June 2009 Archives

I hope you had a chance to read Gina Kolata's "Grant System Leads Cancer Researchers to Play It Safe" in yesterday's New York Times.  

With limited dollars, Kolata reports, researchers are finding it difficult to get the riskier--and potentially more promising--studies funded.   I am often reminded that, for many, much of the drug-research and development process seems shrouded in mystery.  I've read research that says most people believe that new medicines are developed solely by government agencies or through research grants made by these agencies. 

In fact, the pharmaceutical industry is responsible for bringing most new medicines to market.  According to an (admittedly somewhat dated--but I'm looking for more recent numbers) NIH report, 91% of the most-prescribed medicines were developed solely by the pharmaceutical industry, while only 9% were developed in part through NIH-funded research.*  As well, between 2000-2006, the pharmaceutical industry spent $43 billion on R&D, while the NIH's total operating appropriations were $28 billion.

The National Institutes of Health (NIH) and the pharmaceutical industry play vital and complementary roles in advancing the scientific knowledge and understanding of diseases. Most of the government's work is in early research activities that may not lead to specific products, but builds on the scientific knowledge that can aid the development of new medicines.

Kolata's article brought two things to mind for me.  First, we have not gone nearly far enough in the fight against cancer.  There is still so much work to do, and patients are relying on us to step it up.  Second, we're all in this together.  Private/public/academic collaboration is crucial if we are going to beat cancer and other diseases that have eluded us so far. 

* National Institutes of Health. "A Plan to Ensure Taxpayer Interests are Protected." NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' Interests are Protected, July 2001.

Alright, alright, I know.  But it's been a crazy few days.  I intended to post a few things this week but time got away from me.  I promise to be better about this.  Managing GSK's blog in addition to my other responsibilities can be a challenge.  Sometimes I handle it well, sometimes things fall through the cracks (I hope my boss isn't reading this). 

I'm just glad that I am not in charge of GSK's pandemic preparedness program--because that is something that can't fall through the cracks.  People's health--both our employees and our patients--is at stake.  If a company is not prepared for the possibility of a flu pandemic, then employees may fall ill and call out sick, shutting down production lines and wreaking havoc on the business.  If that business happens to be the development and manufacture of medicines--especially for the chronically ill--then the damage could be even worse.  GSK has put a great deal of thought and effort into preparing for an outbreak, both as a company and as a critical partner of public health agencies around the world.

That is why a recent article in the Wall Street Journal should sound an alarm bell.  Earlier this year, the World Economic Forum put the economic impact of an influenza pandemic at around $500 billion--prior to the recent influenza A (H1N1) outbreak.

The fallout from a pandemic could be swift--it is estimated that 15% to 30% of employees would stay home during such a pandemic due to illness, caring for family members, and fear of getting sick at work.   "The result would be to cripple operations and disrupt global supply chains. As in the credit crisis, the fallout likely would spread rapidly because of how connected the world's economies are," the article stated.

Is your company preparing or procrastinating?

Yesterday, our new (well, new-ish--she joined the company in February) North American Pharmaceuticals president, Deirdre Connelly, hosted a town hall meeting for all in-building employees.  These meetings are a good way for senior leadership to update employees on the business and focus on a few key strategies.  A central topic of the discussion was the transformation of our field sales organization.

In recent years, our customers have made clear they'd like to see fewer representatives and sales professionals who are better trained and have more in-depth therapy area knowledge.  As such, we've made some pretty dramatic changes to our primary care sales force aimed at providing doctors offices with representatives they know and trust--individuals who understand reimbursement issues and what it takes to operate a healthcare practice.

In the meeting, a GSK sales professional talked about how these changes are playing out in the field with our customers.  Sometimes we can forget how major corporate decisions impact people on the ground and his comments were pretty bracing: in this representative's situation (which is not unique), since the beginning of the year his territory has changed (it doubled in size, which means many new customers), he has a new manager, and he is responsible for a new product portfolio.   As you can imagine, like any major organizational or business change, this transformation has been challenging and even occasionally disruptive for our sales professionals.

But we're hearing that doctors have noticed the difference and they appreciate the fact we are listening to them.  We're convinced that these changes ultimately will deliver greater value to our customer and put more focus on where it belongs: on our medicines and the benefits they offer patients.

Last week the World Health Organisation (WHO) announced it has raised the current level of influenza pandemic alert from phase 5 to phase 6.

As mentioned a few months ago on this blog, we're working closely with public health authorities to help address this pandemic.

From a GSK corporate press release issued last week:

"Following receipt of the seed strain from the WHO at the end of May, the company has begun the process necessary for development of the new vaccine at both the Canadian and German manufacturing sites.  The first step for manufacturing an influenza vaccine is to prepare the seed strain for production, which will take several weeks.  The company will then start production of the new candidate A (H1N1) influenza vaccine.  The first doses of the A (H1N1) vaccine antigen are expected to be available in four to six months time, subject to regulatory approval.

GSK remains committed to supporting governments and health authorities around the world respond to the emergence of the new A (H1N1) influenza virus, including addressing the needs of developing countries.  GSK has offered to convert its intended donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine once production begins.  As capacity increases, GSK will supply the vaccine to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility." 

