GSK Biologicals

King of Prussia, PA, United States

GSK Biologicals

King of Prussia, PA, United States
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News Article | May 18, 2017
Site: www.businesswire.com

BERTRANGE, Luxembourg--(BUSINESS WIRE)--Vesalius Biocapital, the specialist life sciences venture capital investor, announces the first close of its third fund, Vesalius Biocapital III, securing over €65 million of commitments as at 15 May 2017. Until the final closing in 2018, Vesalius Biocapital III will accept new investors on a “rolling closing” basis. Starting immediately, the fund plans to invest in later-stage European life sciences companies across drug development, medtech, diagnostics and digital health, providing capital to support their development. Now in its tenth year, Vesalius Biocapital has raised over €150 million from a renowned investor base for its two previous funds. The firm has completed over 20 investments with lead or co-lead positions, and achieved numerous exits through trade sales and IPO. With a well balanced portfolio between drug development and non-drug development investments, the firm has developed a track-record of strong and consistent financial performance while generating significant returns for its investors. Recent and notable exits include Ogeda (acquired by Astellas for €800 million), Activaero (sold to Vectura for €130 million), Genkyotex (reverse merger on Euronext) and Fovea (acquired by Sanofi for €370 million). Commenting on the first close, Stéphane Verdood, Managing Partner at Vesalius Biocapital III said: “We are very fortunate to have attracted high quality investors to Vesalius Biocapital III in validation of our successful track record. Furthermore, we are glad that a significant number of investors in our previous funds Vesalius Biocapital I and Vesalius Biocapital II are backing us in our new fund. This is an exciting time in healthcare; the industry is at a key inflection point between science, technology and medicine, and our investors support our strategy to invest in companies developing innovative products and technologies.” “While the primary focus is investing in Europe, we want to provide a bridge to enable European companies to access US capital markets, and for North American companies to have access to Europe for development, expansion or access to innovation. To this extent, we have set up a Boston-based US presence to provide support to the portfolio and evaluate new opportunities.” Vesalius Biocapital III will target later-stage European companies in drug development, medtech, diagnostics and eHealth / mHealth, with the goal of investing in 10-15 companies over the lifetime of the fund. Vesalius Biocapital (Vesalius), the specialist life sciences venture capital investor, has supported companies active in human health through venture capital funds since 2007. In the ten years since inception, Vesalius has raised over €150 million in its first two funds, Vesalius Biocapital I and II, and contributed in the development of over 20 companies. The investment portfolio is well balanced between drug development and non-drug development investments and committed to providing capital to science-backed innovation and ambitious entrepreneurs, with a strong focus on exit within five years. The specialist team consists of seasoned life science professionals with healthcare industry, corporate finance and strategy consulting experience, supporting companies through their growth cycle. The team is based in Europe and the USA to explore investment opportunities and valuation potential for the portfolio. For more information: www.vesaliusbiocapital.com New fund Vesalius Biocapital III, launched in April 2017, targets later-stage European life science companies in drug development, medtech, diagnostics and eHealth / mHealth. The fund secured over €65 million of commitments in a first closing in May 2017, with a target size of €150 million. Managing Partners include Guy Geldhof, Marc Lohrmann, Dr Christian Schneider and Stéphane Verdood. Venture Partners are Dr Cees Wortel and Dr David Braga Malta. The Investors Committee comprises independent members Baron Jean Stéphenne M.Sc., M.B.A. (Chairman of the Investors Committee; previously President and General Manager of GSK Biologicals), Dr Hans-Juergen Leuchs (formerly member of the Board of Managing Directors of Boehringer Ingelheim, Ingelheim, Germany), Dr Gaston Matthyssens (Managing Partner Vesalius Biocapital I and Vesalius Biocapital II), Dr Francois Sarkozy (previously co-founder and chairman of Publicis Healthcare Consulting).and Dr Ajit Shetty (until 2012, Chairman of the Board of Directors of Janssen Pharmaceutica, a pharmaceutical company and subsidiary of Johnson & Johnson). For more information on the fund, please visit http://fund3.vesaliusbiocapital.com/


