Integrated Drug Discovery and Development Services at Piramal Pharma Solutions

8/19/2019 Integrated Drug Discovery and Development Services at Piramal Pharma Solutions

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PIRAMAL DISCOVERY SOLUTIONS


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Delivering Globally Integr ated Solutions across the drug lif ecycle

Our r oots We are an integral part of Piramal Enterprises Ltd.,

a leading business group in India with multiple

business interests. As a Group, we are committed to

achieving excellence and leader ship by pr acticing

leading pharmaceutical company in India and a

dominant player on a global level.

With the changing dynamics of the pharmaceutical

We are the Contract Development & Manuf acturing

arm of Piramal Pharma Solutions, a part of Pir amal

Enterprises Ltd. Our capability as an integr ated

solutions provider enables us to serve Innovator

and Generic companies worldwide.

Our customers can avail a comprehensive r ange

of services across all phases of the drug lif ecycle

which includes Drug Discovery & Development,

Canada Toronto

Manufacturing and Packaging of Clinical Trial

Supplies, Delivering Commercial Volumes of APIs

as well as Finished Dosage products. To provide

flexibility and scalability of operations, we have

invested in a network of contract development and

manufacturing facilities located in North America,

Europe and Asia.

India Ahmedabad | Ennore Pithampur | Digwal | Mumbai

our core values of knowledge, action and car e.

We adhere to innovative, value-driven pr actices

in our diverse business initiatives, ranging fr om

healthcare and glass manufacturing to r eal-estate.

Our beginning in the Healthcare business goes

back to the year 1988 when we acquired Nicholas

Laboratories. Since then we have grown into a

industry worldwide, innovation and cost have

emerged as key challenges for pharmaceutical

companies worldwide. We enable our customers to

address these challenges by offering cost effective

and reliable delivery solutions across the pr oduct

lif ecycle.

U.S.A

United KingdomGrangemouth | Morpeth

Cambridge

Boston | Kentucky China Shanghai (Sourcing Office)

http://www.piramal.com/pharmasolutions/http://www.piramal.com/pharmasolutions/http://www.piramal.com/pharmasolutions/http://www.piramal.com/pharmasolutions/


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The advantage we carry

Our customers enjoy the benefits of

our global network of assets spread

across Europe, North America and

Asia. Our network enables us to

deliver benefits by str ategically

placing projects to take advantage

of low costs, local supply chains and

spec i f i c c u s t omer / mark e t r equir ements.

Piramal Enterprises Ltd.,

currently valued at mor e

than 1 billion USD, is

amongst the largest business

conglomerates in India. We

embrace a rich legacy of over

20 years in the business ofhealthcar e.

Our R&D team is led by scientists

with experience of working with

pharma companies across the

globe and hold expertise acr oss

various chemistries and r ange offormulation types.

Global Network

Integr ated Solutions

Financial Stability

ConsistentTr ack

Record

People &Science

Hallmarkof Quality & Saf ety

With capabilities across drug

discovery, development, scale-

up and manufacturing of APIs as

well as Formulations, we are well

positioned to address customer s’

needs across the entire drug

lifecycle. Our specialization in

Antibody Drug Conjugation,

Clinical Trial Supplies, Packaging

and Biocatalysis enables us to

provide differentiated services to

our customer s.

We are a pioneer in the Contract

Development and Manuf acturing

Services market and have an

experience of over two decades.

We have advanced manuf acturing

facilities approved by leading

regulatory agencies including

the US-FDA and MHRA. We are a

trusted supplier to more than 100

pharma companies across the

US, Europe and Japan including

all major Big Pharma and lar ge

Generic companies.

We believe that the best can

be delivered if only there is

an internal focus on quality.

Stringent quality and safety

norms are followed acr oss

our facilities worldwide.


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PIRAMAL DISCOVERY

SOLUTIONS We, Piramal Discovery Solutions (formerly known as O2h) are an integral part of Pir amal

Pharma Solutions and deliver early stage drug discovery services to Pharma companies,

Biotech companies and Academic institutions.

Our 10,000 m² (100,000+ ft²) greenfield campus is located in a Special Economic Zone

(SEZ), which is a government sponsored industrial park with specialized infr astructur e

to encourage export and industrialization. Our campus benefits from on-site customs

clearance, central waste and power management and secure buildings with access

control points.

