Name

concernedimpartialBiotechnology

Dec 3, 2012 (4 years and 6 months ago)

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Company Profiles



1



Company Profiles

Acologix, Inc.

................................
................................

2

Advinus Therapeutics Pvt. Ltd.

................................
.....

3

Ajinomoto Co., Inc.

................................
.......................

4

Alexandria Real Estate Equities, Inc.

............................

5

Anand And Anand

................................
.........................

6

AstraZeneca, Inc.

................................
..........................

7

Atharva Lifesciences Consulting Pvt. Ltd.

.....................

8

Aurigene Discovery Technologies, Ltd.
.........................

9

Avogadro

................................
................................
....

10

Biocon, Ltd.

................................
................................
.

11

Biomedical Consulting India Pvt. Ltd.
..........................

12

BioXcel Corporation

................................
....................

13

Cellworks Research India Pvt. Ltd.

.............................

14

Connexios Life Sciences Pvt. Ltd.

..............................

15

Curevac Gmbh

................................
............................

16

Cydex Pharmaceuticals, Inc.

................................
......

17

Dabur Research Foundation

................................
.......

18

DesignMedix, Inc.

................................
.......................

19

Development Centre For Biotechnology

.....................

20

Eli Lilly & Company

................................
.....................

22

ERA Consulting Group
................................
................

23

Ernst & Young, LLP

................................
....................

24

Ethicare Clinical Trial Services

................................
...

25

Federated Kaufmann Fund

................................
.........

26

Fulcrum Pharma plc

................................
....................

27

G7 Synergon Pvt. Ltd.
................................
.................

28

Genelogic
-
Ocimum

................................
.....................

29

Genotypic Technology Pvt. Ltd.

................................
..

31

GlaxoSmithKline

................................
.........................

32

Grunenthal GmbH

................................
.......................

33

GVK Biosciences Private Limited

...............................

34

Helsinn Healthcare SA

................................
................

35

Incozen Therapeutics Pvt. Ltd.

................................
...

36

Intas Biopharmaceuticals Limited

...............................

37

Intrexon Corporation

................................
...................

38

Inviragen, Inc.

................................
.............................

39

Johnson & Johnson

................................
....................

40

Jubilant Biosys Pvt. Ltd.

................................
.............

41

Kemwell Pvt. Ltd.

................................
........................

42

Livwel Therapeutics, Inc.

................................
............

43

Lupin Ltd. (Biotech Div.)

................................
.............

44

MakroCare

................................
................................
..

45

Medicamentos Especializados S.A.

...........................

46

MedTRACK

................................
................................

47

Merck & Co, Inc.

................................
.........................

48

Merck Ltd. India

................................
..........................

49

Novartis India Limited

................................
.................

50

Novo Nordisk A/S

................................
.......................

51

Orbimed Advisors India Private Limited
......................

52

Polyclone Bioservices Pvt. Ltd.

................................
..

53

Quintiles

................................
................................
.....

54

Recordati S.p.A.

................................
.........................

55

Roche

................................
................................
.........

56

RxMD

................................
................................
.........

57

Sanofi Pasteur SA

................................
......................

58

Sathguru Management Consultants Pvt. Ltd.

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59

SEDICO Pharmaceutical Co.

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.....

60

Shire Pharmaceuticals, Inc.

................................
........

62

Shook, Hardy & Bacon LLP

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........

63

Spectrum Pharmaceuticals, Inc.

................................
.

64

State Government of Victoria

................................
.....

65

Strand Life Sciences Pvt. Ltd.

................................
....

66

Takeda Pharmaceutical Company Limited

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67

TriStar Technology Group, LLC

................................
..

68

Unique Biotech Limited
................................
...............

69

Valletta Health BV

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......................

70

Vivo Ventures, LLC

................................
....................

71

Vlife Sciences Tech Pvt. Ltd.

................................
......

72

Zydus Cadila Healthcare Ltd.

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.....

73


2



Company Profiles

Acologix, Inc.


D
ELEGATE
(
S
)


Yoshinari Kumagai


M
ISSI
ON
/B
ACKGROUND

Acologix is a biopharmaceutical company focusing on development of novel therapeutic products in osteo
-
renal (hard tissue and
kidney) area. The company's most advanced compound AC
-
820 is in Phase 3 stage for treatment of pruritus in kidney d
ialysis and
other conditions. Acologix has completed the SPA process with the FDA on the protocol for its upcoming Phase 3 trial. The c
ompound
was launched in Japan in March 2009 and has shown strong sales performance. The first FY annual sales exceeded

US $40 million.
The second program at Acologix is a Phase 2 stage hard tissue reparative factor, AC
-
100. AC
-
100 has demonstrated selective growth
activities of cartilage tissues in the knee cartilage defect models. It promotes differentiation of human
chondrocytes.

A
LLIANCES

Most of the pipeline compounds at Acologix were either in
-
licensed from or assigned by the academic institutions through t
he
company
’s sponsorship on specific therapeutic target identification research programs conducted in those in
stitutions. For instance,
AC
-
200 was in
-
licensed from the University College London for its worldwide commercial rights.


P
RODUCTS




Name

Phase

Indication

Milestone

AC
-
820

Phase III

Uremic pruritus

NDA filing

AC
-
820

Phase II, IIa,
IIb

Hepatic pruritus
, atopic dermatitis, and other itching
conditions

Expand indications to multiple itch
conditions

AC
-
100

Phase I

Cartilage repair for RA, OA, and trauma

Initiate Phase 2

AC
-
100

Phase II, IIa,
IIb

Bone repair

Initiate Phase 2 for closed fracture

AC
-
100

Ph
ase II, IIa,
IIb

Dental care

Initiate Phase 2b/3

AC
-
200

Preclinical

CKD
-
MBD, Hyperparathyroidism, Hyperphosphatemia

IND



3960 Point Eden Way

Hayward
,
CA

94545

USA

www.acologix.com

Incorporated:


1992

Employees:

10

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


Acologix has completed Special Protocol
Assessment (SPA) on the protocol for its
upcoming US Phase 3 trial of AC
-
820 for
uremic pruritus (UP).

Acologix presented the data from multiple
kne
e cartilage repair studies and
in vitro

human chondrocyte differentiation studies
with AC
-
100 at Orthopedic Research
Society in March 2010.

Partnering on AC
-
100

Initiate Phase 2 clinical study of AC
-
100 for
cartilage repair in osteoarthritis patient

Company Profiles



3

Advinus Therapeutics Pvt. Ltd.


D
ELEGATE
(
S
)


Rashmi Barbhaiya, CEO & MD

Sivaram V, Director, Business Development

Anjal Cheema, Depu
ty Manager, Business Development


M
ISSION
/B
ACKGROUND

Advinus Therapeutics is a research based Pharma Company promoted by the TATA group. We offer end
-
to
-
end discovery and
development services to the global Pharma and Biotech industry while creating long term

value through internal and collaborative Drug
Discovery.

Of the two core operations of the company, Advinus Drug Discovery, based out of a state
-
of
-
the
-
art facility in Pune, aims to generate its
own drug candidates with the objective of out
-
licensing the
m at preclinical or clinical stage. The primary focus of the company’s
discovery efforts are in Metabolic Diseases, Inflammatory Diseases and Neglected Diseases. Towards this end, Advinus has
established drug discovery and development collaborations with M
erck, Ortho
-
McNeil
-
Janssen Pharmaceuticals Inc. and DNDi.
Advinus has received the approval for starting the Phase I clinical trials for its internally discovered novel molecule on ty
pe II diabetes
and FIH trials have been initiated during last week of
March 2010.

Advinus’ Bangalore facility provides integrated services for preclinical drug development which include
-

Process Development and
Synthesis, Analytical R&D, Drug Metabolism and Pharmacokinetics, Bioanalytical support, Safety Pharmacology, and T
oxicology. The
center is also one of the most accredited facilities of Asia Pacific with accreditation of its animal facility from AAALAC In
ternational and
from the German, Dutch and Indian authorities for GLP compliance.

Advinus has completed 14 IND phar
m

tox packages in the last 2 years. The data from these studies has been accepted by the
USFDA, EMEA, TPP Health Canada, New Zealand and Indian regulatory authorities. In addition Advinus has completed many long
term toxicology studies to support NDA filin
g.

A
LLIANCES

1. Merck Alliance


November 2006

Risk sharing drug discovery and development collaboration in the metabolic disorders area
-

have receievd success based milestone
payments

2.

