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 Healthcare2 n8 }; _$ [) F* P% A3 n# l
Edited by
2 J0 _8 E' e$ C9 }# o) A  C3 FDr. Catherine D. Prescott- l% e4 P! b+ Z1 z' G9 G
Professor Dame Julia Polak' ?" u7 E: s4 i6 ]" u) J0 K

: s- N" N6 q/ w# z5 j. D* }/ E3 jContents
0 [) ~! C. R5 a: I5 o5 I( UForeword...................................................................................................................vii0 i- R6 N& [, u( Z: I; U
Preface.......................................................................................................................ix
% M2 v" b% B' v( o8 vAcknowledgments......................................................................................................xi
1 h- X. P" R% m  W: {: MAbout the Editors.................................................................................................... xiii
/ V: \1 D9 c' W& R5 ]Contributors..............................................................................................................xv
5 G  [6 i. o. Z" mSection 1 I ntroduction) H' n, z6 ]& @1 K' B
Chapter 1 What Is Regenerative Medicine?...........................................................3
8 ]3 e# k3 |+ Q3 eJulia M. Polak3 \8 k) ]2 G6 J) X* F5 n8 A
Section 2 Finance* b& T( O* Q. e+ m0 |% ]
Chapter 2 A New Political–Financial Paradigm for Medical Research:
" {1 U& U4 |: P- _$ ~6 QThe California Model?........................................................................ 11
4 K' T  N5 D; Z) CRobert N. Klein and Alan Trounson6 J1 g; R( n* ?, }: V& J( D
Chapter 3 Investment Models: Public Funding in Australia................................ 35$ D) n' ~! N0 E5 d/ J: Z$ b# w
Graham Macdonald
  F# X2 {# c4 j5 m$ Z& bChapter 4 Canada: Capitalizing on a 50-Year Legacy......................................... 436 N/ K3 @  B0 V; x' i4 ^: Q
Andrew Lyall
* v, s" o' I" V: r" M/ [9 p+ aChapter 5 Investing in Regenerative Medicine: What Drives Private Investors?.... 59
* v; a8 U5 C& Z( N/ `/ j! w8 JCatherine D. Prescott
3 \/ x7 X2 g" k/ Y) R4 KChapter 6 Public Investment Models: Coming out of the Closet and1 _/ m7 ^4 p; C, l
Going Public!...................................................................................... 67
" E) ~" C2 u* k8 N3 s) H+ }! mReni Benjamin
3 {* A; l8 `; T" V; O( ?Section 3 Business Models
# d: P0 X- e* lChapter 7 Cell-Based Products: Allogeneic.........................................................85
2 ?! `" a# r8 H3 cPaul Kemp
; h" d/ z  c9 }4 z( ~1 TChapter 8 Autologous Cell-Based Products: Fulfilling the Promise of
0 Z$ _; X+ ?* vCell Therapy........................................................................................97: b1 `) W& \2 k: X6 ]: h
Eduardo Bravo and Magdalena Blanco-Molina
$ j5 B  M" f( D8 IChapter 9 Business Models for Cord Blood....................................................... 117( Z, ]9 T6 c& s, Q% L/ g; z2 b
Suzanne M. Watt
# X( v" L, m2 A( N" dChapter 10 Changing the Game of Drug Discovery............................................ 131) a8 f1 c( t- _
John Walker. L: A. M# `" P/ y. O  c( M: [- g
Chapter 11 Discovery of Small Molecule Regenerative Drugs........................... 141
: I; s" X4 D' F3 iYen Choo/ a# V+ V' P; X0 l1 t  m, S
Chapter 12 Adoption of Therapeutic Stem Cell Technologies by Large' ~) R: M: N9 g' N+ ^
Pharmaceutical Companies............................................................... 153
1 v2 M. A4 J( G& S. S- v3 N$ gAlain A. Vertès7 s2 |  y1 D4 M0 W7 H6 W8 w% `+ @
Chapter 13 Role of Tool and Technology Companies in Successful
+ d3 [/ S4 n$ c" J4 ^) @. I9 CCommercialization of Regenerative Medicine.................................. 177
$ j5 `8 x, n7 g; uJoydeep Goswami and Paul Pickering( h0 p: A* Y: R7 w& Y
Chapter 14 Key Considerations in Manufacturing of Cellular Therapies........... 189
# Y. x$ w- C  [- g; {% @7 W$ NRobert A. Preti9 U1 D- k9 Q( Z& I% v( w6 G3 B
Chapter 15 State of the Global Regenerative Medicine Industry........................ 213+ F- `1 O  w6 P$ F
R. Lee Buckler, Robert Margolin, and Sarah A. Haecker
* L- S" Y9 X3 o( e7 N3 c! r' ^Section 4 Intellectual Property: l4 W. C% C0 c: }/ d+ E2 u
Chapter 16 Regenerating Intellectual Property: Europe after WARF................. 239$ l0 T3 P/ ~, E; M
Julian Hitchcock and Devanand Crease
2 G2 `  o3 D: p* Z- l+ yChapter 17 Protecting Regenerative Medicine Intellectual Property in the
# s( P3 k! }5 }# P/ P; p7 aUnited States: Problems and Strategies............................................. 2573 [7 v9 m. Q0 ]2 O
David Resnick, Ronald I. Eisenstein, and Joseph M. McWilliams- i" [6 `& J9 A( W! z; ^
Chapter 18 Impacts of Indian Policies and Laws on Regenerative
2 \0 s# _. B4 t! F1 |Medicine Patent Applications........................................................... 281
$ M. O, b9 [# M1 S8 q% RPrabuddha Ganguli2 J' |5 K$ D% y8 c( g5 P& h
Section 5 Regulatory Landscape
  ]; I% f. \9 zChapter 19 A CATalyst for Change: Regulating Regenerative Medicines in
+ H2 g4 c' R6 W/ c/ k' UEurope...............................................................................................295
6 B0 }" _9 h7 @- q' gChristopher A. Bravery0 I" q1 _; W6 Q6 J9 a
Chapter 20 United States Regulatory Reimbursement, Political/ b( C& s! s' E8 C6 X# d. T
Environment, and Strategies for Reform........................................... 323
/ e8 q, D. w1 t8 dMichael J. Werner0 y% a: |" F, |9 \; M0 W, ]0 h3 M
Section 6 Reimbursement
9 T6 [7 y9 j# xChapter 21 The Fourth Hurdle: Reimbursement Strategies for) G/ c/ {; z6 Z* K0 ?6 `
Regenerative Medicine in Europe..................................................... 3373 l' o  u& L. Z
François M. Meurgey and Micheline Wille
9 C1 h2 |, T' s: `Chapter 22 Cellular Therapies and Regenerative Medicine: Preparing for  N* Z. \* F3 L% J4 ]
Reimbursement in the United States................................................. 351
" A+ S* K- B9 N, F8 ?Eric Faulkner
' g2 b' w3 ?# C. X5 l& {Chapter 23 Adoption and Evaluation of Regenerative Medicine and the
8 |: }" i* Q+ r# j  @3 n8 zNational Health Service....................................................................369& z8 F& D3 \, G; H; X: E, I! P
Margaret Parton
3 R' ]7 S; f8 L  @Section 7 I nsurance and Risk Management
! y) E5 p, ?+ w+ @9 h6 c, F! ?Chapter 24 Role of Insurance: If You Build It, Will They Insure It?.................. 379
  y' x% O3 [: q4 r7 f/ T1 _Matthew Clark7 [; T$ p' P0 y( w" ]
Index....................................................................................................................... 391
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