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"FDA’s Draft Guidance of “Least Burdensome Provisions” for Medical Devices"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New draft guidance defines the seven guiding principles to be followed by both FDA and the medical device industry when taking a least burdensome approach to a regulatory issue,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

DOWNLOAD ARTICLE
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.

DOWNLOAD ARTICLE
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.

DOWNLOAD ARTICLE
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.

DOWNLOAD ARTICLE
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.

DOWNLOAD ARTICLE
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.

DOWNLOAD ARTICLE
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.

DOWNLOAD ARTICLE
11/06/2017

"Pharma 4.0: A New Framework & Process for Digital Quality Managment"

Bikash Chatterjee, President & Chief Science Officer

From a starting point of industry risk-aversion, the regulators have empowered manufacturers to keep evolving to combine industrial processes with new advanced analytics capability. The approach known as Pharma 4.0 represents a strategy for the future, derived from an intelligent and fully connected network across the entire value chain.

DOWNLOAD ARTICLE
10/02/2017

"Cover Story, A Breakthrough for Industry and Patients, a Change in Family Dynamics for Patients"

Scott Fotheringham, PhD,

Includes commentary and interview with Mihaela Simianu, PhD

DOWNLOAD ARTICLE
09/26/2017

"How Should I Respond To This FDA Warning Letter? (and Other Compliance Questions Answered)"

Richard Aleman, Vice President, Regulatory Compliance

Richard Aleman, VP of regulatory compliance at Pharmatech Associates, has an insider’s view on global regulatory issues having spent almost three decades at the FDA, specializing in biopharmaceuticals, drugs, and medical devices. In a guest column published in Pharmaceutical Online, talks about warning letter responses and remediation and other important regulatory issues. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.

DOWNLOAD ARTICLE