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Some questions

from our customers…

“I seem to waste a lot of comparator drugs throughout my studies…”
“Where can I find a ERP solution provider for a platform I am currently working on involving a large number of suppliers and hospitals?”
“What kind of supply chain solutions are in development or available to support my hospital based cell therapy manufacturing process?”
“My supplier is really not performing and I cannot see how to turn this around…”
“My current CRO does not seem to understand the complexities of starting a psychedelic based study…”
“I want to expand in Europe, can you help me find some potential target companies…”
“I need to review the contracts in place with my top 15 vendors…”
“Can you manage my clinical supplies by offering a solution that would be more cost effective than a FTE? »
“I realise that my bill of materials contains some single source materials…can you help me de-risk that out…”
“I need to focus on another priority, can you help manage this project for me for a few months...”
“What CDMO could develop my product and support me beyond commercial launch? ”
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… what’s your question for us?

Case studies

Case study 1

Build trust to help innovation

Build trust to help innovation
Acting as trusted intermediary between sponsor & supplier

  • Situation – Sponsor unhappy with supplier performance. Emotions clouding discussions.
  • Solution – An impartial, root cause analysis identified that both parties were partially to blame on performance issues – implementation of improve supplier governance, with clearer responsibilities and simplified communication channels

Key Consideration

Ensure you keep a win-win environment , give a long term perspective to your relationship to vendors. 

Key Consideration

Avoid single source, give a long term perspective to your relationship to vendors.

Case study 2

Clinical supplies category refresh

Changing the relationship using a procurement process driven category update

  • Situation – Sponsor unhappy with supplier performance and single source situation driving lack of motivation on supplier side
  • Solution – Market research, identification of 5 options, data driven assessment and implementation of a second clinical supply and distribution outsourced solution, including LN2 warehousing capabilities globally

Case study 3

Comparator usage optimisation

Reducing overall study budget

  • Situation – comparators/reference drug overage and wastage worth over 1M$+/year.
  • Solution – sale of unused product and implementation of an usage optimization solution (USA), identification of several options, data driven assessment and implementation of a second comparators and ancillaries sourcing solution.

Key Consideration

Think beyond product purchase cost and look at optimizing the overall product usage and wastage.

Key Consideration

You have to explain and demonstrate your vendor selection process to the competent authorities.

Case study 4

Compliance support

Ensuring regulatory requirements

  • Situation – Health Authority GCP inspection for a study
  • Solution – Presentation of supplier selection and management processes to authorities , detailing due diligence and risk assessment of suppliers involved – no non-compliance identified

Case study 5

Supply chain services for decentralized cell therapies

Helping develop a concept by finding suitable partners to develop a new set of services to serve hospital based cell therapy manufacturing

  • Situation – next generation cell therapy start up looking for partners to manage their supply chain including new set of services not yet available
  • Solution – Identification of actors in the field and engagement, including via a consortium approach (one can not do all), to co-develop new solutions under the supervision of the client

Key Consideration

Build a vision to bring your partners to invest time and expertise in your concept.

Key Consideration

Data integration and technical expertise are key, common goals and aligned company cultures are essential.

Case study 6

Cell therapy Tracking System and beyond

Identifying the IT solution to build a customized solution

  • Situation – next generation cell therapy startup looking for a IT platform to build their new approach to cell therapies
  • Solution – Identification of key current and upcoming actors in the cell therapy field (CoC and CoI) field and engagement to co-develop a new solution starting with a strong recognized basis.

Case study 7

Medical device development support

Helping develop a inhaler device for a mid-size biotech

  • Situation – make or buy strategy analysis, business continuity and IP focus. Identification of actors in the field and engagement based on key focuses
  • Solution – identification of partner through procurement process allowing timely production start based on fully owned manufacturing license allowing second source manufacturing potential

Key Consideration

Keep in mind the importance of the long term business continuity (several sources), including sustainability impact and IP impact.