PDF电子书：The Delivery of Regenerative Medicines and Their Impact on Healthcare

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The Delivery of Regenerative Medicines and Their Impact on Healthcare
0 {; i# O) j; xEdited by
: P. n# S" s0 }+ H0 @! h# fDr. Catherine D. Prescott8 S5 W% e% o* l5 Z! @# t
Professor Dame Julia Polak
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Contents* j4 T" K0 {4 f  I/ R  v3 s8 a' O
Foreword...................................................................................................................vii
6 E# g$ p: B1 ^& |9 E4 qPreface.......................................................................................................................ix
$ t( P- ]* s% l( `% ]Acknowledgments......................................................................................................xi
8 L1 U# x& U0 K' OAbout the Editors.................................................................................................... xiii
6 C7 Z) F( U; g; _# HContributors..............................................................................................................xv
& h' m, R7 x" r- r" cSection 1 I ntroduction; N3 {# T4 F9 {: L: Q$ W, ~: ~
Chapter 1 What Is Regenerative Medicine?...........................................................3: C6 [+ V  X) m$ p
Julia M. Polak7 c: s1 Y9 O" M4 z: o: E, R% A
Section 2 Finance$ m" U# ]3 l5 ]7 w# n
Chapter 2 A New Political–Financial Paradigm for Medical Research:
( e! O! N, K. t; Z; i; J6 C, g/ {: fThe California Model?........................................................................ 11
: L! ~" v0 F1 o& m: Z; ?* [Robert N. Klein and Alan Trounson# h9 w1 k, b: U7 r0 e' M/ ]
Chapter 3 Investment Models: Public Funding in Australia................................ 359 h9 X% j* m/ }6 ]2 g
Graham Macdonald5 ]/ c  u8 d8 x3 q3 h# j
Chapter 4 Canada: Capitalizing on a 50-Year Legacy......................................... 43  t% G: ~5 K# q& u! Y
Andrew Lyall
- G4 ?) V( S+ u( w6 L8 OChapter 5 Investing in Regenerative Medicine: What Drives Private Investors?.... 59
6 M6 @2 }" n; d6 J$ v% A2 S" mCatherine D. Prescott
, H) T! `: s5 c! r% ~; \Chapter 6 Public Investment Models: Coming out of the Closet and
3 w- y. e/ Z! R  @1 V8 J; GGoing Public!...................................................................................... 676 w3 O2 o3 [2 p3 M
Reni Benjamin
( Y- f& _8 a1 l! J- kSection 3 Business Models% v: j) k( C9 N8 l
Chapter 7 Cell-Based Products: Allogeneic.........................................................85" _4 b6 k- ~  o
Paul Kemp; l( l7 ~) ?- g- z
Chapter 8 Autologous Cell-Based Products: Fulfilling the Promise of
; Q5 H& M. ^4 ^/ q- MCell Therapy........................................................................................97
; e+ a7 Z. @  v1 |Eduardo Bravo and Magdalena Blanco-Molina) M4 U6 [1 A2 j
Chapter 9 Business Models for Cord Blood....................................................... 117
6 m. f) \0 O) K) DSuzanne M. Watt/ h1 t% ^  m( Y- s. f) }2 E) Q7 {
Chapter 10 Changing the Game of Drug Discovery............................................ 131
! k5 A7 G* @( L# `0 RJohn Walker
+ J! V6 A1 Q# p- ^3 E- vChapter 11 Discovery of Small Molecule Regenerative Drugs........................... 141
0 T) F7 I7 H: R' m; cYen Choo- Z; O/ b: C; @( j9 v) P) b
Chapter 12 Adoption of Therapeutic Stem Cell Technologies by Large
