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Researchers from the University of Toronto have published an overview of clinical trial and health data transparency across the Americas. We speak to the report authors to find out more. Plus, we examine the manufacturing challenges associated with gene and cell therapies, and explore how Amazon’s Pillpack acquisition could rattle the industry.

Also, we take a look at the evolving role of biomarkers in cancer drug development, examine the highs and lows of hormone replacement therapy drugs, and find out how Verge Genomics employs proprietary genomic datasets to create some of the field’s largest, comprehensive sources for ALS and Parkinson’s data.

Finally, we explore what life sciences firms can achieve with AI, find out why setting practical parameters can help to provide more accurate regulatory resourcing, and we find out why cannabis branding will be key to grabbing the attention of consumers in fledgling markets.

In this issue

Clinical trial transparency in the Americas 
A new paper published in the British Medical Journal by two University of Toronto researchers has provided an overview of clinical trial and health data transparency across the Americas. While real strides have been made, more progress is needed, especially as some countries still don’t impose registration of trials in a publicly accessible registry. Sally Turner spoke to the report authors to find out more.
Read the article here.

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Gene and cell therapies: making manufacturing work
Gene and cell therapies are potentially revolutionary, but complex science and manufacturing issues could hold them back in the market. Abi Millar speaks to Dr Pascale Bouillé of France-based Flash Therapeutics, a brand new gene therapy manufacturing and development company, to find out what challenges need to be overcome.
Read the article here.

Amazon and PillPack: an unstoppable pharmacy force?
After months of speculation over Amazon’s ambitions in the healthcare space, news broke in June that the online retail juggernaut had bought PillPack, a US-based online pharmacy. The move rattled the US pharmacy market, which so far has remained sheltered from high street woes by the fact prescription drugs can’t be readily accessed online. But is that set to change? Chris Lo investigates.
Read the article here.

Cancer trials: making the most of biomarkers
Biomarkers are becoming increasingly important in oncology clinical trials, as they offer a route to more effective (and cost-effective) targeted therapies. Dr David Parker of Precision for Medicine spoke to Abi Millar to discuss the evolving role of biomarkers in cancer drug development.
Read the article here.

The highs and lows of hormone replacement therapy
Hormone replacement therapy for women at menopause has been beset with issues over the past few decades, from safety concerns to drug shortages and rising costs. What are the challenges for research and development in this area and what does the future hold for these drugs? Sally Turner investigates.
Read the article here.

Verge Genomics: employing AI to improve drug discovery     
Verge Genomics has successfully seized the immense opportunities offered by AI and machine learning algorithms to develop new drug discovery processes for neurodegenerative diseases such as Parkinson’s. Allie Nawrat speaks to CEO Alice Zhang to find out how the platform works and why she believes it is superior to traditional approaches.
Read the article here.

What can life sciences firms really achieve with AI?
Artificial intelligence has been one of the most hyped technologies of the past decade. It is used by organisations in a variety of sectors in a multitude of ways, and for an industry such as life sciences the potential for AI to transform is rich. But what is achievable, in both the short term and long term? PwC’s Peter Brandstetter shares his expertise.
Read the article here.

Setting practical parameters for more accurate regulatory resourcing
Submissions workloads are soaring and becoming more complex, so approaches to measuring for success need to become more sophisticated too. Kinapse’s Adrian Leibert explains.
Read the article here.

Cannabis branding: Marketing an industry from the ground up
Later this year, Canadians will be able to legally use cannabis recreati onally for the first time in almost a century, creating an unprecedented opportunity for businesses. But, with many companies entering this fledgling market, cannabis branding will be key to grabbing the attention of consumers. Lucy Ingham finds out more.
Read the article here.

Next issue preview

In the next issue of Pharma Technology Focus, we explore the complex topic of personalised medicine, which looks set to bring an end to the one-size-fits-all approach to traditional medicine. In order to bring these benefits from concept to reality, the pharma industry and supply chain will have to embrace dramatic changes in manufacturing methods, as drug makers switch from producing large batches to small and customised supplies. We find out what needs to change to facilitate the rise of precision medicine.

Also in this special issue, we find out about the economics of CAR-T therapy. While CAR-T looks set to revolutionise and individualise the treatment of cancer, will the world be able to afford the price tag on one of the industry’s most advanced – and expensive – therapies?

Plus, we take a look at a new platform which uses AI to optimise drug combination therapy, and examine the importance of microbiome in precision medicine. Could a better understanding of the community of bacteria, viruses and microorganisms that inhabit the human body supplant genetics as the primary target for precision medicine?