DNDi (Swiss non
-
profit organization)


October 2007

5 year collabor
ation for the identification and development of novel therapies for Visceral Leishmaniasis (Kala Azaar)
-
a fatal disease of
the Tropics

3.

Novartis
-

December 2007

Development of drug candidates in the area of Metabolic Disorders.

4.

Ortho
-
McNeil
-
Janssen
Pharmaceuticals, Inc. (OMJPI)


September 2008

Development of drug candidates for various disease targets.

Advinus responsible for drug discovery and early clinical development (phase 2a)


Advinus Therapeutics 21 & 22, Phase
II, Peenya Industrial Area

Bangalore

560058

India

www.advinus.com

Incorporated:


2005

Employees:

430

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


Advinus has received the appro
val for
starting the Phase I clinical trials for its
novel molecule on type II diabetes and
expects to commence FIH trials by end of
March/ Early April 2010.

Advinus has completed and submitted data
for over 14 IND pharm tox packages, in the
last two years
, for regulatory filing at the
US FDA, TPP Canada, EMEA and other
global regulatory agencies.

Advinus has significantly expanded its drug
development and drug discovery facilities,
which are now spread over 80,000 sq. ft.
and 240,000 sq. ft., respectively.

First out licensing of an Advinus discovered
molecule in 2010/11.

Two new molecules are expected to be
confirmed as clinical candidates in early
2010 for COPD and Diabetes and expected
to enter pre
-
clinical development in 2010.

Expansion of our service of
ferings to
Discovery services.

4



Company Profiles

Ajinomoto Co., Inc.


D
ELEGATE
(
S
)


Ken Hirose


M
ISSION
/B
ACKGROUND

Since discovery of umami, the Ajinomoto Group have pursued the many merits of amino
acids and have grown into a unique group of companies, contributing to the fields
of food,
health, and pharmaceuticals using our cutting
-
edge amino acid technology. We aim to be a
“group of companies that contributes to human health globally” by continually creating
unique value to benefit customers.

Ajinomoto Pharmaceuticals Co., Ltd.
is marketing unique products specialized in GI and metabolic diseases based on clinical nutrition
such as infusions and medical foods started from application of amino acids. We are seeking opportunities for in
-
license in GI, liver,
metabolic diseases, inf
usion, nutrition and hemodialysis fields (metabolic disease includes diabetes, obesity, abnormality of lipid
metabolism and renal diseases). There is no criterion for developmental stages; however, early stage program is preferable fo
r program
in metabolic

disease field.


1
-
1 Irifune 2
-
chome
, Chuo
-
ku

Tokyo

104
-
0042

Japan

www.ajinomoto.com

Ownership:

Other

Company Profiles



5

Alexandria Real Estate Equities, Inc.


D
ELEGATE
(
S
)


Joel S. Marcus

Dean Shigenaga

Joseph Hakman

Jackie Clem

Jonathan Kabakoff

Kristina Carlson


M
ISSION
/B
ACKGROUND

Alexandria Real Estate Equities, Inc. (NYSE:ARE), Landlord of Choice to the Life Science Industry®, is the largest owner and
preeminent real estate investment trust (“REIT”) focused principally on cluster development through the owners
hip, operation,
management, selective redevelopment, development, and acquisition of properties containing life science laboratory space. Ale
xandria
has a stellar twelve
-
year operating and financial track record as a NYSE
-
listed company, ranking fifth out
of all publicly traded equity
REITs in total return performance, and had an approximate USD $5.8 billion total market capitalization as of December 31, 200
9.
Alexandria is the leading provider of high
-
quality, environmentally sustainable real estate, techn
ical infrastructure, and services to the
broad and diverse life science industry. Client tenants include institutional (universities and independent not
-
for
-
profit institutions),
pharmaceutical, biotechnology, medical device, product, service, and translat
ional entities, as well as government agencies.
Alexandria’s operating platform is based on the principle of “clustering,” with assets and operations located in key life sci
ence markets.

As Alexandria continues to expand our dominate position in each of o
ur strategic U.S. cluster markets, we are forging the international
extension of our proprietary operating platform by launching what we have mastered domestically into new global markets. Alex
andria’s
capacity to assemble and fuse the principal elements c
rucial to developing a successful science and technology driven cluster

location, talent, science/technology, and capital


has positively differentiated our brand and is being actively sought by scientific
cluster markets around the world.



385 E. Colorado Boulevard

Pasadena, CA 91101

USA

www.labspace.com

Ownership:

Public

New York S
tock Exchange
:
ARE


H
IGHLIGHTS



Recent


Alexandria Centre™ for Science and Innovation
J

fnd楡iis 汯lated 楮 䝥nome sal汥lI
phameerpet C汵sterI eyderabadK 周楳 楳 a one of 楴s k楮i oCa focused centre w楴h
unmatched amen楴楥i and a wor汤lc污ls fac楬ityK

6



Company Profiles

Anand And Anan
d


D
ELEGATE
(
S
)


Neeti Wilson, PhilD, Esq, MSc,BSc, Managing Associate

Archana Shanker , BSC,LLB, Senior Partner

Pravin Anand , BSC,LLB, Managing Partner


M
ISSION
/B
ACKGROUND

Anand and Anand is a full service Intellectual Property law firm that advises the world's
leading companies and institutions. This specialized practice has been servicing a diverse
portfolio of clients worldwide since the year
1923; a long tradition of over eight decades.

The firm has an outstanding reputation for innovation and developing creative solutions.
The firm works with the endeavor of providing its clients with the best quality of service
possible. The central goal und
erpinning this client care objective is that our lawyers provide
commercial advice to clients which is clear and based on a real understanding of issues in Intellectual Property management i
n India.


Anand and Anand's fully focused approach has earned it
the reputation of being the top Intellectual property law firm in the country.
The Firm has been consistently and unanimously rated as India's leading Intellectual property firm in all fields, including,
Trademarks
and Patents. Anand and Anand is conspicu
ous as the only Indian firm listed among the World's Best Intellectual Property Practices in
Global Counsel 3000 as well as The Asia Pacific Legal 500.

Practice areas broadly include Trademarks, Copyrights, Patent, Design, Litigation, IT, Entertainment, Sp
orts Law and Transactional
work.


B
-
41, Nizamuddin East

New Delhi

110013

India

www.anandandanand.com

Incorporated:


1923

Ownership:

Pri
vate

Company Profiles



7

AstraZeneca, Inc.


D
ELEGATE
(
S
)


Jitendra Patel, PhD

Lena Martensson

Magnus Bjorsne


M
ISSION
/B
ACKGROUND

AstraZeneca is a major international research based pharmaceutical company engaged in the development, manuf
acture and
marketing of ethical (prescription) pharmaceutical products. Our long heritage of innovation and documented ability to develo
p new
concepts in medicine has made us one of the world's leading pharmaceutical companies. As one of the world's leadin
g pharmaceutical
companies, our business is focused on turning good ideas into innovative, effective medicines that make a real difference in
important
areas of healthcare.

T
ECHNOLOGY

Atacand®, Betaloc®, Emla®, Entocort® Capsules. Plendil® and Seroquel®, C
restor®, Zestril®, Onglyza®, Merrem/Meronem®,
Nexium®, Prilosec®, ®, Diprivan®, Carbocaine®, Emla®, Naropin®, Marcaine®, Zomig®, Arimidex®, Casodex®, Faslodex®,
Nolvadex®, Iressa®, Pulmonicort®, Rhinocort®, Symbicort®,

Astra Tech is engaged in the resear
ch, development, manufacture and marketing of medical devices and implants for use in healthcare,
primarily in urology but also in odontology, diagnostic radiology and surgery.

Aptium Oncology is a leading provider of outpatient oncology management and co
nsulting services in the US. Aptium manages full
-
service outpatient comprehensive cancer centres in affiliation with major teaching and community hospitals in California, Flo
rida and
New York

A
LLIANCES

At AstraZeneca, we are dedicated to broadening our acc
ess to the world of scientific innovation outside our own laboratories. This is a
long
-
term commitment and a core priority.

In addition to traditional in
-
licensing opportunities, our activities include acquisitions, risk sharing deals, spin
-
outs, equity st
akes,
divestments and out
-
licensing deals.

No two deals are the same. We work in collaboration to structure customised partnerships that allow both parties to leverage
their
unique capabilities and assets to achieve common goals.

Our Strategic Partnering
& Business Development team supports the delivery of this key strategic priority through a globally integrated
organisation.



