The California stem cell agency is going to take a whack Nov. 16 at how it proposes to run its program for research grants to busineses, ranging from ethics to allowable expenses to sharing of biomedical materials.
Biotech businesses have plenty to chew on in the 47 pages of proposed policies that have been released in a nicely timely fashion. No excuses if they don't weigh in now.
The actual occasion is an "interested parties" meeting at sites in San Francisco and San Diego that will be linked telephonically. Here is an Internet link to the meeting notice, which includes a separate link to the 47 pages.
Showing posts with label for-profit research. Show all posts
Showing posts with label for-profit research. Show all posts
Friday, November 09, 2007
Monday, September 10, 2007
California Stem Cell Companies Not Too Displeased with CIRM Rules
Sometimes directors of the $3 billion California stem cell agency worry that they are imposing too many restrictions on future grants to the biotech companies that will be the key to turning research into therapies.
Now comes a report that a number of companies "seem willing to do whatever they must to qualify for state grants." They, in fact, are not looking down their noses at the largess to be disbursed from CIRM.
Reporter Terri Somers of the San Diego Union-Tribune reported on the business response that came out of a CIRM informational meeting Friday that was designed to shape state policy on the qualifications and criteria for companies that receive stem cell grants from the state.
She wrote,
Somers appears to be the only reporter who covered the teleconference meeting on Friday.
Now comes a report that a number of companies "seem willing to do whatever they must to qualify for state grants." They, in fact, are not looking down their noses at the largess to be disbursed from CIRM.
Reporter Terri Somers of the San Diego Union-Tribune reported on the business response that came out of a CIRM informational meeting Friday that was designed to shape state policy on the qualifications and criteria for companies that receive stem cell grants from the state.
She wrote,
"The response yesterday to the institute's questions was a surprise to the institute staff.The response from the companies seems strikingly different than earlier, more hostile reactions from the California Healthcare Institute, which says it represents the biomedical industry in California. However, the reaction was not too surprising to those who attended the Burrill stem cell meeting in San Francisco last spring. A CHI representative appeared on a panel with several representatives of stem cell companies, who did not echo the lobbying group's more strident position.
"Representatives from the biotechnology industry said they only need to tweak the (intellectual property) policy to make it work for companies.
"For instance, the companies don't want to publicly disclose competitive information, such as what percentage of royalties they receive for licensing out their discoveries or the amount of their product sales.
"Industry representatives said they also are concerned about how the state defines money for research and money for goods and services. Currently, Proposition 71, the voter initiative that created the stem cell institute, requires all the research it funds to be conducted in California. Goods and services bought with state funds do not necessarily have to come from California.
"If clinical trials are defined as a 'research' expense, rather than 'goods and services,' it could be a problem, company executives said.
"For speed, efficacy and even savings, companies often conduct clinical trials worldwide in order to get quick enrollment and a diversity of participants."
Somers appears to be the only reporter who covered the teleconference meeting on Friday.
Thursday, August 23, 2007
Cash is Coming: Time for Stem Cell Firms To Show Up
Attention California stem cell firms: If you are looking for millions in grants from the state's stem cell agency and if you want to have an impact on how the money is given out, mark Sept. 7 on your calendar.
On that date, the California Institute for Regenerative Medicine has scheduled an "interested parties" meeting with teleconference locations in San Diego and San Francisco.
Here are some of the topics to be discussed.
"What unique situations might arise in for-profit organizations as opposed to academic or non-profit settings that would impact a current or previously-funded CIRM project (e.g., partnering, bankruptcy)? How should these changes be effectively managed?
"Given that the CIRM will require annual financial and programmatic reports, as well as reports of licensing activities, patent applications, and commercialization activities, what information can reasonably be provided to the CIRM by grantees or their successors? How can the CIRM best monitor the performance and commercial development activities of grantees and licensees of CIRM-funded patented inventions?
"In the context of the CIRM’s preference for California suppliers of goods and services, what proposals or concerns should be considered by the CIRM in managing potential pass-through costs to non-Californian entities?
"Given that there are various methods of accounting for grant-related activities in for-profit organizations, how well do the Proposition 71 definitions of 'direct research funding costs' and 'indirect costs' reflect these activities?"
A couple of things can said about the Sept. 7 session. One is that the CIRM staff has done a fine job of posting a public notice of this session well in advance. That allows time for interested parties to prepare and to come to the table with well-thought-out suggestions. We might add that it is also useful if recommendations are written, which provides more nuanced information that can be easily referred to later. Oral presentations are necessarily shorter and transitory.
The other comment that can be made is that California's biotech community sometimes seems as if it doesn't know that regulations and grant procedures are being established that could have a major impact on their enterprises within the next year or so. While it is difficult to quantify, business turnout at some CIRM sessions seems limited to a handful of firms. CIRM has $3 billion to hand out. If biotech firms want a healthy chunk of that on good terms, now is the time to make their case. Otherwise, they can continue to wrestle with the usual financial alligators. And, as they know, that can be an unpleasant and fruitless experience.
On that date, the California Institute for Regenerative Medicine has scheduled an "interested parties" meeting with teleconference locations in San Diego and San Francisco.
Here are some of the topics to be discussed.
"What unique situations might arise in for-profit organizations as opposed to academic or non-profit settings that would impact a current or previously-funded CIRM project (e.g., partnering, bankruptcy)? How should these changes be effectively managed?
"Given that the CIRM will require annual financial and programmatic reports, as well as reports of licensing activities, patent applications, and commercialization activities, what information can reasonably be provided to the CIRM by grantees or their successors? How can the CIRM best monitor the performance and commercial development activities of grantees and licensees of CIRM-funded patented inventions?
"In the context of the CIRM’s preference for California suppliers of goods and services, what proposals or concerns should be considered by the CIRM in managing potential pass-through costs to non-Californian entities?
"Given that there are various methods of accounting for grant-related activities in for-profit organizations, how well do the Proposition 71 definitions of 'direct research funding costs' and 'indirect costs' reflect these activities?"
A couple of things can said about the Sept. 7 session. One is that the CIRM staff has done a fine job of posting a public notice of this session well in advance. That allows time for interested parties to prepare and to come to the table with well-thought-out suggestions. We might add that it is also useful if recommendations are written, which provides more nuanced information that can be easily referred to later. Oral presentations are necessarily shorter and transitory.
The other comment that can be made is that California's biotech community sometimes seems as if it doesn't know that regulations and grant procedures are being established that could have a major impact on their enterprises within the next year or so. While it is difficult to quantify, business turnout at some CIRM sessions seems limited to a handful of firms. CIRM has $3 billion to hand out. If biotech firms want a healthy chunk of that on good terms, now is the time to make their case. Otherwise, they can continue to wrestle with the usual financial alligators. And, as they know, that can be an unpleasant and fruitless experience.
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