arpl corporate profile 2012

Alticure Research Pvt Ltd… at the pinnacle of clinical research and cure TM

Overviewof

Facilities & Capabilities

Dr. C. Kannan Janakiraman.,B.Pharm., M.Pharm., PhD (Glasgow, UK).,CIB (West of Scotland)., MBA.,

Member of ACRP (USA), ACRO (India)., IPA (India)., AOAC (USA).,AAASc (USA)., FIP (Netherlands)., ISHR (Hungary).,SSG (Scotland)., BPS (UK)., ( MB).,

Founder & President ., ARPL, Altiquest, & JayaJan Biomedical Care.5/28/2012 1

•••••• • • • •What is Alticure

• Alticure is a research company founded for overseeing and managing Clinical laboratory & Clinical research of drugs, devices, clinical nutrition and Vaccines, for Indian and Global Pharma companies

• Alticure was founded in 2004 and registered as a Pvt • Alticure was founded in 2004 and registered as a Pvt Ltd Company under the ROC of Tamilnadu

• Alticure is located strategically in Chennai & Bangalore, India with operations across the country and the globe

• The Key personnel bring in over 200+ Man years of Laboratory Medicine, Health care, Global Pharma, Biotech & Information technology experience

5/28/2012 2

C. Kannan Janakiraman

Founder & CEO

Founder and Chairman, JayaJan Biomedical

Care Foundation

•Pharmacist, with postgraduate , doctoral

and post doctoral training in

Pharmaceutical sciences, Laboratory

medicine, Cardiology, Oncology, Respiratory

Surya Ramchandran

CTO & General Counsel

• Surya has been actively involved in the field of Artificial Intelligence for

20+ years. Over the many years he has gained extensive knowledge and

experience in the design and development of intelligent systems in

several domains including - therapeutic diet planning, crisis

management, configuration planning, defensive/offensive campaign

planning, clinical decision support systems, clinical IT support,

healthcare BI and embedded systems. His expertise stems from working

closely with research and education institutions and has gained him

Management and Key Personnel

medicine, Cardiology, Oncology, Respiratory

medicine, Endocrinology, Biochemical and

Molecular Biology & Pharmacology.

•> 20years of Expertise in Drug, Device and

Clinical Nutrition discovery and

development. Project and Business Unit

management of Pharma, Biotech R&D,

Contract research organizations and Clinical

reference labs.

•Domain consultant to Pharma, Biotech,

Medical Devices and ITES, KPOs in

Information Technology firms.

•Expert in formulating and starting Clinical

Pharmacy Practice

closely with research and education institutions and has gained him

international repute .

• Surya has the confluence of successfully starting up companies that

support well established enterprises with his knowledge of technology,

development infrastructure, business development, market research,

project management and client relationships with their critical business

needs. His proven abilities are closely governed by his sense of helping

bridge the gap between academic and industrial research and his

passion for implementing real-world systems that bring about a

measurable change.

• Surya has published numerous research papers in the fields of Artificial

Intelligence and Healthcare and holds patents in over 25 countries. He

has received his Bachelor degree in computer science from P.S.G.

college, Coimbatore, India and subsequently earned a masters degree

specializing in artificial intelligence from the University of Illinois at

Urbana-Champaign.

5/28/20123

•••••• • • • •Snap short of Operations

Services & Capabilities

�Clinical research management and Central clinical laboratory�Pre-clinical pathology laboratory�Regulatory Affairs & Project Management�In-Licensing, Out-Licensing & Co-development

Therapeutics & Disease areas

�Aging & regenerative medicine�Asthma and COPD* Cardiovascular* Dermatology* Diabetes* Gastrointestinal* HematologyCo-development

Product / Technology type(s)

� BioPharmaceuticals� Cosmoceuticals� Devices� Diagnostics� Drug delivery� NCE (new chemical entities)� Pharmaceuticals / Therapeutics� Phytotherapies� Neutraceuticals / Vitamins� Reagents

* Hematology* Infectious Diseases�Oncology� Urology� Women's Health

5/28/2012 4

Clinical Research Management

• Alticure as a research management

company will assist the physicians who

are potential principle investigators in all

aspects of research for the conduct of

clinical trials.

