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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04/24/2020

"Ensuring Quality In Ventilator Production Scale-Up For COVID-19"

Bikash Chatterjee, Chief Operating & Science Officer

Manufacturers around the world are scrambling to scale up ventilator manufacturing to meet the worldwide needs of COVID-19, and we find ourselves in uncharted territory.

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04/21/2020

"Guest Editorial: Consulting Firms Can Fill In Missing Pieces"

Stephanie Gaulding, Director, Regulator Compliance

Consulting firms routinely find themselves in a highly valued position during a crisis. Their very business models demonstrate an ability to maintain strategic project performance with distributed teams. Their focus can quickly shift to best meet the evolving needs of a client as they recognize and face the challenges of new realities.

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04/03/2020

"Pharma 4.0 Supply Chain Security and Data Integrity for Advanced Therapies"

Bikash Chatterjee, Chief Operating & Science Officer

Key points to consider in a Pharma 4.0 supply chain, for organisations looking to bring advanced therapies to market.

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03/04/2020

"Business Continuity & the Coronavirus: Are Your Pharma Operations at Risk?”"

Bikash Chatterjee, Chief Science & Operations Officer

Bikash Chatterjee proffers a framework for pandemic preparedness to help organizations ensure business continuity, build high-level resilience in all departmental services and sites, and adapt to operational risks.

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