Amgen Announces Rhode Island Will Be Location Of First US Next-Generation Biomanufacturing Plant

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Amgen has announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States, will employ Amgen’s proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets.

A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. Next-generation biomanufacturing plants require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

“Amgen has three decades of experience in biologics manufacturing, and we are proud of our track record of providing a reliable supply of high-quality medicines for patients around the world,” said Esteban Santos, executive vice president of Operations at Amgen. “We are pleased to build the first commercial scale, next-generation biomanufacturing plant in the U.S., leveraging Amgen’s capabilities and incorporating the latest technologies.”

A comprehensive evaluation of global locations was conducted to select the location. Following recent U.S. federal tax reform, which provides company incentives to invest in innovation and advanced technologies, Amgen made the decision to locate the new plant in the U.S. Rhode Island was selected based on the historical success of the Amgen West Greenwich manufacturing facility, its capabilities and talented workforce, and quality of living for staff and potential to grow. The biomanufacturing plant will be built on the current Amgen Rhode Island 75-acre campus and is expected to create approximately 150 additional highly-skilled manufacturing positions and approximately 200 construction and validation jobs.

“I am thrilled that Amgen is planning to expand and bring new, highly skilled jobs to Rhode Island and further enhance the State’s life sciences community and manufacturing expertise,” said Rhode Island Governor Gina Raimondo. “We welcome Amgen’s future health care advancements for patients around the world that will come from this new biomanufacturing plant.”

Amgen opened its first next-generation biomanufacturing plant in Singapore in 2014. This type of plant offers a highly flexible, modular design which can be replicated in future facilities, which enables Amgen to increase production capabilities reliably with greater speed, productivity and flexibility. Within the plant, the equipment is portable, smaller and disposable, which provides greater flexibility and speed when manufacturing different medicines simultaneously. This eliminates costly and complex retrofitting inherent in standard facilities and allows Amgen to respond to changing demands with increased agility, ultimately impacting the speed at which a medicine is available for patients.

“We are excited that Amgen Rhode Island was chosen as the location to build the new biomanufacturing plant,” said Tia Bush, vice president of Operations at Amgen Rhode Island. “It is a testament to our skilled, dedicated workforce and Amgen’s continued presence in Rhode Island, which will enable ongoing collaborations with local academic institutions and the broader Rhode Island community.”

The existing Amgen Rhode Island plant was licensed by the U.S. Food and Drug Administration in September 2005 and houses one of the world’s largest mammalian protein manufacturing facilities. The facility manufactures commercial and clinical bulk drug substance. Amgen has invested more than $1.5 billion in its Rhode Island site, adding more than 500,000 square feet of manufacturing, utility, administrative and laboratory space to the campus. There are 625 full-time staff members employed at the Amgen Rhode Island campus.

Novartis teams up with Harvard to develop next generation biomaterial systems to deliver immunotherapies

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Novartis has announced that it is teaming up with scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Dana-Farber Cancer Institute to develop biomaterial systems for its portfolio of immuno-oncology therapies.

The licensed biomaterial systems aim to overcome barriers that have hampered traditional cancer vaccines, including their limited duration of action and lack of targeting to specific cancer cells. Through many years’ work, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), the Wyss Institute, and Dana-Farber have engineered the biomaterial systems with an aim to provide sustained delivery of immunotherapies and target specific types of cancer. Novartis will further collaborate with the team at the Wyss Institute to advance development of the biomaterial systems, investigating their use to deliver agents from its broad and deep portfolio of second-generation immunotherapies.

“Our collaborators have combined the fields of immuno-oncology and material science to develop novel platforms for delivering immunotherapies to combat cancer,” said Jay Bradner, President of the Novartis Institutes for BioMedical Research (NIBR). “We look forward to collaborating with the Wyss Institute to further develop this technology in conjunction with our growing immunotherapy portfolio.”

The licensing agreement with Harvard’s Office of Technology Development and the collaboration with the Wyss Institute support Novartis’ efforts to develop combination immunotherapy regimens. New immunotherapies have benefited subsets of cancer patients, presenting opportunities to develop new immuno-oncology treatment strategies to help more patients [1]. Novartis is developing combination immunotherapies in clinical trials.

