policy

In 2004, California voters approved Prop 71 to fund the field of stem cell research by setting up the California Institute of Regenerative Medicine, or CIRM, with $3 billion. George W. Bush was in the White House at the time, and since 2001, his administration had been limiting research that used embryonic stem cells.

A lot has changed since then. President Obama reversed the limit on embryonic stem cell research. And in 2006, we saw the first use of induced pluripotent stem cells (iPSC), or stem cells that were not derived from human embryos and therefore less ethically controversial. Today, stem cell research is a vast and ever growing field receiving funding from the NIH, philanthropy and private investors.

So, is there still a need for an organization like CIRM?

Here to answer this question is Neil Littman, CIRM’s new Director of Business Development. Neil argues that though stem cell research has become much more mainstream, there is still not a lot private investment and the field depends on government organizations like CIRM for funding.

“The biotech market has been very hot the past couple years," Neil says "But if you drill down into the details, there’s a real discrepancy between the funds that are flowing into therapies like gene therapy and CAR-T as opposed to funds that are flowing into stem cell based therapies.. . . The stem cells are really lagging. So we think there is the need for the continuation of CIRM and for the types of work that we fund because we’re not really seeing a huge uptake from the private sector or other organizations to do this type of work. Some of our programs have seen partnerships--which is great--but it’s only a very small percentage of the overall programs we are funding. We need to be here to act as an accelerating vehicle.”

Why, in this bull biotech market, hasn’t stem cell therapy attracted more private investment? Neil says it’s because the current programs “are not mature enough.”

Neil gives an update on the most promising of the stem cell trials, lists CIRM’s biggest successes, and addresses the toughest challenges, including how best to invest the remaining $1 billion.

As the FDA works away on final guidance for regulating LDTs, various professional groups unhappy with the course of the FDA have put together and hurried their own proposals up to Captiol Hill. The Diagnostic Testing Working Group (DTWG) has had their proposal drafted into legislation which has already been revised once in the House Energy and Commerce Committeee, while proposals from the College of American Pathologists (CAP) and the Association of Molecular Pathology (AMP) have been presented to both the Senate and the House. Various other groups, including the American Medical Association (AMA) and the American College of Medical Genetics (ACMG), have either signed on in support of one of these proposals or are independently lobbying Congress as well.

What chance do these organizations have at persuading Congress to step in and change the course of LDT regulation?

Here to help us parse through these options and get a sense of congressional reception is Scott McGoohan, the new Director of Science and Regulatory Affairs at BIO. Scott says that all of the proposals fit into “three buckets:”

First, there’s the guidance that the FDA is working on which will bring regulatory oversight to thousands of tests which heretofore have not been regulated.

Second, there’s the CAP and AMP proposals which call for the modernization of CLIA which will include increased oversight of laboratory developed tests. These proposals reserve a small set of high risk tests for FDA oversight.

And third, there’s the DTWG who are hoping to get Congress to establish a new center at the FDA for all in vitro diagnostics.

One thing is for sure, says Scott. Whichever proposal wins out, “the general sense is that there will be a change coming with increased regulatory standards for laboratory developed tests.”

Scott joins BIO at a very busy time in Washington for biotech policy. The House has passed the 21st Century Cures Initiative and the Senate Help Committee is doing active work on their health innovation agenda.

“It is an incredible time [in Washington] and an incredible opportunity for transformative regulatory change,” says Scott.

Certainly not all regulatory change is transformative, as Scott reminds at the conclusion of today's show with a story about a crazy bill in Wisconsin.

Guest:

Jim Greenwood, CEO of BIO

Listen (2:49) 2013 - the year the IPO window opened

Listen (6:02) What has been your primary concern this year?

Listen (6:00) How can we raise the value of diagnostics?

Listen (7:44) Is there still broad bipartisan support for the NIH?

Listen (5:18) Protecting reimbursement tops the list in 2014

At the end of each year we do a program where we look back over the year and forward to the next. We're very pleased to have Jim Greenwood, the CEO of BIO, the national trade organization for our industry, here to do this show.

As the CEO of BIO, Jim represents the life science industry in Washington. Back in the Clinton and George W. Bush administrations, Jim learned the political ropes as a congressman from Pennsylvania. He's been a member of an ever declining species--a Rockefeller Republican. Jim's centrist political views no doubt make him a great choice to represent an industry which doesn't fall neatly along political lines. This past year he's fought for protecting drug and diagnostic reimbursement and lobbied against GMO labeling. When it comes to the sequester he admits there wasn't much anyone could do as the cuts affected every department in government. He says that the NIH budget should steadily increase but sounds doubtful that we'll see the kind of increase that happened when the human genome was sequenced.

Has the IPO boom in 2013 been a long overdue window, or a bubble? How can we raise the value of diagnostics? And what is his top priority in 2014? Jim openly shares his thoughts on these questions and more in today's interview.

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Guest:

Lee M. Silver, PhD, Princeton University Bio and Contact Info

Listen (5:56) What is at stake for biotech in the 2012 election?

Listen (2:05) What do you say to those who insist science should not be on the dole?

Listen (7:39) What is your take on the recent report by Obama's Bioethics Panel?

Listen (6:14) California's Prop 37 a "stupid" thing

Listen (5:56) Controversy over bird flu virus not an easy one

Listen (11:54) GenePeeks offers better filtering at sperm banks

Listen (1:13) Is the consumer genetics movement over?

Lee Silver is an expert on biotech and public policy at Princeton University. He is the author of several books including, Remaking Eden: How Genetic Engineering and Cloning Will Remake the American Family. No time is better to get the thoughts of the renowned author than election season.

Silver has been outspoken about biotech policy differences between the Bush and the Obama administrations, and we ask him to extend his thoughts on the upcoming election. He also weighs in on California's Prop 37 requiring the labeling of genetically modified foods. Lee says it's a "stupid" thing. That even if the law is passed, it is not even doable.

Other topics include the controversy over the modification of the bird flu virus and whether the science should have been published, and GenePeeks, Silver's new company that is creating virtual children.

Podcast Sponsor: DNAnexus- Unlocking the potential of DNA-based medicine and biotechnology with a collaborative and scalable DNA data management and analysis technology platform.

Guest:

Gail Maderis, CEO, BayBio Bio and Contact Info

Listen (6:59) State of Bio in California Report

Listen (2:08) Current business climate in California

Listen (6:51) Help with regulation barriers

Listen (7:27) Preview of CALBIO 2012

Listen (1:25) How will election year politics affect bio industry?

Listen (6:39) What else is BayBio doing for their members?

According to a recent report authored by California Healthcare Institute, BayBio, and PWC, California’s biomedical industry employs nearly 270,000 people, generated a revenue of more than $115 billion per year, wins on average $3.2 billion in NIH grants per year and collects over half of US venture capital investment. Joining us today is Gail Maderis, President & CEO of BayBio, the industry organization serving Northern California’s life science community and co-author of the report This year BayBio and BioCom, the industry group from San Diego are teaming up for their yearly conference, called CALBIO, to be held in San Francisco, March 8-9.