OR NOT TO OUTSOURCE. Omar Merhi, PhD Director, Clinical Research Operations ABIOMED, INC.

Transcription

1 1 TO OUTSOURCE OR NOT TO OUTSOURCE Striking the balance between outsourcing and using in-house resources to improve efficiencies in your trial: which model offers the most value to sponsors? Omar Merhi, PhD Director, Clinical Research Operations ABIOMED, INC.

2 OVERVIEW 2 Abiomed and Impella Clinical Research Team Assessing Clinical Needs Strategic vs. Tactical projects Insourcing vs. Outsourcing

3 ABIOMED AND IMPELLA 33

4 WHO IS ABIOMED Founded in Danvers MA in 1981 Experts in Pumping Blood for over 35 years 1 st US S-T VAD for Heart Recovery 1 st US Totally Implantable AH 1 st US use of microaxial pump, Impella Over 400 patents or patents pending Company Danvers, MA, Aachen GDR & Tokyo Japan >900 Employees 2017 RP Filed for PMA, Impella left side devices for Non-ischemic Cardiogenic Shock 2016 Impella 2.5, CP, 5.0/LD PMA approval 2015 Impella 2.5 PMA Approval 2012 Impella CP 510(k) cleared 2010 AIdC Controller 510(k) cleared 2009 Impella (k) cleared 2008 Impella 2.5 FDA 510 (k) cleared 2005 ABIOMED acquires Impella 2001 First AbioCor Artificial Heart patient 1992 First FDA approved VAD 1987 First heart recovery patient 1981 ABIOMED Founded 4 4

5 ONE OF THE FASTEST GROWING COMPANIES 5 5

6 IMPELLA HEART PUMP CHARACTERISTICS 6 6 9Fr Catheter (9Fr in leg) Quiet, no active driveline 12 fr smooth surface across valve (Impella 2.5) 14 fr smooth surface across valve (Impella CP) 6fr Standard Pigtail

7 IMPELLA DEVICE 7

8 IMPELLA PUMP FAMILY PLATFORM 8 8 Impella 2.5 Impella CP Impella 5.0 Impella RP Pigtail Blood Inlet Area Unique 3D Cannula Design Blood Outlet Area Pump Motor Driveline Catheter Diameter: 9 Fr Flow Rate up to: 2.5L/min Catheter Diameter: 9 Fr Flow Rate up to: 3.5L/min Catheter Diameter: 9 Fr Flow Rate up to: 5.0L/min Catheter Diameter: 11 Fr Flow Rate up to: >4.0L/min Automated Impella Controller

9 IMPELLA RP HEART PUMP 9 9 Percutaneous Right-Side Support Supports flow from the Inferior Vena Cava (IVC) to the Pulmonary Artery (PA) 22 Fr pump, 11 Fr catheter Up to 4 liters/ flow per minute Single vascular access (femoral vein) No sternotomy required No extracorporeal circulation 2 nd Generation Cannula and guidewire for improved placement (2017) Indication for Use Provides circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area (BSA) 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery 2 nd Generation RP is in development and is not approved for use or sale.

10 CLINICAL RESEARCH OPERATIONS $540K /Q $300K/Q CRO A CRO B cvad Registry RP-PAS DTU Protected PCI-PAS Sr. Prog. Mananger Sr. II Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

11 CLINICAL RESEARCH OPERATIONS $540K /Q XCRO A $300K/Q XCRO B cvad Registry RP-PAS DTU Protected PCI-PAS Sr. Prog. Mananger Sr. II Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

12 CLINICAL RESEARCH OPERATIONS cvad Registry RP-PAS DTU Protected PCI-PAS Sr. Prog. Mananger Sr. II Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

13 CLINICAL RESEARCH OPERATIONS cvad Registry Sr. Prog. Mananger RP-PAS Enrollment Complete Close-out DTU Protected PCI-PAS Close-out Sr. II Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

14 CLINICAL RESEARCH OPERATIONS: RE-ORG VENDORS CRO & Clinical Support Monitoring CRO (as needed) CRO in EU (Open) Database Vendor Core Labs CEC cvad Registry Program. Mananger DTU Program. Mananger Open Open Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

15 PROGRAM AND SITE MANAGEMENT : CURRENT STRUCTURE 15 People Driven Model Total Headcount 3 Program/Project Managers 7+ Siloed teams Unnecessary duplication of communication with sites Duplication of effort Not utilizing headcount at optimal capacity Operates at 70-80% cvad Program* 7 Headcounts 1 Program Manager 1 Project Manager 5 Site Managers () DTU-STEMI Program 3 Headcounts 1 Program Manager 2+ Site Managers () * Not including EU

16 PROGRAM AND SITE MANAGEMENT : PROPOSED STRUCTURE 16 Effort Driven Model Total Headcount 2 Program Managers 4-5 (- 2 FTEs) Integrated teams Increased Operational Efficiencies Optimized customer service Decreased risk of down time due to cross training DTU-STEMI RCT n=50 Site Management (effort) cvad Registry n~4000

17 CLINICAL RESEARCH OPERATIONS: RE-ORG VENDORS CRO & Clinical Support Monitoring CRO (as needed) CRO in EU (Open) cvad Registry STEMI-DTU Database Vendor Program. Mananger Program. Mananger Core Labs CEC Open Open Open Open Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

18 INSOURCING VS. OUTSOURCING 18 Cost avoidance of ~$3M/year Direct relationship with the investigative sites One stable point of contact Faster execution of assignments and deliverables Grow an in-house organic team Cumulative knowledge repertoire much needed for a growing enterprise Faster allocation of resource with changing priorities Low or no turn-over No push back due out of scope or not in the task order

19 STRATEGIC VS. TACTICAL cvad Registry Sr. Prog. Mananger RP-PAS Enrollment Complete Close-out DTU Protected PCI-PAS Close-out Sr. II Sr. Biostatistician Clin. Data Man. Clin. Trial Coordinator

20 STRATEGIC VS. TACTICAL cvad Registry RP-PAS Enrollment Complete Close-out DTU Protected PCI-PAS Close-out

21 STRATEGIC VS. TACTICAL Insourcing Outsourcing Strategic Tactical cvad Registry Protected PCI-PAS DTU RP-PAS

22 CHALLENGES Compete for a very small pool of talents home-based Flexibility Competitive total comps Train new resources on a novel therapeutic (MCS) Catch-up to the increased clinical research needs

23 ABIOMED: RECOVERING HEARTS CHANGING LIVES ABIOMED Recovering Hearts. Saving

24 THANK YOU 24 24