"Decentralized Clinical Trials: Does Your Strategy Include These Facets?"

Michael Cooper, Clinical and Regulatory Affairs Program Manager

The FDA has long championed initiatives to make clinical trials more diverse, patient-friendly, and representative of the general population, based on healthcare as delivered in the real world. Pharmatech’s Michael Cooper writes about the ways regulatory and industry are moving toward real-world clinical trials leveraging technology available today.


"An Analysis of ICH Draft Guidance Q13 Continuous Manufacturing of Drug Substance and Drug Products"

Mark Mitchell, Principal Process Engineer

Mark Mitchell of Pharmatech, in BioProcess Online: “The ICH Q13 guideline adequately outlines the challenges and expectations of continuous manufacturing of drug substances and drug products. Most hurdles for implementation are not regulatory, but technological and procedural. Overcoming these hurdles lies with pharmaceutical manufacturers in establishing standard approaches for equipment design, control strategies, PAT instrumentation and validation, material diversion procedures, and RTRT. Proficiencies in these areas are applicable to both continuous and batch processing.”


"American Pharmaceutical Review: Controlled Release Roundtable"

Contribution by Adam Lambert, Ph.D., Vice President, Product and Process Development

Adam Lambert of Pharmatech Associates weighs in with fellow industry experts on how the COVID-19 public health crisis has affected the development of controlled release products and other industry trends, in the latest issue of American Pharmaceutical Review.


"Qualification Considerations for a “Factory-in-a-box”"

Moria Feighery-Ross, Sr. Validation Engineer, Wai Wong, VP Validation

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the “factory-in-a-box,” which can be a game-changer for the industry. Where such modular factories are utilized, manufacturing capacity is limited only by the floor space to house them, which translates to reduced capital investment for scaling up and no lost time to construction.


"FDA Focus Areas of Regulatory Science (FARS): Five Trends to Watch"

Bikash Chatterjee, Chief Executive Officer

FDA’s 2021 Focus Areas of Regulatory Science capture an agency that is looking to provide meaningful regulatory insight on new and emerging approaches to drug development and governance.


"Essential Elements of a Data Management Plan for Outsourced Drug Development"

Bikash Chatterjee, Chief Executive Officer

The world’s need for COVID-19 vaccines has rewritten the rules of drug development. A data management plan is crucial to the ability to gather and use data from across the value chain. As drug sponsors extend the development and manufacturing enterprise to include CDMO partners, sharing access to relevant data affects time to market and simplifies program decision-making.


"FDA Steps Up Support for Advanced Manufacturing Technologies"

Bikash Chatterjee, Chief Executive Officer

Bikash Chatterjee points out that the FDA’s commitment to innovation goes beyond providing guidance alone. The agency supports the adoption of advanced manufacturing technologies (AMTs) that can improve drug quality, address medicine shortages, and speed time-to-market.


"ASQ Quality’s Impact On the Pandemics Global Response"

ASQ Technical Community, Stephanie Gaulding

ASQ Technical Community chairs including, Stephanie Gaulding, Director of Compliance at Pharmatech Associates contributed to this introduction on the role quality played in the COVID-19 vaccination process. This piece highlights how quality principles are foundational for industries integral to each stage of the COVID-19 response (vaccine development and approval, distribution, and administration).


"Certifying Pharmaceutical Exports: A Roadmap To EMA’s Certificate of Medicinal Product"

Michael Cooper, Clinical & Regulatory Affairs Program Manager

In Part 2 of a two-part series, Mike Cooper of Pharmatech Associates reviews how a product approval within the European Economic Area (EEA) can be leveraged to support registration in new markets through the Certificate of Medicinal Product (CMP).


"Best Practices for Designing and Building a Pharmaceutical Manufacturing Facility"

Allison A. Cacciatore, Executive Director Facilities Design and Engineering

For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.