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.

 

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.

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.

Bridging Pharma and IT

"The beatings will continue until morale improves!"

I was reminded of this quote on receiving a brochure from Cambridge Healthtech Institute (CHI) promoting their upcoming "3rd Annual Bridging Pharma and IT" conference. For those who are interested, the meeting will be held in Boston from September 30 to October 2, 2007.

The quote popped into my head after a momentary feeling of dismay that after 20-30 years of discussion this "bridge" has still to be completed. Apparently there has been much talk and little action. Or perhaps, more correctly, very little effective action.

And so, we continue to "beat" the issue in hopes of positive progress. I'd like to suggest, however, that a different approach is needed. Perhaps one that does not require bridges at all.

But first, let me give you my take on this conference.

DIA Reflections: The Importance of Semantics

If you recall, a few posts ago I told you that there would be several talks on Data Warehousing and a few on Data Repositories at the DIA annual meeting. Well, I was only half right. Why? Because there was a failure of communication of the semantic kind.

Let me explain.

Each time I walked into a session that was described to be about data warehousing, it turned out to be a session on the use of standards (e.g. CDISC) and tools to transform clinical trial data into usable datasets for statistical analysis. As far as I know, no self respecting statistician would call the resulting set of datasets to be a warehouse. So why is everyone using the term "data warehouse?"

On reflection, the best explanation I can think of is that 1. most people in Life Sciences don't know what the traditional definition of a data warehouse is and 2. lacking this knowledge they assume that a collection of clean datasets when stored in one place and created according to some standard can somehow be labeled a data warehouse.

This is simply not the case.

Exclusive! Software Exhibitors at DIA 2007

The Exhibit floor at the DIA Annual Meeting is bigger than ever. All 557 exhibit booths are taken!

So what about software firms? How many will be there and what will they be showing? By my reckoning, there will be 88 exhibitors showing a spectrum of applications including:

Note: The number within parentheses is the number of vendors exhibiting such software

• Adverse events (10)
• CAPA (3)
• Clinical Data Management (CDM) (9)
• Clinical Data Repository (CDR) (2)
• Clinical supplies (1)
• Collaboration (3)
• Clinical Trial Management (CTMS) (16)
• Data conversion/migration (2)
• Data mining (3)
• Data reporting (3)
• Data visualization (2)
• Data warehousing (1)
• Document management (16)
• eCTD (9)
• EDC (30)
• eLearning (2)
• Electronic review (1)
• Electronic patient reported outcomes (9)
• eSecurity/eSignature (1)
• eSubmissions (11)
• Expert systems (1)
• Imaging/Image transfer (2)
• Interactive Voice Response (IVRS) (6)
• Market Research (1)
• Oncology trial software (1)
• Pharmacokinetics (1)
• Records Management (2)
• Regulatory compliance (1)
• Regulatory operations management (1)
• Structured product labeling (SPL/PIM) (4)
• Statistical analysis (3)
• Text mining (1)
• Text verification (1)
• Trial registries (2)
• Trial simulation (1)

If you are interested in seeing the entire list of exhibitors by the type of software they are showing, just download this file: dia_2007_software_exhibitors.pdf.

If you want my opinion on what's worth seeing, read on.

DIA Annual Meeting - Accelerating drug development with IT

With the annual DIA meeting only about 4 weeks away, it's time for me to shamelessly plug the session that I will be leading. It's called "The Future of Information Technology in Clinical Development and R&D" and will be at 8:30 a.m. on Thursday morning, room number A314.

The session will be a panel discussion on the application of information technologies and the key issues related to their adoption over the next five years. The discussion will focus on the real-world implementation of new technologies and their integration into the existing IT infrastructure and business landscape.

I am pleased to have the following individuals as panelists:

Alan S Louie, PhD
Research Director
Health Industry Insights, an IDC Company

Tim Rochford
Chief Technical Officer
Phase Forward

Sue Dubman, MA
Vice President, Information Technology and Informatics
Theravance, Inc.

The panelists have pretty strong views about the use of information technology in R&D and you won't be disappointed if you attend this session. As you can tell from their affiliations, each panelist comes from a unique segment of our industry and thus also have unique perspectives on the use of information systems in diverse settings. I am confident that we will discuss topics that will not come up in any of the other DIA sessions.

Yes, the session is on the last day of the DIA meeting. I like to think that they have saved the best for last.

I look forward to seeing you there.

IT Topics at DIA 2007

The DIA 2007 Annual Meeting is only a month away.

Did you know that there will be 80 talks related to information technology at DIA 2007?

Even if you did, it would take a bit of work to figure out which ones you want to attend. So, I'm going to make that a lot easier for you right here.

Just scroll through the following list. It's sorted by topic. When you have identified a topic of interest, go to the DIA web site and search the on-line program to find the day and time it is being presented.

By the way, don't forget to come to my own session on Thursday at 8:30 a.m. The topic is "The future of information technology in clinical development and R&D."

And here is a nice chart to show you how the topics break out. Hold down the <Ctrl> key and click on the image to see a bigger version.

Systems Biology and Discovery IT

Here is a great quote by Mark Fishman of Novartis in an article on Systems Biology in the March 12, 2007 issue of Forbes:

"Some of my best friends run systems biology departments. They still haven't been able to explain to me what it means."

Dr. Fishman (see credentials below) should know what he's talking about and has made me feel a whole lot better about my own lack of understanding about this relatively new field.

However, it did get me thinking again about the role of IT in Discovery. In particular, I was reminded that Discovery IT is an extremely complex area shrouded in mystery and looked on with dread by anyone not educated or experienced in that field. Depending on your point-of-view the mystery and complexity is either good or bad.

Good if you are working in Discovery and want the IT guys to stay out of your way. Bad if you have a broader view of IT and want to make an impact within Discovery as well.