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. 1. 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. 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. 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 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

Source Markets!

Are they the same product ?

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 ??