Uniting the world of pharmaceutical...

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



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


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


• 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


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


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


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


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


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


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



Pharmaceutical Development

Bioavailability & Bioequivalence


EQUIPMENTS AND

FACILITIES


• 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


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


Pharmaceutical Development

Bioavailability & Bioequivalence

Clinical

Development

TRACK RECORD


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


.

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


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


Experienced clinical development team | Enrolment as per protocol requirements | Qualified and experienced medical & scientific writer

* CD – Clinical Development | *BA/BE – Bioavailability & Bioequivalence

ALLIANCE MANAGEMENT


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


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


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


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.


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

[email protected]

HEADQUARTERS

Semler Research Center

28001 Dorothy Dr, Agoura

Hills, CA 91605, USA

T: +1-818-760-1000

F: +1-818-760-2142


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