Implementing Thought Leader Compensation Caps to Remain Compliant with New Legislation

More and more countries are implementing open payment legislation, similar to the US Physician Payment Sunshine Act.  With these laws in place, pharmaceutical, biotechnology and medical device firms must be careful of how they are working with and compensating their key opinion leaders.  These firms must standardize their key opinion leader compensation practices to avoid regulatory scrutiny and hefty fines.

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Benefit-Risk Profiles: Pharmaceutical and Device Products’ Electronic Medical Records

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Benefit-risk analyses help life science teams compare identified safety concerns with product efficacy outcomes.  Often, life science teams begin constructing risk-benefit profiles while products are in the preclinical or early clinical development stages.  After establishing their initial profiles, teams will update risk-benefit information as new data becomes available.  Much like patients’ medical records, products’ benefit-risk profiles remain associated with them for life. Continue reading



Leverage Standalone Groups to Coordinate Drug Safety Activities

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

As part of its 2013 pharmacovigilance research, Cutting Edge Information determined that just under half of surveyed life science teams had standalone groups dedicated to drug safety. More specifically, the survey found that 28 of 57 surveyed pharmaceutical, biotech and device teams (49%) had a standalone drug safety group in place.   Remaining teams relied on other groups, like regulatory and medical affairs, to coordinate both pre- and post-launch drug safety activities. Continue reading


Increasing REMS Program Awareness, One Alliance at a Time

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

In an effort to mitigate associated product risks and reduce patient safety concerns, the US created new legislation in 2007.  Under the Food and Drug Administration Amendments Act (FDAAA) the FDA can require life science teams operating in the US to develop Risk Evaluation and Mitigation Strategy (REMS) programs in situations where products have serious potential or known safety risks.  All REMS require a timetable for submission of assessments—typically around 1.5 years, 3 years and 7 years after a product launches.   REMS may also include medication guides, communication guides, elements to assure safe use (ETASUs) and implementation systems.  Continue reading


The Building Blocks of a Successful Launch Sequence: A Strategic Regulatory Affairs Perspective

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

Developing, refining and coordinating a complex pharmaceutical launch sequence can be a significant challenge for even large global groups.  There are a myriad of market considerations on top of commercial priorities that come into play when setting the launch sequence. Bringing a strategic regulatory affairs function into these discussions is also key in order to keep the license cascade in line with the proposed launch sequence. Continue reading


Proactive Communication Key to Managing Challenging Regulatory Agencies

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies.  Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance.  In other instances, one investigator can simply prove more difficult than others.

To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives.  Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. Continue reading


Signal Detection: The Key to a Sound Pharmacovigilance Strategy

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Thanks to a mixture of recent regulations and negative media coverage, pharmacovigilance remains a hot topic across the life sciences industry. Pharmas, biotechs and device companies alike continue to take an active interest in leveraging new technologies to uncover, assess and mitigate safety concerns associated with the products they develop.  For example, in an effort to streamline the adverse event reporting process, several teams — surveyed for a recent Cutting Edge Information study — have established strong, external-facing social media platforms. Still other organizations have instituted customized adverse event databases to help them track and analyze the adverse event reports that their dedicated teams receive. Continue reading


Document Like the Romans: Maintaining Regulatory Knowledge

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

If anything could be said about the ancient Romans, aside from their insatiable drive for conquest and glory, it was their proclivity for documenting everything that happened around them.  The fact that we know so much about the Romans comes down to the sheer level of documentation that survives from their time.  When pharmaceutical companies are looking at their own documentation priorities, preserving regulatory knowledge and the associated protocols should be close to the top of the list. Continue reading


Manage Regulatory Intelligence Groups to Stay Ahead of New Regulatory Guidelines

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

The rapid pace that regulatory guidelines are updated around the world can be dizzying for even some large and established regulatory affairs groups to keep up with.  Well-managed regulatory intelligence groups brings many advantages to companies, whether operating on a small scale domestically or on a large scale internationally.  Regulatory intelligence can provide vital support to companies both pre- and post-launch. Continue reading