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Harwell Campus SWINDON, 27-Feb-2017 — /EuropaWire/ — A major new £100 million investment by the government into the development of an innovative multi-disciplinary science and technology research centre was announced today (Thursday 23 February 2017) by Business Secretary Greg Clark. The new Rosalind Franklin Institute (RFI) – named in honour of the pioneering British scientist whose use of X-rays to study biological structures played a crucial role in the discovery of DNA‘s ‘double helix’ structure by Francis Crick and James Watson – will bring together UK strengths in the physical sciences, engineering and life sciences to create a national centre of excellence in technology development and innovation. The new Rosalind Franklin Institute will have a hub based at the Harwell campus It will bring together UK expertise to develop new technologies that will transform our understanding of disease and speed up the development of new treatments Part of the government’s Industrial Strategy to maintain the UK’s global leadership in science, innovation and research Business Secretary Greg Clark said: The UK has always been a pioneer in the world of science, technology and medical research. It’s this excellence we want to continue to build on and why we made science and research a central part of our Industrial Strategy – strengthening links between research and industry, ensuring more home-grown innovation continues to benefit millions around the world. Named after one of the UK’s leading chemists, the new Rosalind Franklin Institute will inspire and house scientists who could be responsible for the next great discovery that will maintain the UK’s position at the forefront of global science for years to come. Delivered and managed by the Engineering and Physical Sciences Research Council (EPSRC), the RFI will bring together academic and industry researchers from across the UK to develop disruptive new technologies designed to tackle major challenges in health and life sciences, accelerate the discovery of new treatments for chronic diseases affecting millions of people around the world (such as dementia), and deliver new jobs and long-term growth to the local and UK economies. Chair of the Research Councils and EPSRC Chief Executive, Professor Philip Nelson said: The UK is currently in a world leading position when it comes to developing new medical treatments and technologies in the life sciences. However, other countries are alive to the potential and are already investing heavily. The Rosalind Franklin Institute will help secure the country as one of the best places in the world to research, discover, and innovate. The central hub at Harwell will link to partner sites at the universities of Cambridge, Edinburgh, Manchester and Oxford, Imperial College, King’s College London, and University College London. Industry partners will be on board from the outset, and the Institute will grow over time, as more universities and researchers participate. The work at new Institute will contribute directly to the delivery of EPSRC‘s ‘Healthy Nation’ prosperity outcome, its Healthcare Technologies programme, and to the Technology Touching Life initiative that spans three research councils (the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and EPSRC) and seeks to foster interdisciplinary technology development research across the engineering, physical and life sciences. The development of the RFI has been led by Professor Ian Walmsley, FRS, from the University of Oxford, who said: This is a new joint venture between some of the UK’s leading universities and key partners in industry and research councils. The aim is to speed the application of cutting-edge physical science insights, methods and techniques to health and life sciences by providing an interface between research programmes at the forefront of these areas, co-located at Harwell and connected, dynamically, to the wider UK research base. We anticipate innovative new businesses will grow from this effort over time, as the Institute will engage with a range of key industries from inception. A collaborative joint venture model allows the RFI to make the most of interactions and draw on a wide range of existing research excellence from across the UK. Patrick Vallance, President of R&D at GSK said: We welcome the creation of the RFI which will bring world-leading, multi-disciplinary teams from industry and academia closer together, and will further strengthen the UK as a place to translate excellent science into patient benefit. Through collaboration we will be able to make advances in life science technologies much quicker than we could manage alone. Research at the RFI will initially be centred on five selected technology themes, focusing on next-generation imaging technologies – X-ray science, correlated imaging (combining X-ray, electron and light microscopy), imaging by sound and light, and biological mass spectrometry – and on new chemical methods and strategies for drug discovery. Dame Carol Robinson, FRS, who is leading the RFI‘s biological mass spectrometry theme, and received the 2004 Royal Society Rosalind Franklin Award that recognises outstanding scientific contributions and supports the promotion of women in science, technology, engineering and mathematics, said: It is fitting that this new Institute bears Rosalind Franklin’s name. She achieved so much in a relatively short life and without her work many of the advances that have taken place since would not have come about. Work in the Institute will include development of the next-generation of physical tools including mass spectrometry, instruments for X-ray science and for advanced microscopy – fields directly descended from her research interests. Notes for Editors: The Engineering and Physical Sciences Research Council (EPSRC) As the main funding agency for engineering and physical sciences research, our vision is for the UK to be the best place in the world to Research, Discover and Innovate. By investing £800 million a year in research and postgraduate training, we are building the knowledge and skills base needed to address the scientific and technological challenges facing the nation. Our portfolio covers a vast range of fields from healthcare technologies to structural engineering, manufacturing to mathematics, advanced materials to chemistry. The research we fund has impact across all sectors. It provides a platform for future economic development in the UK and improvements for everyone’s health, lifestyle and culture. We work collectively with our partners and other Research Councils on issues of common concern via Research Councils UK. The Science and Technology Facilities Council (STFC) STFC is keeping the UK at the forefront of international science and tackling some of the most significant challenges facing society such as meeting our future energy needs, monitoring and understanding climate change, and global security. The Council has a broad science portfolio and works with the academic and industrial communities to share its expertise in materials science, space and ground-based astronomy technologies, laser science, microelectronics, wafer scale manufacturing, particle and nuclear physics, alternative energy production, radio communications and radar. STFC operates or hosts world class experimental facilities including in the UK the ISIS pulsed neutron source, the Central Laser Facility, and LOFAR, and is also the majority shareholder in Diamond Light Source Ltd. It enables UK researchers to access leading international science facilities by funding membership of international bodies including European Laboratory for Particle Physics (CERN), the Institut Laue Langevin (ILL), European Synchrotron Radiation Facility (ESRF) and the European Southern Observatory (ESO). STFC is one of seven publicly-funded research councils. It is an independent, non-departmental public body of the Department for Business, Energy and Industrial Strategy (BEIS). The Biotechnology and Biological Sciences Research Council (BBSRC) BBSRC invests in world-class bioscience research and training on behalf of the UK public. Our aim is to further scientific knowledge, to promote economic growth, wealth and job creation and to improve quality of life in the UK and beyond. Funded by Government, BBSRC invested £473M in world-class bioscience, people and research infrastructure in 2015-16. We support research and training in universities and strategically funded institutes. BBSRC research and the people