Artificial Intelligence: organised chaos or chaos ordered?

Artificial Intelligence: organised chaos or chaos ordered?

I recently attended the 7th DIA India Pharmacovigilance (PV) Conference in Mumbai. One of the sessions was dedicated to the Impact of Artificial Intelligence (AI) and Predictive Sciences in the world of PV. The session was moderated by Moin Don and Anju Agarwal; the panel comprised Mengesh Kulkarni, Saikat Biswas, Retesh Kumar and Saurahb Khurana.

The interaction between the panel of guest speakers and the open floor reminded me of the Mumbai traffic: it was frenetic, loud, comprised of many different thought vehicles and yet despite all this – it traveled in the same direction without any head-on collisions! Continue reading “Artificial Intelligence: organised chaos or chaos ordered?”

DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).

DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).

This first session of the conference, chaired by J Vijay Venkatraman, gave the audience a broad overview of the state of flux in pharmacovigilance, essentially resulting from changes initiated in Europe – the impact of evolving Eudrovigilance, Brexit and E2B R3 were the focal points. Continue reading “DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).”

DIA India 2019 – Keynote Presentation: India Implements Initiatives to Encourage Domestic Clinical Trial Activity and Increase Safety

DIA India 2019 – Keynote Presentation: India Implements Initiatives to Encourage Domestic Clinical Trial Activity and Increase Safety

It may not have been his outright intention, but Dr Y.K. Gupta certainly set the scene and piqued the interest of the eager audience ready to receive information regarding multiple aspects of pharmacovigilance that would be lively debated throughout the following two days. Continue reading “DIA India 2019 – Keynote Presentation: India Implements Initiatives to Encourage Domestic Clinical Trial Activity and Increase Safety”

Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)

Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)

The PVRMS19 was presented at the Omni Shoreham Hotel, Washington DC, January 2019. During the packed three-day event, we learned that many aspect governing the development and subsequent safe and effective use of medicines are in a state of flux… and so they should be. As we learn by our actions (triumphs and failures) we make adjustments to enhance the future investigations and create medicinal agents that are effective and safe, or more precisely, have a benefit that outweighs the risks. Continue reading “Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)”

Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease

Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease

Avatrombopag (Doptelet ®) received its first global approval in the US; this was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease”

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”

Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

In July 2018 durvalumab (Imfinzi ®) received a positive opinion from the Committee for Medical Products for Human Use (CHMP). The committee recommended marketing authorisation for the agent in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells, and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. [1] Continue reading “Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe”

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®) was approved by the Japanese Ministry of Health, Labour and Welfare in July 2018, for maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).[1] Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan”