Annual Report 2015 Promoting world-class biopharma investment in Ireland NIBRT Annual Report 2015 Contents About NIBRT 4 Who we are 4 What we do 4 NIBRT’s vision 4 1. Message from NIBRT CEO 4 2. Message from NIBRT Chairman 6 3. 2015 NIBRT by the numbers 7 4. Growth of the Biopharma Industry 7 5. Case study: Bristol-Myers Squibb 9 6. Training and Education 10 7. Research and Innovation 12 8. Contract Research 14 9. Events and Conferences 16 10. 2015 Awards 18 3 NIBRT Annual Report 2015 About NIBRT Who we are NIBRT is a world-class institute, based in Dublin, Ireland whose mission is to deliver training and research solutions for the global biopharmaceutical manufacturing industry NIBRT partners with industry to support international best practice in all aspects of biologics manufacturing Become a global leader in biopharmaceutical manufacturing research, education and training Opened in 2011, NIBRT’s research and training building (6,500m2) features state-of-the-art pilot scale manufacturing facilities Build out our research and development scale, capability and critical mass to establish NIBRT as a globally recognised centre for industry applied research and process development Established with IDA Ireland, NIBRT partners with all higher education institutes to provide training and research infrastructure facilitates not previously available in Ireland What we do Train and educate over 3,800 people annually to work in all areas of biopharma manufacturing Collaborate with industry on scientific research to drive biopharma innovation Support major biopharma investment in Ireland Provide a test bed for new technologies and processes 4 NIBRT’s vision Be the hub for bioprocessing manufacturing research in Ireland and internationally Continue to support the growth and development of the biopharmaceutical industry in Ireland NIBRT Annual Report 2015 1 Message from NIBRT CEO NIBRT has had another excellent year in 2015. It was my first year as CEO and it has been a great pleasure for me to join what is a very enthusiastic, dedicated team and work to build on the excellent reputation that NIBRT has attained to date. Our areas of activity; training and education, manufacturing research, and contract research have all shown strong growth over the last year. In particular, the training needs of major start-up biologics manufacturers were met with significant programmes delivered for Regeneron, Lilly and BioMarin. With the new investments recently announced in Ireland from Bristol-Myers Squibb, Alexion, Mallinckrodt and others, the need for skilled personnel and bioprocessing training continues to grow. Indeed, the industry is heading into a strong growth phase and the demand for bioprocessing talent is high. NIBRT, with its key stakeholders, is focussed on ensuring these skills needs are met. In addition to the customised company specific training, NIBRT prepared many graduates for employment in the sector with its Skillnets, Springboard and Education programmes. Growth of the NIBRT research teams is a priority, the current principal investigators (PI) teams continue to develop rapidly and the attraction of new PIs to NIBRT is well advanced. Core research funding has been secured from IDA Ireland for the next 5 years which allows greater investment in the research teams. Many collaboration projects with industry, vendors and other institutes commenced during the year. I would like to thank all the NIBRT staff for their efforts in the strong 2015 performance. NIBRT comprises excellent state-of-the-art facilities, but it is the delivery of our research and training solutions by our employees that drives our success. Dominic Carolan CEO, NIBRT 5 NIBRT Annual Report 2015 2Message from NIBRT Chairman Ireland continues to be an attractive location for global biopharma investment, thanks to the continued efforts and strong partnership from all stakeholders across Industry, Academia and Government. Key to this success is ensuring the availability of a highly educated and well trained workforce to support the needs of the industry. The strategic decision by the Irish Government and IDA Ireland to invest in NIBRT continues to pay fruitful dividends in ensuring the continued availability of this talent pool to meet the growing needs of new investors, established companies and emerging indigenous biotechs alike. In this respect, NIBRT has recorded its strongest year ever in 2015, with all areas of activity recording strong revenue growth and more people trained than ever before. I am particularly proud of NIBRT’s work in the area of Skillnets and Springboard training, providing opportunities for employment in this growth sector through appropriate cross training and upskilling for those with valued experience in other sectors. 