Source : 'The Pink Sheet'
Pandemic travel restrictions accelerated Genentech, Inc. deployment of digital technologies like head-mounted tablets, Benedicte Lebreton, Genentech’s head of CMC regulatory for biologics development, told a recent CASSS WCBP workshop on the impact of the COVID-19 pandemic on manufacturing operations.
Lebreton said that because of new safety protocols and distancing measures, the company is operating at 50% capacity in its manufacturing facilities compared to a year ago. “The safety protocols and the social distancing and the way people interact are very different than a year ago.”
The pandemic posed a major problem at Genentech when travel restrictions meant no more on-site help for method transfers. Lebreton explained that the exploratory work with RealWear head-mounted tablets was completed in 2019 and “looked like a promising tool for us to leverage. From promising it then it became an essential tool when you have one activity taking place at a site in Hillsboro, Oregon, and we have experts in Europe. People cannot travel so it suddenly becomes essential to have remote work and to have a very clear view of what is happening.”
The tablet is a hands-free wearable computer connected to a Zoom interface that has helped with training, technology and method transfers and troubleshooting, she said.
How it works is that “one person with a headset can hear and is connected to a Zoom conference so that you can have many people spread out listening and helping with troubleshooting.”
The technology, she explained is “helping us with business continuity and making sure that we have access to experts. It is not now a question of when can you get there, it is more a question of when are you available?”
Another advantage is that the tablet can be easily deployed.
She said that “we are really leveraging this across our network.”
Genentech’s adoption of these head-mounted tablets is part of a larger movement of accelerated deployment of digital technologies, including augmented reality headsets for shop floor operators amid the pandemic, McKinsey India’s head of pharmaceuticals and healthcare practices told the Pink Sheet in a recent interview. ()
The pandemic also meant the company hosted a growing number of virtual inspections from regulators last year, as travel restrictions imposed on industry were also imposed on health authorities. Genentech hosted 61 inspections from 15 agencies last year, which were a mix of onsite, virtual, and hybrid inspections where one inspector is on site and the rest are remote.
Hosting these inspections meant that “we’ve all had to be more flexible and adaptable.”
Lebreton said that, if conducted onsite, the company needs to handle each inspection differently to accommodate different local safety directives.
When asked to address some of the technology limitations of remote inspections, Lebreton said that it is important to be prepared for the data expectations and to be flexible.
We have to be very adaptable. We don’t look at it as a bucket of constraints but more as topics to share openly and transparently with the agencies.”
Genentech is also starting to deploy paperless product information (ePI) to ensure that patients and providers get information on drugs in an accelerated manner. This initiative is designed to ensure faster delivery of medicines in a quickly changing environment. The ePI describes a medicine’s safety and conditions of use.
“We see this as an opportunity to ensure that whoever is at the point of care, the patient, or the heath care provider has the access to the latest information on that product.”
Using ePI would also ensure that health care providers have access to new medicines where stability data is still being generated. She said that “having access to the latest expiration date makes sure that we don’t have lots being unused somewhere because they do not have the latest expiration date.”
“We have feedback from pilots and healthcare agencies said it was easier to read and easier to access,” said Lebreton.
Such ePIs are already being used in Singapore.
Lebreton said that as a long-term goal, the industry and regulators should move toward cloud-based regulatory submissions. This would allow for speedier reviews of product applications for new life-saving medications.
“We really believe in data-based submissions would ease the regulatory burdens with a big B, the time it takes for regulators to go through all the information, there are certainly ways to make things easier and to make our interactions more efficient. We believe in harmonized structured data standards with global accessibilities. We think that rolling cloud-based submissions would help with regulatory assessments.”
Currently, submissions are generated from static data that is shared at pre-defined stages, and use a range of data repositories, whereas data-based submissions would involve harmonized structured data standards with global access and rolling cloud-based data submissions.
The US Food and Drug Administration and the industry are looking into developing shared systems for eliminating the static paper-based regulatory submissions and moving to cloud-based submissions. The FDA and many other regulators receive thousands of pages through an electronic gateway that must be processed before they can be assessed. ()
During a question-and-answer discussion, Lebreton was also asked to address some of the obstacles to overcome before cloud-based submissions become a reality.
She said that “number one is data standards. The standards and the nomenclature conventions, because in using the cloud it is about putting data out there and finding it easily and making sure that when we do analytics that we are actually extracting the right data. This is a collective effort, and we have to make sure that we go at it together.”
“Number two is the security of the environment where the data is being shared and the accessibility and managing the security level of the data in that cloud. …. Number three is going at it and trying it by trial and error in using the cloud-based environment.”
By Joanne S. Eglovitch