05.20.21 -- Regulatory Strategies For Start-Ups
Bench To Bedside And Cell and gene therapies have been in development for decades, but they’ve only recently been approved by regulatory authorities such as the FDA. That’s because the science has moved forward to a place where it’s safe and effective for patients.
To achieve rapid clinical and commercial success, a bench process must be scalable and suitable for a manufacturing environment — and that means chemistry, manufacturing and controls (CMC) must be lined up. Most innovators don’t have the regulatory experience to know what manufacturing changes are going to make a difference early on. Biotech founders share their experiences and advice here.  Bench To Bedside
 Clinical Strategy For Successful Cell And Gene Therapy
How Did I Get Here?
ACCESS STRATEGIES FOR YOUR Under the watchful eye of regulators, the CMC team must walk the tightrope between having an efficient process and maintaining product quality. Here is a collection of advice from experts. Manufacturing novel biotherapeutics poses complex challenges that can make it difficult to meet milestones without taking on unexpected risk. Early design choices can affect your overall speed to market. an online community for biotech startups JOIN BIOTECH MAKERS  Network, share expertise, and get perspectives on common challenges. Collaborate, and connect with your peers. Join Now.
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