Charles River

Matthew (Matt) Hewitt

A leader in the cell and gene therapy field, Matthew Hewitt joined Charles River Laboratories in 2021 as Scientific Director, Scientific Solutions in its C and GT space. He is currently the Executive Director, Scientific Solutions Cell & Gene Therapy. In his last position, Hewitt oversaw R&D and Clinical Development for Lonza's C and GT focused Personalized Medicine business unit.

Additionally, Hewitt worked at Bellicum Pharmaceuticals, where he oversaw the Tumor Immunology and Microenvironment program whose goal included boosting cell therapy efficiency in oncology applications, and the University of Pennsylvania within the Gene Therapy Program (GTP), where he served as Associate Director of the Immunology Group focused on AAV gene therapy.

He was a Senior Scientist at Pennsylvania start-up Galleon Pharmaceuticals as well. Hewitt completed his post-doctoral training at Johns Hopkins University, where his work focused on neurological regulation of airway illnesses, after receiving his PhD in physiology/immunology from the University of Alabama-Birmingham. He presently serves on the Coriell Institute for Medical Research's board of trustees.

How is the life sciences industry as a whole looking to become more digitized like other business sectors?

The COVID-19 pandemic was a major disrupter to the life sciences sector, causing organizations to take a closer look at their operations.

It is crucial to enable hybrid (both in-person and remote) collaboration and work among life sciences teams. In addition, it's crucial to manage production quality, safety issues and supply chain difficulties so patients and clinical studies can receive therapeutics without interruption.

Creating and implementing efficient and secure vaccines and anti-viral therapeutics as quickly as possible after the pandemic hit was a primary objective. Therapeutic developers, CRO/CDMOs, and government came together to develop, test, and distribute vaccines and anti-virals quickly and safely to millions of people.

The stakeholders quickly realized they must expand manufacturing and create new supply chain networks concurrently to realize their vision of delivering potentially lifesaving therapeutics to millions of people around the world. Enabling light speed delivery and safe handling of novel therapeutics, sometimes requiring ultra-low cold chain shipping solutions, it became evident as drug development progressed that a new supply chain networks were required.

Why is important to document communication with speakers and other medical professionals organization interacts with to document payments and expenses?

Not surprisingly, the pandemic led to regulators taking different approaches to oversight of life sciences operations. 

We should expect this to continue, interactions between organizations and health practitioners are always under scrutiny.

Life sciences companies should be implementing measures for continuous improvement of compliance systems to ensure they are ready for regulatory scrutiny and oversight, since inspections and enforcement actions can happen at any time. To become and stay compliant, degrees of readiness, supervision, and proactiveness must be increased.

“Life sciences companies should be implementing measures for continuous improvement of compliance systems to ensure they are ready for regulatory scrutiny and oversight, since inspections and enforcement actions can happen at any time”

There is no perfect time to evaluate risk management policies and practices effectiveness which is why it’s a continuous process. A vital first step in locating potential compliance program gaps is conducting and understand an organization’s risk assessment. If done correctly and regular frequency, these activities will provide  life sciences firms better visibility into possible as well as real risks and knowledge on how to resolve them.

The effectiveness of different compliance program components, including leadership, communication, rules and procedures, training, and monitoring, can then be focused on and implemented by life science organizations. In order to help businesses shift to today's renewed regulatory and enforcement climate with clarity, risk awareness, focus, and program robustness, it is crucial to maintain a commitment to program principles.

How does the future of Life Science space look like? What are some of the trends on the horizon that will have an impact in the coming years?

Life sciences companies need to be aware of potential barriers to industry growth and be ready to adapt. Delays in technology adoption and regulatory complexity are two of the most significant ones in the life sciences and health care (HC) industries.

Due to institution-specific characteristics or the type of technology being offered, disruptors have discovered that HC institutions are sometimes wary to be first adopters of new practices and technologies. Exogenous factors, such concerns about a technology’s regulatory acceptance, adoption rate, and robustness are frequently the driving forces controlling new technology uptake.

The commercialization of LS products has particular challenges due to the necessity to pass stringent efficacy and safety requirements throughout the regulatory approval process. Regulatory approval paths are often navigated in a systematic manner by professionals familiar with the processes and regulatory paths. Disruptive enterprises, on the other hand, may need third-party assistance or an incumbent alliance.