15 Stanhope Gate

United Kingdom

www.astrazeneca.com/partnering

Incorporated:


1999

Employees:

65
,
000

Ownership:

Public

New York Stock Exc
hange
:
AZN


H
IGHLIGHTS



Recent


AstraZeneca To Acquire Infection Research Company Novexel And Expand Collaboration
With Forest Laboratories

AstraZeneca and Targacept Form Global Collaboration and Licence Agreement for Late
-
Stage Investigational Produc
t TC
-
5214 for the Treatment of Major Depressive Disorder

AstraZeneca Extends Branded Generics Capability With Torrent Agreement

8



Company Profiles

Atharva Lifesciences Consulting Pvt. Ltd.


D
ELEGATE
(
S
)


Kavanir Mundrey, Business Development


M
ISSION
/B
ACKGROUND

Atharva Lifesciences Consulting Pvt. Ltd. (ALCPL) is a lifesciences consulting firm. ALCPL
helps study the market for national and international clients deliveri
ng reports on subjects
of Pharmaceuticals, Biotechnology, Marine


Biotechnology, Agri


Biotechnology and
Alternative Medicine.

Atharva Lifesciences Consulting Pvt. Ltd. has delivered reports on a number of complex
questions of Lifesciences enabling its c
ustomers to make informed and intelligent decisions
on the market. The consulting work of ALCPL saves its clients time, effort and resultant expense. The research is also more a
ccurate
and precise. In repeated studies work done at ALCPL has saved the clien
t to the extent of 60% in time and expense.

While India continues to be the core focus of Atharva Lifesciences Consulting, the firm has also delivered projects related t
o other
geographies. In Brazil, we mapped out the pharmaceutical and biotech industry


the first ever such exercise in English.

In its team, Atharva Lifesciences has experienced analysts who interact with its numerous consultants, and key opinion leader
s in the
industry to provide timely and up to date information.


11, Nandidurg Road Jayamahal
Ext
ension

Karnataka

560046

India

www.atharvalife.com

Ownership:

Private

Company Profiles



9

Aurigene Discovery Tech
nologies, Ltd.


D
ELEGATE
(
S
)


Veena MM

CSN Murthy, CEO

Saurabh Kapure, Head Business Development

Sudeep Kumar Banerjee


M
ISSION
/
B
ACKGROUND

Established in 2001 in Bangalore, India, Aurigene is a drug discovery biotech with a proven
track record of successful partnerships with 9 collaborators world
-
wide. Aurigene has a
portfolio of 20 discovery programs, at various stages from Hit Ge
neration to late
-
stage Pre
-
Clinical Optimization.

Aurigene's business priorities are focussed around following lines
:

1.

Collaborative Drug Discovery: Aurigene undertakes drug discovery project for its
partners right from target identification stage all the
way to IND submission.

2.

In
-
Licensing: Aurigene is looking at projects of interest from academics, small biotech and progressing them through drug
discovery.

3.

Out
-
Licensing: Aurigene has interesting discovery stage project opportunities that are available for

out partnering.

4.

Services: Aurigene also provides services in niche areas including structural biology, peptides, GLP toxicology, formulation
development and medicinal chemistry.

A
LLIANCES

Aurigene has been working with 6 out of the top 10 pharma companies
. Some of Aurigene's publicly known partners include; Orion,
Debio, Endo.

39
-
40 KIADB Industrial Area

Bangalore

560 100

India

www.aurigene.com

Incorporated:


2001

Employees:

500

Ownership:

Private

10



Company Profiles

Avogadro


D
ELEGATE
(
S
)


Stephane Bronner, Director Biochemistry


M
ISSION
/B
ACKGROUND

Avogadro
is an independent CRO with 125 scientists, and locations in Cambridge,
Massachusetts, USA and Toulouse, France; with full GLP/GMP compliance, specializing in
Pharmaceutical Analysis (method development and validation, s
tability studies), CMC&RA,
Quality Control, Bioanalysis (LC/MS/MS assays), ADME (including metabolite profiling and
identification), Pharmacokinetics (Bioavailability, Bioequivalence), Residues, Target Animal
Safety and Environmental Impact Assessment and
Biochemistry (lipoprotein profiles,
Protein analysis). PHARMACEUTICAL ANALYSIS: Development, validation and transfer of
analytical methods; Stability testing of active substances, medicinal products & clinical batches (ICH/VICH). CMC & RA: Cons
titution of

Quality Files and Variation Dossiers; Quality file is built on the basis of data; Technical and regulatory assistance for the

development of
New Medicinal Products and Generics; Assessment of Existing Dossiers & Drug Master Files (DMF); Update of existing

dossiers;
Constitution of answers to agencies questions. QUALITY CONTROL: Physico
-
chemical characterization on various products; Limit
tests (residual solvents, heavy metals); Sourcing of active ingredients; Analytical batch release (clinical batches & m
arketed products).
BIOANALYTICAL CHEMISTRY & DRUG METABOLISM: Development & validation of analytical methods; Pharmacokinetic studies,
bioavailability, bioequivalence; Early PK studies; Metabolism studies (ADME); Residue depletion studies; Ecotoxicological

studies. IN
-
LIFE PHASE STUDIES: Laboratory species; Food
-
producing species; Local & general tolerance studies in target species.
BIOCHEMISTRY: Lipoprotein profiles; Protein analysis. QUALITY: Full GLP compliance; Full GMP compliance (QC analysis, stabi
lity
studies); ISO 14001 certification (Environment Management System).

T
ECHNOLOGY

ANALYTICAL TECHNIQUES USING: UPLC system, HPLC system coupled with UV detector, DAD, fluorimeter; LC/MS/MS; GC/FID;
GC/MS (EI, CI); GC/HeadSpace; Stability chambers under I
CH conditions + photostability; ADME: radiolabeled studies; Equipment for
automated solid
-
phase extraction system; Automated biochemistry analyzer.


Parc de Génibrat

31470 Fontenilles

France

http://avogadro
-
lab.com

Incorporated:


1998

Employees:

130

Ownership:

Priv
ate

Company Profiles



11

Biocon, Ltd.


D
ELEGATE
(
S
)


Kiran Mazumdar
-
Shaw

Arun Chandavarkar, PhD

Sandeep Rao

Shukrit Chimote

Gopalkri
shna Pai

Sujoy Ghosh


M
ISSION
/B
ACKGROUND

Established in 1978, Biocon Limited is one of India's largest biotechnology companies. The
Group, promoted by Ms
. Kiran Mazumdar
-
Shaw, is a fully
-
integrated, innovation
-
driven
healthcare enterprise with strategic focus on biopharmaceuticals and research services.
Biocon's value chain traverses the entire length of discovery, development and
commercialization of nove
l therapeutics. With successful initiatives in clinical development,
bio
-
processing and global marketing, Biocon delivers products and solutions to partners
and customers in approximately 75 countries across the globe. Many of these products have USFDA and

EMEA acceptance. Biocon's
robust product offering includes the world's first recombinant human insulin, INSUGEN and India's first indigenously produced

monoclonal antibody BIOMAb
-
EGFR

. For more information, visit www.biocon.com


20th KM Hosur Road

Bangalore

560 100

India

www.biocon.com

Incorporated:


1978

Ownership:

Private

12



Company Profiles

Biomedical Consulting India Pvt. Ltd.


D
ELEGATE
(
S
)


Manoj Trivedi


M
ISSION
/B
ACKGROUND

Biomedical Consulting International (BCI) is a global regulatory center of excellence with
office locations around the world. By employing the varied and in
-
depth expertise of our
consultants, we are able to provide a
one
-
stop shop for all regulatory and dossier
submission needs in the development of biotech, pharmaceutical, and medical device
products. Our 50+ consultants are experts in their various fields, which include global
regulatory strategy, product developmen
t, pharmacology and toxicology, chemistry,
manufacturing and controls (CMC), clinical trial design, patient safety, and medical and
regulatory writing. We also have extensive experience in a broad range of therapeutic
areas and provide expert assistance i
n due diligence and in
-

and out
-
licensing of drugs. We are able to develop strategies and create
results from the pre
-
clinical stage through post
-
approval services, and this comprehensive support translates directly into getting
products to the market with

greater speed and ease.

We assist companies with bringing new drugs, generic drugs, and Biosimilars to market.


