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

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; h$ z7 Z9 Q/ G7 \* _6 \# X( \The Delivery of Regenerative Medicines and Their Impact on Healthcare
, b4 M' ]/ X, D4 _: i; M: yEdited by
' R8 ^2 b* @, Q( {6 c/ `* ]Dr. Catherine D. Prescott  m2 l7 n7 P" o1 h5 r" f
Professor Dame Julia Polak
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4 [" k; d  A4 t6 l; x) \) YContents
; p# i8 {' d7 n, hForeword...................................................................................................................vii( n# J  f, L, y0 k" c' w
Preface.......................................................................................................................ix
. @1 Y' j  z& |  S7 m5 ^Acknowledgments......................................................................................................xi
1 j% j) R5 t" `* f% zAbout the Editors.................................................................................................... xiii
9 w. q) D4 g5 L: tContributors..............................................................................................................xv
, ^3 s) ^# i* O& F! ?8 kSection 1 I ntroduction4 F% D) {: E4 E4 v' b% f8 g3 Y
Chapter 1 What Is Regenerative Medicine?...........................................................3
; a# V& i- ~( }% v- |0 SJulia M. Polak. c7 L9 [# Y4 a: o
Section 2 Finance
* T. {9 g1 z$ t, x! ~8 KChapter 2 A New Political–Financial Paradigm for Medical Research:
& _8 X4 l; n  M) x: Z& hThe California Model?........................................................................ 11- k: ~9 X7 }+ c0 r# t
Robert N. Klein and Alan Trounson0 |; ]* Q! {! @* g' g
Chapter 3 Investment Models: Public Funding in Australia................................ 35
' B+ O( k4 F8 L) g3 ^; qGraham Macdonald
9 h$ L3 i  Y2 g/ ?6 G8 A) iChapter 4 Canada: Capitalizing on a 50-Year Legacy......................................... 434 ]6 ]( U: B, a9 A
Andrew Lyall
( P( g/ j$ v7 E3 A2 z+ X0 i0 N, X  MChapter 5 Investing in Regenerative Medicine: What Drives Private Investors?.... 592 H3 \5 P. b5 @- ]/ r
Catherine D. Prescott
4 }% b, W  i) l, p3 F/ l/ eChapter 6 Public Investment Models: Coming out of the Closet and, V4 w7 }2 G# s% ~7 Y( K
Going Public!...................................................................................... 67: ^2 r% B7 ^1 t! p" n: \9 h
Reni Benjamin  @3 v! `* u6 M" B$ I& Q
Section 3 Business Models: q# o: Y$ H, `$ A, m
Chapter 7 Cell-Based Products: Allogeneic.........................................................85" g$ `" |- {+ }2 T6 I* e
Paul Kemp
  d8 U  |- O: |8 }6 ?: e0 qChapter 8 Autologous Cell-Based Products: Fulfilling the Promise of9 L* e- C2 D: D* q
Cell Therapy........................................................................................97  ?$ R& ^! |, t9 p& @
Eduardo Bravo and Magdalena Blanco-Molina
7 A* N. q. I9 b# ]* WChapter 9 Business Models for Cord Blood....................................................... 117
, Y8 A" {! F% Z4 H: U$ ~6 oSuzanne M. Watt: a+ x/ m" d7 m" x! U
Chapter 10 Changing the Game of Drug Discovery............................................ 131
. \% p; I1 ^3 zJohn Walker( T) m- c- ?. K7 L, }
Chapter 11 Discovery of Small Molecule Regenerative Drugs........................... 141. t4 I# U* \" g" M( V# Z) v
Yen Choo
