Wednesday, November 9, 2011

Get Your Resume Out of the Pile

Forbes has an article on commonly used but tired resume words, such as 'experienced', 'team player', 'seasoned' and 'customer focused'.  These words ascribe a quality label to yourself without quantifying your experience.  'Experience' can mean having done something once or 5000 times.  So use that precious resume real estate to paint a picture for the reader of how you obtained your experience.  "Experienced clinical project manager" becomes "Led five large multinational oncology trials to on-time, on-budget conclusion with high quality submission-ready clinical data".  This statement tells much more about your skills than merely that you were in the room when these trials occurred.

'Team player' is another well-worn resume term that can mean anything from 'plays well with others' to 'world's greatest cupcake maker for team meetings'.  Show your potential manager how you work in teams, using statements like "Led (or participated in) a cross-functional clinical team of CRAs, data managers, regulatory advisers in developing a project plan template for managing a cardiovascular clinical development program.

"Dynamic" is a hard quality to describe and is usually better left for the interview itself.  Dynamism on paper is not quite the same thing as in person.  Use your resume to quantify your skills and accomplishments and save your personality for the interview.

Read the article for yourself, follow the links below for other great sometimes free resume advice, courtesy of Lifehacker. Creates an Infographic Resume for You in One Click

Wednesday, October 5, 2011

New German Law Raises the Bar for Drugs Entering the Market

A new law on the books in Germany since the beginning of this year seeks to incentivize innovation by pharmaceutical companies, by structuring pricing models based whether a new drug represents an improvement over existing therapies or not.  This creates in effect a two step process to access the sizable German market; first regulatory approval and then, an assessment of efficacy data by a separate German pricing committee.  If that pricing committee determines that the new drug offers not benefit over existing therapies, the drug may enter the market under a fixed price regime.  If the new drug does offer improvement, then the payers and manufacturer may negotiate a price.

According to the blog The Language of Science, some manufacturers are choosing not to enter the German market at all rather than accept fixed price restrictions on new non-inferior products.  In September, Boehringer Ingelheim and Lilly opted not to launch their new oral anti-diabetes drug Trajenta in Germany after the federal commission relegated it to the fixed price model.  It is interesting to note that the decision was made by comparing Trajenta to a generic diabetes drug, not to other gliptins in Trajenta's class.  Also in September, Novartis pulled their new anti-hypertensive product Rasilamlo after they could not provide differentiating data to the pricing committee's satisfaction.

The German government has presented this law as an incentive to manufacturers to find and develop novel innovative therapies over "me-too" products, perhaps not surprisingly the industry does not see it this way, as their actions of withdrawing products rather than submit to fixed pricing seem to indicate.  Given that Germany is the largest market within the EU, it will be very interesting to watch whether other EU members follow suit in creating a pricing scheme based on benefit.  It will not happen in the US any time soon, because the market, not the government controls pricing in the US marketplace.

Monday, September 26, 2011

Clinical Trials in India

I am thrilled to have a guest commentary this week on Carl Anderson's wonderful GXP Perspectives blog on recent changes in the clinical trials landscape in India.  New rules and guidances emerging in recent months are all pointing - I believe - to an even stronger clinical trials enterprise in a country whose credentials are already very good.   Please go on over to Carl's blog and take a look, make a comment.  I'd love to get your thoughts.

Thanks very much indeed to Carl for his support.

Sunday, September 18, 2011

FDA's New Guidance on Clinical Monitoring Arrives

The FDA has released its long awaited update and replacement to the outdated 1988 guidance on clinical monitoring.  The draft guidance for industry on Oversight of Clinical Investigations - A Risk Based Approach to Monitoring is early evidence that the findings and recommendations of the Clinical Trials Transformation Initiative (CTTI), FDA's public-private partnership with Duke University among others, are beginning to take hold in practice in the clinical trials domain.

According to a CTTI survey, clinical trial sponsors are successfully employing a range of monitoring modalities, such as centralized monitoring by biostatistical and data management personnel, targeted on-site visits to higher risk sites as well as frequent on site visits to all sites by clinical monitoring personnel.  Yet historically, industry sponsors have rarely relied on any mechanism other than comprehensive all-site monitoring performing 100% source data verification, every four to six weeks.  It is a well-understood, costly and time consuming method of monitoring that the industry perceives is preferred by FDA.  Yet, given the vast changes in the clinical trial landscape in the decades since the FDA's previous 1988 guidance and the regulations covering sponsor obligations, including the increase in the number and complexity of clinical trials, investigator experience, changes in ethical oversight, treatment options, and geographical dispersion of clinical trial sites, the FDA now calls on the industry to employ new and more effective methods for monitoring clinical trials.  

This is big news.  As in the recent final rule on safety reporting, which requires sponsors to make judgments about whether a single case is instructive enough to warrant reporting to the authorities, FDA here is encouraging sponsors to reduce their reliance on a one-size-fits-all, on-site, 100% source data verification comprehensive monitoring approach in favor of a more diversified, horses-for-courses approach, building monitoring plans and employing monitoring modalities based on multiple factors such as:
·           type or study and endpoints (whether objectively or subjectively derived)
·           disease state of patient population
·           sponsor experience with investigator and investigator experience with research
·           complexity of protocol, such as adaptive designs, stratified designs, complex dose titrations, etc.
·           availability of EDC to facilitate centralized monitoring

Throughout the guidance, the FDA continually refers to the prevalence of electronic data capture (EDC) that allows for centralized and risk-based monitoring.  It appears that their expectation is that EDC usage is now or very soon will be the norm rather than the exception.  This is certainly one of the most important advancements in clinical trials technology that allows for alternatives to comprehensive on-site 100% monitoring and indicates that despite its earlier struggles for acceptance during the 1990s, remote data capture is here to stay at last.

