Camurus GHD2016

Accelsiors CRO
Angela Weston Chief Commercial Officer
March 1st 2016


Accelsiors Team
• 220 employees worldwide and growing
• Full service provider -16 offices & operations in 30 countries
• Significant number of staff with MD and/or PhD degree
• Strong professional team with expertise across CRO, pharmaceutical, Device Bio-tech, regulatory and academia
• Multilingual and multicultural diversity across the team
• 90% of employees fluent in two or more languages
• Low staff turn over < 12% & high repeat business
• Pro-active commitment to quality
PLAN – ACCELERATE – CONTROL – EXECUTE


GH Disorder Experience
• Accelsiors has a combined people experience of 80 years in GHD
• Conducted over 20 studies to date
• Involved in over 80% of all GHD studies globally
• Currently 8 studies globally in long acting GH
– Accelsiors is/has been involved in 6 of these
• Accelsiors - only CRO to have both Adult and Paediatric GH deficiency
experience
• Investigators & sites trust us and perceive us as ’the expert’
• Trust > respect > loyalty = patients
• Patients = success for everyone
PLAN – ACCELERATE – CONTROL – EXECUTE


Specific People Expertise
• Accelsiors has a team of 220 - the below is the % of people with expertise in Endocrinology:
– Clinicaloperations:70.49%
– Biometrics: 80%
– Safety and Medical Management: 100% – Project Management: 66.66%
• Our CEO and Chief Scientific Officer are experts and have 30 years experience in the design and statistical input to protocols
• Our CEO is an MD and has established relationships with key recruiting sites globally
PLAN – ACCELERATE – CONTROL – EXECUTE
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GHD Experience
No.
Phase
Indication/TA
Start date
No of sites
No of patients
Geography
Population
Responsibility
1.
Phase III
Endocrinology (GHD)
Sep-02
29
168
Europe, US, North Africa
Peadiatric
Protocol, QA clinical supervision preparation of selected sites for EMA inspection, management of sites in 2 countries
2.
Phase III
Endocrinology (GHD)
Jun-03
26
150
Europe, US, North Africa
Peadiatric
Protocol development, medical consultation, selected site management and monitoring
3.
Phase III
Endocrinology (Turner Syndrome)
Nov-03
18
26
Russian Federation
Peadiatric
Responsible for all protocol amendment developments, QA supervision of the entire study, medical consultation, active management of sites in 2 countries
4.
Phase II
Endocrinology (GHD)
Sep-04
16
51 (screene d 170)
Central, Eastern Europe
Pediatric
Complete study management and monitoring, protocol development, safety and medical management, regulatory management
5.
Phase III
Endocrinology (GHD)
Apr-05
71
180 (screene d 490)
Europe, US, India
Peadiatric
Global: protocol development, global medical management, bone age assessment management, Regional: study management and monitoring (Only Central and Eastern Europe- Accelsiors has recruited almost half of the centers)
6.
Phase III
Endocrinology (GHD)
Oct-05
64
152 (198 screene d)
Europe, US, India
Adult
Global: protocol development,
Regional: study management and monitoring (Only Central and Eastern Europe- Accelsiors has recruited almost half of the centers)
7.
Phase II
Endocrinology (Acromegaly)
Sep-06
1
8
Romania
Adult
Protocol development, medical consultation, selected site management and monitoring
PLAN – ACCELERATE – CONTROL – EXECUTE
5


GHD Experience cont’d
No.
Phase
Indication/TA
Start date
No of sites
No of patients
Geography
Population
Responsibility
8.
Phase III
Endocrinology (Acromegaly)
Oct-06
11
68
Central, Eastern Europe
Adult
Complete study management, Protocol development, medical consultation, selected site management and monitoring
9.
Phase IIa
Endocrinology (GHD)
Mar-07
5
24
Central, Eastern Europe
Young Adult
Complete study management, protocol development, safety medical management, complete biometrics, full PK/PD analysis and report
10.
Phase IIa
Endocrinology (GHD)
Nov-09
25
45
Central, Eastern Europe, Germany,
Adult
Complete study management, protocol development, safety medical management, complete biometric, full PK/PD analysis and report
11.
Phase II
Endocrinology (GHD)
3-May- 10
14
56
Central, Eastern, Western Europe, Israel
Adult
Complete study management, protocol development, safety medical management, complete biometric, full PK/PD analysis and report.
12.
Phase II
Endocrinology (GHD)
May-11
15
60
Central, Eastern Europe
Adult
Complete study management and monitoring, protocol development, safety and medical management, regulatory management, data management, statistics, PK/PD
13.
Phase III
Endocrinology (Acromegaly)
Jun-11
22
150
Central, Eastern, Western Europe, Israel, Mexico, Lithuania
Adult
Global:
for protocol development,
Regional:
study management and monitoring (Only Central and Eastern Europe- Accelsiors has recruited almost half of the centers)
PLAN – ACCELERATE – CONTROL – EXECUTE
6