The implantable and injectable systems are made of biodegradable materials that assemble into porous, three-dimensional structures. In lab experiments, the systems release cell-recruiting factors to attract host dendritic cells and present tumor antigens to those specialized immune cells, intending to bolster immune responses to cancer [2]. While these systems have yet not been proven in human clinical trials, they hold great promise because of their potential to serve as engineered microenvironments to educate the immune system about cancer and initiate immune responses against tumors over a sustained period of time.

The technologies licensed under this agreement for target-specific applications are owned or co-owned by Harvard University, Dana-Farber, and the University of Michigan.

Therapeutic application of mAbs will increase in near future, says GlobalData

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Ever since the first commercial monoclonal antibodies (mAbs) was approved in 1986 for human therapeutic purposes, mAbs have been increasingly used in several areas of healthcare. According to GlobalData, a leading data and analytics company, the total number of clinical trials involving mAbs witnessed a robust 115% growth between 2007 and 2016.

The company’s Clinical Trials Database provides a review of company-sponsored, interventional, observational, and expanded-access clinical trials of Monoclonal Antibodies (mAbs) across the globe for the past 10 years from 2007 to 2016.

Marco Borria, PhD, senior clinical trials analyst at GlobalData said, “Even though phase II trials outnumbered all other trials, phase I studies have grown faster than all other phases during the review period.”

During the review period, 57% of trials were completed, out of which 76% reported results. Among these, 79% achieved their primary endpoints.

Out of all the trials initiated, Roche has emerged as the lead sponsor, with the company’s bevacizumab as the most investigated drug. The other top industry sponsors were Novartis, Eli Lilly, Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, Genentech, J&J, and GSK.

Oncology was the top therapy area in terms of number of clinical trials, followed by immunology, central nervous system, musculoskeletal disorders, and gastrointestinal. The most common indication under investigation in these trials was rheumatoid arthritis, followed by solid tumors and non-small cell lung cancer.

There is a near-even split between multinational and single-country trials across the period. However, in the last three years multinational trials outnumbered the trials conducted in a single country.

In terms of clinical trials by geographies, Europe accounted for almost 50% trials, followed by North America, Asia-Pacific, South and Central America and the Middle East and Africa.

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“As phase I studies have proliferated more than other phases, the number of new interventions appear to be on the rise across a wider range of therapy areas and indications”, concluded Dr. Borria.

Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer

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Roche and Flatiron Health had announced that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing equity stake of 12.6%. The transaction is expected to close in the first half of 2018.

Flatiron Health, a privately held healthcare technology and services company headquartered in New York City, US, is a market leader in oncology-specific electronic health record (EHR) software, as well as the curation and development of real-world evidence for cancer research. With its large network of community oncology practices and academic medical centers across the US, Flatiron Health has created a technology platform designed to learn from the experience of every patient.

Daniel O’Day, CEO Roche Pharmaceuticals said, “This is an important step in our personalised healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments. As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry. A key principle of this is to preserve Flatiron’s autonomy and their ability to continue providing their services to all existing and future partners.”

Flatiron Health has worked with industry leaders and regulators to develop new approaches for how real-world evidence may be used in regulatory decision making, including the design and validation of novel endpoints. By working closely with its network of community practices and academic medical centers, Flatiron has also developed a suite of software products that uniquely positions the company to advance the use of real-world evidence at the point of care.

Nat Turner, Flatiron Health Co-Founder and CEO said, “Roche has been a tremendous partner to us over the past two years and shares our vision for building a learning healthcare platform in oncology ultimately designed to improve the lives of cancer patients. This important milestone will allow us to increase our investments in our provider-facing technology and services platform, as well as our evidence-generation platform, which will remain available to the entire healthcare industry.”

Under the terms of the agreement, Roche will make a payment of USD 1.9 billion to Flatiron Health on a fully diluted basis, subject to certain adjustments. The closing of the transaction is subject to customary closing conditions. The parties expect that following the closing, Flatiron Health will continue its current business model, network of partnerships and overall objectives. The integrity of segregated patient protected health information will be preserved, as will dedicated sales and marketing, provider-facing and life science business activities.

