3.3.13 Advanced therapy medicine products

• What is an ATMP?

     a) Advanced Technology Medical Procedure

     b) Advanced Therapeutic Medicinal Product

     c) Advanced Treatment Medical Protocol

     d) Advanced Tissue Management Procedure

  Advanced Therapeutic Medicinal Product
• Which of the following is NOT a category of ATMP?

     a) Gene therapy medicinal product

     b) Somatic cell therapy medicinal product

     c) Biodegradable medical device

     d) Tissue engineered product

  Biodegradable medical device
• Which regulatory agency provides definitions and guidelines for ATMPs?

     a) FDA (Food and Drug Administration)

     b) EMA (European Medicines Agency)

     c) WHO (World Health Organisation)

     d) MHRA (Medicines and Healthcare products Regulatory Agency)

   EMA (European Medicines Agency
• Talimogene laherparepvec is used for the treatment of which condition?

     a) Metastatic melanoma

     b) Breast cancer

     c) Prostate cancer

     d) Leukemia

  Metastatic melanoma
• What type of therapy is talimogene laherparepvec?

     a) Gene therapy

     b) Cell therapy

     c) Tissue engineered product

     d) Combined ATMP

  Gene therapy
• Axicabtagene ciloleucel is commonly known for the treatment of which condition?

     a) Lung cancer

     b) Large B cell lymphoma

     c) Multiple sclerosis

     d) Rheumatoid arthritis

  Large B cell lymphoma
• What is the common name for the treatment using axicabtagene ciloleucel?

     a) CAR-T cell therapy

     b) Immunotherapy

     c) Monoclonal antibody therapy

     d) Stem cell therapy

  CAR-T cell therapy
• Which medical professional is primarily responsible for the governance and management of ATMPs?

     a) Chief Medical Officer

     b) Chief Pharmacist

     c) Chief Regulatory Officer

     d) Chief Clinical Officer

  Chief Medical Officer
• Which of the following is NOT an integral part of ATMP?

     a) Cells embedded in a biodegradable matrix

     b) Somatic cells

     c) Gene-editing technology

     d) Tissue-engineered product

  Gene-editing technology
• What is the main purpose of ATMPs?

      a) To replace traditional medicinal products

      b) To provide a one-time cure for diseases

      c) To enhance the body's immune system

      d) To serve as a preventive measure against diseases

  To provide a one-time cure for diseases
• Which of the following is NOT a component of an ATMP?

      a) Nucleic acids

      b) Proteins

      c) Lipids

      d) Carbohydrates

  Carbohydrates
• What is the main characteristic that distinguishes an ATMP from traditional medicinal products?

      a) It is synthesised in a laboratory

      b) It is derived from living organisms

      c) It is administered orally

      d) It has a longer shelf life

  It is derived from living organisms
• What is the primary focus of gene therapy medicinal products?

      a) Modifying patient behaviour

      b) Modifying the expression of genes

      c) Repairing damaged tissues

      d) Enhancing organ function

  Modifying the expression of genes
• Somatic cell therapy medicinal products primarily involve the manipulation of which type of cells?

      a) Germ cells

      b) Stem cells

      c) Blood cells

      d) Skin cells

  Stem cells
• Which of the following is an example of a tissue-engineered product?

      a) Artificial heart valves

      b) Insulin injections

      c) Chemotherapy drugs

      d) Antibiotics

  Artificial heart valves
• How are combined ATMPs different from regular ATMPs?

      a) They are less effective

      b) They contain additional medical devices

      c) They have shorter shelf life

      d) They are cheaper

  They contain additional medical devices
• In which phase of clinical trials are the majority of ATMPs currently used?

      a) Phase I

      b) Phase II

      c) Phase III

      d) Phase IV

  Phase I
• Which of the following is NOT a challenge associated with the development of ATMPs?

      a) Manufacturing complexity

      b) High cost

      c) Short shelf life

      d) Regulatory hurdles

  Short shelf life
• What role do medical devices play in combined ATMPs?

      a) They serve as a delivery mechanism for the therapy

      b) They provide structural support to the tissues

      c) They enhance the potency of the therapeutic agents

      d) They regulate the body's immune response

  They serve as a delivery mechanism for the therapy
• Who is responsible for ensuring the compliance of ATMPs with regulatory requirements?

      a) Chief Executive Officer

      b) Chief Medical Officer

      c) Chief Regulatory Officer

      d) Chief Financial Officer

  Chief Regulatory Officer