Amatsigroup CORP PRES HUMAN HEALTH 19 05 2016
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Transcript of Amatsigroup CORP PRES HUMAN HEALTH 19 05 2016
Amatsigroup presentationHuman HealthMay 2016
2 Nom de la présentationCorporate Presentation Human Health
Sept 2014
Leading EarlyCDMO * Partner
in Pharmaceutical Product Development
* Contract Development And Manufacturing Organization
Expertise
3 Nom de la présentationCorporate Presentation Human Health
Vision Leading partner in the early phases of pharmaceutical development Active contributor to health improvement.
* Co
ntra
ct D
evel
opm
ent M
anuf
actu
ring
Org
aniza
tionMission As a major European early CDMO*, we collaborate with small to large
bio/pharmaceuticals companies offering integrated high-added-value drug development services.We apply a unique & innovative HighWay-to-Clinic™ approach delivering tailored and troubleproof solutions which help advancing our client’s programs in a timely & cost effective manner.We support life science development through our scientific, technological & regulatory expertise.
Amatsigroup Identity
Transparency, team spirit, authenticity & trust, are the core values that we share with clients.
Values
4 Nom de la présentationCorporate Presentation Human Health
Sept 2014
78%
22%
2015 Revenues
Spanning Human & Animal Health
Expertise
2015 Revenues
Clients Typology
2015 Revenues
Geographic Split
5 Nom de la présentationCorporate Presentation Human Health
Jan 2016Q BiologicalsAcquisition
Sept 2014
25 years of experience
Key Steps
2012AVEPHARMAcquisition
1987 CRID PHARMA Creation
2010• AVOGADRO
acquisition• CRID renamed AMATSI
2000AVEPHARMCreation
2006DBI Creation
2011DBIAcquisitionQ-BiologicalsCreation
1998AVOGADROCreation
2008SEPS PHARMACreation
2013Legal merger
Jan 2015SEPS PHARMA Acquisition
Nov 2015PIERRE FABRE ST AUGUSTIN Acquisition
Oct 2014 Creation
6 Nom de la présentationCorporate Presentation Human Health
Sept 2014
• 300 active clients
• 8 operational sites
• 280 employees
• 33 M € of revenue in 2015
ADMIN. OFFICE
Inc.
Key Figures
7 Nom de la présentationCorporate Presentation Human Health
Sept 2014
Accreditations | Inspections
8 Nom de la présentationCorporate Presentation Human Health
5 areas covering Drug Product Development
* Excluding Clinical Monitoring
Portfolio
CMC & RACMC & RA
9 Nom de la présentationCorporate Presentation Human Health
Expertise
Sept 2014
160 batches released yearly
3 000 shipments yearly
Clinical Trial SupplyPackaging & Logistics
300 + bioanalytical methods developed in 30 + matrices
100 in life studies yearly
Bioservices
Formulation Development & Manufacturing
30 formulation development projects yearly
100 sterile & 145 non-sterile batches manufactured yearly
PharmaceuticalAnalysis Solutions
150 + analytical methods developed yearly
500 analytical CoA, 1200 microbial tests monthly
25 lots put into stability monthly
Experience with 200+ proteins
75 R&D projects in 4 years
Biologicals
10 Nom de la présentationCorporate Presentation Human Health
Sept 2014
Organization highlightsExperienced Senior Management
| Pharmacist| 25 years in
Pharma Industry
Alain SainsotPresident
Jean-Pierre ArnaudCEO
| Veterinarian| 35 years in
Animal Health
Marie-Christine BodinierEVP, Global Business Development
| Biochemist| 25 years in
US & EU Life Sciences
Experts for BUs supervision / cross-sites management| Ph.D. Pharma
Technology| 15 years in
Pharma Industry
Yves GonnissenBU DirectorFormulation Development& Manufacturing
| Ph.D. Chemistry
| 20 years inPharma Industry
Gérald de FontenayBU DirectorPharmaceutical Analysis Solutions
Annie Van BroekhovenBU DirectorBiologicals
| Ph.D. Cell Biology| 35 years in
Biologicals
11 Nom de la présentationCorporate Presentation Human Health
Sept 2014
Organization highlights
Technical & scientific expertise of the Business Team| Business Development Managers with scientific degrees| Commercial Business Unit Managers with strong technical expertise| Quotation Specialists with operational knowledge
| Large scope of expertise : M.Sc, Ph.D, D.V.M. Pharm.D., Eng., B.Sc.| 1 project manager / study director for 2 Technicians (B.Sc.)
Multidisciplinary Operational Teams
12 Nom de la présentationCorporate Presentation Human Health
PHARMA EXPERTISE• Merger of 4 expert companies• Group managed by Industrials for Industrials
Sept 2014
• Customized solutions• Adaptability to schedule changes• Industrial modularity
FLEXIBILITY
PROXIMITY• Dedicated Project Manager• Lean structure• Study designs & quotations supervised by scientists
Core Values
QUALITY• 9 QPs – 12 QA people• GMP & GLP compliance
13 Nom de la présentationCorporate Presentation Human Health
Comprehensive Customer Service
* Chemistry Manufacturing Control
• CMC files drafting Gap analysis & updates IVP & Market Authorization dossiers Variation dossiers
• Product development management Internal CMC*-Regulatory Affairs team Internal coordination of all phases Dedicated customer contact (SPOC) Statistical measurements & Analyses
• Response to Agencies
14 Nom de la présentationCorporate Presentation Human Health
Project management under CMC & RA
Human Health
PRODUCTFormulatio
nAnalytica
l Package
CMC Regulato
ry studies
Manufacturing
QP ReleaseDistribution of
clinical batches
Constitution of CMC
file
Antiseptic Topical SolutionGENERIC
Transfer
AntihypertensiveCapsules
NCEPhase 2
AntiepilepticPediatric soluble
tabletPhase 2
CNS disorderPediatric oral
solutionPhase 2
AntineoplasicSolution for injection
NCEPhase 1
AntiallergenicCutaneous patches
Phase 1 to 3
15 Nom de la présentationCorporate Presentation Human Health
Sept 2014
FREQUENT
Communication
TECHNICAL &
REGULATORY INPUT
For Study Design
INDUSTRIAL
Modularity
FOCUS ON
DATA RELIABILITY
For Regulatory submission
Assets for a sucessful collaboration