Today’s world, whether you associate it with “4.0” or “digital transformation” is changing fast, however the modernization of regulatory and quality approaches at the operational level have generally been lagging as compared to the technological changes that are happening all around us. We need to speed up and get out of old mindsets, by focusing on what is important. In the validation world, that is demonstrating control over all aspects that impact patient safety and product quality, and Validation 4.0 means to move to a state of continuous control and validation through digital data.

Aside from the technology focus, there are much deeper changes that must be made both, from documentation centric processes in validation to deeply rooted cultural ‘quality comforts’ that are ultimately non-value added. We will dive into how we need to shift our thinking when it comes to the approaches taken with validation, and discuss that these changes are not just to support an initiative with a finite beginning and end, but rather they should be part of a continuous modernization that supports getting regulated industries closer to the digital capabilities that we already rely on, and benefit from, in our personal and consumer lives.

The importance of the Product Lifecycle is increasing important in an industry that requires faster time to market, reduced costs and improved scalability. This session will provide an overview from Line Lundsberg-Nielsen on the Product Lifecycle Strategy Maturity Model as developed by the PAT-LCS Community of Practice, and its status in defining and harmonizing key capabilities in order to achieve advanced manufacturing control strategies. Christoph Herwig will also explore the role of the Digital Twin in the product lifecycle, increasing process robustness and productivity and how it will be an essential component in the digital transformation of the biopharmaceutical industry. 

One of the major outcomes for the introduction of new techniques and technologies is the opportunity to develop Real Time Release Testing for biotech products. The presentation by Lorenz Liesum will include discussion of new analytical technologies, multivariate analysis with the goal of simplifying and reducing the overall release lead time.

The pace of innovation in the pharmaceutical field is accelerating and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faster. Since its inception, ICH has been concerned with establishing global convergence and alignment on technical criteria with the intent to harmonize regulatory expectations. 

This session is intended to provide a status update of regulatory changes that will boost innovation. The presentations will set the stage of the current barriers to harmonization and to implementation of innovative technologies such as API continuous manufacturing and will offer a proposal for a more comprehensive QOS document that provides a mechanism for industry to convey a holistic view of their control strategy. 

The session will highlight examples of how to overcome technical and regulatory challenges and enable supply chain resilience.

This panel discussion session will guide the audience through an exploration of distributed ledger (blockchain) technology and data interactions that are needed in the ATMP supply chain. Real life experiences related to ATMP data management with be discussed to support the topic. The panel will convey perspectives on the limits of applications of this technology and debate the use cases to provide a balanced view to attendees. 

This will inform attendees of possible considerations for implementation of distributed ledger technology. Following a brief introduction of distributed ledger technology, participants will hear from industry leaders about current use cases, the challenges, limits, and solutions to utilizing this technology for ATMPs.

With the increasing demand of personalized medicine, new technology is emerging that is at the forefront of front-end facility design that eliminates errors, cross-contamination, failure, and shutdowns; minimizes the timeline to market; and maximizes the output of any facility. The use of digital twins during design and the implementation of a robust operational advocacy campaign that combines the learnings from previous start-ups and operations with augmented reality (AR) design walk-throughs can lead to more effective first-time facility start-up’s and minimize the operational changes needed to bring facilities online faster. 

The use of this technology becomes imperative when the output of the facility is personalized medicine and there is only one chance of success within a confined timeline so there can be no errors or shutdowns with the facility design and its operation. Additional technologies used by such facilities identify those legacy technologies could lead to downtime so companies in the pharmaceutical industry are using collaboration to introduce new technologies that are more responsive, modular, and cost-effective than their legacy counterparts.

Topics of Discussion:
Pain Points for Paper-based Cleaning Validation
Cleaning Validation Life Cycle Model
Automated Product and Equipment Assessments
Automated Worst Case Product and Equipment Identification
Critical Cleaning Matrices Development
Manage Cleaning Validation Program Cleaning Validation Documentation

The pandemic has brought about an expectation of increased speed to deliver new medicines to patients, while the boundaries of science are being extended to deliver life-changing drugs to treat, prevent, modify, and even cure diseases. For example, ATMPS (Advanced Therapy Medicinal Products), MIDD (Model-Informed Drug Development) and advanced manufacturing technologies are being utilized for the next generation of medicines. However, more can be achieved through continual improvement. 

Variations on regulatory assessments for the same drug create challenges to maintain the dossier throughout the lifecycle of the product and to implement post-approval changes that help prevent potential drug shortages. A collaborative effort to understand the degree of divergence and impact is an important step toward improved global harmonization of control strategies. 

The ISPE Global Regulatory Town Hall will provide a forum to initiate a dialog between industry and regulators with the goal to formulate sustainable solutions.