Bristol-Myers Squibb (BMS) and Nektar Therapeutics have announced a partnership deal worth up to $3.6 billion that will lay out a new path for immuno-oncology (I/O) combination therapies.
Getting new treatments to patients is a long and costly endeavor. Most drugs take upward of eight years and billions of dollars to receive regulatory approval. One of the biggest problems sponsor companies face when trying to launch a Phase 3 trial is finding enough patients to take part in the study.
Your employees will always resist technology change. Change tends to bring fear and uncertainty. To overcome fear and make your installation a success, focus on implementation, change management, and providing immediate benefits to users.
For many companies, implementing new clinical technologies can be a difficult endeavor. Compatibility issues, training, and employees who are resistant to change can make implementations a challenge. What can executives can do to better prepare for change when it comes to their companies?
A group of academics who work at the intersection of drug development and medical ethics are jumping into the kerfuffle over proposed Right To Try (RTT) legislation, noting they are deeply concerned about the ramifications of a federal RTT law for patients and families. In a letter to the leadership of the House of Representatives’ Energy and Commerce Committee health subcommittee, the group notes it has “strong opposition’ to the pending legislation.
Abeona Therapeutics recently conducted a Phase 1/2 clinical trial for individuals with Recessive Dystrophic Epidermolysis Bullosa (RDEB). RDEB is an often fatal connective tissue disorder marked by skin blistering and caused by a lack of a collagen protein responsible for anchoring the dermal and epidermal layers together.
The FDAAA Title VIII, which required clinical trial results to be disclosed on ClinicalTrials.gov, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.
If you are involved with clinical trials, you are aware of the shortage of qualified CRAs. Numerous reports have noted the continuous increase in turnover and salaries for these clinical professionals. We know the problem exists, but is there anything we can do about it?
How far would most CEOs go to raise awareness of the diseases they are attempting to treat? Tim Miller, CEO of Abeona Therapeutics, climbed more than 14,000 feet to the top of Mt. Rainier to raise awareness for Sanfilippo Syndrome, a rare and deadly genetic disease that impacts children.
The world of patient recruitment is changing. Whereas pharma and CROs once relied almost entirely on investigator sites to recruit study participants, patient advocacy groups, social media, and new technologies are creating opportunities to access needed patients. But in doing so, are companies running the risk of further alienating treating physicians?