Transcript - Vedic Lifesciences

VEDIC LIFESCIENCES
AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic. Introduction
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A decade of experience as full and functional service Research center
Widest range of services for the Dietary Supplements, Nutraceuticals,
Botanical Drug Products, Medical Foods, Natural Health Products,
Cosmetics & Personal Care Products
Clinical Trials for label claim substantiation
ICH – GCP Compliant data to meet regulatory requirements
Audited by International and Domestic Clients
Complete product development support
ISO 9001:2008 certified
Headquarters in Mumbai, India with office in California, USA
Vedic. Brand Promise
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YOU CLAIM WE PROVE
Vision
To bring down the cost & time of R&D and become a strategic partner
of choice for Nutraceutical, Cosmeceutical and Traditional
Medicine companies.
Vedic. Difference
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Expert team for developing global label claims
Wide therapeutic knowledge and expertise
Esteemed panel of Medical Advisors
Experienced Medical Writers
Flexible payment terms and conditions
Shared risks
Core strengths: ICH-GCP compliant systems and globally accepted
data
GCP trained investigators in several health conditions that India has
to offer
Unique models for data capture
Papers published in peer reviewed journals
Vedic. Core Values
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Commitment to Word and Work
Empathize with Customer: Serve real needs
Ethics – Honesty & Protection of human subjects
Pro-activeness
Vedic. Services
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Product Development
Product Launch
Turn Key Solutions for India
Market Entry (TIME):
Regulatory
Services
Pre-Clinical/
Animal
Studies
Human
Clinical
Studies
Product Design to Market / Sales
distribution channels
• Full range of
support for
regulatory
approval,
registration of
innovative products
or individual
ingredients /
substances
• GRAS Affirmations
• OTC Dossier
Preparation and
submissions
• Patents
• Label Review
• GMP
documentation
Human Clinical Studies
• Product specific
gap analysis
• Design of
Innovative Products
• New / Novel
Formulation
Development for
existing product
• Toxicology testing
• Safety & Efficacy
Testing
• Analytical Method
Development &
Validation
• Vegan certification
Regulatory Services
Pre-Clinical/Animal Studies
Product Development Services
• Human Clinical Studies
• Health claim strategy and
assessment for Food /
Nutritional / Dietary
supplement / Herbal /
Natural Product claim
applications
• Systematic scientific
literature reviews
• Local Regulatory assessments
• Clinical Dossier / application
preparation and submissions
to the regulatory bodies
• Country/Region specific
label development
• Claim substantiation / Safety
/ Efficacy / Post Marketing
Studies
• Manuscript writing / Journal
publications
• Raw material
suppliers
identification &
Development
• Lab batches
• Tech transfer to
manufacturing
scale
• Contract
Manufacturing
Indian Marketing and Sales Services
• Claim
Identification
/ health
Claims
• Regulatory &
Market
evaluation
• Regulatory
Dossiers
• Licenses &
Approvals
• Country
Specific
Labeling
Indian Manufacturing Services
Indian Regulatory Services
Product Launch Services
Turn Key Solutions for Indian Market Entry
• Setting up with
national level
distributors of
nutraceutical/food
supplements.
• Advertising/market
ing support
• New geography
and market
segment
identification
Vedic. Regulatory Support
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Developing, writing, publishing and submission of regulatory files for
various global markets such as:
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Regulatory Strategy input for a Food Supplement Development Plan
Vedic also supports IND, CTA, NDA, ANDA, marketing dossiers, etc for
drug submissions in any markets
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Vedic. Regulatory Support
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Dietary supplement label claims compliant to FTC and other guidelines
Health claim under Article 13.5 or 14 of Regulation (EC) No
1924/2006
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Substantiation of nutrition and health claims in several other countries
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Natural Product Number (NPN) from Health Canada
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OTC/IND/NDA for a Botanical Drug Product
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GRAS Affirmations
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Medical Foods
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Clinical Trial Application to DCGI
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505(b)(2) approvals from US FDA
Vedic. Preclinical
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Pharmacological screening studies - in vitro and in vivo
Toxicology
Pharmacokinetics
Analytical Development
Formulation Development
Completed over 275 studies (GLP and non-GLP)
Vedic. Pre Clinical
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Toxicity Studies
39%
Analytical method Development
33%
Animal Pharmacology
24%
Formulation Development
4%
Vedic. Clinical
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Trial Feasibility
Study Documents
Site Selection
Clinical Monitoring
Project Initiation & Management
Investigational Product Management
Audits
Data Management
Biostatistics
Medical Writing
Clinical Research Papers
Vedic. Certifications
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Audit Certification
Vedic Investigators' Meet, Mumbai: 2011
A Human Growth Hormone Supplement
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Vedic Investigators' Meet, Mumbai: 2011
A Joint Health Supplement
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Vedic. Therapeutic Expertise
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Completed
Ongoing
2
0
Vedic. Global Reach
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Canada, 6
France, 1
USA, 12
Germany, 2
Hong Kong, 5
Netherlands, 4
Malaysia, 1
India, 19
Vedic. Clinical Research Papers (latest
papers to be added)
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Papers published on Joint Health
Vedic. Clinical Research Papers
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Paper published on Sexual Health
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Paper published for Pain Management
CRO. Benefits
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Planned, Structured, Regulatory compliant and accepted documents
High & Unbiased Safety, Ethics in Human Volunteer selection and protection
Regular monitoring and inspections by trained and qualified staff to detect noncompliance
Increased data credibility and acceptability
Dedicated and Trained team to ensure better co-ordination in multi center studies
Product use by several doctors following similar protocol leading to more doctor
confidence.