While this is a draft guidance, the FDA is putting teeth into it by:
·           withdrawing the extremely outdated 1988 guidance
·           ensuring that BIMO guidance manuals are compatible with the recommendations
·           ensuring affected areas of FDA are aware of the goals of the guidance
·           will consider establishing processes within CDER for sponsors to voluntarily submit feedback on proposed monitoring plans.
It will be interesting to watch how sponsors and CROs implement this new guidance. Having traditionally supported comprehensive, frequent on-site monitoring methodology, CROs will have to develop new pricing models other than X monitors spending Y days onsite every Z weeks.  Sponsors by their turn will have to revise their SOPs and employ different kinds of training to use centralized electronic monitoring methods efficiently.

This post was published at the Clinical Leader site.  I am grateful to Rob Wright, Chief Editor of Life Science Leader magazine for his support.

Monday, April 4, 2011

Follow up on All Things Makena

BioCentury TV covers the wild week that was KV Pharmaceutical's, after the FDA nixed their plans for exclusive marketing of a form of progesterone that had previously been used widely and cheaply for decades by women to prevent premature birth.  See the video report here and read the PDF followup here.

Wednesday, March 30, 2011

Followup to the Makena/KV Pharma Saga

Sometimes the little guy wins.  Sometimes it pays to stand up and fight back.  That's what has happened in the case of KV Pharmaceutical and its Makena, a form of progesterone indicated for preventing premature birth and approved by the FDA recently under the Orphan Drug Act.  This blog has addressed this twice recently, here and here (scroll down).  The injectable form of the drug, for which no one holds a patent including KV, has been available for decades from compounding pharmacists at a cost of $10-20 per week for weekly injections during critical weeks of gestation.  Under the Orphan Drug Act, KV Pharma was able to augment the available clinical research with some additional clinical data and obtain approval for sale under accelerated review, and receive considerable government assistance (read: tax breaks), plus 7 years' market exclusivity, for a product on which they don't hold a patent and in which their development investment was relatively low.  Meanwhile, KVeliminated the competition - the compounding pharmacists - by sending them letters stating that under the terms of their approval, the FDA would no longer 'exercise enforcement discretion with regard to compounded versions of Makena."  KV priced the product at a whopping $1500 per weekly injection - and neither the FDA nor any other arm of the US government controls drug pricing in this country - made some weak noises about providing assistance to certain women, and thought that was the end of that. 

Not so fast, say the patients and their physicians.  Public response to this story has been swift and loud.  A sampling of coverage of the outcry is at the bottom of this post.  Patients and physicians were outraged at KV's wantonness in so drastically inflating the price by a hundred fold, and their rationalization that weekly dosing would still cost less than a stay in the NICU fell on unsympathetic ears.

Not so fast, also says the FDA.  In a statement released today on FDA's web site, the FDA makes it clear that while it cannot tell KV how much to charge for their product, it indeed can exercise its enforcement discretion and will not come after pharmacists that "compound hydroxyprogesterone caproate based on a valid prescription...unless the compounded products are unsafe of substandard quality", or not compounded according to proper technique.

According to FiercePharma, KV has yet to comment on the FDA's statement and it is not yet clear what effect if any this will have on pricing.

Sunday, March 27, 2011

KV Pharma and the Drug Price Wars

At the bottom of my last post I looked at the recent case of KV Pharma and its new drug Makena, which was approved last month by the FDA under the Orphan Drug Act for prevention of premature birth.  Makena is a form of progesterone that has been available for decades at a cost of $10-20 per week from compounding pharmacies, but now KV Pharma, which went to the trouble of registering their version of the product has a 7 year monopoly on sales of the product (thanks to the Orphan Drug Act), which they have priced at $1500 per injection.  The drug is dosed weekly from weeks 16 through 20 of gestation.  The penalties associated with trying to provide the compound the old way should give any pharmacist reason to think twice.

Two US Senators (Amy Klobuchar, D-Minn and Sherrod Brown, D-Ohio) have asked the Federal Trade Commission to look into the pricing matter and investigate whether the $1500/injection price tag constitutes anti-competitive behavior.  The senators also charge that KV Pharma's patient assistance program is insufficient.  You can see the press release and letter, which uses words like 'price gouging', here.

As is often the case, Pharmalot is all over this.  This week they asked for an explanation from Jamie Love of Knowledge Ecology International.  Love points out a number of issues stemming from the use of the Orphan Drug Act to secure this approval along with its exclusivity.  The Orphan Drug Act was originally enacted to incentivize manufacturers to make otherwise unprofitable medicines available for diseases that strike relatively few patients.  In the case of Makena, the compound was already available to pregnant women since the 1950's.  So even though KV Pharmaceuticals did perform clinical trials, and the rest of the research was done by the NIH (see here for the full list of trials), and KV does not hold the patent on the progesterone compound (hydroxyprogesterone capoate, apparently no one does according to the Orange Book), they still receive the seven-year market exclusivity under the law.  The Pharmalot Q&A with Love is here, which includes links back to their earlier coverage of the story.  Love's blog noting how the Orphan Drug Act could be improved is here.