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
$ T. z' X* |8 e! J/ v4 bEdited by
: N+ y" I' v, t+ R; s( Q  iDr. Catherine D. Prescott
5 m0 z$ j# j* ~! O; BProfessor Dame Julia Polak
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Contents
, H# S4 U2 Y4 N5 MForeword...................................................................................................................vii1 l  }0 |9 G7 C2 N( w
Preface.......................................................................................................................ix* }0 M1 ^' S; }. _- y8 T
Acknowledgments......................................................................................................xi" `8 o! T5 M" ]) W; E; s
About the Editors.................................................................................................... xiii: c8 i0 M& f" l% ~. G
Contributors..............................................................................................................xv2 i1 q  [. C/ l9 e
Section 1 I ntroduction
" x! Z6 _( M* p, }/ }" E& wChapter 1 What Is Regenerative Medicine?...........................................................3
' Y6 o/ N7 o& b2 B8 fJulia M. Polak, D6 f4 ?  m& ^! C6 u; g
Section 2 Finance3 z$ }$ r  a( Z! ~9 k
Chapter 2 A New Political–Financial Paradigm for Medical Research:$ I2 q' c1 X; j) S8 S
The California Model?........................................................................ 11
0 c; d5 z* H6 a$ B6 T9 cRobert N. Klein and Alan Trounson3 l7 Y* e( t, k  [
Chapter 3 Investment Models: Public Funding in Australia................................ 35
/ f( y" _% O( {- R0 B. s: D8 FGraham Macdonald
* \$ ^# c+ X: @3 WChapter 4 Canada: Capitalizing on a 50-Year Legacy......................................... 43
- Y8 G, d" T: K5 d: p2 C4 \0 x6 P5 ^0 yAndrew Lyall: O  T* Y% y4 k# L+ m9 k) ^6 n# A
Chapter 5 Investing in Regenerative Medicine: What Drives Private Investors?.... 59# h7 y3 a8 \$ q' ~4 N" p
Catherine D. Prescott
& Z$ M$ T* t3 q1 oChapter 6 Public Investment Models: Coming out of the Closet and# g1 |6 d) d6 c2 }; b
Going Public!...................................................................................... 67
* ~+ G8 ]2 B& @0 o' G# z; n5 l( jReni Benjamin8 n5 }. N3 h0 ?
Section 3 Business Models, M' l" h  G! W# ~# `* O
Chapter 7 Cell-Based Products: Allogeneic.........................................................85
) V$ E0 j5 T' b8 KPaul Kemp" H9 a9 Q8 K& B
Chapter 8 Autologous Cell-Based Products: Fulfilling the Promise of( @7 x  _2 a& T8 f
Cell Therapy........................................................................................97
* x# i+ m* G! i) ^6 a4 |Eduardo Bravo and Magdalena Blanco-Molina2 S2 `" b6 L4 @* _
Chapter 9 Business Models for Cord Blood....................................................... 117
1 H& w4 ?/ h8 ], o0 U5 e# b  HSuzanne M. Watt  N9 P. j* m; v  R! s
Chapter 10 Changing the Game of Drug Discovery............................................ 131+ s" I. B7 \8 r. M3 l8 @7 z( N
John Walker) d. L; k* p4 [+ z& D7 ?
Chapter 11 Discovery of Small Molecule Regenerative Drugs........................... 141
3 b; g, r4 W0 ~Yen Choo
; j% Q4 {: M. s9 c% BChapter 12 Adoption of Therapeutic Stem Cell Technologies by Large0 }: Y4 Y. D5 P0 Q. J* k: |
Pharmaceutical Companies............................................................... 153
8 A3 R) I: W2 ZAlain A. Vertès
4 M" u9 Z9 Y4 D- \$ ^, w  oChapter 13 Role of Tool and Technology Companies in Successful
) }6 p8 F8 U3 B0 p. YCommercialization of Regenerative Medicine.................................. 177$ Z4 B; Q1 f7 l! p& ?6 \3 q
Joydeep Goswami and Paul Pickering
/ i9 M3 \# r# M8 C  v& mChapter 14 Key Considerations in Manufacturing of Cellular Therapies........... 189
2 B& P  j* Y1 u! mRobert A. Preti
. b# ?: O* X( Z6 [* \7 XChapter 15 State of the Global Regenerative Medicine Industry........................ 213
% V3 \9 W7 c1 d8 U7 P' eR. Lee Buckler, Robert Margolin, and Sarah A. Haecker- x+ W# p1 }9 ?' k
Section 4 Intellectual Property( x6 L  ?9 C! @+ p1 S
Chapter 16 Regenerating Intellectual Property: Europe after WARF................. 239& m2 y( ]3 h* C7 e) ~4 Q) D3 `2 {
Julian Hitchcock and Devanand Crease
; V+ L  h+ z: U2 K, u1 V' `& pChapter 17 Protecting Regenerative Medicine Intellectual Property in the& v$ o. ~9 W4 u/ E: q5 P) C
United States: Problems and Strategies............................................. 257
/ I3 u( u( }4 w; `7 gDavid Resnick, Ronald I. Eisenstein, and Joseph M. McWilliams
$ ^" f. L+ p5 w7 T0 u3 HChapter 18 Impacts of Indian Policies and Laws on Regenerative) k2 s9 e8 N. q( e
Medicine Patent Applications........................................................... 281
5 Q& ]- m' Y) A" pPrabuddha Ganguli% R: Z5 s4 @% _' z! Q
Section 5 Regulatory Landscape
; X5 s+ z- s1 k! wChapter 19 A CATalyst for Change: Regulating Regenerative Medicines in; B1 d) j* I) d4 k7 Y% f) X6 x
Europe...............................................................................................2954 ~3 N1 I2 ]" f- M6 E% @
Christopher A. Bravery
- r$ ~5 P6 _6 |5 P6 x0 y2 `$ PChapter 20 United States Regulatory Reimbursement, Political: t! ~9 f& w7 O, {7 b  x
Environment, and Strategies for Reform........................................... 323
3 l+ r/ ?9 Q8 @8 q- I5 Z: RMichael J. Werner
4 f1 t+ w9 K3 O8 K" S8 s, K% ?8 i, kSection 6 Reimbursement! H6 D7 B3 N1 o, K: d7 a( y
Chapter 21 The Fourth Hurdle: Reimbursement Strategies for% h/ a) V( C5 [5 G  j6 t5 X
Regenerative Medicine in Europe..................................................... 337
, d7 X/ T* q& @7 Z) {+ oFrançois M. Meurgey and Micheline Wille2 G+ ?- ^" ?6 O4 x/ a
Chapter 22 Cellular Therapies and Regenerative Medicine: Preparing for/ p9 X+ k$ d- }, Z' G2 h
Reimbursement in the United States................................................. 3513 T8 u4 D# j! _# Y% k; f* ?: F
Eric Faulkner: V% ~! d0 B' L4 P2 O& ?
Chapter 23 Adoption and Evaluation of Regenerative Medicine and the
& I) s1 Y; @2 @National Health Service....................................................................369
8 c: s% e5 G1 Y8 HMargaret Parton) d$ t: N- W+ ]
Section 7 I nsurance and Risk Management
! e  C3 `" }4 c6 {, m: SChapter 24 Role of Insurance: If You Build It, Will They Insure It?.................. 3793 L- x! l7 x7 |  X% B
Matthew Clark& K  O" G; p. D& ~4 h# }
Index....................................................................................................................... 391
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$ x  w" F& b! a5 l( I# g0 R9 p8 P[hide][/hide]

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