Biobanking  in  Puerto  Rico:    Challenges  and  Opportuni9es  

Idhaliz  Flores-‐Caldera,  PhD  Professor,  Microbiology  and  Ob-‐Gyn  Ponce  Health  Sciences  University  Co-‐Leader  Puerto  Rico  Biobank  

(Co-‐Leader  MCC:  Dr.  Teresita  Muñoz-‐Antonoa_    

2016  PACHE  WORKSHOP  Rockville,  Maryland  June  13-‐14,  2016  

PRBB PRBB

SHARED  RESOURCES-‐  PUERTO  RICO  BIOBANK  (PRBB)  

Community    Health    

Educator  (CHE)  

Training/Educa9on  Core  Courses,  Workshops  seminars,  student  exchanges  &  mini-‐

sabbaRcals  

Pilot  Projects  Breast  Cancer  

CommunicaRons  GeneRc  Counseling  

Full  Projects  Lung  cancer  Breast  cancer  

 

Career    Development    

Plans  

 

Outreach  Core  Community  Advisors  Community  educaRon  

Partnership  Structure  

Planning  and  Evalua9on  Core  (PIs,  PSC,  and  IAC)  

MCC  CEO  MCC  Director  

MCC  Admin  Core  Scien9fic  Leadership  

Program  Steering  CommiYee  

PSM  President/CEO  PRI  President  

PSM  Admin  Core  Scien9fic  Leadership  

 Developmental  Core  

 

•  Collec&on,  processing,  and  distribu&on  of  biospecimens  for  biomedical  research  

•  Cancer,  adjacent  and  normal  fresh  Rssue,  paraffin  blocks  •  Blood,  serum/plasma  •  Blood  (DNA)  from  populaRon  (healthy)  controls  

•  Foster  research  projects  focusing  on  cancer-‐related  health  dispari&es  affecRng  minority  popula&ons.  

PRBB PRBB

The  Puerto  Rico  Biobank  (PRBB)  Aims  

2010 2006 2008 2012 2016 2014 2018

U56  Planning  grant     U54  Partnership  grant    

Biobanking  Workshop    &    

GMaP  Supplement  

Timeline  

1st  community  event  

2015

1st  1000  cases  consented  

2007 2009 2011 2013

1st  student  in  clerkship  

1st  publicaRon  1st  paRent  consented  

1st  study  using  

Rssues        

Development  of  SOPs,  

QuesRonnaires,  IRB  approval    

MeeRngs,  presentaRons  seminars;  permits  obtained  in  Hospitals  

1st  100  biospecimens  

collected  

AdministraRve  Structure  Developed  

Team  and  lab  assembled  

PRBB  @  PSM   PRBB  @  MCC  Leadership  

Co-‐Leader:  Idhaliz  Flores,  PhD  Lab  Coordinator:  Patricia  Casbas,  PhD  Pathologist:  Sylvia  Gu9errez,  MD  

Co-‐Leader:  Teresita  Muñoz-‐Antonia,  PhD    Co-‐Leader:  Domenico  Coppola,  MD  Bioinforma1cs:  Steve  Eschrich,  PhD  Director  TPC  Opera1ons,  Honest  Broker:  Ed  Seijo  

Suppor9ng  staff    Research  Nurse:  Sonia  Abac,  RN    Lab  Technician:  Dagmar  Correa,  MT    Histotechnologist:  Alcira  Benitez  Honest  broker:  Aixa  Ramos  

IT:  Rodrigo  Caravajal  Biorepository  specialist:  Edna  Gordián,  MS  Data  entry:  Farah  Benalall    

Hospital  Staff  San  Lucas  Hospital  (SLH):  Recruiter:  L  Rivera,  MD;  Runner:  Z  Rodríguez,  MD,  Surgeons,  Urologists,    Gynecologists,IntervenRonal  radiologists  Damas  Hospital  (DH):  Dr.  Ingrid  Ramírez,  Gyne-‐Oncologist    

