S U P R A S P I N A T U S

JULY 14, 2008
2008 World Stem Cell Summit, Madison, WI
From StemCell.com's recent newsletter, The Genetics Policy Institute will present the 2008 World Stem Cell Summit in Madison, Wisconsin on September 22-23, 2008. Read more about it.(1)
BIOTECH ARCHIVE INDEX FOR POSTINGS 7/13/07-7/12/08
For the biotech part of Supra, I'd hoped to develop a reference tool in part.

BIOTECH ARCHIVE INDEX OF WEBLINKS PER POSTING 7/13,07 TO 7/12/08
Here is a second document for archives purposes which I also hope will be helpful.

JULY 24, 2008
Benchmarking of research output- a global study
From Biomed Central, a 'Health Research Policy and Systems 2008' paper provides a large set of data which the authors (1) point out needs qualitative aspects estimated.
AUGUST 2, 2008
The Niche blog by Nature.com
Since June 2007, Nature Reports Stem Cells has hosted a blog, 'The Niche" to provide an informal forum for debate and commentary on stem cell research and its wider implications for ethics, policy, business, and medicine.

In the spotlight: FDA key initiatives
Today's FDA webpage show key initatives in their 'Spotlight' focus.
COI- a topic of intense current importance to NIH
From the front page of the 'NIH Record' dated July 25, 2008, (1) a new story about the Ethics Grand Rounds (2) called on NHLBI's (National Heart, Lung, and Blood Institute) Dr. Nancy DiFronzo and the University of Pennsylvania’s Dr. Arthur Caplan to tackle, in microcosm, a topic of intense current importance to NIH at large—how to manage conflict of interest in the grantee community.

AUGUST 5, 2008
GAO examines FDA oversight of promotion of drugs for off label uses
July 2008, US GAO published, 'Prescription Drugs FDA’s Oversight of the Promotion of Drugs for Off-Label Uses', a Report to the Honorable Charles E. Grassley, Ranking Member on Finance , US Senate. (29 pp + appendices)

AUGUST 6, 2008
2008 UN Report on Global AIDS epidemic
The UNAIDS report clearly shows that stronger measures are needed to turn the epidemic around and that ‘knowing your local epidemic’ remains critical to an effective response.(1)
AUGUST 10, 2008
CDER : certain COI aspects+the 1998 perspective.
From CDER's 8/8/08 email news:The Center for Drug Evaluation and Research’s (CDER) recently published/made effective 7/1/2008 CDER’s MAPP 4641.3 ( superseding MAPPs dated 9/23/96 and 3/23/98).
AUGUST 21, 2008
2 New FDA websites:Health Professionals Website(interactive)+ Andy's Take(issues discussed)
August 2008.
FDA recently launched a new Health Professionals web page as part of a larger effort by the agency to increase interactions and communications with health professional organizations.
AUGUST 22, 2008
FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US.
From CDER email news today:
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements.
SEPTEMBER 2, 2008
NYSTEM's Ethics Committee: gamete donation discussion
On September 4, 2008, the Empire State Stem Cell Board (ESSCB) Ethics Committee Meeting will meet from 10:00 a.m. – 3:00 p.m. at the DOH offices, 4th Floor conference room, at 90 Church Street, New York, NY.(1)

SEPTEMBER 6, 2008
FDA's Quarterly Report: products and potential signals of serious risks/new safety information, AERS database.
Sept 5, 2008 FDA announced (1) that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.(2) The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

SEPTEMBER 15, 2008
Empire State Stem Cell Board's Funding Committee
On Friday, September 19, 2008, The ESSCB is scheduled to hold a Funding Committee Meeting from 10:30 a.m. - 3:45 p.m. in the 4th Floor conference room at the DOH offices, 90 Church Street, New York, New York.

NYS Council on Food Policy
From the DOH website: New York State Agriculture Commissioner Patrick Hooker announced the creation of a website dedicated to the NYS Council on Food Policy (CFP).
SEPTEMBER 16, 2008
Human Clinical Trials,Marketing Authorization for Pharmaceuticals-ICH
From FDA/CBER, Sept 4, 2008, a follow up on an ICH Harmonised Tripartite Guideline document, 'Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals' (M3(R2) Current Step 2 version dated 15 July 2008). (1)
Nature news, JAMA publishes study/report on BPA- health effects/disease
'Bisphenol A linked to disease in humans- More studies of the controversial chemical are on the way', a Nature news article by Heidi Ledford, reports that high levels of bisphenol A (BPA) — a chemical used in some containers for food and drink — may be associated with an increased risk of diabetes and cardiovascular disease in humans, a new study has found.

SEPTEMBER 28, 2008
FDA Steering Committee/Expert Working Groups for ICH on Quality, Safety, Efficacy, Electronic Standards
International Conference on Harmonization (ICH) Public Meeting
October 21, 2008, Rockville MD
FDA announced a public meeting entitled “Preparation for ICH meetings in Brussels, Belgium” to provide information and receive comments on the ICH as well as the upcoming meetings in Brussels, Belgium. (1)

OCTOBER 5, 2008
NIH Epigenetics Program, DNA banking, Research Festival Oct 14-17
Sept 29, 2008- NIH announced funding for the new NIH Roadmap Epigenomics Program. Epigenetic processes control normal growth and development, and epigenomics is a study of epigenetic processes at a genome-wide scale.
OCTOBER 8, 2008
ESSCB to discuss gamete donor issues
Empire State Stem Cell Board will hold an Ethics Committee Meeting on Thursday, October 16, 2008,10:00a.m. - 3:30 p.m. at the DOH offices, 90 Church Street, New York, New York.