9 R& z% R" W! g) c# [Chapter 12 Adoption of Therapeutic Stem Cell Technologies by Large: |, _3 P0 d8 y/ P* E& h4 Q/ g* \
Pharmaceutical Companies............................................................... 1534 r" l; y8 }1 b7 w. y' r$ M& H' ^
Alain A. Vertès
) S$ G3 g% C# r6 d' }Chapter 13 Role of Tool and Technology Companies in Successful
. O9 W# W+ }# z( J4 i8 OCommercialization of Regenerative Medicine.................................. 177$ k0 v3 }+ m5 |9 z: i1 W5 {3 D. S
Joydeep Goswami and Paul Pickering% U% x. P+ I! l' K: R8 m
Chapter 14 Key Considerations in Manufacturing of Cellular Therapies........... 1894 b% @! T2 D8 ?( Y1 [5 U# x
Robert A. Preti
4 q, Q( H- s4 u  ?Chapter 15 State of the Global Regenerative Medicine Industry........................ 213
% X' v* V* K% C: H0 NR. Lee Buckler, Robert Margolin, and Sarah A. Haecker
# z" V7 b: l8 r& [* ]& GSection 4 Intellectual Property& t3 F7 v5 f! R- G8 [4 y
Chapter 16 Regenerating Intellectual Property: Europe after WARF................. 239
% q$ Q# T( z& RJulian Hitchcock and Devanand Crease* E+ ?& C/ _# ]7 H( S0 X, a
Chapter 17 Protecting Regenerative Medicine Intellectual Property in the
5 ]5 W. n) x( ]2 v, v4 J3 BUnited States: Problems and Strategies............................................. 257
; K) {1 w3 A1 T/ ~9 {David Resnick, Ronald I. Eisenstein, and Joseph M. McWilliams
  U; G2 S  U, \, JChapter 18 Impacts of Indian Policies and Laws on Regenerative
$ J6 G0 V2 y! `! wMedicine Patent Applications........................................................... 281
# |* [$ y+ J- ?; ~" |/ gPrabuddha Ganguli
: g; S5 Q% X* j# z) @2 MSection 5 Regulatory Landscape
" V1 B3 j, r1 a2 x; ?Chapter 19 A CATalyst for Change: Regulating Regenerative Medicines in
+ n! b% P& s/ ?3 Q/ J) s/ W- oEurope...............................................................................................295
8 {' y$ X# m6 fChristopher A. Bravery( {' O$ o; z, x/ J6 y
Chapter 20 United States Regulatory Reimbursement, Political6 G, C  ?! u) w1 \! K
Environment, and Strategies for Reform........................................... 3230 h: ~- U6 q% x9 f
Michael J. Werner
9 S, X1 R, O3 O: q$ O1 h/ E: FSection 6 Reimbursement3 z$ u! W. r) @( Q, K  t" d, {
Chapter 21 The Fourth Hurdle: Reimbursement Strategies for
( d5 A3 i* M: BRegenerative Medicine in Europe..................................................... 337( d+ ]) W9 Y* n! v/ g
François M. Meurgey and Micheline Wille" ]. ?& G  H4 @5 I8 _/ \# b. g
Chapter 22 Cellular Therapies and Regenerative Medicine: Preparing for; l+ Y# H1 @3 V! e, W# }9 k3 s" d
Reimbursement in the United States................................................. 351* S7 i( P2 x! z4 h  W5 J! k
Eric Faulkner
7 {) O- |* d  Y, k$ f0 JChapter 23 Adoption and Evaluation of Regenerative Medicine and the
: v: g" {, @; f# G2 q* v& qNational Health Service....................................................................369: c& |3 `1 F4 U! [; H: p
Margaret Parton
0 J# e+ p/ W* [' f, X8 U8 X+ QSection 7 I nsurance and Risk Management
5 s; h* u) T" U7 [! K5 GChapter 24 Role of Insurance: If You Build It, Will They Insure It?.................. 379% H- N9 L6 c: `
Matthew Clark
  i# @) u6 S6 j7 t- |. eIndex....................................................................................................................... 391# a8 U9 a! _; C$ L  w0 U7 \6 i: u

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