Merck and three partners start ExploreBio, a € 20 million pre-seed investment initiative in Israel

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Merck has announced ExploreBio, a pre-seed-investment vehicle by four investment funds targeted at early-stage companies in the biotechnology landscape in Israel. For this purpose the strategic corporate venture capital arm of Merck has partnered with Arkin Holdings, Pontifax and WuXi AppTec to create the € 20 million pre-seed investment vehicle.

“Israel’s start-up spirit is unique and so inspiring. We are proud to be an active part of this great success story. Now we are taking a next important investment step as we believe in the innovative potential of ExploreBio,” said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany.

ExploreBio is an initiative comprising pre-seed investments and management services for proof-of-concept-experiments in biotechnology. Additionally, companies benefiting from the ExploreBio initiative will be given the opportunity to work at the BioIncubator facilities of Merck KGaA, Darmstadt, Germany, in Yavne, Israel. Interested parties should submit their investment proposal here.

The commitment involves a total volume of € 20 million for five years. ExploreBio aims to invest € 1 million to € 1.5 million per company across up to four investments per year over a period of five years. The early-stage companies would benefit from quick access to funding and easy access to follow-up capital.

The four investors have worked together on investments in different companies in the past, such as Metabomed (targeted cancer therapy) and Artsavit (using apoptosis-induction to treat cancer).

With the new ExploreBio initiative, Merck and its three partners aim to engage with start-up companies in which it would otherwise be too early to invest. A second advantage for the four partners is being able to leverage the consortium’s resources and their strong relationships to work with the investments more closely and effectively.

ExploreBio complements the activities of Merck in helping early-stage companies in Israel to mature. The company set up PMatX last year and has been running its BioIncubator in Yavne since 2011.

PMatX addresses the topic of next-generation electronics and is a joint endeavor with Flex, San Jose, California, USA, and also backed by additional industry partners including HP, Palo Alto, California, USA, and the U.S.- based global investment firm Battery Ventures. PMAtX is supported by the Technology Innovation Lab program of the Israel Innovation Authority (IIA). The overall investment volume of the program involving all parties is around € 20 million and the initial commitment is for three years.

The site of Merck in Yavne houses the company’s Healthcare and Life Science incubator called BioIncubator. This successful undertaking was started in 2011 and has committed to invest up to € 10 million until 2018 in biomedically focused start-up companies in Israel.

Merck employs more than 300 people in Israel, mainly scientists, and has sites in Yavne, Herziliya, Rehovot, and Jerusalem. All three of itsbusiness sectors, Healthcare, Life Science and Performance Materials, have R&D sites in Israel.

The company also announces today that the Israel Patent Office as well as the Korean Intellectual Property Office have each issued notices granting patent applications of Merck KGaA, Darmstadt, Germany, for its CRISPR technology used in a genomic-integration method for eukaryotic cells. These decisions mark the fifth and sixth patent allowances for the unique CRISPR technology of Merck KGaA, Darmstadt, Germany, following Singapore, Australia, the European Union, and Canada. Merck KGaA, Darmstadt, Germany, also has patent filings for its insertion CRISPR method in the United States, Brazil, China, India, and Japan.

The future is now – Pharmapack Europe 2018 to showcase evolution and revolution in packaging and drug delivery

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Pharmapack Europe 2018, Europe’s dedicated pharmaceutical packaging and drug delivery conference and exhibition, takes place on 7 & 8 February at Paris Expo Porte de Versailles, Paris. The packed event programme includes key note speeches from leading industry figures, a symposium, educational workshops, and a learning lab that will explore regulatory changes and impacts, challenges in packaging & devices development: biologics, materials, sustainability and quality consistency, and how new patient-centric innovations in drug delivery will revolutionise lives and improve treatment adherence. Furthermore, new for Pharmapack Europe 2018 is the Start-up Pitch, a unique opportunity for companies at an early stage or pre-commercialisation phase to present their idea in front of industry experts.

