This document discusses the importance of pharmacovigilance for biotechnology companies. It notes that the full safety profile of a drug is not known at launch due to limitations of clinical trials. Post-marketing surveillance is needed to continuously monitor a drug's safety profile. It highlights specific challenges for biopharmaceuticals like immunogenicity and difficulties in causality assessment. The document emphasizes the role of registries and pooled clinical trial data in pharmacovigilance for biologics. It also lists some adverse drug reactions peculiar to biopharmaceuticals. Finally, it discusses factors that can affect the scale of pharmacovigilance operations and the consequences of ineffective pharmacovigilance.
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Importance of Pharmacovigilance for a Biotechnology company
1. Importance of Pharmacovigilance for a Biotechnology company Vivek Ahuja, MD Director, Asia Pacific – Pharmacovigilance Baxter Healthcare –Asia Pacific
2. 2 Risks and Benefits Show me a drug without side effects and I shall show you a drug that does not work . - Anon
15. 15 Evolution of the Indications for Diazepam 1974 1968 1967 Year of Introduction 1966 1965 1964 1963 Dermatology GI disorders Obstetrics Cor.throm. Relief of anxiety Sedation Surgery Alcoholism Stress Thy.disorders. Anaesthesia Rheumatism. Urology Poisoning Asthma Tetanus Convulsions Narcotic poisoning
17. 17 Pharmacovigilance The ADR profiles of drugs and their Risk- Benefit balance need to be continuously monitored during their development (Investigational Product Pharmacovigilance) and for their lifetime post-launch (Marketed Product Pharmacovigilance)
18. Traditional small molecule drugs vs. Biopharmaceuticals Complex production process Limited predictability of preclinical to clinical data – hence the need for enhanced Pharmacovigilance A high potential for immunogenicity Adverse events can often be related to an exaggerated pharmacology
19. Difficulties in causality assessment Biopharmaceuticals, are often indicated to treat severe and/or life-threatening diseases in patients who often have other diseases and are treated with concomitant medications
20. Spontaneous data vs. Registries Since biopharmaceuticals are often used in a specialized hospital setting, it is expected that large population-based databases will contain limited information on biopharmaceuticals. Registries have therefore been shown to be an important tool to obtain Pharmacovigilance data.
21. Pooled Data from RCTs In addition to registries, pooling of data from randomized controlled clinical trials has also been shown to serve as a valuable tool E.g.observed 3.3-fold increased risk for malignancies and the 2.0-fold increased risk for serious infections in patients treated with TNF antagonists after pooling of clinical trial data
22. ADRs peculiar to Biopharmaceuticals Occurrence of tuberculosis with the use of (TNF)-alphainhibitors, especially Infliximab (role in immune response to mycobacteria) Dramatically increased incidence of pure red cell aplasia in patients treated with one particular formulation of recombinant human epoetin (immunogenic response to endogenous molecules, which occurred following changes in the manufacturing of epoetinalfa) Cytokine storm occurring in healthy volunteers treated with the superagonist anti-CD28 monoclonal antibody TGN1412 (TeGenero) (cytokine storm had not been seen in the preclinical phases) Hamilton CD. Infectious complications of treatment with biologic agents. CurrOpinRheumatol 2004 Jul; 16 (4):393-8 ImperatoAK, Smiles S, Abramson SB. Long-term risks associated with biologic response modifiers used in rheumatic diseases. CurrOpinRheumatol 2004 May; 16 (3): 199-205 Schellekens H. Immunologic mechanisms of EPO associated pure red cell aplasia. Best Pract Res ClinHaematol 2005 Sep; 18 (3): 473-80 Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006 Sep; 355 (10):1018-28
23. Safety data from Clinical Studies Full safety profile of a drug is limited at the point of marketing due to the limitations of randomized controlled trials, limited sample size & duration & a homogeneous population For biopharmaceuticals - further complicated due to limited data available from animal studies Post marketing safety data therefore offers a valuable and necessary complement to the clinical trials Additional pharmacovigilance (Post-Authorization Safety Studies [PASS] is the recommendation
24. Post Marketing follow up Changes in the complex production and purification processes of biopharmaceuticals can lead to serious health problems. To be able to identify this type of problem at an early stage, activities to improve traceability of the biopharmaceutical responsible for the ADR, for example the specific batch, should specifically be taken into account.