Medical and Regulatory Affairs

Consulting

A Security Plan for All Stakeholders Involved in Digital Medicine: What Device Manufacturers Need to Know

Connected medical devices, like all other computer systems, are vulnerable to threats that may lead to compromise of data confidentiality, integrity, and availability. To address these challenges, the Healthcare and Public Health Sector Coordinating Council (HSCC) Joint Cybersecurity Working Group recently issued the Medical Device and Health Information Technology (IT) Joint Security Plan (JSP). [1]...

Clinical Research: Phase 1 - Phase 4

Principles Of CAR T-Cell Therapy And The Pathway To Regulatory Approval

For many years, the primary forms of cancer treatment have been chemotherapy, radiation and surgery, but the toughest forms of cancer demand breakthrough therapies. Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as...

Global Compliance

Strategic Planning for Compliance With the EU Medical Device Regulation

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance. Establishing a leadership team Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanisms...

Consulting

Strengthening Neuroscience Clinical Research Through Innovation

There’s a lot of discussions these days about innovative ideas to make clinical research more patient-focused. The concept goes hand-in-hand with the development of technology that permits researchers to design and execute trials that can significantly reduce the burden of participation. Development of neuroscience drugs is benefiting from these advances in patient-focused research, as new...

Consulting

FAQ: How the EU Medical Devices Regulation Affects Existing Products

With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance. Is it possible to avoid compliance with the EU MDR? The short answer...

Medical and Regulatory Affairs

The FDA’s New Guidance on Natural History Studies in Rare Diseases: What You Need to Know

In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases. The document, Rare Diseases: Natural History Studies for Drug Development,[1] addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lack...

Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Managing Clinical Trial Complexity as Gene Therapy Progresses

The field of gene medicine has a history filled with hope and tragedy, successes and cautionary tales. The world’s first gene therapy was approved in Europe in 2012, only to be taken off the market five years later due to regulatory and commercial barriers. Now, more than six years after the first approval, gene therapy...

Consulting

Medical Design & Outsourcing – Medical device cybersecurity: It’s time to get real

Medical Design & Outsourcing – Medical device cybersecurity: It’s time to get realcontribution by John Pappan, Director of Regulatory Affairs, Medical Device & Business Strategy

Global Compliance

Data Protection Part 3: Key Considerations for Clinical Trial Recruitment

With the advent of the EU’s General Data Protection Regulation, individuals now have expanded rights to information regarding the use of their personal data. These changes impact several aspects of the clinical trial recruitment process and may require sponsors and CROs to update their data collection and protection protocols and processes for informed consent. Consent...

Consulting

Regulatory Oversight on Gene Therapy in the U.S. and EU

Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. The approvals of voretigene neparvovec-rzyl (Luxturna) for inherited vision loss, tisagenlecleucel (Kymriah) for lymphoblastic leukemia, and axicabtagene ciloleucel (Yescarta) for lymphoma have ushered in a new era of therapeutics. With the rapid evolution of the...