Transcript BA/BE - Semler Research Center

SRC/CPPT/2013/DECEMBER/Version15
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Part of US based Arnold A Semler Inc, in business since 1946
Uniting the World of Pharmaceutical Research
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Company Overview
SRC/CPPT/2013/DECEMBER/Version15
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Established in 2006
Internally funded, with strong financials
Combined leadership experience of over 250 years in the pharmaceutical, biotechnology and device industries
A qualified team of over 200 professionals with extensive expertise in the development of both generic and
patented products
Europe
Los Angeles
China
Japan
South Korea
Bangladesh
Taiwan
Bangalore
Salem
Malaysia
Locations in red denotes SRC offices and blue denotes partner offices
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Corporate Philosophy
To be one of the most trusted
partners in pharmaceutical
development to assist our clients in
improving the quality of human life.
To build long-term relationships with
our customers, vendors, staff and
investors through best-in-class
business practices, R&D services and
scientific innovation.
To be committed to deliver the
highest quality of services in meeting
our customers’ requirements on time
and every time.
Mission
Vision
Quality
Policy
Values
Sincerity
Respect for people
Commitment
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Quality Strategy & Deployment
SRC/CPPT/2013/DECEMBER/Version15
People
Infrastructure
Process &
Systems
*QMS: Quality Management System
*GCP: Good Clinical Practice
• Team of over 200 professionals
• Talent sourced from various global pharma
& CRO’s
• Thought leaders
• State of the art facilities
• Regulatory accepted hardware/
software applications
• Secured networks across locations
• *QMS with well defined SOP’s/Plan/
Policy & Quality manual
• Validated metric management & *IQA
• *Compliance to GCP, GLP, ISO standards
& CFR Part 11 requirements
• Deployed SAP for effective & optimal
utilization of resources
*IQA: Institute of Quality Assurance
*ISO: International Organization for Standardization
*GLP: Good Laboratory Practice
*CFR: Code of Federal Regulations
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Service Overview
Pharmaceutical Development
Formulation Development
• Generics & *NCEs
• Diverse dosage forms
Analytical Development
• Assay & *RS methods development
• Stability studies
• Polymorphic form characterization
• Validation
• Method conversions
More…
Bioavailability & Bioequivalence
Clinical
• *PK (compartmental & non –
compartmental studies)
• Food effects & drug interactions studies
• Special population studies
• Narcotic /controlled substance studies
Bioanalytical
• Method development & validation
• Sample analysis
• Invitro binding BE studies
More…
Clinical Development
[Patient Studies]
Clinical Development
• Project management for Phase I, II and III
clinical studies
• Allied Services*
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Study types
Clinical end point studies
Patient *PK studies
Stem cells studies
Diagnostics/ Devices
More…
*Allied Services
• Medical and scientific writing
• Biometrics & data management
• Regulatory services (*ANDA, NDA, Scheduled drugs, DMF preparation and submission)
*NCE: New Chemical Entity
*NDA: New Drug Application
*RS: Related Substances
*DMF: Drug Master File
*ANDA: Abbreviated New Drug Application
*PK: Pharmacokinetics
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Equipment and Facilities - Overview
SRC/CPPT/2013/DECEMBER/Version15
Pharmaceutical Development
Bioavailability & Bioequivalence (BABE)
Well-equipped pharmaceutical development laboratories
More…
152-bed, well-equipped,
GCP compliant facility
Sample analysis capability:
over 20,000/month
USFDA, WHO, MoH Turkey MoH Chile & EMA audited
BABE facility
Over 200 methods available
More…
Clinical Development
Experienced clinical
development team
Enrolment as per protocol
requirements
Qualified and experienced
medical & scientific writers
More…
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Regulatory & Quality Compliance
Type
Description
Facility Approval
Drugs Controller General of India (DCGI) approved facilities
(Salem & Bangalore)
Pharmacy
•State Drug Controller approved facilities in Bangalore & Salem
•Approved to store and dispense Schedule X drugs including
controlled substances (Narcotic Drug Permission)
Pollution Control
Karnataka State Pollution Control Board approval for J.P. Nagar and
Hebbal facilities in Bangalore
Regulatory Inspection
•United States Food & Drug Administration (USFDA)
•Drugs Controller General of India (DCGI)
•World Health Organization (WHO)
•Ministry of Health Turkey (MoH Turkey)
•Instituto De Salud Publica De Chile (ISP- MoH Chile)
•European Medicines Agency (EMA)
• Acceptance of study reports by National Pharmaceutical Control
Bureau (MoH, Malaysia)
•Certifications
•*ISO 9001 : 2008 for Quality Management System
•*ISO 27001 : 2005 for Information Security Management System
•Department of Scientific and Industrial Research (DSIR)
Recognition
*ISO: International Organization for Standardization
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Regulatory Competency
Regulator
Details (Approved & pending for approval)
Service
Sponsor
WHO
Various studies approved
BA/BE
Indian generics
USFDA
Various studies approved
BA/BE
Indian generics
EMA
Study inspected
BA/BE
Indian generics
USFDA
Pending for approval
PD
US generics
USFDA
Pending for approval
CD
US generics
Turkey
Inspected and approved
BA/BE
NA
Chile
Inspected
BA/BE
NA
Brazil
Pending for submission
PD
US generics
• SRC has adequate experience in various regulatory guidelines with a cumulative experience of
over 500 regulatory submissions.
