CMK SELECT
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The Rising Value of Medical Affairs – Engagement with External Stakeholders (KOLs, TLs, EEs)

AUTHOR: N. Borinshteyn

The ever-evolving relationship between the pharmaceutical industry and its key opinion leaders (KOLs) has been a hot topic for a while, and there are several reasons for that: Recent innovative medicines are so complex that many consumers can’t understand them…
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Launch Excellence: Is It Achievable?

AUTHOR: CMK SELECT

The numbers are dramatic: 50% of pharma launches fail to meet forecasts, with 25% widely missing the mark. If you’re in a pre-launch phase, with the odds stacked against launch excellence, what can you do? To achieve excellence, or even…
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Do Brands Have Value After Exclusivity?

AUTHOR: I. Deza

When a successful product is about to lose its exclusivity, and is facing incursions by generics or biosimilars, a pharmaceutical manufacturer sometimes decides to walk away. Rather than stand and fight the intruders, resources are demobilized, sales forces are reassigned…
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Medical Events Compliance

AUTHOR: CMK SELECT

A major pharmaceutical company was in need of a review and approval process to help streamline the planning and execution of its external medical events. While the company had certain policies and procedures already in place – including a strict…
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Co-Promotion Optimization

AUTHOR: CMK SELECT

A notable pharmaceutical company had agreed to co-promote a drug and, in turn, was obligated to provide a list of contractual deliverables to the partner company. Because both teams were fairly new to co-promotion, there were many questions about how…
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The Continuously Increasing Value of Medical Affairs in Product Launches – Part II

AUTHOR: N. Borinshteyn

As we’ve already begun to look into in Part I of this two-part blog, Medical Affairs teams play a critical role in bringing new treatment options to market in the current pharma industry environment. In the first part, we focused…
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The Continuously Increasing Value of Medical Affairs in Product Launches – Part I

AUTHOR: N. Borinshteyn

Bringing each new pharmaceutical product to market is a complex and somewhat unique process led and executed by a cross-functional team who undertakes a number of activities to ensure the success of the product launch. In the current pharma industry…
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Case for an IT-enabling Business Strategy for companies in the Life Sciences Industry

AUTHOR: D. Douglas

The major trends in the life sciences industry are profoundly affecting the way we all work – from conducting research to distributing products, and everything in between. These major changes have made the need for an IT-enabling business strategy all…
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Expense Report Compliance Audit

AUTHOR: CMK SELECT

A major pharmaceutical company engaged CMK Select to create a streamlined process for submitting, processing and approving monthly expense reports generated from their sales team’s lunch-and-learn meetings with healthcare professionals. With a field sales force of more than 800 representatives,…
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Clinical Data Standards

AUTHOR: CMK SELECT

Following the December 17, 2014, FDA binding guidance that all pharma studies starting after December 17, 2016, must conform to a set of FDA-sponsored standards, formats and technologies, pharmaceutical companies found themselves in need of a tool or process for…
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Product Launch Optimization

AUTHOR: CMK SELECT

When the FDA announced its new Breakthrough Therapy Designation in 2012, it meant that the pharma industry would be able to move new life-saving drugs more efficiently through the approval process, allowing for the right drugs and therapies to reach…
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Project Transition

AUTHOR: CMK SELECT

A major pharmaceutical company hired CMK Select to manage all of its therapeutic compounds in early development – from proof of concept to regulatory submission. The CMK Select team soon identified a need for a new process for transitioning projects…
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