Together for
Advanced Therapies

Different types of ATMPs

Advanced therapy medicinal products or ATMPs are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of life-threatening diseases where one or limited doses have a curative effect.

There is a significant increase in investments in this area which is largely driven by advancements in science and favorable regulatory support.

Active Regenerative Medicine and Advanced Therapy Developers Worldwide

Ongoing Regenerative Medicine and Advanced Therapy Clinical Trials Worldwide

(source: ARM Global Regenerative & Advanced Therapy Medicine Sector Report: H1 2020)

Some of the recent ATMPs that have been granted approvals include Strimvelis, Kymriah, Yescarta, Luxturna and Zolgensma.

Novelty of ATMP makes it the future of medication

Breakthrough treatments resulting from ATMPs allow biopharmaceutical companies to get accelerated regulatory approvals.

Major safety challenges faced by ATMP companies

ATMP companies need to take a long-term approach towards collection and analysis of safety data for maintaining the overall risk-benefit balance.

Novel therapeutic products require a Specialized Safety Expert

Most of the ATMP companies are offering one to two products. These companies are pre-dominantly focused on development and successful commercialization of drugs. However, new technologies and product platforms create uncharted regulatory paths for drug development and marketing authorization.

They require a Safety partner who brings specialized skills to help them strategize and manage their complex Safety requirements throughout their ATMP life cycle.

APCER Life Sciences – Specialized Safety Partner for ATMP Life Cycle Management

We are your trusted Safety Partner for full life cycle management across risk minimization documentation and planning, clinical trials, submission phase, post-approval planning and post-approval.

Our experienced Safety team is proficient in:

  • Complex case processing and long term follow ups
  • Large risk management and REMS programs
  • Multi-therapeutic area expertise including rare diseases and oncology
  • Regulatory support including BLAs and expedited submissions
  • Medical writing for all clinical trial documentations across the ATMP life cycle

We will partner with you to navigate the uncharted Safety landscape within the ATMP life cycle.

APCER Advantage

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Testimonials

  • Medical Director
    APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
    Medical Director
    US-based specialty pharmaceutical company
  • QPPV and Pharmacovigilance Head
    The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
    QPPV and Pharmacovigilance Head
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company
  • Head, Clinical Trial Transparency
    APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
    Head, Clinical Trial Transparency
    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

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