Our modern and advanced facility hosts 28 lab units (12 fume-hood r econfigur able

modules), a write-up area and research campus that accommodates over300 scientists.

Our specialized areas ar e

- Medicinal and Synthetic Chemistry

- In vitro Biology

http://www.piramal.com/pharmasolutions/service-offerings/innovator/drug-discovery/http://www.piramal.com/pharmasolutions/service-offerings/innovator/drug-discovery/http://www.piramal.com/pharmasolutions/service-offerings/innovator/drug-discovery/http://www.piramal.com/pharmasolutions/service-offerings/innovator/drug-discovery/http://www.piramal.com/pharmasolutions/service-offerings/innovator/drug-discovery/


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MEDICINAL ANDSYNTHETIC CHEMISTRY We are a reputed service provider of discovery chemistry. W e have partnered with

a r ange of well known pharmaceutical and biotechnology companies from Europe,

USA and Japan. Our specialized team at PDS has a wide array of experience in

preparing small molecule NCEs with the requisite high quality specifications.

Our medicinal chemistry expertise includes hit expansion, hit to lead optimisation,

lead generation and lead optimisation. All of these can beaccessed as stand-alone

offerings or as a part of an integrated drug discovery pr oject.

Our demonstrated expertise lies in thefollowing chemistries

• Complex / multi-stage synthesis

• Heter ocyclic

• Chiral

• Carbohydr ate

• Peptide

• Aliphatic

• Nucleoside

• Natural pr oduct

Our techniques include

• Microwave chemistry

• High pressure chemistry

• Cryogenic chemistry

• Parallel synthesis

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Our specificities include

• Cambridge (UK) project office providing logistical, communications and objective pr oject

management support

• We have perfected clear templates which enable the systematic day-to-day reporting and

measurement of scientific progress in the most effective manner

•

Performance and productivity metrics are represented in a graphical form and shared internally as well as with the client

• Communications with clients range from direct communication to secure space on our intranet

site for depositing documents and data arising during the pr ojects

• Our dedicated team of personnel includes purchasing officers, store/stock managers as well as

in-house customs liaising officer for efficient sourcing of starting materials

• Our IP (Intellectual Property) security model is designed to protect the I P of the clients during

the project lifecycle and beyond

• Our scientists at are supported by a 360º support system which aims at maximising their time

to focus on their pr ojects

• We value integrity in communication and action; social responsibility with respect to

waste management and making a contribution to the community

Our capabilities include

• Synthesis of small molecules on mg to kg scale (non-GMP) with the requiredhigh quality

specifications, using diverse synthetic methodologies

• Modular custom-built lab units accommodating 12 FTE chemists each

• Lab units can be tailored to customer requirement, with key-card access and IP / IP security

• Supported with latest equipment - NMR, LC-MS / MS, microwave, combiflashes and access

to literature (journals, patents etc.)

• Typical projects undertaken by us include: design and synthesis of discrete or series of

compounds, as well as synthesis of focused libraries for SAR / SPR optimization


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I. In vitro assays

• ADME: solubility, permeability, CYP inhibition / induction, plasma stability (across diff er ent

species), microsomal / S9 stability (across different species), plasma protein binding

• Tar get-based: enzymatic / kinase assays, binding assays, GPCR assays

• Cell-based: ELISA, proliferation, apoptosis, phosphorylation status, insulin sensitizer assays,

cytokine production assays using hPBMCs, signal transduction assays

IN VITRO BIOLOGY Our biology f acilities have been developed

to pr ovide f as

ter decision-making

points for our chemistry clients. Since 2008, we have doubled both our

capacity as well as capability to include a r ange of In vitro services to evaluate

activity and/ or potential liability of compounds. Currently, we are executing

biology studies for several of our clients whose medicinal chemistry work is

also being carried out by us; thus reducing the iterative cycle time of drug

discovery and helping clients progress their compounds faster through the

discovery stage. The biology work is available on a stand-alone basis as well

as part of an integrated drug discovery pr oject.