• Studies conducted at SRC’s facilities viz Salem and Bangalore (Clinical and Analytical) have
been inspected and approved by WHO, USFDA, EMA & ISP- MoH Chile.
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Regulatory Inspection -Experience
Period
Reg
Man-days & Inspectors
Area
Outcome
July 2010
WHO
10
(2 inspectors)
BA/BE
Completed without critical/major
findings
July 2011
WHO
10
(2 inspectors)
BA/BE
Completed without critical/major
findings
Dec 2011
MoH
08
(4 auditors)
BA/BE facility,
Bangalore
Inspection completed and BA/BE
facility approved
May 2012
USFDA
05
(01 inspector)
BA/BE
Inspection completed successfully
Sept 2012
USFDA
10
(2 inspectors)
BA/BE
Inspection completed successfully
Mar 2013
WHO
08
(2 inspectors)
BA/BE
Completed without critical findings
June 2013
ISP, MoH –
Chile
02
(2 inspectors)
BA/BE facility
Bangalore & Salem
Inspection completed successfully
July 2013
USFDA
06
(2 inspectors)
BA/BE
Inspection completed successfully
Aug 2013
USFDA
06
( 1 inspector)
BA/BE
Inspection completed successfully
Oct 2013
EMA
10
(2 inspectors)
BA/BE
Inspection completed successfully
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Activity milestone with key achievements
SRC/CPPT/2013/DECEMBER/Version15
Opening of Formulation & Analytical lab
Initiation of commercial activities
2007
Acquired Salem clinical facility
2006
2009
 Change in business strategy and initiation of
new services
2011
“Bio Excellence” award by Govt of Karnataka
“No 1 Company” in LS category by growth
 DSIR accreditation by DST, Govt of India
 ISO 9001 & 27001 certification
WHO inspection
 MoH Turkey inspection
 Geographical expansion
(Asia CRO & Logic trials)
Opening of new clinical lab at Bangalore
First WHO inspection
2010
Conduct of First USFDA study
 Awarded First International study
 2 USFDA inspection
Udyog Rattan Excellence Award
Geographical expansion
(ICDDR)
WHO inspection
 MoH Chile Inspection
 First ANDA approval from USFDA
USFDA inspection
EMA inspection
2012
 Year of incorporation
2013
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Alliance Management
SRC/CPPT/2013/DECEMBER/Version15
Name /
Alliance
Type of Alliance
*CD
*PD
*BA/BE
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Logic Trials
Strategic alliance to manage South Africa
specific studies / projects.
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Asia CRO
Alliance
Strategic alliance to manage South East Asia
sponsor requirements.
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USA & Europe
Service alliance with reputed CROs in US
and EU to manage global clinical studies.
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ICDDR
Alliance to cater Bangladesh sponsor
requirements and global clinical studies
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* CD – Clinical Development, PD – Pharmaceutical Development, BA/BE – Bioavailability & Bioequivalence
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Awards and Recognitions
Bio – Excellence Award 2012
DSIR Recognition by DBT
ISO 27001 : 2005
ISO 9001 : 2008
Udyog Ratan Excellence Award
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Track Record
Pharmaceutical Development
Generic drug development (US, EU, Lat-AM and others)
Solid Orals
IR, MR Tablets/Capsules
• Dedicated Oncology / High Potency
SRC/CPPT/2013/DECEMBER/Version15
Products Area with Isolators
Liquid orals
Solutions, Suspensions, Dry Syrups
Topicals
Ointments/Creams/Gels
Ophthalmics
Suspension/ Ointments / Solutions
Parenterals
Liquid Injections – Vials, Ampoules, PFS,
Lyophilized injections
• Process Development Laboratories
• Process Scale Up Facilities
• Analytical Testing Laboratories
Innovative Generics [e.g. 505 (B) (2)]
• Fixed dose combination immediate release tablets/capsules
• Fixed dose combination extended release capsules
Innovative Drug Delivery Technologies
• Effervescent Formulation (Lubrication optimizations studies)
• Tablet in Tablet Formulation (Compression coating)
• Novel drug delivery systems including Liposomes …
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Track Record
SRC/CPPT/2013/DECEMBER/Version15
Bioavailability & Bioequivalence
TYPE OF STUDIES
PILOT
STUDIES
21%
MHRA LA TGA
5% 3% 3%
WHO
13%
HEALTH
CANADA
3%
PIVOTAL
STUDIES
79%
Total number of studies
EU
15%
ROW
4% DCGI
2%
MCC
2%
370
Volunteers dosed
23,360
Samples analyzed
4,15,000
USFDA
50%
EXPERIENCE BY REGULATORY SUBMISSION
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Track Record
Bioavailability & Bioequivalence
(cont.)