OCTOBER 15, 2008
"Glowing Proteins- a guiding star for biochemistry"-Royal Swedish Academy of Sciences
The Royal Swedish Academy of Sciences awarded the Nobel Prize in Chemistry for 2008 "for the discovery and development of the green fluorescent protein, GFP".

OCTOBER 19, 2008
"Probing the genomic basis for cancer" MSK
Research planning perspectives: eg. probing the genomic basis for cancer.(1)
OCTOBER 26, 2008
Some NIH tips on finding reliable health information online
'Finding Reliable Health Information Online' , a webpage from an NIH educational initiative provides tips with links (1), and presents a good organizational tool to frame a health info query.

OCTOBER 29, 2008
FDA Science Board Subcommittee on BPA, Scientific Peer Review of FDA's draft assessment of BPA use in food contact applications
FDA observes that this BPA Subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the Subcommittee's report by the Science Board on Oct. 31.(1)
NOVEMBER 7, 2008
Scientists Coax Central Nervous System Cell Regrowth In Lab Mice
There's no apparent "law" aspect to this post, so it's very far afield from our usual fare. But I find this type of development absolutely fascinating:
Scientists have found a way to get damaged nerve cells in the brains of mice to repair themselves, a finding that may lead to new treatments for spinal cord and brain injuries.
By turning off proteins that keep nerve cell growth in check, the researchers were able to stimulate regrowth in mice with damaged optic nerves, they reported on Thursday.
Paul Gillan’s posting.
NOVEMBER 12, 2008
FDA Warns Public of Extortion Scam by FDA Impersonators
Public awareness note: FDA news today reports that FDA is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as 'FDA special agents' or other FDA officials. (1)
NOVEMBER 17, 2008
"New Attitudes, New Opportunities, New York" Welcome news.
November 13, 2008-Governor David A. Paterson announced that New York State has been ranked number one in attracting international investment among all North American destinations – including the United States, Canada and Mexico – according to IBM’s Global Business Services’ recently-released 2007 Global Location Trends Report.

NOVEMBER 26, 2008
NYS DOH Health IT-prescribing webinar series
From NYS DOH Health IT news Nov 18, 2008 "Electronic Prescribing Webinar Series"
eHealth Initiative Webinar Series offers a series of bi-monthly webinars (90 minute educational programs) focused on key topics related to electronic prescribing.(1)

OHRP's 2009 International Compilation of Human Subject Protections laws/regs/guidelines
The newly released 2009 edition of the International Compilation of Human Subject Protections (85 pp) is a compilation, prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services,designed for use by IRBs, researchers, sponsors, and others involved in human subject research around the world.

NOVEMBER 27, 2008
FTC rescinds its 1966 Guidance: the Cambridge Filter Method on cigarette tar/nicotine yields
Federal Trade Commission (FTC) FYI news of Nov 26,2008: FTC has rescinded guidance issued in 1966 (1). Advertisers who include statements of tar and nicotine yields as measured by the Cambridge Filter method must ensure that such claims comport with the FTC Act; in addition advertisers should no longer use the phrase 'by FTC method' or other terms or phrases that state or imply that the Commission's approval or endorsement of the Cambridge Filter Method, or yields derived from that method or other machine-based test methods.

DECEMBER 3, 2008
FDA/WebMD collaboration; FDA Co Branding Policy- Consumer Health Info.
FDA and WebMD announced a collaboration that expands consumers' access to the agency's timely and reliable important health information.
ESSCB's Annual Report: New York's stem cell research program off to a strong start
The 2007-2008 Annual Report of the Empire State Stem Cell Board is now
available online (1).
DECEMBER 30, 2008
ESSCB Funding Committee Meeting 12/18/2008 Awards:Targeted Research and Investigator-Initiated Research
The webcast of the ESSCB Funding committee meeting held December 18 2008 is archived for the public to view on the NYS DOH website.(1)

JANUARY 9, 2009
Governor Paterson’s State of the State Address 2009 and stem cell research
Governor David A. Paterson’s State of the State Address 2009
acknowledged New York State’s historic economic challenges and the difficult choices that all New Yorkers must face in the coming months and years but he also spoke of the strength of character that New Yorkers possess and used his remarks as a call for action, hope and courage even in the face of adversity.

Public policy,on-line medical records, privacy concerns-analysis by CDT
From CDT, here is an up to date and concise resource-- a helpful frame of reference about some of the issues regarding online medical records and related privacy concerns.
JANUARY 21, 2009
Pres. Obama's Proclamation for Inauguration Day, Jan. 20, 2009
From The White House website's "Briefing Room":
In his first official act since taking the oath of office, President Barack Obama issued a proclamation, calling on Americans to serve one another and our common purpose on this National Day of Renewal and Reconciliation 2009.

