Transcript making investor presentations - FTF

7/7/2015
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FTF Pharma Ltd.
Your partner of choice in
identifying, analyzing, developing,
scaling up, filing and
commercializing your valuable
products.
• First To File ( FTF) is the beginning of success.
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• Vision :
Our vision is to provide best and affordable solutions based on
innovative thought process and their implementation. We aim
to provide pharmaceutical solutions and services to the generic
and branded pharmaceutical companies.
• Mission :
FTF Pharma Ltd aims to be one of the best pharmaceutical
solution providers through consultation, innovation and
development to meet the aspirations of its clients/partners .We
plan to achieve the vision and mission through our experience
and expertise in formulation development, patent
understanding, pharmacokinetic expertise and innovative
thinking .
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Services Offered
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Identification of New Products.
Regulatory Strategy.
Non Infringing and IP strategy .
Business Development
Bioequivalence/ clinical trial strategy
Pharmaceutical Services
Investing opportunity
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We infuse confidence in implementation of our
solutions to our partners
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Identification of new products
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The first and most critical step of a business process is to select
the best and most profitable product. Based on the huge data
base and experience in generic industry, FTF Pharma offers its
expertise in selecting the best product which is best fit to the
clients’ portfolio and need.
Scientific, legal and commercial analysis of a products.
Technological feasibility, competition analysis, cost of
development and Return on Investment projections.
Incremental innovations to work around maze of patents and
make the product niche .
New Dosage Form, New Combination and New Drug .
Product differentiation and life cycle management of high value
products.
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Strategic Regulatory Services
 Regulatory Strategy is the key to optimizing the development
resources for global development of API and finished products.
• Assess the global regulatory landscape based on each local
regulatory and market needs ( ANDA,ANDS,MA’s though DCP or
CP or MRP etc).
• 505(b)2 and Pre NDA preparations.
• Collaboration between API and Drug Product companies for
mutual benefit.
• DMF/COS evaluation to limit the resources of its clients to bare
minimum.
• Mock up audits for its clients for their API/FP and BE/CT sites to
preempt issues well in advance .
• Formulate CMC and BE/CT related queries effectively on time.
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Patent Strategy
• Evaluation and Recommendations of API and Drug product
for IP landscape across the globe.
• Product, process, method of use patent for US,Canada,EU
and ANZ markets.
• Formulation patents.
• Polymorph selection.
• Patent opinion.
• Patent notifications and Responses.
• Litigation advise and identifying right legal attorney for
different markets .
• Settlement/ litigation strategy.
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Business Development
• CRAMS model
• Out licensing deals with supply
• In licensing and due diligence
• Extending products to new markets
• Strategic Collaboration/ tie ups
• Contract Manufacturing tie ups
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Bioequivalence & Clinical Trials
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Right Designing of protocol.
Organizing CRO
IVIVC and IVIVR studies
BE/CT failure investigation and reformulation strategy.
BCS waiver
Impurity qualification
Genotoxicity evaluation.
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Pharmaceutical Services
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Forward integration of API companies.
Backward Integration of Finished Dosage Forms (FP) companies.
Infrastructure Development ( Man, Machine ).
QbD Implementation .
Galenical/Lab scale Oral, Topical and Injectable Formulation
Development.
Formulation Development of NCE
Bioavailabiltiy Enhancement of API through Formulation.
Formulation upgradation
Technology Transfer.
New Dosage Form
New Combinations.
s-New Drug Applications.
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Investing Opportunities
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7/7/2015
Project Based Funding.
Better EBIDTA.
HNI/Angel Investor Funding.
ROI Analysis
Due Diligence of projects, ANDA’s, IP’s.
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Expertise of Lead Consultant
 Jayanta Kr Mandal, M.Pharm has 20 years experience in Pharma
R&D, IPR & business development. Worked in top 10 companies
in India.
 Lastly headed R&D, Patent cell and Pharmcokinetic cells and
managing product selection ,all BE and CT studies for the
company for all regulated and semi regulated markets.
Also actively involved in business development for dossier and
toll manufacturing businesses.
 Mr. Mandal has wide range of experience in developing
Immediate Release,Sustained Release, MUPS Oral formulations ,
Liquid and Lyophilised oncology and general Injectable
products,Topical Dosage forms, Ophthalmic Dosage forms and
Liquid Oral Products through s NDA ,ANDA,DCP,CP,MRP and
national procedures.
 Mr. Mandal has experience in dealing with US and EU patent
attorneys and counsels for patent opinion, document discovery,
deposition etc leading to settlement or legal outcome.
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