加州干细胞研究所升级版规划出台(CIRM 2.0)

tcaact

CIRM 2.0的规划将加快项目审批速度、加大审评频度、更积极地投资和协助项目发展，并纳入病人等建立临床咨询委员会(Clinical Advisory Panel)。值得国内相关机构和组织借鉴。
! n; y. P  b$ \) R! a% H6 K
2 }+ T( n! _* }& b  Y* R7 G% GURL: http://www.cirm.ca.gov/about-cir ... 12312014/california’s-stem-cell-agency-officially-launches-cirm* Q  j% D( J, T+ B

# b  e9 K% e, i) A  e$ `1 T另有CIRM主席 Dr. C. Randal Mills 的视频文件，阐述CIRB 2.0：http://www.cirm.ca.gov/our-progr ... mills-president-ceo
8 O8 Y3 k* T' V5 s5 \6 u2 x. s0 i
$ Q7 w, i" Z9 w0 h- q

California’s stem cell agency officially launches CIRM 2.0

; i$ C, Z- I5 q9 d- E( e
( _2 ]; E) g% D/ m" w+ @( eDecember 31, 2014
' j4 Q( o# D% i$ y0 n% v2 j: D& cSan Francisco, CA – “Our mission is to accelerate the development of stem cell therapies for patients with unmet medical needs. Today, in officially launching the first three programs under CIRM 2.0, we have boldly reaffirmed our commitment to continuously seek new and innovative ways to better serve that mission,” says Dr. C. Randal Mills, the President and CEO of CIRM, California’s stem cell agency.
: Y3 S  ^( f$ C* F7 `, x) U3 x: W" Z: J& S1 @
CIRM 2.0 is a radical overhaul of the way the Agency does business, implementing efficient new systems and programs that place added emphasis on speed, partnerships, and patients.- n5 }+ Q+ A3 ~7 \6 X' W5 m; \

1 I$ \1 B. }+ y/ u  G7 YCIRM 2.0 makes it easier for both companies and academic researchers with promising projects to partner with CIRM to get the support they need when they need it, reducing the time from application to funding from around two years to just 120 days.: C, w9 q4 v* @: s4 k: F
2 T) t5 h1 r2 O( v. v, @3 ~( j
Highlights of CIRM 2.0 improvements include:; ]; F. b! s9 a4 S! J9 \' _/ {! F
) j1 n6 D$ q& Z  d1 l
Speed:  In addition in to reducing the time to funding to 120 days, new clinical stage projects may be submitted to CIRM year round instead of only once or twice a year as in the past. Applications simply have to be filed by 5pm PT on the last business day of the month to be eligible for consideration in that round of review. If you miss the deadline one month, you only have to wait 30 days for the next one.' c6 j# _, Y% C/ c3 [9 l

& f# H' K1 W4 g: L; {  x* |2 QPartnerships:  Under CIRM 2.0, the Agency will not act as a passive funding source, but instead will be an active investor, devoting significant internal resources and leveraging its vast external team of world-class subject matter experts to advance the projects it selects. This will result in a true partnership that both accelerates programs and gives them the greatest opportunity for success.
" U3 R6 s$ M' M! v! P9 S& q" m- C$ Q( P$ ~8 E
Patients: Each project will be partnered with a project-specific Clinical Advisory Panel  (CAP) to help advise and guide it forward.  Importantly, every panel will include at least one patient advisor with first-hand experience of the specific condition, who will provide input, recommendations and the appropriate sense of urgency that can only come from the unique perspective of someone living with the disease.
" L* z5 G8 e1 R
# b7 z0 B& B- |. j2 H- SThe CIRM Board, at its meeting on December 11, 2014, unanimously approved $50M in funding to invest in clinical trials for the first six months of the program The first three programs under the initiative apply to projects that are ready to start a clinical trial or are doing the work required by the Food and Drug Administration to gain approval for a clinical trial. However, in 2015 CIRM will present proposals to the Board to expand the program to include earlier stage projects in the discovery and translational stages.
6 u  \/ D8 r6 ?+ f! B6 R8 [
3 }9 g/ z- M6 r) D% jYou can read the Program Announcements for the first three funding opportunities here:  Y  T+ F' g6 r0 F, p
- d0 V5 Y8 N. K5 t" ~  B" L
PA 15-01: Partnering opportunity for late stage preclinical projects
1 j, Q& F. g$ y. \& Y1 O" H* c6 T7 n* ~, S, ^: R& B2 g
PA 15-02: Partnering opportunity for clinical trial stage projects
' ]" i" x1 Q4 ?4 E$ c" S3 Y
7 M6 |- `) Q0 S5 W0 YPA 15-03: Partnering opportunity for supplemental accelerating activities- K( F9 b0 l: ^5 x9 l& y
* d5 r1 J& q1 k6 ^2 R2 }
“We are thrilled to launch such a significant new initiative this quickly,” said Mills. "It is a testament to the professionalism of the CIRM team and their dedication to the urgency and importance of our mission. My sincere thanks go out to them and to the CIRM Board, who worked hand-in-hand to make it happen and quickly deliver this high-quality product.”0 {3 m* F  C0 ^7 v- X' h( C

7 U/ y/ K# m  b/ \' d6 `: Z8 V' q7 h
6 E3 M- F5 c% T8 u7 K6 fAbout CIRM
: U0 P5 l1 \" n9 `! h
! E" o9 [) g/ k/ J' nAt CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency commensurate with that mission.
8 _: M9 ]/ a3 H8 Q9 o. {1 _$ T8 }* M; n) {! ~. U- F2 W
To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell technologies.: Y( `3 ~; h7 l

" Z. K, e% h5 {% Y" y4 Z' RWith $3 billion in funding and approximately 300 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality.