Posts tagged ‘Biotech Strategy Blog’
Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining case
April 28th, 2011
Daedalus
It is always a pleasure to be recognized by others. Pieter Droppert’s writing on Biotech Strategy Blog was recently quoted by the Los Angeles Times, alongside Pharmalot’s Ed Silverman, in a story about the Sorrell v. IMS Health case heard by the United States Supreme Court earlier this week.
Pieter is a 2005 graduate of Rutgers School of Law-Newark and recalls that the constitutional theory class he did was one of the most demanding! His post on Biotech Strategy Blog earlier this year, “US Supreme Court to decide whether Vermont can control the use of prescribing data by IMS Health and Pharma companies” was also linked to by the Cornell University Law School Legal Information Institute.
The attempt by the State of Vermont to regulate the use of pharmacy prescribing data and restrict its use for pharmaceutical marketing and sales is something that Pieter has followed on Biotech Strategy Blog. Earlier this week he wrote a preview on the Supreme Court oral argument in Sorrell v. IMS Health and what he thought the Justices would focus on.
His analysis of Tuesday’s oral argument that focused on First Amendment rights and commercial free speech, is that Vermont appear unlikely to prevail and that the law restricting access by data mining companies such as IMS Health will not be upheld.
This is good news for the U.S. pharmaceutical industry that is facing increasing challenges in obtaining access to physicians for sales and marketing.
As marketing strategy consultants we are often called upon to look at the market opportunity in the United states for a company, a new drug or indication.
In order to do this it’s necessary to keep on top of the regulatory and reimbursement challenges that pharmaceutical and biotechnology companies face in the U.S. market.
Healthcare reform is a topic of active debate, especially with the passing of the Affordable Care Act (ACA) by Congress. Pieter Droppert on Biotech Strategy Blog looks at what we can learn two years after healthcare reform took place in Massachusetts.
The findings are interesting, access to insurance coverage is not the same as access to healthcare, and the spiraling costs remain the biggest challenge that has to be overcome. You can read more on Biotech Strategy Blog.
Pieter Droppert in a previous position worked as a Global Project Director for a phase II Alzheimer’s clinical trial program in emerging markets. He maintains an interest in this area and the new products in drug development.
In a new post on Biotech Strategy Blog, Pieter writes about research published in the journal Neurology that showed magnetic resonance imaging (MRI) could detect pre-symptomatic Alzheimer’s disease (AD).
Brad Dickerson and colleagues from Mass General and Rush University in Chicago looked at two groups of subjects who were cognitively normal, and then over time investigated the brain differences seen in those patients who developed AD.
Their conclusion is that changes in cortical thickness are a biomarker for AD, in other words structural brain changes can be seen before they develop clinical symptoms.
This research is still very early and has a number of limitations, including the low sample size and the need for computer power to do the analysis.
That said, the promise of all the biomarkers under development to diagnose early stage AD, whether they be amyloid imaging of plaque through PET scans or via MRI, is they offer the hope of being able to detect those patients at risk before the brain becomes irreparable.
By the time clinical symptoms of dementia or mild cognitive impairment manifests itself, then it’s likely the damage has already been done, and the brain has been snagged or disrupted by the disease in a way that is hard to reverse.
Early detection of those individuals at risk allows the prospect of using neuroprotective drugs to delay the onset of clinical symptoms.
Recognition of the importance of preclinical diagnosis i.e. before symptoms develop was also shown by the announcement yesterday by the National Institute on Aging, a branch of the NIH – National Institutes on Health of new diagnostic guidelines for Alzheimer’s patients.
These guidelines divide patients into three diagnostic groups: preclinical, mild cognitive impairment (MCI) and dementia. The preclinical group is completely new and a recognition that structural and molecular changes occur in the brain before clinical symptoms manifest themselves.
There is considerable research into AD biomarkers to suggest that in the next 5 years we will be able to detect those people at risk, but the challenge remains in developing new drugs that slow down or reverse the onset of the neuronal tangling that occurs.
AD is a disease that will touch many families as the population in many countries becomes older. If you are interested in this area, you can read more on Biotech Strategy Blog.
