The Publications

Clinical Trials Insight 2018 Vol. 2

In this issue, The growth of direct-to-patient (DtP) clinical trial strategies is expected to continue for the foreseeable future. Adopting a DtP approach has the potential to improve recruitment, retention and efficiencies, as well as reduce costs. However, legal and regularity barriers can hinder implementation. Emma Green considers the challenges.

A number of strategies are being developed to help the UK compete in the global research market post-Brexit, including the creation of ‘highthroughputcentres’ to accelerate phase-II and III trials. Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, speaks to Louise Thomas about the potential of these centres to deliver efficient patient-focused clinical trials, thus increasing the speed of getting drugs to market.

Additionally, social media can be harnessed to build strong relationships between sponsors, site physicians and patients. Wolfgang Eglmeier of Witten/Herdecke University talks to Emma Green about how to optimise social media strategies to foster these connections. Plus: the way clinical trials are conducted in the EU will experience a significant shift when Regulation (EU) no. 536/2014 (termed Clinical Trial Regulation) is implemented in 2019. Louise Thomas discusses the key changes arising from this  legislation and how clinical trials will be affected.

Clinical Trials Insight (CTP011)

Finding the right balance of funding in an age of shrinking budgets is a tightrope walk that could easily set a clinical trial back. Andrew Putwain speaks to Didier Basseras, vice-president of clinical supplies at Sanofi, about this issue and how best to tackle it.

Uncontrolled temperature fluctuation during distribution and storage of investigational medicinal products can be a significant source of revenue loss. James Krupa, director of clinical supplies at Shire, speaks about the efficacy of sharing strategies and other best practice.

Also in this issue: Alex Robertson, senior director of supply chain management at AstraZeneca, explores how to develop strategies to optimise supply, drive efficiency and reduce waste in modern trials. Plus, Clinical Trials Insight editor Andrew Putwain speaks to Subrata Bose, head of feasibility operations and recruitment strategy at Bayer.

Clinical Trials Insight 2016 Vol. 2

How do you overcome the challenges of the very end of the clinical supply chain and ensure temperature is maintained through to destination? Julian Piallat, R&D global distribution manager at Sanofi, speaks to Abi Miller about maintaining the correct shipment temperature once a product has reached an investigational site, or even a patient’s home.

How do clinical trials guarantee they have enough participants while meeting tight deadlines? Pharma expert Narinder Chopra considers the benefits of increasing awareness of clinical trials through social media, and designing procedures around patients.

Also in this issue: Pharmaceutical firms frequently rely on CMOs for essential clinical trials materials. Elly Earls explores this crucial relationship in the drug development cycle. Plus, Sarah Williams catches up with the recently seconded head of the TransCelerate comparator network, Janssen’s Jason LaRoche, to find out why a collective approach to comparator supply fosters efficiency and ingenuity

Clinical Trials Insight Vol. 1 2016

Cloud-based temperature-monitoring solutions offer big benefits to pharmaceutical operators, but they're not easy systems to implement. Elly Earls meets Doug Meyer, associate director of clinical drug supply at Biogen; and clinical supply consultant Philip Chou to find out why they're worth the hassle.

The developmental issues have been resolved and now the new drug that is to be used in a clinical trial needs to be packaged and labelled in a way that is economical and compliance-friendly. Kerry Taylor-Smith investigates how best to deal with packaging and labelling processes within global clinical supply chains, and why it can, at times, present problems for trials.

Also in this issue: Large-scale, multinational trials involve more patients than ever before, and the later the stage, the more complex they become. Clinical Trials Insight takes a look at best practice in forecasting for larger studies to help prevent pitfalls and achieve timely drug supply. Plus, Niklas Mattsson at Merck discusses the intricacies of comparator sourcing.

World Pharmaceutical Frontiers 2017 Vol. 1

Transporting medical supplies and pharmaceuticals through complex routes and at precise temperatures requires companies to meet supply chain standards without compromising product quality, often at 24/7 availability. Sophie Peacock speaks to Nikos Konstantinidis at Roche Diagnostics about how the company ensures that overnight shipping of stock is as efficient and safe as possible.

Pharmaceutical companies are producing more drug-device combinations as patients seek simpler ways of administering medicine. What are the key ingredients for successfully launching combination products and how can the industry overcome regulatory challenges? World Pharmaceutical Frontiers asks Paul Jansen, global head of medical devices at Sanofi-Aventis.

Also in this issue: Manfred Maeder of Novartis speaks to Bradford Keen about how patient-centric designs can empower users and the value of applying technology to treatment; Sarah Williams talks to Pfizer’s Sandeep Nema about the challenges of formulating novel excipients, and Graham McCurdy of Abbott Diagnostics discusses how manufacturing processes be automated cost-effectively.

