bursts, or detecting the first wisp of proverbial smoke before a fire can start in earnest. In other words, neglecting to iron out a regular schedule of risk assessment reports could have disastrous consequences.

We recently had an opportunity to speak with Michael C. Barnes, Executive Director of CLAAD, about some of the obstacles and future trends that Life Sciences ADF drug manufacturers are facing today. Read his answers and begin to prepare for the FDA led discussions at CBI's Abuse-Deterrent Formulations Summit in March.

Medical device manufacturers and pharmaceutical providers, alike, have discovered a wealth of options in Latin America. Since the late 1990s, the rapidly growing market has facilitated new regulations. As industry standards evolve, countries have developed increasingly stringent standards. The trends continue, and the Latin American regulatory environment continues to enforce requirements on both a country and region-specific basis.

I recently had the pleasure of attending CBI’s Global Transparency Reporting Congress and wanted to share a few key takeaways from the event. This conference was attended by high-profile members of pharmaceutical industry national associations (ABPI, FarmaIndustria, others), EFPIA, clinical research organizations, compliance software suppliers, pharmaceutical consulting organizations and compliance law firms.

Prescription opioid abuse is at a crisis point that demands our immediate attention. An estimated 16,000 lives are lost each year due to prescription opioid abuse. That’s 46 people every single day of the year. In 2013, only 16% of Americans believed that the United States is making progress in its efforts to reduce prescription drug abuse. And 37% of Americans say the country was losing its grip on the problem of prescription drug abuse. Action is needed now before more lives are lost and more families are impacted.

With increased pressure on the pharmaceutical industry to come up with creative solutions for the growing drug abuse epidemic in America and a new FDA legislation in effect, the time is now for bio/pharma manufacturers to analyze their formulations and ensure that new and existing products are meeting regulatory standards, reducing misuse potential and minimizing abuse liability. It is critical that the industry adapts quickly in order to ensure their drugs adhere to pre-marketing and post-marketing study requirements, as well as labeling mandates for improving drug safety and achieving market access.

As global health care providers (HCPs) focus on transparency to deliver quality care, it has become more complex than simply targeting high-level care. A recent study by international consulting firm, Deloitte Consulting LLP, generated interesting results for global life sciences organizations. U.S. pharmaceutical companies have experience dealing with transparency regulations for some time.