International Association of
Therapeutic Drug Monitoring and Clinical Toxicology
Fostering education, research and practice in TDM and CT

TDM of Biologics

Núria Padullés-Zamora


Núria Padullés-Zamora
Barcelona, Spain

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Scientific Committees
TDM of Biologics Committee

Murray Barclay


Murray Barclay
Christchurch, New Zealand

Background & Purpose of the Committee

Biologic therapy has revolutionized the treatment of immune mediated inflammatory diseases (IMID), cancer and infectious diseases. However, there is a considerable variation in clinical response to biologic therapy. Primary non-response and loss of therapeutic response to biologics have been attributed to pharmacokinetics (e.g. inadequate trough concentrations) and inflammatory processes (mechanistic failure). In addition, this lack or loss of response may originate from several little-known epigenetic mechanisms. Factors that influence the pharmacokinetics of a biologic should be taken into account (antidrug antibodies, serum albumin, serum levels of C-reactive protein, disease mediated clearance, body weight, and gender among others). Hence, to optimize the efficacy of biologic treatment, there is a need to implement personalized medicine in IMID and oncology. This can be guided by therapeutic drug monitoring (TDM).

The TDM of Biologics Scientific Committee was officially installed in the 2019 IATDMCT Congress. The aims of the committee are:

  • To develop guidelines for the use of TDM of biologics.
  • To encourage the use of TDM of biologics with the aim of optimizing clinical drug use and outcomes.
  • To promote development of PK and PKPD models that can be used for dose adjustment in clinical practice.
  • To provide knowledge of PK and the PK-response interaction.
  • To promote best practice in relation to laboratory analysis of biologics.
  • To enhance collaboration between groups working in the field and disseminate research in this area.
  • To provide information on the measurement and clinical relevance of antibodies to biologics.
  • To focus on harmonization and standardization of assays for TDM.

Activities Held/Committee Initiatives

Contributions to COMPASS 2019:
December 2019: A NEW SCIENTIFIC COMMITTEE HAS BEEN CREATED WITHIN IATDMCT. THE COMMITTEE IS DEDICATED TO PROMOTING THE USE OF THERAPEUTIC DRUG MONITORING OF BIOLOGICS. By Núria Padullés-Zamora, Department of Pharmacy, Hospital Universitari de Bellvitge-HUB. Pharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Program, Institut d’Investigació Biomèdica de Bellvitge-IDIBELL. Barcelona, Spain And Murray Barclay, Gastroenterologist and Clinical Pharmacologist, Christchurch Hospital, Christchurch and Clinical Professor, University of Otago, New Zealand; On behalf of the TDM of Biologics Committee.

Participation in Symposiums and workshops:
Contributions to the scientific program of 17th IATDMCT Congress, Brazil 2019. Proposals for: symposiums.

Minutes of Committee Meetings