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.

Different types of ATMPs

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.

Personalized Therapy with Advanced Therapy Medicinal Products:
A Paradigm Shift

Personalized therapy with biologics, especially cell and gene therapy products, is a rapidly growing field and represents a paradigm shift in the conventional approach to healthcare. The researchers are unlocking the secrets of how an individual’s genetics impacts his or her likelihood of disease susceptibility, progression and outcomes.

How can we work together for better health?

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