Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.
Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.
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 ??