2015 was also a year of significant change for NIBRT, with the appointment of a new CEO in Dominic Carolan and a number of changes at Board level, to support the Institute’s commitment to growing it’s research capabilities and services, complementing the strong competencies that have been developed to date in the provision of world class training solutions to the biopharma industry, both on-line and in-class. 6 The company structures that have been established, coupled with the open-architecture model that is being encouraged across all academic centres active in the biotech arena, will enable the Institute build on the strong research foundations that exist today, but with greater momentum as we build out our scale and specific areas of competence. I am particularly grateful to the Irish Government for their commitment to sustained funding for NIBRT research over the coming years. I would like to thank those outgoing Board members (Prof Briain MacCraith, Prof Vinny Cahill, Ger O’Mahony, Eucharia Meehan, Michael Kamarck and Dr Reg Shaw) for their outstanding support to NIBRT through these recent transitions. Most of all, I would like to thank Dominic and all his staff, the dedicated employees of NIBRT, for their continued commitment to the mission of the Institute and the clients we serve. It is your talent and commitment that give me confidence in the ability of NIBRT to meet the growing needs of the biopharma sector, both locally in Ireland and further afield. Brendan O’Callaghan, Chairman, NIBRT NIBRT Annual Report 2015 32015 NIBRT by the numbers 2015 NIBRT BY THE NUMBERS 92% % OF NIBRT’S COSTS THAT ARE COVERED BY INCOME NIBRT GENERATES 3,800 NUMBER OF TRAINEES IN 2015 17,480 NUMBER OF TRAINING DAYS DELIVERED 15% INCREASE FROM 2014 22% % OF TRAINING WHICH IS INTERNATIONAL 91% 47% % OF DAYS TRAINING OCCURRED IN NIBRT FACILITY % OF NIBRT RESEARCH THAT IS FUNDED BY INDUSTRY 646 24 NUMBER OF SPRINGBOARD STUDENTS TRAINED IN 2015 NUMBER OF CONFERENCES HELD IN NIBRT 1,565 NUMBER OF ATTENDEES AT NIBRT CONFERENCES 4Growth of the Biopharma Industry 18 BIOPHARMA MANUFACTURING SITES IN IRELAND $9 BILLION OF CAPITAL INVESTMENT IN LAST DECADE 7 NIBRT Annual Report 2015 The biopharmaceutical industry in Ireland is going through a period of unprecedented growth and development. BIOPHARMA INVESTMENTS IN 2015 Since 2005 there has been $9 billion in capital investment via IDA companies1 in the biopharma industry. The number of biopharma manufacturing sites in Ireland has risen from 2 in 2003 to 18 in 2015, contributing to €39 billion in lifescience exports in 20132. From a global perspective, “biopharmaceuticals generate revenues of $163 billion, making up about 20 percent of the pharma market. It’s by far the fastest-growing part of the industry: biopharma’s current annual growth rate of more than 8 percent is double that of conventional pharma, and growth is expected to continue at that rate for the foreseeable future”3. There is currently a global shortage of biopharma skills4,5 and NIBRT’s role in providing access to skilled talent is a key determinant in attracting biopharma foreign direct investment. Regeneron Announces an additional $350 million Investment and 200 New Jobs in Limerick by End-20176 Pfizer announces 130 jobs across Irish operations over next year7 Amgen opens new $300 facility8 million PAREXEL Opens a Global DecisionMaking Hub in Dublin9 Mallinckrodt to create 45 new with €45million investment10 jobs Nexvet secures Biomanufacturing Facility in Tullamore11 Alexion Pharmaceuticals announces €450 million expansion in Dublin – 200 new jobs and 800 construction jobs to be created over four years12 Horizon Pharma plc celebrates official opening of new Global Corporate headquarters in Dublin13 ABEC Inc. to establish European HQ and manufacturing centre in Fermoy, Co. Cork, creating up to 100 new jobs14 