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Veeda Capabilities Presentation
 

Veeda Capabilities Presentation

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Veeda Capabilities Presentation

Veeda Capabilities Presentation

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    Veeda Capabilities Presentation Veeda Capabilities Presentation Presentation Transcript

    • Presentation to Company X May 2009
    • Veeda Clinical Research • Veeda is a global CRO focussed on the early phase of clinical development (phase I/IIa) • Veeda Locations: – India: Ahmedabad, Mumbai – UK: Plymouth, Oxford – Europe: Brussels, Paris – US: Columbus, OH
    • Veeda Services Pre-clinical Phase I Phase II Phase III/IV Veeda Clinical Research Veeda Oncology Biometrics Bioanalytical & Biomarker Labs Advinus
    • The Veeda advantage • Unique blend of Eastern and Western facilities and expertise • Privately owned company • Small enough to be responsive and flexible • Large enough to offer global capabilities covering everything from preclinical through to patient studies • Most experienced Phase I CRO in India
    • The Veeda Model Global Phase I Clinical Pharmacology Europe Joint India Services Common Training for all Staff Common SOPs for all staff Common Equipment for all units Division of Laboratory tasks within Group
    • The Veeda model in action • Veeda was asked to perform a programme of studies for a novel anti-diabetic drug • Programme included First in Human, multiple dose and QTc as well as other studies • Client priorities – save time, save cost, maintain quality • Programme split across Veeda UK and India: – UK – FIH, drug interactions – India – Multiple dose, QTc • All bioanalysis of drug and metabolites at Veeda India Labs • Joint project management from UK and India, joint team meetings for all studies • Result - Entire programme was completed by Veeda with significant time (ca 8-10 weeks) and cost savings (ca 40%)
    • Veeda UK - Plymouth Plymouth
    • Advantages of Plymouth location • Veeda is the only CRO in this region – closest competitor is 150 miles away by road • Extensive volunteer access – around 5 million people live in the South West • Stable volunteer population • Good links with major regional hospitals, GPs and Consultants
    • Veeda India Ahmedabad Nadiad Mumbai
    • Veeda India – facts and figures • India – country of ca 1.1 billion people • Ahmedabad and Nadiad units in Gujarat State, state population 15 million • Ahmedabad is India’s 7th largest city, population of 5 million • Centre of academic excellence • Capital of CRO industry in India • Location of many Indian Pharma companies
    • Veeda Accreditations India no 483’s – 3 complete inspections no critical findings ANVISA approved WHO approved “Partner of Choice” for phase I studies 2007 UK Oxford November 2007, awarded GLP/GCP accreditation Plymouth awaiting Phase I accreditation
    • Veeda’s clients • Veeda works with clients from across the globe, large and small • Currently working with 10 of the top 15 Global Pharmaceutical companies • Clients include: – Global pharma companies – Mid-size pharma from UK, US, India, Japan – Small/virtual companies from Australia, UK, India, US and others
    • Veeda’s experience Female Health Diabetes CNS Cardiovascular Respiratory GI Dermatology Pain Urology Other Over 500 studies performed globally
    • Special Populations at Veeda • Veeda has worked with the following special populations: – Elderly – Renal impaired – Hepatic impaired – Diabetes – BPH – Psoriasis – Females (sterile, non-sterilised, post-meno) – Many others!
    • Veeda’s UK Unit • Established 22 years ago • 61 beds, 21 monitored • 100 staff • On site pathology Lab • Specialists in technically complex studies, elderly and female studies
    • Veeda’s India unit Ahmedabad • 116 beds, 12 monitored • 250 staff • >100 studies submitted to FDA for approval • Expertise in BA / BE studies • Most experienced Phase I unit in India
    • Veeda’s Indian unit (cont.) Nadiad Renal Unit • 6 Bed unit in specialist renal & urology hospital • Staffed by Veeda personnel • Studies in mild, moderate and severe renal impairment patients • Access to hospital database of over 5,000 renal patients
    • India Facilities – Phase I
    • India facilities – BA/BE studies
    • Why Veeda UK? • Experience: 21 years in Phase 1 • Volunteers: Extensive database, stable population • Special populations: Elderly, Female, Diabetic • Patients: GP network gives access to over 50,000 patients • Reliable recruitment: Proven track record in recruiting patients and special populations
    • Why Veeda India? • Quality: High quality, Western style Unit, run to Western standards • Expertise: Staff trained to Western standards, very low staff turnover • Access to patients: Good links with consultants and speciality hospitals across India • Specialists: Purpose built units in renal and diabetes hospitals
    • Veeda Laboratory Facilities • Ahmedabad, India • Oxford, UK • Small molecule PK • Biomarkers • LC-MS/MS • Large molecule PK • UPLC • Immunogenicity • HPLC
    • Veeda Laboratory - India • Equipment: 12 LC/MS-MS; UPLC, HPLC, Tomtec, Watson LIMS • Method development, validation and sample analysis for NCEs and generic compounds • Led by experienced UK scientist with experience in major Pharma and CROs • Over 150 methods validated in 3 years • True 24/7 operation allows rapid turnaround of data
    • Veeda Laboratory - UK • Large Molecule Bioanalysis (Oxford) – Immunochemistry, PK & Immunogenicity • Bespoke Biomarker Laboratory (Oxford) – Immunochemistry, Flow Cytometry, Multiplexing • Many different platforms available • Central Clinical Laboratory (Plymouth)
    • Biomarkers at Veeda • Biomarkers can be a useful addition to clinical drug development. They can offer: – Early indications of efficacy – Confirmation of mechanism of action – Aid in dose range finding – Early indications of toxicity or side effects • Veeda can develop, validate and analyse samples for existing or new biomarkers • Veeda has globally recognised expertise in this field, notably in “fit for purpose” validation
    • Biomarkers at Veeda Fit for Purpose Biomarker assay development
    • Veeda Biometrics • Veeda offers a full Data Management & Statistics service • Data entry, data management, medical coding, pharmacovigilance, statistical analysis • Located in Brussels and Mumbai • More than 20 years experience of all phases of clinical development from Phase I through to Phase III/IV • ClinTrial system installed and validated • All systems fully CFR 11 Part 21 compliant
    • Veeda Regulatory Services • In house consultancy – Advice on study design – Advice on regulatory requirements – Wealth of experience in Europe and in India • Regulatory consultancy – CTA preparation, legal representative for EU
    • Regulatory in India • For new drug substances discovered in India: Trials may be carried out in India right from FIM and required data needs to be submitted. • For new drug substances discovered in countries other than India: FIM data must be generated outside India, permission may be granted to repeat phase 1. All Phases after FIM approved • Administrative/Logistic Protocols and usual documentation submitted to DCGI and EC simultaneously
    • Study Timeframes India & UK UK India • MHRA Approval • DCGI Approval • Ethics Approval • Ethics approval • Parallel application • Parallel application • Approval = 5 weeks • Approval = 8-12 weeks BUT…. Recruitment, screening and clinical phases much faster in India
    • Veeda – The Gateway to India • Veeda offers an efficient, rapid and cost effective route to take a compound from FIH to POC • Veeda can provide a full service from program and protocol development through to final reporting • Veeda is focussed on the early phase of clinical development so understands the challenges at this crucial stage • Veeda understand the needs and objectives of both large pharma and SMEs and can provide advice and support through all stages of the development process