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19-04-2018 (Singapore)

P40075 Pharma Life Cycle Management and Super-Generics
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Pharma Life Cycle Management and Super-Generics

19 – 20 Apr 2018, Singapore

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Team Savings: Register 2 Delegates & the 3rd Comes free!


Attend this informative event to gain practical insights into:

  • Understanding the pressures on the innovative biopharmaceutical and generics industry which ard increasing the focus on LCM
  • The whole spectrum of possible LCM measures, by lifecycle phase and by functional area
  • How the changing industry environment will influence LCM in the future
  • How to leverage super-generics to innovate and differentiate
  • How company structures, systems and processes can be modified to improve LCM
  • Understanding the place of LCM within the company strategy, and its product and project portfolio
  • Examine in detail the challenges to LCM as the generic companies improve their approach to circumventing LCM

Who Should Attend

All stakeholders responsible for:

  • Commercial Strategy, Portfolio and Product Management
  • Development & Technology Transfer
  • Marketing, Market Access and Brand Managers
  • Regulatory Affairs
  • Product Innovation
  • Licensing
  • Patent Managers
  • In house Counsel
  • Business Development


Packages Price
2 Day Training$3495Early Bird

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate.
For Group Registrations, email or call +65 6508 2477


  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.


Malcolm Ross

President, Generapharm


An introduction to the science of Lifecycle management and Supergenerics

Session 1
The instability of the pharmaceutical industry

  • Why the cost of developing new drugs has skyrocketed but the success rate has remained the same or even gone down
  • The pressure on pharmaceutical pricing
    • Innovative pricing
    • Generic pricing

Session 2
The need for new models and new partnerships

  • The status of the block buster model and the new “niche buster”
  • Is the hybrid company model (innovation and generic combined) collapsing?
  • The search for alternative models
    • Biotechnology and Biosimilars
    • LCM versus Supergenerics (looking in or looking out)

Session 3
Types of Life cycle management

  • Line extensions
  • Fixed dose combinations
  • Modified delivery models and devices
  • Rx to OTC switches

Session 4
What is a Supergeneric?

  • What makes a Supergeneric product
    • The possibility for generic companies to innovate and differentiate
  • The definition of added value – the need for a commercial approach
  • The three “re’s”
    • Reformulating
    • Repurposing
    • Repositioning

Group exercise: The importance of customer identity in development of a Supergeneric

Session 5
Planning aspects of LCM

  • The need for planning, project management and a multidisciplinary approach
  • Pricing and reimbursement
  • Timing as a key factor in LCM launch


Regulatory and Intellectual Property aspects of Life cycle management and Supergenerics

Session 1
Regulatory aspects of LCM and Supergenerics

  • Regulatory pathways to approval of LCM products and Supergenerics
  • Regulatory strategies used to prevent competition
    • Authorised generics
    • Pay for delay
    • The use of REMS as a barrier for obtaining reference product

Session 2
The link between patentability and profitability

  • What is a patent and what is patent infringement?
    • The need for innovativeness, novelty  and non-obviousness and how these terms are interpreted
      • The importance of prior art and “the person ordinarily skilled in the art”
    • Specifications and claims
    • Types of infringement and the doctrine of equivalence

Case study: Megace-how getting round a patent can lead to a serious market advantage

Session 3
Patent law specifically related to the pharmaceutical industry

  • The Pharmaceutical industry-a special case
    • The Hatch-Waxman act
      • The US research exemption (Roche Bolar)
      • The Eu research exemption (EU Directive 2004/27/EC Article 10)
    • Patent term extensions, Supplementary protection certificates and exclusivity
    • Compulsory licensing

Session 4
Types of pharmaceutical patents

  • Chemistry – process, salts  and  polymorphs
  • Biotechnology – the process defines the product argument
  • Dosage form design
  • Routes of administration and dosage regimes
  • New indications and “skinny” (cut out) labelling

Case study: The Pfizer case for Lyrica and its possible effect on the future of Biosimilars

Session 5
Intellectual property as a fundamental tool in LCM and the generation of Supergenerics

  • The mechanisms involved in challenging and appealing patents
  • How and why the courts may rule differently from country to country
  • The changing attitude of the courts to challenges and the effect of this on LCM risk and contingency planning

Session 6
The future

  • The futility of crystal gazing
  • The nature of discontinuity

when & where

19 - 20 Apr 2018

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.


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