uniting the world of pharmaceutical...
TRANSCRIPT
Uniting the world of pharmaceutical research
Part of US based Arnold A Semler Inc, in business since 1946
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
COMPANY OVERVIEW
• 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 184 professionals with extensive expertise in the
development of both generic and patented products
www.semlerresearch.com An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Los Angeles
Bangalore
Ukraine
Bangladesh
Malaysia
South Korea
China Japan
Taiwan
Singapore
Locations in RED denotes SRC offices and BLUE denotes partner offices
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
CORPORATE PHILOSOPHY
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
To be one of the most trusted partners
in pharmaceutical development to
assist our clients in improving the
quality of human life
Sincerity
Respect for people
Commitment
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
QUALITY
STRATEGY
& DEPLOYMENT
People
• Team of over 184 professionals
• Talent sourced from various global pharma & CRO’s
• Thought leaders
Infrastructure
• State-of-the-art facilities
• Regulatory accepted hardware/ software applications
• Secured networks across locations
Process & Systems
• *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
*QMS: Quality Management System *IQA: Institute of Quality Assurance *GLP: Good Laboratory Practice
*GCP: Good Clinical Practice *ISO: International Organization for Standardization *CFR: Code of Federal Regulations
Pharmaceutical
Development
Formulation Development
• Generics & *NCEs
• Diverse dosage forms
Analytical Development
• Assay & *RS methods
development
• Stability studies
• Polymorphic form
characterization
• Validation
• Method conversions
Bioavailability &
Bioequivalence
Clinical
• * PK (Compartmental &
non-Compartmental
studies)
• Food effects & drug
interactions studies
• Controlled substance
Bioanalytical
• Method development &
validations
• Sample analysis
• Invitro binding BE studies
Clinical Development
Clinical Development
• Project management for
Phase I, II and III clinical
studies
• Allied Services*
Study Types
• Clinical end point studies
• Patient *PK studies
• Stem cells studies
• Diagnostics/ Devices
SERVICE OVERVIEW
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Allied Services
• Medical and scientific writing
•Biometrics & data management
•Regulatory services (*ANDA,
NDA, Scheduled drugs, DMF
preparation and submission)
www.semlerresearch.com
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
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)
Key Pre-clinical Services: • Proof-of-concept & prototype formulations • Bio-analytical support • Screening through CACO-2 cell/ animal models
Animal Models: • Rat, mouse, rabbit, guinea pig & dog
Phase II & III: • Formulation development finalizing the trade dress of the formulation • Complete analytical validation as per ICH guidelines • Development of discriminating dissolution media • Scale-up, process optimization & validation & manufacture of exhibit batches • Final product specification for QC • CMC support
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
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
Pharmaceutical
Development
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
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
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Formulations:
• Oral –
Tablets
Capsules
Disintegrating tablets
Suspensions
• Sub lingual
• Intramuscular
• Intravenous
Key Bioanalytical Services:
• Method development
• Method validation
• Method transfer
• Analysis of in vitro ADME and in vivo
PK/ ADME samples by HPLC and LC-MS/ MS
• Analysis of drug and metabolites in different biological fluids
by HPLC and LC-MS/ 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 humor)
PK Studies in Patients:
• Oncology
• Ophthalmology
• Dermatology
• Psychiatric
• Renal
Bioavailability &
Bioequivalence
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
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
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
Type of Activity Phase
I, II, III
Patient PK
studies
Devices &
Diagnostics
PMS /
NIS
Project feasibilities
Pre-study documentation
& planning
Regulatory
Project & site
management
Monitoring
Biostatistics &
Data management
Post Study documentation
Clinical
Development
*ISO: International Organization for Standardization
REGULATORY
AND
QUALITY
COMPLIANCE
TYPE DESCRIPTION
Facility Approval Drugs Controller General of India (DCGI) approved facility in Bangalore, India
Pharmacy •State Drug Controller approved facility in Bangalore , India •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, India
Regulatory
Inspection
•United States Food & Drug Administration (USFDA) •Drugs Controller General of India (DCGI) •World Health Organization (WHO) •Ministry of Health Turkey (MoH Turkey) •Ministry of Health Malaysia (MoH Malaysia)
• Instituto De Salud Publica De Chile (ISP- MoH Chile) •European Medicines Agency (EMA) •Acceptance of study reports by ANVISA
*Certifications * ISO 9001 : 2008 for Quality Management System
* ISO 27001 : 2005 for Information Security Management System
Department of Scientific and Industrial Research (DSIR) Recognition
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
REGULATORY
INSPECTION
EXPERIENCE
SRC has adequate experience in various
regulatory guidelines with a cumulative
experience of over 500 submissions.
Studies conducted at SRC’s facility in
Bangalore, India (Clinical and Analytical) have
been inspected and approved by USFDA, WHO,
MoH Turkey, MoH Chile, EMA, MoH Malaysia &
ANVISA.
Over 94 man days of managing
regulatory inspections.