PRBB  Administra9ve  Infrastructure  

Tissue  Distribu9on  CommiYee  Honest  Broker  

Database generation and maintenace

Bioinformatics, IT support

Information and sample processing and storage

Slide Eval Pathologist

Laboratory personnel

Participant consent and Biospecimen collection

Hospitals, Physicians Recruiter, Nurses

Pathologist

Overall organization and management Leadership/Pathologists

Sample QA/QC Slide Eval

Back-up storage Pathologist

Laboratory personnel

PSM MCC

Biospecimen  &  Informa9on  Collec9on  

Biospecimen  Management  System  (BMS)  

Cancer Patients Controls

Biospecimen Management System

1.   Tissue  Inventory  2.   Slide  Evalua9on  3.   Pathology  Report  4.   Ques9onnaire    In  development:  1.   Clinical  Data  2.   Releases  (Data  &  

Biospecimens)  3.   Molecular  Data    

Biospecimen  Management  System  (BMS)  

Current  modules:  

In  collabora9on  with  Medical    Informa9cs  Department  -‐  MCC  

Biospecimen Management System

Dashboard  

Biospecimen  Management  System  (BMS)  

Access  through  secure  Web  Portal  

Biospecimen  Collec9on  Types of biospecimens collected by the PRBB between 2008-2016  

U54    

Biospecimen collection and processing Biospecimen  Collec9on  Biospecimens  collected  by  the  PRBB  by  site  of  origin  

Participants* All

N=740 Breast N=145

Prostate N=100

Colon N=57

Mean Age (SD) Years

61.0 (14.7) 64.0 (12.0) 65 (6.9) 69.1 (9.2)

Sex Female 449 (61.9) 145 (100) - 27 (48.2) Male 276 (38.1) - 100 (100) 29 (51.8) Missing 15 - 1

Race White 453 (63.6) 81 (58.3) 69 (70.4) 34 (60.7)

Black/African American

52 (7.3) 9 (6.5) 13 (13.3) 3 (5.4)

Asian/American Indian

4 (0.6) 1 (0.7) - -

Don’t Know not sure

23 (3.2) 5 (3.6) 2 (2.0) 3 (5.4)

Prefer not to Answer

95 (13.3) 36 (25.9) 6 (6.1) 11 (19.6)

Other 85 (11.2) 7 (5.0) 8 (8.2) 5 (8.9) Missing 28 6 2 1

Hispanic/Latino Yes 674 (94.0) 125 (87.5) 95 (97.9) 48 (87.3)

No 43 (6.0) 18 12.6 2 (2.1) 7 (12.7) Missing 23 2 3 2

State of Residence

PR 584 (97.7) 108 99.1 93 (96.9) 45 (100) Other 14 (2.3) 1 0.92 3 (4.2) - Missing 142 36 4 12

Fam. History Cancer

Yes 526 (73.0) 99 (69.2) 85 (85.9) 23 (41.1) No 195 (27.0) 44 (30.8) 14 (14.1) 33 (58.9) Missing 19 2 1 1

Marital Status Single 157 (21.5) 30 (20.8) 9 (9.1) 11 (19.6) Consensual 33 (0.05) 8 (5.6) 4 (4.0) 2 (3.6)

Married 450 (62.3) 85 (59.4) 80 (80.9) 38 (67.9) Divorced 30 (0.04) 7 (4.9) 4 (4.0) 1 (1.8)

 •  Female  (61.9%)  •  LaRno/Hispanic  (94.9%)  •  Live  in  PR  (97.7%)  •  Family  History  of  Cancer  (73.0%)  •  Married  (62.3%)  •  Overweight  (37.4%)  or  obese  (34.3%)  •  Low  educaRon  (48.9%  high  school  of  less)    

•  PRBB  quesRonnaire  captures  demographics,  clinical  history,  family  history,  risk  factors  (e.g.,  smoking  history).    

