Scope and Opportunities of Contract

Research Services in India

Vijay Vijay Dahiya Dahiya
Sr.Business Sr.Business Manager Manager New Initiatives (R&D) New Initiatives (R&D)
Panacea Biotec Ltd., New Delhi, Panacea Biotec Ltd., New Delhi,
INDIA INDIA
Introduction
The Indian Drugs & Pharmaceuticals industry has made rapid
strides in both National and international markets
India offers both Cost and Value arbitrage
Skill base, knowledge, innovative capacity, reduced timelines &
costs are only a few of the advantages.
Drug Discovery - Issues
Blockbusters pipeline getting dried up
About 90% of drugs sell less than $150M per year
About 30% drugs in the above mentioned category cant recover the cost in
their life time
It is widely believed that most of the low hanging fruits are already picked
up
Drug approving authorities are tightening the rules every year
All these attributes to the phenomenal cost of discovery
Whats already there
370 Biotech medicines to treat 200 diseases are in the development
pipeline from 144 companies
178 for cancer, 47 for infectious diseases, 26 for autoimmune
diseases, 21 for HIV/AIDS
Of every 5000 compounds only 5 make it to clinical trials
In spite of sluggish economy R&D spending is on the rise
For the first 8 pharma companies there is 6.8% increase in the R&D
spending. Approx. $8B spent on R&D in 2002
Contrary to popular perception FDA approval time has come down
from 2.4 to 1.9 years from 60s to 99
Merck introduced 16 new drugs in 7 years
Research Strategy
In the past companies out-sourced only minor components or some thing
completely outside of their domain
Once VP, Merck stated that outsourcing research is next to give away the
company strategy
Research efforts has to be more intense to be in the business
How can a company maximize the research efforts without assuming
tremendous liability otherwise?
Growth of Global Chemistry Services Market
(US$ Billions)
0
0.5
1
1.5
2
2.5
3
3.5
2001 2002 2003 2004 2005 2006 2007 2008
Year
V
a
l
u
e
Working with CROs
Risk/Benefit Review
Expected Benefit
Reduced time to discovery and
development
Access to new technologies and
expertise
Access to focused, flexible
infrastructure
Lower capital investment, higher
ROI
Lower total cost
Perceived Risks
Loss of control
Atrophy of critical discovery and
developmental skill
Regulatory risk
Leaking Intellectual Property
Mismatch of work culture leading to
incompatibility
Dishonoring exclusivity
Working with CROs
Issues to consider
Technical ability, reputation, experience
Communication skill
Knowledge of specification/regulatory requirements
Quality systems, Accreditation
Track record of honoring IPRs
Adherence to timelines
Price/Cost
Long-term partnership
To achieve the desired goals with minimum
resource input
Outsourcing Process
Speed
Cost
Science & Quality
C x S x SQ = Productivity
Indian Weakness:
Raw material resourcing
Private courier regulations
Customs trappings
CROs in the developing countries
QUALITY COMES FIRST
CROs in the developing countries lose credibility very fast on this
account
Accurate Certificate Of Analysis report must accompany the
deliverables
Prior clear understanding with the clients on the parameters of QC.
TIMELY delivery is very important but not at the expense of QUALITY
CROs in the developing countries
COMMUNICATION
India has a distinct advantage over its competitors and its of prime
importance
Telecom revolution has helped enormously
Cultural acquaintance may be helpful
(like BPO?)
INDIAN ADVANTAGE
Communication
Documentation
Good analytical set up
cGMP compliance
(if necessary - more credibility required)
Consistency
Long term commitment
Strong legal system (Better than our competitors)
Straight forward pricing
Current Gloom Prevailing in the Biotech World
NEARLY 40% BIOTECH COMPANIES HAVE STOCK
VALUES BELOW $2.00 PER SHARE, AND 20% HAVE
VALUES BELOW $1.00 AND FACE DELISTING. SOME 25%
OF COMPANIES ARE TRADING AT A VALUE LESS THAN
THEIR AVAILABLE CASH PER SHARE. AND MANY HAVE
LESS THAN A YEARS WORTH OF MONEY TO FUND
OPERATION
CHEMICAL & ENGINEERING NEWS, JAN. 27, 2003, PP.41
WHATS INDIAN CROs PROSPECT IN THIS BACK
DROP?
The discovery companies will rely more on sophisticated technologies
currently not available in India
In spite of that business will not be seriously affected as this constitutes a
miniscule fraction of the total cost but we will not see the great surge till the
market improves
More companies will be willing to work if they can pay by stock swapping
etc. - Introducing cash substitute
CROs should change gear and be prepared for short term projects -
intense marketing effort required to bring in more customers - not merely
using as a backend hub
Credible Value Addition will determine a CROs future
CONCLUSION
Contract Research Services holds lots of promise for India.
Communication - India has a distinct advantage.
IT - Strength for the the bioinformatics applications.
The best R&D companies have already setup operations in India.
Ability to provide ICH GCP compliant clinical research studies.
Clinical research that accounts for majority of drug development costs
,could be immensely controlled by outsourcing from India.
The diverse population and genetic pool available offers wide ranging
opportunities for Clinical research.
A large no. of research labs, universities and other academic institutions
can provide cost effective interdisciplinary research.
Spare capacity can offer long term facility /resource commitment to
projects .
India has the second largest no. of cGMP facilities outside of US.
Change of legislation, understanding of the urgency, realization of the
fierce competition from the neighborhood will facilitate growth.
Availability of quality research capacity and the ability to meet the
research objectives at very economical terms on committed
timelines makes India the destination for outsourcing Drug
development and clinical research .
Innovation has to be continuous
and has to better every single time
Panacea Biotec addresses another strategic. need
few of the endorsements
.20th Oct2004