PERIOD INSPECTIONS MAN-DAYS AREA OUTCOME
July 2010 WHO 10 BA/BE Inspection completed successfully
July 2011 WHO 10 BA/BE Inspection completed successfully
Dec 2011 MoH Turkey 08 BA/BE Inspection completed successfully
May 2012 USFDA 05 BA/BE Inspection completed successfully
Sept 2012 USFDA 10 BA/BE Inspection completed successfully
Mar 2013 WHO 08 BA/BE Inspection completed successfully
June 2013 ISP, MoH – Chile 02 BA/BE Inspection completed successfully
July 2013 USFDA 06 BA/BE Inspection completed successfully
Aug 2013 USFDA 06 BA/BE Inspection completed successfully
Oct 2013 EMA (ANSM) 10 BA/BE Inspection completed successfully
Dec 2013 USFDA 10 BA/BE Inspection completed successfully
Dec 2013 ANVISA 06 BA/BE Inspection completed successfully
Jan 2014 WHO 03 BA/BE Inspection completed successfully
Sep 2014 USFDA 08 BA/BE Inspection completed successfully
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
2006 Year of incorporation
ACTIVITY MILESTONE
WITH KEY ACHIEVEMENTS
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)
2007 Opening of Formulation & Analytical lab | Initiation of commercial activities | Acquired Salem clinical facility
2009 Change in business strategy and initiation of new services
2010 Opening of new clinical lab at Bangalore | First WHO inspection | Conduct of First USFDA study | Awarded First
International study
2012 2 USFDA inspection | Udyog Rattan Excellence award | Geographical expansion (ICDDR) | Inauguration of Pilot Plant
2013 WHO inspection | MoH Chile inspection | First ANDA approval from USFDA | USFDA inspection | EMA inspection |
MoH Malaysia inspection | ANVISA inspection | Inauguration of dedicated oncology facility
2014 WHO inspection | USFDA inspection
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Pharmaceutical Development
Bioavailability & Bioequivalence
Clinical Development
EQUIPMENTS AND
FACILITIES
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
• Granulators (High Shear, Fluidbed)
• Fluid Bed Processor (top spray, bottom spray, tangential
• Multi-purpose equipment - Planetary Mixer, Granulator,
and other attachments
• Diffusion Blenders – V, Octagonal, Double Cone types
• Roller compactor
• Comminution Mill
• Ampoule filling , Vial filling, Lyophilizer (external lab)
• Instrumented Multi Station Tablet Press (D, B & BB
Tooling)
• Bilayer Tablet press (D, B, BB tooling)
• Tablet Coating – solid pan of various sizes
• Blister (PVC-Alu and Alu-Alu) and Bottle packaging
• Homogenizer
• Dermatologicals processing pilot plant
• Stability Chambers (set to ICH Guidelines)
• HPLC (Waters, Agilent, Dionex) with PDA, RI,
fluorescence detectors and autosamplers
• UPLC with PDA detector
• Autotitrator with Karl-Fischer attachment
• FTIR and UV-Vis Spectrophotometer
• Brookefield Viscometer
• Osmometer
• Vertical Diffusion Cell (Franz) Apparatus
• Differential Scanning Calorimeter (Shimadzu)
• Thermo Gravimetric Analyzer (TGA) (Shimadzu)
• Moisture Analyzer
• USP dissolution Apparatus with auto sampler
• Tablet: USP Hardness Tester, USP Disintegration
Tester & USP
Friability Tester
Pharmaceutical
Development
5,000 sq.ft
Independent facility in JP Nagar,
Bangalore, Karnataka (Heart of
Bangalore city)
• Sciex and Micromesh 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)
• High sensitive Q-Trap API 4000
• 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
GLP-compliant SOPs
Independent facility in Sahakarnagar, Bangalore, Karnataka (30 minutes drive from the
international airport)
FACILITY: 106 bedded facility having multiple housing units, screening area, pharmacy,
sample storage area and clinical diagnostic service.
Bioavailability &
Bioequivalence
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Pharmacology Unit
Bioanalytical Equipments
Independent facility in JP Nagar, Bangalore, Karnataka (Heart of Bangalore city)
20,000 sq.ft
5,000 sq.ft
Resources Role Experience
Project Managers Overall project delivery (timeline & quality) 6-8
Clinical Team Leaders Oversight to trial monitors Planning & coordination of site management activities
4-6
Medical Writers Protocol development of ICD, IB, Diaries 3-5
Regulatory Experts Development of regulatory dossier 5-6
Medical Monitors Safety issues oversight Medical query management
5-6
Biostatisticians Study Design CRF Design Generation of reports
3-6
Clinical Research Associates
In-house & field-based monitoring 1-6
Pharmacists Management of IMP supplies & inventory 4-6
Clinical Trial Assistants TMF & trial logistics management 0-2
Clinical
Development
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Pharmaceutical Development
Bioavailability & Bioequivalence
Clinical
Development
TRACK RECORD
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Generic drug development (US, EU, Lat-AM and others)
Innovative Drug Delivery Technologies
• Effervescent Formulation (Lubrication optimizations studies)
• Tablet in Tablet Formulation (Compression coating)
• Novel drug delivery systems including Liposomes
Solid Orals IR, MR Tablets/Capsules
Liquid orals Solutions, Suspensions, Dry Syrups
Topicals Ointments/Creams/Gels
Ophthalmics Suspension/ Ointments / Solutions
Parenterals Liquid Injections – Vials, Ampoules, PFS,
Lyophilized injections
• Dedicated Oncology / High Potency
Products Area with Isolators
• 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
Pharmaceutical
Development
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
.