we fund are helping society to meet major challenges, including food security, green energy and healthier, longer lives. Our investments underpin important UK economic sectors, such as farming, food, industrial biotechnology and pharmaceuticals. More information about BBSRC strategically funded institutes. The Medical Research Council (MRC) The Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-one MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. www.mrc.ac.uk Diamond Light Source Diamond Light Source is the UK’s synchrotron science facility, and is approximately the size of Wembley Stadium. It works like a giant microscope, harnessing the power of electrons to produce bright light that scientists can use to study anything from fossils to jet engines to viruses and vaccines. Diamond is used by thousands of academic and industrial researchers across a wide range of disciplines, including structural biology, health and medicine, solid-state physics, materials & magnetism, nanoscience, electronics, earth & environmental sciences, chemistry, cultural heritage, energy and engineering. Many everyday commodities that we take for granted, from food manufacturing to consumer products, from revolutionary drugs to surgical tools, from computers to mobile phones, have all been developed or improved using synchrotron light. Diamond generates extremely intense pin-point beams of synchrotron light. These are of exceptional quality, and range from X-rays to ultraviolet to infrared. Diamond’s X-rays are around 10 billion times brighter than the sun. Diamond is one of the most advanced scientific facilities in the world, and its pioneering capabilities are helping to keep the UK at the forefront of scientific research. 2017 marks a double celebration for Diamond – 15 years since the company was formed, and 10 years of research and innovation. In this time, researchers who have obtained their data at Diamond have authored over 5,000 papers. The institute is funded by the UK Government through the Science and Technology Facilities Council (STFC), and by the Wellcome Trust The Harwell Campus Harwell Campus is a public private partnership between Harwell Oxford Partners, U+I Group PLC and two Government backed agencies, the Science and Technology Facilities Council (STFC) and the UK Atomic Energy Agency (UKAEA). Harwell is one of the world’s most important science and innovation locations. It has a growing reputation as the UK’s gateway to space with over 65 space and satellite applications related organisations located on campus and is now seeing rapid growth in the Life Sciences and HealthTec sector with over 1,000 people working in this field alone at Harwell. In addition to space and life sciences, the campus hosts an array of other key sectors including, Big Data and Supercomputing, Energy and Environment and Advanced Engineering and Materials. With a legacy of many world firsts, the campus comprises 710 acres, over 200 organisations and 5,500 people. Harwell Campus is the UK’s National Science Facility and is among Europe and the world’s leading sites dedicated to the advancement of science, technology and innovation. Having spent 75 years at the forefront of British innovation and discovery, Harwell Campus continues to drive scientific advancements to the benefit of the UK economy and centred around a community hub. Science experts, academics, government organisations, private sector R&D departments and investors create an environment where innovation, collaboration and discovery thrive. Harwell’s Cluster Strategy The Cluster of about 70 Space organisations at Harwell is testament to the power of co-locating industry, academia and the public sector alongside investors and entrepreneurs. The European Space Agency, RAL Space, The UK Space Agency, Airbus, Thales Alenia Space, Lockheed Martin, and Deimos Space UK can all be found on the Campus. This creates many opportunities for collaboration, increasing capability and sharing risk. Being within a Cluster brings access to high-quality common infrastructure, facilities and expertise, alongside exposure to new markets The Harwell vision is to be home to a number of Clusters that exploit the existing strengths of the Campus. The next step is a new HealthTec Cluster that will benefit from the considerable synergies across the life and physical sciences capabilities of the Campus and the Space cluster. These clusters will enrich each other, creating a powerful multidisciplinary environment tailored to problem solving that will allow the UK to compete with the best in the world. The clustering of industries, facilities and science experts has given rise to the term Harwell Effect – and is an ideal model for future science and business innovation programmes. Science clusters drive economic growth. MIT has created businesses with a combined value of $3tn, the equivalent of California’s GDP. Harwell Campus is the only location in the UK with the potential to emulate this success. To find out more about events, open days or the new developments, visit the Harwell Campus website. SOURCE: EPSRC Contact Details In the following table, contact information relevant to the page. The first column is for visual reference only. Data is in the right column. Name: EPSRC Press Office Telephone: 01793 444404


CrowdReviews.com Partnered with SMi to Announce: Boehringer Ingelheim Explore Overcoming Challenges to Industry in the Device Development Process at Asthma & COPD 2017 SMi will return to London once more for the 13th annual Asthma & COPD show taking place on the 29th & 30th March 2017. Stefan Leiner, Chemical-Pharmaceutical Expert from Boehringer Ingelheim will be speaking at this year’s event on "Overcoming challenges to industry in the device development process." Stefan will discuss: moving away from generic development, taking age group into consideration when developing a device; considerations for paediatric and elderly patients, incorporating clinical trials as a key step in obtaining device approval as well as USP regulatory updates on spacers in new devices. In the lead up to the event, SMi conducted a quick Q & A with Stefan to discuss the current landscape of the fields of asthma & COPD: "SMi: What do you see as the greatest hurdle to asthma and COPD treatments? Stefan: One hurdle is the complexity of inhalers: Inhalation therapy requires attentive patients. The second hurdle is the long-term treatment which triggers adherence problems. And thirdly, current therapies are not curing, todays therapies target symptoms, not the cause of the diseases. SMi: What should be done to address this? Stefan: We made some progress to make inhalers easier. However, a lot of research is needed to move to curing – we need new approaches." Inhalers will be just one of the topics discussed throughout the two days. Other talking points include: regulatory updates, formulation development, therapeutic developments, personalised treatments, biologics, biomarkers, COPD updates, The Salford Lung Study and so much more from respiratory experts from MHRA, GSK, Boehringer Ingelheim, Glenmark Pharmaceuticals, Janssen, Teva, AstraZeneca, MedImmune, Mylan, Imperial College of London, Actavis and many more. A CPD certified pre-conference workshop will be hosted alongside the conference by Cambridge Consultants on "The future of Asthma & COPD management; from connected inhalers to therapy management." For further information on the two day agenda or those wishing to attend, visit the event website on Asthma & COPD 2017 is sponsored by Vitalograph and Nemera. For sponsorship packages: Contact Alia Malick on +44 (0)20 7827 6168 or email amalick@smi-online.co.uk For group delegate bookings: Contact Ameenah Begum on +44 (0)20 7827 6166 or email For media enquiries, contact Zoe Gale on +44 20 7827 6138 or 13th annual Asthma & COPD 29-30 March 2017 London, UK www.asthma-copd.co.uk/crowdreview Sponsored by Vitalograph and Nemera Contact e-mail: zgale@smi-online.co.uk Contact tel: +44 (0) 207 827 6166 #asthmacopdsmi About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Naples, FL, February 14, 2017 --( PR.com )-- The 2017 agenda will bring together senior scientists and respiratory and inhalation specialists to discuss ongoing challenges and explore leading strategies to novel treatments and solutions for these respiratory diseases.Stefan Leiner, Chemical-Pharmaceutical Expert from Boehringer Ingelheim will be speaking at this year’s event on "Overcoming challenges to industry in the device development process." Stefan will discuss: moving away