Indication
wise Experience
SRC/CPPT/2013/DECEMBER/Version15
14%
12%
Indication Wise Experience
10%
8%
6%
4%
2%
0%
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Track Record
SRC/CPPT/2013/DECEMBER/Version15
Clinical Development
Studies Initiated
[2010-12]
Completed Recruitment
[2011-13]
Scheduled Recruitment
[2013-14]
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[Global – 9 & Local - 9]
Over 1000 patients
Over 1500 patients
Niche Expertise
Completed/Ongoing Studies [2010 - Current]
Ophthalmology
Oncology
Stem cells
Infection
17%
6%
5%
50%
22%
Dermatology
Special population studies in:
 Renal & hepatic impaired patients
 Obese subjects
 Healthy premenopausal women
 Postmenopausal women
Patient PK studies in:
 Oncology
 Ophthalmology
 Nephrology
Stem cell studies in:
 Gastroenterology
 Dermatology
Device studies in:
 Neurology
 Nephrology
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Value Proposition
Integrated Services
SRC/CPPT/2013/DECEMBER/Version15
India’s first, independent organization to
fully integrate drug development, clinical
development and manufacturing services
Capital Solutions
Innovative
capital
solutions to emerging
pharma, biotech and
virtual companies.
Scientific Expertise
Combined leadership experience of
over 250 years in the pharmaceutical
industry; a qualified team of over 200
professionals with extensive expertise
in the development & manufacturing
of both generic and patented products
Adequate Resources
State-of-the-art equipment and
infrastructure across locations
(over 60,000sft.) to facilitate
smooth and quality services
Global Regulatory Experience
Several decades of exposure to various
regulatory bodies across the globe for
both generic and patented products
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Value Proposition (cont.)
SRC/CPPT/2013/DECEMBER/Version15
Integrated Services
Analytical Development
Plant Setup
Formulation Development
API Characterization
Preformulation
Prototypes
Stability Studies (short & long term)
Pilot & Pivotal Batch
Manufacturing
Pre Clinical Studies
Facilitation of manufacturing
licenses
Commercial
Manufacturing
Scale up and Tech Transfer
Phase I
Phase II
Phase III
SRC Services
(BA/BE)
Partner Services
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
A Case Study in Integrated Services
Pharmaceutical Development Team
Bioanalytical Team
• Method development
(aqueous humor matrix)
• Method validation
• Sample analysis
Method Development &
Sample Analyses
Knowledge Transfer
SRC/CPPT/2013/DECEMBER/Version15
Product Development
• Formulation development
• Analytical method development &
validation
• Tech transfer
Clinical Development Team
• Protocol development
• Site selection
• Project management
• Monitoring
• Stat & PK support
• Reports
Patient Recruitment
(550+ patients)
Client
A US based pharmaceutical company
Products
•Ophthalmology suspensions
•Ophthalmology ointments
Regulatory Authority
US FDA
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
SRC/CPPT/2013/DECEMBER/Version15
Testimonials
“We first contacted Semler Research to conduct some analytical method development work for an ANDA
product. We were so impressed with the quality, timelines and dedication to the project, we have created a longstanding partnership with Semler Research in our drug development process which now also includes bio/clinical
studies. For us, it has become a turnkey operation because Semler Research Services provides high quality integrated
scientific solutions with a complete innovative approach to project management which exceeds the expectations of
our drug development partners.”
Chairman (US Pharma)
“We are very pleased to have built a professional relationship with Semler Research Center (SRC). They offer an in–
depth understanding of pharmacology, study designs and analytical processes. They ensure thorough strategic
planning for study execution and generate well articulated study reports. They are honest, diligent and forward
thinking while retaining high quality. Their flexibility and responsiveness is remarkable. We look forward to
continuing and growing our successful association with SRC.”