• We will address and manage key areas

of research constraints like time for

regular practice, additional staffing,

insurances, staff education etc.

AlticureAlticure Research Research PvtPvt LtdLtd

insurances, staff education etc.

• We are determined to streamline the

clinical research process and improving

data quality with a total commitment

towards protecting human subjects

participating in research.

…..….. at the Pinnacle of Biomedical Research & at the Pinnacle of Biomedical Research & CureCureTMTM5/28/2012 5


• We are committed to increase the

number of physicians participating in

clinical research by offering an

additional stream of income and

academic prestige, thus enabling them

to participate in the future of medicine

while immensely limiting the burden of

clinical research from their practices .

• We will ensure that their patients


• We will ensure that their patients

participating in the research will have

access to medical care, treatment

options , health education which they

wouldn’t have access to otherwise



• Alticure manages all aspects of the clinical trial process (Phase II-IV trials) including adherence to Good Clinical Research Practice (GCRP) as per ICH/Indian GCP guidelines and Good Clinical Laboratory practice (GCLP) as per ISO 15189 standards.

• Our Clinical research sites are centres of clinical excellence strategically located


clinical excellence strategically located manned by experienced site personnel to implement successful patient recruitment,and retention enabling successfull completion of the clinical development.



• Alticure's service capabilities encompass the full range of Phase II-IV clinical development of novel therapeutics and medical devices including diagnostic aids.

• The extensive scientific and business experience of our senior management, often as Principal Investigators for national and international studies, provides the Alticure'steam with the capability to offer full-service management of clinical trials.


management of clinical trials.

• We serve as liaison between clinical trials sponsors and an extensive network of investigative sites comprised of practicing physicians, specialists, super specialists, tertiary care hospitals and academic medical centres around the country.



Alticure will manage all aspects of clinical trial process which includes:‐

Trial Initiation:

• Study and Protocol feasibility

• Investigator meetings, trial agreements andcontracts

• Completion of regulatory documents

• Coordination of Ethics committee reviews

• Budget and contract negotiation

• The hosting of scheduled site visits from thesponsor or CRO and their staff, to includepersonally escorting all persons involved and


sponsor or CRO and their staff, to includepersonally escorting all persons involved andacting as a liaison

• All aspects of communication

• Training for physician investigators and staff incompliance with DCGI, ICMR and ICH standards,

ethical considerations in the protection of humansubjects in medical research, and industry

standards of Good Clinical Practice (GCP)


Clinical Research

Management

Trial Management:

• Maintenance of all study documents onsite in our local offices

• Maintenance of all study related material to include study drug, device and lab kits

• Performance of all study related ancillary services to include, but not be limited to, ECGs,

phlebotomy, specimen collection, testing and storage, drug infusion, radiology services, in‐ house

pharmacist support and study related nursing

• Clinical coordinator, nursing, regulatory document


• Clinical coordinator, nursing, regulatory document specialist, and research physician support

• staffing with trained and experienced clinical research coordinators

• ethically aggressive subject recruitment

• internal monitoring for adherence to protocol

• the production of high quality, unbiased data

• accurate data management

• internal auditing and monitoring


Discovery and Preclinical

Services

• Alticure's capabilities extend to Pre-Clinical Development (Discovery and Screening) services comprising of In house Central Laboratory, Biochemical and Molecular Pharmacology (both invitro and invivo) facilities with OECD GLP compliance.



Our Operational

milestones from Jan 2010

till date with the

Government of Tamilnadu

1. Identified and Shortlisted four state and

federalgovernmentmanaged Centres of clinical excellence in

the field of Oncology, Dermatology, Endocrinology and

Respiratory diseases. Conducted CME on Good Clinical

Research Practice for clinicians and support staff at these

centres to initiate clinical research programmes

2. Formation of the Institutional Review Board as per

ICMR/Schedule Y guidelines and Registration of the IRB with

FERCAP/FERCI

3. Liasing with Directoratge of Medical Education (DME) and

Secretary to the Government, Ministry of Family Health and

Welfare (MHFW)Government of Tamilnadu Welfare (MHFW)

4. Participation and sponsor of disease awareness programme in

coordination and support from the state government.

