March 12 th, New Trends in Bioanalytical Outsourcing: The Buyer s Guide. Dominique Gouty, Ph.D.

Transcription

1 March 12 th, 2015 New Trends in Bianalytical Outsurcing: The Buyer s Guide Dminique Guty, Ph.D. 1

2 The Trend Outsurcing earlier in the drug develpment Prcess: What are the risks??? 2

3 3 The Trend

4 New Paradigm New Challenges Fewer staff Tighter deadlines Quality standards The pharmaceutical and bitechnlgy industries are at a crssrads. Grwing pressures frm increased cmpetitin. New pprtunities frm recent patent expiries. Keep ahead f cmpetitrs with the right partners & strategy. 4

5 Custmer Pain Pints Pr Quality Inadequate expertise Missed deadlines Pr cmmunicatin Limited visibility Little cllabratin Missed handffs Budget verruns Outsurcing - far frm a panacea fr pharma and bitech 5

6 Recent Data - Yur Timeline and Budget Accrding t a recent study by the Ecnmist Intelligence Unit, spnsrs said the biggest challenges fr a successful relatinship with their CRO were 2 : 6 2) Finding Alignment: Opprtunities and Obstacles in the Pharma/CRO Relatinship, Ecnmist Intelligence Unit (2012)

7 Chsing the Right Partner Pr Quality N visibility Delays Cst creep Deep expertise Transparency Quality results On-time On-budget..if it were nly this bvius! 7

8 Prject Criteria Cnsideratins Will they ffer cnsultative supprt? The spnsr/cro relatinship has traditinally been transactinal in nature This mdel is quickly changing. Best-in-class rganizatins are seeking strategic input frm CRO partners. A practive and cllabrative CRO partner will: Custm-tailr methds, ptimizing fr assay demands. Mitigate cmmn challenges (cmmunicatin break dwn, timeline creep, etc.) 8

9 As pharma cmpanies rely mre and mre n CRO s, the CRO business mdel is shifting frm being task-riented t ffering value, input and prblem slving. Oxbridge Rundtable Ltd 1 9 1) Re-Thinking Outsurcing: The Pwer f the Cntract Research Organizatin, Oxbridge BiTech (2013)

10 Prject Criteria Cnsideratins Hw specialized is the CRO s large mlecule fcus? CRO s vary greatly in their expertise. The key is finding a partner with the ptimal breadth and depth f scientific skill in bilgics. A specialized CRO partner will be mre successful with cmplex and challenging assay demands. 10

11 Prject Criteria Cnsideratins Level f Regulatry Need and Cmpliance Regulatry cmpliance is a critical cncern when utsurcing large mlecule bianalysis. If standards are cmprmised, s is the discvery/drug develpment. A CRO partner must be well-versed in scientific aspects f cmpliance, data integrity, and reprting. Uphld all necessary requirements under GLP, GCP, r GMP. 11

12 Prject Criteria Cnsideratins Yur Timeline and Budget Yur bianalytical service prvider must meet lgistical & cst demands. Hw much will pr quality cst me? Yu get what yu pay fr Lack f specialized team/platfrms csts in the lng run Is the timeline put frth by the CRO realistic? Have recrd reflecting CRO s prven ability t get prjects dne n time. Make sure CRO can be held accuntable fr deadlines and timeline creep. 12

13 Prject Manager Custmer 13

14 Lst In Translatin!!! Scientific knwledge Infrmatin Details 14

15 Wrking Relatinship Cnsideratins The Prject Management Prcesses in Place Prject Oversight: Wh is acting as prject head? A bilgic expert is wanted as main lead in the case f large mlecule prjects. Cnsider turnver; mid-study lss f prject manager impacts prject s prgress. Transparency and Respnsiveness: They nly call me when there is a prblem. Cnsistent and cntinuus cmmunicatin helps identify ptential risks befre becming cstly hurdles. Trust CROs that see their rle as anticipating, cmmunicating, and cllabrating n all bianalytical challenges. 15

16 Cmmunicatin The Main Prblem With Cmmunicatin Is The Illusin That It Has Taken Place. 16

17 Wrking Relatinship Cnsideratins Lcatin(s) and Capacity Cnsider prspective CRO partner s infrastructure dealing with prject-specific cnstraints. Physical Lcatin: Running a study within specific regin cnsider a lcally-based bianalytical lab t streamline shipping and management. If study is glbal, lcatin matters less. Capacity: Prspective partner s wrklad plays a factr in ultimate prject timeline. Understand brader picture: staff allcatin, lab size, client base, etc. Assess CRO s true ability t handle high vlume prjects. 17

18 Wrking Relatinship Cnsideratins Success in Track Recrd Cmpany Successes: Hw many drugs nw n the market has the CRO helped supprt? Any prestigius awards? Any case studies r custmer testimnials fr validatin? Staff-Level Recgnitin: Have the CRO s scientists been published r recgnized by industry? Are team members cnsidered specialized experts r pinin leaders? A partner with prven experience can prvide veteran insight fr quickly navigating bth scientific and regulatry demands. 18

19 March 12th, 2015 Case Studies 19

20 Case Study #1 Prviding a Slutin Phase I diabetes study ~8000 samples Needed analysis f 14 bimarkers IRB prhibits mre than 5 x 1 ml bld/time pint Sample turn arund time f 1 week Multiplex Platfrms + Multiplex Scientist + Autmatin 20

21 Case Study #2 Assay Quality Imprvement High %CV assciated with an assay develped and validated fr release f a prduct. FDA did nt allw the release f the prduct until the %CV is at 25% r less. The assay required the use f live cells. Cntrl f cell batches Lng term supply f cell batches (primary cells) Standardizatin f cell culturing techniques and supplies: Dissciatin reagents and incubatins Estimatin f cnfluency Plasticware matters Management f critical reagents: serum, grwth factrs 21

22 Case Study #3 Accuracy f the Infrmatin Transfer frm the Spnsr Assay in supprt f Alzheimer s prject Assay was run internally fr 15 years Spnsr lking t utsurce the assay t keep up with the sample analysis demand The assay was described as dialed in and ready t g. Upn assay transfer, the fllwing were bserved: There was nly ne analyst in the entire cmpany that was running the assay fr almst 20 years. The SOP did nt match what the analyst was ding Over time the analyst had changed many f the reagents withut any assay validatin The analyst wuld run the assay enugh times until see the results expected r the grup was happy with the results. 22

23 Thanks fr Yur Attentin and Nt Falling Asleep! 23