The iconic Empire State Building in New York City is lit up with orange and white lights this weekend in honor of the Michael J. Fox Foundation for Parkinson’s Research.
Parkinson’s disease is debilitating with no known cure. In a timely post for Parkinson’s disease awareness month, Pieter Droppert on Biotech Strategy Blog asks Dr Todd Sherer, Chief Program Officer of the Michael J. Fox Foundation, why we don’t have a cure and where the next major breakthrough will come from?
In the interview, Dr Sherer discusses the hope that biomarkers may offer. You can read more on Biotech Strategy Blog.
Icarus Consultants is a marketing strategy consulting company to biotechnology, pharmaceutical and life science companies. We don’t offer marketing communications services.
Source: Wikipedia
However, we like to keep our finger on the pulse of the market, so read with interest the recent United States Supreme Court decision in Matrixx Initiatives, Inc. v. Siracusano that involved a failure of Matrixx to share adverse event information with investors.
You may recall the issue of loss of smell associated with use of Zicam Cold Remedy Nasal Gel that contained zinc sulfate.
Matrixx argued that only statistically significant adverse events are material and need to be disclosed to investors, a position the Supreme Court disagreed with. In general terms, the Court held that adverse events that may be linked to a product that could impact a reasonable investor’s decision making need to be disclosed.
What’s the impact of this decision? The Matrixx decision will require companies and their PR agencies to think carefully about the need to include negative information as well as positive when making press releases. Clinical teams will need to talk to investor relations and marketing, something that may be a challenge in the silos of big pharma.
You can read more about this case, and a more in-depth analysis of Justice Sotomayor’s Supreme Court opinion on Biotech Strategy Blog.
Today on Biotech Strategy Blog, Pieter Droppert writes about recent research that suggests that paclitaxel may help those with spinal cord injuries (SCI).
Although this animal research has yet to be confirmed in humans, it suggests that microtubule inhibitors such as paclitaxel may be able to reduce scarring, fibrosis and promote nerve regeneration at the site of traumatic nerve injury.
This research is well worth reading about, and may lead to the development of new products or treatments for spinal cord injury.
Blogging requires time, energy and effort. Ask anyone to tell a story about science and medicine in 300-500 words that captures your attention, and they will tell you it is not easy.
In a world where so much of what constitutes science news is a rehash of press releases, generating original blog content is something that our pharma & biotech consultants do by night, while working by day (or is it the other way round?).
Both Biotech Strategy Blog and Pharma Strategy Blog are part of the Research Blogging network (ResearchBlogging.org), that allows a link back to original scientific papers using the digital object identifier (DOI) reference that journals now publish. As a company focused on bringing new to products to market, we believe that scientific data is the key to commercial success.
Pieter Droppert recently received an “Editor’s Selection” from ResearchBlogging.org for his post on “Regenerative Medicine – can we rebuild our bodies as we get older?” Recognition is always appreciated. Many thanks to Dr Peter Janiszewski for that.
It is hard to imagine what going blind must be like, so any new technology that restores some sense of vision and shape perception is of tremendous value to those affected.
Pieter Droppert who has worked on ophthalmology clinical trials, comments on the recent news that aptly named, Second Sight, has obtained a CE mark for their Argus II Retinal Prosthesis System; the first device of its kind to be approved.
Obtaining a CE (Conformité Européenne) mark indicates that a medical device has met an appropriate quality and safety standard. The result is that it can be freely marketed and sold throughout the 30 member countries of the European Economic Area (EEA) without any further regulatory approval being necessary. It is a major landmark for any medical device company, equivalent to obtaining FDA approval in the United States.
Further commentary on how Second Sight’s “artificial retina” works and what this “bionic eye” means for those who are blind can be found on Biotech Strategy Blog.
Clinical Research Integrity is essential to bring novel Pharma, Biotech and Medical Device Products to Market
March 6th, 2011
Daedalus
News that a leading German anesthesiologist has undertaken multiple clinical trials, including some that appear to have been industry sponsored, without proper ethics committee/institutional review board consent is a cause for concern.
The pharma, biotech and medical device industries rely on the integrity of the clinical research process, and this type of news undermines public confidence in clinical trials.
You can read more about this breaking story on Biotech Strategy Blog.