By Stefanie Ramsperger
From the March/April 2016 Issue
The life sciences industry has fared reasonably well in past economic recessions, but today it must weather a volatile marketplace-characterized by economic uncertainty, reform-driven pricing pressures, increased demand for innovation and value, more focus on the consumer (and consumer engagement), and an ever-changing regulatory and risk environment.
According to Deloitte’s annual global biotech report, the life sciences sector’s growth correlates highly with each country’s general economic strength and healthcare spending levels, two factors which vary widely around the world. The Economist Intelligence Unit (EIU) is projecting an increase in biotech spending growth in 2016, but notes that the pressure to reduce costs, increase efficiency and prove value remains intense. Because of these contradictory trends, global healthcare spending is expected to increase by only an average of 4.3 percent between 2015-2019, which is lower than the average increases before the Great Recession. Spending as a percentage of GDP also is expected to decline, from the 10.3 percent level in 2014 to about 10.1 percent in 2019.
Per capita health spending is projected to increase from 2014’s level of $1,145 to about $1,412 in 2019; however, spending levels will vary greatly among developed and developing countries, ranging from $11,038 in the United States to $58 in Pakistan.
Entering the second half of this decade, most life sciences organizations have adopted an attitude of cautious optimism, the Deloitte report concludes.
MANCHESTER: UK BIO HUB
Manchester has attracted over 250 biomedical companies in the past years. Home to four universities who have a strong track record of working with industry on biotechnological projects, Manchester provides a climate where innovation can grow and prosper.
The region is the largest producer of pharmaceuticals in the UK and is home to over 250 core biomedical companies who employ over 3,400 people. There is a rich supply chain for these companies providing a complete ecosystem to support business growth. The city also houses the largest cancer research and treatment center in Europe, the UK’s largest children’s hospital and a leading center for genomic medicine.
Companies with a presence in the region include: AstraZeneca, Waters Corporation, Bristol Myers Squibb, Eli Lilly, Epistem Health, GlaxoSmithKline, Medimmune, Novartis, Qiagen, Premaitha, Sanofi, Teva, Shimadzu/Kratos Molnlycke, Baxter, Terumo, Thermofisher, and Hologic Genprobe.
Manchester experienced a period of significant growth and expansion in the city over the past three years. Some notable entries include Hitachi European Big Data Laboratory, Premaitha, Allscripts and Syngenta, which established their new Global Operations Center in Manchester last year.
There also have been a number of expansions and research collaborations including Omnicell’s consolidation, Dishman’s research and development, and expansions at Vivatinell, Premaitha Health and Qiagen. Qiagen has based its European Center for Personalized Medicine in Manchester following its acquisition of DxS for $90 million and along with Epistem, an AIM listed Manchester University Spin out are leading players in this area.
The city is the home of the UK BioBank, this coupled with the extensive research base in Biomarkers, the Centre for Genomics Medicine Research and the ability to access high quality patient data all place Manchester as a leading center to take forward this emerging area. Substantial funding is being placed into this new research area with a large investment from TSB and the Research Councils.
As a member of the European Super League of biomedical clusters, and the European City of Science for 2016, Manchester offers not just international connectivity but also unique gateway organizations and support systems to help companies gain a foothold in the National Health Service (NHS). With over 30 NHS organizations, Greater Manchester has a significant proportion of the UK National Health Service market.
Tim Newns, CEO of Manchester’s inward investment agency, MIDAS, explains: “The concept of highly connected urban science parks linked with academia, the NHS and excellent connectivity is enabling the city to gain recognition as a top location for biomedical companies around the world.” He continues: “Manchester is well placed to lead in this area with Europe’s largest clinical/academic campus located here. It is closely connected with a wide range of incubator and growth facilities ideal for all stages of a company’s life cycle. This—coupled with a large, stable talent pool and relatively low costs of operating and living—provides a winning formula for business innovation and investment.”
