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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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.

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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

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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.

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09/06/2017

"Preparing for the New European Medical Device Regulation"

Bikash Chatterjee, President & Chief Science Officer

The European parliament published new regulations for medical devices (MDR) and in-vitro diagnoistics (IVDR) on May 5, 2017, capping almost eight years of negotiations between the European Union Council, Parliament, and Commission. Each regulation was published in the European Official Journal on May 25, 2017.

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08/30/2017

"Process Design & Risk Management – A Proactive Approach"

Sandra Wassink, Principal Process Engineer

The latest article by Sandra Wassink of Pharmatech Associates in Pharmaceutical Online discusses a strategy to implement risk management during the process design stage of process validation for quality product, and to use as a proactive means of addressing quality controls during the subsequent stages of development. Managing risk from the outset helps prioritize what efforts need to be made during process design.

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05/02/2017

"Electronic Transer of Regulatory Information: Deadline Looms for eCTD Submission of DMFs"

Bikash Chatterjee, President & Chief Science Officer

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that is used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs typically contain critical details required in support of the Chemistry, Manufacturing, and Controls (CMC) elements within a regulatory filing. They can also be used to provide non-CMC details such as toxicology information in support of a third-party regulatory submission. There is no regulatory requirement to file a DMF. However, detailed information required to support a regulatory filing (IND, NDA, BLA, etc.) can be included directly into the regulatory document if acceptable to all parties involved in providing the information.

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