Increased chance of promoting/marketing/sales of product(s) in various other new
geographies or market segments
Increased compliance to international systems and regulations
Internationally acceptable tools for collection of data
Structured & Planned Analysis and Presentation of the data
Publication
of
data
in
international
peer
reviewed
journals
India. Benefits
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Study Start Up’s / initiations in 2months
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Shorter recruitment timelines and increased patient compliance
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Faster Approval from Ethics Committee
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World class data processing infrastructure for data management and biostatistics.
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Increasing adoption of Good Clinical Practice (GCP) Guidelines
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Products can be protected under TRIPS (Trade Related Intellectual Property Rights)
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Large number of cGMP certified Contract Manufacturing Units providing local
support for product manufacturing services.
 NOT TO FORGET
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Lower R&D, Drug Discovery & Clinical Trial Cost
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Increasing prevalence of diseases
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Well trained and world class facilities
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No language barrier
Vedic. Case Study - Reparagen
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Background
Challenge
Solution
Impact
• North American
client
• Proprietary joint
health
supplement
• Claims
substantiation
through human
clinical studies.
• Stringent
timelines
• Budget
constraints
• Publication in a
peer – reviewed
journal
• Robust Study
Designs under
guidance of
experienced
Medical Advisory
Board
• Faster Ethics
Committee
Approvals
• DSR® for faster
recruitment
• Dedicated Project
Management
Team
• ICH-GCP
compliant data
• Own science v/s
borrowed
sciences
• Publication in
high impact peer
reviewed journal
• Increased Brand
credibility
• Increase in sales
Vedic. Medical Advisory Panel
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Dr. Arun Nanivadekar is former Medical Director, Pfizer & Wyeth. He has been a member
of Several Ethics Committees and editorial advisory boards. He has been honored with the
Lifetime Achievement award by Indian Society of Clinical Research in 2008, for his
contributions to the field of clinical research. Dr. Nanivadekar at Vedic provides strategic
regulatory inputs for innovative study design.
Dr. Shanta Banerjee is Managing Director of Phytomed Service and Plantachem GbR,
Germany. She has received her PhD degree in Pharmaceutical chemistry and worked as
postdoctoral Scientist in renowned research laboratories across Europe and America. She
has co authored a number of publications on active constituents of medicinal plants. Dr.
Shanta Banerjee plays a key role in the areas of clinical study design and botanical product
development.
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Dr. Chungath Jolly completed his PhD and M.Sc. in Pharmacognosy and Phytochemistry.
He has served in the positions of Research Advisor, Technical Advisor and Director at
prestigious and meritorious organizations. Dr. Jolly adds tremendous value to the projects in
the areas of Pharmacognosy and Phytochemistry for all the herbal formulations.
Vedic. Key people
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Jayesh Chaudhary, as Founder, has been involved in product development and international
business since 1994. He has over two decades of experience in nutraceutical regulatory affairs
and claim substantiation for the EU, US and other markets. With a Major in Pharmacy and
Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst
and Natural Products technical support Boehringer Mannheim GmbH in the early ‘90s, before he
founded Vedic Lifesciences. Jayesh’s key interest remains innovations in research methodologies
to suit the current market conditions and challenges being faced by industry.
Dr. Navneet Sonawane heading Clinical Research, has 13 years of experience in clinical practice
including 7 years in nutraceutical clinical research, which include areas such as medical writing,
regulatory affairs, project management & quality assurance. Navneet has successfully managed
Human studies for a large number of health conditions. At Vedic, she has developed a strong
network of GCP trained clinical investigators and research sites and has been appreciated by
clients around the globe. Navneet is experienced in efficiently managing nutraceutical research
projects ensuring strict timelines and regulatory compliance.
Vedic. Key people
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Kunal Bhatt heads Business Development and has also led several Global Phase II - IV drug
studies, in various capacities and diverse therapeutic areas. A Masters in Pharmacology and
Biotechnology from Sheffield Hallam University, UK, Kunal has worked in areas of global
project management and clinical operations. Kunal has been instrumental in creating a
network of collaborators and business partners for our global expansion and has helped
manage a large number of research studies..
Anil Yadav leads Quality Assurance at Vedic. He brings in over 7 years of experience in the
field of Quality assurance with experience in writing and implementation of standard operating
procedures, documentation, qualification audits and training. His focus at Vedic on system
development and training activities has helped in constant upgradation of the team’s expertise
and capabilities. Anil, a Biochemistry and Microbiology major, has successfully led the Vedic
teams for several ISO 9001:2008 and ICH-GCP sponsor audits.
Vedic. Organogram
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Vedic. Social Media
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India
203, Morya Landmark 1, Off new Link Road, Andheri West,
Mumbai 400053
Tel.: +91 22 42172300 / +91 22 42025719
USA
16 Barcelona Circle, Redwood Shores, CA 94065, USA
Tel: 1(650)855-4832
[email protected], www.vediclifesciences.com