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Simon Hammett, Director of Life Sciences, Deloitte

IMS

IMS

From what to what?
The conversion of bulk-pharmaceutical products to something that is in a patient-ready dosage is something discussed greatly within professional literature. But what does it mean and how has this process changed over the years? As technologies and regulations continually change so too must pharma processes. Where next for this one? Dr Maurice Parlane of the ISPE in New Zealand, talks to World Pharmaceutical Frontiers. 

Paying the price
With a rash of recent studies concluding that some already-to-market drugs may be linked to serious illness (e.g. diabetes treatment and a further recent link between HRT and cancer) it has never been more prevalent for pharma to ensure they are fully protected. With the market changing at such pace, and global regulations moving to match it, what are the steps that manufacturers should be taking to ensure they are adequately covered no matter how long the drug has been in use? World Pharmaceutical Frontiers talks to Jean Duvall, general counsel at Ferring and Dr. Steven Galson, director of the CDER, FDA.

The future with RNAi
RNAi technologies have, undoubtedly, changed the way drugs are researched and developed over recent years. But, asks John Rossi, associate director for Laboratory Research, Comprehensive Cancer Center, where did this development begin and more importantly, where is it headed? He takes a look at the key industry players, where investment is coming from and how beneficial it actually is to R&D?

Taming the dragon
A string of scandals has hit the Chinese pharmaceutical industry in recent months, culminating in the execution of the country’s former head of the food and drug safety agency. What lies ahead for the country’s sector, said to be riddled with unscrupulous manufacturers, and how can the authorities put it right? World Pharmaceutical Frontiers talks to Raj Long, executive director for the Asia-Pacific at Bristol Mysers Squib, senior analyst Shijie Guo at Research in China and Dr Engerlbert Guenster Asia area manager for Boehringer-Ingelheim.

Securing the supply
With the world now more security conscious than ever what can pharma do to ensure the security and safety of their products? Recent terrorist attempts to attack in ways previously unthinkable has drawn public attention to the fact that we are now not as safe as we used to be. How can the pharma industry protect against attacks such as deliberate contamination and what are the risks that such threats actually pose? World Pharmaceutical Frontiers hears from Andrew Jackson, deputy global head, Corporate Security, Novartis.

The Latino swing?
With the developing world looking an increasingly attractive prospect for many industries, what does Latin America offer the pharma market? Clinical trials are an area where pharma can save considerable amounts of money but doing it right is key. How do South American legislation and standards compare with those of the rest of the world, what are the key geopolitical drivers and what should be considered when sourcing subject pools? World Pharmaceutical Frontiers talks to Ernest Egli of Roche South America, Mahabir P Gupta, PhD, research professor of Pharmacognosy at the University of Panama, and Peter Gray, chief executive of iCON to get their thoughts.


Childs play?
Clinical trials are essential to try and ensure the success of a product once it comes to market. Until now these have not involved children, regardless of whether they are the ultimate intended users. However, one leading pedeatrition has called for the testing on children to ensure that drugs are better developed. But what are the ethics surrounding such research and development strategies and would it really help achieve the ultimate goal? World Pharmaceutical Frontiers talks to Professor John Warner, the head of the department of paediatrics at Imperial College, London.

Is it time for a breath of fresh air?
At present aerosol devices intended for the delivery of drugs follow the same design, aimed at delivering medication to a patient at the required dosage. However, these devices fail to take into account the age of the patients as well as an array of other factors. This can prove particularly troublesome for the very young: infants and children. For some time a ‘one size fits all’ approach has been hotly contested by the industry but what are the dangers? How do they translate into everyday treatments and what is and should pharma be doing to address them? Dr Kenneth Deans-Bruce, lecturer in molecular microbiology at King’s College London shares his thoughts.

Pharma pack security
Maintaining packaging integrity is crucial, particularly within pharma. However, it is being compromised by current regulations according to Julian Mount, European director of trade at Pfizer. He looks at the risks associated with re-packaging of medicines, the need for a packaging based medicines authentication, and what Pfizer is doing unilaterally and in coordination with other stakeholders.

Australia – a time to invest?
Whilst the international market for pharma is fragmented and lack parity, it is fair to say that some regions in the world have, in recent times, been able to attract investment through manufacturing and clinical trials – those being the key market drivers. Australia is no exception and can in fact boast healthy investment conditions. Invest Australia, a government agency charged with attracting inward investment, looks at the country’s market conditions and investigates some of the opportunities for investment within the country’s pharma industry, and some of the benefits on offer to foreign investors.

Making IT
For years the so-called ‘IT revolution’ has been changing the way industry operates; helping global business to be done with little effort. IT technologies are helping create more efficient procedures with greater levels of accuracy. But how are they helping the pharma industry, in particular increasing the speed, cost-effectiveness, and accuracy of manufacturing processes? Rudiger Dorn, director of worldwide life sciences at Microsoft, investigates.

What PATential?
Despite concerns over the regulatory burden associated with the implementation of PAT, pharma have nonetheless maintained their determination to innovate. However, governments and other legislators have moved to improve the conditions for investment – steps greatly appreciated by the sector. But what now are the challenges needed to overcome in order to achieve successful PAT implementation? How will it be integrated into existing systems, how can the design processes help reduce the risks and to what cost?