Industry Insights
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Building Quality Into Everything We Do – From A To Z
7/7/2022
By having better control over our manufacturing processes we are able to minimize the risk of out-of-specification intermediates all the way through to final products.
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Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs
8/29/2019
Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.
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How To Maximize Medical Device Patient Retention
5/10/2021
The accelerated shift to telehealth during the COVID-19 pandemic has given patients greater autonomy. However, this benefit is not without its challenges, particularly for patients who use medical devices at home to manage chronic health conditions. Fortunately, there are opportunities to remedy these issues.
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A Brief Overview Of Vaccine Purification Technologies And Analytical Tools
3/23/2023
Downstream processing remains a major bottleneck for vaccine production, and the industry is racing to develop new purification technologies. Here's a snapshot of where we stand and of what needs to happen next to increase quality and yields.
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The Formulation Development Journey
Successful formulation journeys start with a roadmap where scientific studies and decision points create a route for understanding a molecule’s personality and its viability to help it along the way to the patients.
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5 Qualifying Questions To Evaluate Solution Providers For Temperature-Controlled Shipping
1/3/2019
Life sciences companies with complex warehousing and shipping requirements have a lot of questions. Here are the questions to ask to identify a logistics vendor with the right competency.
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Referencing A Listed Drug For The 505(b)(2) Pathway
8/27/2021
Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
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What Is The Best Way To Keep Up With Changes In FDA Standards?
This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.” Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.
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FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products
1/19/2022
The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.
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Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance
11/29/2017
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.