While Manchester has tremendous breadth and depth of clinical and academic excellence, it has recognized that the key challenge for business is gaining access to the market and ensuring that innovation that can meet unmet medical needs is adopted by the market. As a result, the city has developed a combination of gateway organizations that are focused on unmet medical needs, but also prepared to collaborate with and support industry to meet these needs. These organizations include Northwest EHealth (NWEH), Manchester Academic Health Science Centre (MAHSC), Manchester Integrating Medicine and Innovative Technology (MIMIT), The Farr Institute and University of Manchester Intellectual Property, TRUSTECH:
- NorthWest EHealth (NWEH) is a partnership between the University of Manchester and the NHS. NWEH works to unlock the value of routinely collected health care data and provides software and information systems that allow healthcare data to be linked and utilized. Services cover the spectrum of clinical trial feasibility, study design, study mobilization, study management, data linkage, real world evidence and analysis and reporting. NWEH’s CEO Martin Gibson says: “NWEH benefits greatly from its location in Manchester and its strong relationship with the other elements of the health eco-system and digital economy.” He continues: “The unique set of circumstances has attracted a lot of interest from industry for example GlaxoSmithKline (Salford Lung Study) have come to work with us to get the benefits of the integrated systems. Quite recently we have got an understanding with Hitachi who have set up their big data laboratory in Manchester partly because we and our partner organizations have the resources to help them with what they want to do in the healthcare sector as well and we work closely with all these organizations.”
- Manchester Academic Health Science Centre (MAHSC) is a partnership between The University of Manchester and six leading NHS organizations. They share a common goal of giving patients and clinicians rapid access to the latest research discoveries, and improving the quality and effectiveness of patient care. MAHSC has been designated as one of six Academic Health Science Centers in the UK.
- Manchester Integrating Medicine and Innovative Technology (MIMIT™) is the first international affiliate of the Center for Integrating Medicine & Innovative Technology (CIMIT®), a collaborative initiative of academic and healthcare delivery organizations in Boston, MA.
MIMIT™ uses its Innovation Development Pathway (IDP™) to facilitate collaborations between clinicians, scientists, engineers and industry to develop innovative technology for patient benefit. MIMIT™ forms a cornerstone of Manchester Academic Health Science Centre (MAHSC) Health Technology Hub. MAHSC is working with Hitachi on a proof-of-concept study harnessing novel informatics capabilities to enhance a lifestyle improvement program for diabetes care.
An aging population and an increase in lifestyle-related illnesses—including diabetes—is a growing challenge to the NHS. The pilot trial is part of a much larger program of work between MAHSC and Hitachi initiated in April 2013 and has already resulted in the launch of Hitachi’s European Big Data Laboratory in the city in October last year. The Laboratory aims to create technologies in response to global needs.
- The Farr Institute of Health Informatics Research comprises four nodes distributed across the UK and led from University of Manchester (Farr Institute @ HeRC N8). With a $24.7-million research award from a 10-funder consortium, plus additional $28.3-million capital funds from the Medical Research Council, the Farr Institute delivers cutting-edge research linking electronic health data with other forms of research and routinely collected data, as well as build capacity in health informatics research. Manchester is one of only four Health eResearch Centers that make up the UK’s Farr Institute. Greater Manchester is also home to England’s only fully e-enabled health trust.
- TRUSTECH is an NHS organization that improves healthcare through the development of innovative products and services. The organization works with innovation from within the NHS as well as from business to develop and evaluate technologies for the NHS market. TRUSTECH is linked directly with NHS hospitals as well as science park facilities and can provide many services from desk research to physician and patient evaluation of technology.
Manchester is also home of several research institutes. The Manchester Collaborative Centre for Inflammation Research (MCCIR), for example, was established to bring together clinical, industrial, and academic scientists. It addresses current priorities in inflammatory disease in an open innovation, pre-competitive collaboration between academia and the pharmaceutical industry. GlaxoSmithKline, AstraZeneca and the University of Manchester have each invested $7 million to promote “blue skies” research. Blue skies research is scientific research in domains where “real-world” applications are not immediately apparent.
The Health e-Research Centre (HeRC) is a $25.4-million center of excellence that operates across the North of England and unites research skills and knowledge in the field of health data science.
