In a recent news report[i] Bayer AG was asked to obtain “more data about the quality of life for patients” who use its expensive “new cancer medicine Stivarga” (regorafenib). The request came “from a German panel that makes coverage decisions for public insurers.” The Federal Joint Committee “voted to give the company 18 months to provide the new data, which could come in the form of a clinical trial,” and unveiled a “temporary ruling today that Stivarga offers patients a slight added benefit compared to existing therapy that costs less than a quarter as much.”[ii]
It seems both sensible and practical that evidence for efficacy and effectiveness should be accompanied with a measurement of QoL benefit. Even if QoL results cannot reach the level of content validity required by FDA for a claim, payers and formularies want to know how patients would benefit if they cover the costs of a newly approved medication.
As we slipped into the booth at the local diner, it occurred to me that the last time I had spoken to Glen was at this same venue. “Yeah, that was two years ago,” he said with a tinge of nostalgia. Two years ago? Time had flown by for me but I know it was not the case for him. Glen still had not found a new full-time position.
A Ph.D. scientist (organic chemistry) with solid people skills and senior management experience, I was surprised when he got down-sized. I was just as sure he would end up in a good place in the long-run. Unfortunately, the long-run never came. After pursuing “more than 100 legitimate job leads and conversations throughout the pharmaceutical industry,” Glen is still looking for a new job. And just like that, I found myself sitting face-to-face with the long-term unemployment epidemic that is afflicting many individuals in the U.S., as well as scientists and pharmaceutical employees from around the world.
With the rationale of making Europe a better environment for clinical research, the European Union is taking steps towards greater transparency of clinical trial data. In this article, CROS NT highlights the connection between traceability and transparency, and makes recommendations on how to satisfy the regulatory authorities and be prepared for future clinical data transparency obligations.
Background
A recent initiative (April 2014) by the European Medicine Agency (EMA) on data transparency was finally passed into draft law by the European Union, requiring that detailed summaries of clinical trials are published in a publicly accessible database once marketing authorization is granted. Sponsors could face strict fines for not complying. Also, in March 2014, the EMA published the first summary of a risk management plan (RMP) for a newly authorized medicine, stating “the Agency will pilot the publishing of RMP summaries for all newly centrally authorized medicines during 2014 and at a later stage will start producing RMP summaries for previously authorized medicines”. The RMP will be a publicly available document that describes all that is known and unknown about a drug’s safety and what actions will be taken to monitor the drug on the market and mitigate any risks.
Regulators expect electronic clinical outcome assessments (COAs). As a result, sponsors ask patients to record their study data via smartphones, tablets, browsers, digital pen and interactive voice response systems (IVRS). What do patients favor? This article reviews current literature which describes patient preference for ePRO, which is intuitive. However it was surprising to learn that patients prefer paper over IVRS. This meta-analysis will describe which devices patients prefer, and why.
The end of 2013 saw numerous drugs change clinical phase or receive approval and launch, creating an exciting landscape for drugs to watch in 2014. Whether it’s a new HIV drug gaining approval or the advancement of a rheumatoid arthritis therapy from phase II to phase III trials, The Ones to Watch, a quarterly report from Thomson Reuters, keeps a finger on the pulse of the most promising drugs by mining strategic data from CortellisTM Competitive Intelligence.
Using these insights, Thomson Reuters analysts found that orphan drugs feature prominently in the market, with the recent launch of two drugs for orphan cancer indications: GazyvaTM and ValchlorTM, and important phase transitions for several others. In the US there have been nearly 250 labeled indications relating to orphan drug designations approved since the enactment of the Orphan Drug Act in 1983. Cortellis Competitive Intelligence describes over 800 drugs that have received at least one orphan designation.
When performing clinical work, life science companies have different models to choose from when deciding how best to use available resources. Some may opt for a full-service approach with specified strategic partners, while others choose to use a functional approach with various vendors with expertise in specific service areas. Each one will affect the use of in-house staff and consultants, and have different cost ramifications.
In parts 1 and 2 of this 3-part column by Daniel Chapple, he discussed in-house support, contractors, competitive bidding outsourcing, and the functional service provision. In this final segment he considers the centralized service provision and full-service divisional strategic support models, as well as using locations to optimize cost.
When performing clinical work, life science companies have different models to choose from when deciding how best to use available resources. Some may opt for a full-service approach with specified strategic partners, while others choose to use a functional approach with various vendors with expertise in specific service areas. Each one will affect the use of in-house staff and consultants, and have different cost ramifications.
In part 2 of this 3-part column by Daniel Chapple, he discusses competitive bidding outsourcing and the functional service provision. In the final segment he will consider the centralized service provision and full-service divisional strategic support models, as well as using locations to optimize cost.
When performing clinical work, life science companies have different models to choose from when deciding how best to use available resources. Some may opt for a full-service approach with specified strategic partners, while others choose to use a functional approach with various vendors with expertise in specific service areas. Each one will affect the use of in-house staff and consultants, and have different cost ramifications.
In part 2 of this 3-part column by Daniel Chapple, he discusses competitive bidding outsourcing and the functional service provision. In the final segment he will consider the centralized service provision and full-service divisional strategic support models, as well as using locations to optimize cost.
When you read some of the news regarding pharma manufacturing in India, the headlines are not good. Much of the narrative is negative and seems to be spiraling downward. Unfortunately, in today’s world the perception is often the reality, and the reality has us shaking our heads in wonder.
FDA commissioner Margaret Hamburg has come out with a clear statement on the situation: Indian companies have to take more responsibility for quality control. Oh, and by the way, the FDA is also ramping up cGMP audits in India. When the FDA makes these kinds of statements, the industry listens.
Sanofi is a multinational pharmaceutical company engaged in the research and development, manufacturing, and marketing of prescription drugs, vaccines, and over-the-counter healthcare products.
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