11/16/2020

"System Impact Assessment: A Risk Managment Framework for a COVID World by Wai Wong"

Wai Wong, Vice President, Validation

The new normal created by the recent COVID-19 pandemic has created disruptions in many sectors of life sciences. In the case of vaccine development, pairing SIA with digital twin modeling can provide invaluable insight into whether your equipment has the necessary capabilities to accept the process.

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11/04/2020

"Interacting with FDA During Biosimilar Development: From Initial Advisory Meeting to BLA"

Mary Lou Zett, Principal Consultant

Pharmatech’s Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part series in BioProcess Online. In part one, she details the biosimilar development path. Part two discusses how to prepare for your meetings with the FDA.

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10/29/2020

"Mapping the Development of a Biosimilar Candidate: Analytical & Regulatory Decisions"

Mary Lou Zett, Principal Consultant

Pharmatech’s Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part article in BioProcess Online.

In part one, she details the biosimilar development path. In the second part of the article discusses what–and when–to present research findings and how to prepare for your meetings with the FDA.

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10/12/2020

"CPhl: Dramatic Changes Ahead for the Generics Market"

Bikash Chatterjee, Chief Executive Officer

In the CPhI Annual Report for 2020, Bikash Chatterjee, CEO of Pharmatech Associates, said the concept of patient centricity has gone beyond being a buzzword to being a core value and that telemedicine will have a long-lasting impact. Chatterjee also foresees the industry will see voice collection of data in the home begin to be incorporated into both home and health settings.

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08/17/2020

"In Memoriam: A tribute to Warren G. Baker"

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We are deeply saddened to announce the unexpected passing of Warren G. Baker, CEO of Pharmatech Associates. While we mourn the passing of an inspriational leader, a succession plan was in place and announce the appointment of Mr. Bikash Chatterjee as CEO.

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08/11/2020

"CBER Takes on More Oversight of Biologic and Biosimilar Master Files"

Michael Cooper, Clinical & Regulatory Affairs Program Manager

What The DMF?! Industry and FDA
Ultimately, the change of oversight from CDER to CBER will affect all past, present, and future biologic-related master files and marketing applications/approvals. It will be interesting to observe how much CBER will honor past CDER reviews and approvals, and how much sponsors will have to re-defend already approved submissions and regulatory strategies.

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07/07/2020

"Responding to COVID-19 in Pharma Facility Design and Operation"

Jennifer Markarian, PharmTech.com

Jennifer Markarian interviewed Bikash Chatterjee for Pharmaceutical Technology’s June 2020 Equipment and Processing Report:
Manufacturers are adapting with virtual work, remote monitoring, and re-evaluation of facility design to ensure worker safety.

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06/25/2020

"Controlled Release Roundtable in American Pharmaceutical Review"

Bikash Chatterjee, Chief Operating and Science Officer & Adam Lambert Ph.D., VP Product & Process Development,

Bikash Chatterjee and Adam Lambert of Pharmatech Associates weigh in with fellow industry experts on developing and manufacturing controlled release products, in the latest issue of American Pharmaceutical Review.

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06/12/2020

"A Continuous Education"

Gareth Carpenter,

“People tend to think of continuous manufacturing as something that you have to do only on a large-scale, with metric tons of material, but the reality is you can do it at small scale and have exquisite control” – Bikash Chatterjee, Pharmatech Associates

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05/19/2020

"Navigating The FDA’s Emergency Use Authorization Process"

Bikash Chatterjee, Chief Operating & Science Officer

In an article in Outsourced Pharma, Bikash Chatterjee writes that understanding the FDA’s expectations will allow drug sponsors to make the most of available data derived during the emergency use authorization (EUA) and position them for a smoother regulatory process.

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