SPECIAL REPORT: OUTSOURCING HEAD IN THE CLOUDS OVER E-TMF DATA MINING FOR SERIALISATION: NO TIME TO DELAY

Transcription

1 Volume 85 Number 10 October 2014 Development Formulation Processing Outsourcing Packaging Equipment Ingredients Regulatory The new platform excipient for tablets, sachets and more first rate filler-binder properties due to excellent compressibility fast and slow disintegrating tablets (chewables, effervescents, suckables, FDDTs ) ideal in sachets for direct oral application or dry suspensions outstanding flow and mixing properties high dilution potential and high content uniformity very low hygroscopicity and excellent stability GMO-free and non-animal origin BENEO-Palatinit GmbH Phone: galeniq@beneo.com DATA MINING FOR personalised medicines 35 As deadlines loom, not all players are as ready as they should be 41 Cloud-based Trial Master Files can bring huge value but not all systems are equal 45 The Smart Excipient PRECISION DRUGS Employing the best tools to progress SERIALISATION: NO TIME TO DELAY HEAD IN THE CLOUDS OVER E-TMF SPECIAL REPORT: OUTSOURCING MEDIA INFORMATION 2015

2 The new platform excipient for tablets, sachets and more first rate filler-binder properties due to excellent compressibility fast and slow disintegrating tablets (chewables, effervescents, suckables, FDDTs ) ideal in sachets for direct oral application or dry suspensions outstanding flow and mixing properties high dilution potential and high content uniformity very low hygroscopicity and excellent stability GMO-free and non-animal origin BENEO-Palatinit GmbH Phone: galeniq@beneo.com DATA MINING FOR Volume 85 Number 10 October 2014 CLICK TO SELECT YOUR PREFERENCE OR SIMPLY SCROLL THROUGH Development Formulation Processing Outsourcing Packaging Equipment Ingredients Regulatory The Smart Excipient PRECISION DRUGS Employing the best tools to progress personalised medicines 35 SERIALISATION: NO TIME TO DELAY As deadlines loom, not all players are as ready as they should be 41 HEAD IN THE CLOUDS OVER E-TMF Cloud-based Trial Master Files can bring huge value but not all systems are equal 45 SPECIAL REPORT: OUTSOURCING ONLINE PRINT FOR BEST RESULTS THIS MEDIA PACK SHOULD BE VIEWED IN ACROBAT READER

3 IN PRINT SPECIAL REPORT: DRUG DISCOVERY Volume 85 Number 10 October 2014 Development Formulation Processing Outsourcing Packaging Equipment Ingredients Regulatory March 2013 The Smart Excipient You may be thinking discovery Let s talk about discoveries The new platform excipient for tablets, sachets and more first rate filler-binder properties due to excellent compressibility fast and slow disintegrating tablets (chewables, effervescents, suckables, FDDTs ) ideal in sachets for direct oral application or dry suspensions outstanding flow and mixing properties high dilution potential and high content uniformity very low hygroscopicity and excellent stability GMO-free and non-animal origin BENEO-Palatinit GmbH Phone: galeniq@beneo.com DATA MINING FOR PRECISION DRUGS Employing the best tools to progress personalised medicines 35 SERIALISATION: NO TIME TO DELAY As deadlines loom, not all players are as ready as they should be 41 HEAD IN THE CLOUDS OVER E-TMF Cloud-based Trial Master Files can bring huge value but not all systems are equal 45 SPECIAL REPORT: OUTSOURCING APPROVED NCE NUMBERS RISE While numbers of new entities bounce back, the targets remain niche vii BUILDING FOR DISCOVERY With its modern facility in Pune (above), SAI looks at outsourcing services in India xiii SAI Life Sciences Discovery Unit - Pune, India SOFTWARE FOR SMARTER R&D Software has evolved to speed discovery R&D without losing flexibility xvi manufacturingchemist.com The pharmaceutical manufacturing sector is remarkable not only for its complexity but also for the speed at which it changes both in terms of technological innovation and the dynamic of the market. The format of Manufacturing Chemist allows us to bring you up to-the-minute developments as well as in-depth technical articles, market analysis and the views and insights of those who are shaping the industry on a daily basis. The experienced editorial team brings you the news as it happens through the constantly updated website, with a monthly digest of the top stories in print, covering research and development, business, drugs, process technology, packaging, laboratory equipment and regulatory affairs. Each issue contains technical articles that pick out the emerging trends and developing technologies across all areas of the pharma supply chain. Every issue includes an Interview feature, where top industry figures have the chance to put industry events in context, discuss current challenges and opportunities and express their hopes and fears concerning what the future may hold for their companies and the sector as a whole. Each month there is a Focus on Pharma special market report. Over the course of the year this looks in detail at ingredients, packaging, drug discovery, process technology, high potency and sterility, clinical trials, personalised medicine, drug delivery, outsourcing, biotechnology and QA/QC. This discrete section of the publication includes an overview of the market and its trends, articles on technical innovations, and new product stories. With its own front cover and contents, Focus on Pharma forms a pull-out library of valuable information. However, because the industry is changing at such a rapid pace, every issue of Manufacturing Chemist also brings you features on the latest technical developments as they occur to ensure that your knowledge base is constantly kept up-to-date across all sectors of the industry. In combination with the Focus on Pharma section, this pipeline of new product and technology articles enables us to give you the best of both worlds: a focused view of the major market sectors as well as details of the latest developments as they happen.

