Government Allows Oxytocin Sale Through Private Chemists
New Delhi: (PTI) Setting aside its ban on the sale of oxytocin, the Health Ministry has allowed private retail shops to sell the life-saving hormone from September 1, an official said recently. The ministry in its notification dated April 27 had stated that sale of oxytocin through private retail chemists would be banned from July 1 and that the drug would be sold only in government hospitals and clinics. Later, it deferred the implementation of the ban till September 1. "All retail sale shops are permitted to sell oxytocin," the official said. The government has restricted the manufacture of oxytocin formulations for domestic use to just one public sector company. State-owned Karnataka Antibiotics Pvt Ltd (KAPL) will be the only company to manufacture and distribute oxytocin in India from September 1. In a meeting on August 6, the ministry had asked the state governments and Union territories to place purchase orders with KAPL to ensure that there is no shortage of oxytocin injections in government hospitals and clinics. Oxytocin is a naturally-occurring hormone that causes uterine contractions during labour and helps new mothers lactate. But its misuse is widespread in the dairy industry where livestock are injected with oxytocin to make them release milk at a time convenient to farmers. The hormone is also used to increase the size of vegetables such as pumpkins, watermelons, brinjals, gourds and cucumbers. The government has already banned the import of oxytocin and its formulations.


Supreme Court Exempts Saridon, Piriton Expectorant from Government's Ban List
New Delhi: The Supreme Court allowed the sale of Saridon, Piriton expectorant and Dart tablets, three combination drugs among more than 300 that the government banned last week for being risky for patients. While hearing a plea by GlaxoSmith-Kline, Piramal and Jagdale Industries, the court allowed them to continue selling the drugs because they were being manufactured before 1988, said a lawyer present at the proceedings. “The Union of India disputed this position, saying that these fixed dose combinations are not pre-1988 combinations,” a second lawyer said. The court had earlier said the health ministry could not rely on its technical committee’s report to ban 15 combination drugs that were manufactured since before 1988, another lawyer said. The apex court directed the government to reply within two weeks to a separate application by the Federation of Pharma Entrepreneurs seeking a stay on the ban against all 328 combination drugs. The federation contended the government did not follow due process, one of the lawyers said. Several popular cough syrups, painkillers and cold medicines are combination drugs, containing two or more therapeutic ingredients in a single dose. Saridon is marketed by Piramal to treat headaches. GSK’s Piriton is a cough syrup. “The court has passed an interim order permitting us (and other pre-1988 manufacturers who were excluded from the exempt list) to continue manufacturing and sale of the product subject to its final decision on our application,” a GSK spokesperson told ET. “This allows the distribution and sales of Saridon to continue,” Piramal’s spokesperson said. ET’s queries to Jagdale Industries remained unanswered. Wockhardt, Lupin, Alkem, Mankind and MacLeods Pharmaceuticals are among the drug companies that have approached the Delhi High Court for relief from the ban, according to a lawyer aware of the development. The high court said on Friday it was not inclined to grant an interim stay of the ban for Wockhardt’s Ace-Proxyvon medicine. However, the court prevented the government from taking punitive action against Wockhardt in case it was unable to recall the stock of the banned drug already in the market, a lawyer said. An official from Mankind confirmed that the company has approached the high court.


Price Control, ad-hoc Regulatory Changes May Hamper Pharma Sector Growth: Pfizer
Mumbai: Pharma major Pfizer fears that the pharma industry is expected to face challenges from price controls, ad-hoc regulatory changes and new policies that may impact sustainable growth. "Even though economic outlook is expected to remain positive, there are several headwinds in the healthcare and pharmaceutical regulatory space," the company had said in its annual note to shareholders. "While implementation of large-scale healthcare initiatives expected to provide a boost to the pharma industry, there will be continued challenges in the areas of price controls, ad-hoc regulatory changes and new policies that may impact predictability and sustainable growth," it further said. The Indian pharma market (IPM) stood at Rs 121,833 crore at the end of financial year 2018, growing at 6.3 per cent over the last 12 months period. This represents a significant slowdown from the historic 13-14 per cent CAGR trends (2010-2016). This slowdown was largely due to regulatory, policy and GST challenges that impacted industry performance. "We will continue to face policy unpredictability that will impact our operating environment. During FY18, a process to amend the Drug Price Control Order (DPCO) was initiated that may again change the price control methodologies in India. The industry may also continue to see changes in policies around labelling requirements and revisions to the essential medicines list," Pfizer managing director S Sridhar said. After several years of abeyance, the government announced its commitment to increase the total health expenditure to 2.5 per cent of gross domestic product (GDP) by 2025 from the current 1.15 per cent. While attention and deliberation on public health are welcome, it has also brought with it heightened uncertainty with amendments and modifications being implemented in practically all policies governing healthcare and pharmaceuticals, the note said. In several cases, such interventions have created challenges for sustainable growth and an unpredictable investment environment for the industry, it pointed out. In light of these challenges, IQVIAs growth prognosis for the Indian pharma market has been revised to a CAGR of 9.7 per cent for 2018-2022 as opposed to the previous estimate of 10-12 per cent as per IQVIA Prognosis research report Q1 2018, it said. In the short term, the government may need to enhance its funding allocation towards its healthcare programs significantly and also find ways to improve the availability of infrastructure like hospital beds and more resources to meet the expected demand, the company said. Pfizers sales for the financial year ended March 31, 2018 were Rs 1,925 crore as compared to Rs 2,017 crore in the previous year, which represents a decline of 4.6 per cent. The profit after tax grew by 6.9 per cent to Rs 360 crore in FY 18 as compared to Rs 337 crore in the previous year. Pfizer will continue to navigate through these uncertainties on the strength of our business strategy and our execution excellence, Sridhar said. Commenting on the future growth plans, Sridhar said, in the next few years, new introductions and volumes will be among the most important drivers of growth. Global teams are working with our medical and marketing colleagues to further strengthen the India capabilities and support new launches, he added.


