It’s hard to fault fibromyalgia patients for feeling ignored and underserved. For years, many health professionals doubted and discounted their symptoms, even labeling them as malingerers. Physicians and researchers cannot easily or directly observe fibromyalgia’s manifestations, but must rely on patient reports of pain and a range of other symptoms. What’s more, no clear biomarkers...
Hailed by many as the future of cancer therapy, immuno-oncology leverages and unleashes the body’s immune system to recognize and eliminate cancer cells. Immune checkpoint inhibitors have already revolutionized the treatment of certain solid tumors and hematologic malignancies by acting on pathways that cancers co-opt to evade immune recognition. Now, emerging therapies, such as chimeric...
Immuno-oncology is a unique approach to cancer treatment that leverages the body’s immune system to help fight cancer. Immuno-modulating agents such as interleukin-2 (IL-2) and interferon (IFN) have been used in the treatment of some solid malignancies for years, but their use has generally been limited to cancers that are immunogenic, such as melanoma and...
Clinical trials can be dauntingly complex. The high-stakes culmination of years – sometimes decades – of research, they involve rigorous data requirements, close regulatory scrutiny, intricate logistics, and intense cost pressures. Add the stress of trial outcomes sometimes being a make or break proposition for the sponsor, and it makes sense to hire a professional...
Drug Development & Delivery – Device Regulations, Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulationsby Joanne Emmett, Vice President, Medical Devices
A true strategic partnership has benefits for both the sponsor and the contract research organization (CRO). The partnership is grounded in working together towards a common goal, and for both the sponsor and the CRO the success of one is the success of the other—with processes and talent evolving on both sides to produce enhanced...
PharmaVoice – Trending 2018: Rare Diseasescontribution by Angi Robinson, Executive Director, Strategic Development Department, Rare Disease & Pediatrics
Immuno-oncology is a unique approach to cancer treatment that leverages the body’s immune system to help fight cancer. In recent years, immune checkpoint inhibitors have changed the landscape of immunotherapy, and emerging therapies such as chimeric antigen receptor T-cells (CAR-T), dendritic cell vaccines and bi-specific T-cell engager (BiTE) antibodies are pushing the envelope even further....
“Rare disease” may be the biggest misnomer in the pharmaceutical industry. Around the world, 350 million people live with conditions classified as rare because each afflicts a relatively small segment of the population. In the U.S., 30 million—nearly one in 10 Americans—suffer from one of about 7,000 known rare diseases. As it applies to this...
Clinical drug trials require enormous commitments of money and time, and sponsors are understandably motivated to ensure they’re run efficiently. Late patient enrollment, delayed site activation, and missteps during the course of the trial are just some occurrences that can raise the already high stakes in developing new therapies. So when we recently performed a...