In addition to our work in flu, as a global pharmaceutical company that makes and markets several critical medicines for serious chronic and even deadly diseases, we also have an obligation to ensure our manufacturing and supply chains continue to operate effectively through this health crisis.  GSK teams are now implementing carefully-developed plans to help continue an un-interrupted supply of these medicines to the people that need them throughout the world.

Stay tuned for future updates.

Earlier this year--in the space of one week in April--we announced two major agreements that will be critical in the continuing transformation of our business.  By acquiring Stiefel Laboratories, GSK will assume a global leadership role in the specialty dermatology business, an area of critical healthcare importance.

Just days before the Stiefel announcement, GSK and Pfizer announced an agreement to create a new world-leading HIV company focused solely on research, development and commercialization of HIV medicines.

These are both promising new business opportunities that align with our CEO Andrew Witty's stated goal to consider innovative and targeted acquisitions and collaborations that make good financial sense for our shareholders--but also best serve patients.

You haven't heard much about these deals since the spring (in large part due to limits on what we can communicate until the transactions close), but be assured that major effort is going on behind the scenes to ensure the new organizations are ready to go on day one. 

Pulling off strategic integrations requires long-hours of intense work by talented teams from every part of the organizations involved.  The complexities can be extraordinary--integrating systems of all kinds from IT to HR to field sales groups, important determinations on key positions and management structure, agreement on strategic business plans, etc.  All the while taking into the utmost care and consideration how these decisions will impact our patients, customers, employees and all the stakeholders touched by these sizable businesses--including the communities where they reside. 

(Getting something like this post approved wasn't easy either--legions of folks at three different companies had to sign off.)

And all this occurs while the businesses themselves must continue to roll along fluidly--and independently--without a hitch.  Stay tuned for further updates on the close of these transactions.

I came across this website sponsored by PhRMAs Partnership for Prescription Assistance.  Sharing Miracles "is a forum for people to relate their own stories of hope and survival."

The site includes testimonials from athletes and celebrities regarding their personal experiences with serious health issues and chronic diseases, and invites anyone interested to post their own stories.  So many of these stories are quite compelling, and remind us how frightening and painful it can be to cope with a deadly or debilitating disease.  For those of us in the pharmaceutical industry, it also helps us reflect on our special mission and get re-energized to serve these patients every day.

Pharma companies have gotten some heat in recent years for working with celebrities to promote specific products or diseases they treat.  GSK has joined with several notable personalities from entertainment and sports including a few who appear on the Sharing Miracles site.  We've chosen to work with prominent figures in certain circumstances when their involvement can help reach audiences that might otherwise not be aware of a serious health condition or treatment option.  But these campaigns have to be handled appropriately--with full disclosure and transparency about our involvement and in a way that adequately addresses the risks and benefits of medicines--or we risk losing the trust of the very people we're trying to reach. 

When conducted the right way, these campaigns--and the celebrity's notoriety and credibility--can be extremely valuable in encouraging a dialogue around important health topics and driving people to consult with their doctor about diagnosis and treatment.  That's not to say that celebrities are healthcare experts, but it's important to look at the experiences of patients--including these celebrities--to help inform others about prevention and treatment of these conditions. 

Check out the site and see for yourself.

The American Society of Clinical Oncology (ASCO) meeting this year is focused on personalized cancer care.  As a scientist/clinician, I am very encouraged by the progress we've made in the nearly twenty years I've been attending ASCO. We have moved from broad based chemotherapies to targeted agents--and this year ASCO is highlighting the significant strides we have made in the field of translational medicine, or treating patients from "bench to bedside." 

I heard there are about 30,000 members of the global oncology research community here.  For me, this is a time to renew old friendships, meet the next generation of cancer researchers, and learn about the recent advances in the field.  It is also a time to reflect on how much further we still have to go. 

At GSK, we've established a dedicated Oncology R&D Unit focusing on translational medicine and the next generation of cancer science.  Our goal is to find the right drug for the right patient and identify ways of intervening as early as possible in the disease process.  To help accomplish this, we have built a pipeline of medicines that includes biologicals, vaccines, biopharmaceuticals, small molecules, and targeted therapies. We currently have ongoing studies with eighteen different molecules and our research focuses on seventeen different tumor types.

Our goal is to redefine and streamline drug development by, for example, stratifying patients at the inception of a study, combining the medicines in a way that makes scientific sense, and having a quicker read-out on results.  We also are using a "bench to bedside" model where we take what we learn in the lab to the clinic and from the clinic back to the lab.  This process allows us to, hopefully, better identify which patients will benefit from the new medicines and create medicines more uniquely targeted to a specific group of patients.  Cancer research is a collaborative process--and we are currently developing our medicines in cooperation with 160 of the leading cancer centers worldwide.

ASCO 2009 boasts participants from more than 100 different countries and over 4,000 abstracts will be presented.  Clearly, the fight against cancer is a global partnership with all of us trying to understand what advances will make a meaningful difference to patients.  Together, we are focused on finding the treatments that will yield the best outcomes, minimize side effects, and reduce costs.  I am proud of the role GSK is playing in advancing the science and working toward the goal of personalized cancer care.