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