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"FDA’s Draft Guidance of “Least Burdensome Provisions” for Medical Devices"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New draft guidance defines the seven guiding principles to be followed by both FDA and the medical device industry when taking a least burdensome approach to a regulatory issue,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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04/02/2018

"The Right Stuff: Making the Transition from Development to Commercial Manufacturing with you CMO"

Bikash Chatterjee, President & Chief Science Officer

The emergence of virtual biotech, specialty drug delivery companies and the increase in the number of in-licensed and collaboration development programs has spawned a new generation of Contract Manufacturing Organizations (CMOs) offering services spanning almost every aspect of the drug development lifecycle. Evaluating and selecting a CMO is a seminal decision that affects the overall success of a development program. However, the factors that make a good development partner may not always translate to the ideal commercial partner. What is the best way to sift through to the essential elements that align the process and promote the partnership? This article uses a recent case study to illustrate some specific areas at risk that can impact a drug sponsor’s regulatory risk profile and on-going commercial operations as a drug sponsor’s development program transitions to commercial launch.

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03/19/2018

"FDA Updates Guidance on Electronic Records, Signatures"

Bikash Chatterjee, President & Chief Science Officer

After issuing its controversial Guidance for Industry — Part 11, Electronic Records; Electronic Signatures — Scope and Application1 20 years ago, the FDA struggled with consistent enforcement of the guidance. At the time, industry countered with feedback that the new guidance presented an overhead model that was untenable from a business perspective. We have gained little insight into the FDA’s thinking since their 2003 commitment to revisit the guidance.

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03/12/2018

"The Value Of Standardizing Risk Assessment Across Quality Systems"

Moria Feighery-Ross, Project Manager

In Pharmaceutical Online, Moria Feighery-Ross of Pharmatech Associates discusses risk and how to manage it. Development, validation, regulatory approval, compliance, and continuous improvement are all features of the overall process of manufacturing and releasing product that can be enhanced by proper use of risk assessment.

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