High hopes for fridge-free jabs
A new technology developed in the UK could
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need for refrigeration.

British Scientists Develop New Vaccine
Technology
LONDON (Reuters) - British scientists have taken tips from
Mother Nature to develop a new technology that could...

Scientists develop fridge-free vaccine
WEDNESDAY, OCTOBER 20, 2004 : A leading Indian
bio-tech firm is on the cusp of manufacturing a
revolutionary new, UK-developed vaccine...
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Press Release - 9th OCT. 2004
Panacea Biotec to manufacture CBLs
revolutionary vaccine
Wednesday, October 20, 2004 : A new technology,
based on processes that are two billion years old,
promises to revolutionise ...

Forget The Fridge, wait for vaccine in sugarbox
NEW DELHI, OCTOBER 19: A low-cost child vaccine that
can be transported and stored in the most remote villages
without need for refrigeration will be out in a couple of years.

DFID BOOST FOR NEW VACCINE
TECHNOLOGY WHICH COULD
PROTECT 10 MILLION MORE
CHILDREN FROM KILLER..
read more....

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Introduction
Panacea Biotec is one of the leading and fastest growing health
companies, involved in research, production and marketing of ethical
pharmaceuticals, vaccines, and biopharmaceuticals products .
Panacea Biotec is a proactive customer centric company and lays
emphasis on innovation and quality.
Core Competencies
3 State-of-the-art Research & Development Centers
with over 155 Scientists
Collaborative Research & Development Programme
J oint Ventures & Product Licensing Arrangements
3 Production Facilities Meeting cGMP Norms
Established Brand Equity In Many Therapeutic Areas
Dedicated Sales and Marketing team of more than
1000 professionals.
BestOnhealth.com Health Portal
Ranking
Panacea Biotec is ranked 43rd in terms of retail sales audit (IMS-ORG
April 2004, MAT) and 38th in prescription audit (CMARC, Nov03- Feb04).
Panacea Biotec is ranked 2nd amongst 200 biotechnology companies
in India.(Biospectrum, Vol. 1, Issue 7, September 2003).
Panacea Biotec also features in first 250 companies in the D&Bs
annual report Indias top 500 companies.
Achievements
Indias most valuable companies.
Panacea Biotec is among
Indias biggest wealth creators
(The BT-Stern ranking of companies - Business Today, 11 April 2004).
Research & Development
Core Research Areas:
- Drug Delivery
- Natural Products
- Drug Discovery
- Vaccines
- Biopharmaceuticals
Supporting Functions:
- Analytical / Bio-analytical
- Process Chemistry
- Information Science
- Intellectual Property Rights
- Documentation & Regulatory Affairs
- Pre-Clinical & Clinical Research
Pharmaceuticals
A state-of-the-art 30,000 sq.ft. research facility with 110 scientists dedicated for
Pharmaceutical Research. Panacea Biotec has extensive research capabilities
on the following areas :
- Self Microemulsifying Drug Delivery Systems (SMEDDS)
- Mucoadhesive / Bioadhesive formulations
- Specialized tablets (inlay / bilayer / tablet in tablet)
- Gastroretentive Systems
- Targeted Drug Delivery
- Hydrophillic Matrix Systems
- Nanoparticles
- Taste Masking
- Mouth Dissolving / Dispersion Systems
-Transdermal Drug Delivery
- Particle coating / Beads
Pharmaceutical
Facilities Include
- Sophisticated Drug Delivery Labs equipped with Lyophilizer, Zetasizer, Particle
Size Analyzer, High Pressure Homogenizer, Differential Scanning Calorimeter,
Fluidized Bed Processor, Spray Drier, Multilayer/Tablet-in-Tablet Machines etc.
- Pilot Plant Facility for Clinical Trial Batches
- Sophisticated Analytical & Bio-analytical Labs equipped with an array of HPLCs,
Gas Chromatography equipment, FTIR, LC-MS/MS etc.
Animal House
Species available mice, rats, guinea pigs, hamsters and rabbits.
Breeding facility - mice, rats, guinea pigs and rabbits.
Approved by Govt. of India and monitored
by Institutional Animal Ethics Committee.
-Evaluation of conventional & newer vaccines
-Respiratory Pharmacology
-Nociception / Inflammopharmacology
-Neuropharmacology
-Gastrointestinal permeability studies
-Pharmacodynamic studies
-Biochemical and Hematology studies
-Pre-clinical and toxicity studies
