Post on 02-Jun-2018
8/10/2019 Outsourcing Opportunities India
1/42
Scope and Opportunities of Contract
Research Services in India
VijayVijay DahiyaDahiya
Sr.BusinessSr.Business ManagerManager New Initiatives (R&D)New Initiatives (R&D)
Panacea Biotec Ltd., New Delhi,Panacea Biotec Ltd., New Delhi,
INDIAINDIA
8/10/2019 Outsourcing Opportunities India
2/42
Introduction
The Indian Drugs & Pharmaceuticals industry has made rapidstrides 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.
8/10/2019 Outsourcing Opportunities India
3/42
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 intheir life time
It is widely believed that most of the low hanging fruits are already pickedup
Drug approving authorities are tightening the rules every year
All these attributes to the phenomenal cost of discovery
8/10/2019 Outsourcing Opportunities India
4/42
Whats already there
370 Biotech medicines to treat 200 diseases are in the developmentpipeline from 144 companies
178 for cancer, 47 for infectious diseases, 26 for autoimmunediseases, 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&Dspending. Approx. $8B spent on R&D in 2002
Contrary to popular perception FDA approval time has come down
from 2.4 to 1.9 years from 60s to 99
Merck introduced 16 new drugs in 7 years
8/10/2019 Outsourcing Opportunities India
5/42
Research Strategy
In the past companies out-sourced only minor components or some thingcompletely outside of their domain
Once VP, Merck stated that outsourcing research is next to give away thecompany strategy
Research efforts has to be more intense to be in the business
How can a company maximize the research efforts without assumingtremendous liability otherwise?
8/10/2019 Outsourcing Opportunities India
6/42
Growth of Global Chemistry Services Market
(US$ Billions)
0
0.5
1
1.5
2
2.5
3
3.5
2001 2002 2003 2004 2005 2006 2007 2008
Year
Value
8/10/2019 Outsourcing Opportunities India
7/42
Working with CROsRisk/Benefit Review
Expected Benefit
Reduced time to discovery anddevelopment
Access to new technologies andexpertise
Access to focused, flexibleinfrastructure
Lower capital investment, higherROI
Lower total cost
Perceived Risks
Loss of control
Atrophy of critical discovery anddevelopmental skill
Regulatory risk
Leaking Intellectual Property Mismatch of work culture leading to
incompatibility
Dishonoring exclusivity
8/10/2019 Outsourcing Opportunities India
8/42
Working with CROsIssues 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 minimumresource input
8/10/2019 Outsourcing Opportunities India
9/42
Outsourcing Process
Speed
Cost Science & Quality
C x S x SQ = Productivity
Indian Weakness:
Raw material resourcing
Private courier regulations
Customs trappings
8/10/2019 Outsourcing Opportunities India
10/42
CROs in the developing countries
QUALITY COMES FIRST
CROs in the developing countries lose credibility very fast on thisaccount
Accurate Certificate Of Analysis report must accompany thedeliverables
Prior clear understanding with the clients on the parameters of QC.
TIMELY delivery is very important but not at the expense of QUALITY
8/10/2019 Outsourcing Opportunities India
11/42
CROs in the developing countries
COMMUNICATION
India has a distinct advantage over its competitors and its of primeimportance
Telecom revolution has helped enormously
Cultural acquaintance may be helpful
(like BPO?)
8/10/2019 Outsourcing Opportunities India
12/42
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
8/10/2019 Outsourcing Opportunities India
13/42
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
8/10/2019 Outsourcing Opportunities India
14/42
WHATS INDIAN CROs PROSPECT IN THIS BACKDROP?
The discovery companies will rely more on sophisticated technologiescurrently not available in India
In spite of that business will not be seriously affected as this constitutes aminiscule fraction of the total cost but we will not see the great surge till themarket improves
More companies will be willing to work if they can pay by stock swappingetc. - Introducing cash substitute
CROs should change gear and be prepared for short term projects -intense marketing effort required to bring in more customers - not merelyusing as a backend hub
Credible Value Addition will determine a CROs future
8/10/2019 Outsourcing Opportunities India
15/42
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 theresearch objectives at very economical terms on committedtimelines makes India the destination for outsourcing Drug
development and clinical research .
