Transcript Slide 1

Vedic Lifesciences – Claim Substantiation
through Human Clinical Studies
AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic. Introduction
2







A decade of experience as full and functional service CRO
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
Headquarters in Mumbai, India with office in California, USA
Vedic. Brand Promise
3
We offer an opportunity to substantiate your product claims in a
scientific and credible environment. Conforming to USA, EU and
other Global Regulations, our expertise and resources help you
deliver on your promise to enable people to live healthier lives.
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
4










Expert team for developing global regulatory strategies
Wide therapeutic knowledge and expertise
Esteemed panel of Medical Advisors
Experienced Medical Writers
Flexible payment terms and conditions
Shared risks
Core strengths: Our people and ICH-GCP compliant systems
GCP trained investigators in several disease indications that India
has to offer
Unique models for data capture
Papers published in peer reviewed journals
Vedic. Core Values
5




Commitment to Word and Work
Empathize with Customer: Serve real needs
Ethics – Honesty & Protection of human subjects
Pro-activeness
Vedic. Services
6
Regulatory
Dossier
Preparation
&
Consulting
Preclinical
Formulation
and
Standardization
Toxicology
Clinical
In vitro
&
In vivo
Animal
studies
Human
Bioavailability
Studies
Human
Clinical
Studies
Medical
Writing
Vedic. Regulatory
7


Regulatory Strategy input for a Food Supplement Development Plan.
Developing, writing, publishing and submission of regulatory files for
global regulatory authorities such as:







Federal Trade Commission (FTC) – USA
Food and Drug Administration (FDA) – USA
European Food Safety Authority (EFSA) – Europe
Natural Health Products Directorate (NHPD) – Canada
Therapeutic Goods Administration (TGA) – Australia
Food Standard Australia New Zealand
National Pharmaceutical Control Bureau – Malaysia
Vedic also supports IND, CTA, NDA, ANDA, marketing dossiers, etc for
drug submissions in any markets
Vedic. Preclinical
8






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
9
Regulatory
23%
Toxicity Studies
30%
Analytical method
Development
25%
Animal
Pharmacology
19%
Formulation
Development
3%
Vedic. Clinical
10









Trial Feasibility
Project Management
Site Selection
Clinical Monitoring
Investigational Product Management
Audits
Data Management
Biostatistics
Medical Writing
Vedic. Certifications
11
Audit Certification
ISO 9001:2008
Vedic Investigators' Meet, Mumbai: 2011
A Human Growth Hormone Supplement
12
Vedic Investigators' Meet, Mumbai: 2011
A Joint Health Supplement
13
Vedic. Therapeutic Expertise
Number of Studies
14
10
9
8
7
6
5
4
3
2
1
0
Completed
Ongoing
Vedic. Global Reach
15
Canada, 6
USA, 9
France, 1
Germany, 2
Netherlands, 3
Hong Kong, 3
Malaysia, 1
India, 19
Vedic. Clinical Research Papers
16

Papers published on Joint Health
Vedic. Clinical Research Papers
17

Paper published on Sexual Health

Paper published for Pain Management
Vedic. Initiatives
18

NUTRACEUTICAL RESEARCH ASSISTANCE PROGRAM
 No obligation quote with suitable study design
 Consulting for in house project management

ACElerator
 Generation of own data
 Faster mobilization of product into the market
 Strong marketing tool to increase sales and credibility of the product
Vedic. Case Study - Reparagen
19
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
20
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.

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
21

Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been
involved in product development and international business since 1994. He is thorough with
regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives
and formulations for the EU and US markets. Trained in Pharmacy and Microbial
Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and
Natural Products technical support and national sales at Boehringer Mannheim India in the
early ‘90s.
• Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years of
experience in the field of Medical Science & Clinical Research, which include areas such as
Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed
Global Clinical Studies across various therapeutic segments. During her tenure at Vedic, she
has developed a strong network of GCP trained clinical investigators around India and has
been appreciated by Sponsors around globe. She places a high premium for meeting time line
while ensuring delivering of quality.
Vedic. Key people
22
Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led
several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas
like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.
Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked
in areas of Global Project Management, Clinical Operations and Regulatory. As a Global
Business Development Manager his good business planning acumen and interpersonal relations
help in crafting Business & Marketing Plans.
ANIL YADAV leads VL’s QA department. After completing his graduation in
Microbiology he obtained a Master degree in Biochemistry from the Mumbai University.
He brings in over 7 years of experience in the field of Quality Assurance with actual
hands on experience in Product development, Documentation and Training.. His focus at
VL on System development and Training activities has helped in constant up-gradation of
our expertise and abilities.
Vedic. Organogram
23
Vedic. Social Media
24
25
India
203, Morya Landmark 1, Off new Link Road, Andheri West,
Mumbai 400053
Tel.: +91 22 42172300 / +91 22 42025719
USA
552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065
Tel.: (650) 855-4832
[email protected], www.vediclifesciences.com