The market for combination products is rapidly expanding. World Pharmaceutical Frontiers considers the directions these developments are taking, the challenges when integrating digital solutions into medical treatments, and how pharma companies can plan for a future.
Patrick Kingsland speaks to ‘Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products’ co-author Stephanie Wilkins about the challenges that cross-contamination still pose within the pharmaceutical industry, and the strategies the guide suggests to combat the issue.
Also in this issue, Erik Agterhuis, senior manager of logistics and EU supply chain at Kite Pharma, outlines the considerations one must make in order to ensure the consistently successful delivery of pharmaceuticals. And: Steve Dew, associate director of combination products and medical devices at Biogen, speaks with Emily Gibbs about the key issues regarding the current prevalence of combination products and the regulatory challenges they pose.
The exposure of a shipment to elevated – or freezing – temperatures can spoil pharma products beyond use. To combat this problem, numerous insulation technologies have been created and innovative ground, air and ocean transportation systems have evolved. But is it enough? Andrea Gruber, head of special cargo at the International Air Transport Association, discusses methods to reduce ‘on-tarmac time’
Needle manufacturers are embracing new polymers while an ageing population is driving the demand for safe prefilled syringes – but could pharma be on the verge of getting rid of needles entirely? Eleanor Wilson explores the state of syringe safety innovation and new developments in needle-free technology.
Also in this issue: Buccal and sublingual drug delivery methods have seen a renaissance. World Pharmaceutical Frontiers highlights the current status of these methods, and looks into the possibilities and limitations. Plus, David Brown, vice-president of technical operations at Alcresta Pharmaceuticals, talks about the importance of securing reliable partners
Eleanor Wilson discusses new EU guidance on transparency and disclosure landscape with Merete Jørgensen at Novo Nordisk and Behtash Bahador of the Centre for Information and Study on Clinical Research Participation.
The overwhelming majority of pharmaceuticals fail when tested in humans, particularly in oncology, where 95% of drugs tested in phase-I trials never make it to market. Kim Thomas speaks with Italo Poggesi, scientific director of global clinical pharmacology/quantitative sciences at Janssen, about how that figure might be brought down.
Also in this issue: Balancing risk and cost is a delicate undertaking where controlled room temperature clinical trial shipments are concerned. Lundbeck Pharmaceuticals’ Lisbeth Nielsen, tells Andrew Putwain how proper monitoring improves safety and saves money. Plus, an integrated data management platform can reduce trial costs and times, as Margaretta Nyilas, senior vice-president, clinical and business operations, at Otsuka Pharmaceutical Development & Commercialization, tells Ross Davies.
The use of injectable biologic therapies and wearables is rising, but present challenges for manufacturers and patients. Dr Olivia Merkel, from Ludwig-Maximilian University in Germany, explains how the industry is addressing these problems.
Philippe François, global head of supply chain management at Novartis, discusses issues such as budget allocation and temperature-maintenance visibility.
Also in this issue: Savvas Koulouridas, general manager at Fagron Hellas, speaks to Bradford Keen about using passive and active packaging to maintain cost-effectiveness, as well as creating a new approach to supply chain management. Plus, World Pharmaceutical Frontiers looks at outsourcing in a special supplement.
While continuing to occupy a smaller market share of drug delivery than oral solid dosage, parenteral formulations are today a major focal point – not least because of rapidly growing interest in biopharmaceuticals. Meanwhile, parenteral-grade excipients continue to be in short supply, are expensive to produce and require stringent test data. Sarah Williams speaks to Sandeep Nema, executive director portfolio and project management, global biologics, at Pfizer, about the challenges of formulating novel excipients, how the industry has progressed in recent years and where future developments might lead.
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, head of device development and commercialisation in biologics technical development and manufacturing at Novartis, speaks to Bradford Keen about how patient-centric designs can empower users and the value of applying technology to treatment.
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.
Peter Johnson works at the Experimental Cancer Medicine Centre and is a professor at the University of Southampton; he talks to Kerry Taylor-Smith about minimising operational challenges in the design of a trial for immune-oncology. We look at how to ensure that protocols are not overly burdensome for the patient, and explain how to overcome operational challenges.
Also in this issue: Pharmaceutical firms frequently rely on CMOs for essential clinical trialsmaterials. Elly Earls explores this crucial relationship in the drug development cycle. Plus, Clinical Trials Insight speaks to Dr Robert Temple, deputy director for clinical science at FDA's Center for Drug Evaluation and Research, about the challenges of working in an increasingly global manner without harmonised international regulations.
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.
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.
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.
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.
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 Garcia 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.
Temptingly cheap and readily available, false pharmaceuticals are a growing, potentially lethal menace. In this issue of World Pharmaceutical Frontiers, Chris Godfrey speaks with the Medicines and Healthcare Products Regulatory Agency's head of enforcement, Alastair Jeffrey, to find out what's new in the war to purge falsified goods from the market and paralyse those perpetrating them.
Pharmaceutical manufacturing processes are falling behind other industries in terms of technology and efficiency, and the advent of personalised medicine requires fundamental changes to be made. Salvatore Mascia, founder of CONTINUUS Pharmaceuticals, puts forward the case for a move towards integrated continuous manufacturing - an opportunity for pharma to save billions while enhancing patient benefit.
Also in this issue: Joel Richard, Ipsen's senior vice-president of peptides, highlights the innovative tablet-manufacturing methods about to take the industry by storm; Aarthi Janakiraman, analyst at Frost and Sullivan, explores how 'smart' packaging techniques can address compliance, sustainability and counterfeiting concerns; and we look at how unwanted clinical trial data could be put to better use.
