Download - 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
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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.
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•••••• • • • •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
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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.
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Clinical Research Management
• 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
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• 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
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Clinical Research Management
• 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
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clinical excellence strategically located manned by experienced site personnel to implement successful patient recruitment,and retention enabling successfull completion of the clinical development.
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Clinical Research Management
• 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.
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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.
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Clinical Research Management
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
AlticureAlticure Research Research PvtPvt LtdLtd
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)
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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
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• 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
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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.
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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
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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
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•••••• • • • •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
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•••••• • • • •Central Laboratory Capabilities
• Histopathology/Cytology
• Immunohistochemistry
• Cellular & subcellularBiomarkers
• Prenatal & neonatal screening
• Genomics
• ProteomicsBiomarkers
• Bioimaging
• Specialized biomarkers
• Scintigraphy
• Therapeutic Drug Monitoring
• Pharmacogenomics
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••• • • • •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
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••• • • • • 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
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•••••• • •
•••••• • • • •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
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RECEPTION
Preclinical Laboratory Facility
RECEPTION
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•••••• • • • •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
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•••••• • • • • 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
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Mobile Medical Unit for Patient Population Support Programme
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•••••• • • • •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
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•••••• • • • •Customer Driven Needs for CRL
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
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•••••• • • • •Customer Driven Needs for CRL
Patients• Disease information
• Treatment/diagnostic options
• Layman's test information
• Interpreted test results• Interpreted test results
• Physician-Patient connectivity
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•••••• • • • •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)
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Thank You
• For more details please
contact :
www.alticure.comwww.alticure.com
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