1503, Dheeraj Valley Towers, Sai
Baba Complex, Goregaon(East),
Mumbai
-
4

Mumbai

400 098

India

www.biomedconsult.com

Incorporated:


1999

Owners
hip:

Private

Company Profiles



13

BioXcel Corporation


D
ELEGATE
(
S
)


Samayita Choudhuri

Aman Kant


M
ISSION
/B
ACKGROUND

BioXcel Corporation, a premier analytics and knowledge management company with
headquarters in Connecticut, USA. BioXcel has more than 60 global clients ranging from
pre
-
IPO biotech’s to large bi
o
-
pharmaceutical, CROs, diagnostic and medical device
companies. Corporate expertise spans the Drug Development Lifecycle: from drug
discovery/development to product launch to post
-
marketing LOE strategy. BioXcel
understands the dynamics of this continuum

allowing us to customize each engagement to
align with your specific business needs.

BioXcel has a unique and cost
-
effective global hybrid delivery model which capitalizes on an experienced management team of US
-
based executives, (collectively over 150 ye
ars of experience with bio
-
pharmaceutical companies) and the BioXcel Analytical and
Commercial Center (BACC) based in India. The BACC offers a broad range of highly
-
skilled professionals (PhD, MD, MBA, Patent
Agents) with analytics expertise in scientific
, clinical/medical, intellectual property and business disciplines.

Business Analytics:

Corporate, R&D and therapeutic area (TA) strategy and planning;



Global disease area landscape, including major areas in CNS (Neurodegenerative and Neuropsychiatry), On
cology, CV/Met,
Inflammation, Antivirals and Anti
-
infectives,etc.;



Integrated analytics landscaping for licensing opportunity prioritization


across the value chain (seven analytics areas,
including MOA and failed
-
molecule analysis);



Competitive intellige
nce (secondary and primary);



Emerging market evaluation (competitive intelligence, epidemiology, regulatory/distribution/manufacturing, socio
-
political
concerns).

IP Analytics:



Freedom to operate and prior art searches;



Patent landscape and validation/in
-
validation;



Technology watch, etc.


780 East Main Street

Branford
,
CT

06405

USA

www.bioxcel.com

Incorporated:


2
005

Employees:

50

Ownership:

Private

14



Company Profiles

Cellworks Research India Pvt. Ltd.


D
ELEGATE
(
S
)


Anand Anandkumar, Managing Director

Taher Abbasi


M
ISSION
/B
ACKGROUND

Cellworks Group Inc. is designing novel therapies for Cancer and Auto
-
immune diseases. Cellworks does this via a breakthrough
proteomics b
ased “Therapy design” platform, which addresses one of the biggest issues in drug discovery, predicting human related
efficacy and toxicity of molecularly targeted (MT) therapeutics before expensive clinical trials. The approach is driven by v
irtual
protot
yping of cellular physiology enabling emulation of cell line(s)and animal/human experiments in a high throughput system. The
ability to perform complex experiments, and assay thousands of markers insilico, enables accurate and thorough analysis in an

order
s
of magnitude more cost effective and time efficient manner than today’s “wet” approaches.

Cellworks Advantage: CWG’s robust “Therapy design” platform is a being used to develop a rational and systematic approach for

designing novel therapies. While the
system can be used to identify novel targets and understand their holistic impact on disease
systems, Cellworks is initially focused on identifying synergistic combinations of off, on
-
patent approved

drugs for the treatment of
serious diseases. Unlike toda
y’s MT therapies which are focused on single pathways, synergistic

combinations hold the promise of
modulating multiple pathways which amplify the therapeutic effect while minimizing sideeffects.

“Virtual prototyping” of drug
-
disease
-
dosage interaction and

measuring hundreds of efficacy and toxicity markers in the integrated
disease systems, enables the identification of optimal combinations and dosage regimens. The selection of preapproved drugs w
ith well
understood pharmacology, further increases the succ
ess rate of the therapies identified.

Business Strategy: Out
-
licensing of Combination therapies for Lung/Colo
-
rectal cancer and Rheumatoid Arthritis.

Partnering with Pharma, Biotech companies to design, analyze, derisk new and ongoing therapeutic programs.

T
ECHNOLOGY

The underlying proprietary technology enabling this design process is based on a predictive technology which is a virtual fun
ctional
proteomics system. Cellworks curates the world’s proteomics information, and has created the world’s largest a
nd most comprehensive
set of dynamic, functional and dynamic models

The technology encompasses integration of multiple cell systems representing a co
-
culture environment. It includes the most
comprehensive aggregation of pathways interaction with cross
-
tal
ks and autocrine/paracrine loops in context of disease associated
phenotypes. Such a framework responds in a similar fashion to perturbations, the way the natural system in question would.
Applications include Target Identification/validation and Patient s
ubgroup includion/exclusion criteria.

A
LLIANCES

Multiple peer reviewed publications on Cancer, Inflammation, Parkinson’s Disease, Pigmentation, E. Coli.

Collaborations with AZ, Cancer UK, ISP Corp, Ranbaxy, UC Davis, UCSD, UCLA, Garvan, NUS, Harvard, NIMHA
NS.

Partnered with AZ as part of EU sponsored anti
-
TB consortium (FP7).

Owing to customer sensitivity, we cannot share the other partner list in this forum.


P
RODUCTS




Name

Phase

Indication

Milestone

CWG_Onco1

Preclinical

Lung Cancer

Currently going th
rough Invitro validation

CWG_Onco2

Preclinical

Colo Rectal

Currently going through invitro validation

CWG_inflm1

Preclinical

RA

Invitro


3rd Floor, West Wing, Neil Rao
Tower, 118 Road 3, EPIP, Whitefield

Bangalore

560066

India

Incorporated:


2006

Employee
s:

90

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


Cellworks has more than 20 active
collaborations with academic and
commercial partners. Cellworks has
prospective validations of in
-
silico
predictions of combination therapies, drug
targets and bi
omarkers in Oncology, RA,
Pigmentation and diabetes.

Selected as a partner with AZ on an EU
FP07 project on TB

Cellworks technolgy is being used to study
target vulnerability

Won a DBT grant to prototype a new strain
of e
-
coli that create chiral synthons i
n
-
situ
with very high yields.

Multiyear agreement with a leading
Pharma company in California. Cellworks
technology will be used to study target
validation and patient subgroup
classification studies. Tremendous savings
in cost and timelines are anticipate
d.

Collaboration on Oncology Preclinical
project with top tier Pharma company.
Cellworks to provide the Virtual Biology
based assay capabilities which will shorten
time for target validation and patient
stratification studies. Will be announced in
2010.

An
ticipating the closure on a multiyear grant
in the area of Drug resistance TB.
Cellworks is the principal driver of this grant
along with a world class top tier Pharma
partner. Results to be announced 4Q10.

Anticipating the announcement to of a
Collaborati
on program in Type II diabetes,
with a top tier Pharma major, to be
announced before end of 2011.

Company Profiles



15

Connexios Life Sciences Pvt. Ltd.


D
ELEGATE
(
S
)


M.K. Govind

Suri Venkatachalam


M
ISSION
/B
ACKGROUND

Connexios is a privately held biopharmaceutical company focused on the drug discovery
and development of novel therapeutics addressing Type
2 Diabetes and the larger
Metabolic Disease area.

Connexios is a venture
-
backed company established in 2004. We have over 150
employees and represent a large concentration of scientific talent in India. The company is
supported by Nadathur Holdings and
Investments.


T
ECHNOLOGY

Connexios has developed a proprietary Translational Network Biology (TNB) that allows ‘engagement’ with the clinical complexi
ty of
disease and drug action across various stages of drug discovery and development. The platform is cre
ated through a convergence of
technologies integrating genomics, proteomics, computation and experimental biology.

Highlights of the Platform include:



Systems Biology approach, computationally enabled Network model of Metabolism;



R&D assets & tools in
cluding key targets and mechanisms impacting metabolic diseases, predictive toxicity assays and
biomarkers for clinical development;



Translational approach to enable integration of the clinical complexity of disease and drug action into the various stages

of
drug discovery and development.


49, Shilpa Vidya, 1st Main Road

Ban
galore

560078

India

www.connexios.com

Incorporated:


2004

Employees:

150

Ownership:

Private

16



Company Profiles

Curevac Gmbh


D
ELEGATE
(
S
)


Ingmar Hoerr


M
ISSION
/B
ACKGROUND

Cur
eVac is a biopharmaceutical company pioneering the direct therapeutic application of messenger RNA (mRNA), the biomolecule
that physically transfers genetic information from the nucleus to the cellular protein production machinery. CureVac´s propri
etary
te
chnologies transform mRNA in potent drug candidates. Located in Tuebingen (Germany), CureVac set up a proprietary cGMP
production facility for all mRNA based compounds.