1.http://www.idaireland.com/how-we-help/resources/infographics/biopharmaceutical-industr/index.xml 2. Annual Business Survey of Economic Impact 2013 (ABSEI) 3.http://www.mckinsey.com/insights/health_systems_and_services/rapid_growth_in_biopharma 4. BioPlan’s 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production 5. UK Needs Biomanufacturing Skills, Association of the British Pharmaceutical Industry (ABPI), 2015 6.http://www.idaireland.com/newsroom/regeneron-announces-an-ad/ 7.http://www.pfizer.ie/news/2015/10/23/pfizer-announces-130-jobs-across-irish-operations-over-next-year 8.http://www.idaireland.com/newsroom/amgen/index.xml 9.http://www.idaireland.com/newsroom/parexel/ 10.http://www.irishtimes.com/business/health-pharma/mallinckrodt-to-create-45-new-jobs-with-45m-investment-1.2219289 11.http://www.idaireland.com/business-in-ireland/industry-sectors/bio-pharmaceuticals/ 12.http://www.idaireland.com/newsroom/alexion-pharmaceuticals-a/ 13.http://www.idaireland.com/newsroom/horizon-pharma-plc-celebr/ 14.http://www.idaireland.com/newsroom/abec-inc.-to-establish-eu/ 8 NIBRT Annual Report 2015 5Case study Bristol-Myers Squibb BMS Staff at NIBRT for Careers in BMS event, November 2015. In November 2014, Bristol-Myers Squibb (BMS) announced plans to construct a new state-of-the-art, large-scale biologics manufacturing facility in Cruiserath, County Dublin that will produce multiple therapies for the company’s growing biologics portfolio. 350 to 400 manufacturing jobs and about 2,000 construction jobs are expected to be created. BMS are now working closely with NIBRT to help hire and training their employees for this landmark investment. The cutting-edge, 30,000 square metre project will house six 15,000 litre bioreactors and a purification area, as well as contemporary office and laboratory space. The plant will be built on the grounds of the company’s existing bulk pharmaceutical manufacturing plant, and is planned as one of the most accelerated built plants of this size and specification in history. The new high-tech campus will have modern laboratory amenities. BMS employees will be able to work and collaborate with other teams on the floor, and their work will truly make a difference to patient’s lives. The new Dublin facility at Cruiserath represents a significant investment in the local area, and BMS has been an established presence in Ireland for more than 50 years. This investment provides opportunities to potential and existing employees, as well as offering careers in a place that supports best-in-class systems and processes, and is always striving for continuous improvement. BMS are hiring now with staff increasing to around 400 roles by 2019 across many business functions, including manufacturing, quality and manufacturing, science and technology (MS&T). With a healthy pipeline of products, BMS are dedicated to providing excellent opportunities for growth and career development. A company with a strong commitment to top quality people management, BMS believe in passion, accountability, innovation and speed. 9 NIBRT Annual Report 2015 6Training and Education Amgen trainees at NIBRT. In addition to training industry directly, NIBRT works closely with the Higher Education Institutes to ensure there is a strong supply of graduates in Ireland with the skills required for the biopharma and related sectors. Industry Training 2015 was a very busy and productive year for NIBRT training. We were pleased to deliver over 17,000 learning days to 3,800 trainees. Key clients include Abbvie, Alexion, Allergan, Amgen, Astellas, BioMarin, Bioquell, Genzyme, Ecolab, Janssen Biologics, Eli Lilly, Pfizer, Regeneron, Sanofi Genzyme, Sartorius Stedim Biotech, Pfizer, Thermo Scientific. Skilled Graduates In 2015, NIBRT partnered with 12 Higher Education Institutes to deliver practical and experiential training to their students including University College Dublin, Dublin City University, Institute of Technology Sligo, Trinity College Dublin, Dundalk Institute of Technology, Dublin Institute of Technology, Cork Institute of Technology, Institute of Technology Tallaght, Galway Mayo Institute of Technology, National University of Ireland Galway, University of Limerick and Limerick Institute of Technology. 