Comparators The 'Check Nut' of Clinical Trials

By

DR. PIYUSH GUPTA (MBBS, MBA)
ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
GNH INDIA
MUMBA, INDIA

Index
  1. What’s A Check Nut ?
  2. Reverse Planning
  3. Significance Of Source Markets
  4. Ef fects On Registration, Costs And Time To Market
  5. Key points in sourcing Comparators
  6. Comparator Souring Organisation – Roles and Services.
    1. Check Nut !!
      Check-Nut

      • Definition: A Secondary nut, screwing down upon the primary nut to secure it.
      • A nut which is screwed up tightly against another nut on the same bolt or screw, in order to prevent accidental unscrewing of the first nut.
      • Why comparators :
      • Have you heard disclaimers such as : Manufactured by “Non Patent Infringing Method
      • So Until we Indians come up with : “No need to prove comparison with Innovator – Method” we will need comparators.
      • Comparators help us stay on course and ensure we reach our goal.
      • If we don’t have a comparator then: Jana Tha Japan, Pohooch Gaye Chin yane yane……
        Confidential
    1. REVERSE PLANNING
      • What is Reverse planning?
      • Conventional RnD approach do not work for Large Molecules / Bio-similars development
      • Top down approach of planning the development process, Trials, Study protocol etc… and then looking for Comparators is not workable in Today’s scenario….. I am sure there is a number of such planning sitting in this conference today. Where Comparator has disrupted the study.
      • Comparator supply is tightly controlled, supply chain restricted and Outages common
      • Comparators are the only element in your RnD process that is not under your control. It is a 3rd party product
      • The first thing that’s planned for, in an Army operations or Risk Management is for elements not in your control. It’s called Risk Reduction
      • So plan your comparator sourcing first and reduce your risks.
    1. Source Market !
      • What is your Destination Market ? Does any one ask this question ?
      • For Example: a Bio-similar to be registered in EU needs a EU sourced comparator with EU registration number on the pack.
      • While a Bio-similar for registration in RoW markets will accept comparator from any markets as long as it’s from the innovator.
      • The cost difference : 3x – 4x

      Source-Markets

      • Source Markets should be chosen based on your Destination markets
      • For Example if you plan to Target RoW Markets, there’s no point in souring products from US market
      • US products with NDC numbers are at least 3 time more expensive as compared to same brand in International packs
      • US stocks are dif ficult to get, highly controlled, traced and the sheer cost makes the development process un-viable.

In contrast to this : An International pack from Europe / Eastern Europe is available at 1/3rd the cost, in Large quantities, with multiple batches with Pedigree Documents.

  • It’s easier to build Reference library with International packs than with US NDC stock.

 

Market Intelligence

Market-Intelligence

Source Markets!
Are they the same product ?

CTD-Triangle

Module 1 – CPP and FSC

 

  • Effects on Development process
    • Ultimate goal of any development is to SELL the product
    • Sell – Fast and First to Market
    • Sell – At Most competitive price
    • If your destination is RoW – there’s no point in Sourcing of US / EU stock for development
    • Lack of reverse planning : Only increase development cost hence the END product COST
    • Lack of product availability from US / EU markets – delays development
    • Lack of product availability from US / EU markets – delays development
    • And off course you are not FAST or FIRST to market

 

 

  • Key points in Sourcing Comparators
    • Identify your Destination Markets First
    • Check availability, Pack descriptions, SPC etc… of your comparator in planning stage
    • Call for Pack photos, Pack Scans in planning stage
    • Estimate the Quantity, Frequency etc…. in advance
    • Understand availability issues for Comparators right in the beginning.
    • Tie up your source even before you start development processs
    • Ensure Pedigree trail of your comparators

 

 

  • CSO – Comparator Sourcing Organisation
    • While Development and RnD is the a focus of Manufacturers or CROs
    • Sourcing of Innovators / Comparators has become an “Achilles Heel” of this industry.
    • An ideal CSO should be :
      • WHO cGSDP Certified Site
      • With validated Storage and Shipping systems
      • With Global Reach
      • Ability to source and transport products world wide
      • Knowledgable about Global Market place
      • In depth Experience in Sourcing, Imports and Exports process

 

GNH India – 1st CSO in India
  • A WHO GDP certified by SGS India
  • DFGT recognised Export house
  • Over 12 years of Industry Experience
  • Qualified QP on site in Warehouse
  • Fully licensed by State FDA and DGFT to carry imports and Exports of Drugs and related products
  • Over 135,000 products
  • Shipping and importing Globally to over 180 countries
  • Validated Storage and Shipping systems
  • Full Traceability and Pedigree for every supply
  • In Depth Market knowledge and Market intelligence
  • Complete Regulatory and compliance support up-till Market launch
Market Intelligence – 1 product – 2 packs ??

Market-Intelligence-1-product-2-packs
thank-you
global-leader-local-partner

Other Resources

Comparator Sourcing, Europe 2019

Comparator Sourcing, Europe 2019

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Comparator Sourcing from Row Markets : Busting Myths!

Comparator Sourcing from Row Markets : Busting Myths!

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