from generic development, taking age group into consideration when developing a device; considerations for paediatric and elderly patients, incorporating clinical trials as a key step in obtaining device approval as well as USP regulatory updates on spacers in new devices.In the lead up to the event, SMi conducted a quick Q & A with Stefan to discuss the current landscape of the fields of asthma & COPD:"SMi: What do you see as the greatest hurdle to asthma and COPD treatments?Stefan: One hurdle is the complexity of inhalers: Inhalation therapy requires attentive patients. The second hurdle is the long-term treatment which triggers adherence problems. And thirdly, current therapies are not curing, todays therapies target symptoms, not the cause of the diseases.SMi: What should be done to address this?Stefan: We made some progress to make inhalers easier. However, a lot of research is needed to move to curing – we need new approaches."Inhalers will be just one of the topics discussed throughout the two days. Other talking points include: regulatory updates, formulation development, therapeutic developments, personalised treatments, biologics, biomarkers, COPD updates, The Salford Lung Study and so much more from respiratory experts from MHRA, GSK, Boehringer Ingelheim, Glenmark Pharmaceuticals, Janssen, Teva, AstraZeneca, MedImmune, Mylan, Imperial College of London, Actavis and many more.A CPD certified pre-conference workshop will be hosted alongside the conference by Cambridge Consultants on "The future of Asthma & COPD management; from connected inhalers to therapy management."For further information on the two day agenda or those wishing to attend, visit the event website on www.asthma-copd.co.uk/crowdreview Asthma & COPD 2017 is sponsored by Vitalograph and Nemera.For sponsorship packages: Contact Alia Malick on +44 (0)20 7827 6168 or email amalick@smi-online.co.ukFor group delegate bookings: Contact Ameenah Begum on +44 (0)20 7827 6166 or email abegum@smi-online.co.uk For media enquiries, contact Zoe Gale on +44 20 7827 6138 or zgale@smi-online.co.uk 13th annual Asthma & COPD29-30 March 2017London, UKSponsored by Vitalograph and NemeraContact e-mail: zgale@smi-online.co.ukContact tel: +44 (0) 207 827 6166#asthmacopdsmiAbout SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk


News Article | February 22, 2017
Site: www.PR.com

SMi’s Paediatric Clinical Trials show returns to London for the 11th year on 20th-21st March 2017. London, United Kingdom, February 22, 2017 --( Through a series of interactive conference sessions, presentations and a workshop led by industry experts; the 2017 agenda will discuss current clinical trials, implementation, drug development, recruitment and retention, ethical issues and regulations. Key presentations not to be missed: - Bianca McDade, Director Regulatory Affairs, GSK - Tom Willgoss, Senior Outcomes Research Scientist, Patient-Centred Outcomes Research, Roche - Karl-Heinz Huemer, Scientific Committee Member and Expert, EMA, PDCO - Hernando Patino, Paediatric Drug Development Lead, Johnson & Johnson - Deborah Lee, VP Clinical Development, Insys Therapeutics - Andy Kenwright, Senior Statistical Scientist, Roche - Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech Highlights for 2017: - Update from the EMA on the PDCO's 10 year review into paediatric investigation plans - Discuss clinical trial legislation in the EU and US - Review challenges in paediatric drug development for rare diseases - Optimise approaches to paediatric drug formulation to improve clinical success - Evaluate recruitment and retention - Discuss hot topic of data extrapolation In the lead up to the event SMi have released some pre-conference interviews with some of the speakers. For further insight into the topics being discussed at this year’s conference and an overall look into the paediatric trials field visit the download centre of the event website to access the 2017 speaker interview series. Interviews available to download include: Roche, Insys Therapeutics, Paediatric Research Consultancy, The Birmingham Children’s Hospital and Klausrose Consulting. Countries attending Paediatric Clinical Trials 2017 include: Australia, Austria, Belgium, Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom & USA. For those who are interested in attending register online at the event website www.paediatric-trials.co.uk/prcom Paediatric Clinical Trials 20-21 March 2017 Copthorne Tara Hotel, London, UK www.paediatric-trials.co.uk/prcom Sponsorship enquiries: Contact Alia Malick on: +44 (0) 20 7827 6168 or email amalick@smi-online.co.uk Group bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email abegum@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, February 22, 2017 --( PR.com )-- With just 4 weeks to go, registration will be closing soon for SMi’s Paediatric Clinical Trials 2017. The event will bring together Clinical Operations Leads and Heads of Clinical Trials to review the developments leading to the advancement of paediatric medicines.Through a series of interactive conference sessions, presentations and a workshop led by industry experts; the 2017 agenda will discuss current clinical trials, implementation, drug development, recruitment and retention, ethical issues and regulations.Key presentations not to be missed:- Bianca McDade, Director Regulatory Affairs, GSK- Tom Willgoss, Senior Outcomes Research Scientist, Patient-Centred Outcomes Research, Roche- Karl-Heinz Huemer, Scientific Committee Member and Expert, EMA, PDCO- Hernando Patino, Paediatric Drug Development Lead, Johnson & Johnson- Deborah Lee, VP Clinical Development, Insys Therapeutics- Andy Kenwright, Senior Statistical Scientist, Roche- Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, GenentechHighlights for 2017:- Update from the EMA on the PDCO's 10 year review into paediatric investigation plans- Discuss clinical trial legislation in the EU and US- Review challenges in paediatric drug development for rare diseases- Optimise approaches to paediatric drug formulation to improve clinical success- Evaluate recruitment and retention- Discuss hot topic of data extrapolationIn the lead up to the event SMi have released some pre-conference interviews with some of the speakers. For further insight into the topics being discussed at this year’s conference and an overall look into the paediatric trials field visit the download centre of the event website to access the 2017 speaker interview series. Interviews available to download include: Roche, Insys Therapeutics, Paediatric Research Consultancy, The Birmingham Children’s Hospital and Klausrose Consulting.Countries attending Paediatric Clinical Trials 2017 include: Australia, Austria, Belgium, Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom & USA. For those who are interested in attending register online at the event website www.paediatric-trials.co.uk/prcomPaediatric Clinical Trials20-21 March 2017Copthorne Tara Hotel, London, UKwww.paediatric-trials.co.uk/prcomSponsorship enquiries: Contact Alia Malick on: +44 (0) 20 7827 6168 or email amalick@smi-online.co.ukGroup bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email abegum@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


News Article | February 22, 2017
Site: www.PR.com