4 2015 EDITORIAL FEATURES JANUARY Focus on Pharma: INGREDIENTS Raw materials, intermediates, excipients, taste-masking, coatings, catalysts, APIs, colourings, enzymes, disintegrants, binders, fillers, compression agents, ligands, peptides, raw materials testing and analysis, mixing and blending FEBRUARY Focus on Pharma: PHARMACEUTICAL PACKAGING Containers, closures, materials, labels, track and trace, anticounterfeiting, tamper-evidence, child-resistance, syringes, cartons, inspection systems, machinery and equipment MARCH Focus on Pharma: DRUG DISCOVERY New clinical entities, proteomics, genomics, pharmacokinetics, gene expression, chiral chemistry, high throughput screening, libraries, assays, bioavailability, purification, chromatography, spectroscopy, conjugation, protein engineering, knock-out genes, gene silencing, gene shuffling, laboratory equipment APRIL Focus on Pharma: PROCESS TECHNOLOGY AND EQUIPMENT Automation and control systems, mixing and blending, pumps and valves, drying, granulation, lyophilisation, extrusion, milling, sieving, materials handling and transfer, reactors, tanks and vessels MAY Focus on Pharma: PRECISION MEDICINE Genomics, regenerative medicine, stem cells, biomarkers, diagnostics, radiolabelling, SNPs, genetic engineering, molecular chemistry, cell therapy, epigenetics JULY/AUGUST Focus on Pharma: QUALITY ASSURANCE Validation, calibration, measurement, testing and analysis equipment, weighing equipment, sampling, vision systems, metal detection, microbiological testing, leak testing, tablet counting, anticounterfeiting, batch identification, particle sizing, stability studies SEPTEMBER Focus on Pharma: DRUG DELIVERY Inhalers, syringes, tablets, ODTs, capsules, injectables, parenterals, soluble films, extended release formulations, chewing gum, transdermal patches, medical devices, nanotechnology, vaccines, containers and closures OCTOBER Focus on Pharma: OUTSOURCING Contract research, contract manufacturing, contract process development, analytical services, consultancy, facility design and build, custom synthesis, contract packing, contract clinical trial services, logistics, waste management NOVEMBER Focus on Pharma: LOGISTICS Cold chain management, shipping services, containers, storage, legislation, GDP, air freight, sea freight, road transport, labelling, hazardous goods, UN certified packaging, time/temperature monitors DECEMBER Focus on Pharma: LEGISLATION AND REGULATORY AFFAIRS Clinical trials Directive, Falsified Medicines Directive, animal testing, validation, international standards, best practice, intellectual property, auditing schemes JUNE Focus on Pharma: BIOTECHNOLOGY Fermentation, culture media, microbiology, mabs, cell culture, biocatalysis, biosensors, purification, bioreactors, peptides, vaccines

5 EXTRA DISTRIBUTION In addition Manufacturing Chemist and Focus on Pharma will be distributed at Informex USA; Pharmapack; Interphex; TechnoPharm; 3C/Medtech; Pharmtech; Chemspec; CPhI JANUARY Shows: Informex, New Orleans, USA 2-5 February FEBRUARY Shows: Pharmapack, Paris, France February APRIL Shows: Interphex, New York, USA April JUNE Shows: ACHEMA, Frankfurt, Germany June, Chemspec Europe, Cologne, Gemany June SEPTEMBER Shows: TechnoPharm, Nuremburg, Germany TBC PPMA, Birmingham, UK TBC OCTOBER Shows: CPhI Worldwide TBC Lab Innovations, UK TBC NOVEMBER Shows: PharmTech Moscow, Russia TBC