JANUARY 23, 2009
1/23/09 World's first HESC-based therapy in man by Geron
Big News Release from Geron's Website:1/23/09 Geron Corporation (1) announced that:
the FDA has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.
JANUARY 29, 2009
U.S. Senate Resolution: National Data Privacy Day 1/28/09
From the U.S. Senate Daily Digest, 1/28/09: The Senate agreed on Wed. to S. Res. 25, expressing support for designation of 1/28/09, as ``National Data Privacy Day''.(1)
JANUARY 30, 2009
1/26/09 ESSCB Ethics Committee meeting , (includes funding report update)
The ESSCB Ethics Committee met for their 11th meeting on Jan. 26, 2009 at which the ESSCB Funding Committee reported on their Nov. 6 and Dec 18 meetings.
FEBRUARY 3, 2009
'iSCNT' -interspecies somatic cell nuclear transfer:Animal eggs sources for patient specific stem cells
Scientific research about stem cells continues to burgeon.
MARCH 9, 2009
Pres. Obama: ' Removing Barriers to Responsible Scientific Research Involving Human Stem Cells", "Scientific Integrity"
Monday, March 9th, 2009 - excerpts from The White House blog (1):
...President Obama marked a monumental moment for hope with an audience of Nobel Laureates, leaders of the faith community, and patient advocates.
MARCH 10, 2009
Gov. Paterson applauds Pres. Obama's Action
Excerpts from Governor David A. Paterson’s press release 3/9/09 (1):
In 2007 New York State strengthened its position as a leader in biomedical research when we adopted an 11-year, $600 million initiative that provided State funding for stem cell research, in part to counter President Bush’s policy restricting federal funding for human embryonic stem cell (hESC) research to those hESC lines in existence prior to August 9, 2001.
NIH's new 'Challenge Grants'. Bioethics, 'Nature' on the stem cell EO
Post Edit 3/13/09: From NIH (1):'The American Recovery and Reinvestment Act of 2009 ( the Recovery Act)... [2/17/09] makes supplemental appropriations for job preservation/creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization, for the fiscal year ending 9/30/09, and for other purposes.
MARCH 14, 2009
Pres. Obama's Weekly Address: 'Reversing a Troubling Trend in Food Safety' new FDA appointments
Pres. Obama's Weekly Address (3/14/09), excerpts from the Blog, White House transcript.
MARCH 17, 2009
AHRQ: Methods Guide for Comparative Effectiveness Reviews
Newsletter excerpts from AHRQ News and Numbers 3/16/09 Issue #272 :
AHRQ is excited about the new opportunities under ARRA to provide patients, clinicians, and others evidence-based information to make informed decisions about health care.
MARCH 30, 2009
new global edition website
The New York TImes and Int'l Herald Tribune are launching a new joint website: the Global Edition at global.nytimes.com combining their international reporting and voices from a distinctly global perspective.

APRIL 9, 2009
AERS: a useful tool for FDA
Excerpts from (FDA) CDER news 4/6/09. AERS, the Adverse Event Reporting System,contains over 4 million reports of adverse events and reflects data from 1969 to the present.
MAY 1, 2009
HHS' Planfirst webcast-let science drive the protocol
HHS Secretary Sebelius and DHS Secretary Napolitano hosted a Webcast to answer questions from the American people regarding the H1N1 flu, moderated by Lark McCarthy.
MAY 6, 2009
Expanding the Global Health Initiative
From The White House press releases today, on expanding the global heatlh inititative (1):
In the 21st century, disease flows freely across borders and oceans, and, in recent days, the 2009 H1N1 virus has reminded us of the urgent need for action.
Update on 'HHS' Planfirst webcast-let science drive the protocol'
Here's an UPDATE on my Supra post: 'HHS' Planfirst webcast-let science drive the protocol'
Dr. Doug Melton, HSCI:A conversation about stem cells
Here is an exciting conversation with Dr. Doug Melton, co director of the Harvard Stem Cell Institute, one of the best places in the world to do stem cell reseach.
MAY 13, 2009
ACLU + PUBPAT lawsuit: 'Gene Patents Stifle Patient Access To Medical Care And Critical Research'
5/12/09 The Public Patent Foundation at Benjamin N. Cardozo School of Law (PUBPAT) website news (1), (2), reports that ACLU and PUBPAT filed a lawsuit charging that patents on 2 human genes associated with breast and ovarian cancer stifle research that could lead to cures and limit women's options regarding their medical care.
MAY 24, 2009
PublicMarkup.org, an ongoing experiment in preparing legislation more inclusively
New York's Senate 'Legislation Markup' (1) allows the public to comment on legislation that is under consideration.
JUNE 10, 2009
HHS on health care disparities; CDT on PHR; E-Health Policy in NYS program
HHS has released a new report on health care disparities in America.
JUNE 26, 2009
Welcoming the New FDA.gov website; Transparency Blog with Comments
Commissioner Hamburg recently presented the new FDA.gov website (1-see the video).