FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
This article emphasizes the importance of implementing a regular routine maintenance schedule for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided.
With several first-in-class gene therapies now approved, distinct new challenges are now coming into focus. This article provides a high-level overview of the gene therapy pipeline for non-oncology rare diseases and discuss key issues impacting clinical development.
Artificial intelligence (AI), blockchain technology, predictive analytics, cloud computing, and speech and image recognition are the latest buzzwords across industries. Numerous companies are looking to inject these technologies into their operations, and a great deal of funding is pouring into related startups.
What is the cost of a failed partnership between a pharma company and its CROs? Is it financial? Research and development time?
Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Around the holidays, I reminisce about family dinners: three generations under one roof for a few hours, catching up on the past year. My mother presided over the festivities for several decades until her passing. For 10 years, she was a survivor of a rare cancer. She had two surgical resections and treatments before the cancer returned. There was only one approved orphan drug, which was 50 percent effective in decreasing mortality for six months. There weren’t many options in clinical trials and no Internet patient-centric community for information and support.
The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.