6 CIRCULATION AND READERSHIP Manufacturing Chemist is circulated to 7,816 managers, scientists, engineers working for the world s leading companies involved in manufacturing and marketing the world s top selling biopharma and pharmaceutical prescription, generic and over-the-counter medicines. Abbott Laboratories, Alexion, Allergen, Astellas, AstraZeneca, Amgen, Bayer Schering, Baxter BioScience, Biogen Idec, Boehringer- Ingelheim, Bristol Myers Squibb, CSL Ltd, Daiichi-Sankyo, Dendreon, EISAI, Eli Lilly & Co, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Merck Serono, Mylan, Novartis, Novo Nordisk, Otsuka Pharmaceutical, Pfizer, Roche, Sanofi, Takeda Pharma, Teva, Vertex Geographical profile Europe 56% Americas 26% Asia 16% ROW 2% Europe UK 48% Germany 21% France 14% Switzerland 8% Rest of Europe 9% Primary Job function profile R & D, Formulation 28% Production, Manufacturing 24% Packaging 17% Quality Control, Assurance, Validation 12% Purchasing 8% Regulatory Affairs 6% Management 4% Sales & Marketing 1%

7 BENEO-Palatinit GmbH Phone: Volume 85 Number 10 October 2014 ADVERTISEMENT FEATURE Hygienic processing places high demands on the reliability and cleanability of production facilities. Common challenges such as corrosion in pipe systems, valve manifolds and tank installations in different pharmaceutical, chemical and biotech facilities for example can be reduced, thereby reducing costs and improving plant availability - by using multiport valves and multiport-based manifolds. Multi-port solutions such as the Robolux valve were developed with exactly this type of high-purity installation in mind. The stand-out feature of the patented Robolux valve design is that two independent process switching functions can be achieved with one membrane. This reduces the installation space requirement, eliminates T- adapters and minimises the overall number of valves and membranes required. The multiport membrane valves were designed for high-purity installations and make it possible to design complex systems that are considerably more compact than those using conventional fluid control valves. The design is also intended to minimise the internal volume and produce no dead flow zones, which results in a number of advantages: In addition to improved flow and evacuation properties, both cleaning and changeover of the interfaces for the manufacture of other products is easier and faster, with less wastage of expensive chemicals and ingredients. This technology makes it possible to replace two traditional shut-off diaphragm valves and at the same time eliminate all dead legs and one tee-piece with one single valve. When combined with reduced installation and commissioning costs, the Robolux valve delivers a number of crucial advantages to process control within hygienic applications. Bürkert is able to test cleaning cycles and provide 100% reliability on the flow properties and cleanability of the complete valve by using a riboflavin test rig. As part of a factory acceptance test, Bürkert is currently the only manufacturer of fittings and valve interfaces in the world that owns and operates such a test rig. In hygienic applications where CIP / SIP are operated, it is essential to be able to ensure the cleaning cycle is both effective and efficient; a criterion which can be completely fulfilled and demonstrated by Bürkert. As part of the concept to decentralise valve control systems, the Robolux valve can now be combined with Bürkert's ELEMENT control head to provide a complete process solution which is compatible with the entire valve product range. The valves at field level can be equipped with all the required automation components including pilot valves, electrical feedback units and optical status indicators. By integrating an AS interface as a field bus interface, the entire range of advantages of this approach can be fully utilised. All that is required for power supply, feedback and communication is a two-wire line connecting the PLC with up to 62 valves. The new decentralized automation concept can provide a viable and extremely compact alternative to the use of central switching cabinets by integrating all the required automation functions in the control heads themselves. This provides considerable savings in installation costs and also provides commissioning and maintenance engineers with an instant indication of the status of each valve, which reduces the amount of time required for installation and trouble-shooting. Using the control head as a central unit for the control of the hygienic process valves, enables it to perform all pneumatic actuation, feedback and diagnostic functions, as well as bus communication. A three-colour optical status display with high-power LEDs, which is integrated in the control head, provides for a visual overview of the valve status at the field level. In addition to electrical feedback to the master controller, it also signals the current switching position of the process valve, facilitating diagnosis and maintenance within the system itself. Due to the compatibility of the IP67 ELEMENT control head with a wide range of process control valves from Bürkert and many other manufacturers, greater plant