8/10/2019 Outsourcing Opportunities India
16/42
Innovation has to be continuousand has to better every single time
Panacea Biotec addresses another strategic. needfew of the endorsements
.20th Oct2004
High hopes for fridge-free jabsA new technology developed in the UK couldrevolutionise vaccine delivery by eliminating theneed for refrigeration.
British Scientists Develop New VaccineTechnologyLONDON (Reuters) - British scientists have taken tips fromMother Nature to develop a new technology that could...
Scientists develop fridge-free vaccineWEDNESDAY, OCTOBER 20, 2004 :A leading Indianbio-tech firm is on the cusp of manufacturing arevolutionary new, UK-developed vaccine...
read more... read more... read more...
Press Release - 9th OCT. 2004Panacea Biotec to manufacture CBLsrevolutionary vaccineWednesday, 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 sugarboxNEW DELHI, OCTOBER 19:A low-cost child vaccine thatcan be transported and stored in the most remote villageswithout need for refrigeration will be out in a couple of years.
DFID BOOST FOR NEW VACCINETECHNOLOGY WHICH COULDPROTECT 10 MILLION MORECHILDREN FROM KILLER..
read more.... read more... read more...
8/10/2019 Outsourcing Opportunities India
17/42
I t d ti
8/10/2019 Outsourcing Opportunities India
18/42
Introduction
Panacea Biotec is one of the leading and fastest growing healthcompanies, 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.
C C t i
8/10/2019 Outsourcing Opportunities India
19/42
Core Competencies
3 State-of-the-art Research & Development Centers
with over 155 Scientists
Collaborative Research & Development Programme
Joint 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
8/10/2019 Outsourcing Opportunities India
20/42
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 companiesin 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
8/10/2019 Outsourcing Opportunities India
21/42
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
8/10/2019 Outsourcing Opportunities India
22/42
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
8/10/2019 Outsourcing Opportunities India
23/42
Pharmaceuticals
A state-of-the-art 30,000 sq.ft. research facility with 110 scientists dedicated for
Pharmaceutical Research. Panacea Biotec has extensive research capabilitieson 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
8/10/2019 Outsourcing Opportunities India
24/42
Pharmaceutical
Facil ities 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
8/10/2019 Outsourcing Opportunities India
25/42
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
8/10/2019 Outsourcing Opportunities India
26/42
Vaccine & Biologicals Research
Centered on the knowledge-base of over 45 scientists, the division hasdelivered 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 , Choleravaccine, Dengue Fever etc. in collaboration with reputed institutes /universities.
Vaccines
8/10/2019 Outsourcing Opportunities India
27/42
Vaccines
Product Manufacturing
& AnalyticalValidation
Developmental
stages Mfg &Analyt ical
Standardisation
Pre-
Clinical
Clinical trial
Phase I
Clinical trial
Phase II/III
Final Mfg
PentavalentVaccine
(DTP-Hb-Hib)
Completed Completed Completed
Completed
InProgress
Initiated
Initiated
Completed Completed In Progress
TetravalentVaccine
Completed Completed Completed Completed In Progress
Recombinant
AnthraxVaccine
Completed Completed Initiated
Sabin basedInactivated Polio
Vaccine
Completed UnderCompletion
Hib ConjugateVaccine
UnderCompletion
UnderCompletion
Recombinant
HIV Vaccine
In Progress In Progress
JapaneseEncephalitis
Vaccine
In Progress In Progress
- Confidential -
Vaccines
8/10/2019 Outsourcing Opportunities India
28/42
Vaccines
Product Manufacturing &
Analyt ical
Validation
Developmental stages
Manufacturing &
Analyt ical
Standardisation
Pre-Clinical Clinical t rial
phase I
Clinical trial
phase II/III
Tetanus Toxoidin Uniject
Completed Completed Completed
In Progress
To Be Initiated
VaricellaVaccine, LiveAttenuated
In Progress In Progress To Be Initiated
Hepatitis AVaccine
In Progress In Progress
Typhoid Vaccine In Progress In Progress
HexavalentVaccine
In Progress In Progress
MeningococcalConjugate
Vaccine
In Progress
PneumococcalVaccine
Initiated
- Confidential -
Clinical Research
8/10/2019 Outsourcing Opportunities India
29/42
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
8/10/2019 Outsourcing Opportunities India
30/42
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
8/10/2019 Outsourcing Opportunities India
31/42
p y
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
8/10/2019 Outsourcing Opportunities India
32/42
Panacea Biotec has three cGMPcertified production units equippedwith state of the art facilities for
Pharmaceuticals , Biopharmaceuticalsand Vaccines.
