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New Drug Delivery Systems

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3 Rubicon Research Pvt. Ltd. 2007. New Drug Discovery And Development Process ... Rubicon Research Pvt. Ltd. 2007. Role of Drug Delivery Systems in R&D ... – PowerPoint PPT presentation

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Title: New Drug Delivery Systems


1
New Drug Delivery Systems
A Global Opportunity
Maharukh Rustomjee Founder and Chief Operating
Officer Rubicon Research Pvt. Ltd. Email
maharukh_at_rubicon.co.in
BIOINVEST 2007 - MUMBAI - NOV 01 02, 2007
2
Overview
  • Product Development Cycle
  • Role of Drug Delivery Systems in Product Life
    Cycle
  • New Drug Delivery Systems Business opportunity
  • Case studies
  • NDDS Partnership Model
  • Advantage India
  • NDDS at Rubicon Research

3
New Drug Discovery And Development Process
(sourcewww.montrealinternational.com)
4
Declining RD Productivity
RD spend vs. NMEs approved
Cost per NME approved
So. PhRMA, US FDA
5
Role of Drug Delivery Systems in RD
Novel Drug Delivery Systems
6
Drug Delivery Systems Strategic Tool
N D D S
7
Desired Aspects of Drug Delivery Systems
PATIENT BENEFIT
Commercial Success
8
New Drug Delivery Systems (NDDS) Market
  • Global pharmaceutical - 555.5 billion in
    20061
  • 72 billion (13) is accounted for drugs
    incorporating NDDS 1
  • NDDS market has a CAGR of 15 v/s 6 CAGR of
    global
  • pharmaceutical market
  • There are 700 NDDS companies with more than
    1700
  • technologies2

Source 1 IMS Health 2 Pharmacircle 3
Company Annual Reports
9
NDDS - Market Segment
Segment wise share of NDDS expected in 2007
  • Oral Controlled Release Systems continues to
    dominate NDDS

Source FrontLine strategic Consulting Inc. 2002
10
Applications of NDDS
11
Case Study LCM of an old drug
Route of administration Oral
Alternate Route Transdermal , Daytrana by
Shire
12
Case Study Life cycle management
13
Marketed by Genentech using technology of
Alkermes Injection SR formulation of human
growth hormone Children deficient in Growth
Harmone Receives injection for years until
completion of puberty.Once a month or twice a
month dosage form highly desiredNutropin depot
was developed using ProLease Technology
comprising of biodegradable polymeric
microspheres.
Case Study-BioNDDS Nutropin Depot
14
Case Study-BioNDDS Permeability Enhancement
  • Emisphere has designed and synthesized gt1800
    delivery agents to facilitate delivery of
    therapeutic agents.
  • Technology enables to select and customize
    delivery agents to facilitate the oral delivery
    of broad range of actives. e.g. Heparin.

15
Partnership Model
Drug delivery companies develop
technologies Create business with this asset
  • Typical Business Model
  • Out licensing model
  • Fee for service model
  • Risk sharing model
  • Revenue Components
  • RD collaboration revenues
  • ( Development Fees)
  • License fees/ milestone payments / Royalties
  • Material Sales Manufacturing Revenues

16
Reasons for Partnership
  • Parameters that companies look at during their
    DDS partner
  • selection process

Average ratings on a scale of 0 - 9
So. EY Survey, 2007
17
Key Criteria for Successful NDDS Partnership
18
NDDS Partnership Success Stories
Source Specialty Pharma Jul/Aug 2006 Vol.2 No.4
19
NDDS Partnership Success Stories
Source Internet
20
NDDS Partnership - Advantage India
  • Signatory to WTO, acceptance of IPR
  • Proven scientific talent pool
  • No language barrier
  • Cost effective
  • Established regulatory skills
  • India has highest number of US-FDA approved
    facilities outside USA
  • Indian players account for about 25-30 of the
    total DMFs filed with the US FDA

21
RD Initiatives at Rubicon Research
Identification of unmet therapeutic need
Determining novel technologies to meet the need
Product with desired therapeutic benefits
22
DDS Technologies of Rubicon Research
23
(No Transcript)
24
THANK YOU
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