Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining case

LA Times Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining caseIt 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.

Impact of healthcare reform on US pharma market

Marblehead MA © Pieter Droppert 300x225 Impact of healthcare reform on US pharma marketAs 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.

Future of Alzheimer’s disease is in biomarkers and preclinical diagnosis

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.

Nanotechnology may help the fight against antibiotic resistance

Antibiotic resistance is a major public health issue throughout the world. The prospect that at some point, in the not too distant future, we may no longer be able to treat common infectious diseases, is one that we should all be concerned about.

Last year in Europe, more than 25,000 people died of bacterial infections resistant to antibiotics, and bacterial mutations resistant to current drugs continue to evolve.

Recently, it was reported that bacteria with the transmissible genetic element, New Delhi metallo-beta-lactamase 1 (NDM-1) had spread from India to the United Kingdom.  What’s scary is this strain is resistant to most known beta-lactam antibiotics.

Which makes the discovery that biodegradable nanoparticles can break down the cell membranes of bacteria an important discovery.  You can read more on Biotech Strategy Blog on how nanotechnology may help develop new anti-microbial therapies