10 Ireland is rapidly becoming a very important centre for the global biopharmaceutical sector. A highly skilled workforce will be essential to support this. As the IBEC sector group that represents the pharmaceutical, biologics and biopharma manufacturers in Ireland, we are glad to support the development of such an important programme and to see NIBRT plays such valuable role in providing the necessary training for these employees. Matt Moran, Director, PharmaChemical Ireland NIBRT Annual Report 2015 Jobseekers In 2015, NIBRT partnered with six Higher Education Institutes to provide free training programmes to over 600 jobseekers under the Springboard+ programme. On average, 65% of NIBRT trainees secure employment after participating in these very popular courses which are designed to meet the needs of the fast growing biopharma industry. 2015 TRAINING BY THE NUMBERS DELIVERED TO 17,480 3,800 TRAINING DAYS TRAINEES 22% OF TRAINING WITH AN INTERNATIONAL AUDIENCE International Clients International clients who travelled to NIBRT to access the state-of-the-art pilot plant facilities accounted for 22% of our 2015 training clientele. This included the provision of a global training programme with AbbVie for Key Opinion Leaders and Health Care Practitioners. NIBRT’s partnership with North Eastern University, MA, USA continued with undergraduate students travelling to NIBRT for training in biopharmaceuticals as part of their final year programme. New Industry Masterclasses In 2015 NIBRT partnered with Steris Technical services to deliver a new program in Applied Cleaning Validation Procedures which offered industrial practitioners in the validation space the opportunity to engage with subject matter experts and to discuss case studies and best practices. Theory sessions were complimented with direct hands-on practical sessions using state-of-the-art bioprocessing equipment located in the NIBRT production training facility. Suppliers NIBRT partnered with several vendors to install new equipment in the NIBRT facility including the Bioquell’s Qube M19, which is a four-glove aseptic workstation with two glove separated decontamination unit and a material transfer device. It is fully integrated with rapid hydrogen peroxide vapour (HPV) decontamination to deliver ISO5 / Grade A conditions. OVER 600 JOBSEEKERS RECEIVING FREE TRAINING PROGRAMMES 2,534 5,548 2,354 TRAINING DELIVERED ON 91% OF AVAILABLE DAYS HOT LUNCHES SERVED TEAS/COFFEES SERVED SANDWICH ORDERS NIBRT had a huge impact on my employability for this sector. My learning with NIBRT has really allowed me to hit the ground running, as the course was so specific to the job I actually perform. It is hands down the best decision I have made so far in terms of career progression. I would 100% recommend this course, it’s a no brainer. Testimonial from Springboard student 11 NIBRT Annual Report 2015 7Research and Innovation Damien English TD, Minister for Skills, Research and Innovation with Anna Lindberg, BioMarin and NIBRT CEO Dominic Carolan at NIBRT’s Opportunities in Biopharma Research Conference, September 2015. NIBRT research provides access to leading scientists in world class facilities to address key issues in the manufacture of innovative biologic medicines. Bioinformatics and Data Analytics Following the award of a prestigious SFI Starting Investigator Research Grant (SIRG) in 2014, Dr. Colin Clarke’s CHO cell bioinformatics team is now firmly established at NIBRT. The NIBRT Bioinformatics and Data Analytics Laboratory specialises in the application of multivariate statistics and machine learning algorithms for the analysis of complex CHO cell biological datasets. Dr. Clarke’s team have been actively building a number of high profile academic (e.g. University of California at San Diego and Johns Hopkins University) and industry collaborations since his arrival. Host Cell Protein Removal Work funded through Dr Jonathan Bones’ SFI SIRG award has applied a proteomic platform to evaluate the removal of host cell proteins (HCPs) from monoclonal antibody samples following Protein A purification. 