Category: Entrepreneurs

Pfizer and iCardiac announce cardiac safety alliance

published date
January 30th, 2007 by

I recently joined the board of iCardiac Technologies, which is commercializing ECG analysis technology from the University of Rochester’s renowned Heart Research Follow-Up Program (HRFUP). I’m excited to pass along the news that Pfizer and iCardiac have agreed to an alliance. According to the press release:

The aim of the research alliance is the further development of iCardiac’s COMPAS platform and advanced ECG markers for use in the safety testing of in-development and on-market drugs, and includes a cross-licensing arrangement by which iCardiac will receive rights to ECG analysis technologies developed within Pfizer.

Under the terms of the agreement, iCardiac and Pfizer will collaborate on a research program comprised of a series of studies, including retrospective and prospective ECG data analyses. iCardiac will receive an equity investment and technology license payment, plus research and development funding over the term of the alliance. iCardiac will retain commercial rights to the validated technology platform and new biomarkers for future application in cardiac safety clinical trials and technologies.

…As part of the Critical Path Initiative, the FDA has stated that there is a significant opportunity to further improve the cardiac safety testing process and identify better markers of cardiac risk. The long-term goal of the alliance is to improve the precision, increase the speed and reduce the costs of cardiac safety clinical trials. Â

Pfizer spokeswoman Kate Robbins said:

“Cardiac safety is one of the most challenging hurdles in developing new medicines. We support the development of new tools that may enhance our ability to predict the safety of potential new medicines in early stages of research and development.”

iCardiac’s tools are exciting in two ways: 1) They may knock out drugs with cardiac safety problems earlier in development –saving lives, money, and time. 2) For certain drugs that are wrongly flagged as potentially dangerous using cruder methods, they may allow development to proceed. That would help more good drugs make it to market.

Congratulations to CEO Mikael Totterman and the entire iCardiac Technologies team.

Roll on Columbia, roll on

published date
November 29th, 2006 by

Roll on Columbia, roll on

From the Columbia University Spectator:

When it comes to patents, Columbia is the big man across campuses.According to the University, patent-related deals pulled in more than $230 million in the 2006 fiscal year, more than almost any other university earned on such deals. The University has made patent-building one of its most significant endeavors, focusing on high-powered discoveries and pushing scientific research toward lucrative investment.
In light of this, other institutions have taken a cue; the Crimson reported in November 2004 that after Harvard made $24 million to Columbia’s $178 million in 2003, the university planned to overhaul its own technology transfer office in hopes of cashing in.
The article goes on to cite some individual patents that have brought in a lot of money, but the difference between Columbia and Harvard is not just random. Harvard has been hyper-vigilant about conflict of interest laws, to the point of discouraging industry collaboration and driving away some top innovators.
Former Harvard President Larry Summers understood this and hoped to make the climate more business-friendly, but that effort is now on hold.

Job opening for Vice President of Software Development at iCardiac Technologies

published date
October 5th, 2006 by

Job opening for Vice President of Software Development at iCardiac Technologies

Over the coming days and months I plan to post a fair bit about iCardiac Technologies, a new company I’m involved with that provides advanced cardiac safety analysis technologies for clinical trials. Think of it as a more sophisticated version of eResearch Technology. The company emerged from the Heart Research Follow-up Program at the University of Rochester and is the winner of the Frost & Sullivan Innovation of the Year Award for Cardiac Safety Analytics.

Right now they are seeking a Vice President of Software Development. Contact Mike Totterman [mikael DOT totterman AT icardiac DOT com] if you are interested.

JOB OVERVIEW:

The Vice President of Software Development is responsible for the software development operations of iCardiac Technologies. You will be overseeing a staff of algorithm developers, software developers and software testers to ensure that the companyÂ’s suite of products meet user requirements for analyzing electrocardiogram data from pharmaceutical clinical trials in determining a drugÂ’s cardio toxicity. Familiarity with structured software life cycle management systems (such as AAMI/ANSI SW:68) including use of standard operating procedures common in the medical software arena is a critical requirement for the position. Leadership experience in environments with strong quality systems such as those defined by the ISO guidelines such as ISO 9001:2000 or ISO 13485 or similar quality systems is important for the position. Additionally, the position requires comfort and understanding of FDA regulations including FDA 21 CFR part 820 as it pertains to design control in software development (or similar structured design control procedures), FDA 21 CFR part 11 for digital signatures as well as strong understanding of structured validation requirements as specified in FDAÂ’s Guidelines for Use of Computerized Systems in Clinical Trials.

