05/31/2019

"Jump into cGMP: An FDA Roadmap to Manufacturing Tissue-based Products"

Lynn Hansen, Director, Regulatory Affairs

Lynn Hansen, RAC, explores a basic roadmap for the process of migration to the new regulatory environment, within the 36-month timetable mandated by the FDA and ending on November 16, 2020.

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05/21/2019

"What Pharma Needs to Understand About Combination Product Development"

Bikash Chatterjee, President & Chief Science Officer

Pharmaceutical Technology spoke with Kerri-Anne Mallet, Clinical and Regulatory Affairs at Pharmatech Associates and with Bikash Chatterjee, Chief Science Officer and president; Lynn Hansen, RAC, director, Regulatory Affairs; and Caitlin Bancroft, Regulatory Affairs; all at Pharmatech Associates, about some of the differences in drug and device development, best practices for combination product development, and issues specific to Internet-connected combination products.

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05/14/2019

"Techniques for Risk-based Validation Using ASTM E2500"

Michele Levenson, Senior Program Manager

Michele Levenson of Pharmatech Associates writes about risk-based validation in an expert column in Pharmaceutical Online. Depending on where your organization is on the pendulum of risk tolerance, there are many benefits to adopting risk-based validation (RBV) and ASTM E2500 within an overall validation strategy, as long as the organization is structured appropriately.

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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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