5. Inception of clinical research wing with fulltime research

coordinator and project manager to monitor and manage clinical

research programmes sponsored by pharma/biotech and those

of Department of Biotechnology/Indian Council of Medical

Research Grants.

6. Participation in institutional CME programme to enable

clinicians and paramedical staff understand need for research

programmesAlticureAlticure Research Research PvtPvt LtdLtd


Our Operational

milestones from Jan 2010

till date with the

Government of Tamilnadu

7. Obtaining No Objection Certificate (NOC) and initiating

Government order (G.O) from Govt. of Tamilandu, Ministry of

Health and Human Welfare to execute the clinical research

programme in cancer patients

8. Evaluation of the clinical research programme for 40 generic

oncology drugs across all types of cancers including Leukamia,

Lung, Cervical, Breast, Ovarian, Head & Neck. And Obtaining

commitment from the sponsor for patient support programme to

avail the first line of treatment for the research participants

10. Conducted CME programme at Regional cancer centres at

Kancheepuram, JIPMER and Meenakshi Medical CollegeGovernment of Tamilnadu Kancheepuram, JIPMER and Meenakshi Medical College

Hospital focussed on Oncology research

11. Availing 60bed ICU facility services to support Phase I first in man

clinical research and emergency care of research participants

12. Providing periodical support for patient care and management



•••••• • • • •Clinical Laboratory Technology

• Biochemistry

• Nephelometry

• Immunohistochemistry

• Radioimmunoassay

• Histopathology

• Cytogenetics

• Metal Toxicity

• Flow Cytometry • Radioimmunoassay

• Chemiluminescence

• ELISA

• PCR

• Electrophoresis

• Microbiology

• Flow Cytometry

• High Performance Liquid

Chromatography

• Coagulation Studies

• Neonatal screening

5/28/2012 14

…..….. at the Pinnacle of Biomedical Research & at the Pinnacle of Biomedical Research & CureCureTMTM

•••••• • • • •Central Laboratory Capabilities

• Histopathology/Cytology

• Immunohistochemistry

• Cellular & subcellularBiomarkers

• Prenatal & neonatal screening

• Genomics

• ProteomicsBiomarkers

• Bioimaging

• Specialized biomarkers

• Scintigraphy

• Therapeutic Drug Monitoring

• Pharmacogenomics

5/28/2012 15…..….. at the Pinnacle of Biomedical Research & at the Pinnacle of Biomedical Research & CureCureTMTM

••• • • • •Alticure’s Services and Capabilities

MaternalHealth

Pregnant MotherPre-EclampsiaIUGRPTB

AdultFertility

MotherOvarian ReserveFertilityIVF Genotyping

Potential ParentsGene Carrier TestingCystic FibrosisLSDsThrombosisHemaglobinopathies

ParentalHealth

Womens Health

AdultOvarian / Breast / CxCervical / EndometrialCervical ViralAging Diseases

AdultHealth

AdultCancerAutoimmuneCardiacGastricNeurology

... Neonatal � Prenatal � Maternal Health

NeonatalHealth

Newborn ChildCongental DeafnessLysosomal StorageInborn Metabolic Errors

ChildhoodHealth

ChildrenCeliac DiseaseLactose IntoleranceAllergiesType I DiabetesCystic FibrosisAsthma Childhood Onset

Diseases

ChildrenDiabetes OnsetChild LeukemiasAutismLearning Difficulties

PrenatalHealth

Unborn ChildTrisomiesKaryotypingFetal Cell Analysis

OB / GYN

Pediatrician

5/28/2012 16

••• • • • • What are we positioning for

��First trimesterFirst trimester

PAPPPAPP--AA

��Metabolic disorders (e.g. PKU)Metabolic disorders (e.g. PKU)

��Endocrine disorders Endocrine disorders �� AnemiaAnemia

… to address new … to address new clinical evaluation clinical evaluation areasareas

PAPPPAPP--AA

Free hCGFree hCGββ

��Second trimesterSecond trimester

hAFPhAFP

hCGhCG

uE3uE3

hAFP/free hCGhAFP/free hCGββ

�� Pre-eclampsia

� Pre-term birth

� IUGR

��Endocrine disorders Endocrine disorders (e.g. congenital hypothyroidism)(e.g. congenital hypothyroidism)

