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Breaking through Barriers: Critical Success Factors for Launching Products with Breakthrough Therapy Designation
The FDA’s Breakthrough Therapy Designation (BTD) expedites patient access to innovative new treatments. While speeding up these processes can get new drugs to patients in need faster than they normally would through standard tracks, limited clinical…
BLOG: Pharmaceutical Value-based Contracts: Adherence and Supportive Contracts
While there is a great deal of talk regarding value-based contracts in the life sciences industry, there are few successful examples. The difficulties in structuring these contracts begin with identification of outcomes that are directly and…
Navigating the Transition to Post-Approval Pharmacovigilance With EVERSANA and ArisGlobal
Partnering with a contract research organization (CRO) provider during clinical development fills an important role in the product life cycle, providing pharmaceutical companies with pharmacovigilance expertise and support during clinical trials. After product approvals, it can…
Case Study: Launching a New Therapy for HER2-Positive Metastatic Breast Cancer
When MacroGenics partnered with EVERSANA, they had less than five months to launch their first product in the midst of the global pandemic. To meet their timeline and streamlined launch, MacroGenics needed a commercialization partner with…
The Patient Access Paradox: How the New CMS Rule Could Prioritize Drug Pricing Before Clinical Decision-Making
In January 2023, co-pay programs will be put to the test, consequently examining how well your brand can adapt to the Final Rule changes to meet patient and provider needs. Our recommendation: Don’t wait – start…
Global Regulations Push Accelerated Approvals, Access and Treatment Distribution: June 2021
Improving patient access and treatment affordability is quickly becoming a global priority reflected in current regulatory actions. This month, the U.S. FDA approved Aduhelm (aducanumab) for Alzheimer’s through an Accelerated Approval pathway, which will open treatment opportunities for patients. Meanwhile, the world continues to push on…
BLOG: Medical vs. Pharmacy Benefit: A Look at UM Differences
Medicare medical and pharmacy benefits are very different in their utilization management (UM). As such, it is valuable to know the distinctions between benefits, as strategies differ depending on which ones apply. The most significant differentiator…
Next Gen Commercialization: Accelerating Patient Access to Life-Changing Therapies
Fifty years ago, only half of the patients diagnosed with cancer in the United States would have been alive five years later. By 2009, patient survival climbed to 70%. The problem is, in all our years working…
Fearless in Pharma: Addressing Unmet Medical Needs Through Bold Innovation
5,789 new oncology products are currently in development, with 3,677 in phases I and II. Science continues to evolve and provide more patients life-changing therapies, but the commercialization model of these new therapies has not changed…
A SpaceX Philosophy to Launching in Pharma
In thinking about the economics around the launch of pharmaceutical products, it is useful to compare the situation to another area that has seen its economics evolve in recent years: space travel. For decades, the only…