  x; B$ Z) {) b6 n  e8 `Pharmaceutical Companies............................................................... 153: h/ X; ~. e- X$ Q) o6 y
Alain A. Vertès- e2 j- ]  ^1 ?. t2 e" B
Chapter 13 Role of Tool and Technology Companies in Successful0 ^+ Y- h: i0 D  n  R; ?
Commercialization of Regenerative Medicine.................................. 177
% e7 P- ]  E' X& y2 ]; T- M: d6 `' x* xJoydeep Goswami and Paul Pickering' h# H& T' D0 F8 D# K
Chapter 14 Key Considerations in Manufacturing of Cellular Therapies........... 189" m& e" [( D% a( M
Robert A. Preti
; |* t9 C* Z# o3 g6 y" o+ {1 o$ lChapter 15 State of the Global Regenerative Medicine Industry........................ 2137 g3 I: P8 S* N8 \8 t
R. Lee Buckler, Robert Margolin, and Sarah A. Haecker+ x! g$ H4 P5 m4 V6 t+ a! P# \
Section 4 Intellectual Property
: p* p6 y( p, F6 Y% `Chapter 16 Regenerating Intellectual Property: Europe after WARF................. 239
. [4 z5 M! b# [1 L! [. J, iJulian Hitchcock and Devanand Crease
: Q$ T9 n- J, p" {3 i# N+ ZChapter 17 Protecting Regenerative Medicine Intellectual Property in the
: t$ e$ @) ?5 A, M- tUnited States: Problems and Strategies............................................. 2574 f6 o/ i& \2 s- a' q
David Resnick, Ronald I. Eisenstein, and Joseph M. McWilliams
9 g9 T  e$ t  Z: F; CChapter 18 Impacts of Indian Policies and Laws on Regenerative! _7 k5 F0 A" `  K6 ]( ~0 U" H( `
Medicine Patent Applications........................................................... 281: P5 z! z0 `- r
Prabuddha Ganguli$ M  B/ o6 J, J$ B+ _
Section 5 Regulatory Landscape
/ H3 X8 \$ [5 w2 [Chapter 19 A CATalyst for Change: Regulating Regenerative Medicines in  \6 h; _2 S# I# X7 L* E9 ~
Europe...............................................................................................295  V: ?" G. C1 X
Christopher A. Bravery! m6 u1 H  N8 U) u
Chapter 20 United States Regulatory Reimbursement, Political
# c! |" x2 q" @4 P0 ?1 f! o% CEnvironment, and Strategies for Reform........................................... 323
: M  H, b; Y1 r, d  gMichael J. Werner
9 G; e* r4 F' B+ X5 X) D% wSection 6 Reimbursement6 H4 U: N( ~& f1 ^0 _: M
Chapter 21 The Fourth Hurdle: Reimbursement Strategies for
# I* k# B7 f/ e5 Y2 f9 o" _8 J% H# {Regenerative Medicine in Europe..................................................... 337
' @2 D# N2 T( E; S! @5 |# y1 TFrançois M. Meurgey and Micheline Wille0 @( X9 N8 `) ]* p% ?
Chapter 22 Cellular Therapies and Regenerative Medicine: Preparing for
3 q- s1 c3 K0 f" u& C) gReimbursement in the United States................................................. 351' P7 s3 f4 c, o* M4 Q6 u7 z
Eric Faulkner. S, u: `/ M1 \, ^
Chapter 23 Adoption and Evaluation of Regenerative Medicine and the! J  X( {8 ~0 e5 \& i* H
National Health Service....................................................................3693 B3 c6 ^, ~* U: n& S
Margaret Parton
) o4 h( `3 l' `9 o& A2 XSection 7 I nsurance and Risk Management
* S' H1 r$ l% I' t" \7 YChapter 24 Role of Insurance: If You Build It, Will They Insure It?.................. 379& \) T& ]$ f! j+ E
Matthew Clark# U! u' c$ L- ^/ L& l
Index....................................................................................................................... 3915 e7 v$ `/ {" g% [

% ]. P  J5 W4 g8 R) z5 y( o% k[hide][/hide]

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