Ascent Innovative Medicines Pvt. Ltd. - PharmaCompass.com · 2017. 7. 26. · Developed viable...
Transcript of Ascent Innovative Medicines Pvt. Ltd. - PharmaCompass.com · 2017. 7. 26. · Developed viable...
Ascent Innovative Medicines Pvt. Ltd.
A 327, Road No. 25/34, Wagle Estate,
Thane, Maharashtra, India - 400604
An Integrated Drug Development Solutions Provider Established by experienced pharmaceutical professionals with global exposure.
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Ascent is a Pharmaceutical Research and Development company with innovation at its core
Striving to be Global leader in
Pharmaceutical Drug Development Founded in 2016 in Thane, Maharashtra, India
Total employees (June 2017) 41
• Formulation 10
• Analytical D 18
• Marketing & Sales 02
• Support Functions 09
Impressive 15 drugs in development within one year of Operations
Privately Held, Investors with deep interests and investments in Pharma domain
No external borrowing or debt
Founder Dr SB Roy, PhD MBA, more than 35 yrs in the industry
Drive innovation forward
Pursue top quality science, internally
and externally, balanced with medical
need and commercial potential
Practice highest standards of ethics
Quality, Confidentiality, Data Protection
is crucial and ingrained across all
functions in all we do
Add Global Clientele
Expand innovative commercial
capabilities to new customers and
regions. Manage alliances putting the
product first
Four Goals for Ascent
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Maximize the value of innovation
Develop projects ourselves and seek
partners or out-license when necessary
to maximize value
Ascent’s strategy and advantages
Low cost drug development and technology transfer
Team filing experience of more than 400+ formulations across various dosage forms
Team Track-record of successful drug development and commercialization in major
markets
Use internal accrual revenues in the funding of drug development and commercial
expansion
Investors history of astute capital management coupled with real-world experience in
pharma healthcare and proven customer insights
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New Products - Generics, Specialty (Novel Drug Delivery)
Reformulation
Life Cycle Extension of existing molecules
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>35 years of rich experience in pharmaceutical industry
Ranbaxy, Sandoz, Astra, Warner and Zydus Cadila
Enabled companies to develop cost effective drugs and
generate a global footprint
Directed development of various dosage forms for
regulated markets- USFDA, MHRA, EMA, ANVISA, Japan,
TGA etc
Developed viable portfolio of products across a range of
generic and differentiated formulations.
Development, registration and commercialization of novel,
value creating medicines that improve patients’ lives.
Developed a robust pipeline in various therapeutic
segments.
Registrations in
+ 60 countries
US
Japan
EU: France, UK, Spain, Denmark & Latvia
LATAM: Brazil & Mexico
Russia, Ukraine, Belarus, Uzbek & Kazakhstan
Middle East : UAE Dubai, Kuwait & Oman
Africa - South Africa, Uganda, Kenya, Nigeria, Ethiopia & Ghana
Asia Pacific - Sri Lanka, Malaysia, Philippines, Taiwan, Singapore, Myanmar & Vietnam
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Generic Pharma Leadership Outcome
Significantly Low cost to filing per product √
Significantly low Manpower to filing ratio √
Exponential increase in filings √
Time to develop and register a generic drug
(includes several first to files and block busters) √
Introduction of multitude of dosage forms √ Benefit from Ascent’s experienced leadership and
management
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Dr. S B Roy CEO & Director
Accounts
Plant Head
Business
Development
Analytical
Development
Packaging
Development
Intellectual Property Business
Development,
Planning &
Sourcing
Formulation
Development
Quality Assurance
Regulatory
HR &
Administration
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Cumulatively 200+ years of Technical Team Experience
Flexible and nimble to client needs
Blend of experience with advanced degrees in pharmaceutical sciences
90% of the team with post graduate qualifications
Agile team with a rich experience in honoring client deliverables
Worked across Indian and Western Multinational Generic Companies
Rich experience across entire Development value chain - IP, Preformulation,
Formulation, Analytical Method Development, Validation, Pharmacokinetic,
Packaging, Manufacturing, Clinical Research and Development
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Product development CMO Regulatory
• RLD Selection • Development Plan
strategy • IP assessment • API Vendor selection • API DMF gap analysis • Review and
finalization of development documents
• Site selection for commercial batches
• Support to CMO for Tech transfer
• Exhibit batches (BMR, MFR,BPR)
• 6M Stability data from exhibit batches
• Process Validation • Successful BE
outcomes
• Patent/Exclusivity time frame
• Product Labelling • Dossier
Compilation & Filing
• Compliance review of regulatory documents
• e-CTD Submission
Fully Integrated or Standalone
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Development only OR
Development + Supplies Models
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Pharmacopoeia Merck Index Florey Vidal Orange Book
Literature search
Active Sourcing Active
Evaluation Active Purchasing
and Testing DMF
Innovator Product Purchasing and
Testing
Bulk Active Testing and VQ
Excipient Selection and
Testing
Formulation and Analytical Method
Development
Manufacturing Process Evaluation
Container Closure Evaluation
IP Clearance Process Optimization
Report Analytical Method Transfer Report
Pilot Stability and BE study
Finished Product Specification
TT Documents Scale Up/ Pre
registration batches
Process Qualification BMR and BPR
Registration Batches Production
An Integrated Drug Development Solutions Provider Established by experienced pharmaceutical professionals with global exposure.
25/07/2017
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