Tuesday 26 May 2020

A3 Targeting networks: Systems pharmacology approaches to develop disease-modifying therapies

Progress in cell-biology, genetics, molecular and systems pharmacology has led to a paradigm shift in medicines research. Novel systems therapeutic interventions (STI’s) are personalized treatments aimed at modification of the disease process. The introduction of STI’s has major implications for the therapeutic evaluation in the context of regulatory review and approval. First, as STI’s are typically highly individualized treatments, each patient is treated differently. As a consequence the evaluation has to focus on the efficacy of a procedure rather than a specific product with a fixed composition. Second, as STI’s are designed to modify disease progression, their clinical effects are delayed and may not become manifest  until several months to years after the initiation of the treatment. Traditional statistical techniques for the demonstration of efficacy are invalid in these situations. Finally, STI’s typically target multiple foci in a biological system to overcome resilience. As a result the interactions in the biological system need to be taken into account when designing STI’s.

The focus of this session is on the development of novel systems pharmacology concepts as the scientific basis for therapeutic evaluation and regulatory approval of novel systems therapeutic interventions. As these systems pharmacology concepts have a mechanistic basis, their application may be particularly useful to obtain substantial evidence of effectiveness.

A - Novel Concepts

B3 Manufacturing cell and gene therapies: Current challenges and future trends

B - Advanced Strategies

C3 Genomics: Realising its full potential in clinical practice

C - Effective Translation

D3 Safety culture: From population health to patient care

D - Societal Impact

E3 Pharmaceutical scientists of the future – Ensuring quality

E - Late-breaking topics, special symposia
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A4 Short communications

A - Novel Concepts

B4 Short communications

B - Advanced Strategies

C4 Short communications

C - Effective Translation

D4 Short communications

D - Societal Impact

Lunch, Poster session and Exhibits

K1 Keynote lecture

A5 Gut microbiota in disease and therapy

A - Novel Concepts

B5 Scientific session

B - Advanced Strategies

C5 Taking nanomedicine from bench to bedside: Breaking down the barriers

C - Effective Translation
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D5 More effective but unaffordable? Maintaining the sustainable access to new curative therapies

The 21st century brings the introduction of therapies that can restore health or prevent prematurely fatal conditions (chronic hepatitis C infection, leukemia, lymphoma, rare retinal conditions, immunotherapy, gene and cell therapies. At the advent of this new area, the challenges are what is the potential impact of curative therapies might be, whether HTA bodies and payers are ready for them, what aspects of evaluation may need to be modified or expanded and how we might pay for them.

D - Societal Impact

E5 Integrating artificial intelligence in drug R&D: The evolving role of pharmaceutical scientists

E - Late-breaking topics, special symposia

Banquet