Blog | HemaCare

The Changing Landscape of Clinical Approval

Aug 27, 2019 10:04:00 AM / by Nancy Andon, MSc

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HemaCare is pleased to announce the publication of our latest article [1] in the journal International Clinical Trials (ICT). The paper, entitled “The Landscape of Clinical Approval” describes how changes in the clinical drug approval process are impacting starting material suppliers, and what suppliers are doing to meet increased demands.

Both the FDA in the U.S., and the EMA in the E.U. have rolled out expedited approval pathways in order to accommodate the revolutionary potential of regenerative medicines that address unmet medical needs. These expedited pathways guarantee clinical trial drugs that successfully meet predetermined clinical criteria increased access to regulatory evaluation of the drug’s progress. They also establish eligibility guidelines for priority review and accelerated approval.

ICT-Figure-1 (002)

Accelerated regulatory approval pathways and an expanding clinical trial pipeline are pressuring cell therapy starting material suppliers to expand their collection capacity and find new ways to reduce variability and ensure consistent efficacy. Taylor B, and Clarke D. ICT 2019.

The clinical success of cell and gene therapies and the creation of updated approval pathways have had 2 clear results:

  1. The number of cell and gene therapies filling the clinical pipeline is steadily increasing
  2. The disproportionate number of drug approvals based on new cancer therapies and/or orphan drug status has resulted in a record number of drug approvals based on a single pivotal clinical trial

The upshot of these developments is that starting material suppliers are facing increased demands for cellular materials, as well as increased pressure to ensure that the material provided is of the highest possible quality.

Many of the hospitals and cell collection centers involved in providing apheresis material are already under strain to meet current demands for cell therapy starting materials. These centers are looking to add additional trained staff, expand working hours, and add collection facility space, but resources are often limited. One solution is to develop closer partnerships with the manufacturers developing these therapies, while expanding donor outreach efforts.

Larger cell collection centers are already making efforts to expand cell collection capacity, and also to ensure that quality oversight systems are in place throughout starting material collection and processing. HemaCare recently opened a new 40,000 square foot facility in order to double its donor collection and onsite processing capabilities. This facility will include GMP-compliant cleanrooms as part of the effort to maximize quality and regulatory compliance from the start.

As our new publication states, “The translation of strong cell therapy pipelines into successful life-saving medicines requires a shift in how cell therapy starting materials are viewed and leveraged. Both cell therapy suppliers and pharmaceutical manufacturers must take steps to mitigate risks in terms of variability, efficacy, consistency, and quality oversight of starting materials.”

Please read our new publication here for more information!


  1. Taylor B., and Clarke D. The Landscape of Clinical Approval. ICT. 2019.

Topics: Gene Therapy, Cell Therapy, Drug Discovery

Nancy Andon, MSc

Written by Nancy Andon, MSc

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