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Comparators The “Check Nut” of Clinical Trials
By
DR. PIYUSH GUPTA (MBBS, MBA)
ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
GNH INDIA
MUMBA, INDIA
Index
- What’s A Check Nut ?
- Reverse Planning
- Significance Of Source Markets
- Ef fects On Registration, Costs And Time To Market
- Key points in sourcing Comparators
- Comparator Souring Organisation – Roles and Services.
- 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
- Check Nut !!
- 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.
- REVERSE PLANNING
- 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.
- Source Market !
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 ??