Pharmapack Europe is an essential event for industry insights and the latest industry innovations that are reimagining the capabilities of pharmaceutical packaging and drug delivery. One area that provides opportunities and challenges is biologics, a growth area for the pharmaceutical industry both now and in the future with biologics representing 70% of drugs currently in development. Pharmapack Europe 2018 will include keynote presentations on the key factors for successful collaboration on pharmaceutical packaging development for biologics, speeches on integrated approaches towards the design of drug delivery platforms for biologics, and case studies assessing delivery options for injectable biologics. In addition, patient-centric considerations provide new avenues of innovation in drug delivery solutions. Sessions will be dedicated to innovations in packaging that improve patients’ lives, identifying new areas of opportunity in designing the future of drug delivery packaging, and practical solutions to help stakeholders innovate in this area.

The 2018 Start-up Hub will showcase young companies as being amongst the most innovative in the industry. Companies in the Start-up Hub will benefit from increased access to potential customers, partners and investors at Pharmapack Europe 2018 from which to forge new and lasting relationships. New for 2018 is the Start-up Pitch, offering non-commercialised companies the opportunity to present in front of a start-up panel of experts and an audience of industry professionals. The Start-up Hub and Start-up Pitch are organised in collaboration with Early Metrics, the pan-European rating agency for start-ups and innovative SMEs, assessing the potential growth of early stage ventures by analysing a company’s non-financial metrics.

Register now for free! : https://registration.n200.com/survey/3l2lujn6zr6dx?actioncode=PAR1241

Sandoz announces exclusive global collaboration with Biocon on next-generation biosimilars

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Sandoz, a Novartis division has announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide.

Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU, while Biocon will lead commercialization in Rest of the World.

“Today’s announcement bolsters our leadership position in biosimilars and positions us to continue to lead well into the future,” said Richard Francis, CEO, Sandoz. “Biocon is a great complement to our proven biosimilar capabilities at Sandoz. Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics.”

“Together, we will be able to realize benefits at every stage of the value chain, from development, through manufacturing to commercialization,” said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. “This collaboration further strengthens our ability to deliver next-generation biosimilar medicines to patients.”

Sandoz is committed to increasing patient access to high-quality biosimilars. We are the global leader in biosimilars, with five biosimilars currently marketed worldwide, as well as a leading global pipeline. Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

As an innovation-led biopharmaceutical company, Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogs from ‘lab to market’. The collaboration with Sandoz builds upon Biocon’s successful progress in its existing global biosimilars program. An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, trastuzumab and bevacizumab biosimilars in India and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets; and it was the first Indian company to have a biosimilar approved by the US Food and Drug Administration.

Roche and GE enter partnership to develop integrated digital diagnostics platform to improve oncology and critical care treatment

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Roche has announced a strategic, long-term partnership with GE Healthcare in order to jointly develop and co-market digital clinical decision support solutions. The partnership will initially focus on products that accelerate and improve individualised treatment options for cancer and critical care patients.

The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration and analysis of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.

For example, oncology care teams with multiple specialists will have a comprehensive data dashboard to review, collaborate and align on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, genomic and sequencing data, helping physicians to identify, or even predict severe complications before they strike.

“This unique partnership will deliver innovative solutions and insights in clinical decision-making. Our goal is to support clinicians and other relevant stakeholders for the benefit of patients by providing the right decision support at the right time and through comprehensive digital offerings,” said Roland Diggelmann, CEO Roche Diagnostics.

Roche Diagnostics is the global leader in in-vitro diagnostics, and GE Healthcare is a worldwide leader in medical imaging equipment. “This is the first time that two major players in healthcare have combined digital, in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said Kieran Murphy, President & CEO of GE Healthcare.

Pre-diabetes discovery marks step towards precision medicine

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Researchers from the University of Sydney’s Charles Perkins Centre have identified three specific molecules that accurately indicate insulin resistance, or pre-diabetes – a major predictor of metabolic syndrome, the collection of medical conditions that include abdominal obesity, high blood pressure and high blood sugar levels.

The finding, from a study undertaken in mice, could make earlier detection of pre-diabetes in humans much easier for doctors and allow for more personalised and effective treatments for patients in the future.