Inspections are a fact of life for any GMP-licensed manufacturer. While these may seem daunting, they need not be a source of panic if personnel are fully prepared. In this special report, Ross Davies meets Richard Bonner, chairman of the European QP Association, to look at what manufacturing sites can do to ready themselves, as well as the challenges that come with new regulations.
In an industry seeking to improve its green credentials, pharmaceutical companies are realising that packaging is an area ripe for innovation, though ideas for new materials and novel designs may initially take root in the consumer goods market. Johnson & Johnson's director of sustainability Philip Dahlin explains to Jim Banks how new concepts to improve packaging sustainability can find their way in the heavily regulated pharma sector.
Also in this issue: Jon Weisberg of SAFE-BioPharma reports on the DIA's 50th annual meeting, the largest multidisciplinary event for life sciences professionals, and Paul Jansen, associate vice-president of medical device development at Sanofi, explores how the latest advancements in prefilled syringes and auto-injectors are moving healthcare from the hospital to the home.
How secure is your supply chain? While recent years have seen clear improvements in the field, cargo thievery is a growing problem. Charles Forsaith, chair of the Pharmaceutical Cargo Security Coalition, discusses how pharma companies can protect their shipments with a 'layered approach' to cargo security.
Another key problem is counterfeiting. Following the introduction of the US Drug Quality and Security Act (HR 3204) and the EU's Falsified Medicines Directive, Blue Sphere Health's Mark Davison explains what new regulations will mean for pharma companies and the counterfeiters they hope to thwart.
In this issue we also explore the cutting edge of drug delivery, asking Actavis' Philippe Rogueda about the potential for single-dose disposable inhalers (SDDIs). We address interoperable IT solutions with Microsoft's Gabor Fari and explore the benefits of Raman spectroscopy with Dr Sulaf Assi of Bournemouth University. Dr Terence Barnhart of Sandoz discusses the scope for 'lean' manufacturing and Walter Berghahn of the Healthcare Compliance Packaging Council calls for action to promote medication adherence.
As drug companies continue to grapple with a well-documented set of challenges, it is sometimes easy to overlook the positives, but as this issue of World Pharmaceutical Frontiers makes clear, the industry still has plenty to celebrate. The patent cliff has largely been scaled, sterility standards are improving, the regulatory environment stands to benefit from recent technological leaps and companies are cottoning on to the fact that going green can make good business sense. Our awards feature also highlights eight strong leaders, innovators, philanthropists and regulators spearheading change throughout the sector. The most encouraging developments of all, however, surely lie with the drugs themselves. In our cover story, Joel Richard of Ipsen explains how we may be witnessing the emergence of a new, powerful superclass of drug treatments: peptide therapeutics.
Much of what you'll read in this edition of World Pharmaceutical Frontiers to some extent covers regulation. Some articles discuss how existing requirements are making the role of the pharma company more difficult, while others talk about how new requirements will improve safety and security, raising standards within the sector and among its suppliers. In addition to regulatory wranglings, we hear a lot about the other challenges facing pharma: the patent cliff, counterfeiting, increasing costs with dwindling finance and a more challenging geopolitical environment. We also feature GlobalData casting an analytical eye over the biggest M&As of 2012, Kim Steffensen discussing how strengthened regulations my impact on the use of CMOs, and Sudip Das arguing for greater collaboration between pharma and medical device manufacturers.
Pharmaceutical supply chain security has hit the headlines in recent months leading to a raft of new legislative consultations. Andrew Jackson, head of global security and aviation at Novartis, features in our special report, outlining the impact the new legislation will have on the supply chain and explaining how the industry is responding to the proliferation of counterfeit medicines. We also talk to Jo Pisani, PwC, about how collaboration and creativity will overcome the challenges of productivity and funding; Gino Martini, Patrick Cowley and Brian Carlin discuss the FDA's co-crystal classification guidelines; and Bernhard Trout, MIT, reveals the influence of lean engineering and new technology on continuous manufacturing.
Now in its sixth year, the Pharma 40 continues to map the most influential people in the diverse and innovative pharmaceuticals and biotechnology industry. Here, World Pharmaceutical Frontiers presents the definitive list of the top 40 most influential people in the industry as judged by our panel of experts.
Elsewhere in this issue, GlobalData reveals the top ten pharmaceutical companies by revenue, GSK's Susan Howard explains the need for industry-wide standards for electronic clinical data collection and Hugh Pullen of EFPIA tells us how serialisation can help lock counterfeiters out of the legitimate supply chain.
With medicinal drugs becoming increasingly complex, overcoming solubility issues is one of the most common formulation challenges facing pharmaceutical companies today. Bayer HealthCare's Andreas Ohm tells us about some of the ways his company is addressing the problem.
We also hear from Dr Antony Fake and Jacqueline Sawyer, who discuss WHO's Prequalification of Medicines Programme, and Novo Nordisk's Kim Steffensen explains how to successfully work with CMOs in emerging markets.
Combination drugs are becoming increasingly important to pharmaceutical companies, but developing and bringing such products to market is far from easy. This issue, Fangdong Yin of Eli Lilly tells World Pharmaceutical Frontiers about the challenges, and the ways to overcome them.
We talk to Roland Wolf of MARCAR, who reveals how biomarkers can be used to predict the effects of non-genotoxic carcinogens. Tom van Laar tells us that the only way to maximise efficiencies is to integrate IT into the business process. Also, Jean-Marc Bobée and Tassilo Korab discuss the impact that a new EU directive will have on pharma packaging.