Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Adeline Siew, PhD

 The European Medicines Agency (EMA) recently conducted a 

 on clinical-trial data and transparency in London following the agency’s decision, made earlier this year, to proactively publish all data from clinical trials and enable interested parties to access to full data sets. Guido Rasi, executive director of the EMA, said as he kicked off the event, “The European Medicines Agency is committed to proactive publication of clinical-trial data, once the marketing-authorisation process has ended. We are not here to decide if we publish clinical-trial data, but how.” 

 Nevertheless, before moving forward with this process, there are several practical and political considerations that need to be addressed and resolved. The purpose of the workshop was to gather the views, interests and concerns from a broad range of institutions, groups and individuals to help the EMA define the modalities of proactive access to clinical-trial data in a way that best serves patients and public health. 

 Transparency is important for building trust and confidence, and the EMA is striving to achieve this by allowing stakeholders to access and reanalyse data from clinical trials. This workshop is a starting point and based on discussions that took place, the EMA will establish policies in close dialogue with its stakeholders in five areas, namely, protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice; and legal aspects. 

 Advisory boards, represented by various parties, will be formed and work on these five topics will commence early next year with final advice from each group anticipated by April 2013. In a 

, the EMA stated that the proactive publication of clinical-trial data is expected come into effect on 1 January 2014. 

Articles

The European Medicines Agency (EMA) recently conducted a workshop on clinical-trial data and transparency in London following the agency's decision to proactively publish all data from clinical trials and enable interested parties to access to full data sets.

Access to Clinical-Trial Data and Transparency Workshop

	No one likes needles, so imagine the benefits of needle-free delivery systems, especially for chronic conditions where lifetime therapy is required, for example rheumatoid arthritis (RA). Patients already have enough stress to deal with and can definitely do without the added fear and anxiety associated with needles. Other advantages of course include the lack of contamination risks and needle stick injuries, plus disposals are easier when you don’t need a bin for sharps.

	Zogenix and Battelle recently conducted a survey on more than 300 patients with RA to investigate the acceptability of self-injectable therapies. The survey was carried out to gain insights on what influenced preference, adoption and adherence to injectables, and how the availability of needle-free alternatives impact a patient’s willingness to use them. Preliminary results showed that 53% of patients were likely to accept a prescription for a self-injectable therapy. Not surprisingly, this figure increased to 70% when patients were offered a needle-free option.

	45% of patients who participated in this survey had phobia of needles; results showed that 8% were ‘extremely’ needle-phobic, 14% considered themselves ‘very’ and 23% were ‘somewhat’ needle-phobia. Another important finding was that 20% would not consider self-injectable therapies.

	Virginia Ladd, president of the American Autoimmune Related Diseases Association, stated the obvious by saying in a 

 that “the ability to increase adoption and adherence to medication in any capacity can significantly help to improve patient outcomes.” She added that drug developers should therefore consider all drug delivery alternatives that can improve adoption, adherence, and persistence with drug therapy.

	Zogenix will be presenting detailed findings of this patient survey at the Injectable Drug Delivery 2013 conference, which will take place in London, UK on 5–6 March. Zogenix and Batelle have partnered in the co-development and co-marketing of Zogenix’s 

 needle-free injection technology for the subcutaneous administration of pharmaceuticals. The first needle-free product commercialised is Sumavel DosePro (sumatriptan) for the treatment of migraine. The technology is also used in Zogenix’s investigational candidate Relday (risperidone) for schizophrenia.

No one likes needles, so imagine the benefits of needle-free delivery systems, especially for chronic conditions where lifetime therapy is required, for example rheumatoid arthritis (RA).

In Favour of Needle-Free Injectables

 Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT). A laboratory-scale reactor of the PreEMT high-pressure protein-refolding technology will be installed at Boehringer Ingelheim's microbial facility in Vienna, Austria. The technology will be used for the development of biopharmaceutical production processes. 

 PreEMT uses high pressure to disaggregate and control the refolding of recombinant proteins to their native structures at yields and efficiencies that cannot be achieved with existing technologies. PreEMT can substantially reduce the cost of manufacturing because of its increased yield and throughput at high protein concentrations. The technology is readily scalable and has been used for the cGMP production of clinical materials for Phase I to Phase III trials. 

 Georg Klima, executive director of Process Science Austria at Boehringer Ingelheim, said in a 

, "This collaboration builds upon the exciting work we have completed with BaroFold over the last 18 months and enhances our strategy to integrate the most innovative technologies for biologic manufacturing. We will be able to leverage BaroFold's high pressure refold technology on a variety of proteins under development at our facility in Vienna." 

Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).

Boehringer Ingelheim Licenses BaroFold's PreEMT High-Pressure Protein-Refolding Technology

As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation. From January onwards, the British Medical Journal (BMJ) will only publish studies on drugs and devices, whether industry funded or not, where there is a commitment to “make the relevant anonymised patient level data available on reasonable request.” The move was fully supported by GlaxoSmithKline (GSK), who is already posting results from all its clinical trials on the company’s website. In a 

, Patrick Vallance, the president of pharmaceuticals R&D at GSK, said, “Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines.”