GHD Experience cont’d
No.
Phase
Indication/TA
Start date
No of sites
No of patients
Geography
Population
Responsibility
14.
Phase II
Endocrinology (GHD)
Oct-11
30
56
Central, Eastern, Europe, Israel, Spain
Peadiatric
Complete study management and monitoring, protocol development, safety and medical management, regulatory management, data management, statistics, PK/PD analysis with report, PK/PD modeling, PIP development
15.
Phase II
Endocrinology (GHD)
Jul-12
20
50
Central, Eastern, Western Europe, Israel, Sweden, USA
Adult
Complete study management and monitoring, protocol development, safety and medical management, regulatory management, data management, statistics, support of PK/PD analysis with report, support of PK/PD modeling
16.
Phase II
Endocrinology (GHD)
Nov-12
30-40
52
Central, Eastern, Western Europe, Egypt
Peadiatric
Complete study management and monitoring, protocol development, safety and medical management, regulatory
17.
Phase III
Endocrinology (GHD)
Apr-13
60
54
USA, Israel, Western, Eastern Europe
Adult
Complete study management, protocol development, complete biometric, full PK/PD analysis and report
PLAN – ACCELERATE – CONTROL – EXECUTE
7


GHD Experience cont’d
No.
Phase
Indication/TA
Start date
No of sites
No of patients
Geography
Population
Responsibility
18.
Phase II
Endocrinology (GHD)
Sep-13
40
63
Eastern, Central Europe, Greece, Israel, Turkey
Peadiatric
study management and monitoring, protocol development, safety and safety medical management, regulatory management, data management, statistics, support of PK/PD analysis with report,
19.
Phase III
Endocrinology (Acromegaly)
1-Mar- 15
30
155
Central, Western, Eastern Europe, Israel
Adult
Protocol development, Central lab vendor management, complete biometrics,
Regional responsibility:
Central Eastern Europe study management, recruitment, monitoring (delivery of 70% of patients)
20.
Phase IIa
Endocrinology (GHD)
21- May-15
52
60
Central, Eastern Europe, Northern Africa
Peadiatric
Compete study management, protocol development, safety medical management, complete biometric, full PK/PD analysis and report, PIP development
PLAN – ACCELERATE – CONTROL – EXECUTE
8


Accelsiors Key Strengths in GHD
• Expertise to design and review synopsis/protocol to minimize SF rate
• Trusted ‘go to’ relationships with KOL
• Trusted ‘go to’ relationships with sites (international)
• Recommendations for expert DSMB members
• Medical risk assessment knowledge
• Regulatory and Ethics expertise for efficient and timely submissions
• Experienced operational teams in GHD:
– Project Director
– Project Manager
– Medical Monitor
– Biometrics
– CTL/CRA
PLAN – ACCELERATE – CONTROL – EXECUTE


Acromegaly Case Study
• Phase III
• Monitored by 3 CROs
• 13 countries involved
• Accelsiors:
• Responsible for 7 countries in Western, Central and Eastern Europe
• Full site selection, start up, monitoring, project management, QA
• 37 sites activated (less than half managed by Accelsiors)
PLAN – ACCELERATE – CONTROL – EXECUTE
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Acromegaly Case Study
• Recruitment between three CROs was competitive and unlimited
• Accelsiors was expected to contribute 30%
– Accelsiors delivered almost 60% total patient population
– Accelsiors delivered a significant number of patients for PK/PD sub-study
• First subjects screened at Accelsiors managed site
• 6 out of 10 countries who participated in optional PK sub-study were managed by Accelsiors
PLAN – ACCELERATE – CONTROL – EXECUTE
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Acromegaly Case Study
• Accelsiors site selected for FDA inspection
– Top 5 recruiting sites (all Accelsiors sites) had a mock inspection performed
by client
• Top 2 highest recruiting sites were managed by Accelsiors and were inspected by FDA
• FDA focused on:
– Drug accountability processes (including IP shipment documentation)
– Laboratory procedures and results
– Interactions/communication with vendors
After 5 days on site at (each) site by FDA inspectors zero FDA 483 forms issued
Reference: Melmed et al- The Journal of Clinical Endocrinology & Metabolism
PLAN – ACCELERATE – CONTROL – EXECUTE
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Acromegaly Case Study
Screen Failure
Reason
17% 61%
IGF-1
GH Test
Consent Withdrawal Radiotherapy Prohibited Medication Other
PLAN – ACCELERATE – CONTROL – EXECUTE
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Why Choose Accelsiors
• Accelsiors is a recognized as a leader in GHD
• Established longstanding client relationships and repeat business
• We contributed to almost 80% of all GHD programmes Globally to date
• To date we have conducted 25 GHD studies both Peadiatric & Adult
• Through our participation in most GHD studies we have established trusted relationship with key recruiting sites globally – this extends to KOL for DSMB on a Global scale
• More than other CRO we understand the status of competitive recruitment, the main success drivers and biggest drawbacks for patient recruitment
• In summary we have access to the patients
PLAN – ACCELERATE – CONTROL – EXECUTE


Next Steps
• We would welcome the opportunity to speak with the Camurus team to formally introduce our company and our experience in managing clinical trials.
PLAN – ACCELERATE – CONTROL – EXECUTE
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Accelsiors CRO
Angela Weston Chief Commercial Officer [email protected] 00 44 (0) 770 941 1449
March 2016