•  Data  from  completed  quesRonnaires  (N=740)  indicated  that  consented  parRcipants  are:    

PRBB  Ques9onnaire  

Geoloca9on  of  pa9ents  enrolled  in  the  PRBB  in  PR  and  FL    

PONCE TAMPA

Tissue  and  Data  Usage  by  Projects  • DNA  Repair  and  Gene  Expression  associated  with  Suscep9bility  to  Breast  Carcinoma  –  MaYa    • Development  of  mul9-‐ethnic  breast  cancer  TMA  –  BMaP  Region  3  • Infiltra9ng  immune  cells  in  breast  cancer  subtypes  –  Casbas/Pilon-‐Thomas  

Breast  Cancer  

• Characteriza9on  of  the  Epidemiological  Profile  of  Prostate  Cancer  Pa9ents  in  the  PRBB  –  Soler/Onneil  Prostate  Cancer  

• Molecular  Biology  of  Lung  Cancer  in  Puerto  Ricans  –  San9ago/Cress  • Muta9on  profile  of  lung  cancer  in  Puerto  Rican  pa9ents  –  Muñoz-‐Antonia  • Collabora9ve  biospecimen  network  to  support  lung  CHD  research  –  BMaP  Region  2  

   Lung  Cancer    

• DNA  Mismatch  Repair  Protein  Expression  in  Colorectal  Cancer  from  Puerto  Rican  pa9ents  -‐  Coppola  

• Epidemiological  and  Pathological  Analysis  of  Colorectal  Cancer  Cases  in  the  PRBB  –  Bredy/Flores  

Colon  Cancer  

• The  Role  of  EZH2  and  H3J27me3  in  the  Pathophysiology  of  Endometriosis  –  Flores/Colon-‐Caraballo  

• Role  of  the  Ovarian  Endometriosis  Histone  Code  in  Neoplas9c  Transforma9on  –  Monteiro/Seto  

Endometrium/  Endometriosis  

• MC1R  variants  in  Hispanic  popula9ons  living  in  Tampa  Bay  and  in  Puerto  Rico  –Kanetsky/Du9l/Flores  Healthy  Controls  

EGFR  Muta9ons  in  Hispanic  NSCLC  pa9ents  

SanRago,  P,    Cress,  DC,  et  al,  Full  Project  

Hispanic  Lung  Cancer  Database/Cohort    Puerto  Rico  BioBank  and  Total  Cancer  Care  TM  

T790M

A298T(exon 7)

Identification of novel mutations

•  Iden1fica1on  of  hereditary  cancer  muta1ons  in  high-‐risk  non-‐BRCA  breast  cancer  pa1ents  from  Puerto  Rico    –  DuRl,  J,    Monteiro,  A,    et  al.,  PSM  and  PHSU,  Pilot  Project  –  Poster  presentaRon  Monday,  June  13,  2016;  1:00  to  2:30  PM  

Research    Projects    

•  Quadruple  Nega1ve  Breast  Cancers  are  More  Prevalent  in  African  American  Women  with  an  Enriched  Immune  Signature    (BMaP  Breast  TMA)  –  Clayton  Yates,  Tuskegee  University/Morehouse  School  of  Medicine/  

 University  of  Alabama  at  Birmingham  U54Partnership    –  PresentaRon  Monday,  June  13,  2016;  9:30  AM    

PRBB  Training  Ac9vi9es  

Ac9vity   Par9cipants   Results  Biobanking  Clerkship   27  medical  students  

5  MPH  students  1  Pharm  D  5  volunteer  

1.  Quality  Analysis  of  Tissues  collected  at  PRBB  2.  Demographic  profile  of  prostate  cancer  cases  

in  the  PRBB  3.  Demographic  and  pathologic  profile  of  colon  

cancer  cases  in  the  PRBB  4.  Receptor  status  profile  of  breast  cancer  1ssues  

collected  at  the  PRBB  

TMA  Data  Analysis  Workshop  

BMaP  Region  3  invesRgators  

1.  25  ParRcipants  2.  5  invesRgators  using  the  BMaP  breast  TMA  

1st  Puerto  Rico  Biobanking  Workshop  (joint  with  PRCC/MDA  PACHE  Partnership)  