-Newer animal models
Facilitates research relating to
Vaccine & Biologicals Research
Centered on the knowledge-base of over 45 scientists, the division has
delivered two products in the market: ENIVAC HB in Uniject and Quadruple
(DTwP-HB) vaccine. The novel combination vaccine Liquid Pentavalent
(DTwP-HB-HIB) is scheduled to be launched by Dec2004.
The division is focussed on the following areas of development:
Cell - culture based viral vaccines
Bacterial Vaccines
The division also plans to carry out research on J .E.V.Vaccine , Cholera
vaccine, Dengue Fever etc. in collaboration with reputed institutes /
universities.
Vaccines
Product Manufacturing
& Analytical
Validation
Developmental
stages Mfg &
Analytical
Standardisation
Pre-
Clinical
Clinical trial
Phase I
Clinical trial
Phase II/III
Final Mfg
Pentavalent
Vaccine
(DTP-Hb-Hib)
Completed Completed Completed
Completed
In
Progress
Initiated
Initiated
Completed Completed In Progress
Tetravalent
Vaccine
Completed Completed Completed Completed In Progress
Recombinant
Anthrax
Vaccine
Completed Completed Initiated
Sabin based
Inactivated Polio
Vaccine
Completed Under
Completion
Hib Conjugate
Vaccine
Under
Completion
Under
Completion
Recombinant
HIV Vaccine
In Progress In Progress
J apanese
Encephalitis
Vaccine
In Progress In Progress
- Confidential -
Vaccines
Product Manufacturing &
Analytical
Validation
Developmental stages
Manufacturing &
Analytical
Standardisation
Pre-Clinical Clinical trial
phase I
Clinical trial
phase II/III
Tetanus Toxoid
in Uniject
Completed Completed Completed
In Progress
To Be Initiated
Varicella
Vaccine, Live
Attenuated
In Progress In Progress To Be Initiated
Hepatitis A
Vaccine
In Progress In Progress
Typhoid Vaccine In Progress In Progress
Hexavalent
Vaccine
In Progress In Progress
Meningococcal
Conjugate
Vaccine
In Progress
Pneumococcal
Vaccine
Initiated
- Confidential -
Clinical Research
The Clinical Research Department successfully coordinated Clinical Trials on:
- Enivac HB (Recombinant Hepatitis B vaccine) Phase III
- Ecovac 4 (DTP-HB vaccine) Phase III
- Pentavalent Vaccine (DTP-HB-Hib) Phase III
- Tetravalent Vaccine (DTP-Hib) Phase III
- Recombinant Anthrax Vaccine Phase I
- Nimulid Safeinject Phase II, Phase III
- Manyana Phase III
- ThankGod Phase II
- Routine Phase III & bioequivalence studies are carried out for a large number of
products.
Publications
- Scientific Papers : 25
- Poster Presentations : 8
- Book Chapters : 3
Intellectual Property
With a pragmatic approach towards Research and Development, Panacea Biotec has
been able to develop some of the most exclusive products,
XEED (Antitubercular FDC with innovative Drug Delivery for optimum bioavailability of all drugs)
Nimulid SafeInject (Parenteral formulation of Nimesulide based on co-solvent technique)
Panimun Bioral (Cyclosporine formulation based on SEDDS technology)
ThankGod (Euphorbia prostrata extract for the comprehensive management of Haemorrohoids)
Nimulid MD (Nimesulide tablets based on Fast Mouth Dissolving Technology)
Willgo (Nimesulide controlled release formulation)
Nimulid Transgel (Nimesulide Transdermal Gel)
NIMCET (Synergistic combination of Nimesulide Long Acting + Cetirizine)
Manyana (Antispasmodic agent)
Total no. of International Patents granted : 110
Intellectual Property
Patent applications filed for a number of products, to name a few:
0202 (Novel peptide for the treatment of Diabetes)
2 Good (Amoxicillin once daily)
Odipep (Synergistic combination of Prokinetic agent and PPI)
Niacin Extended Release
Recombinant Anthrax Vaccine
Injectable Polio Vaccine Sabin Strain
Novel Compositions for topical delivery
Pending Patent Applications : 114
Production Facilities
Panacea Biotec has three cGMP
certified production units equipped
with state of the art facilities for
Pharmaceuticals , Biopharmaceuticals
and Vaccines.
Panacea Biotec is a WHO Prequalified Supplier for Oral Polio
Vaccine (OPV) and Diethyl Carbamazine (DEC) tablets
Biological Manufacturing Facilities
Panacea Biotec commissioned and validated large scale manufacturing facilities
for Recombinant Vaccines (e.g. Hepatitis B vaccine).
Facilities include fermentors, harvesting and large scale purification equipments
