Upload File

anthony’d.’so,’md,’mpa director,)program)on)global)health ...€¦ ·...

  • Home
  • Documents
  • Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)
20
Anthony D. So, MD, MPA Director, Program on Global Health and Technology Access Duke University Director, Strategic Policy Unit ReActAc@on on An@bio@c Resistance Medical Innova6on—Changing Business Models Geneva, Switzerland 05 July 2013

Upload: others

Post on 12-Oct-2020

2 views

Category:

Documents


0 download

Report

TRANSCRIPT

Page 1: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Anthony  D.  So,  MD,  MPA  Director,  Program  on  Global  Health  and  Technology  Access  

Duke  University  Director,  Strategic  Policy  Unit  

ReAct-­‐-­‐Ac@on  on  An@bio@c  Resistance      

Medical  Innova6on—Changing  Business  Models    

Geneva,  Switzerland  05  July  2013  

Page 2: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

An6bio6cs  Success  Story  

Source:  Infec@ous  Diseases  Society  of  America  (IDSA).  Comba@ng  An@microbial  Resistance:  Policy  Recommenda@ons  to  Save  Lives.  Clinical  Infec+ous  Diseases  2011;  52  (S5):  S397-­‐428.  

Page 3: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

An6bio6c  Resistance  is  a  Global  Threat  

Source:  Adapted  from  Howell  L,  ed.  “The  Dangers  of  Hubris  on  Human  Health,”  Global  Risks  Report  2013,  8th  ed.  Geneva,  Switzerland:  World  Economic  Forum  Insight  Report,  2013,  page  30.  Available  at:    h\p://www3.weforum.org/docs/WEF_GlobalRisks_Report_2013.pdf    

Costs  

Growing  Resistance  

Shortages  

Page 4: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Spread  of  NDM-­‐1  Producing  Enterobacteriaceae  

Source:  Nordmann  P,  Naas  T,  Poirel  L.  Global  Spread  of  Carbapenemase-­‐producing  Enterobacteriaceae.  Emerging  Infec+ous  Diseases  2011;  17  (10):  1791-­‐1798.  

New  Delhi  sewage  sites   Source:  Walsh  TR,  Weeks  J,  Livermore  DM,  Toleman  MA.  Dissemina@on  of  NDM-­‐1  posi@ve  bacteria  in  the  New  Delhi    environment  and  its  implica@ons  for  human  health:  an    environmental  point  prevalence  study.  Lancet  Infec+ous  Disease  2011;  11:  355-­‐62.    

Page 5: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Framing  Technology  Policy  Op6ons  

• Decrease need for antibacterial use Vaccines

Diagnostics

Drugs

•  Improve the rational use of antibacterials •  Accelerate the

development of new antibacterials

Page 6: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Few  Novel  Classes  of  An6bio6cs  

Source:  Adapted  by  World  Economic  Forum  from  Silver  LL.  Challenges  of  An@bacterial  Discovery.  Clinical  Microbiology  Reviews  2011;  24  (1):  71-­‐109.  Available  at:    h\p://www.ncbi.nlm.nih.gov/pmc/ar@cles/PMC3021209/figure/f1/      

Page 7: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

EMA-­‐ECDC-­‐ReAct  analysis  

Identified  90  antibacterials  against  organisms  of  public  health  importance  

(66  new  active  substances)  

27  with  new  targets  or    new  mechanisms    

of  action  

15  are    systemic  

8  against    Gram-­‐  

2  act  on  new  targets,  but  none  with  new  mechanisms  

of  action  Source:  Freire-­‐Moran,  et  al.    Cri@cal  shortage  of  new  an@bio@cs  in  development  against  mul@drug-­‐resistant  bacteria—Time  to  react  is  now.  Drug  Resistance  Updates  2011;  14:  118-­‐124.    Available  at  h\p://www.sciencedirect.com/science/journal/13687646/14/2    

Faltering  Pipeline  for  An6bio6cs  

Page 8: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

HTS to Lead

*Hit  to  Phase  2  starts  based  on  GSK  data.  Phase  2  and  Phase  3  success  based  on  Centers  for  Medicines  Research  (CMR)  2003  averages  for  an6bacterials  (likely  based  on    agents  from  established  classes).    #Paul,  et  al  (2010).  Nature  Reviews  Drug  Discovery  9:  203-­‐214.    

