Time for the US HHS to take a lesson from early stage venture capitalists re accelerated approval.

Recent case: drug found to have proof of concept but not of benefit (ie does not pass the “so what” test — yet.) So we permit full commercialization in exchange for a promise of eventually completing a confirmatory study proving the thus far hinted at benefit.

Full commercialization means premium pricing, co-pays — the works. With the usual “we don’t negotiate drug prices” hands off on the part of CMS. A great term sheet, if you can get it.

Substitute an early stage…

I’ve become a regular listener of Griffin Jones’ podcast “Inside Reproductive Health,” and his episode this week is particularly enlightening. He had on Brian Levine, a founding RE at CCRM in New York.

I initially met Brian a couple of years ago, and found him to be an admirably entrepreneurial minded doctor. A couple of things came up on the podcast that I found notable. First, a bit of nomenclature. Griffin threw out the term “KPI.” This stands for “key performance indicator.”

There’s an excellent business text, “Measure What Matters” by John Doerr, that defines the term; his point is…

A Digital Future For Women’s Health

I spent some time with the excellent Women’s Health Investment piece by @chrissyfarr et al (https://ovsecondopinion.substack.com/p/why-were-betting-big-on-womens-health). At the risk of mansplaining women’s health, some observations, with an Ob/Gyn/reproductive endocrinologist bias:

The article is spot on that women’s health is only now emerging from healthcare’s analog past — what I leaned in med school, residency and fellowship decades ago. While oncology and immunology have taken advantage of the Rosetta stones of. …

My Columbia Classroom Is Not A Safe Place

Originally published in Forbes, Dec 11, 2015

Today is the last day of class for BIOT 4180, Entrepreneurship in Biotechnology. This semester was a bit of a departure from past versions of the course. Instead of the 400+ students I lectured to last fall, I chose seven particularly motivated entrepreneurs-to-be from a competitive process and put them through an interactive, highly participatory seminar aimed at preparing them to commit to an idea and grind through its transformation into a company.

You’ll never be irrelevant if your self-image is flexible enough to permit…

Working on an IVF investment thesis and wanted yet another data point to support the size of the as-yet unmet market. This question is usually approached (appropriately) by patient metrics: infertility prevalence, recurrent preg loss, oncofertility, LGBTQ eg. Wanting to add another layer to the data, I looked for policy / macroeconomic factors that would lend support to my assumption that reproductive medicine will be one of the fastest, if not the fastest growing area in healthcare in the coming decades. Evidence of negative economic impact of, for example, declining fertility rates, would suggest that expansion of reproductive medicine access…

(originally appeared in Forbes, Mar 7, 2014, titled “Hedging Strategies in a Hot Biotech Market (part 2)”)

The Wall Street Journal reported this morning that the Allman Brothers are ending their yearly March concert series at the Beacon Theater in my Upper West Side neighborhood. The end of winter will never be the same.

I’m bummed about the Allman Brothers at the Beacon, but I think biotechnology has a very bright future, near-term and long-term.

A few days ago, we considered a couple of strategies to protect gains from the recent biotechnology stock run. Let’s take a deeper look.


What does precision medicine mean for biotechnology? It means a future where every inherited genetic disease is curable.

What does precision medicine mean for assisted reproduction? It means a present where these same diseases are preventable. And the prevention is cheaper, and safer, and prevents pain and suffering and restores a normal life expectancy.

As a life sciences investor and advocate for entrepreneurship in the sciences, I have boundless admiration for what has been achieved in biotechnology and with gene therapy. But I cannot help but contrast the current enthusiasm for (and the billions of dollars invested in) our slow…

The Columbia Business School Alumni Association packed a midtown conference room last week to discuss the Business of Reproductive Medicine. I had the privilege of moderating a panel that included RMA of NY founder and reproductive endocrinologist Alan Copperman, Prelude Fertility CEO Susan Hertzberg, Union Square Ventures’ Rebecca Kaden, Anne Morriss, CEO of Genepeeks and reproductive endocrinologist Mylene Yao, CEO of Univfy.

We have all sat through (and on) tedious industry panels where the participants look at each other after every question, each hoping someone else will think of something novel to say and speak up. This panel was the…

Oct 7, 2018

This afternoon I leave for Denver for the American Society of Reproductive Medicine (ASRM) meetings, a conference I have attended since 1988. Having lived in the in vitro fertilization (IVF) world in varying roles for three decades, I offer the following observations about what’s good and what’s bad about assisted reproduction today.

What Can Be Better:

Access — still. There are 7 million women with infertility in the United States. Using in vitro fertilization, approximately 1% of those successfully deliver a baby per year. Imagine another area of medicine where the percentage is that low. …

Last summer, a group of leaders from the world’s in vitro fertilization (IVF) community and a group of engineers from IBM convened a virtual meeting to discuss safety; in particular, the need to reduce misidentification of IVF specimens to zero using a solution called ivfOPEN.

To place the importance of effective specimen identification into perspective, consider the names Jessica and Jennifer Smith.

According to Social Security administration records, about two and a quarter percent of female babies born in the United States in the 1990’s were named Jessica or Jennifer. During that same decade, the most common last name was…

David Sable

bio fund manager, Columbia prof, ex-reproductive endocrinologist, roadie for @PriyaMayadas

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