CBI Scene Blog

Launching an Orphan Drug: A Case Study by AmerisourceBergen

Posted by Sabrina Delio on Dec 9, 2016 2:31:24 PM


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Topics: Patient Access, Rare Disease & Orphan Drugs, product launch

Acing CRA Interviews – The Ball is in Your Court

Posted by Harmony Chan on Jun 1, 2016 8:38:20 AM

The consistent demand for Clinical Research Associates in the health sciences market means that opportunities are abound for experienced candidates in the marketplace. However, newer candidates may find the interview process overwhelming, especially when you feel you are out of your comfort zone or haven’t had to “sell yourself” to a potential employer for some time. This is why preparation is key.

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The Changing Role of the CRA in an RBM World

Posted by Anushka Paul on Apr 5, 2016 4:05:50 PM

Approximately a third of clinical trials conducted utilize some elements of Risk Based Monitoring (RBM), with this figure expected to increase. Site monitoring has been identified as one of the largest components of clinical trial expenditure. With the change in the way that site monitoring is performed, the role of the Clinical Research Associate (CRA) is significantly changing.

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Topics: Clinical

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

Biosimilars: European Versus US Market

Posted by Joe G on Nov 30, 2015 10:46:00 AM

As the US prepares for the release of final guidelines in making biosimilars more available to the public, policy officials and decision-makers have the opportunity to learn from the European Union’s experience on the subject. Biosimilars have been around in the EU for nearly a decade, and many of the complications and discussions about biosimilars in the US can be improved and fast-tracked by following European models of testing, naming, guidelines, and interchangeability. To fully understand how the future of biosimilars in the US will benefit from the existing framework in Europe, consider how today’s biosimilar market in the US compares to the history and marketability of biosimilars in Europe.

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Topics: Biosimilars

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

Effective Global Access Programs within an International Regulatory Landscape

Posted by Lisa Tandy on Jun 23, 2015 3:19:30 PM

Like most ethical questions in the medical field, the use of Expanded Access Programs eludes simple answers. The decision to grant expanded access requests can be complicated even though the patients making these requests have exhausted many if not all of their other options for survival. Because these drugs are still in their clinical stages, companies might hesitate to grant access for a number of reasons. In clinical trials, for example, companies have complete control over the administration of drugs. The drugs are administered in a highly controlled and regulated manner in hopes of achieving the best results and retrieving the most accurate data.

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Topics: Patient Access

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

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