Ph 3 to File

Lead optimization to Development Candidate (DC)

Ph 1 to Ph 2 start

DC to Ph 1 start

File to Launch

Ph 2 to Ph 3 start

                          2yr   3-­‐5yr   1yr   1yr   2yr   2yr   1yr  

*Novel  An6bacts:  

7%   50%   50%   33%   50%   67%   25%  

#Industry  average      (all  therapeu6c  areas)  

80%   85%   69%   54%   34%   70%   91%  

Scien6fic  bo_lenecks:    Upstream  science  

Source:  David  Payne,  GlaxoSmithKline,  Proceedings  of  “Global  Need  for  Effec@ve  An@bio@cs-­‐-­‐-­‐Moving  toward  concerted  ac@on,”  Uppsala  Sweden.  September  6-­‐8,  2010.  Available  at  h\p://www.reactgroup.org/uploads/publica@ons/presenta@ons/workshop2.pdf    

Page 9: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Financial  Bo_lenecks:    Net  Present  Value,  by  Drug  Class  

Project  therapeu6c  class                    Risk-­‐adjusted  NPV  x  $1,000,000    Musculoskeletal          1,150    Neuroscience              720    Oncology              300    Vaccines                  160    Injectable  an6bio6c  (Gm+)          100    Oral  contracep6ve                10  

Source:  Projan  SJ.  Why  is  Big  Pharma  gejng  out  of  an@bacterial  drug  discovery?  Current  Opinion  in  Microbiology  2003;  6:  427-­‐430.  

Page 10: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Market  Entry   Generic  Entry  

Investment

Return on Investment

Drug  Invention   Multiple  Generic  Producers  

R&D  Investment  

Market  Life  Cycle  of  a  Drug  

Page 11: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Reengineering  the  business  model  � Tiering:    Preferential  treatment  for  one  segment  of  the  market  over  another      

�  Pooling:    Lowering  transaction  costs  by  bringing  R&D  inputs  or  outputs  together    

�  Push:  Decrease  R&D  Cost    

�  Pull:  Ensure  return  on  investment  (ROI)    

Page 12: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Tiering  and  the  Bo_om  Billion  

World  Bank  Income  Level   Trypanosomiasis   Leishmaniasis   Tuberculosis  

Lower  Respiratory  Infec6ons  

Non-­‐low  income   13,812  (25%)   17,923  (70%)      939,424  (70%)   2,417,430  (70%)  

Low  income   40,477  (75%)   8,057  (30%)   402,347  (30%)   1,045,864  (30%)    

Global  Burden  of  Disease  by  Country  Income  level,  2008  

Source:    Data  from  “Cause-­‐specific  mortality,  2008:  World  Bank  income  group  by  country,”  Global  Health  Observatory  Data  Repository.  Geneva,  Switzerland:  World  Health  Organiza@on,  2011.    Available  at:  h\p://www.who.int/en@ty/gho/mortality_burden_disease/global_burden_disease_DTHInc_2008.xls    

Page 13: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Strategic  Collabora@on—  What  If…We  Pooled  

• GlaxoSmithKline  open  collection  of  13,533  compounds  inhibiting  malaria  for  public  R&D.  

 Compound  libraries  

• Coalition  Against  Major  Diseases  pooled  control  arms  of  clinical  trials  on  Alzheimer’s  disease.  

Clinical  trial  data  

• Global  Alliance  for  TB  Drug  Development,  Gates  Foundation  and  the  Critical  Path  Institute  work  to  shave  years  off  the  regulatory  approval  of  TB  combination  regimens.    

Combination  treatments  

Page 14: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Push  –  Diminishing  R&D  Risks  

Market Entry Generic Entry

Time

Revenue

Discovery of Entity Multiple Generic Producers

Investment

Push--Reduce risk through public R&D funding or bootstrap philanthropy

Page 15: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Pooling  and  Push:  Europe’s  Innova6ve  Medicines  Ini6a6ve(IMI)  New  Drugs  4  Bad  Bugs  (ND4BB)  Program  

Sharing  best  prac@ces  for  an@bio@c  R&D    Co-­‐Develop  Lead  Candidates    Clinical  Trials  Consor@um  

