Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘pharmaceutical’

PeRSSonalized Pharma

By on January 5, 2010

One of my Twitter buddies, Dr Bertalan Mesko (@Berci) has built a superb collection of RSS aggregators, catchily called PeRSSonalized Medicine, on his Webicina site around different medical topics a broad range of topics including diabetes, depression, cancer, psoriasis, nephrology etc. He graduated from medical school last year (while running ScienceRoll and Webicina!) and is now a qualified doctor with a strong interest in genetics as well as research in psoriasis and rheumatoid arthritis.

Here's the full list you can choose from:

Picture 80
 

More recently, he extended this excellent theme and launched his Pharma resource as you can see at the bottom of the above checklist.  Here's the Pharma site in more detail:

Picture 79
As you can see from the screen shot above, it includes medical journals, blogs, news and web 2.0 tools shared via various Pharma bloggers on Twitter; all the content is efficiently organised alphabetically.

Of course, I was delighted to see this humble little blog included, but do check Berci's excellent resource out because it's well worth looking at. You can also follow him on Twitter for more regular updates. The site is free, just sign up and away you go. 

Overall: It is a well executed and nicely curated medical site for physicians and patients alike – great job, Berci!


{Disclosure: This website, Pharma Strategy Blog, is included in the Pharma site I just reviewed and I am therefore undoubtedly biased in reviewing PeRRSonalised Pharma, but please do check it out and see for yourselves what can be achieved with medical information and web 2.0 tools.  If more pharma sponsored sites had half a much independently curated and unbiased information, they would probably do very well.}

2 Comments

Shifting gears: another year in Pharma and Biotech

By on January 4, 2010

As the New Year begins and everyone shifts gears after the two week break over the Holidays, I realised a few things that were relevant to me personally.  This year will mark my 7th seventh year in consulting, six of those running Icarus.  Is it really that long?  Wow.

Over time, this has become a blessing because while consultants come and go ‘in between jobs’, we’re still here providing longevity and reassurance that a relationship is there for the long haul and not as flash in the pan merchants.

That’s a good thing and a bad thing though.  Those that stand still will not grow but be left behind.  You have to keep innovating and creating to survive in this world.  Reliability is also important, but delivering value and intelligent insight and analysis rather than mere data is what most of our customers seem to want and need.

The other day, someone asked me why we read a lot of scientific papers as well as going to so many conference and meetings.  The answer is that’s how we stay ahead of current and future trends, new ideas and innovation.  It’s a lot of data to shift through but then, that’s what clients want: more than they understand themselves, as no one wants to hear what they already know back.

Still, I have a long list of lot’s of interesting concepts and ideas to discuss on this blog in 2010, some new, some reinvention of old ideas in different guises, some yet to reveal their true results (from phase III studies) at conferences such as AACR, ASCO and ASH.  It will be fascinating to see what new technologies and pipeline drugs emerge as real new advances in their area.  Somehow, the New Year also brings a renewed sense of urgency and hope quite unlike any other month in the year.

Last week, I was browsing through company pipelines and was struck at how little is ready for market this year, with many phase III projects probably not maturing until 2011.  2010 may well be the year of consolidation in Pharma and Biotech, where many companies take stock and get ready for a big push in 2011, when the biggest patent expiries are most likely to hit. There’s a few expected this year too, though, as Pharma Gossip nicely highlighted this morning.

January promises to be a busy start to the year:

  1. It heralds many companies presenting year end reviews and their forward look at 2010.  I’ll be keeping an eye on these and observing any new trends as they come out.  
  2. The AACR-IASLC joint conference on Lung Cancer is also being held later this month from 11-14th Jan in San Diego (details here and here), so if anyone wants to meet up for networking then, let me know.  There’s a lot on pathways, stem cells, genome-wide approaches, as well as models for earlier detection, so it should be a very interesting meeting.

In the meantime, we also have a stack of client reports due, proposals to write, phone calls and email enquiries to return etc… sound familiar?  

Ok, let’s roll!  

Welcome back everyone, a wonderful New Year to y’all.

PS 

If you enjoy reading this blog, do avail yourselves of a free subscription, delivered to you inbox or News Page by clicking on the Subscription link at the top of the page or the email button in the top right.

2 Comments

Impact of the OIG guidelines on Pharma and Biotech

By on December 9, 2009

One of the most noticeable changes at the American Society of Hematology meeting this weekend was the impact of banning chotchkes and giveaways for health care professionals in the US:

  1. Traffic in the exhibition hall was noticeably slow, except for a couple of booths
  2. The booths were much smaller
  3. Pharma companies provided more medical information staff and fewer sales reps
  4. With the lack of credit and high cost of the booths, several small biotechs were also noticeably absent

Pens Of course, when you needed a pen to jot something urgent down, none was to be found.  I tried switching to the notepad on the iPhone to record a name and phone number and managed to drop the call twice.  Oops.