T
ECHNOLOGY

RNActive®
-
derived molecules are based on messenger RNA (mRNA), a nucleic aci
d molecule that is found in all forms of life and is
related to DNA, the molecule genes are made of. CureVac applies its proprietary RNActive® technology platform to deliver modi
fied
mRNA
-
molecules with enhanced translatory potency and to formulate modifie
d mRNA
-
molecules. As a result, RNActive®
-
derived
molecules can be used e.g to express antigens, and coincidentally to stimulate an immune response.

RNAdjuvant® is our technology for the use of RNA as a potent immune stimulant to improve the efficacy of pro
phylactic and therapeutic
vaccines.

PUREmessenger® is a technology for the cGMP
-
production of full
-
length mRNA up to gram scale within a short timeframe.


P
RODUCTS




Name

Phase

Indication

Milestone

CV9103
-

RNActive®
-
derived
prostate cancer vaccine

Phas
e II,
IIa, IIb

Prostate
Cancer

Results from the Phase I show CV9103 to be safe and well
tolerated. Results from Phase IIa are expected in
2H
10

CV9201
-

RNActive®
-
derived
NSCLC vaccine

Phase II,
IIa, IIb

NSCLC

First in man clinical data are
expected to be
obtained in 2H
11

RNActive®
-
derived prophylactic
vaccines

Other

Viral
Infection




Paul
-
Ehrlich
-
Str. 15

72076

Tuebingen


Germany

www.curevac.com

Incorporated:


2000

Employees:

70

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


In November 2009, German au
thorities
approved the start of the multi
-
centric
Phase IIa trial in Germany and Italy. All
patients are included. Results from the
Phase I show CV9103 to be safe and well
tolerated.

A multicentre phase IIa clinical study with
CV9201 has started in June 20
10 and will
be conducted in Switzerland and Germany.

In May 2010 CureVa
c received €27.6
浩汬楯i 楮iits th楲i f楮inc楮i round by d楥i楮椠
eopp B楯呥ch ho汤楮g dmbe C CoK h䜮

䙩牳t 楮i浡m data for CsVNMP from mhase
ffa are expected by Q儱MK

䙩牳t 楮i浡m data for CsVOMN from mhase
ffa are expected 楮iOeNNK

Company Profiles



17

Cydex Pharmaceuticals, Inc.


D
ELEGATE
(
S
)


Theron Odlaug, Chief Executive Officer


M
ISSION
/B
ACKGROUND

CyDex Pharmac
euticals, Inc. is a specialty pharmaceutical company developing products and licensing its Captisol® technology.
Captisol is currently incorporated in five FDA approved medications and marketed by four of the company’s licensees: Pfizer,
Bristol
-
Myers Squi
bb and Prism Pharmaceuticals. In addition, the company is supporting drug development efforts with more than 40 other
companies worldwide. The company maintains patents in the U.S. and worldwide for its Captisol technology and Captisol enabled

products. Af
ter 17 years of experience, CyDex has also built a comprehensive FDA Manufacturing and Safety Drug Master File. For
additional information on business development opportunities, please contact Richard White at rwhite@cydexpharma.com or 913
-
685
-
8850. CyDex

is a privately held company located in suburban Kansas City. To learn more about the company, please visit
www.cydexpharma.com.

T
ECHNOLOGY

The advanced drug formulation technology of CyDex, Captisol®, is based on a modified cyclodextrin molecule that enab
les creation of
new products by significantly improving the solubility, stability, bioavailablity, safety and dosing of active pharmaceutical

ingredients
(APIs).

Captisol® is one of a series of anionically charged sulfobutyl ether ß
-
cyclodextrins (SBE
-
CDs)

that were originally synthesized and
patented by scientists from the University of Kansas Higuchi Biosciences Center for Drug Delivery Research.

Two Captisol
-
enabled® drugs, Vfend I.V. and Zeldox/Geodon for Injection, have been brought to market in the US

and EU by Pfizer
Inc., a CyDex corporate partner. Pfizer also recently received approval for Vfend I.V. in Japan.


P
RODUCTS



Name

Phase

Indication

Melphalan CDX
-
353

Phase II, IIa, IIb

Oncology

Clopidogrel PM
-
103

Phase II, IIa, IIb

Cardiovascular

Topi
ramate

Phase II, IIa, IIb

Neurology

Budesonide/ Azelastine CDX
-
313

Phase II, IIa, IIb

Pulmonary
-

Allergy

Fosphenytoin

Phase III

Neurology



10513 West 84th Terrace

Lenexa
,
KS

66214

USA

www.cydexpharma.com

Incorporated:


1993

Empl
oyees:

18

Ownership:

Private


H
IGHLIGHTS



Recent


CyDex Pharmaceuticals announced the initiation of patient dosing in the company’s Phase
OA c汩nica氠tr楡氠of its Captisol
J
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J
PRPFK je汰la污l 楳 an 䙄A
J
approved chemotherapy for

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Cyaex recente汹 rece楶ed a hey rKpK matent for Co浰msit楯i of jatter and mrocess of
janufactur楮i e楧i
J
murity Captiso沮 prov楤楮g broader protect楯i to c汩ents us楮i Captiso氮

18



Company Profiles

Dabur Research Foundation


D
ELEGATE
(
S
)


Manu Jaggi, Director
-

R&D

Anula Taneja Singh


M
ISSION
/B
ACKGROUND

Dabur Research Foundation (DRF) is a Contract Research Organization based in India, which provides Integrated Research Soluti
ons
in Pre
-
clinical Biology to national and
international pharmaceutical, chemical and biotechnology companies. We provide comprehensive
range of services for pharmacological, biological and analytical testing of drugs and chemicals
in vitro

and in vivo. We have more than
20 years of experience in c
onducting GLP / non
-
GLP preclinical studies in oncology. Additionally we work in other therapeutic areas like
Inflammation, Immunomodulation, Dermatology, Hair Biology & Diabetes.

A
LLIANCES

We have marquee clients in India and Asia
-
Pacific including China,

Hong Kong and Thailand. In Europe we have worked with
companies based in Germany, United Kingdom and Finland. We also have clients in the large biotech hubs in the United States.
While
some of our clients are small startups, others are mid
-
size companies
to large multinationals. We have conducted preclinical studies for
companies in diverse segments of healthcare including Pharma, Generics, Biotechnology, Ayurveda, Natural Products and
Nutraceuticals. We also work with autonomous Government Organizations a
nd Universities. A majority of our clients have oncology
pipelines with molecules as early as in the discovery phase to proof of concept stage in advanced preclinical development.


22, Site IV, Sahibabad

G
haziabad Uttar Pradesh

201 010

India

www.daburresearch.in

Incorporated:


1979

Employees:

60

Ownership:

Private


H
IGHLIGHTS



Recent

Orion Pharma partners with DRF to develop an anti
-
alopecic drug.

Elephant Capital buys stake in ClinTec Intl for Rs 58 cr.

Burmans plan Rs 925
-
crore healthcare fund, Business Standard.


Company Profiles



19

DesignMedix, Inc.


D
ELEGATE
(
S
)


Lynnor Stevenson, PhD, CEO


M
ISSION
/B
ACKGROUND

DesignMedix, Inc. develops drugs to combat drug resistance in multiple diseases. Our initial focus is on malaria, which kills

over a
million children per year and affects up to 500 million people. Our platform approach is also used to d
evelop antibacterials that
overcome drug resistance while retaining broad spectrum activity.

T
ECHNOLOGY

DesignMedix’s novel anti
-
malarial drugs have the potential to be low
-
cost as well as safe for the key patient groups of children and
pregnant women. The

first series of oral candidate drugs are in preclinical studies, and have been shown to kill chloroquine
-
resistant
malaria in human cells and in animal models. Large doses are non
-
toxic in mice.

A
LLIANCES

Collaborations with Portland State University; Ore
gon Health & Science University/Veterans Hospital; Oregon Nano and Micro
-
technology Institute; NIH


P
RODUCTS




Name

Phase

Indication

Milestone

RCQ

Preclinical

malaria

IND

Quinolone antibacterials

Research

Various

Candidate selection

Acridone anti
-
mala
rials

Research

Liver
-
stage malaria

Candidate selection



2828 SW Corbet
t Avenue

Portland
,
OR

97201

USA

www.designmedix.com

Incorporated:


2008

Employees:

6

Ownership:

Private


H
IGHLIGHTS



Recent

Completion of initial PK studies of RCQ drugs in rats.