InvesRgators  in  PR   1.  34  ParRcipants  2.  1  publicaRon  3.  Site  visit  by  experts  in  the  field  4.  Membership  in  REBLAC  

Training  in  Biobanking   PRBB  Staff   @MCC  

PRBB  interac9ons  with  Outreach  Core  

Ac9vi9es  Outreach  Core  Educa9onal  Events  

1.  Hablemos  de  cáncer  2.  El  Puente  3.  ¡Salud!  Serie  de  charlas  4.  Community  leaders’  meeRngs  

Community  Events  (educate  the  general  populaRon  and  obtain  samples  from  populaRon  controls)  

1.  Conversatorio:  Cáncer  y  ahora  qué?,  Peñuelas,  PR  –  210  atendees  

2.  Marcha  por  una  causa,  Yauco,  PR  –  42  samples  3.  Mammography  Clinic,  Yauco  –  22  samples  4.  PHSU  10K  for  Cancer  Research  –  12  samples    5.  PHSU  ScienRfic  Conference  –  14  samples  

U9liza9on  and  promo9on  of  Biobanking  DVD  and  booklet  developed  for  PR  popula9on  by  Outreach  Team  

Summary:  Challenges  &  Lessons  Learned  Build  interest  and  enthusiasm  among  hospital  

administrators  and  clinical  faculty        

Inventory  and  data  management  system    

Development,  harmoniza9on  and  implementa9on  of  SOPs  

Collec9on  of  serum/plasma  

Expansion  of  collec9on  to  other  hospitals  

Clinical  data  abstrac9on,  Tx  outcomes  

Tissue  usage  

Sustainability  

Clear  informa9on  about  benefits  to  hospitals,  doctors,  residency  programs  

Access  to  a  user-‐friendly  system  for  coding  and  keeping  track  of  samples  -‐  BMS  Mul9ple  mee9ngs,  training  sessions,  retreats  to  discuss  issues  and  implementa9on  plans  

Adver9sement  of  resources,  and  distribu9on  protocol,  assess  inves9gator-‐driven  needs  

Addi9onal  personnel  and  resources  needed  

Grants,  other  ini9a9ves  

Summary:  Opportuni9es  

•  OpportuniRes  for  research  in  a  unique  populaRon  underrepresented  in  other  cohorts  -‐  with  admixture  data.  

•  OpportuniRes  to  teach  about  biobanking  and  research  to  doctors  in  training  and  the  community.  

•  OpportuniRes  for  collaboraRon  via  development  of  shared  resources  (e.g.,  breast,  colon  and  lung  TMA)  

•  Last  but  not  least….the  PRBB  impacts  all  levels  of  the  Partnership  

•  The  PRBB  Team  •  NCI-‐NIH  grants    

–  PSM  –  U54  CA163071  and  MCC  –  U54  CA163068  •  Hospital  AdministraRve  officials  

–  San  Lucas  Hospital  and  Damas  Hospital    •  Pathology  Labs  

–  Centro  Citopatológico  de  Puerto  Rico  –  Southern  Pathology  

•  Clinical  Faculty  –  Drs.  Diaz,  Bolaños,  Soler,  Romero,  Quintana,  Ramirez-‐Lizardi,  Mulero,  Burgos,  Escobar,  Domenech    –  Dr.  Hector  Velez,  Hema-‐Oncologist        –  Dr.  Ingrid  Ramírez,  Gyne-‐oncologist  –  Dr.  Melendez  and  Buonomo,  IntervenRonal  radiologists  –  Dr.  Ruiz-‐Deya  ,  Dr.  Santana,  CasRllo  -‐  Urologists  

Acknowledgements  

Special  thanks  to  the  ins9tu9onal  support  from  PSM  and  MCC  

Questions

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