Researchers combined the high-tech mathematical approach of machine learning with omics technology that examines the various types of molecules that make up the cells of an organism to successfully identify specific molecules in mice. That information was used to classify the mice according to what kind of food they eat, their genetic origin and their whole-body insulin sensitivity.

Published in the Journal of Biological Chemistry, the research was conducted with the Garvan Institute of Medical Research, Duke University (USA) and the University of Melbourne.

 

Technology key to uncovering factors that contribute to pre-diabetes

Co-lead author Dr Jacqueline Stöckli, a research fellow with the University’s Charles Perkins Centre and School of Life and Environmental Sciences, said the study suggested there are likely multiple factors that contribute to pre-diabetes and this is why more traditional approaches have failed to identify similar highly predictive signatures or indicators of disease.

“Our study identified a three molecule signature that was able to diagnose insulin resistance or pre-diabetes, a condition that is often associated with diabetes, obesity and high blood pressure,” she said.

“But we know the story is much more complicated; strikingly, each of the three molecules on their own was considerably less predictive of pre-diabetes than when combined.

“The next step is to further exploit these technologies to uncover the full suite of pathways and factors that contribute to pre-diabetes – which will include genetic, environmental and possibly epigenetic influences – at a population level.”

 

Customised treatments for pre-diabetes patients step closer

The study represented a segue into precision medicine for humans, said senior author Professor David James, Leonard P. Ullmann Chair of Metabolic Systems Biology at the Charles Perkins Centre.

Precision medicine classifies individuals according to their susceptibility or response to a particular disease, and tailors healthcare treatments and practices accordingly.

“Once we can identify the molecules and other factors that contribute to pre-diabetes, we can customise treatments to suit patients’ specific make up and needs,” Professor James said.

“This study demonstrates the power of combining technologies to solve some of the world’s biggest problems,” he added.

“The burden of the ‘lifestyle diseases’ the Charles Perkins Centre is dedicated to easing – which include obesity, diabetes and cardiovascular disease – stubbornly remain at high levels globally; we need to innovate in order to tackle these conditions effectively.”

Using Social Media Big Data to Combat Prescription Drug Crisis

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Researchers at Dartmouth, Stanford University, and IBM Research, conducted a critical review of existing literature to determine whether social media big data can be used to understand communication and behavioral patterns related to prescription drug abuse. Their study found that with proper research methods and attention to privacy and ethical issues, social media big data can reveal important information concerning drug abuse, such as user-reported side effects, drug cravings, emotional states, and risky behaviors.

Their work, “Scaling Up Prescription Drug Abuse and Addiction Research Through Social Media Big Data,” is reported in the Journal of Medical Internet Research.

Prescription drug addiction is a well-known nationwide problem. Many people who are unable to get help for their addiction seek out peer support groups on Facebook or other social media platforms to share stories about their experiences and also provide social peer-based support.

Lead author, Sunny Jung Kim, PhD, an e-health communication scholar in the departments of biomedical data science and psychiatry at Dartmouth’s Geisel School of Medicine, says that because we are prolific consumers of social media, which is not limited to geography—globally, people spend more than two hours every day on social media platforms generating vast amounts of big data about our personal communications and activities—we can use these platforms to enhance public health communication strategies to help people on a large scale.

“Harnessing social media platforms and data can provide insight into important novel discoveries of collective public health risk behavior, a better understanding of peoples’ struggles with addiction, and their process of recovery,” Kim says. “I started this project because there were few studies about why people use social networking sites to share unsolicited, highly personal information about their drug use, nor about the psychological effects or consequences of this type of user-generated communication.”

Co-author Jeffrey Hancock, PhD, a professor in the department of communication and the director of computational social science at Stanford University, says, “Given the importance of this problem for the U.S. population, it’s imperative that we understand how social media is playing a role and how it can be part of the solution.”

Based on their findings, the researchers designed an evidence-based, multi-level framework to inform future social media-based substance use prevention and recovery intervention programs.

“Our review and typology suggests that social media big data and platforms can be a tremendous resource for monitoring and intervening on behalf of people with drug addiction and abuse problems,” Kim says.