Returning to Central London for the 14th year, SMi’s Controlled Release Delivery conference will take place on the 3rd & 4th of April 2017. London, United Kingdom, February 22, 2017 --( Hear from Merck, Novartis, Janssen, Actelion, GSK, Boehringer Ingelheim and many more as they evaluate: generic drug development, biopharmaceutical approaches, oral bioavailability and parenteral drug delivery. Keynote addresses for Controlled Release Delivery 2017: René Holm, Head and Scientific Director, Liquids & Parenterals, from Janssen will be presenting on "Lipid suspensions - how, when and with what?" René will discuss: - What is a lipid based suspension and how could it look from a commercialisation perspective? - When can lipid based suspensions be used to improve the oral bioavailability? - How large a proportion of the compound needs to be solubilised in the lipid phase? - What excipients to use for lipid based formulation? Mark Wilson, Director, Technology Licensing, PTS from GlaxoSmithKline will be speaking on "The development and commercialisation of drug delivery systems Challenges and opportunities," where he will provide attendees with information on the following: - GSK’s experiences in developing technologies - The collaborative “open innovation” approach - Commercialisation challenges – finding the breakthrough application - Examples of successful development and exploitation projects - GSK’s approach to working with other organisations A full speaker line-up and detailed conference agenda is available to download online at www.controlledreleasedelivery.com/prcom. For those looking to attend, there is currently a £100 discount available which expires on 28th February 2017. Controlled Release Delivery Strengthening innovation and overcoming the challenging regulatory landscape 3rd & 4th April 2017 London, UK Sponsored by: Avanti Polar Lipids, Buchi, Data Detection Technologies, Precision NanoSystems and Sirius Analytical www.controlledreleasedelivery.com/prcom Contact Information: For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email: zgale@smi-online.co.uk To register for the conference, visit www.controlledreleasedelivery.com/prcom or contact Ameenah Begum for group bookings on Tel: +44 (0)20 7827 6166 / Email: abegum@smi-online.co.uk To sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, February 22, 2017 --( PR.com )-- The two day conference will provide attendees with 5+ hours of networking time, an exclusive post-conference workshop and 16 thought provoking presentations covering the topics of; innovations in drug delivery; nanoparticles, nanomedicine & QbD, CNS drug delivery and therapeutic applications.Hear from Merck, Novartis, Janssen, Actelion, GSK, Boehringer Ingelheim and many more as they evaluate: generic drug development, biopharmaceutical approaches, oral bioavailability and parenteral drug delivery.Keynote addresses for Controlled Release Delivery 2017:René Holm, Head and Scientific Director, Liquids & Parenterals, from Janssen will be presenting on "Lipid suspensions - how, when and with what?" René will discuss:- What is a lipid based suspension and how could it look from a commercialisation perspective?- When can lipid based suspensions be used to improve the oral bioavailability?- How large a proportion of the compound needs to be solubilised in the lipid phase?- What excipients to use for lipid based formulation?Mark Wilson, Director, Technology Licensing, PTS from GlaxoSmithKline will be speaking on "The development and commercialisation of drug delivery systems Challenges and opportunities," where he will provide attendees with information on the following:- GSK’s experiences in developing technologies- The collaborative “open innovation” approach- Commercialisation challenges – finding the breakthrough application- Examples of successful development and exploitation projects- GSK’s approach to working with other organisationsA full speaker line-up and detailed conference agenda is available to download online at www.controlledreleasedelivery.com/prcom. For those looking to attend, there is currently a £100 discount available which expires on 28th February 2017.Controlled Release DeliveryStrengthening innovation and overcoming the challenging regulatory landscape3rd & 4th April 2017London, UKSponsored by: Avanti Polar Lipids, Buchi, Data Detection Technologies, Precision NanoSystems and Sirius Analyticalwww.controlledreleasedelivery.com/prcomContact Information:For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email: zgale@smi-online.co.ukTo register for the conference, visit www.controlledreleasedelivery.com/prcom or contact Ameenah Begum for group bookings on Tel: +44 (0)20 7827 6166 / Email: abegum@smi-online.co.ukTo sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


WALTHAM, Mass. & VIENNA & LEBANON, N.H.--(BUSINESS WIRE)--Arsanis, Inc., a clinical-stage biopharmaceutical company developing targeted monoclonal antibodies for pre-emptive and post-infection treatment of serious infectious diseases, and Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, announced today they have entered into an agreement under which Arsanis has secured the exclusive, worldwide license to antibodies targeting respiratory syncytial virus (RSV) that were discovered by Adimab. Arsanis will initially focus on the selection of a lead RSV antibody candidate and has received a grant of up to $9.3 million from the Bill & Melinda Gates Foundation to advance the selected antibody to IND filing. “Arsanis’ partnerships with Adimab and the Gates Foundation will allow us to apply our deep expertise in the discovery and development of anti-infective antibodies to advance highly potent human monoclonal antibodies for the prevention of RSV infection,” said Rene Russo, Pharm.D., BCPS, President and Chief Executive Officer, Arsanis. “We believe this approach has the potential to address a significant global need for effective and accessible RSV therapeutics in both developed and developing countries.” Under the agreement with Adimab, Arsanis has exclusively licensed a panel of RSV antibodies for the purpose of evaluating and selecting the best therapeutic leads under an exclusive global development and commercialization license. Adimab will be entitled to receive license fees and development milestones, as well as a royalty on net sales. “We are very pleased that Arsanis and the Gates Foundation are collaborating on this important program. Through our B cell isolation approach, Adimab has identified highly potent antibodies against a number of infectious disease targets. The RSV antibodies licensed to Arsanis include some of the most potent RSV neutralizers reported to date,” said Guy Van Meter, VP of Business Development at Adimab. “This new agreement expands an already successful relationship with Arsanis, under which Arsanis’ lead program ASN100 for S. aureus pneumonia, currently in a Phase 2 clinical study, was discovered.” RSV is a highly contagious virus that causes infections in both the upper and lower respiratory tract. RSV infects nearly every child at least once by the age of two years and is a major cause of hospitalization due to respiratory infection in children, the elderly, and immunocompromised patients. RSV infection typically results in cold-like symptoms but can lead to more serious respiratory illnesses such as croup, pneumonia, bronchiolitis, and in extreme cases, death. RSV infection in the pediatric and adult populations account for more than 300,000 hospitalizations per year in the U.S. In the developing world, RSV is responsible for 30 million cases of acute respiratory tract infection and 200,000 deaths per year. As a result, there is a significant need for novel therapeutics to prevent RSV infection. Arsanis is a clinical-stage biotechnology company leading the development of targeted monoclonal antibodies (mAbs) for pre-emptive therapy and treatment of serious infectious diseases. The company’s current programs address pathogenic processes selectively, aiming to preserve the healthy microbiome and potentially allowing Arsanis to address critical infections without contributing to the problem of resistance. The company is building a broad product pipeline addressing the most important infectious diseases that threaten patients globally. Its lead clinical program, ASN100, is aimed at serious Staphylococcus aureus infections and is being evaluated in a Phase 2 clinical study for the prevention of S. aureus pneumonia in high-risk patients. Arsanis is a U.S. company headquartered in Waltham, Massachusetts, with European research and preclinical development operations headquartered in Vienna, Austria (Arsanis Biosciences GmbH). For more information, please visit the Arsanis website at www.arsanis.com. Adimab has established antibody discovery collaborations with many leading pharmaceutical companies, such as Merck, Novo Nordisk, Biogen, GSK, Roche, Novartis, Eli Lilly, Genentech, Celgene, Gilead, Kyowa Hakko Kirin, Takeda and Sanofi. In addition, Adimab has partnered with several smaller publicly traded companies, such as Acceleron, Merrimack Pharmaceuticals, Kite, Five Prime, as well as leading venture-backed companies including Jounce, Mersana, Alector, Surface Oncology, Potenza, Tizona, Tusk and several academic institutions such as Memorial Sloan Kettering and MD Anderson. The Adimab antibody discovery and optimization platform has also been internalized by several large pharma partners; Adi-inside partners include Merck, Novo Nordisk, Biogen and GSK. Adimab's integrated antibody discovery and optimization platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most aggressive standards for affinity, epitope coverage, species cross-reactivity and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, please visit the Adimab website at http://www.adimab.com.