Funded by the Medical Research Council and led by The University of Manchester, HeRC harnesses large-scale health data for patient and public benefit by advancing computational thinking in health informatics and developing e-health innovations for healthcare services.
The National Graphene Institute (NGI) is the UK’s home of research into the world’s thinnest, strongest and most conductive material, providing the opportunity for researchers and industry to work together on a huge variety of potential applications, including biohealth applications.
The Manchester Informatics-Connected Health Innovation Centre & the Manchester Connected Health Ecosystem (CHIC) aims to exploit the rapid evolution of mobile, wireless technology (Connected Health) to address both the opportunities and the challenges of health and social care.
In Manchester, various disciplines are highly interwoven. The city boasts a dedicated biomedical corridor. The Corridor is home to a wealth of knowledge intensive organizations and businesses that operate in the area of biomedical, pharmaceuticals, clinical trials, medical devices and oncology related healthcare. Its state-of-the-art facilities include the internationally renowned Manchester Science Partnerships and Citylabs, Manchester’s biomedical center of excellence.
The Corridor also is the location of the University of Manchester, Manchester Metropolitan University, the hospitals of the Central Manchester Foundation Trust, several leading medical research institutes, a large cancer treatment center and the largest clinical trials unit in the world. This environment offers businesses the ability to be closely co-located with academia, gateway organizations and NHS.
GERMANY: EU BIOTECH POWERHOUSE
With the largest amount of biotech companies in Europe, world-class research infrastructure, and internationally renowned scientists, Germany has established itself as an international medical biotech hub.
The Federal Ministry for Education and Research (BMBF) established two funding programs. The Health Research Programme was funded with $6.17 billion until 2014. It focused on the fight against diseases. Climate change, sustainability of food, bioenergy and industry production is in the focus of the Research Strategy BioEconomy 2030, which is being funded with $2.7 billion until 2017. Furthermore, the German Federal Ministry of Research and Technology guarantees institutional funding for the four research societies Max-Planck-Society, Leibniz Association, Helmholtz Association and the Fraunhofer Gesellschaft.
Over the past three decades, Germany’s 36 biotechnology clusters have developed into Europe’s leading research and development hubs. The BioRegions also include technology parks tailored to the specific needs of biotechnology companies. Each region specializes in particular areas and facilitates the collaboration between universities, R&D institutes and companies.
The cluster that is located in the Berlin-Brandenburg area is called BioTop. Focus areas are drug development, personalized medicine, diagnostics and bioanalytics, regenerative medicine, systems biology, health IT and RNA- and glycobiotechnology. At the beginning of 2015, 566 companies employed more than 27,000 workers, with an average employment growth of more than five percent per year. And the sector keeps growing: In the past five years, the number of jobs in the field of life sciences has increased by 22 percent. 241 of these are core biotech companies, employing almost 5,000 people.
In the past five years, more than 90 life sciences companies were founded in the capital region. Berlin Cures, for example, is a joint spin-off from Charité and the Max Delbrück Center for Molecular Medicine.
One of the reasons why startups decided to come to Berlin-Brandenburg, are favorable location factors: biotech parks provide affordable laboratories and technical infrastructure. Berlin Adlershof Center for Biotechnology and Environment is one of the capital region’s Biotech Parks. It focuses on Photonics and optical technologies, material and microsystems technology, information and media technology, biological, environmental and energy technology. 25 biotech companies in Adlershof occupy 18,200 square meters of lab and office space.
Berlinbiotechpark is located at the heart of Berlin and offers 57,000 square meters of office, laboratory and production space. Another 45,000 square meters are free yet. Biotech Campus Potsdam is located on a peninsula in the Havel River. It is operated by a subsidiary of the Investment Bank of the State of Brandenburg. Biotechnology Park Luckenwalde is located 30 miles south of Berlin. It is one of the most modern facilities of its kind; 35 companies are located at Biotechnology Park Luckenwalde, employing 500 people.