Steele A.D.,Initiative for Vaccine Research | Steele A.D.,University of Limpopo | Madhi S.A.,University of Witwatersrand | Louw C.E.,Madibeng Center for Research | And 7 more authors.
Pediatric Infectious Disease Journal | Year: 2011

Background: Rotavirus and human immunodeficiency virus (HIV) infections are a cause of great public health concern in developing countries. The current study evaluated the safety, reactogenicity, and immunogenicity of RIX4414 vaccine in asymptomatic or mildly symptomatic (clinical stages I and II according to WHO classification) HIV-infected South African infants. Methods: A total of 100 HIV-positive infants aged 6 to 10 weeks enrolled in this double-blind, 1:1 randomized, placebo-controlled study were allocated into 2 groups to receive 3 doses of RIX4414 vaccine/placebo according to a 0-, 1-, and 2-month schedule. Routine vaccines were concomitantly administered. Solicited and unsolicited symptoms were recorded for 15 and 31 days after each dose, respectively. Serious adverse events were recorded throughout the study period. Serum antirotavirus IgA concentrations (enzyme-linked immunosorbent assay, cut-off 20 U/mL) and the immunodeficiency status were determined at screening and 2 months post-Dose 3. Stool samples were analyzed for rotavirus using enzyme-linked immunosorbent assay at predetermined points and during diarrhea episodes. Results: All symptoms (solicited and unsolicited) occurred at a similar frequency in both groups. Six fatal serious adverse events in RIX4414 and 9 in placebo groups were reported. At 2 months post-Dose 3, the seroconversion rates were 57.1% (95% CI: 34-78.2) in RIX4414 and 18.2% (95% CI: 5.2-40.3) in the placebo group. The mean absolute CD4 cell count, CD4 percentage, and HIV-1 viral load were comparable in both groups at screening and 2 months post-Dose 3. Rotavirus shedding peaked at Day 7 after Dose 1 of RIX4414 with prolonged shedding was observed in 1 infant only. Conclusions: Three doses of RIX4414 vaccine was tolerated well by the South African HIV-positive infants. A satisfactory immune response was mounted without aggravating their immunologic or HIV condition. Copyright © 2011 by Lippincott Williams & Wilkins.


Rivera L.,Hospital Maternidad Nuestra Sra Of La Altagracia | Pena L.M.,Hospital Maternidad Nuestra Sra Of La Altagracia | Stainier I.,GSK Biologicals | Gillard P.,GSK Biologicals | And 4 more authors.
Vaccine | Year: 2011

Transmission of excreted vaccine-derived infectious virus from vaccinated to unvaccinated individuals is possible within close contacts. This randomized (1:1), double-blind study evaluated the potential for transmission of human rotavirus vaccine strain, HRV (Rotarix™) from vaccine recipients to unvaccinated close contacts (twins). 100 pairs of healthy twins aged 6-14 weeks at the time of Dose 1 of HRV vaccine/placebo were enrolled and one randomly selected twin from each pair received two vaccine doses and the other received placebo doses (at 2 and 4 months of age). Presence of vaccine strain in the stool samples of placebo recipients was an indicator of transmission. Serial stool samples were tested for rotavirus using ELISA at pre-determined time points; rotavirus positive stool samples were tested with RT-PCR and reverse hybridization assay to identify G1P[8] vaccine strain. If G1P[8] vaccine strain was detected, the complete genome was sequenced to assess the similarity between viral isolates. Immunogenicity and safety of HRV vaccine in transmission cases was assessed. 15 transmission cases were reported in 80 evaluable twins who received placebo and the transmission rate was 18.8% (95% CI: 10.9-29.0%). None of the transmission cases was associated with gastroenteritis symptoms. Anti-rotavirus IgA seroconversion was 62.5% (95% CI: 51.0-73.1%) (HRV) and 21.3% (95% CI: 12.9-31.8%) (placebo) 7-weeks post-Dose 2; seroconversion in transmission cases was 26.7% (95% CI: 7.8-55.1%). Genetic variations or amino acid substitutions in transmission cases were similar to that seen in corresponding vaccine recipients. Transmission of HRV vaccine strain to unvaccinated twins living in close contact occurred, however, they were not associated with increased of gastroenteritis. Whether transmission leads to indirect protection among unvaccinated individuals remains unknown at this stage. © 2011.