12 Amy Farrell, a NIBRT PhD candidate working on this project, won a CASSS Mass Spec Student Travel Grant to present these findings at 11th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry in Napa, CA, USA (Sept 2014). Dr. Bones was also invited to present this work at the Biological Production Forum in Dusseldorf in March 2015. This work was published in the peer-reviewed research journal Analytical Chemistry in 2015. The technology is available as to a contract research offering through NIBRT. NIBRT is the only dedicated biopharma research and training institute in the world. The Institute plays a key part in positioning Ireland as a location of choice for international biopharma development projects. Martin Shanahan, CEO, IDA Ireland NIBRT Annual Report 2015 PATsule - Irish Invention could Revolutionise Production of Future Medicine In 2015, Drs. Jonathan Bones (NIBRT) and Karen Twomey (Tyndall National Institute) launched the interdisciplinary PATsule project. The two year project was funded through the Enterprise Ireland Commercialisation Fund to develop wireless sensor capsules for bioreactor monitoring. This project is the first collaborative effort between the two Institutes and has attracted significant media coverage16,17. The PATsule was also included on Silicon Republic’s list of the 10 Irish breakthrough innovations of 201518. 2015 RESEARCH BY THE NUMBERS 47% OF NIBRT RESEARCH IS DIRECTLY FUNDED BY INDUSTRY TOTAL RESEARCH INCOME FROM INDUSTRY 2011-2015 €4.4 million Inaugural Opportunities in Biopharma Research The inaugural “Opportunities in Biopharma Research” event was held in NIBRT on 29th September 2015. The event attracted approximately 100 delegates, 33 of whom were industry representatives. Over 20 posters were presented at the event with NIBRT researchers securing the SFI-funded poster prizes in both the postgraduate category (Craig Monger, Dr. Clarke research group) and the post doctorate category (Drs. Noemi Dorival Garcia and Christine Ta, both part of Dr. Bones’ research group). Dr Jonathan Bones (NIBRT) and Dr Karen Twomey (Tyndall National Institute). 15. Farrell, A., Mittermayr, S., Morrissey, B., McLoughlin, N., Iglesias, N.N., Marison, I.W., Bones, J. Quantitative Host Cell Protein Analysis Using Two Dimensional Data Independent LC-MSE, Analytical Chemistry, 87(18), p.9186-9193, 2015 16.http://www.theengineer.co.uk/more-sectors/medical/news/wireless-sensor-capsules-monitor-production-ofbiopharmaceuticals/1021299.article 17.http://www.biopharma-reporter.com/Upstream-Processing/Irish-research-hubs-invent-roaming-reactor-sensor 18.https://www.siliconrepublic.com/innovation/2015/12/29/10-irish-breakthrough-innovations-of-2015-that-are-a-bit-special 13 NIBRT Annual Report 2015 8Contract Research Barry Heavey, Head of Life Sciences, IDA Ireland; Marcella Corcoran Kennedy TD; Minister Damien English TD; Mark Heffernan, CEO Nextvet and ‘Duffer’ the dog announcing NextVet’s investment in Tullamore, September 2015. NIBRT Contract Research offers a range of bespoke analytical services to the biopharmaceutical industry. Glycan analysis New services in 2015 Glycan analysis services continue to be in high demand with NIBRT’s N-Glycan and O-Glycan services offerings now including; The expansion of analytical platforms for protein analysis continues in 2015 with service offering now including: Glycan profiling studies- quantitative glycan comparison between product batches and comparison of biosimilars.19 Glycan characterisation- structural elucidation to reveal detailed glycan composition of products. Glycan site occupancy- occupancy site identification and percentage occupancy determination. Intact Protein analysis-mass accurate measurement of the product or product subcomponents e.g. mAb heavy and light chains. Post Translation Modification profilingquantitative comparison of PTMs between product batches and comparison of biosimilars. Peptide sequencing. Analytical Ultra Centrifugation-quantification of product aggregates. 19.Martin, S.M., Delporte, C., Farrell, A., Iglesias, N.N., McLoughlin, N., Bones, J., Comparative analysis of monoclonal antibody N-glycosylation using stable isotope labelling and UPLC-fluorescence-MS, The Analyst, 140(5), p.1442-7, 2015 14 NIBRT Annual Report 2015 Host Cell Protein Analysis Following on from ground breaking publication20 by Dr Bones team, NIBRT is delighted to offer Identification of Host Cell Proteins present in the product and simultaneous quantification using the Hi-3 MSe approach. Targeted quantification of known Host Cell Proteins using multiple reaction monitoring- mass spectrometry. NEW IN 2016 - HYDROGEN DEUTERIUM EXCHANGE MASS