Comparator Sourcing, Europe 2019

Open House – Comparator Sourcing

Common Myths and Challenges

Clinical Trial Supply, Europe 2019

Open House – Comparator Sourcing
  • Why talk about: Comparators sourcing
  • Legal basis behind Comparators usage and their increasing demand
  • Reverse Planning in comparator souring
  • Source Markets – US or EU or RoW
  • Can Comparators be sourced without CT data
  • Questions / Queries from Audiences
Why talk about comparators?
  • Only element in your trial not under your control.
  • Neither controlled by Sponsor nor CRO.
  • A 3rd party asset with high probability of outages, shortages, expiries, damages, change in colours, excursions …….
  • Murphy’s law : “Everything that can go wrong, goes wrong” is in full force during Comparator sourcing!

Clinical Trial Supply, Europe 2019

Legal basis
  • Declaration of Helsinki, June 1964 https://www.wma.net/policies-post/wmadeclaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
  • Most recently updated in 2013.
  • Gives specific situations where placebos can be used and recommend to keep to a minimum their usage.
  • Has lead to increased selection of comparator Arm in last 5 – 8 years.
  • Leading to a dramatic increase in comparator demand, making innovator brand owners quite alert.
Reverse Planing
  • Reverse Planning : When you plan in reverse, you start with your end goal and then work your way backwards from there to develop a plan of action.
  • Traditionally sponsors finalise protocol and then mail out to vendors asking for comparator supplies.
  • This has not worked with several instances of trial delays.
  • It’s important to onboard a Comparator vendor right from Protocol discussion phase, collect market data on stock status, batches in market, pack variations, colour of caps / syringes etc…. from the start to avoid surprises and disappointment later.
Source Markets
  • How do you decide your source markets ?
  • Do we ask : What’s my destination market ? If we are running a trial in RoW, a RoW source market will do just fine!
  • Traditionally US / EU have been the chief source markets.
  • With increasing demand, competition amongst developers and CROs for limited stocks, everyone has been forced to look at RoW markets as a source.
  • Are RoW stocks Bio Equivalent to US / EU stocks ?
Are RoW stocks Equivalent to US / EU stocks ?
  • Two Manufacturing site challenge for Biologics : Myozyme gets changed to Lumizyme.

In the United States, alglucosidase alfa is manufactured at two different production scales. Alglucosidase alfa manufactured at the 160L scale (initial pilot scale) has a brand name of Myozyme® (alglucosidase alfa) and alglucosidase alfa manufactured at the 4000L (final manufacturing scale) has a brand name of Lumizyme.

FDA ruled that in the process of scaling up from 160L to 2000L the product had changed sufficiently to require a new biologic license application (BLA).

  • Are RoW stocks Bio Equivalent to US / EU stocks ?
Biologic Distribution Map

drug-distribution

  • Are RoW stocks Bio Equivalent to US / EU stocks ?
Are RoW stocks Equivalent to US / EU stocks?
  • This can be easily verified from the pack shots, leaflet and labelling without going into the compilation of Equivalency statements, CoC etc….
  • Common Myths :
  • Brands sold in RoW don’t have same efficacy and safety !
  • Brands sold in RoW cannot be used for trials !
  • Such assumptions only help inflate trial budgets. Thorough due diligence of comparator options from RoW can help save millions.
Are RoW stocks Bio-Equivalent to US / EU stocks?

Herclon-440mg

Are RoW stocks Bio-Equivalent to US / EU stocks?

kadcyla

OPEN HOUSE
Comments from the Audience
  • Are RoW stocks Equivalent to US / EU stocks?
  • Can you source comparators without CT data?

Other Resources

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Comparator Sourcing from Row Markets : Busting Myths!

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White-paper: Unlicensed Drugs VS Counterfeit Drugs

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