Pharma Cold Chain Distribution: Big Pharma, MHRA and Leading Logistics Companies to Meet in London This December at SMi's Cold Chain Distribution SMi Group reports: World Courier, Finnair, MHRA, IATA, Teva, GSK, J&J, Sanofi will meet in London this December at Cold Chain Distribution 2016. London, United Kingdom, November 30, 2016 --( Just a fortnight remains until the SMi Group opens their doors to host the 11th annual conference on Cold Chain Distribution. This year’s event will bring over 120 attendees from all over the world including senior representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments. Further information available at www.coldchain-distribution.com/PrCom. Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more. The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PrCom. "The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair Confirmed attendees include key decision makers from Accord Healthcare, Actelion Pharmaceuticals UK, Al Medicines, Alliance Healthcare, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Brussels Airport Company, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Eli Lilly Italia SpA, Envirotainer, Exelsius, Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Novartis Business Services, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more. “We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” - David Spillett, Key Account Director, World Courier Further information available at www.coldchain-distribution.com/PrCom. Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier. Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, NEFTAG, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport. 11th Annual Cold Chain Distribution Conference and Exhibition Park Plaza Victoria, London, UK 12th-13th December, 2016 www.coldchain-distribution.com/PrCom Sponsors/Exhibitors: Contact Alia Malick on amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum on fbegum@smi-online.co.uk Media Enquiries: Contact Julia Rotar on jrotar@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, November 30, 2016 --( PR.com )-- Over the last 24 months, the new logistics hubs have been established around the globe by forwarders and distributors, in order to service and support a more round-the-clock global network for pharmaceutical product supply. Nonetheless, challenges remain with the increasingly fragile biologics product and tightened GDP regulations.Just a fortnight remains until the SMi Group opens their doors to host the 11th annual conference on Cold Chain Distribution. This year’s event will bring over 120 attendees from all over the world including senior representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments.Further information available at www.coldchain-distribution.com/PrCom.Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more.The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PrCom."The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, FinnairConfirmed attendees include key decision makers from Accord Healthcare, Actelion Pharmaceuticals UK, Al Medicines, Alliance Healthcare, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Brussels Airport Company, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Eli Lilly Italia SpA, Envirotainer, Exelsius, Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Novartis Business Services, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more.“We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” - David Spillett, Key Account Director, World CourierFurther information available at www.coldchain-distribution.com/PrCom.Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier.Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, NEFTAG, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport.11th Annual Cold Chain Distribution Conference and ExhibitionPark Plaza Victoria, London, UK12th-13th December, 2016www.coldchain-distribution.com/PrComSponsors/Exhibitors: Contact Alia Malick on amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum on fbegum@smi-online.co.ukMedia Enquiries: Contact Julia Rotar on jrotar@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


SMi Group reports: World Courier, Finnair, MHRA, IATA, Teva, GSK, J&J, Sanofi will meet in London this December at Cold Chain Distribution 2016 London, United Kingdom, November 17, 2016 --( 11th annual Cold Chain Distribution, taking place in London, UK, on the 12th and 13th of December, brings together 100+ representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments! Further information available at www.coldchain-distribution.com/PRCom Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more. The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PRCom “The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair. Confirmed attendees include key decision makers from Accord Healthcare, Al Medicines, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Envirotainer, Exelsius , Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more! “We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” -David Spillett, Key Account Director, World Courier. Further information available at www.coldchain-distribution.com/PRCom Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier. Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport. 11th Annual Cold Chain Distribution Conference and Exhibition Park Plaza Victoria, London, UK 12th-13th December, 2016 www.coldchain-distribution.com/PRCom Sponsors/Exhibitors: Contact Alia Malick at +44 (0) 7827 6168, amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum at +44 (0) 20 7827 6184, fbegum@smi-online.co.uk Media Enquiries: Contact Julia Rotar at jrotar@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, November 17, 2016 --( PR.com )-- Over the last 24 months, new logistics hubs have been established around the globe by forwarders and distributors, in order to service and support a more round-the-clock global network for pharmaceutical product supply. Nonetheless, challenges remain with the increasingly fragile biologics product and tightened GDP regulations.11th annual Cold Chain Distribution, taking place in London, UK, on the 12th and 13th of December, brings together 100+ representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments!Further information available at www.coldchain-distribution.com/PRComCold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more.The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PRCom“The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair.Confirmed attendees include key decision makers from Accord Healthcare, Al Medicines, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Envirotainer, Exelsius , Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more!“We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” -David Spillett, Key Account Director, World Courier.Further information available at www.coldchain-distribution.com/PRComCold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier.Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport.11th Annual Cold Chain Distribution Conference and ExhibitionPark Plaza Victoria, London, UK12th-13th December, 2016www.coldchain-distribution.com/PRComSponsors/Exhibitors: Contact Alia Malick at +44 (0) 7827 6168, amalick@smi-online.co.ukDelegates/Groups: Contact Fateja Begum at +44 (0) 20 7827 6184, fbegum@smi-online.co.ukMedia Enquiries: Contact Julia Rotar at jrotar@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


