Category: Entrepreneurs

Reimportation and Zionism

published date
March 9th, 2007 by

Looking to stand out in the vast wave of drug reimportation companies, several –including IsraMeds, Magen David Meds, and Pharmacy International– have focused on reimportation of drugs from Israel to the US. In addition to the usual value proposition of getting identical meds for lower prices, these companies add the bonus of helping support the Israeli economy. Magen David Meds, for example,  buys from community pharmacists.

The companies market to the Jewish community through Jewish newspapers and mailings to synagogues. I recall seeing some of these ads in our local Jewish Advocate.

From the Jewish Telegraphic Agency:

Epstein buys Tamoxifen, a drug used to treat advanced breast cancer, from Pharmacy International…

Epstein, a former New Yorker, learned of the Israeli option through an advertisement in the New York Jewish Week.

“I asked my doctor about it and he said sure,” she said.

She also asked her husband, a rabbi, if it was ethical to buy the drug from a country other than Israel if it could be bought for less.

“He said to do what was best financially,” she said. Fortunately, she said, at the moment she does not have to make a choice. “Tamoxifen is cheaper in Israel than anywhere else.”

Judith Aaronson, 89, of Los Angeles, purchases her medications from Pharmacy International even when she doesn’t save “that much,” she says.

“The drugs are mainly identical to what I would buy here. They look the same. My reasoning is to support Israel. I trust they know what they’re doing,” she said.

Plenty of people in the US –not just Jews– buy Israeli when they can. This is another way to do so.

In good company

published date
February 15th, 2007 by

Today I officially joined the board of iCardiac Technologies, an innovative firm in Rochester, NY, which develops and markets novel ECG-based biomarkers and improved methods for measuring standard ECG-based biomarkers in clinical trials. You can read the press release or the article in the Rochester Business Journal.

The technology holds the promise to deliver exciting benefits for pharmaceutical development and prescribing:

  • Prediction of arrhythmia risks earlier in drug development. This would help companies kill drugs sooner rather than after spending tens of millions or more on late stage trials. It may also help rescue drugs that are safe, but which would be killed based on today’s less accurate assessment tools
  • Better assessment of cardiac risk so prescribers and patients can make better risk/benefit analyses to guide treatment decisions

The company has first-rate business and scientific leadership. The recent announcement of a major collaboration with Pfizer is a good sign.

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