Pending award of NIH grant for preclinical studies of antimalarials.


20



Company Profiles

Development Centre For Biotechnology


D
ELEGATE
(
S
)


Ying
-
Jye Wu, Director of Division of Technology Transfer


M
ISSION
/B
ACKGROUND

The Development Center for Biotechnology (DCB) of Taiwan is a nonprofit organization founded in 1984. DCB's purpose is to adv
ance
Taiwan's biotech
-
pharma industry

by building infrastructure, developing key technologies, and training talented workforces in
coordination with government, industry, and academic institutions.

DCB positions itself as a "Preclinical Value
-
Adding R&D Center for Biopharmaceuticals". This r
ole is to be fulfilled by devoting
concerted R&D efforts on protein, small molecule and botanical drug leads in the preclinical stage of development and setting

top
priorities for attaining Investigational New Drug (IND) approvals.

DCB is dedicated to rea
lizing the vision of becoming an "Internationally Outstanding Preclinical Research and Service Institute for
Biopharmaceutical Development". This goal is to be achieved by building world
-
caliber infrastructures, establishing key technologies for
preclinica
l development, and fostering the growth of highly
-
trained technology and business teams. In the long run, these efforts should
help bring about success stories of new drug development in Taiwan, and catalyze vigorous growth and prosperity for Taiwan's
biot
ech
-
pharma industry.

DCB also facilitates technology cooperation and product commercialization processes by employing suitable business models cov
ering:
patent licensing, technology transfer, strategic alliance, research collaboration, contract service, an
d spin
-
out venture. DCB's objective
is to help create win
-
win opportunities for partnership stakeholders with optimized coordination and integration of resources in Taiwan,
and eventually, to facilitate business expansion into the global biotech
-
pharma mar
ket.

T
ECHNOLOGY

Biopharmaceutical; biololgics; small molecules; botanicals; preclinical toxicology; cGMP biopharmaceutical/protein clinical p
roduction;
vaccine adjuvant; drug formulation

A
LLIANCES

In 2007, the CGMP Biopharmaceutical Pilot Plant Facility of

DCB signed a priority
-
cooperation agreement with Boehringer Ingelheim
GmbH (Germany) and joined its Production Alliance Network.

DCB formed a technology cooperation with Crucell, N.V. (Holland) in 2007 for technology transfer of monoclonal antibody produ
cing
cell lines and further cooperation.

Merck KGaA (Germany) established its first Asian Technology and Training Center (ATTC) on the campus of DCB headquarters in
2008. In addition to providing technical services, application supports and user
-
trainin
g platforms for Merck’s customers in the region,
the center also serves as a business link for DCB’s CGMP Biopharmaceutical Pilot Plant Facility in its international business

networks.


P
RODUCTS




Name

Phase

Indication

Milestone

DCB
-
SLE1

Phase II,
IIa,
IIb

Systemic Lupus
Erythematosus

Phase II clinical trials undergoing in Taiwan at TVGH
and TSGH

DCB
-
CA2

Preclinical

Cancer Cachexia

Patch production and efficacy validation completed

INFa
-
Fc Fusion Protein

Preclinical

Hepatitis C

Received from US
-
FDA Pre
-
IND consultation
comments for pre
-
clinical and phase I study designs

Anti
-
herpes simplex virus
(HSV) antibodies

Optimized
Lead

Prophylax and treatment of
Herpes Simplex Virus (HSV)
infection

The preliminary animal studies show that these
mAbs have prophy
lactic and therapeutic effect for
HSV infection. Patents have been filed.

Contract Manufacturing
Service (CGMP
Biopharmaceutical Pilot Plant
Facility)

Other

N/A

CGMP certificate for compliance with ICH and WHO
guidelines in 2005; A drug master file (DMF t
ype V,
No.19164) was registered with the US FDA in 2006.

101, Lane 169, Kangning Street

Taipei

221


Taiwan

www.dcb.org.tw

Incorporated:


1984

Emp
loyees:

450

Ownership:

Other


H
IGHLIGHTS



Recent

Upcoming


March, 2010
-

DCB gave a presentation at
the Biological Manufacturing World Asia
2010 conference. Dr. Wei
-
Kuang Chi, VP
of DCB, was one of the panelists
introducing Asia as a new emerging pla
yer
for contract manufacturing business.

October, 2008
-

Merck KGaA opens Asian
Technology and Training Center in the
DCB campus. In April 2008, DCB’s
modif楥i enterotox楮iEi周qhF for nasa氠
spray 楮i汵lnza vacc楮is rece楶ed fka
approva氠楮i呡楷anK

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〷M
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ketwork of Boehr楮ier fnge汨li洮

Partnership for DCB’s LThaK adjuvant
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Company Profiles



21

P
RODUCTS




Contract Research Service
(Center of Toxicology and
Preclinical Sciences)

Other

N/A

Technical and support procedures are in full
compliance with Taiwan DOH, OECD and US FDA
GLP guidelines.

FLB5, an
ti
-
IL
-
20 mAb
(Humanized)

Preclinical

,Rheumatoid Arthritis, IL
-
20
-
induced inflammatory
diseases

Preclinical studies will be finished in 2011. Filing of
IND will begin in 2012. Several patents have been
granted.

LTh(aK) adjuvant

IND Filed

nasal influenza v
accine,
bacterial capsular
polysaccharide vaccine and
allergy vaccine.

The clinical phase I study protocol for this project
[the mixture of LTh(aK) adjuvant with seasonal flu
antigens (trivalent split flu)] was approved by the IRB
of National Taiwan Univer
sity Hospital in Oct. 2008.

Long
-
acting Amikacin
Inhalation

Research

Nosocomial preumonia

PLGA loaded with Amikacin are intended to provide
prolonged and increased concentration of the drug in
the lung to improve delivery of incorporated drug to
the lung.

Looking for a partner to co
-
develop this
technology.

Ropivacaine In
-
Situ Gel for
Injection

Research

Pain control, Post
-
surgical
pain control

The entrapped Ropivacaine will be continuously
releasing from the gelling matrix for up to 72 hours.
Looking for
a partner to co
-
develop this technology.



22



Company Profiles

Eli Lilly & Company


D
ELEGATE
(
S
)


Jude E. Onyia

Uma Kuchibhotla

Hardik Valera

Mukta Arora

Rajiv Gulati


M
ISSION
/B
ACKGROUND

We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical
company in the world. We have steadfastly remained independent, but not isolated. Across
the globe, Lill
y has developed productive alliances and partnerships that advance our
capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one
of the best companies in the world to work for, and generations of Lilly employees have
sust
ained a culture that values excellence, integrity, and respect for people.

Discovering and developing innovative therapies for many of the world's unmet medical
needs is at the core of Lilly Research Lab's (LRL) mission.

Approximately 7,000 people work in

LRL in the U.S. and other countries around the world. Research and development locations in the
United States include several sites in Indiana and California.

The most recent listing of sites has been revised to United States, Canada, China, England, Jap
an, Singapore, Spain, and a joint
venture facility in Australia. In addition, LRL conducts clinical research in more than 50 countries around the world.

A
LLIANCES

At Lilly, we value partnerships. Our history has proven

and our strategy continues to prove

t
hat by working together, we can
discover, develop, and deliver the innovative pharmaceutical therapies that will help people live longer, healthier, and more

active lives.

We seek the best ideas, capabilities, and research available, whatever the source.
Having excellent in
-
house talent and resources is
one of the pillars of our R&D success, but at the same time, we're excited about the opportunities that exist to collaborate.

Great work is
being done in all corners of the world and in multiple settings. O
ur goal is to find it, advance it, and put it to work for the patients who
need it.