Campus Berlin-Buch is one of the largest biotech parks in Germany. It offers 31,000 square meters of lab and office space. It is located in the northeast of Berlin and hosts 41 biotech companies. In total, 56 companies are located there. Co:bios Technology Center has rental opportunities particularly for startups. It is located in Henningsdorf.
Another hotspot in Germany for biotech companies is in the state of Hessen. Hessen is in the middle of Germany and it has a traditionally strong chemical and pharmaceutical industry. Meanwhile, biotechnology contributes greatly to the Hessian economy. 207 biotech companies are home to Hessen, employing 51,000 people. 16.400 of which can be allocated to biotech alone. $13.6 billion in revenue has been generated with biotech products and services in Hessen in the past year and biotech is still on the rise.
That Hessian biotech companies are satisfied with their business situation became apparent when surveyed: 77 percent of the companies see their own situation as positive and around 90 percent expect increasing numbers of employees.
Hessen’s biotech landscape focuses on two regional clusters: one cluster is in the central region, around the cities of Marburg and Gießen. The other cluster is near the cities of Wiesbaden, Darmstadt and Hanau, with Frankfurt at the center.
Chemical and pharmaceutical industries are strong in both regions, which helps biotech companies in doing their business. Hessen also has a strong network of universities, universities of applied sciences and non-university institutions. They are located near both clusters, in Frankfurt, Darmstadt, Gießen and Marburg. 39 university institutes and departments work in biotech. Medical research is one focus of the schools. Extensive research for example is conducted in virology, cancer and stem cell research and gene therapy.
Further important players in the biotech sector are the Paul Ehrlich Institute, which is based in Langen, and the TH Mittelhessen University of Applied Sciences, which is defined by its close connection with medical technology. The Max Planck Institute for Terrestrial Microbiology, which is based in Marburg, and the Philipps University of Marburg have a focus in the field of Synthetic Biology. Since 2010, the then founded LOEWE Center for Synthetic Microbiology GYNMIKRO is a great help for biotech companies in the region.
Another institution that can be helpful for biotech companies is the Frankfurt Biotechnology Innovation Center (FIZ). Recently in 2014, a third site was opened, because the first two sites reached full capacity. 16 companies with more than 600 employees work at the FIZ, among them GenXPro, bio.logis and Cyntegrity. The Center covers 23.500 square meters of lab space.
With regard to patent application, Hessen ranks top in Germany: According to the OECD, the Hessian facilities belong to the leading applicants concerning biotech inventions. The state holds 13 patents per 1 million inhabitants. As a comparison: Rhine-Palatinate holds 15.7 patents per 1 million inhabitants, but all other states follow behind Hessen: Baden-Württemberg is strong with 10.6 patents per 1 million inhabitants, North Rhine-Westphalia has 10.0, Berlin 9.2 and Bavaria 8.4.
Recently, Sanofi-Aventis Deutschland, which is currently based in Frankfurt, has established a Natural Product Center of Excellence in Hessen, together with the Fraunhofer Institute. The team works in Frankfurt/Höchst, but a move to the Fraunhofer-site in Gießen is planned for 2017. The center will be affiliated to a new center for insect biotechnology, which is also based in Gießen. The state of Hessen will provide $20.3 million of funding. Together with the German government, an additional $33.8 million will be invested for a new construction site, which will break ground this year.
A group of institutions working on drug research, called Translational Medicine and Pharmacology TMP, will also receive funding: The TMP is supported by the LOEWE initiative with $20.6 million until the end of 2017.
BAVARIA IS A BIOTECH HOTSPOT
The network Bavarian Biotech Cluster thereby creates contact opportunities between the biotech locations in Bayreuth, Erlangen-Nuremberg, Munich, Regensburg, Straubing and Würzburg.
BIOTECH CENTERS IN BAVARIA
The Bavarian biotech cluster focuses on pharmaceutical biotech, combined with findings from genomic research. At the end of 2014, the Bavarian cluster experienced a Bavarian-American success story, when AMGEN2012 acquired a product by Munich-based company, MICROMET, at the largest M&A deal of the German biotech industry for about $1.2 billion.
