CBI Scene Blog

Monitoring and Auditing with Limited Resources – How Often Should Comprehensive Risk Assessments Be Done?

Posted by Evanna Payen on Jan 16, 2018 2:43:54 PM

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.

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Topics: Compliance & Regulatory, Compliance Monitoring

Q&A With Executive Director of the Center for Lawful Access and Abuse Deterrence (CLAAD) on the Challenges and Future of ADFs

Posted by Sabrina Delio on Mar 8, 2016 10:46:19 AM

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.

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Topics: Compliance & Regulatory, Clinical, abuse deterrent formulations

Q&A With Editor and Chief of CIO Magazine and Events on Pharma Enterprise Customer Data Integration

Posted by Curry Wilson on Oct 27, 2015 9:51:04 AM

We recently had an opportunity to speak with Maryfran Johnson, Editor in Chief of CIO Magazine about some of the challenges and trends that CIO's in Life Sciences are facing today around customer and commercial data. Read her answers and begin to prepare for discussions at CBI's Enterprise Customer Data Integration and Innovation Summit in November.

  1. What are some of the top priorities of CIOs today? Are the interests and focus of CIOs at pharmaceutical and biotech companies different than other industries?

    Currently, many of the top priorities for CIOs are centered on digital transformation and customer experience. For the first time, Pharma IT has really had to shift its attention to think about the far end-user/customer. 

    There is a growing need for collaboration between IT and marketing. While many industries are finding innovative ways to bridge this gap, Pharma still seems to be lagging or, at the very least, struggling to catch up. 

    At this point, it's up to the CIO's to market IT to rest of the organization and really show what a strategic asset it could be - not only for business innovation, but to better connect the brand to the end-user and prove the ROI of tech investments. To be successful, CIO's and their IT teams need to be both tactical and strategic. They especially need to start working more cohesively with all departments throughout the business: marketing, operations, finance, sales, etc. 

  2. Looking ahead at 2016 and beyond, are there any emerging trends or innovations that will impact the Life Sciences?

    One of the biggest trends is the use of predictive analytics to gather data that increases speed to market, or creates products generated out of data that better predicts consumer behaviors. I think pharma is starting to make strides in this already, and that executives are realizing the importance of finding creative ways to not only integrate predictive data, but deploy the best methods of analysis to drive brands forward. 

    Another trend is the intensifying focus around customer centricity. Right now, this seems to be happening around patient data and the evaluation and planning on how to use such data. 

  3. In the future, how do you see social media playing a prominent role in customer data capture? Are there companies that have started to explore this successfully?

    Most CIOs really care about leadership, business strategy and innovation. There is a lot of conversation around the use of cloud and SaaS (Software as a Service) providers, but when it comes to social media, Pharma still has a lot of "social anxiety." Historically, Pharma has considered social media to be something that marketing should deal with, but in reality it can be a profoundly useful data-collecting machine. What a lot of companies are struggling with, is how to leverage communication points through social media to better position their brands. There are amazing things starting to happen from companies like Merck and GSK, but all around this piece of the puzzle is still in flux. 

    As we move forward, I think Pharma will step up to the plate and really start doing things worth watching. For example, using social media to explore adverse drug effects, or gathering other insights from customers and using those touch points as data generators. In addition, we might see more pharma using social listening tools to penetrate into new product areas and new audiences.

Maryfran Johnson will be moderating one of our featured sessions "Reinventing the Digital Channel for MDM - A Meeting of the Minds." Take this opportunity to join your peers and this esteemed cast of industry experts for this one-of-a-kind Life Sciences Commercial Data event. 

Check out the conference agenda or register now!

An award-winning IT journalist and editorial executive, Maryfran Johnson has been Editor in Chief of CIO magazine & Events since January 2009. 

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Topics: Compliance & Regulatory

Best Practices for Cohesive Global Compliance Programs in Latin America

Posted by Lee J on Aug 10, 2015 1:33:00 PM

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.

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Topics: Compliance & Regulatory

EFPIA Transparency Directive and Data Privacy in EU: 3 Clear Patterns

Posted by Ned Mumtaz on Jun 15, 2015 3:26:17 PM

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.

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Topics: Compliance & Regulatory

Why Should ADFs (Abuse Deterrent Formulations) Be Mandatory?

Posted by Daniel L. Cohen on May 19, 2015 1:39:17 PM

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.

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Topics: Compliance & Regulatory, abuse deterrent formulations

Inside Secrets: The Future of Abuse Deterrent Formulations

Posted by Daria Binder on Apr 30, 2015 11:10:16 AM

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.

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Topics: Compliance & Regulatory, Clinical, abuse deterrent formulations

The Future of Global Transparency of HCP Data

Posted by Logan Fleck on Jan 12, 2015 9:23:00 AM

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.

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Topics: Compliance & Regulatory

Unique Challenges When Commercializing Specialty Drugs & How to Mitigate Risk

Posted by Sarah S on Nov 12, 2014 10:09:42 AM

It is understandable that drug companies wish to extend the use of a product they spent considerable time and money developing. Similarly, patients who have been unable to find answers to their medical issues can hardly be blamed for championing off-label use of a medication to help alleviate a problem.

Opening up a drug to uses other than the one explicitly stated on its label, however, brings significant challenges. Regulators must ensure that drug manufacturers aren’t pushing product or advertising it in misleading or untruthful ways. Medical affairs departments and physicians must remain compliant but still do their utmost to help patients.

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Topics: Compliance & Regulatory

5 Best Practices to Secure Enterprise-Wide Buy-In for Master Data Management

Posted by Stephanie V on Oct 9, 2014 9:43:05 AM


The benefits of master data management in the life sciences industry cannot be understated; the enterprise-wide MDM approach allows for better communication across departments, ultimately leading to a reduction in overhead cost and significant improvements in overall business functioning. Unfortunately, in spite of the ample evidence suggesting that MDM is the way of the future in the world of life sciences, stakeholders may not be in favor of this approach. Convincing reluctant stakeholders is possible, but it requires thorough research and a compelling presentation littered with case studies and industry-wide analytics. The securing of an enterprise-wide buy-in may be a guaranteed challenge, but the following five best practices should make reluctant stakeholders more amenable to the idea of MDM.

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Topics: Compliance & Regulatory, Commercial & Patient Programs