CARY, NC--(Marketwired - February 08, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Drug Product Contract Manufacturer Quality Benchmarking report reveals that buyers of outsourced drug product manufacturing services value a strong regulatory history and reliable on-time delivery more than low cost when selecting a CMO for drug product manufacturing. The report includes information on respondents' outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the drug product offerings of 70 contract manufacturing organizations. 302 respondents provide rating assessments on 673 service encounters. "A strong regulatory track record topped the list of attributes as the most important factor influencing drug product CMO selection," said Kate Hammeke, Vice President, Market Research at Industry Standard Research. "Reliable on-time delivery placed second and a track record for meeting quality performance metrics came in third. Low cost had fewer than one-in-ten respondents mention it as the most important selection driver. We are hearing this more and more from service buyers. Cost is not necessarily becoming less important, but that multiple factors beyond project price impact overall costs and consequently those attributes outweigh 'low cost' as a selection criterion." The report provides a Consumer Reports-style analysis where each of the 70 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for drug product manufacturing projects. There are several stand-out CMOs this year: Pfizer CentreOne placed among the leaders across each of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics) and Samsung BioLogics received top scores for its Organization Factors and Capabilities. Fareva received top marks for its Delivery Factors and among emerging market CMOs, Wuxi AppTec appeared among the leaders for its Organization Factors. CMO performance attributes evaluated by respondents include Full range of manufacturing for the dosage forms we require, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 20 of the 70 featured contract manufacturers, including AbbVie Contract Manufacturing, Albany Molecular Research Inc. (AMRI), Almac, Baxter BioPharma Solutions, Boehringer Ingelheim, Capsugel, Catalent, Dr. Reddy's CPS, Evonik, Fareva, GSK Contract Manufacturing, Patheon, PCI Pharma Services, Pfizer CentreOne, Piramal Pharma Solutions, Samsung BioLogics, Sandoz, Sanofi CEPiA, Vetter and Wuxi AppTec. For more information on ISR's "Drug Product Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/drug-product-contract-manufacturer-quality-benchmarking-2nd-edition/. Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


Expects Further Growth in Sales and EBITDA, R&D Progress in 2017 The Company today announced its unaudited FY 2016 revenues and cash-balance, estimated EBITDA and 2017 outlook Lyon (France), February 23, 2017 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, published today its unaudited revenues and cash balance, and estimated EBITDA for the fourth quarter and the full year ended December 31, 2016. Audited full year financial results are scheduled to be released on March 23, 2017. Significant sales growth following establishment of new commercial network In 2016, IXIARO®/JESPECT® revenues increased to €53.2 million compared to €30.7 million in 2015, representing a 73.1% year-on-year growth which was supported by robust fourth quarter revenues of €13.1 million. The increase in revenue was largely the result of Valneva taking over marketing and distribution responsibilities for the product in several geographic territories. Valneva expects IXIARO®/JESPECT® revenues to continue to grow double-digit in 2017 through continued marketing and sales efforts and increase in product adoption by travelers. DUKORAL® revenues grew to €24.6 million in 2016 compared to €21.2 million reported in 2015. In the fourth quarter of 2016, DUKORAL® revenues were €9.6 million compared to €8.5 million in the fourth quarter of 2015 primarily due to increased sales in Canada, a country which accounts for more than 50% of global revenue. Valneva will continue to invest in growing the DUKORAL® vaccine by way of promotional efforts and geographic expansion and expects DUKORAL® sales to grow by approximately 10% in 2017. In 2016, Valneva signed 10 new agreements (9 research agreements and 1 commercial agreement) for the development of human and veterinary vaccines on its EB66® platform. GE Healthcare and Valneva also announced the launch of a new cell culture medium, CDM4Avian, to optimize virus productivity in the EB66® cell-line. Valneva also expects that the European Medical Agency's decision in 2016 to issue new guidelines allowing the production of live attenuated vaccines in immortal cell-lines such as EB66® will open new markets for the technology. Valneva will continue to licence its vaccine platform in 2017 and has already signed two new research agreements since the beginning of the year. Clostridium difficile (C. difficile) is the most common infectious cause for nosocomial diarrhea in Europe and the US. There are an estimated 450,000 cases of C. difficile in the US annually[1] and no vaccine against the disease is commercially available. Valneva seeks to partner its Clostridium difficile vaccine candidate and has ongoing discussions with interested parties. Published Phase II data[2]from the most advanced vaccine program targeting primary prevention of Clostridium Difficile Infections (CDI) indicates that Valneva's VLA84 provides a comparable immunological profile to that other product. Phase I clinical trial initiated - First patient vaccinated at the end of January Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection affecting 300,000 Americans each year. Following clearance from the Food & Drug Administration (FDA) and the Belgian authorities at the end of December 2016, Valneva has initiated a Phase I clinical trial in the US and Europe, and vaccinated the first patient at the end of January.In 2017, the company expects to execute the Phase I trial of its Lyme vaccine candidate and to accelerate the program's progression towards Phase II. Valneva also plans to progress at least one additional vaccine candidate from its promising preclinical portfolio into Phase I in the second half of 2017. The pipeline includes candidates against Chikungunya and Zika. Valneva's aggregate fourth quarter 2016 revenues and grants increased by 19.9% to €27.2 million compared to €22.7 million in the fourth quarter of 2015. Product sales in the fourth quarter of 2016 increased to €23.8 million from €17.4 million in the same period of the previous year. The increase in product sales was driven by Valneva's two proprietary vaccines. IXIARO®/JESPECT® sales contributed €13.1 million to revenues in the fourth quarter of 2016 significantly increasing from €5.9 million in the fourth quarter of 2015. DUKORAL® contributed €9.7 million to the fourth quarter 2016 product sales, growing by 11.6% from €8.7 million in the fourth quarter of 2015. Sales of third party products marketed by Valneva decreased to €1.0 million in the past quarter compared to €2.8 million in the fourth quarter of 2015. Revenues from collaborations