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 Healthcare7 g  D; s* \* i
Edited by
! p+ a6 ?- |4 Q" T: vDr. Catherine D. Prescott
. @7 R, ]5 c' o: V7 gProfessor Dame Julia Polak0 q! s: o3 w. T3 P( x5 Y, _

5 O: c% [7 Y& mContents
; O3 b# \3 Q+ c2 q8 \5 XForeword...................................................................................................................vii
- L4 |# E8 D  I( g* w+ @Preface.......................................................................................................................ix
/ H! a: i# l" [Acknowledgments......................................................................................................xi
( \; a1 k5 Z, k& C2 c. MAbout the Editors.................................................................................................... xiii
, \& K. p' ^( }" r& [; P4 IContributors..............................................................................................................xv
3 C, T9 f# l; J8 i3 Z' ESection 1 I ntroduction
9 m2 a  L! f! a% q: O5 ~Chapter 1 What Is Regenerative Medicine?...........................................................3! J! z$ O* {$ X- E2 a
Julia M. Polak
) o& ~& l1 V- j* @' A/ }Section 2 Finance; \0 }4 `" @/ x3 ~* R. e
Chapter 2 A New Political–Financial Paradigm for Medical Research:
1 N: ^. A( f0 {' m( ~2 |# dThe California Model?........................................................................ 115 H6 G7 f$ H( E6 ?' A
Robert N. Klein and Alan Trounson, S; a% b/ u# ^) P9 [+ Q, r
Chapter 3 Investment Models: Public Funding in Australia................................ 35  e( [% p; l' [$ x
Graham Macdonald( m, E8 @' ^9 ]# w2 J5 k% ~
Chapter 4 Canada: Capitalizing on a 50-Year Legacy......................................... 432 s& Z1 Z9 Z  L! s) [* r
Andrew Lyall& H$ b0 p) I* o" i2 X% J9 o  H2 n# }
Chapter 5 Investing in Regenerative Medicine: What Drives Private Investors?.... 59; h" L$ Y) d, i, n
Catherine D. Prescott
; G4 c$ u) i* u9 \8 h3 k8 `, LChapter 6 Public Investment Models: Coming out of the Closet and
; a, H; o6 ~% [4 ZGoing Public!...................................................................................... 67
- R. T4 P0 {) i" T" _Reni Benjamin
  f- Y% y# \  `' @$ ~3 lSection 3 Business Models2 Y* l2 I, W( S( o( A
Chapter 7 Cell-Based Products: Allogeneic.........................................................85, j, |* Y. F5 P6 I& a! `9 a. B
Paul Kemp; J0 G2 v8 Q+ B* ^8 P% G
Chapter 8 Autologous Cell-Based Products: Fulfilling the Promise of
1 X  t( o5 C+ Y% y' gCell Therapy........................................................................................97
; Y% v7 S3 M9 _6 y  v! s$ dEduardo Bravo and Magdalena Blanco-Molina8 E" X: p8 Z: ~/ ^3 @
Chapter 9 Business Models for Cord Blood....................................................... 117
4 N- |: X# t# T: m$ G; ?& PSuzanne M. Watt
7 k8 I$ j# O0 n) c3 D0 r$ AChapter 10 Changing the Game of Drug Discovery............................................ 1310 p! Y% J/ G+ T% z! N
John Walker, Z! I1 }; N( \/ I6 I. @. ^
Chapter 11 Discovery of Small Molecule Regenerative Drugs........................... 141' R; U' `4 e/ I' e3 Y
Yen Choo
7 {, z" x. o; PChapter 12 Adoption of Therapeutic Stem Cell Technologies by Large
5 N; C. H( W+ u1 IPharmaceutical Companies............................................................... 153! N. v; o4 V, U/ ~2 y1 R* ?
Alain A. Vertès
! ?7 G* ^9 m; a% JChapter 13 Role of Tool and Technology Companies in Successful" {# i" o( |( u
Commercialization of Regenerative Medicine.................................. 177
# Q  B' B' G0 FJoydeep Goswami and Paul Pickering
9 F' J# P# s- e. U, o: F2 q9 cChapter 14 Key Considerations in Manufacturing of Cellular Therapies........... 189
4 w0 }! O9 ]: ]* m0 LRobert A. Preti; T9 U. X- C+ {# X. ]' D$ B
Chapter 15 State of the Global Regenerative Medicine Industry........................ 213- d9 S+ }( T: S1 e; V
R. Lee Buckler, Robert Margolin, and Sarah A. Haecker
/ Y8 @3 Z4 G8 {5 jSection 4 Intellectual Property5 Y. P, \# B1 d  V! n0 t
Chapter 16 Regenerating Intellectual Property: Europe after WARF................. 239
$ |) \' `; s/ C( UJulian Hitchcock and Devanand Crease
+ z8 b: g4 o9 M+ {% |0 ?" YChapter 17 Protecting Regenerative Medicine Intellectual Property in the
( I* D+ X0 @) e4 H- U1 _United States: Problems and Strategies............................................. 257
4 _3 x2 P0 r+ ~$ W- F& @David Resnick, Ronald I. Eisenstein, and Joseph M. McWilliams
# I7 f* A# q- n1 a: UChapter 18 Impacts of Indian Policies and Laws on Regenerative8 T$ q- x: ]6 \. a5 ?
Medicine Patent Applications........................................................... 281. s0 A$ x0 p# h* \! t* s, h; @
Prabuddha Ganguli/ J' [& _3 M) T, w: }
Section 5 Regulatory Landscape
5 A7 }$ v( `' w. aChapter 19 A CATalyst for Change: Regulating Regenerative Medicines in
6 B1 J+ s4 i1 fEurope...............................................................................................295
2 _0 X4 V* S* ~2 BChristopher A. Bravery
- ^2 E& M7 {. C  A& @; }! i- U5 lChapter 20 United States Regulatory Reimbursement, Political5 ]5 h' @8 Q# i! q
Environment, and Strategies for Reform........................................... 323& j2 H4 ]* _, G; F% O% D
Michael J. Werner8 X$ \: `3 ?2 H
Section 6 Reimbursement( }8 `, W& m1 W
Chapter 21 The Fourth Hurdle: Reimbursement Strategies for* v1 s) K& W3 e3 Y4 I" R
Regenerative Medicine in Europe..................................................... 337# Y1 w8 u% q& \0 l: Y" M' q$ x
François M. Meurgey and Micheline Wille
. {& v) [4 P2 J# y! q- w7 yChapter 22 Cellular Therapies and Regenerative Medicine: Preparing for
8 [! o( v* v* @# ^+ d9 y8 uReimbursement in the United States................................................. 351
7 C+ P: Y- ~! ~Eric Faulkner
& i! J5 z; Y% B& r1 vChapter 23 Adoption and Evaluation of Regenerative Medicine and the
) ?5 T4 z7 Q, i4 b" d3 m* [National Health Service....................................................................369' h; X! {& e  O
Margaret Parton
9 z9 R! V2 T  [3 T/ HSection 7 I nsurance and Risk Management
' Z2 d/ X# H$ d. M: C& XChapter 24 Role of Insurance: If You Build It, Will They Insure It?.................. 379
# A4 `& [' q! N$ pMatthew Clark2 Q: p  H0 K2 L8 g& E: d5 V0 w
Index....................................................................................................................... 391
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