Our capabilities

• Purpose-built labs include industry standard formats of fluorescence, luminescence and

absorbance to help develop and optimize biochemical and / or cellular assays in a r ange of

therapeutic ar eas • In-depth expertise in pathophysiologically r elevant experimental models for multiple

therapeutic indications

• Customization of assays based on client’s r equir ement(s)


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We consider the ultimate metric to measure Each of the varied modules of the drugthe success of an IDD project is the capacity discovery process is available as a unique

to create intellectual property and value to point of entry individually as a subset of

our customers. Our goal of IDD is to afford services or as the traditional drug discovery

our clients access to specialized skills without pathway from hit identification through to

incurring their own fixed costs and operating lead generation and beyond. Our expertise

in a dynamic, flexible manner that suits the includes medicinal chemistry: hit expansion,

competitive commercial environment of drug hit to lead, lead generation/ optimization,discovery. computational chemistry, in vitro enzymatic

Successful IDD projects rely on efficientand cell-based screening, DMPK.

integration of various disciplines

- Medicinal chemistry

- In vitro & in vivo discoverybiology / pharmacology

- ADMET

- Computer-Aided Drug Discovery

- Operational excellence and expertise

INTEGRATEDDRUG DISCOVERY Our highly skilled team of scientists deliver services in Integr ated

Drug Discovery (IDD) projects incorporating medicinal chemistry (lead

generation, hit-to-lead and lead optimisation), and in vitro and in vivo

pharmacology. We offer expertise in multiple therapeutic indications.


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Our Cor e Values

Our Intellectual Property Policy

The cornerstone of our philosophy on

intellectual property rights (IPR) is built

on upholding the IP generated by the

company and all its associates. In order to

achieve this objective, wehave set up

various systems which ensure that we:

• Respect the IPR of all its clients, partners and competitor s

• Do not infringe any process or product knowingly and / or unknowingly

• Protect and enforce the IPR of the Company, our clients and partner s

• Introduce measures to r educe IPR infringement related risks

• Promote a culture of IPR compliance within the or ganization

• Conduct periodic IntellectualProperty Audits for effective IPR

management andmonitoring

Respectfor IP

We value the relationships we have

built with our customers. We believe

that ‘Customer Centricity’ is the driver

behind all our actions. Our perf ormance

is measured on the value delivered to

our customers. We partner with our

customers in developing and delivering

solutions.

Customer

Centricity Client Quality

All our manufacturing sites have been approved

by leading global regulatory agencies. All major

sites have been approved by the US-FDA without

any 483s

Our aspiration is to be the best in class in global

standards. Our process has evolved through the

stages of:

• Create robust quality base

• Strengthen and implement system

• Quality culture across the or ganization

• Execute best in class standar ds

Envir onment

We function as an envir onmental-friendly organization and our practices have enabled us to

• Pursue continuous improvement: Periodic audits and gap analysis are conducted

by Corporate EHS and cross functional teams

• Implementing EHS best practices through:ISO: 14001 and OHSAS: 18001

• Aim towards the goal of Sustainable Development by targeting the triple bottom

line growth in the fields of Economics, Environment and Society

• Ensuring continuity of the business processes through Business Continuity Plans

• Execute Process safety by implementing safety systems at all sites

• Enhance awareness, knowledge and skills of employees towards a safe, clean,

greener and healthier work place

Win Awards and Recognition

• Safety Award from National Safety Council of India, 2004 and 2005

• Runners-up at the ‘NE Business Awards Corporate Responsibility

& Envir onment’, 2009

• CII-National Award for Energy Efficient Operations, 2009

• Winner of State’s ‘EnvironmentAwar d’, 2010

• Golden Peacock Award for Occupational Health & Safety, 2012

• Frostand Sullivan’s Green Manufacturing Excellence award, 2012


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P P S / P D S / D E C 2

0 1 5

Piramal Enterprises Limited

247 Business Park, A - Wing, 6th floor,

LBS Marg, Vikhroli (W), Mumbai – 400 083. India. Phone: +91 22 3095 6666 Fax: +91 22 3095 6665

Email: str ategicmarketing.cell@pir amal.com

www.piramal.com/pharmasolutions/
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Integrated Drug Discovery and Development Services at Piramal Pharma Solutions