Grants  for  R&D  funding  

Sharing  data  on  successes/  failures  of  screenings  &  compounds  

Push  Pooling  

Source:  Based  on  Innova@ve  Medicines  Ini@a@ve  Website.  Available  at:  http://www.imi.europa.eu/content/mission  (Accessed  02  Jul  2013)    

Page 16: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Push  -­‐  Leveraging  Public  Sector  Investments:    Microbial  Synthesis  of  Artemisinin  

One World Health (PATH) UC- Berkeley

Amyris Biotechnologies

Gates Foundation

$42.6M

$12M

$8 M

License

Sanofi  Aventis  

$10.7M

Page 17: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Pull  –  Reducing  Risk  of  Resource-­‐limited  Market  

Time Investment

Revenue

Market Entry Discovery of Entity

Pull—Advance Purchase Commitment, Prizes, Patent buyouts

Page 18: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Reengineering  R&D  Value  Chain  –    The  3Rs  

Discovery   Pre-­‐Clinical   Clinical   Development  Post-­‐

marketing  

Compound  Library  Access  

Medicinal  Chemistry  

Crossing  the  Valley  of  Death  

Regulatory  Approval   Ra@onal  Use  

Sharing RISKS

Sharing RESOURCES

Sharing REWARDS Source:    So  AD,  Ruiz-­‐Esparza  Q,  Gupta  N,  Cars  O.  3Rs  for  innova@ng  novel  an@bio@cs:  sharing  resources,  risks,  and  rewards.                                Bri+sh  Medical  Journal  2012;  344:e1782.                                  Available  at:  h\p://www.bmj.com/content/344/bmj.e1782?ijkey=TXeqN1NcCsPpzC1&keytype=ref    

Page 19: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

India’s Open Source Drug Discovery Initiative: The 3Rs at Work

Phase  II  Clinical  Trial  Application  filed  in  2013  in  collaboration  

with  

New

 Che

mical  

Entity  by  20

16  

Source:    Zakir  Thomas,  Open  Source  Drug  Discovery  Ini@a@ve,  India's  Council  on  Scien@fic  and  Industrial  Research,  2013.  

Page 20: Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health ...€¦ · Anthony’D.’So,’MD,’MPA Director,)Program)on)Global)Health)and)Technology)Access) Duke)University)

Back  to  the  Future  �  1929:    Fleming’s  discovery  of  penicillin  

�  1940:    Florey  and  Chain’s  crucial  experiment  

�  1941  on:  Commi\ee  on  Medical  Research  assists  to  scale  up  penicillin  produc@on  

�  1944:    Twenty-­‐one  firms  produce  penicillin  

Photo  source:    Penicillin  mold,  Archbishop  Holgate  2013,  CC  BY-­‐SA  3.0  Available  at  h\p://ahsbiology3.wikispaces.com/file/view/penicillin_g_sm.jpg/135823945/penicillin_g_sm.jpg    


John J. Kiefer, Ph.D. Associate Professor & Director MPA Program 1

MPA News - Oakland University€¦ · MPA NEWS OAKLAND UNIVERSITY | February 2015 Issue 4 Marian Reich, MPA student and Detroit’s Executive Director of the International Visitor’s

Influenza Vaccination Coverage Among Pregnant … · Stephanie Zaza, MD, MPH, Director, ... Nan Ruffo, MPA, Mary Elizabeth O’Neil, MPH, Pregnancy Risk Assessment Monitoring Team,

Department of Emergency Medicine Michael Richards, MD, MPA

Developmental Screens in the Office Setting Nathaniel Beers, MD, MPA

Fatima Cody Stanford, MD, MPH, MPA - Harvard Universityscholar.harvard.edu/files/fatimacodystanford/files/... · 1 Fatima Cody Stanford, MD, MPH, MPA. Date Prepared: August 10, 2015

Advisory Committees Linda Ann Sherman, MD, MPA Advisory Committee Oversight and Management Staff, Director U.S. Food and Drug Administration April 20,

Global Trade and Healthcare Timothy F Christian, MD,MPA

RHIO Development: The Delaware Experience Edward Ewen, MD, FACP Gina B. Perez, MPA

Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FAHA, …1 Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FAHA, FTOS Date Prepared: September 18, 2019 Name: Fatima Cody Stanford,