SPECTROMETRY ANALYSIS Epitope mapping Protein-drug binding Protein-protein interactions Aggregation studies The NIBRT building. Ireland is the ideal place to grow our business. It has great infrastructure, routes to market, expansion opportunities and the availability of highly skilled personnel along with a strong scientific community and access to the National Institute of Bioprocessing Research and Training (NIBRT) capabilities. Mr. Jean-Jacques Bienaime, Chief Executive Officer, BioMarin Pharmaceutical Inc 20. Farrell, A., Mittermayr, S., Morrissey, B., McLoughlin, N., Iglesias, N.N., Marison, I.W., Bones, J. Quantitative Host Cell Protein Analysis Using Two Dimensional Data Independent LC-MSE, Analytical Chemistry, 87(18), p.9186-9193, 2015 15 NIBRT Annual Report 2015 9Events and Conferences Minister Bruton TD, Minister for Jobs, Enterprise & Innovation with NIBRT Springboard students at NIBRT’s Careers in Biopharma event, April 2015. In 2015, NIBRT hosted 24 events with over 1,560 thousand attending. Some notable events included: In February and September 2015, NIBRT hosted the Biocluster zone at CareerZoo, Ireland’s foremost careers events for professionals and innovative employers. Over 20,000 people attended both events at the National Convention Centre which included exhibitors from BMS, Regeneron, Alexion, Amgen, MSD, PPD, Janssen Biologics, Sanofi Genzyme, NextVet, Pfizer. NIBRT was delighted to partner with Informa to see the return of the leading industry conference Bioproduction 2015 to CityWest, Dublin in October 2015. Featuring over 400 attendees BioProduction provides the platform for the key biologic manufacturers from across Europe, and the rest of the World to discuss their plans to both advance and refine this evolving industry. 16 Working closely with BMS, the “Career Open Day for BMS” was held on Saturday Nov 21st 2015 in NIBRT with over 500 attendees. 35 journalists from 22 countries attended the global NIBRT-AbbVie event “Managing Complexity: the new biologics landscape”, in Nov 24-25th 2015. In March 2015, NIBRT in partnership with IDA and Enterprise Ireland hosted “Biopharma Manufacturing Competitiveness - driving competitiveness via innovative supplier relationships”. This unique event featured seminars and networking events between buyers and suppliers. NIBRT Annual Report 2015 DATE 2015 EVENTS PARTNER Feb NIBRT Biocluster at CareerZoo CareerZoo March Biopharma Manufacturing Competitiveness: Driving competitiveness via innovative supplier relationships IDA, EI, ISPE April NIBRT Careers in Biopharma NIBRT May Disposable Solutions for Fill Finish Operations DPS Engineering, Saint-Gobain, Colder Products Company and BPSA Micro Industries August Moving Beyond Industry 3.0 ATS Sept NIBRT Biocluster at CareerZoo CareerZoo Oct Opportunities in Biopharma Research PCI Oct Bioproduction 2015 Informa Nov Managing Complexity: the new biologics landscape AbbVie Nov Bristol-Myers Squibb Careers Day at NIBRT BMS My NIBRT experience was transformative. As an industry professional with 10 years’ experience in BioPharma, NIBRT offered a training course that I had never seen in the field previously. Expertly balanced in theory and practice, the course centred on hands-on practicals that mirrored what Trainees could expect in reallife manufacturing facilities. The result was highly-engaged, knowledgeable individuals with new-found confidence through learning by doing. I would recommend NIBRT’s course offerings having personally experienced the positive effect it has had on my career. Anne Marie Molloy, NIBRT student NIBRT laboratories. 17 NIBRT Annual Report 2015 10 2015 Awards Winners of three awards at Irish Pharma Awards: Pharma Education and Training Award Partnership Alliance of the Year Pharma Leader of the Year Other Awards: LifeSciences 50 Award, Business and Finance magazine: Dr Reg Shaw (outgoing CEO NIBRT) American Chamber of Commerce Ireland US- Ireland Research Innovation Awards 2015, shortlist: Prof Pauline Rudd NIBRTWaters collaboration. Silicon Republic’s list of the 10 Irish breakthrough innovations of 2015: NIBRT’s PATsule partnership with Tyndall 18 www.nibrt.ie Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland. Tel: +353 1 215 8100 Fax: +353 1 215 8116 Email: [email protected]
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