ATMPs

Offering end-to-end solutions for Advanced Therapy Medicinal Products (ATMPs)

ATMPs

Asphalion’s team has specific expertise and broad scientific background in regulatory strategy, CMC and clinical development in ATMPs.

ATMPs complexity requires specific development approaches and regulatory adaptations to overcome the challenging environment involving ATMPs.

Asphalion can elaborate all regulatory, non-clinical, clinical and CMC documentation required during development, registration and lifecycle of ATMPs. In addition, strategic inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimum time-to-market.

Asphalion’s team has specific expertise and broad scientific background in regulatory strategy, CMC and clinical development in ATMPs.

ATMPs complexity requires specific development approaches and regulatory adaptations to overcome the challenging environment involving ATMPs.

Asphalion can elaborate all regulatory, non-clinical, clinical and CMC documentation required during development, registration and lifecycle of ATMPs. In addition, strategic inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimum time-to-market.

Our Solutions

Advanced Therapy Medicinal Product (ATMP) specific services

  • CMC consultancy
  • Preclinical and clinical regulatory advice
  • GMO Submissions
  • ATMP classification and certification
  • Long-term project management and consulting with investigator groups and biotech companies

 

Regulatory Roadmaps

  • Strategic regulatory and scientific assessment by providing CMC, non-clinical and clinical development plans to bring your product to the patient in the most efficient way
  • Feasibility assessment, including overview of development timelines and costs

 

Scientific Advice

  • Preparation of briefing packages and attendance to the meetings with authorities
  • National Competent Authorities (NCAs) in Europe
  • EMA: Scientific Advice, Protocol Assistance, Innovation Task Force (ITF)
  • FDA: INTERACT, Pre- BLA/NDA, PRE-IND, EOP2

 

Orphan Drugs Designation (ODD)

  • Management of ODD procedure, including pre-submission
  • Preparation of ODD applications, including significant benefit, prevalence calculation and medical plausibility
  • Experience with both EMA and FDA

 

Support in Clinical Trial Application in EU (preparation and submission)

  • Preparation of Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB)
  • Clinical Trial Application (CTA) submission in EU
  • Ad hoc support during Clinical Trial conduction
  • IND Preparation and Submission

 

Regulatory Tools

  • Classification of your company as SME (Small Medium Enterprise)
  • PRIority MEdicines (PRIME) and accelerated assessment
  • Qualification of novel methodologies

 

Paediatric Investigation Plan (PIP) and Pediatric Study Plans (PSPs)

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Why Asphalion?

First MAA for an ATMP in Europe prepared by Asphalion (2005)

Involvement in several Horizon Europe projects with key ATMP investigators and active participation in societies and meetings. Solid network of partners, CMOs and CROs supporting ATMP development

Several years’ experience providing ad hoc regulatory support and project management for several biotech companies and startups working in the ATMPs field

Strong track record in ATMP projects since 2005 providing regulatory support in more than 30 projects including cell therapy (Autologous and allogenic derived stem cells, CAR-T) and gene therapy (Oncolytic viruses, Adeno-associated virus (AAV), Modified Vaccinia Virus (MVA), Plasmids, Lentivirus, Adenovirus (AdV), etc.).

Main benefits

  • Get specialized ATMPs expertise
  • Minimize time-to-market by choosing the best strategy
  • Asphalion provides modular support in all stages of your ATMPs development
  • Our experts are up-to-date with latest developments in this field, maintain an extensive network and are in close contact with authorities and associations

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

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