Anabella Aspiras, MPA, RN, BSN Director for Patient ......Anabella Aspiras, MPA, RN, BSN Director for Patient Engagement Cancer Moonshot Task Force The 23rd Annual Maryland State Council

1 National Forum on Biomedical Imaging in Oncology CMS UPDATE Steve Phurrough MD, MPA Director, Coverage and Analysis Group

David Chapman, PhD Graduate Program Director - …...8/13/2020 1 David Chapman, PhD Graduate Program Director - MPA [email protected] Some housekeeping: Please stay on mute Please ask questions

Fatima Cody Stanford, MD, MPH, MPA, FTOSscholar.harvard.edu/.../files/fcs_resume_11.15_revised.pdf · 07/14-05/15 Master of Public Administration (MPA) Mid-Career Program- Leadership,

Master of Professional Accounting (MPA) Associate Professor Prem Yapa Program Director

John J. Kiefer, Ph.D. Associate Professor & Director MPA ...nhma.info/uploads/presentations/Kiefer...John J. Kiefer, Ph.D. Associate Professor & Director MPA Program 1 2 3 • What

February 10, 2015 Martin Lang, MPA Deputy Director of Field Operations

HIV Pain Management: Considerations, Ideas & Suggestions Barry Eliot Cole, MD, MPA Executive Director, American Society of Pain Educators

March 30, 2021 Lara Szent -Gyorgyi, MPA Director

Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FTOS

Fatima Cody Stanford, MD, MPH, MPA - Harvard University · 1 Fatima Cody Stanford, MD, MPH, MPA. Date Prepared: August 10, 2015 Name: Fatima Cody Stanford, MD, MPH, MPA Office Address:

¯^cœ †nvK `yišÍ · Arifur Rahman Managing Director Director Md. Shah Alam Director Md. Ataullah Managing Director - Badar Spinning Mills Ltd. Managing Director - Blue Planet

Jessica Harrington, MPA, CNP, CELDC Director of Student ...apps.nacada.ksu.edu/conferences/ProposalsPHP/... · Jessica Harrington, MPA, CNP, CELDC Director of Student Life Johns Hopkins

Improving Office Practice: Process Flows Mark Murray, MD, MPA Mark Murray and Associates

Central Massachusetts Regional Public Health Alliance Michael Hirsh, MD, Commissioner Derek Brindisi, MPA, Director

Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FAHA, FTOS · 2020. 11. 30. · Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FAHA, FTOS Date Prepared: November 20, 2020 Name: Fatima

Left Atrial Appendage Closure Devices - asecho.org · 10/10/2017 1 Muhamed Sarić MD, PhD, MPA Director of Noninvasive Cardiology | Echo Lab Associate Professor of Medicine Left Atrial

DOR15-05 The PolyClinic Vascular Surgery Center€¦ · Kelly White, MD Title Director Director Director Director Title President Secretary Director Name Rex Ochi, MD Peter Baciewiz,

Navneet Kathuria, MD, MPA, MBA Executive Director and Chief Medical Officer Premier Healthcare Carolyn Driscoll, LMSW Research Associate YAI Network PHC

 · Executive — MD & Group CEO Chairman - (Independent Director) Independent Director Executive— MD & Grou CEO Executive - Wholetime Director Executive - Wholetime Director Corporate

2015 CONFERENCE AGENDA & FACULTY - … · n Sarah Boses, RN, BSN, Integrative ... n Bruce Smith, MD, Executive Medical Director, Government ... MPA, Managing Director, Strategic Partnerships,

Pierre Kory, MPA, MD Medical Director, Trauma and Life ... · ICU Echo in 1980’s, Lung and GCCUS –1990’s ... “ training in ultrasound guided CVC and thoracentesis.. ... Taken

Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FTOS...1 Fatima Cody Stanford, MD, MPH, MPA, FAAP, FACP, FTOS Date Prepared: April 27, 2018 Name: Fatima Cody Stanford, MD, MPH, MPA

RIDDELL - Official Sponsor of MPA · 2 3 OFFiCiAL MPA SPONSORS ARCHIE MANNING Executive Director COOPER MANNING Associate Director PEyTON MANNING Associate Director ELI MANNING Associate

Contents · PDF file3 LaMar Hasbrouck, MD, MPH, Executive Director, National Association of County and City Health Officials Rain Henderson, MPA, CEO, Clinton Health Matters Initiative,