Panacea Biotec is a WHO Prequalified Supplier for Oral PolioVaccine (OPV) and Diethyl Carbamazine (DEC) tablets
Biological Manufacturing Facilities
8/10/2019 Outsourcing Opportunities India
33/42
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 equipmentsbased 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
8/10/2019 Outsourcing Opportunities India
34/42
Marketing
Panacea Biotec has countrywide marketingsetup represented by a strong marketingteam of more than 1000 professionalssynergizing their efforts to transform the
companys brands to winning brands in themarketplace.
The marketing team is positioned inmultiple SBUs, so as to have appropriate
focus in the concerned therapeuticsegments.
DIACAR
Critical Care
SBUsSBUs
BOH
GROWPRO
Brands
8/10/2019 Outsourcing Opportunities India
35/42
Panacea Biotec has pioneered the launch of various technology
driven pharmaceutical specialities in numerous therapeuticsegments including :
Pain Management
Diabetes Management Organ Transplantation Immunization
Respiratory Diseases Gastrointestinal Diseases Osteoporosis
Future Plans
8/10/2019 Outsourcing Opportunities India
36/42
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 overnext two years.
Production Facil itiesA new production facility for Pharmaceuticals inNorth of India conforming to the cGMP norms ofUSFDA,E.U and other regulatory agencies is expectedto be functional by Jan2005.
Panacea Biotec plans to build a state of artmanufacturing facility for bacterial and cell basedvaccines.
Drug Discovery
8/10/2019 Outsourcing Opportunities India
37/42
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 infectiousdiseases, 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
8/10/2019 Outsourcing Opportunities India
38/42
- Panacea Biotec plans:
- To build state of art manufacturing facility for bacterial and cell basedvaccines.
- To augment vaccine filling unit.- Newer vaccines will be developed in house or through in-licensed
technology.
Strategic Tie-ups
8/10/2019 Outsourcing Opportunities India
39/42
Panacea Biotec has entered into synergistic tie-ups with a number ofresearch 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
- Jawaharlal Nehru University, India
- Institute of Himalayan Bio-resources & Technology, India
- Confidential -
Strategic Tie-ups
8/10/2019 Outsourcing Opportunities India
40/42
Joint Ventures
Joint venture with Center for Genetic Engineering & Biotechnology,
Cuba for the production of recombinant proteins in India.
Joint 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
8/10/2019 Outsourcing Opportunities India
41/42
j
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 (RespiratoryDiseases ),Diabetes Management,, Pain management and
for the management of Post Organ Transplant Complications.
8/10/2019 Outsourcing Opportunities India
42/42
For more information, please visit our website at
www.panaceabiotec.comwww.panaceabiotec.com
Panacea Biotec Ltd.Panacea Biotec Ltd.BB--1 Ext./G1 Ext./G--3, Mohan Co3, Mohan Co--op.op. IndlIndl. Estate,. Estate, MathuraMathura Road,Road,
New DelhiNew Delhi--110 044, INDIA110 044, INDIA
Phone : +91 11 5167 9000/8000, 2694 5270Phone : +91 11 5167 9000/8000, 2694 5270Fax : +91 11 2694 0199, 2694 0621Fax : +91 11 2694 0199, 2694 0621
Email :Email : vijaydahiya@panaceavijaydahiya@panacea--biotec.combiotec.comvijaydahiya@pblintranet.comvijaydahiya@pblintranet.com