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…
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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…
In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases.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…
They say that great leaders aren’t born, but grow into their positions through sweat and tears. No matter what stage in life, industry, or phase of your career you’re at, it is important to continuously strengthen your skills, and this ongoing development is one of the key values we look to foster in our team…
Oncology & Hematology
Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research
Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of…
Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, including clinical research. The objective of the GDPR is to strengthen and standardize the protection of personal data across the EU, including ex-EU data that is processed within the…
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…
At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blogpost, we focus on four GDPR articles that are relevant to study start-up. Article 131 As the data controller, the sponsor must provide a privacy notice…
As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency…
Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront British…