standardisation can be achieved by equipping process system with components from the ELEMENT platform. Fluid Control Centre, 1 Bridge End, Cirencester, Gloucestershire, GL7 1QY, United Kingdom T: +44 (0) E: helen.christopher@burkert.com F: +44 (0) W: Solenoid Valves Process & Control Va alves Pneumatics & Process Interfaces Sensors Transmit ransmitters & Controllers MicroFluidics Mass Flow Controllers Solenoid Control Valves RATES AND DATA Prime positions Communicate your message with a powerful statement in a dominant position. There are a limited number of opportunities to promote brand awareness and publish information on your company, its corporate capabilities and products and services. Development Formulation Processing Outsourcing Packaging Equipment Ingredients Regulatory The Smart Excipient Prime position rates Per insertion d $ Front Cover Inside Front Cover Outside Back Cover Prime positions deliver an unbeatable package that includes a cover position and reserves a double page spread dedicated to communicating your key messages to Manufacturing Chemist subscribers. The new platform excipient for tablets, sachets and more first rate filler-binder properties due to excellent compressibility fast and slow disintegrating tablets (chewables, effervescents, suckables, FDDTs ) ideal in sachets for direct oral application or dry suspensions outstanding flow and mixing properties high dilution potential and high content uniformity very low hygroscopicity and excellent stability GMO-free and non-animal origin DATA MINING FOR PRECISION DRUGS Employing the best tools to progress personalised medicines 35 SERIALISATION: NO TIME TO DELAY As deadlines loom, not all players are as ready as they should be 41 HEAD IN THE CLOUDS OVER E-TMF Cloud-based Trial Master Files can bring huge value but not all systems are equal 45 SPECIAL REPORT: OUTSOURCING NEW INTELLIGENT VALVE FROM BÜRKERT REDUCES PIPEWORK BY SWITCHING MULTIPLE FLOWS The ideal valve for use in a hygienic processing environment is easy to clean using CIP, contains a low internal volume and a minimum number of connections as well as offer super precise flow control abilities. These exact criteria were used to design the revolutionary Robolux valve from Bürkert, which, now compatible with its ELEMENT control heads offers a cost saving, space saving, intelligent field device which is ideally suited for use in pharmaceutical, chemical, food and beverage processing applications. REDUCED INSTALLATION SPACE INTELLIGENT FIELD DEVICE DECENTRALISED CONTROL OPERATIONAL FEEDBACK Ready. Set. Go. With our new Robolux valve block you are always one step ahead. By combining our established Robolux series with our robust ELEMENT EMENT stainless steel actuators, we have created a real winner with prime qualities: internal volume, dead volume and dead legs have been reduced to a minimum, making for easy cleaning and enhancing your plant s oductivity. The compact design and small footprint otprint save space, and the high degree of automation will allow you to clear any hurdle your process. Ta ake your marks! We make ideas flow. Please call +44 (0) , sales.uk@burkert.com or visit Mechanical data 22 manufacturing chemist September 2013 UNIQUE TESTING ABILITY CONTACT BÜRKERT All sizes in mm. Width x Height 1 Front cover 180 x 185 trim 2 Corporate profile, for bleed add 3mm on 420 x 297 trim all edges 3 DPS, for bleed add 3mm on all edges 420 x 297 trim 4 Full page, for bleed add 3mm on all edges 210 x 297 trim 5 Half page horizontal 190 x Half page vertical 90 x Quarter page vertical 90 x Quarter page horizontal 190 x 65 9 Eighth page horizontal 92 x 64 Please supply digitally, ideally a press ready PDF. Alternatively supply as a flat image file (Tiff, Jpeg, EPS, PSD etc) ensuring that all fonts are embedded, the images are high-resolution and the file is CMYK. Magazine advertising rates Single insertion d $ 1 Corporate profile DPS Full page /5 Half page /7 Quarter page Eighth page Book more than one insertion and the rates will be discounted. Inserts, reprints, data rental and recruitment advertisers rates are available on application. Guaranteed right hand page add 15%. For more information contact pharma@hpcimedia.com

8 VISITORS Google analytics report that 656,817 unique people visited Manufacturing Chemist online since Visitors include professionals working for the leading companies involved manufacturing and marketing the world s topselling biopharma and pharmaceutical products. Abbott Laboratories, Alexion, Allergen, Astellas, AstraZeneca, Amgen, Bayer Schering, Baxter BioScience, Biogen Idec, Boehringer-Ingelheim, Bristol Myers Squibb, CSL Ltd, Daiichi-Sankyo, Dendreon, EISAI, Eli Lilly & Co, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Merck Serono, Mylan, Novartis, Novo Nordisk, Otsuka Pharmaceutical, Pfizer, Roche, Sanofi, Takeda Pharma, Teva, Vertex. Visitors were involved in research and development, drug discovery, formulation, analytics, production, containment and sterility, quality assurance/quality control, regulatory affairs and procurement and were responsible for purchasing ingredients, packaging, machinery and equipment, drug delivery, IT, and selecting outsourcing partners.