Van Effelterre T.,GSK Biologicals | Moore M.R.,Centers for Disease Control and Prevention | Fierens F.,GSK Biologicals | Whitney C.G.,Centers for Disease Control and Prevention | And 3 more authors.
Vaccine | Year: 2010

Universal infant vaccination with the 7-valent pneumococcal conjugate vaccine (PCV7) has nearly eliminated PCV7-serotype invasive pneumococcal disease (IPD) in young U.S. children, but has been accompanied by increases in the incidence of serotype 19A IPD. Because antibiotic-non-susceptible 19A has increased more than antibiotic-susceptible 19A, antibiotic selection pressure could be contributing to this trend. We developed a dynamic compartmental transmission model of pneumococcus to better understand the causes of this rise and to estimate the impact of vaccines or changes in antibiotic use on future IPD incidence in the U.S. in <2 year-olds. The model predicted that with current practices, serotype 19A IPD incidence will plateau at about the 2007 level over the next few years. The model suggests that antibiotic usage played a major role in the rise in antibiotic-non-susceptible 19A IPD, with a lesser contribution from PCV7 vaccination. However, hypothetical large decreases in antibiotic use starting in 2008 are predicted to yield only gradual decreases in antibiotic-non-susceptible 19A IPD. On the other hand, vaccines with modest (20%) effectiveness against 19A (or 6A or PCV7-serotypes) carriage are predicted to substantially (by 80%) decrease the incidence of IPD caused by those serotypes within 10 years of implementation. Our findings highlight that vaccine effects on colonization are key to their overall benefits. In addition, serotype changes following vaccine introduction may have multifactorial origins, with antibiotic use an important factor for resistant strains such as 19A. © 2010 Elsevier Ltd. All rights reserved.


Barrington P.,Eli Lilly and Company | Chien J.Y.,Eli Lilly and Company | Tibaldi F.,GSK Biologicals | Showalter H.D.H.,Eli Lilly and Company | And 2 more authors.
Diabetes, Obesity and Metabolism | Year: 2011

Aim: To assess the safety, tolerability, pharmacokinetics, pharmacodynamics and potential immunogenicity of single, escalating subcutaneous injections of a once-weekly glucagon-like peptide-1 analogue in healthy subjects. Methods: This phase 1, three-period, crossover, double-blind, placebo-controlled study investigated single, escalating subcutaneous doses of LY2189265 (LY) ranging from 0.1 to 12 mg; approximately six subjects were randomized to each dose. Parameters of safety, including adverse events, were assessed. The pharmacokinetic profile was assessed over 14 days. Pharmacodynamic parameters (glucose and insulin concentrations) were measured following a step-glucose infusion (day 3) and as part of an oral glucose tolerance test (OGTT) (day 5). Results: LY was generally well tolerated with some increase in gastrointestinal symptoms with escalating doses. There were small dose-dependent increases in pulse rate with doses ≥1.0 mg and diastolic blood pressure with doses ≥3.0 mg. The half-life of LY was approximately 90 h, with Cmax occurring between 24 and 48 h in most subjects. Evidence of increase in glucose-dependent insulin secretion and suppression of serum glucose excursions were observed during an OGTT at all doses compared to placebo; no episodes of hypoglycaemia occurred. No subjects developed antibodies to LY2189265. Conclusions: LY showed an acceptable safety profile and exhibited the expected glucagon-like peptide-1 pharmacological effects on glucose suppression and insulin secretion with a half-life that supports once-weekly dosing. © 2011 Blackwell Publishing Ltd.