Talking to several oncologist and hematologists in the exhibit hall about the topic was interesting.  Getting pounced on by desperate or bored reps trying to promote something is never pleasant.  They don't want to collect tonnes of paper based clinical trial and medical information when a flash key is smaller and easier to manage/access later. Of course, several Pharma companies defensive response was that legal had taken a draconian position of ultra conservatism and declared flash keys chotchkes and therefore not allowed under any circumstances.

Several of the booths had interesting interactive tools for browsing clinical trials or their pipeline for useful information.  The problem was, you could only see it on the screen, no printouts or downloadable files of any kind, rendering the fancy program pretty but totally useless and impractical.

Here's some ideas they could have considered:

  • Mini CD's or flash keys with relevant medical or clinical trials information on them for later use.
  • Interactive tools for case based management enquiries, which allow the doctors to sign up and ask an expert peer for advice on patients via email, video or phone later.
  • Ditto, but have materials available in label that the sales reps can deliver offline post meeting.
  • Ditto, but information based on ongoing company clinical trials with a visit from the MLSO.  This would encourage more trial participation in US or EU co-operative studies.
  • Incorporating social media programs that foster engagement and dialogue between peers to improve patient outcomes.
  • Sign up to have specific medical information enquiries about data presented at the meeting answered via SMS or email with a protected link to relevant clinical information from the medical affairs department.
  • Create useful and interesting medical iPhone and Droid apps such the excellent BlackBag news one that J&J did (but wasn't in evidence at the ASH meeting) so doctors can play with a demo at the booth and request an email with a link to the app for later downloading and use.

The ideas are endless, if applied creatively.  

What was marketing thinking just creating loads of glossy paper based brochures no one wanted to carry home or destroy the forests?  Or all those ads on light boxes pushing the name of your product?

Instead, Pharma seems slow to change from old media (print) and push marketing (DTC, ads) to more useful interactive PDA apps or digital tools, yet the vast majority of doctors were walking around with PDA's and using them constantly.  A wasted opportunity to interact and build deeper relationships with your most important customers in many ways.

Maybe it's time for the industry to run syndicated surveys at a neutral booth to learn what health care professionals attending their annual meeting actually want or need?  They can then tailor future programs to what the customers want.

For me, I'm mourning the loss of flash keys, the single most useful giveaway I can get hold of yet can never get enough of.

2 Comments

Clinical trial results show Denosumab is superior to Zometa in breast cancer patients with bone metastases

By on July 13, 2009

Amgen’s recent announcement of phase III trial data showing that it’s monoclonal antibody, denosumab was superior to Novartis’ Zometa (zoledronic acid) for the treatment of breast cancer patients with bone mestastases is further news that scientifically driven drug development can yield exciting results.

Denosumab is in essence a targeted therapy like Gleevec, Avastin or Herceptin.  It’s development came about from basic research that discovered the cellular control of bone remodelling and regulation of bone density is reglated by the RANK Ligand pathway.

RANK Ligand is a TNF famly member, a protein that is expressed on the sufrace of marrow, stromal cells and osteoblasts (the cells responsible for bone formation). When RANK-L binds with its receptor RANK it stimulates the activity of osteoclasts (cells responsible for bone resorption).  In the body, RANK-L production is naturally regulated by the protein Osteoprotegerin (OPG), which binds with RANK-L thereby preventing it from binding to its receptor, RANK.  When there is insufficient OPG, or too much RANK-L produced, excess bone loss occurs.   This occurs in post-menopausal women or in cancer related bone loss.

Denosumab acts by attaching itself to RANK-L, thereby inhibiting its action. Deprived of RANK-L, osteoclasts cannot form, function or survive.  The result is less bone destruction and bone loss.  Understanding the RANK Ligand pathway has been a breakthrough step in understanding bone biology.

Many cancer patients end up with bone metastases that not only causes pain, but also bone destruction.  Roodman, in a 2004 New England Journal article, proposed the “vicious cycle” hypothesis to explain this: Tumor cells produce parathyroid hormone-related peptide (PTHrP), which stimulates osteoblasts to produce RANK ligand leading to less production (downregulation) of osteoprotegerin (OPG), thereby stimulating osteoclasts to resorb more bone.  At the same time, production of PTHrP promotes tumor growth directly.  Therefore, it should come as no surprise that denosumab would be effective in cancer patients with bone mets and skeletal related events.

What does the future hold for denosumab?  In the postmenopausal osteoporosis market, a once or twice yearly injection is extremely attractive given its ease of use. Compliance is a real issue with bisphosphates such as alendronate or risedronate where a daily pill must be taken.  Many primary care physicians are not set-up to administer an infusion, which is what Novartis’ once a year osteoporosis treatment, Reclast requires.