P
RODUCTS



Name

Phase

Indication

Semagacestat

Phase III

Alzheimer's

Solanezumab

Phase III

Alzheimer's

GLP
-
1 Fc

Phase III

Diabetes

IMC
-
11F8

Phase III

NSCLC

IMC
-
1121B

Phase III

Breast Cancer and Gastric Cancer

Tasisulam

Phase III

Melanoma

IL
-
17 antibody

Phase II, IIa, IIb

Rheumatoid Arthritis

IL
-
23 antibody

Phase II, IIa, IIb

Psoriasis

iGluR5 antagonist

Phase II, IIa, IIb

Pain

IL
-
1beta antibody

Phase II, IIa, IIb

D
iabetes



Lilly Corporate Center

Indianapolis
,
IN

46285
-
0001

USA

www.lilly.com

Incorporated:


1876

Employees:

40360

O
wnership:

Public

New York Stock Exchange
:
LLY

Company Profiles



23

ERA Consulting Group


D
ELEGATE
(
S
)


Dianne Enid Jackson
-
Matthews, Deputy Principal Consultant

Tristan William Elliott, Business Development & Operations (Asia Pacific)


M
ISSION
/B
ACKGROUND

The ERA Consulting Group is one of the longest established and most experienced consulting groups serving the biopharmaceutic
al
industry.

Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development

strategy
and regulatory requirements. Biopharmaceutical products and biomarkers are our particular speciality. ERA has the knowle
dge and
experience to assist at all stages of product development, from conception to registration, and beyond.

Our expertise covers a wide range of products (over 400 products to date), including products of recombinant DNA and hybridom
a
technology, synth
etic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products
comprising gene therapy, somatic cell therapy and tissue
-
engineered products. ERA also consults on innovative new chemical entities,
particular
ly those indicated for neurological, oncological and immunological diseases. Last, but not least, the ERA team includes
specialists for companion diagnostics and biomarkers, offering dedicated services in this cutting edge field.

Our specialised internatio
nal team of 30 professionals includes scientists with a research and development background, those with
extensive industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can

benefit.

ERA has sophist
icated and well
-
equipped office facilities, currently in four locations (Germany, UK, USA and Australia), with the in
-
house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.

T
ECHNOLOGY

Regulato
ry affairs and product/process development consulting services for biopharmaceutical products and biomarkers.


London Gas Museum, Twelvetrees
Crescent

United Kingdom

www.eraconsulting.com

Incorporated:


1987

Employees:

30

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


Dr. Chris Holloway presented at Quotient
Bioresearch (UK) on "Immunogenicity for
Biopharmaceuticals
-

Case studies in
regulatory failures related to
immunogenicity."

D
r. David Kirke presented at the World
Vaccine Congress (USA) on "The
feasability of a global regulatory strategy
for vaccines."

Dr. Dianne Jackson
-
Matthews presented at
the ARCS 2010 Congress (Australia) on
"Dilligence in Early
-
phase Biotech
Development: P
reclinical, Regulatory and
Clinical strategies."

Dr. Dianne Jackson
-
Matthews will present
at BIO Korea 2010 (Korea) on "The
regulation of Advanced Therapies in
Europe."

Dr. Douglas Francis will present at TRX10
(Australia) on "Translating Preclinical
Findi
ngs into First
-
in
-
man Studies."

Dr. Chris Holloway will present at the RAPS
Annual Meeting (USA).

24



Company Profiles

Ernst & Young, LLP


D
ELEGATE
(
S
)


Hitesh Sharma, Partner and Leader, Life Science Practice

Gautam Jaggi

Glen Giovannetti


M
ISSION
/B
ACKGROUND

Ernst & Young has been a leader in serving biotechnology companies since the industry
began 30 years ago. Our relationships with several of bi
otechnology’s earliest pioneers
began when these companies were start
-
ups. Ernst & Young’s global network of skilled
professionals continues to assist scores of other biotechnology clients with their critical
challenges at every stage of their development.

After three decades of serving the
pioneers and market leaders in biotechnology, Ernst & Young continues to be a
professional services firm of choice.



5 Times Square

New Yor
k
,
NY

10036
-
6530

USA

www.ey.com

Incorporated:


1989

Employees:

140
,
000

Ownership:

Private

Company Profiles



25

Ethicare Clinical Trial Services


D
ELEGATE
(
S
)


Milan Satia, President & CEO


M
ISSION
/B
ACKGROUND

Ethicare Clinical Trial Services is a privately held, full service Contract Research Organization serving the Pharmaceutical,

Biotechnology and allied industries. Ethicare is

located in Ahmedabad, Gujarat, India. This highly synergistic company offers a
seamless comprehensive array of clinical trial services from protocol development to clinical summary. We offer full range o
f (Phase I
-
IV) clinical development services acros
s multiple therapeutics specialties.

Ethicare’s mission is to be present best practices on creating, managing and sustaining GCP that enable more efficient and sa
fe clinical
trials leading to the availability of new life saving and life extending therapeu
tics while building partnerships within the healthcare
industry across the globe.

Clinical Trial Services:



Selection of Investigational sites;



Protocol Planning, development and training;



Designing of CRFs, ICF, Investigator brochure and other documents;



M
onitoring (pre
-
study, during study and study close out visits);



Investigators’ and staff training on GCP guideline;



QA audit visits;



Medical Writing and report writing.

Consultation Services:



Setting up of BioEquivalence Center with respect to Infrastructu
re, Facility Systems etc.;



Audit of Bioequivalence CROs with respect to regulatory requirements;



Identification of right CRO for placement of the BE studies and Project;



Management & Co
-
ordination with CRO, if required;



Pharmacokinetic data evaluation to h
elp formulation group for go / no go decision;



Business Development for CRO in Phase I area;



Toxicology studies.


11, Devipark, B/h Lake V
iew Appt.

Ahmedabad

380054

India

www.ethicare
-
cro.com

Incorporated:


2009

Employees:

10

Ownership:

Other


H
IGHLIGHTS



Recent

Upcoming


Ethicare has completed three clinical trials
recently in the field of Gastroenterology,
Cardiovascular and Malaria a
nd also
completed number of successful
pharmacokinetic consultation assignments
for companies within India as well as
outside India.

Ethicare helps Indian couterpart of a
German CRO for medical/protoocl writing
of their vaccine project.

Ethicare has a vast

investigator data base
across India with diversified therapeutic
areas.

One protocol approved by DCGI for
Oncology and will be started soon. Second
protocol for oncology is under clearance
from DCGI which is for US FDA
submission.

Protocol is being finali
zed for a clinical trial
of autologous cell culture product.

26



Company Profiles

Federated Kaufmann Fund


D
ELEGATE
(
S
)


Tom Brakel, Portfolio Manager


M
ISSION
/B
ACKGROUND

Since 1955, millions of investors in the United States and around the globe have relied on
Federated Investors, Inc. (NYSE: FII) for world
-
class investment management.

Federated
has grown to become one of the nation's largest investment managers with more than
USD
$336 billion in assets under management.

Federated has honed its disciplined investment process over a half
-
century to deliver style
-
consistent investment prod
ucts, including 135 domestic and international equity, fixed
-
income and money market funds, as well as a variety of separately managed accounts.
Federated's diversified product line is distributed through approximately 5,200 financial
intermediaries and in
stitutions who assist investors in meeting their unique objectives.


140 East 45th Steet

New York
,
NY

10017

USA

www.federatedinvestors.com

In
corporated:


1955

Ownership:

Public

New York Stock Exchange
:
FII

Company Profiles



27

Fulcrum Pharma plc


D
ELEGATE
(
S
)


Robert Miller, Chief Medical Officer

Sarah Arbe
-
Barnes, Senior Vice President


M
ISSION
/B
ACKGROUND

Fulcrum Pharma is a product development consulting company who function as Drug
Development Architects to provide global strategic advice in design of drug development
programmes and its impl
ementation. We have specific expertise in a number of therapeutic
areas to include specialist advisory boards, development planning, preclinical and clinical
trial management.

Based in the EU, US and Japan Fulcrum’s seasoned industry professionals have wo
rked in
both Biopharma and the service sector, giving them a unique perspective. We bring considerable expertise in our chosen areas
(specialist therapeutic area, small and large molecules, preclinical, CMC, clinical, regulatory, safety) and work cohesivel
y as an
integrated team to deliver the most robust solutions for our clients.

Since 1999, Fulcrum has worked with a range of Pharma, not for profit, biotech clients and more recently VC groups and their
portfolio
companies, to include technical due diligen
ce, adaptive development planning and execution

Fulcrum specialises in alternative models of drug development that progress early clinical stage assets through pre
-
clinical/CMC to later
stages of development in a creative and cost efficient manner. We off
er immediate access to a highly credible, integrated development
team that provides the strategic and operational leadership required to ensure that new drugs move smoothly from discovery re
search
to product approval and beyond.

Fulcrum Pharma is a private
ly held company and is part of an integrated group of high value specialist service companies owned by SV
Life Sciences and The Halifax Group.



