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 Healthcare3 G( A# O; |% s) }
Edited by* `: ~# M0 E9 Y0 N
Dr. Catherine D. Prescott
' Y4 s0 P9 e8 AProfessor Dame Julia Polak6 N/ z. u1 |& ~! G1 @
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Contents
) y) X# U: }' P2 s- m. V4 sForeword...................................................................................................................vii
7 T# l4 [2 f! D4 U+ lPreface.......................................................................................................................ix
) n( W9 z( v- dAcknowledgments......................................................................................................xi
* M7 a$ g' l( EAbout the Editors.................................................................................................... xiii
' X- `4 ?3 H) f5 wContributors..............................................................................................................xv
/ O2 Q- r6 R( V* c/ mSection 1 I ntroduction8 r5 A0 X" Z/ }& |3 Q
Chapter 1 What Is Regenerative Medicine?...........................................................3
1 s2 N4 U& y! r* @  v6 X+ bJulia M. Polak
- T* i' `2 N2 }1 GSection 2 Finance0 r. G4 G/ K3 X% i
Chapter 2 A New Political–Financial Paradigm for Medical Research:
0 h4 m3 q! l( G: R& D6 G/ C- _- ^  qThe California Model?........................................................................ 11
$ o2 T; `/ B( U# Y# O2 bRobert N. Klein and Alan Trounson6 P( \  i, v" p# [, Q7 Q. ?
Chapter 3 Investment Models: Public Funding in Australia................................ 35
# P* \- n- _* d& _( S1 EGraham Macdonald
7 f: q- j" K% s" h( x4 wChapter 4 Canada: Capitalizing on a 50-Year Legacy......................................... 43. L5 _* M3 w2 u4 y# a- Q& |9 K3 T
Andrew Lyall
0 c5 [; \! J& Z4 VChapter 5 Investing in Regenerative Medicine: What Drives Private Investors?.... 59
0 b( q  V* L! l% E, f5 ]Catherine D. Prescott' [0 e6 Q7 M. k3 w) s' Q
Chapter 6 Public Investment Models: Coming out of the Closet and
: b" E; r  e: u/ @. e$ @& U9 VGoing Public!...................................................................................... 67
# y! E" o- h7 r3 ~3 mReni Benjamin
3 e. l6 K* U& V$ W6 N! PSection 3 Business Models* o5 G+ j- b* I, ^: H
Chapter 7 Cell-Based Products: Allogeneic.........................................................85! X* H; Z4 |0 n/ J: H: _  {. O9 ]6 J
Paul Kemp
2 C! E; B0 \3 T% B2 }! B; H1 {2 tChapter 8 Autologous Cell-Based Products: Fulfilling the Promise of# j1 D& t6 a1 p" K$ C4 V2 b# ]- Z
Cell Therapy........................................................................................97
$ n5 k4 k# v' b' A1 rEduardo Bravo and Magdalena Blanco-Molina6 B/ Y  J: M* H+ N) i9 P
Chapter 9 Business Models for Cord Blood....................................................... 117  b# h$ [- h$ I3 C) V; Q% {8 z# n
Suzanne M. Watt+ Z% u$ z" H! C, Q( U8 L
Chapter 10 Changing the Game of Drug Discovery............................................ 131
0 V/ }4 b1 U+ L0 {John Walker
9 o% Z+ y9 {1 W- u' DChapter 11 Discovery of Small Molecule Regenerative Drugs........................... 141% J4 Y; w, p: C3 A, x* m5 |
Yen Choo: }* K$ y& h6 f& L
Chapter 12 Adoption of Therapeutic Stem Cell Technologies by Large4 x& |2 W' b' B+ z* g
Pharmaceutical Companies............................................................... 153
4 I: ?$ F% ]4 d4 P6 MAlain A. Vertès
: o" f2 F; v" B  h. M/ ^" AChapter 13 Role of Tool and Technology Companies in Successful
. R8 x- E1 n, V. YCommercialization of Regenerative Medicine.................................. 177
: I5 o8 z$ g9 R- u8 ^: ?Joydeep Goswami and Paul Pickering; B/ ]8 a  D+ ]" x+ `
Chapter 14 Key Considerations in Manufacturing of Cellular Therapies........... 189
2 h4 I" E4 a+ z* ^$ B: B9 hRobert A. Preti' h: e* N8 F$ {
Chapter 15 State of the Global Regenerative Medicine Industry........................ 213$ c0 B, G3 i6 l* f) t, L
R. Lee Buckler, Robert Margolin, and Sarah A. Haecker( ^& T# {; o5 K1 e" `! x" e) C2 o
Section 4 Intellectual Property
3 ~- c' e* k; J! Z* yChapter 16 Regenerating Intellectual Property: Europe after WARF................. 239; ]8 b: {; u8 E. n
Julian Hitchcock and Devanand Crease
! |' X3 @1 S8 W* T4 o$ F  R9 bChapter 17 Protecting Regenerative Medicine Intellectual Property in the
1 {& {1 u( c- X: kUnited States: Problems and Strategies............................................. 257
8 C3 u, Z& O# Y4 {# MDavid Resnick, Ronald I. Eisenstein, and Joseph M. McWilliams! X/ C, _( D; ^4 V$ `4 F' E  A
Chapter 18 Impacts of Indian Policies and Laws on Regenerative# D! l; w7 @. y4 s
Medicine Patent Applications........................................................... 281
% Z5 j# l) j" ^/ d0 ]" H* [Prabuddha Ganguli( j1 P( P. X2 Q- Q& n
Section 5 Regulatory Landscape
5 k8 t: ~) F, y$ B3 I% uChapter 19 A CATalyst for Change: Regulating Regenerative Medicines in
+ E" W9 l* w. q, XEurope...............................................................................................295
0 j3 o2 j  g0 K: w3 o1 i* e: sChristopher A. Bravery
( ^0 x: u1 b8 D# O* HChapter 20 United States Regulatory Reimbursement, Political$ B# C" Z; C" \
Environment, and Strategies for Reform........................................... 323
7 Y- ~: P2 z  ?1 q; FMichael J. Werner7 G; e! R3 r' B0 N
Section 6 Reimbursement4 j& ?9 R5 _( a: G# X
Chapter 21 The Fourth Hurdle: Reimbursement Strategies for( ?+ w4 k! ^) W! s
Regenerative Medicine in Europe..................................................... 337
6 U$ Q, q& w5 W- ^François M. Meurgey and Micheline Wille6 R8 c0 F8 H' U5 n* v
Chapter 22 Cellular Therapies and Regenerative Medicine: Preparing for7 F! }0 W* c, @1 |7 f
Reimbursement in the United States................................................. 3518 S4 J& b6 y- y
Eric Faulkner; q) U/ B: g' o5 B4 U# O
Chapter 23 Adoption and Evaluation of Regenerative Medicine and the
* ^. I# y3 t  t9 R; K1 nNational Health Service....................................................................369
6 t( [0 N- i2 z- HMargaret Parton
& S( F; j, Q; s$ VSection 7 I nsurance and Risk Management6 ^- h" u2 X% i$ Q$ z' @
Chapter 24 Role of Insurance: If You Build It, Will They Insure It?.................. 379
- a6 L/ S4 V* k/ c3 @0 oMatthew Clark
1 ?3 c' a. R6 C5 K6 t7 dIndex....................................................................................................................... 391
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