Biotech revenues in Bavaria totaled to $1.6-billion in 2014. 347 biotech companies employed almost 30.000 people in industry and further 10.000 employees in science.
There are 212 core biotech companies. Pharma and supplier companies contribute another 135 companies to the sector. The biotech cluster benefitted from acquisitions in 2014, such as Vectra acquiring Activaero and AstraZeneca to form Definiens AG. Evotec acquired Kinaxo to build Evotec Munich, and Amgen acquired Micromet to found Amgen Research Munich. Plus, international subsidiaries were founded in Bavaria. Examples are Exosome Diagnostics, Myriad Genetics and Vertex as additions to Biogen, Celgene and Gilead.
Bavarian biotech recently attracted some startups but also relocations in the Munich Biotech Cluster. Some examples for startups include Imevax GmbH, Lindis Biotech GmbH, MetaHeps GmbH, and Cinfa Biotech GmbH, Bioskinco GmbH and Karyopharm Europe GmbH as new subsidiaries.
SPECIALTIES THRIVE IN TUSCANY
Tuscany represents a consolidated reality that spans from the most traditional sectors to specializations in biotech and in the medical-devices field. It counts 19 production sites, eight research centers, 800 researchers and more than $225 million in R&D investments. More than 300 life sciences companies are active in Tuscany. The Italian region ranks third in terms of employee number in the sector.
Research in the field focuses around vaccines, oncology, cardiovascular, neurology, stem cells, metabolic disorder, genomics, biorobotics, bioengineering and biomaterials. Small companies, too, find a highly supportive environment in Tuscany: four business incubators in the region help them grow. Tuscany also offers a regional office for exploitation of biomedical and pharmaceutical research. Recently, the biotech company Philogen S.p.A. Announced that it has entered into an option and license agreement with Pfizer. Philogen develops antibody and small molecule targeted therapies. It brings to the partnership validated antibodies with precise specificity in certain diseases characterized by angiogenesis. Pfizer will be responsible for R&D and potential commercialization of candidate molecules.
The Tuscany Life Science Cluster provides opportunities for business and investment, for example in the fields of degenerative diseases, cardiovascular diseases, biorobotics, bioengineering or biomaterial. The cluster has gathered almost two hundred companies since its creation in 2011 on 37.000 square meters of laboratories. It groups all of the public and private subjects operating in various capacities in the sectors of biotech, pharmaceutics, medical devices, nutraceutics and cosmeceutics. Almost 1.000 patents came out since its creation. Startups are involved as well as major players and various research institutes. Over 11.000 employees work there, 1.400 of which in research and development. The Tuscan Universities in Florence, Pisa and Siena have research focuses on biotech, as do the institutes of CNR, the university hospitals and other research facilities.
The Siena based Life Science Park and Bio-Incubator is located on a 3.000-square-meter area with lab space. By 2013 it had already attracted approximately $56 million in investment.
The city of Pisa hosts two lab and research areas: The Technological Pole of Navacchio is designed mostly for High tech startups. The 18.000 square meter area has 1.360 for incubation. Pisa’s second research area is the Pole of Sant’Anna Valdera. It aims to enhance the research activities of Sant’Anna School by hosting workshops in biotech and related disciplines. It has seven laboratories and research centers as well as two CAD laboratories for electronic and mechanical design and one precision mechanical workshop.
LOUISIANA: SOLID BASE FOR BIOTECH
From Shreveport to Baton Rouge and New Orleans, and from Lake Charles and Lafayette to Ruston and Monroe, university researchers, biotech entrepreneurs, government and hospital labs, energy and fuel companies, and many others are working to develop new technologies and new products in agriculture, food science, chemicals, drugs and pharmaceuticals, medical devices, energy and fuel. And they’re doing it under the biotechnology umbrella.
In the Crescent City, he New Orleans BioInnovation Center (NOBIC) is open for business. The center is a 65,000-square foot biotech business incubator created to foster entrepreneurship within the New Orleans bioscience community and help commercialize technologies developed at Tulane, Louisiana State University, University of New Orleans and Xavier University of Louisiana. The building is home to more than 13 tenants, including two venture-capital firms, and at capacity will house up to 50 companies and employ 200 people. In addition to featuring wet labs, offices and conference space, NOBIC offers its tenants commercialization services, such as support for researchers who are dealing with angel investors, IP attorneys and companies interested in licensing or buying their technologies.