��Cystic fibrosisCystic fibrosis

��Sickle cell anemiaSickle cell anemia

��ThalassemiasThalassemias

��DiabetesDiabetes

��Tandem mass spec as well as Tandem mass spec as well as traditional chemistriestraditional chemistries

�� LSD, Wilson

� Asthma/Allergy

�� Thyroid functionThyroid function

�� AutoimmunityAutoimmunity

�� OncologyOncology

�� DiabetesDiabetes

�Cardiovascular

�Gastro

�Adverse Drug Reaction

� Neurology

5/28/2012 17

•••••• • •

•••••• • • • •Central Laboratory Equipments

• Quantitative Real-time PCR • Flow Cytometer • Bio-Chemistry Analyzer • 5 Part Differential Coulter • Immuno-assay Analyzer • ELISA Processor • RIA - Fully Automated • ELISA Processor • RIA - Fully Automated

Scintillation Counter • Nephelometer • Electrophoresis • Coagulometer • ICP-AES Spectrometer • Atomic Absorption Spectrometer• HPLC, LCMS-MS, GCMS-MS • Time Resolved Fluorimetry


RECEPTION

Preclinical Laboratory Facility

RECEPTION

5/28/2012 19

•••••• • • • •Central Laboratory Personnel

• Pathologists• Clinical Biochemists • Microbiologists• Molecular Biologists • Analytical Chemists • Pharmacologists

• Clinicians who are specialists &

super specialists in the panel of

opinion leaders to design and

interpret patient evaluation

outcome

• Pharmacologists• GLP Auditors• Customer Relations

Executives with 24 X 7helpline

• Advisory board consisting of world

renowned laboratory scientists,

pathologists, biochemists, cell

biologists and pharmacologists to

impart continuous value addition to

the lab management and operations

to set Global standards


•••••• • • • • IT Infrastructure

• SAS®

• WinNonlin ®

• Oracle Clinical with RDA ®

• Altiquest ®

• State-of-the-art data center with high end servers with • State-of-the-art data center with high end servers with adequate storage space

• Cable transferring Data at high Speeds

• Validation of the data center, managed by Alticure, is currently in progress

• Bi-directional Interfacing of clinical lab equipments

• Direct data transfer to net5/28/2012 21…..….. at the Pinnacle of Biomedical Research & at the Pinnacle of Biomedical Research & CureCureTMTM

•Address and attend to opinion leaders

•Technical awareness

(newsletters/seminars/workshops)

• Help them create awareness among patients

• >14 million patients per day

• Patients flock to brand names

Physicians

Payors

• 14% Prepaid

• 64% out of pocket

• Patients flock to brand names

• Patients naturally trust hospitals and

physicians

• Who better to deliver disease-based

information to patients than local

laboratories and pathologists!

• Initiate & establish excellence in niche

Segments like TDM, Women’s health,

Child health, age management

&preventive medicine

Patients


Mobile Medical Unit for Patient Population Support Programme


•••••• • • • •Customer Driven Needs for CRL

Physicians Office• Good courier services Specimen tracking

• Excellent customer service Online help

• Easy ordering Order entry system

• Assistance with compliance Compliance checker

• Rapid TAT Online reporting

• Flexible report formats Customized reports

• Discounts for patients Good billing system

• Convenient draw stations Online directions



Hospitals and AMCs• Comprehensive test menu• Online test catalog• Rapid TAT on esoteric tests• Single system ordering• Low prices• Low prices• Good billing system• Consultative services• Educational programs

• Outreach assistance



Patients• Disease information

• Treatment/diagnostic options

• Layman's test information

• Interpreted test results• Interpreted test results

• Physician-Patient connectivity


•••••• • • • •Our Partners in Health Care

• Pharmaceuticals, Biologicals, Medical devices Industry • Tertiary care hospitals• Academic Medical Centers• Contract Clinical research organizations (CROs)• Contract Clinical research organizations (CROs)• Medical insurance providers• Public and private sector enterprises• Non-Government Organisations (NGOs)• Non-Profit driven trusts• Pharma/Biotech • Contract Research Organisations (Preclinical)• Site Management Organisations (SMOs)


Thank You

• For more details please

contact :

[email protected]

www.alticure.comwww.alticure.com


arpl corporate profile 2012

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