04/05/2019

"Analytical Testing Strategies For Clinical And Commercial Operations"

Bikash Chatterjee, President & Chief Science Officer

Central to every drug development program is the need to establish a capable analytical testing strategy.

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03/01/2019

"Understanding the FDA’s Priority Review Voucher System"

Bikash Chatterjee, President & Chief Science Officer

FDA’s priority review reduces the standard drug submission review time to an expedited six-month review cycle, to increase the number of rare disease therapies pursued.

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02/14/2019

"Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture"

Barrett Fallentine, Director, Product & Process Development

Barrett Fallentine outlines how 21st-century biopharma and biotech companies advance pipeline products to preclinical with best practices for technology transfer at each phase.

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11/16/2018

"Selecting and Qualifying a Regenerative Medicine CMO"

Matthew Finch, Project Manager

Selecting a CMO capable of adapting the novel processes that regenerative medicines require is a seminal decision that affects the success of a development program.

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11/16/2018

"Combination Products vs. Combination Therapies: What Is the Difference?"

Lynn Hansen, Director, Regulatory Affairs

Lynn Hansen’s article in Pharmaceutical Online lays out the challenge for regulatory professionals in aligning breakthrough therapies with application-filing strategies for investigational new drug applications, biologics, and medical devices.

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10/22/2018

"Drug Delivery Technologies – Autoinjectors"

Lynn Hansen, Director, Regulatory Affairs

The 21st Century Care Act (CCA) offers the promise of a quicker regulatory review and lower cost for medical devices, drugs, and combination products. Within the medical device and combination product sectors the autoinjector is positioned as a major contender with the potential to expand the target patient audience for many biotech therapies.

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06/01/2018

"FDA’s Draft Guidance of “Least Burdensome Provisions” for Medical Devices"

Bikash Chatterjee, President & Chief Science Officer

New draft guidance defines the seven guiding principles to be followed by both FDA and the medical device industry when taking a least burdensome approach to a regulatory issue, discussed in the latest Regulatory Forum column by Bikash Chatterjee, in Controlled Environments magazine.

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06/01/2018

"Technical Transfer to CDMO – Case Study Best Practices for Success"

Sandra Wassink, Principal Process Engineer

Sandra Wassink writes that success in manufacturing at the contract development and manufacturing organization (CDMO) is reliant on full disclosure of early development history, collaborative fine-tuning of critical attributes through Phase III and continued teamwork into commercial manufacturing. And in turn, the flexibility, experience, and professionalism of both companies is required to achieve safe, consistent, and quality product commercialization throughout the product lifecycle.

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05/29/2018

"Breaking Through FDA’s New “Accelerated” Pathway"

Kerri Anne Mallet, Vice President, Clinical & Regulatory Affairs

For years, FDA’s Center for Device and Radiological Health (CDRH) has been criticized for stalling innovation due to long review times. In 2011, CDRH proposed the Innovation Pathway, a priority review program to help breakthrough medical devices reach patients in a timely manner by improving collaboration between FDA and manufacturers and shorten the time and reduce the costs from concept to commercialization for innovative medical devices.

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04/16/2018

"Considerations for Biologic Drug Substance and Drug Product Training"

Bikash Chatterjee, President & Chief Science Officer

Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.

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