Optimising Clinical Laboratory Operations. Alan Brown SLAS Compound Management March 2017

Transcription

1 Optimising Clinical Laboratory Operations Alan Brown SLAS Compound Management March 2017

2 What I will cover Introduction Alan AstraZeneca Clinical Sample Sciences The challenge before Clinical Sample and Bioanalytical Sciences The big idea Considerations and lessons learnt

3 Alan Brown - Bio

4 AstraZeneca overview 4

5 CSBS Clinical Sample and Bioanalytical Sciences What we do 5

6 Clinical Sample Sciences Laboratory selection

7 Clinical Sample Sciences Laboratory contracting

8 Clinical Sample Sciences Laboratory management and oversight

9 Clinical Sample Sciences Global clinical sample logistics

10 Clinical Sample Sciences Delivery of high-quality samples to laboratories, bio-banks or destruction per patient consent

11 Volume >250 ongoing studies Samples coming from >50 countries across 3 continents for safety, biomarker, bioanalytical and exploratory testing Testing performed by a network of >50 providers Mix of prospective testing, retrospective testing and long term storage to track Billion sample movements per year

12 The Challenge

13 We needed to overcome: Sub-optimal processes Studies and sample life cycles more complex Reducing budgets Increasing use of specialist laboratories Almost entirely new team

14 How?

15 The Big Idea Make manual processes (tracking) automated Simplify sample life cycles (we can t do much about the study design) Reduce costs Streamline use of specialist laboratories Central to them all: Enter a strategic partnership with a single, preferred provider and co-develop processes to tackle AZ and industry wide challenges

16 5 key areas 1. Stakeholder Engagement 2. Region Specific Challenges 3. Global Tracking 4. Ensuring Consistency 5. Governance

17 Stakeholder Engagement

18 The Hidden Stakeholders Obvious Study Team Laboratories Not so obvious Procurement Legal Regulatory Monitors Site Bio Banks Regional coordinators Data management Scientific teams Medical Scientists CRO partners

19 A tangled web of interaction 19

20 Regional Challenges

21 What is HGRAC (HGR or CHGRAO) HGRAC: Human Genetic Resources Administration of China (aka, China Human Genetic Resources Administration Office, CHGRAO) Governance and Policies: 1. The Interim Measures for the Administration of Human Genetic Resources (No. (1998) 36) issued by the MOST and Ministry of Health (MOH) in Draft Regulation for the Administration of Human Genetic Resources issued in 2012 (for solicitation of comments only with minor additions to the 1998 version, not made into law yet) Notice from MOST Regarding Further Strengthening the Administration of Human Genetic Resource; Notice number (2013) No. 615

22 Samples subject to HGRAC Tumour Block Tumour Slides Plasma Whole Blood Paxgene CPT PBMC Serum Tissue Microarray Urine 22 Recombinant DNA Human

23 Examples of data subject to HGRAC PK Pathology Central lab (FBC, Chem etc) X-ray Whole Genome sequence Flow cytometry Viral Loads 23

24 Global tracking

25 Studies used to be simple Archival tumour & fresh biopsies taken during Drug 1 nab study PK Drug 1 Drug 1 ADA Safety Samples Ambient Daily Pathology Laboratory Frozen End of Study Aliquot 1 Frozen Quarterly Aliquot 1 Frozen Quarterly Repatriated Analytical laboratory Analytical laboratory Analytical laboratory Central Analytical laboratory

26 How are we simplifying? Fresh Fixed tumour Archival tumour & fresh biopsies taken during study Fresh frozen tumour RNA Circulating soluble factors PBMC Drug 1 nab Drug 1 ADA Drug 2 nab Drug 2 ADA PGx (optional) PK Drug 1 PK Drug 2 Safety Samples Frozen Daily Ambient Daily Ambient Daily Ambient Daily spd-l1 Analytical laboratory Ambient End of study On request Analytical laboratory * Pathology Laboratory Repatriated or biobank Frozen End of Aliquot 2 Aliquot 1 Aliquot 1 Aliquot 1 Frozen Frozen Frozen Frozen Frozen Frozen Frozen Frozen Frozen Study End of Quarterly Quarterly Quarterly Aliquot 1 Aliquot 1 Aliquot 1 & 2 study Quarterly Frozen Frozen Frozen Quarterly Quarterly Quarterly End of study End of study End of Study Analytical laboratory End of Study Central Analytical laboratory Analytical laboratory Analytical laboratory Analytical laboratory Analytical laboratory Analytical laboratory AZBiobank

27 Umbrella trial Lung cancer patients x Outcomes monitored learning taken from the results Drug 1 Drug 2 Drug 3 Drug 4

28 Ensuring Consistency A B C B C A

29 Ensuring Consistency Study teams geographically separate Number of vendors Site inconsistency Study design

30 Oversight

31 Oversight Robust governance structure Operational Steering team Executive Steering team Service Level Agreements - Metrics

32 Final thought..

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