Barrington P.,Eli Lilly and Company | Chien J.Y.,Eli Lilly and Company | Showalter H.D.H.,Eli Lilly and Company | Schneck K.,Eli Lilly and Company | And 4 more authors.
Diabetes, Obesity and Metabolism | Year: 2011

Aim: To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LY2189265 (LY), a novel, long-acting glucagen-like peptide-1 analogue, administered once weekly to subjects with type 2 diabetes. Methods: This was a placebo-controlled, parallel-group, subject- and investigator-blind study of LY in subjects (N = 43) with type 2 diabetes mellitus controlled with diet and exercise alone or with a single oral antidiabetic medication. Subjects taking metformin or thiazolidinediones continued on their therapy. Subjects receiving sulfonylurea, acarbose, repaglinide or nateglinide were switched to metformin prior to enrollment. Subjects received five once-weekly doses of 0.05, 0.3, 1, 3, 5 or 8 mg. Effects on glucose, insulin and C-peptide concentrations were determined during fasting and following standard test meals. The pharmacokinetics of LY and its effects on HBA1c, glucagon, body weight, gastric emptying and safety parameters were assessed. Results: Once-weekly administration of LY significantly reduced (p < 0.01) fasting plasma glucose, 2-h post-test meal postprandial glucose and area under the curve (AUC) of glucose after test meals at doses ≥1 mg. These effects were seen after the first dose and were sustained through the weekly dosing cycle. Most doses produced statistically significant increases in insulin and C-peptide AUC when normalized for glucose AUC. Statistically significant reductions in HBA1c were observed for all dose groups except 0.3 mg. The most commonly reported adverse effects (AEs) were nausea (35 events), headache (20 events), vomiting (18 events) and diarrhoea (8 events). Conclusions: LY showed improvement in fasting and postprandial glycaemic parameters when administered once weekly in subjects with type 2 diabetes. The pharmacokinetics and safety profiles also support further investigation of this novel agent. © 2011 Blackwell Publishing Ltd.


Klugman K.P.,University of Witwatersrand | Klugman K.P.,Emory University | Madhi S.A.,University of Witwatersrand | Adegbola R.A.,Bill and Melinda Gates Foundation | And 2 more authors.
Vaccine | Year: 2011

Protection against serotype 1 could not be demonstrated in two randomized trials of 9 valent pneumococcal conjugate vaccines. An analysis of the timing of type 1 cases among vaccinees and controls shows that the vaccine failures occurred among cases occurring after the first year of life. Vaccination was given as three doses in infancy with no booster dose. These data suggest that a booster dose given at 9 months of age, or early in the second year of life, should be evaluated for protection against type 1 pneumococcal disease. © 2011 Elsevier Ltd.


Benoit A.,Catholic University of Leuven | Legrand C.,Catholic University of Leuven | Dewe W.,GSK Biologicals
Pharmaceutical Statistics | Year: 2015

The success of a seasonal influenza vaccine efficacy trial depends not only upon the design but also upon the annual epidemic characteristics. In this context, simulation methods are an essential tool in evaluating the performances of study designs under various circumstances. However, traditional methods for simulating time-to-event data are not suitable for the simulation of influenza vaccine efficacy trials because of the seasonality and heterogeneity of influenza epidemics. Instead, we propose a mathematical model parameterized with historical surveillance data, heterogeneous frailty among the subjects, survey-based heterogeneous number of daily contact, and a mixed vaccine protection mechanism. We illustrate our methodology by generating multiple-trial data similar to a large phase III trial that failed to show additional relative vaccine efficacy of an experimental adjuvanted vaccine compared with the reference vaccine. We show that small departures from the designing assumptions, such as a smaller range of strain protection for the experimental vaccine or the chosen endpoint, could lead to smaller probabilities of success in showing significant relative vaccine efficacy. Copyright © 2015 John Wiley & Sons, Ltd.

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