However, despite impressive clinical data, Amgen does not yet have a home run.  It lacks a large sales force and infrastructure to sell to primary care physicians. Also with generic fosamax (alendronate) available, the cost/benefit trade off is going to be a key factor in uptake.  The cost of denosumab will need to be carefully considered for Amgen to enter this competitive market.  The FDA advisory board meets on August 13 to discuss Amgen’s BLA application and consider whether to recommend approval for the treatment and prevention of osteoporosis, and treatment of bone loss in patients undergoing hormone ablation for prostrate and breast cancer.  Given the positive data from the phase III pivotal studies, a positive recommendation is expected with approval by the FDA expected in October.

For cancer patients, denosumab could become the gold-standard for treatment of bone metastases given its superiority over Novartis’ Zometa.  For oncologists, the fact that denosumab only requires an injection while Zometa requires an infusion is less of an issue.  The key to success for oncology drugs is based solely on the data. If the positive results continue, Amgen are likely to take market share from Zometa once approval for the treatment of bone metastases is obtained in 2010 or 2011.

So, my take on this is that denosumab is a real winner for Amgen.  Whether it will capture the market for postmenopausal osteoporosis remains to be seen, but it is an exciting new drug that will benefit cancer patients.  Further data on denosumab can be expected from the September meeting of the American Society of Bone and Mineral Research (ASBMR) in Denver.

Related articles by Zemanta
Reblog this post [with Zemanta]

The importance of messaging in new product launches

By on October 21, 2008

What is messaging and why is it important? 

Well, in this context, it is essentially a communication about a company's product(s) or even the pharma/biotechnology company itself.  It takes the form of either the written word or verbal communications about data or a product's features.  These can be from employees of the manufacturer, the press, patients, caregivers, members of the public or doctors. 

From a company's perspective, having everyone on the same hymn sheet across promotion, PR and medical education is the desired goal, but few achieve this nirvana mainly because it is constantly like herding cats and requires an enormous amount of confidence, energy and effort, although it can be done.  The marketers nightmare is realising that there are different messages from the sales force, key opinion leaders and company press releases.  This limits the effectiveness of the overall message and ultimately will lead to confused and unsure patients and doctors.

The most successful brands are often those with a coherent, cogent and potent message that convey the essential essence of the product in a few simple words.  Rarely do you see a successful brand with poor messaging, but brands with poor messaging generally do less well.  Gleevec and Avastin are two recent blockbuster cancer drugs that spring to mind as examples of utilising effective messaging strategies to generate share of voice.  Constantly referring to new data, new clinical trials and extended survival of patients in the earlier trials adds to the body of evidence that the drugs are safe and effective.

The other side of the coin is that smart companies continually evaluate their competitors messaging and the intentions that they signal in the process.  This is competitive intelligence at its best; honing and refining your brand to best take advantage in a highly competitive market, so that you can proactively respond to your rivals rather than react six or nine months later down the line as you assess the market data.  Often by then it is too late and momentum has been lost. 

Another example would be an existing brand on the market and a new competitor is due out in the same indication; what can be done to effectively limit their market share?  Information about competitor messaging can be gleaned from press releases, conference data, online forums, key opinion leader research, third party medical education etc. 

Using these in-depth strategic analyses, brand teams can better understand the competitor positioning and message signalling in order to put in place their own effective brand strategy to defend their market.  Two recent examples of this were Gleevec (Novartis) in the CML market, which effectively limited Sprycel's (BMS) penetration while extending it's own in other indications and ImClone's Erbitux, which continued to grow it's revenues across several indications in the face of stiff competition from Amgen's Vectibix.

How companies position themselves and their portfolio is also important – Genentech's success with Herceptin, Rituxan and Avastin was no mean feat.  Each drug and new indication added not only new data, but also a clear message that monoclonal antibodies worked and were here to stay.  Contrast that with the experiences of the vaccine companies during the same period.

Messaging then, is not only important to brands already on the market but also to new products in development and company portfolios.  Getting the messages right is partly about leveraging your data, but also one of simplicity, especially if you have several drugs targeting the same tumour type, for example.  How should they be differentiated?  Is the messaging to customers clear and explicit?  It is a partly art and partly science; in oncology at least, it is important to understand the science and biology of the disease, the competitor set you are competing against and having the boldness of imagination to execute a strategy well.

At Icarus Consultants we advise companies on brand messaging, competitor messaging signals, how to work with key opinion leaders to maximise messaging and for companies with a portfolio of products, evolving a messaging strategy to take to avoid confusion between the brands.  After all, it's all about driving peak sales as fast as possible.

2 Comments
error: Content is protected !!