NOBIC, and facilities like it, provide a valuable and intangible asset to taxpayers who ultimately fund the initiative. Firstly, the citizens of Louisiana reap the financial rewards of commercialized research that spins out of academia—through increased tax revenue and royalties collected by state institutions. Secondly, and of invaluable long-term benefit, research incubators are an effective means of stemming the tide of brain drain. Not only will the innovators stay in Louisiana, but the resulting newly created jobs will remain as well.
For every job created in the biotech industry, up to five additional jobs are created to build research facilities; maintain laboratory and computer equipment; supply laboratory and office equipment, and provide basic services to even the most modest biotechnology facilities.
According to Aaron Miscenich, president of the New Orleans BioInnovation Center and Chairman of LouisianaBio, access to capital is one of the three legs of a life science startup; the second being technology and the third being experienced management. NOBIC has developed and is working to expand its angel community and has the ability to offer startups pre-seed funding.
Louisiana’s state legislature has in recent years supported innovative research by establishing an angel investor tax credit, an R&D tax credit and has eliminated certain capital gains taxes, along with developing other incentives for the establishment of biotech companies. While the state currently is facing a budget crisis, biotech startups say the maintenance of these credits are critical to the future of innovation-based industries in the state.
Furthermore, the Louisiana State University Health Sciences Center plans to build a multi-billion dollar hospital complex adjacent to the proposed U.S. Department of Veterans Affairs hospital. These two state-of-the-art medical campuses will anchor a bioscience hub with vastly expanded opportunities for life sciences research, clinical trials and technology transfer.
Xavier University is making use of federal education funding to expand their pharmacy program to accommodate our industry’s growing need for skilled professionals. Proximity to an educated workforce is a critical component of a successful and thriving bioscience community. This competitive advantage will not go unnoticed by an industry in constant need of doctors, scientists, researchers and technicians.
PA BIOTECH CENTER OF BUCKS COUNTY IS AN ECONOMIC ENGINE
The Pennsylvania Biotechnology Center of Bucks County generated an economic impact of $1.8 billion for the state—including $1.6 billion for the county—during the past three years, according to a recently report from the 10-year-old Buckingham, PA, life sciences incubator.
The figure includes $593 million in direct spending by, and investments in, the 38 companies and about a dozen research organizations leasing space in the center. Another $1.2 billion represents indirect and induced spending by suppliers and other companies doing business at the center, and the household spending by people whose jobs are tied to the facility.
The report, prepared by Richard Stein of Klios Consulting Inc., also determined the biotech center is responsible for 727 jobs, of which 325 represent employees at the state-funded facility established through a partnership of the Hepatitis B Foundation and Delaware Valley University. The center is hoping to expand at its current site on Old Easton Road near routes 313 and 611 and has applied for an extension to meet the matching requirements that were part of a $4.2 million federal grant the center secured from the Department of Community and Economic Development in late 2014.
According to Jordan Krause, executive director of the Bucks County Industrial Development Authority, the authority is working with county, Penn Engineering and local municipalities on an initiative to create an “Old Easton Road Corridor” that could include a new life sciences campus on 80-acres near the existing biotech center in Buckingham. The corridor would be created, he said, so companies have a place to go—and still stay in Bucks County—when they outgrow their incubator space.
Among the companies leasing space at the center are: Arbutus BioPharma, a publicly traded company led by Chief Scientific Officer Mike Sofia, who invented the medicine Solvaldi that is used to cure hepatitis C; FlowMetric, which created a mobile and self-contained medical lab that can deliver personalized diagnostic services to patients anywhere in the world, and Synergy Pharmaceuticals, which earlier this year filed a new drug application for its experimental chronic idiopathic constipation treatment. The facility has another 20 “membership” companies that have access to the biotech center, but do not lease space.