9 WEBINARS New for 2015 Manufacturing Chemist is able to provide clients with the ability to engage with prospective customers through Webinars. Webinars offer a dynamic and interactive platform for business to engage with potential customers Inform, Educate and Communicate with your target customers in greater detail than alternative marketing channels Receive real-time feedback and questions from potential customers during the event to ensure understanding Create greater impact with your audience by being positioned as an expert in field, and use your Thought Leadership to educate them Manufacturing Chemist has the ability to promote your webinar to your exact target audience We provide the technology to host the webinar as well as moderation services during the live event to ensure a high level of professionalism We provide data capture of the the pre-registrations and those attending the live event, for your sales teams to follow-up We provide opportunity to use the webinar post event as a video unit on your Manufacturing Chemist content marketing solution on our website extending the effectiveness of the event for a further 12 months. (*subject to having purchased this option)

10 CONTENT MARKETING SOLUTION Lists your company, its contact details and a profile of the company. Publishes more information about your company, news, product information, articles/technical papers, events you attend, job vacancies. Medium Rectangle Banner and Leaderboard banners Publish Videos Publish Technical Articles Publish White Papers Publish Job Listings Publish Events Free Banners and articles on weekly newsletters The benefits include: Your company will be tagged to appear at or near the top each time a visitor searches for suppliers, news, products, jobs, events, articles. Product news is published in the Manufacturing Chemist newsletter and sent to more than 10,000 industry professionals. In addition, by inserting key words into your company profile, news, product information, jobs, events and articles about your company will also appear at or near the top of a free text search and provide visitors with information about your company and its capabilities. Full usage stats are available. Rates The price is 2880 for a 12 month contract, equivalent to just 240 per month.

11 COMPANY PROFILE Lists your company, its contact details and a profile of the company. Publish Technical Articles Publish White Papers Publish Job Listings Publish Events The benefits include: Your company will be tagged to appear at or near the top each time a visitor searches for suppliers. In addition, by inserting key words into your company profile it will also appear at or near the top of a free text search and provide visitors with information about your company and its capabilities. Rates The price is 840 for a 12 month contract, equivalent to just 70 per month.

12 NEWSLETTERS Manufacturing Chemist magazine e-alerts for the latest business news, product news, events and technical papers from the global pharmaceutical and biopharma development and manufacturing community. Manufacturing Chemist news is sent to more than 10,000 professionals working for the leading companies involved in manufacturing and marketing the world s top selling biopharma and pharmaceutical products. Top story Press release Rectangle banner Leaderboard Newsletter rates Per insertion d $ Leaderboard banner 728x90 pixels Medium Rectangle 300x250 pixels E-shot d $ Press release Recruitment Top Story

13 ESHOT An e-shot is an excellent opportunity for businesses to communicate with specific sectors of customers within the pharmaceutical industry Within our database of c16,000 registered pharmaceutical professionals it is possible to apply targeting filters such as location and primary job function. Applying these filters ensures that your e-shot is read by only the most relevant prospects. As the exclusive advertiser on the e-shot you have an excellent opportunity to engage with your target customers without competition from other advertisers. The combination of targeting specific customer sectors, the e-shot being a requested product, and being an exclusive advertising opportunity means the e-shot delivers superior results compared to other marketing methods

14 ONLINE ADVERTISING Banners are now sold on the website with a guaranteed number of impressions. Your banner will stay live until it reaches that number. Tag your banner to specific keywords that relate to your business and make each impression really count! Leaderboard 728x90 Medium Rectangle 300x250 Website by impressions 10,000 guaranteed impressions for only 85 per 1000 Leaderboard 728x90 pixels 850 d 1063 $ 1360 Medium rectangle 300x250 pixels CONTACT PHARMA@HPCIMEDIA.COM T +44 (0)

15 CONTACT HPCi Media Limited Unit 1 Vogans Mill Wharf 17 Mill Street London SE1 2BZ Sales Director Adrian Goldfinch Telephone: +44(0) adriang@hpcimedia.com Account Manager Don Phares Telephone: +44(0) donp@hpcimedia.com Editorial Hilary Ayshford Telephone: +44 (0) hilarya@hpcimedia.com Subscriptions hotline Telephone: +44 (0) juliew@hpcimedia.com General enquiries Telephone: +44 (0) info@hpcimedia.com