based on chromatography, MPLC etc.
Automated system for formulating vaccines using adjuvants.
Quality Control facilities for vaccines: immunochemistry, physico-chemical,
microbiological and animal testing methods.
An independent Quality Control / Quality Assurance unit.
Marketing
Panacea Biotec has countrywide marketing
setup represented by a strong marketing
team of more than 1000 professionals
synergizing their efforts to transform the
companys brands to winning brands in the
marketplace.
The marketing team is positioned in
multiple SBUs, so as to have appropriate
focus in the concerned therapeutic
segments.
DIACAR
Critical Care
SBUs
SBUs
BOH
GROW
PRO
Brands
Panacea Biotec has pioneered the launch of various technology
driven pharmaceutical specialities in numerous therapeutic
segments including :
Pain Management
Diabetes Management
Organ Transplantation
Immunization
Respiratory Diseases
Gastrointestinal Diseases
Osteoporosis
Future Plans
Panacea Biotec plans
Research Facilities
One new dedicated R&D center for Drug Discovery
One R&D center for Biopharmaceuticals
and
increase the no. of Scientists to ~ 500 over
next two years.
Production Facilities
A new production facility for Pharmaceuticals in
North of India conforming to the cGMP norms of
USFDA,E.U and other regulatory agencies is expected
to be functional by J an2005.
Panacea Biotec plans to build a state of art
manufacturing facility for bacterial and cell based
vaccines.
Drug Discovery
The upcoming ultra-modern Drug Discovery Center having more than 35,000
sq.ft. of lab-space, will be manned by 150 scientists focusing on infectious
diseases, cancer and metabolic disorders. The facility will specialize in:
- Chemical synthesis
- Medium Throughput Screening
- Complete pre-clinical profiling
- ADME studies
- Development of Humanized Antibodies
- Development of Antibody-Drug conjugates
Biological Manufacturing : Future Plans
- Panacea Biotec plans:
- To build state of art manufacturing facility for bacterial and cell based
vaccines.
- To augment vaccine filling unit.
- Newer vaccines will be developed in house or through in-licensed
technology.
Strategic Tie-ups
Panacea Biotec has entered into synergistic tie-ups with a number of
research oriented organizations & institutions, including:
- Chiron Corporation, USA
- Cambridge Biostability, UK
- Center for Genetic Engineering & Biotechnology, Cuba
- Biopharma Pte., Indonesia
- Solvay, Netherlands
- National Institute of Immunology, India
- National Research & Development Corp., India
- J awaharlal Nehru University, India
- Institute of Himalayan Bio-resources & Technology, India
- Confidential -
Strategic Tie-ups
Joint Ventures
J oint venture with Center for Genetic Engineering & Biotechnology,
Cuba for the production of recombinant proteins in India.
J oint venture with Chiron Corporation for vaccines in India.
Collaborations
Research collaboration with Solvay, Netherlands for the development
of Drug Delivery System for NCE SLV 306.
Panacea Biotec is developing thermostable vaccines under
collaboration with Cambridge Biostability, UK with grants from DFID.
Objectives of the visit
In Licensing / joint development :
Preventive and Therapeutic vaccines for infectious diseases
Human or humanized monoclonal antibodies for therapeutic
applications for the management of :
Post Organ Transplant Complications
Rheumatoid Arthritis
Asthma & Allergy
Psoriasis
New drug interventions for Infectious diseases (Respiratory
Diseases ),Diabetes Management,, Pain management and
for the management of Post Organ Transplant Complications.
For more information, please visit our website at
www.panaceabiotec.com
www.panaceabiotec.com
Panacea Biotec Ltd.
Panacea Biotec Ltd.
B B- -1 Ext./G 1 Ext./G- -3, Mohan Co 3, Mohan Co- -op. op. Indl Indl. Estate, . Estate, Mathura Mathura Road, Road,
New Delhi New Delhi- -110 044, INDIA 110 044, INDIA
Phone : +91 11 5167 9000/8000, 2694 5270 Phone : +91 11 5167 9000/8000, 2694 5270
Fax : +91 11 2694 0199, 2694 0621 Fax : +91 11 2694 0199, 2694 0621
Email : Email : vijaydahiya@panacea vijaydahiya@panacea- -biotec.com biotec.com
vijaydahiya@pblintranet.com vijaydahiya@pblintranet.com