QUALIFICATIONS:

  • Bachelors or Masters degree in computer science with strong academic performance
  • Previous experience in leading a software development team
  • Strong understanding of software life cycle management processes
  • Strong communication skills and ability to work with senior management to prioritize various software development projects to meet customer requirements and company financial goal
  • Previous experience in FDA regulated software environments such as software development for clinical trials or software development for medical devices
  • Experience with C++, C# as well as database programming
  • Previous experience with quality systems as they relate to software development
  • Ability to learn quickly, function independently and handle increasing levels of responsibility

Here comes Healia

published date
September 18th, 2006 by

Here comes Healia

I devote a fair amount of space on this blog to whining about Google (1, 2, 3, 4, 5, 6) . The company retains too much information about searchers and fundamentally is more interested in segmenting searchers for advertisers than in serving the end user. However, I have to admit they are damn good at what they do, and like most people I know, I use Google all the time despite my reservations.

I’ve mentioned before a new health care focused search engine, Healia. It’s been in beta for awhile; it’s now being launched officially. I like Healia’s philosophy:

Generic search engines provide good results for many general topic areas, but they often provide questionable or “harmful” results for many health-related topics. This is especially true for health topics that are commonly the subject of scams and questionable activities. For example, most search engines produce links to questionable results promoting or selling unproven products and services in response to searches within the areas of alternative medicine, nutrition, diet and weight loss, prescription drugs, and cures. Healia’s innovative technology ensures you get high quality results from the most trusted sources on the Web.

One of the nice things about Healia is the ability to filter searches. Type in a search term like “diabetes” and Healia will give you the opportunity to filter the results by criteria such as male/female, kids/teens/seniors, and to look for content of different types, e.g., basic/advanced reading, easy to scan/fast loading/interactive tools. Then there are a number of tabs containing results by type, such as symptoms, diagnosis/tests, and treatment.

I tried a search on diabetes, which should be a good term since there is so much published about the topic and the filtering function should be helpful. I decided to filter for males and basic reading. Results weren’t good. I clicked the Symptoms tab and found the following:

  • The first listing was a dead link for Advocate Health. I’m not even sure from the description that the result was relevant.
  • The second listing was to the Polycystic Ovarian Syndrome Association discussion board, and contained a marginally relevant post related to gestational diabetes.

Moving on to the Diagnosis/Tests tab, results weren’t much better:

I did receive a warning that, “Selecting multiple filters may produce few results; deselect one or more filters to see more links.” But for a topic as broad as diabetes, that’s a fairly lame message. Plus the problem wasn’t the number of links but the quality of them. When I deselected the links I got more relevant results. Maybe that’s because there isn’t that much of a difference between men and women for diabetes, I don’t know. In any case it requires too much thinking and the results aren’t clearly better than Google’s.

I tried searching on Google for diabetes symptoms males and got better results. Google’s algorithm incorporated the “males” term but since it wasn’t terribly differentiating it didn’t throw off the results :

  • The first link was to MaleHealth: Diabetes, which talked about diabetes symptoms and had links to male health topics
  • There was a sponsored link to Diabetes Symptom Directory

I then went to Google Co-op, which I’ve maligned in the past, and typed in diabetes. It brought up a similar list of filters and topics as Healia, but it only lets you select one filter at a time (probably a good idea given the Healia experience). There’s also a long list of sponsored ads. I then selected symptoms and got relevant results and two relevant ads. Same deal when I selected tests/diagnosis.

I don’t doubt that there are other searches where Healia does a better job than Google. In particular, searches for topics like diet pills or Viagra –or any topic that generates a lot of spam– are likely to benefit from human moderation.

Unfortunately for Healia it will need to be not just at parity but clearly superior to Google to persuade people to use it. Considering that Google has a gaggle of unpaid consultants helping it improve its health care searches, that’s going to be tough. (You don’t see as many volunteers for Microsoft, helping them keep upstarts like Linux at bay!)

We really do need alternatives to Google for health care searches, and I hope Healia can hang in there. At a minimum, it will have to make the filters work better to win me over.

Help wanted

published date
September 15th, 2006 by

Help wanted

It’s been hard to find a replacement for outgoing National Coordinator for Health Information Technology, Dr. David Brailer. An interim replacement already in government service is likely to be named soon. According to Health Data Management:

There are several reasons why it’s been a tough position to fill. First, it’s a political position, which means it requires a candidate with bargaining skills. And it’s likely to last only two years, until the end of President Bush’s term in office. In addition, “the position has to be politically screened,” Brailer noted. “That means there are fewer people interested in doing the job and so a smaller universe of candidates.”

Here’s what the unofficial job description would look like:

Cheerleader wanted! Must be excited about heading a department with no authority and a small, shrinking budget. Must toe the Bush Administration line. Low pay, long hours, heavy travel, no chance of advancement. Must have an MD and be an expert in technology.

A major issue complicating the search is the idea that the candidate needs to be a physician. All the people I’ve heard about being approached have been docs. It would make sense to me to open up the search to health care IT experts more broadly. The only real advantage of the MD is the credibility it brings in dealing with physicians. That can be challenging for a non-doc, but it’s a challenge that is surmounted regularly in the private sector.