Regulatory
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Is The FDA About To Reclassify Your Drug Product As A Device?
9/27/2021
Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.
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Cell And Gene Therapies: Solving Six Challenges
9/20/2021
This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.
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CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward
9/17/2021
In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.
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6 Key Steps For Cell Therapy Clinical Development Success
9/14/2021
While the simplest option for a small or emerging biotech is to outsource protocol and clinical development to a consultant or CRO, a disengaged or absent sponsor is unlikely to have its objectives realized. Prior to engaging with a consultant or CRO, you can take these six steps that are likely to leave both parties engaged in the clinical development process.
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Biotech Patenting: 4 Tips & Personal Experiences
9/13/2021
When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.
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FDA's Final Rule On Intended Use For Drugs & Devices
9/10/2021
On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. It provides clarity to manufacturers, but many remain dissatisfied with the evidentiary standard for determining intended use. Might legal challenges follow?
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FDA’s Evolving Regulatory Stance For SaMDs, Wearables, Digital Health & DTx
9/8/2021
In addition to discussing how the FDA has evolved its approach to SaMDs, wearables, digital health, and digital therapeutics over the last couple of years, this article also specifies what can you do to influence future regulations on such devices.
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How To Find & Manage Biotech Consultants Effectively
9/6/2021
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.
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What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
9/3/2021
When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?
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What Biopharmas Need To Know About Genetic Data Privacy
9/1/2021
Although accessing genomic data provides biopharmas valuable insight to develop therapeutically effective drugs, the access to such data also escalates the possibility of exposing consumers’ personal and private information.