Principal Scientist (Indian Pharma)
“We have successfully worked with Semler Research Center (SRC) for bioavailability and bioequivalence studies.
SRC’s in–depth understanding of clinical R&D and their sharp analytical approach clearly differentiates them. The
SRC team is always focused on our specific requirements while providing a perspective of a large pharmaceutical
corporation. Our association has been efficient, valuable and constructive.”
Vice President (Indian Pharma)
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Contact Information
SRC/CPPT/2013/DECEMBER/Version15
REGISTERED OFFICE
Semler Research Center,
#75A, 15th Cross, 1st Phase, J.P.Nagar,
Bangalore 560078, India
T: +91-80-4262-7200
F: +91-80-2664-0683
CLINICAL FACILITIES
PA Arcade, # 21, 22, 23,
Kodigehalli Main Road, Sahakarnagar,
Bangalore – 560092, India
Sharon Hospital Campus, 18,
Tanmag Road, Vinayagampatti,
Salem 636006, India
HEADQUARTERS
Semler Research Center,
28001 Dorothy Dr,
Agoura Hills,
CA 91605, USA
T: +1-818-760-1000
F: +1-818-760-2142
Website: www.semlerresearch.com
E mail: [email protected]
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SRC/CPPT/2013/DECEMBER/Version15
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Additional Information
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Equipment and Facilities
SRC/CPPT/2013/DECEMBER/Version15
Pharmaceutical Development
•Granulators (High Shear, Fluidbed)
•HPLC (Waters, Agilent) with PDA, RI, fluorescence
•Vial and Ampoule filling machines
detectors and autosamplers
•Multi-purpose equipment - Planetary Mixer, Granulator,
•UPLC with PDA detector
Blender and other attachments
•Autotitrator with Karl-Fischer attachment
•Diffusion Blenders – V, Octagonal, Double Cone types
•FTIR and UV-Vis Spectrophotometer
•Roller compactor
•Brookefield Viscometer
•Comminution Mill
•Osmometer
•Fluid Bed Processor (top spray, bottom spray, tangential
•Franz Diffusion Cell Apparatus
•Instrumented Multi Station Tablet Press (D, B & BB
•Differential Scanning Calorimeter (Shimadzu)
Tooling)
•Thermo Gravimetric Analyzer (TGA) (Shimadzu)
•Bilayer Tablet press (D, B, BB tooling)
•Moisture Analyzer
•Tablet Coating – solid pan of various sizes
•USP dissolution Apparatus with auto sampler
•Blister (PVC-Alu and Alu-Alu) and Bottle packaging
•Tablet: USP Hardness Tester, USP Disintegration Tester
•Homogenizer
& USP Friability Tester
•Dermatologicals processing pilot plant
•Stability Chambers (set to ICH Guidelines)
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Equipment and Facilities
SRC/CPPT/2013/DECEMBER/Version15
Bioavailability & Bioequivalence
Pharmacology Units
Bioanalytical Facility
LOCATION 1
Independent facility in Bangalore, Karnataka (30 minutes
drive from the international airport)
AREA: 20,000 sq. ft. equipped to conduct first-in-man,
bioavailability and bioequivalence studies
FACILITY: Independent facility with 104 beds having
multiple housing units, screening area, pharmacy and a
food court
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LOCATION 2
Dedicated facility located within Sharon Cancer Hospital
campus in Salem, Tamil Nadu
AREA: 15,000 sq. ft. with state-of-the-art technology for
conducting BA/ BE studies including wireless monitoring
system and access controlled pharmacy
FACILITY: Dedicated facility with 48 beds having a
separate screening area, ambulatory sample collection
area, sample processing area and check-in areas
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Sciex and Micromass instruments
MDS Sciex LCMS/MS (API 3200 and API-4000)
Waters quattro micro with HPLC as front end
Water purification system Millipore RiOs 16 and Milli-Q
Deep freezer with temperature control with GSM alarm
system
HPLC (Waters, Alliance 2695)
UPLC (Waters)
Refrigerated centrifuge (Hettich)
ULTF (-800C and -200C)(Dairei)
Fully secured facilities monitored with access controls and
cameras
Uninterrupted power supply-protected laboratory
instrumentation
Ocea Soft wireless monitoring system - environmental and
instrument monitoring with alarm and mobile alarm system
Full backup - daily, weekly, monthly and offsite
Tandem Labs with highly efficient, streamlined and GLPcompliant SOPs
Back to Equipment and Facilities Overview
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Team Profile
Clinical Development
SRC/CPPT/2013/DECEMBER/Version15
Resource
Project managers
Clinical team leaders
Medical writers
Regulatory experts
Medical monitors
Biostatisticians
Clinical research
associates
Role
•Overall project delivery (timeline &
quality)
•Oversight to trial monitors
•Planning & coordination of site