World Pharmaceutical Frontiers 2016 Vol. 2

The field of biologic drug delivery has evolved from low to high-concentration liquid formulations. Dr Kerstin Walke of Boehringer Ingelheim explains how this has had an impact upon development, primary packaging and devices.

Internal capacity gaps need to be solved with the right outsourcing strategy. Kerry Taylor-Smith explains how document-centric organisations can switch to an information-centric setup in order to align better with new identification of medicinal products (IDMP) processes and maximise the mapping of source data systems.

Also in this issue: Minitablets provide a platform for flexible delivery, as Aditya Tatavarti, principal scientist of oral formulation science and technology at Merck Research Laboratories, explains. Plus, World Pharmaceutical Frontiers looks into the dos and don'ts of the current regulatory environment with Aaron Graham, a senior security executive in the pharmaceutical industry.

World Pharmaceutical Frontiers 2016 Vol. 1

For years, pharmaceutical companies have used air freight to transport their cargo, but as cost pressures grow and security concerns rise, some are switching to the oceans. How significant is this shift, and what challenges does it present? World Pharmaceutical Frontiers asks Jeroen Janssens, senior manager at the centre of excellence for packaging and cold chains at GlaxoSmithKline Vaccines.

A new biomedical informatics course at the University of Chicago aims to give medical practitioners the technical knowledge they need to best make use of the technology available. Samuel Volchenboum, the head of the course, speaks to World Pharmaceutical Frontiers about this goal.

Also in this issue: Greg Noone talks to Dr Philippe Rogueda, executive director of inhaler-device consultant Aedestra, about new avenues of research and greater competition from Asian pharmaceutical companies. Plus, Dr Elanor Pinto-Cocozza from Catalent Pharma Solutions speaks about the current challenges in the NCE market.

World Pharmaceutical Frontiers 2015 Vol. 2

There is plenty of hype about 3D printing, across multiple industries, but could it also make its mark on pharmaceutical manufacturing? In this edition of World Pharmaceutical Frontier, Lee Cronin, Regius professor of chemistry at the University of Glasgow, discusses his research and its implications for drug making, producing personalised medicine and unprecedented access to healthcare.

Pharmaceutical manufacturers are attempting to switch from batch processing to continuous methods of production, but there are hurdles to jump, such as the need to monitor critical quality attributes of continuously produced drugs in real time. Process-analytical technology (PAT) provides a framework for achieving this. Markus Krumme of Novartis shares his views.

Also in this issue: Controlled-room-temperature (CRT) technology must now be implemented on previously exempt product lines. We discuss this with Alejandro Rosado García Cano, of Novo Nordisk. Plus, id Dajani, chair of the Royal Pharmaceutical Society's Falsified Medicines Directive Stakeholders Group, discusses the EU's Falsified Medicines Directive.

Clinical Trials Insight Vol. 2 2015

Obtaining comparator drugs can be hard enough, but what is a pharmaceutical company to do when it finds it has a surplus at the end of a trial? Clinical Trials Insight asks Steven Jacobs, president of Global BioPharm Solutions, about the rules governing the sale of unused comparators and what the industry can do to overcome its reluctance to buy them.

Results generated by point-of-care diagnostics are increasingly being used in trials as decision-makers prior to administering treatments or to generate actual trial data. Clinical Trials Insight speaks with Dr Jorge Villacian, chief medical officer at Janssen Research and Development, about the progress being made and how far there is to go.

Also in this issue: Ken Getz of the Tufts Center for the Study of Drug Development reveals how novel patient engagement initiatives are redefining the sponsor-CRO relationship, and Clinical Trials Insight explores best practice for safeguarding the supply chain in trials that require several different therapeutics with Didier Basseras, vice-president clinical supplies at Sanofi.

Clinical Trials Insight Vol. 1 2015

As pharma shifts to more personalised therapies, challenges arise in the way clinical trials are conducted. In this edition of Clinical Trials Insight, Natalie Healey speaks to Pei He, a statistical scientist at Genentech, about how to choose the most appropriate study design for trials that apply biomarkers.

Many sponsor companies choose to outsource their sample testing to central laboratories rather than specialised local facilities. Robert Hoek, global outsourcing manager at Roche, explores the pros and cons of each.

Also in this issue: Richard Markus, VP of global development, head of research and development for biosimilars at Amgen, shares his views on biosimilar clinical trials; the need for transparent packaging information in the EU and US; and Craig Lipset of Pfizer discusses which mobile technologies will most benefit clinical trials leaders.

Clinical Trials Insight Vol. 2 2014

Cloud computing may have become part of the zeitgeist, but what are the challenges of adapting it for clinical trial data, and do the benefits outweigh the risks compared with a single storage system? Dan Ringenbach, R&D IT director at Shire Pharmaceuticals, puts forward a compelling case for having your head in the cloud.

