The Laszlo Letter

R&D - The need for accountability. Pfizer weighs in again.

 
Matthew Herper of Forbes magazine wrote a review of a press conference held by Ian Read, the new CEO of Pfizer. Of interest to me was the following paragraph:

"One of the main goals of the changes is to try and prevent any repeat of Pfizer’s disastrous investment in Exubera, the inhaled insulin, which the company spent years developing before it hit the market and bombed. Without accountability, Read says, projects were handed off from one team to the next without demands that they actually be ready. 'You get the transfer from one stage to the next stage, always investing in hope rather than strong clarity of signals and clarity of medicine and clarity of mechanism.'"

While I continue to fault Pfizer for their lack of imagination when it comes to R&D, this statement is right on.

Some of you may have read my point of view on the Exubera debacle on this web site. Mr. Read seems to understand that once a project takes on a life of its own within the R&D pipeline it is nearly impossible to stop it.

Why is this the case? Because pharmaceutical firms have gotten so specialized and compartmentilized that people are simply completing the work assigned to them without seeing the big picture. It seems that even Lifecycle Teams are not able to complete a holistic review of a drug candidate. The stakeholders are simply focusing on getting their part of the work done right and on time and are rewarded for doing so. If the incentives are not based on team success then the chances of getting a compound on the market are significantly reduced. This is where the idea of accountability comes in and was highlighted by Mr. Read.

Now, Mr. Read's observation is not original. We have heard many times about the need to "fail early." Unfortunately, the acceptance of failure and the possibility of being rewarded for it has not really become a visceral behavior at most companies. Perhaps Mr. Read will take steps that will make this happen at Pfizer. If that happens others are sure to follow.

 

Leveraging social media by biopharma

Having just returned from the DIA Clinical Forum meeting in Lisbon, I was happy to see a notice within my LinkedIn account about a new posting by Daniel Ghinn of Creation Healthcare. This is not only a good overview of the Medical Informatics session at the DIA meeting but also makes reference to the recent DigiPharm Europe conference recently held in London. Daniel also delivered an insight packed presentation at the DIA meeting on the use of social media (e.g. Facebook, Twitter, Flickr) by pharmaceutical companies. In this presentation, Daniel cited work done by Johnson & Johnson, Pfizer and Boehringer-Ingelheim. Both are worth your time.

Software for Clinical Development

Having recently particiapted in two DIA meetings, I thought it would be useful to pull together a spreadsheet of vendors offering software used in clinical development. This can serve as the basis for a more comprehensive list built and maintained by reader input.

For now, the list is kept in an Excel spreadsheet:

Download ClinDevSoftwareVendors-April2008.xls

Please note that I consider this spreadsheet as the intellectual property of The Laszlo Letter. In other words, it is copyrighted. You may use it as a reference document but not benefit from it in any financial manner or reproduce it without my permission.

To contribute new items or update those that already exist, just use the comment function of the blog. I will take it from there and post new versions of the spreadsheet as necessary.

Thanks in advance for your help.

Apple iPhone: Life Sciences applications needed. Money available.

As you know by now, I am betting that the Apple iPhone will become an important communication and collaboration tool in our industry. This, in spite of many dissenting voices that the iPhone is not ready to handle real business applications.

Apple has now reported that over 100,000 downloads have been made of its Software Development Kit (SDK) since its launch on March 6th, 2008.

Now, Kleiner Perkin Caufield & Byers (KPCB) has launched a $100 million fund to support the development of iPhone applications. According to its web site, the fund "will invest in companies building applications, services and components. Focus areas include location based services, social networking, mCommerce (including advertising and payments), communication, and entertainment. The iFund™ will back innovators pursuing transformative, high-impact ideas with an eye towards building independent durable companies atop the iPhone / iPod touch platform."

According to the FAQ on the KPCB web site, the funding can be anywhere betweek $100K and $15M. The application form can be found here.

So, this is a great opportunity for all you entrepreneurs out there to show how the iPhone can be leveraged to support the R&D, Sales & Marketing and/or Manufacturing & Logistics segments of our industry. Even if you don't end up being funded by KPCB, only $99 stands between you and the SDK.

First, think BIG! Then start coding.

iPhone and EDC: Screen shots of the Nextrials Prism system

In prior posts, I have talked about the potential use of the Apple iPhone in the life sciences setting. These have included it's use as an SFA device or a solution for EDC & CTM. I have also discussed whether Apple could compete in the business world.

The EDC post revealed how Nextrials is using the iPhone to give its customers mobile access to their Prism EDC system. At that time I promised that I'd try to get some screen shots of the software in action. I am happy to report that the people at Nextrials took the time to have professional photos made for me. So please click the "Continue reading..." hyperlink to see these photos.

On a separate note, Apple has also announced the coming availability of their iPhone Software Development Kit (SDK).  Read this article to get an idea about the SDK. I'm expecting this SDK to be the catalyst that will prompt many existing and new software companies to build applications for our industry.

Havidol: Just don't take this too seriously

The October issue of Pharmaceutical Executive came with a supplement entitled "Guide to Branding." Unlike most people, I tend to look at these supplements before relegating them to the trash bin. And so, it was with distinct pleasure that the article on Page 8 led me to the following web site:

                                                          Havidol

Check out the site. Then read the article.

Just don't try to get an Rx for this stuff from your physician!

Biopharma: The Next 10 Years

Every so often my colleagues in the Consulting world get the urge to gaze into the crystal ball and wax poetic about what our industry must do to survive and prosper in the future. Typically you get these reports from firms like PricewaterhouseCoopers (PwC), Accenture, McKinsey & Co. and IBM. So, I was pleasantly surprised to see one from British Telecom (BT), not a name that one normally thinks about in the Life Sciences space.

Click on the illustration to see a larger version. Illustration taken from the BT report and is the Copyright of British Telecom.

Pfizer: Irrational EXUBERAnce

The other shoe has dropped!

Pfizer has decided to stop selling Exubera, it's highly self-touted inhalable insulin product. As you have read here before, Exubera may be a technical breakthrough but it's also one without a proven benefit to the consumer. For whatever reason, management at both Nektar (the developer of the inhaler) and Pfizer got too enamored about the technology and chose to put their head in the sand about market demand and acceptance for such a product.

The consequences are devastating for both companies financially and highly damaging to their reputations as both researchers and marketers. On the financial front, Pfizer is taking a $2.8 billion pretax writedown. This, in light of blockbuster sales projections of $2 billion per year and an actual performance of just $12 million.

EMC buys Business Edge - Implications for Life Sciences

Although I've known about this for quite some time, it is now official that EMC has purchased New Jersey based Business Edge Solutions.

A recent article here, for example, discusses EMC's reaction to concerns in the channel that by building its consulting business through acquisitions, it will take business away from their own channel partners. This is known as channel conflict.

That, however, is not the focus of this article, which is more about the impact of this acquisition on our own Life Sciences Industry.

IT Sessions at DIA 2007

We are now exactly one week away from DIA 2007.

What follows is a selective and somewhat biased list of IT topics that will be given at the annual meeting. Somewhat biased since it is focused on topics of greatest interest to me. Another way to look at it is that I am less interested in topics that have gotten a lot of coverage over the past 3 years and more so in those that focus on emerging issues/opportunities.

As you will see, some of the sessions fall in the same time slot. I was hoping that the DIA could at least have found a way to put sessions on the same topic in different time slot. Maybe next time.