Here is an interview I recorded with Miguel Valenzuela, Head of Business Intelligence and Oversight at Bayer PLC.
Miguel will be presenting on risk-adaptive monitoring at a conference on Risk-Based Approaches to Clinical Trials, held in London on April 24-25, 2013. I am also pleased to confirm that the conference organisers have offered a 15% discount off the full delegate rate for all ClinDev readers. Simply use the code CQ4173ClinDev when registering.
We discuss a variety of topics, including:
- Whether risk-adaptive monitoring is about more than cutting costs
- How performance and quality metrics can facilitate better use of personnel
- What regulators still need to do to help organisations to adopt the approach more quickly
- How quickly risk-adaptive monitoring could be as ubiquitous as EDC is today
The conference will cover all of the key factors which must be taken into consideration when making the transition to a risk-based approach – with the aim of improving efficiency whilst remaining compliant and without impacting deliverables. It is estimated that sponsors can save 23% of trial costs with a risk-based approach… but as Miguel points out, there’s far more to risk-adaptive monitoring than simply cutting costs!
Other speakers at the conference will include:
- Geoff Taylor, Eisai (also interviewed for ClinDev)
- François Beckers, GSK Vaccines
- Patricia Eriksson, Sanofi Pasteur
- Natalia Zurita, Almirall
- Marc Buyse, IDDI & CluePoints
- Daniel Milikowski, AstraZeneca
The decision today by India’s Supreme Court to deny Novartis a patent for its cancer drug Glivec® (imatinib mesylate) has been welcomed by Indian patient activists and generics manufacturers. However, it causes concern for the Swiss pharma company, along with Pfizer, Bayer and Roche, who are currently challenging patent decisions in India for their drugs Sutent, Nexavar and Pegasys respectively. The implications for pharma investment in R&D in India will also be worrying for the growing India CRO sector.
The Supreme Court ruled that the patent application was an example of “evergreening” – making a small alteration to an existing drug in order to gain additional patent protection. The compound is based on a drug originally patented in 1993, and its patent in the USA was granted an extension to expire in 2015. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, stated that “Novartis has never been granted an original patent for Glivec in India” and that the company “provides Glivec free of charge to 95% of patients prescribed the drug in India, currently more than 16,000 patients”.
The ruling also raises questions around global pharma’s willingness to invest in India, which has a massive population although many of them cannot afford conventional drug prices. Issues around protection of Intellectual Property have dogged India for many years, with pharma patenting only being introduced in 2005. Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India, and other companies will doubtless be considering this when distributing their global R&D investment.