and licensing in the fourth quarter of 2016 decreased to €2.2 million compared to €3.6 million in the fourth quarter of 2015. Grant income in the fourth quarter of 2016 decreased to €1.1 million from €1.7 million in the fourth quarter of 2015. Valneva's aggregate revenues and grants in the full year 2016 increased to €97.9 million from €83.3 million in 2015. This increase was mainly a result of strong growth of IXIARO®/JESPECT® product sales. Total product sales increased to €80.4 million in the full year 2016 from €61.5 million in the year 2015. IXIARO®/JESPECT® product sales contributed €53.0 million to revenues in 2016 compared to €30.6 million in 2015 representing 73.1% growth. The strong increase was driven by the capturing of additional revenue margins under the new sales and distribution network and also benefited from strong demand from the US military and from private markets in Germany and the UK. DUKORAL® sales contributed €24.6 million to 2016 product sales representing growth of €3.5 million, or 16.8% compared the year 2015. Third Party product sales for the year 2016 decreased to €2.9 million from €9.9 million in the year 2015, due to the fact that several GSK vaccines were no longer marketed by Valneva. Revenues from collaborations and licensing decreased from €16.8 million in 2015 to €13.6 million in the year 2016. Grant income decreased from €5.0 million in 2015 to €3.8 million in 2016. Liquid funds on December 31, 2016 stood at €42.2 million, compared to €42.6 million on December 31, 2015 and consisted of €35.3 million in cash and cash equivalents and €6.9 million in restricted cash. Valneva's full year 2016 estimated EBITDA showed a strong improvement and amounted to an EBITDA profit of €2.8 million, compared to an EBITDA loss of €8.5 million in the year 2015. EBITDA is calculated by excluding depreciation, amortization and impairment charges from the operating loss as recorded under IFRS. EBITDA also excludes gains from bargain purchase in the calculation for the comparator period of the previous year. Final full year 2016 results and audited financial statements will be released on March 23rd, 2017. As previously reported, Valneva's operating loss for the year 2016 will be impacted by €34.1 million of non-cash impairment charges which were recognized in the second quarter following negative Phase II/III study results for the Pseudomonas vaccine candidate and discontinuation of the program. The Company seeks financial returns through focused R&D investments in promising product candidates and growing financial contributions from commercial products, striving towards financial self-sustainability. Valneva's portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including candidates against Clostridium difficile and Lyme Borreliosis. A variety of partnerships with leading pharmaceutical companies complement the Company's value proposition and include vaccines being developed using Valneva's innovative and validated technology platforms (EB66® vaccine production cell line, IC31® adjuvant). Valneva is listed on Euronext-Paris and the Vienna stock exchange and has operations in France, Austria, Great Britain, Sweden, Canada and the US with over 400 employees. More information is available at www.valneva.com. This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the  ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing the information in these materials as of the date of this press release, and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. [1] Lessa et al, Burden of Clostridium difficile Infection in the United States. N Engl J Med 2015;372:825-34


News Article | February 23, 2017
Site: globenewswire.com

SOUTH SAN FRANCISCO, Calif., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, today provided a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2016. "2016 was a year of tremendous progress in Five Prime’s clinical and preclinical pipeline,” said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "We advanced our three clinical-stage programs and look forward to announcing data from each of these programs this year. With a concerted focus on building out our pipeline, we also unveiled three preclinical programs that we advanced into IND-enabling activities. We are on track to meet our goal of filing at least one IND application for a new molecule each year for the foreseeable future, beginning this year.” - Initiated Phase 1b portion of cabiralizumab/OPDIVO trial.  In October 2016, Five Prime initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab with the PD- 1 immune checkpoint inhibitor OPDIVO® (nivolumab) in multiple tumor types. Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the combination in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer. Five Prime expects to complete enrollment in the current Phase 1b trial cohorts in the second half of 2017.      - Advanced the Phase 2 trial of cabiralizumab in patients with tenosynovial giant cell tumor (TGCT), also known as pigmented villonodular synovitis (PVNS). Five Prime expects to complete enrollment of the Phase 2 trial of cabiralizumab in PVNS in the first half of 2017. Five Prime is evaluating clinical measures, including response rate, pain and range of motion in approximately 30 PVNS patients.      - Five Prime plans to seek regulatory guidance on a pivotal trial in diffuse PVNS.     - Five Prime plans to disclose clinical data from the cabiralizumab PVNS trial at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting and from the cabiralizumab immuno-oncology trial in the second half of 2017.  - Opened new gastric cancer cohorts and added a bladder cancer cohort in Phase 1 monotherapy trial of FPA144. Enrollment continues in the expansion portion of the trial, evaluating the safety, PK and efficacy of biweekly 15 mg/kg infusions of FPA144 in patients with gastric cancer whose tumors highly overexpress FGFR2b. During the third quarter of 2016, Five Prime added cohorts to evaluate FPA144 in patients with bladder cancer whose tumors overexpress FGFR2b and in patients with gastric cancer whose tumors express moderate or low levels of FGFR2b. Five Prime reported initial single-agent efficacy and safety data at the ASCO 2016 Annual Meeting and at the ASCO 2016 Gastrointestinal Cancers Symposium.     - Five Prime plans to seek regulatory guidance on a registrational path for FPA144 in combination with chemotherapy as an early-line gastric cancer therapy. - Five Prime plans to make decisions on potential future development of FP-1039 in mesothelioma after data on objective response rate, disease control rate and progression-free survival are mature. Five Prime regained full rights to FP-1039 from GlaxoSmithKline (GSK) in September 2016. GSK is completing the ongoing Phase 1b trial combining FP-1039 with 1st-line pemetrexed and cisplatin in untreated, unresectable mesothelioma. GSK concluded trial recruitment with 25 patients enrolled at the 15 mg/kg dose in June 2016, and continues to dose and follow patients.    - Five Prime plans to disclose clinical data from this program at the European Society for Medical Oncology (ESMO) 2017 Congress. -- An antibody designed for two mechanisms of action: to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4-expressing tumors by ADCC.         -- Investigational New Drug (IND) application planned for the fourth quarter of 2017.         -- A tetravalent agonist antibody designed for greater GITR activation versus conventional antibodies. Conventional GITR agonist antibodies have two GITR binding sites while FPA154 has four.         -- IND application planned for the fourth quarter of 2017.         -- A natural, multi-targeting immune modulator that stimulates T cell responses through three critical pathways: CTLA4 blockade, CD28 agonism (without superagonism) and PD-L1 blockade that removes a potent inhibitory checkpoint.         -- IND planned in 2018. Summary of Financial Results and Guidance: Cash Guidance. Five Prime expects full-year 2017 net cash used in operating activities to be less than $120 million. The company estimates ending 2017 with approximately $300 million in cash, cash equivalents and marketable securities. Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 60580589. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime's website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime's website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call. About Five Prime Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com. Cautionary Note on Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements about (i) the timing of IND filings; (ii) the timing of initiation, progress and scope of clinical trials for Five Prime's product candidates, including regarding the completion of enrollment in such trials; (iii) Five Prime's full-year 2017 net cash used in operating activities; and (iv) the estimated amount of Five Prime's cash, cash equivalents and marketable securities at the end of 2017. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Five Prime's collaborators to support or advance collaborations or product candidates, and unexpected litigation or other disputes. Other factors that may cause Five Prime's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Five Prime's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


News Article | February 16, 2017
Site: www.PR.com

The agenda has been released and registration is now open for SMi’s Pharmaceutical Microbiology USA show. The seventh in its series, this event will take place in San Diego, on the 8th and 9th June 2017. San Diego, CA, February 16, 2017 --( Through a series of presentations from handpicked industry experts, two pre-conference workshops and an additional interactive training session, the agenda will discuss hot topics such as rapid microbiology methods (RMM), risk assessment, challenges in endotoxin recovery, environmental monitoring, sterility assurance, data integrity and much more. Chairs for 2017: - Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK - John Duguid, Senior Director, Research & Development, Vericel Corporation Expert Speaker Line-Up: - Ron Smith, Director, External Supply Integration Quality, Janssen - Ren-Yo Forng, Scientific Director, Amgen - Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda - Elizabeth Hulanick, Microbiologist, Renaissance Pharmaceuticals - Paul Ricciatti, Sterility Assurance Manager, Bimeda - Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting - Akua Gilbert-Arthur, Principal Scientist, Roche Molecular Systems - Jarett Scalzo, QC, Microbiology Manager, Kite Pharma Benefits of attending: - Discuss the challenges involved with microbial control with Takeda - Following the path to efficient sterility assurance with GSK - Bimeda highlight the importance of environmental modelling - Delve into the latest developments in rapid microbial methods with Janssen - Hear the latest on data integrity and compliance with Roche - Take part in an interactive extended training session with Microrite Running alongside the conference will be two pre-conference workshops held on the 7th June. Workshop A: Technologies for Monitoring Contamination Control and Case Studies on Contamination Control. Hosted by Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko, Research Leader, Battelle Memorial Institute. Workshop B: Microbial Required Use for Terminal Sterilization. Hosted by Jerry Dalfors, Principal, JD Technologies For those wanting to attend, there is currently an early bird offer available; book by 28th February to save $300 off the conference price. Register at www.pharma-microbiology-usa.com/prcom Pharmaceutical Microbiology USA is sponsored by Charles River and Rapid Microbiosytems For sponsorship packages: Contact Alia Malick +44 (0) 207 827 6168 or e-mail amalick@smi-online.co.uk. For delegate enquiries: Contact Fateja Begum on +44 (0) 20 7827 6184 or email fbegum@smi-online.co.uk For media enquiries, contact Zoe Gale on +44 (0) 20 7827 6138 or zgale@smi-online.co.uk Pharmaceutical Microbiology USA 8 - 9 June 2017 San Diego, California, USA www.pharma-microbiology-usa.com/prcom Contact e-mail: zgale@smi-online.co.uk Contact tel: +44 (0) 207 827 6184 #smimicrobiology About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk San Diego, CA, February 16, 2017 --( PR.com )-- Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology USA 2017 will address the current challenges and developing trends of the pharmaceutical microbiology field.Through a series of presentations from handpicked industry experts, two pre-conference workshops and an additional interactive training session, the agenda will discuss hot topics such as rapid microbiology methods (RMM), risk assessment, challenges in endotoxin recovery, environmental monitoring, sterility assurance, data integrity and much more.Chairs for 2017:- Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK- John Duguid, Senior Director, Research & Development, Vericel CorporationExpert Speaker Line-Up:- Ron Smith, Director, External Supply Integration Quality, Janssen- Ren-Yo Forng, Scientific Director, Amgen- Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda- Elizabeth Hulanick, Microbiologist, Renaissance Pharmaceuticals- Paul Ricciatti, Sterility Assurance Manager, Bimeda- Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting- Akua Gilbert-Arthur, Principal Scientist, Roche Molecular Systems- Jarett Scalzo, QC, Microbiology Manager, Kite PharmaBenefits of attending:- Discuss the challenges involved with microbial control with Takeda- Following the path to efficient sterility assurance with GSK- Bimeda highlight the importance of environmental modelling- Delve into the latest developments in rapid microbial methods with Janssen- Hear the latest on data integrity and compliance with Roche- Take part in an interactive extended training session with MicroriteRunning alongside the conference will be two pre-conference workshops held on the 7th June.Workshop A: Technologies for Monitoring Contamination Control and Case Studies on Contamination Control. Hosted by Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko, Research Leader, Battelle Memorial Institute.Workshop B: Microbial Required Use for Terminal Sterilization. Hosted by Jerry Dalfors, Principal, JD TechnologiesFor those wanting to attend, there is currently an early bird offer available; book by 28th February to save $300 off the conference price. Register at www.pharma-microbiology-usa.com/prcomPharmaceutical Microbiology USA is sponsored by Charles River and Rapid MicrobiosytemsFor sponsorship packages: Contact Alia Malick +44 (0) 207 827 6168 or e-mail amalick@smi-online.co.uk.For delegate enquiries: Contact Fateja Begum on +44 (0) 20 7827 6184 or emailfbegum@smi-online.co.ukFor media enquiries, contact Zoe Gale on +44 (0) 20 7827 6138 or zgale@smi-online.co.ukPharmaceutical Microbiology USA8 - 9 June 2017San Diego, California, USAwww.pharma-microbiology-usa.com/prcomContact e-mail: zgale@smi-online.co.ukContact tel: +44 (0) 207 827 6184#smimicrobiologyAbout SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


