Outsourcing Opportunities India

8/10/2019 Outsourcing Opportunities India

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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


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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.


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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


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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


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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?


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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


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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


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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


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Outsourcing Process

Speed

Cost Science & Quality

C x S x SQ = Productivity

Indian Weakness:

Raw material resourcing

Private courier regulations

Customs trappings


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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


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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?)


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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


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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


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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


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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 .


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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...


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I t d ti


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


- Confidential -

Vaccines


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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


Typhoid Vaccine In Progress In Progress

HexavalentVaccine


MeningococcalConjugate

Vaccine

In Progress

PneumococcalVaccine

Initiated

- Confidential -

Clinical Research


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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


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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



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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


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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


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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


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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


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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


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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


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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


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- 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


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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


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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


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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.


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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@[email protected]@[email protected]

Outsourcing Opportunities India

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