Experience by Regulatory Submission
USFDA 50% Health CANADA 3%
EU 15%
MHRA 5%
LA 3%
TGA 3%
WHO 13% ROW 4%
DCGI 2% MCC 2%
106-bed, well-equipped, GCP complaint facility with over 225 methods and sample analysis capability of over 25,000/month
USFDA, WHO, MoH Turkey, MoH Chile, EMA, MoH Malaysia & ANVISA audited BABE facility
Bioavailability &
Bioequivalence
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Total number of studies 400
Volunteers dosed 26,000
Samples analyzed 5,25,000
Type of Studies Pilot Studies 21%
Pivotal Studies 79% Volunteer database
(Male & Female)
11,800
Niche Expertise
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
Studies Initiated [2010-12]
Completed Recruitment
[2011-13]
Scheduled Recruitment [2013-14]
29 [Global – 15 & Local - 14]
Over 1000 patients Over 1300 patients
38%
14%
4%3%
21%
7%
7%
3% 3%
Completed/Ongoing Studies [2010 - Current]
Ophthalmology
Oncology
Stem cells
Infection
Dermatology
Nutraceuticals
Gastroenterology
Diabetes
Clinical
Development
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Experienced clinical development team | Enrolment as per protocol requirements | Qualified and experienced medical & scientific writer
* CD – Clinical Development | *BA/BE – Bioavailability & Bioequivalence
ALLIANCE MANAGEMENT
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
Name/ Alliance Type of Alliance *CD *BA / BE
Logical Trials Strategic alliance to manager
South Africa specific studies/
projects
------ ------
Asia CRO Alliance Strategic alliance to manager
South East Asia sponsor
requirements
------ ------
USA & Europe Service alliance with reputed
CRO in US and EU to manage
global clinical studies
------ ------
ICDDR Alliance to cater Bangladesh
sponsor requirements and
global clinical studies
------
------
BIO – Excellence Award 2013 DSIR Recognition by DBT
ISO 27001 : 2005
Udyog Ratan Excellence Award
ISO 9001 : 2008
AWARDS AND
RECOGNITION
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
State-of-the-art equipment and
infrastructure across locations (over
60,000sft.) to facilitate smooth and
quality services
India’s first, independent organization to
fully integrate drug development, clinical
development and manufacturing services
Several decades of exposure to various
regulatory bodies across the globe for
both generic and patented products
SRC Adequate
Resources
Integrated Services
Global Regulator Experience
Scientific
Expertise
Combined leadership experience of over 250 years in the pharmaceutical industry; a qualified team of over 184 professionals with extensive expertise in the development & manufacturing of both generic and patented products
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
VALUE PROPOSITION
SRC services
Partner Services
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company
Integrated Services
Scale up and
Tech transfer
Formulation
Development
Phase I Phase II Phase III
Plant Setup
Facilitation of
Manufacturing
Licenses
Commercial
Manufacturing
(BA/BE)
VALUE PROPOSITION
www.semlerresearch.com
Analytical
Development
API Characterization
Pre-formulation
Prototypes
Stability Studies(Short & Long term)
Pilot & Pivotal batch
manufacturing
Pre-clinical studies
Bioanalytcial Team
• Method development
(aqueous humor matrix)
• Method validation
• Sample analysis
Patient Recruitment
(500+ Patients)
Clinical
Development Team
• Protocol development
• Site selection
• Project management
• Monitoring
• Stat & PK support
• Reports
Pharmaceutical
Development Pharmaceutical Development
Team
• Formulation development
• Analytical method development
• Tech transfer to CMO
Kn
ow
led
ge
Tra
ns
fer
Method
Development &
Sample Analysis
Client
A US based pharmaceutical company
Products
• Ophthalmology suspensions
• Ophthalmology ointments
Regulatory Authority
US FDA
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
A CASE STUDY IN
INTEGRATED
SERVICES
“
“
TESTIMONIALS
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)
“ 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 long-standing
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.
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com
REACH US
REGISTERED OFFICE
#75A, 15th Cross,
1st Phase J P Nagar
Bangalore 560078
India
T: +91-80-4262-7200
F: +91-80-2664-0683
CLINICAL FACILITY
PA Arcade, # 21, 22, 23
Kodigehalli Main Road
Sahakarnagar, Bangalore
560092, India
T:+91-80-4302-7100
F:+91-80-4302-7142
SINGAPORE OFFICE
1 Raffles Place
#39-01
One Raffles Place
Singapore – 048616
HEADQUARTERS
Semler Research Center
28001 Dorothy Dr, Agoura
Hills, CA 91605, USA
T: +1-818-760-1000
F: +1-818-760-2142
An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company www.semlerresearch.com