Hemel One, Boundary Way

United Kingdom

www.fulcrumpharma.com

Incorporated:


1999

Employees:

140

Ownership:

Private

28



Company Profiles

G7 Synergon Pvt. Ltd.


D
ELEGATE
(
S
)


Dhanraj Bhosle, Buisness Development Manager
-
Asia Pacific

Chandra Shekar Ra
o M.V, Project Manager
-

Clinical Operation

Priya Sengupta, Director

Rashmi Sidharthan

Ramakishore EG


M
ISSION
/B
ACKGROUND

G7 SYNERGON is a fastest
-
growing integrated biopharmaceutical service provider, offers life science Research (Dr
ug Discovery &
Pre
-
clinical Development), Clinical Research (Phase II
-

IV), Life Science Technology (Clinical Data Management, Biostatistics and
Medical affairs) and Life Science Consulting solutions to the global pharmaceutical, biotech and healthcare in
dustry.

G7 SYNERGON is part of the INR 1400Cr, 2000 employee strong G7 Group which is also a major player in Life Insurance, IT, ITeS
,
and computer hardware manufacturing sectors.

A
LLIANCES

Biocon India Pvt. Ltd.

Biocon in partnership with G7 SYNERGON, h
as launched a massive patient awareness / counseling / management campaign “Winning
with Diabetes” in India. This initiative follows the mantra that Self Monitoring of Blood Glucose (SMBG) is the most importan
t part of
Diabetes Management.

BIONEEDS PRECLIN
ICAL SERVICES

This alliance enables us to provide Animal Studies and Pre
-
clinical services to the global pharmaceutical industry.




No. 537/3, 5th Main

Bangalore

560092

India

www.g7synergon.in

Incorporated:


2008

Employees:

40

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


Hea
lthcare BPO and a Patient
Management inititative for diabetes is fully
functional and running with 99% accuracy.
New process is qualified for Nephrology
patient counselling and management

Cervical cancer lead molecule (GQ123)
has been developed & evaluated

for
pharmacokinetic studies & filing will be
done shortly

Partial development of GPCR target agonist
for type 2 diabetes.

Company Profiles



29

Genelogic
-
Ocimum


D
ELEGATE
(
S
)


Anu Acharya, CEO

Dhanya Menon


M
ISSION
/B
ACKGROUND

Ocimum Biosolutions is a global integrated genomic services company with operations in Hyderabad, India and Gaithersbur
g, MD
(Gene Logic). We provide comprehensive (research level and GLP
-
compliant) genomic services, reference databases, and LIMS
solutions. Our distinct platform "Research as a Service" (RaaS) allows complete outsourcing of genomics


from storing biologica
l
samples and performing on demand DNA and RNA based services to validating biomarkers using our proprietary databases and
providing data and bioinformatic analysis. We have been chosen as a global preferred outsourcing provider for more than 75%
of top
2
5 pharma and biotech companies plus leading research institutes. Our partners recognize our expertise for understanding disea
se
mechanisms in correlation with discovery, prioritization of gene targets and biomarkers, and sample analysis for clinical stu
die
s.

With our global infrastructure's standardized procedures, capacity, and highly skilled staff, we are capable of supporting dr
ug
development programs from pre
-
clinical target development and toxicogenomic assessment to clinical biomarker identification a
nd
patient stratification. Our expertise is unparalleled and was gained through the creation of the world's largest commercial g
ene
expression databases


BioExpress® and ToxExpress®. Ocimum has been consistently ranked as India's fastest growing
biotechno
logy company and one of the fastest growing technology companies over the last five years by Deloitte Touche Tohmatsu.

T
ECHNOLOGY



ToxExpress® Program
-

Toxicity analysis suite with over 14,000 untreated, vehicle and drug
-
treated animal tissue samples;



BioE
xpress® System
-

Most comprehensive gene expression data for over 22,000 clinically relevant samples;



ASCENTA® System
-

Web based Biomarker discovery platform based on validated gene expression data;



Genesis Enterprise System® Software
-

Examine expression

data and sample attributes simultaneously and perform a wide
variety of analyses.

A
LLIANCES

Ocimum has an extensive world
-
wide Genomic Technology Partner network with: FDA; EPA; Affymetrix; Agilent; Apple; Sun; Microsoft;
Tecan; Clintox; Illumina; NuGen;

Genstruct; Clarmon; Biotrove; Jeevan Bio.


P
RODUCTS



Name

Phase

Indication

ToxExpress® Program

On
Market

Toxicity analysis suite with over 14,000 untreated, vehicle and drug
-
treated
animal tissue samples

BioExpress® System

On
Market

Most comprehensive

gene expression data for over 22,000 clinically relevant
samples

ASCENTA® System

On
Market

Web based Biomarker discovery platform based on validated gene expression
data

Genesis Enterprise System®
Software

On
Market

Examine expression data and sample at
tributes simultaneously and perform a
wide variety of analyses

Biotracker™ LIMS


jarket

ifjp des楧ied for pequenc楮iI dene bxpress楯iI 䝥notyp楮iI mroteomics and
B楯
J
specimen bank楮i fac楬it楥i

䝥no浩cs perv楣es


jarket

䝥ne bxpress楯iI pkm 䝥notyp楮gI 浩okAI qo呐CoI 佰enArray®
J

呌qAI
jAiaf
J
呏q

䝥no浩c aata Anal
ysis and
jethods aeve汯lment


jarket

B楯楮formatic ana汹ses for express楯iI 浩okA and pkm data

Sth 䙬潯rI oe汩ance C污ssicI

eyderabad

㔰〰㌴

fnd楡

wwwPKoci
mumb楯icom

Incorporated:


2000

Employees:

250

Ownership:

Private


H
IGHLIGHTS



Recent

Upcoming


Ocimum Biosolutions has expanded its
range of service offerings with the launch
of miRNA microarrays, Software as a
Service version of Biotracker
™ Lite and
Biotracker™ Biobanking LIMS. MALDI
J
呏䘠and qoq
J
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EoaapF offer楮i wou汤l楮iegrate a
techno汯ly p污lfor洠of data 浡magement
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30



Company Profiles

P
RODUCTS



Biorepository Services

On
Market

Sample management at Gene Logic facilities

Microarrays

On
Market

Affymetrix/Agilent/Illumina platforms and OciChip™

B楯楮fo
rmatic mroducts


jarket

Genchek™ (sequence analysis), OptGene™ (gene design), Genowiz™
(microarray data analysis) and iRNAchek™



Company Profiles



31

Genotypic Technology Pvt
.

Ltd.


D
ELEGATE
(
S
)


Dr. Anand Damodaran, Research Director

Raja Mugasimangalam


M
ISSION
/B
ACKGROUND

We are a 10
-
year
-
old genomics and bioinformatics company providing comprehensive and customized services and solutions to clients
worldwide.

We are pioneeri
ng work in Next Gen Sequencing (NGS)
-

Illumina GAIIX platform (in
-
house), Microarrays (Agilent platform) and Next
Gen Sequencing (NGS), Target DNA Capture (Agilent “SureSelect”), NGS Data Analysis. We are a very specialized unit handling
multiple customize
d projects with extensive client support, yet we are economical, flexible and open to test novel ideas. Our clientele
include all major academic Institutes and top pharmaceutical and biotech companies.

Some of our applications have been in the fields of:
Pharmaceutical, Biomarker discovery, Agribiotech, Animal Husbandry, Human
Genetics, Molecular Diagnostics, Vaccine Research, Genome sequencing, Personalized Medicine, Systems Biology, Sequence
Informatics.

T
ECHNOLOGY

Biointerpreter software for microarray
data analysis;

SeQC
-

informatics tool for Raw Data QC of NGS Sequence Data;

Multiplexing in On
-
Array DNA Target Capture.

A
LLIANCES

Agilent Technologies; Illumina; Eldan Scientific, Israel; Sciencewerke, Singapore; Yale University, USA;


P
RODUCTS



Name

Phase

Indication

Biointerpreter: http://genotypic.co.in/biointerpreter.html?mnu=1

On Market

Microarray Data Analysis

MedRuner
-

http://genotypic.co.in/medruner.html?mnu=1

On Market

Literature mining

SeQC
-

http://www.genotypic.co.in/SeqQC.html

On Market

N
GS Sequence Data QC tool
-

free download

Multiplexing in On
-
Array DNA capture

On Market

Low cost targeted gene sequencing



#259,
Apurva
, 4th

Cross