As globalisation continues to pervade the pharmaceutical space, Dr David Gilliland, director of clinical supply operations at Daiichi Sankyo, talks to Clinical Trials Insight about optimal packaging and labelling of materials.

Also in this issue: Jennifer Gewandter of the University of Rochester outlines promising techniques for using POC trials to reduce late-stage attrition rates in drug development; why collaboration is essential to source clinical trial comparator drugs as more sophisticated therapies enter the market; and Niels Vermeer of Utrecht University and the Medicines Evaluation Board discusses his team's study to determine knowledge gained since the implementation of risk management plans.

Clinical Trials Insight Vol. 1 2014

Adaptive clinical trials hold great potential for the drug development process, saving time and money while better targeting patients. But to realise these advantages, a strong methodology and infrastructure are needed, as Terry Katz, director of global data management and statistics at Merck Animal Health, explains.

As clinical trials become more globalised, Western pharmaceutical companies are assessing the pros and cons of conducting them in emerging markets. Clinical Trials Insight speaks to Juan Mendoza, director of clinical supplies at Sanofi, about the strategies pharma companies must adopt as they enter new geographies.

Despite a surge in comparative effectiveness trials internationally, sourcing the necessary comparator drugs is far from easy. Ron Raby of GlaxoSmithKline discusses the logistical and regulatory hurdles. Also in this issue, Juan Mendoza, director of clinical supplies at Sanofi, discusses the strategies pharma companies must adopt as they enter new geographies and Lundbeck's Charlotte Ullits Houlbjerg explains the thought process behind the design of packaging of drugs for clinical trials.

Clinical Trials Insight Vol. 2 2013

Interactive response technologies (IRTs) have been employed for many years as a means of increasing the efficiency of clinical trials. The challenge now is to maximise efficiency gains by more rapidly making IRTs study-specific and integrating them with other systems. Pfizer's Michael Moorman tells Clinical Trials Insight what is being done to achieve this.

Maintaining products within required temperature ranges while in the warehouse is essential, so temperature mapping is a vital process. Jim Banks speaks to Octapharma's Marc-Oliver Rechsteiner about the warehouse in the context of the cold chain.

Also in this issue: Mitsubishi Pharma Europe's Dainius Ulpis explains why he believes the principles behind good data management ought to make submissions relatively straightforward; the Clinical Trials Insight Awards highlight the most influential people making waves in legislation, philanthropy, business and science; and Almirall's Dr Estrella Garcia suggests key factors to consider when choosing a contract research organisation (CRO).

Clinical Trials Insight Vol. 1 2013

The ability to make the best decision is essential. We too often hear of the dangers of bad choices, the delays that they can cause and the costs those delays can equate to. From selecting the right CRO to choosing the most suitable cold chain; establishing an appropriate trial design to finding the right trial site and hence patient recruitment; and opting for one supplier over another to data capture techniques and report the choices made at every stage will have a huge impact on the success or otherwise of a study. In this edition of Clinical Trials Insight Annika Ekelöw shares some thoughts on how it's crucial to engage with CROs more actively if pharmaceutical companies are not to risk their trial in the push to control costs while Craig Coffman discusses how sponsors can ensure their decisions are right for them.

Clinical Trials Insight Vol. 2 2012

In this issue of Clinical Trials Insight, we take a look at the role of temperature monitoring devices in the clinical cold chain. Philip Chou of Elan Pharmaceuticals tells us how the technology has advanced significantly in recent years, and is now playing a major part in maintaining product integrity. Elsewhere in this edition, ICD Research brings us pharmaceutical industry procurement behaviours and strategy, Daiichi Sankyo's Dr David Gilliland explains packaging and converting kits for clinical trials, and Lisa C Feeney and Lauri Sirabella of ExecuPharm help us find the right contract research organisation.

Clinical Trials Insight Vol. 1 2012

Today's innovative, science-led, regulated, international clinical trial sector is worlds apart from that of early medicine. Nevertheless, the principles of this type of research remain the same: to study the safety and efficacy of pharmaceuticals in development. This method of testing can be traced back hundreds of years, although it wasn't until the 18th century that it became widely documented. Today, this type of clinical research is the cornerstone of the pharmaceutical sector and the reason drugs can enter the marketplace in confidence.

In this first edition of Clinical Trials Insight, we hear from Pierre-Yves Lastic about how clinical data management has evolved over the years to the point where industry-wide standards are the next step, ICD Research looks at emerging markets and CRO/CMO recruitment trends, Carol Schaffer discusses the importance of good leadership in clinical studies and Heather DiBenedetto shares her views on how best to ensure you're recruiting the right sample group.

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