Interactive Training Session on Cleanrooms and Environmental Monitoring at Pharmaceutical Microbiology USA SMi Group presents the seventh in its series, Pharmaceutical Microbiology USA will take place in San Diego, on the 8th and 9th June 2017. San Diego, CA, March 01, 2017 --( Morgan Polen the Subject Matter Expert on Contamination Control from Microrite will be hosting the training session on 'Effects of cleanrooms and barrier systems on environmental monitoring data'. Recent warning letters show that manufacturers of aseptic products are receiving the most 483s; many are related to smoke studies. Smoke / Airflow Visualization tests are often performed by third party certifiers. However, per FDA guidance, dynamic in-situ air pattern analysis is more complex. These studies should be investigative and effective at identifying design flaws or airflow issues. They should be performed using the correct type of smoke, smoke density, and camera angles. Therefore this exclusive one hour interactive training session will cover: • Regulations and guidelines related to smoke studies • Types of smoke (and equipment) used for smoke studies-pros and cons • Execution of an investigative smoke study • Case studies with videos of bad airflows and barrier system flaws • Practical demonstration of smoke vs fog • Discussions on 483s related to smoke studies • Mistakes made during environmental monitoring in barriers with inadequate laminar flow that lead to excursions. Alongside hosting the extended training sessions, Microrite will be providing a presentation throughout the two day conference where they will be joined by GSK, Bimeda, Sanofi, Amgen, Excellent Pharma Consulting, Renaissance Pharmaceuticals, Takeda, Vericel Corporation, Roche, Merck and more. All of the speakers have been carefully handpicked to provide insightful presentations from industry experts who will share recent case studies and discuss the developing trends in the field of pharmaceutical microbiology. Running alongside the conference will be two pre-conference workshops held on the 7th June. Workshop A: Technologies for Monitoring Contamination Control and Case Studies on Contamination Control. Hosted by Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko, Research Leader, Battelle Memorial Institute. Workshop B: Microbial Required Use for Terminal Sterilization. Hosted by Jerry Dalfors, Principal, JD Technologies For those wanting to attend, there is currently an early bird offer available; book by 31st March to save $200 off the conference price. Register at www.pharma-microbiology-usa.com/prcom Pharmaceutical Microbiology USA is sponsored by Charles River and Rapid Microbiosytems For sponsorship packages: Contact Alia Malick +44 (0) 207 827 6168 or e-mail amalick@smi-online.co.uk. For delegate enquiries: Contact Fateja Begum on +44 (0) 20 7827 6184 or email fbegum@smi-online.co.uk For media enquiries, contact Zoe Gale on +44 (0) 20 7827 6138 or zgale@smi-online.co.uk Pharmaceutical Microbiology USA 8 - 9 June 2017 San Diego, California, USA www.pharma-microbiology-usa.com/prcom Contact e-mail: zgale@smi-online.co.uk Contact tel: +44 (0) 207 827 6184 #smimicrobiology About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk San Diego, CA, March 01, 2017 --( PR.com )-- The 2017 agenda will provide, 16 thought provoking presentations, 17 leading expert speakers, 2 pre-conference workshops and an extended interactive training session.Morgan Polen the Subject Matter Expert on Contamination Control from Microrite will be hosting the training session on 'Effects of cleanrooms and barrier systems on environmental monitoring data'.Recent warning letters show that manufacturers of aseptic products are receiving the most 483s; many are related to smoke studies. Smoke / Airflow Visualization tests are often performed by third party certifiers. However, per FDA guidance, dynamic in-situ air pattern analysis is more complex. These studies should be investigative and effective at identifying design flaws or airflow issues. They should be performed using the correct type of smoke, smoke density, and camera angles. Therefore this exclusive one hour interactive training session will cover:• Regulations and guidelines related to smoke studies• Types of smoke (and equipment) used for smoke studies-pros and cons• Execution of an investigative smoke study• Case studies with videos of bad airflows and barrier system flaws• Practical demonstration of smoke vs fog• Discussions on 483s related to smoke studies• Mistakes made during environmental monitoring in barriers with inadequate laminar flow that lead to excursions.Alongside hosting the extended training sessions, Microrite will be providing a presentation throughout the two day conference where they will be joined by GSK, Bimeda, Sanofi, Amgen, Excellent Pharma Consulting, Renaissance Pharmaceuticals, Takeda, Vericel Corporation, Roche, Merck and more. All of the speakers have been carefully handpicked to provide insightful presentations from industry experts who will share recent case studies and discuss the developing trends in the field of pharmaceutical microbiology.Running alongside the conference will be two pre-conference workshops held on the 7th June.Workshop A: Technologies for Monitoring Contamination Control and Case Studies on Contamination Control. Hosted by Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko, Research Leader, Battelle Memorial Institute.Workshop B: Microbial Required Use for Terminal Sterilization. Hosted by Jerry Dalfors, Principal, JD TechnologiesFor those wanting to attend, there is currently an early bird offer available; book by 31st March to save $200 off the conference price. Register at www.pharma-microbiology-usa.com/prcomPharmaceutical Microbiology USA is sponsored by Charles River and Rapid MicrobiosytemsFor sponsorship packages: Contact Alia Malick +44 (0) 207 827 6168 or e-mail amalick@smi-online.co.uk.For delegate enquiries: Contact Fateja Begum on +44 (0) 20 7827 6184 or emailfbegum@smi-online.co.ukFor media enquiries, contact Zoe Gale on +44 (0) 20 7827 6138 or zgale@smi-online.co.ukPharmaceutical Microbiology USA8 - 9 June 2017San Diego, California, USAwww.pharma-microbiology-usa.com/prcomContact e-mail: zgale@smi-online.co.ukContact tel: +44 (0) 207 827 6184#smimicrobiologyAbout SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group

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