		GSK’s response is indeed a sharp contrast from Roche. Last month, Dr Fiona Godlee, the editor-in-chief of BMJ, wrote an 

 calling for greater transparency within the pharmaceutical arena, apparently sparked by Roche’s reluctance to disclose complete raw data sets for its influenza drug, Tamiflu (oseltamivir). The data were requested by researchers at Cochrane, who wanted to conduct a meta-analysis on the safety and efficacy of Roche’s antiviral. According to the Swiss drugmaker, the Cochrane group had been provided with 3200 pages of highly detailed information addressing their concerns. Ironically, at least to me, Roche continues to insist that Tamiflu is safe and effective, despite news that it is under investigation by the European Medicines Agency (EMA) for failure to comply with legal obligations to report side effects associated with 19 medicines licensed for use in Europe.

		The European Federation of Pharmaceutical Industries and Associations (EFPIA), whilst acknowledging the importance of advancing transparency in clinical research, has however cautioned that this drive for full disclosure of trial data could potentially caused “significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way.”

, “Medicines should benefit patients. We support measures that enhance the way they are used and enable the industry to continue to innovate. These measures include improved transparency. As a global industry, we are focused on working towards responsible transparency, as shown by the commitments already made. Building on these initiatives, we recognise and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders.” EFPIA further added that apart from personal privacy, commercial confidentiality must be taken into account considering the number of products and new uses that are not protected by patents.

		As the debate on open data gathers momentum, we’ll just have to sit back and watch how the industry responds. After all, what has pharma got to hide if our medicines are really as safe and as effective as claimed by these drugmakers who are making millions, if not billions. Surely we have the right to know.

As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation.

Towards Greater Transparency of Clinical Trials Data

Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The company has invested nearly $20 million in the 12,000-m

) plant, which will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing customer demand in China and other regions in Asia Pacific. The new facility will serve the life-sciences and pharmaceutical industries, including research, diagnostics, and bioproduction, and customers in the chemical, environmental, and electronics industries. More than 150 employees will be housed in this facility and there is room for expansion.

, Marc Casper, president and CEO of Thermo Fisher Scientific said, “China is one of our fastest-growing markets and has been a key contributor to our success. The Suzhou facility builds on our well-established presence in China and is an important next step as we closely align our depth of capabilities with China’s five-year plan to develop strategic industries, including pharmaceutical, healthcare, and environmental.”

Thermo Fisher entered the Chinese market 30 years ago and will manufacture plastic labware and consumables in Suzhou, including sample preparation products and filterware, as well as laboratory refrigerators, freezers, incubators, and centrifuges. The new facility will adopt best global and local manufacturing practices, including ISO9001, ISO14001, and ISO13485 standards to ensure an environmentally friendly and safe work environment.

Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The $20-million plant will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing demand in China and other regions in Asia Pacific.

Thermo Fisher Scientific Opens New Manufacturing Facility in China

Novartis is investing more than half a billion US dollars in the construction of a new state-of-the-art biotechnology production site in Singapore for the manufacturing of drugs based on cell culture technology. The plant, located in Tuas, Singapore, will support the company’s growing biologics portfolio, which currently accounts for a quarter of Novartis’ clinical pharmaceutical research pipeline. 

, Joseph Jimenez, CEO of Novartis, said that this investment further strengthens the company’s strategy to establish key strategic sites based on technological competencies. "We have chosen Singapore as strategic supply point as it offers a wide range of advantages due to its strong local biomedical presence and knowledge, skilled labor as well as proximity to growth markets in Asia." 

Construction is scheduled to begin in early 2013 with the new production facility expected to be fully operational by the end of 2016. The plant will be designed to accommodate small- and large-scale manufacturing of cell-based products for clinical and commercial purposes, which includes monoclonal antibodies for autoimmune, respiratory and oncology indications.

At the moment, Novartis has Lucentis (ranibizumab) and Xolair (omalizumab) in its biologics portfolio and both products have already attained blockbuster status, reaching sales in billions. Developed in collaboration with Genentech/Roche, Lucentis is the only anti-VEGF therapy marketed for the treatment of wet age-related macular degeneration (wet AMD), visual impairment due to diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO). Xolair is a first-in-class anti-IgE antibody approved in more than 90 countries for the treatment of persistent allergic asthma.

Novartis has several operations in Singapore, including the Novartis Institute for Tropical Diseases (NITD), the Novartis Asia-Pacific head offices and two production facilities for Alcon as well as one pharmaceutical manufacturing site. It is anticipated that Singapore will be a technological competence center for both biotechnology and pharmaceutical manufacturing for Novartis in the near future.

Novartis is investing more than half a billion US dollars in the construction of a new state-of-the-art biotechnology production site in Singapore for the manufacturing of drugs based on cell culture technology.