management activities
•Protocol development
•Development of ICD, IB, Diaries
•Development of regulatory dossier
•Safety issues oversight
•Medical query management
•Study design
•CRF design
•Generation of reports
•In-house & field-based monitoring
•Management of IMP supplies &
inventory
Clinical trial assistants •TMF & trial logistics management
Pharmacists
Experience (Yrs)
6-8
4-6
3-5
5-6
5-6
3-6
1-6
4-6
0-2
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Services
SRC/CPPT/2013/DECEMBER/Version15
Pharmaceutical Development
Generics and NCEs:
•Pre-formulation
•Proof of Concept
•Phase Appropriate CT Formulations
•Process development studies
•Scale-up and Technology transfer
•Commercial process / Formula development
•CACO-2 Cell permeability studies (out-sourced)
•Life cycle management
•Differentiated generics, 505 (b) (2)
Dosage Forms:
•Tablets/Capsules – IR, MR
•Oral liquids / suspensions
•Injectables and Ophthalmics – liquids / lyophilized
powders / suspensions
•Topicals – ointments / creams / gels
•NDDS - liposomes/ transdermals/ Liquid filled hard
gelatin capsules
Key Pre-clinical
Services:
•Proof-of-concept &
prototype formulations
•Bio-analytical support
•Screening through
CACO-2 cell/animal
models
Phase I:
•Small scale formulation for FIH / PoC study
•Tentative specifications for API
•Manufacturing of feasibility batches
•CTM manufacturing and packing as per GMP
with strategic partners
•Early phase stability studies in HDPE bottles
and various blister packs
Animal Models:
•Rat, mouse, rabbit,
guinea pig & dog
Phase II & III:
•Formulation dvpt. finalizing the trade dress
of the formulation
•Complete analytical validation as per ICH
guidelines
•Dvpt. of discriminating dissolution media
•Scale-up, process optimization & validation &
manufacture of exhibit batches
•Final product specification for QC
•CMC support
Pre-Formulation Services:
•Physico chemical evaluation
•Solubility studies (pH dependent aqueous solubility, solubility
in co-solvents surfactant assisted solubility, equilibrium
solubility)
•Intrinsic dissolution study in various pH conditions
•Salt design/screening and selection
•Dissociation constant redetermination
•Partition coefficient and log P determination
•Polymorphism studies
•Particle size, surface area, bulk/ tapped density determination
•Particle size distribution
•Bulk/tapped density determination
•Binding constant determination
•Drug- excipient compatibility studies
•Containers and Closure studies
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Services
SRC/CPPT/2013/DECEMBER/Version15
Bioavailability & Bioequivalence
Formulations:
•Oral –
tablets
capsules
disintegrating tablets
suspensions
•Sub lingual
•Intramuscular
•Intravenous
Routes of administration:
•Routine systemic
•Dermal/topical
•Ocular
•Infusion
•Intra-arterial
•Intra-nasal
•Intra-thecal
•Intra-tracheal
•Intra-intestinal
•Intra-rectal
•Intra-vaginal
•Intra-vesicular
Key Bioanalytical Services:
•Method development
•Method validation
•Method transfer
•Analysis of in vitro ADME and in vivo PK/ADME samples by HPLC and LCMS/MS
•Analysis of drug and metabolites in different biological fluids by HPLC and LCMS/MS
•Analysis of toxico-kinetic study samples by HPLC and LC-MS/MS
•Analysis of drug and metabolites in different biological fluids (Plasma, Urine, Whole
Blood, Aqueous)
PK studies in patients:
•Oncology
•Ophthalmology
•Dermatology
•Psychiatric
•Renal
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An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Services
SRC/CPPT/2013/DECEMBER/Version15
Clinical Development
Phase I,II,
III
Patient PK
Studies
Devices &
Diagnostics
PMS/NIS
Project feasibilities
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Pre-study
documentation &
planning
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Regulatory
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Project & site
management
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Monitoring
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Biostatistics & data
management
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Post study
documentation
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Therapy Area Expertise
•Infectious diseases
•Neuro Psychiatry
•Oncology
•Gastroenterology
•Ear, Nose and Throat
•Ophthalmology
•Endocrinology
•Cardiovascular
•Auto immune & Rheumatology
•Dental
•Orthopedics
•Nutritional and metabolic disorders
•Respiratory/ Pulmonology
•Dermatology
•Urinary & Nephrology
•Gynecology
PMS: Post Marketing Studies
NIS: Non-Interventional Studies
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