Niti Aayog Working on Blockchain Tech for Drug Industry
Niti Aayog is working with Apollo Hospitals and information technology major Oracle on applying blockchain (decentralised) technology in pharmaceutical supply chain management to detect spurious drugs, Chief Executive Officer of NITI Aayog Amitabh Kant said. Addressing a gathering through video-conferencing at the inaugural session of International Blockchain Congress 2018 for which Niti Aayog was a co-host, Kant said the organisation was working on applying the blockchain technology to pressing problems of the country in areas such as land registry, health records and fertiliser subsidy distribution m among others. "There is a need to use blockchain to track and trace medicines and spurious drugs. Therefore, Niti Aayog, in collaboration with Apollo Hospitals and Oracle, is putting pharmaceutical supply chain in blockchain for complete traceability of drugs from manufacturer to consumer to protect our citizens from the menace of spuriousmedicines, he said. The agency was working with judiciary too to see the civil cases related to land registration and mutation were expedited, he said. "The government has to play a leading role in allowing the application of blockchain technology. As the government, we need to make it easier to apply blockchain in pressing areas such as disbursement, land records, health records. Countries around the world had to improve and change the legal system to make themselves use blockchain technology," Kant said. Emerging technologies such as blockchain technology were key drivers for ease of doing business and were essential for a free market, he added.


Chhatisgarh Firms up Plans to Establish Biotech Park
The Chhattisgarh Government has decided to establish a bio-technology park with an objective to promote setting up of biotechnology units and generation of more employment opportunities. Twenty three hectares of land has been acquired in village Mungi of Aarang block in Raipur district for this park. Sum of `1 crore have been provisioned for this in the budget of new fiscal year 2017-18. Agriculture and Bio-technology Minister Brijmohan Agrawal informed that this Park will be equipped with incubation centre, central facility lab and testing centre, and training and entrepreneurship centre. Developed land will be made available to the investors for setting up agriculture and environment based industries, he said. Bio-tech industries includes industries related to agriculture inputs, pharmaceuticals, biotechnology, drug discovery and diagnostics used in tissue culture, medicinal and aromatic industries, seed industries, nursery based industries, bio-fertilizer, bio-pesticide, bio-leeching, and organic farming, the Minister said.


Aurobindo Pharma Acquires Dermatology Business from Sandoz in a $900 Million Cash Deal
Hyderabad: Hyderabad based Aurobindo pharmaNSE 0.48 % recently announced that it will acquire the dermatology and oral solid business from Sandoz Inc, a subsidiary of Swiss drug maker NovartisNSE 0.00 % for an upfront purchase price of $900 million in cash, making it the second largest generic player in the US by number of prescriptions. The transaction will be an all cash transaction which Aurobindo will finance through a fully committed debt facility. The acquisition will add approximately 300 products including projects in development as well as commercial and manufacturing capabilities in the US for Aurobindo. The portfolio that Sandoz is divesting generated sales to the tune of $600 million in HI 2018. "The acquisition announced today is in line with our strategy to grow and diversify our business in the US. Acquiring these businesses from Sandoz will allow us to further expand our product offering and to become a leading player in the generic dermatology market", said N. Govindarajan, Managing Director of Aurobindo. "As we have done in some of our previous acquisitions, we will be focused on leveraging our Group's market leading vertically integrated and highly efficient manufacturing base to enhance the market position and medium-term profitability of the businesses we are acquiring, " Govindarajan added. This acquisition is expected to be accretive to normalized EPS from first full year of ownership. Some of the portfolio of products under the deal includes topical antibiotics, gynaecological and dermatological antifungal agents, anti-acne agents, local anaesthetic analgesics, anti-itch, and a dermatological chemotherapeutic agent. The transaction is expected to close in the course of 2019.


Lupin Launches Generic Clobetasol Propionate Cream in the US
Pharma major Lupin announced the launch of its Clobetasol Propionate Cream USP 0.05%, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Clobetasol Propionate Cream USP 0.05% is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate® Cream, 0.05%. It is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Clobetasol Propionate Cream USP 0.05% had annual sales of approximately $08.6mn in the US (IQVIA MAT June 2018).


Lupin to train over 1,000 graduates for pharma industry
Pharmceutical giant, Lupin Limited expects to train more than 1,000 under graduates into pharma professionals by the year 2020 under its Learn and Earn Initiative, a senior company official said recently. Lupin has launched its 'Learn and Earn' initiative in which candidate who has passed Standard 12 in the science stream with a minimum of 50 per cent marks but are facing financial constraints are taken for three-year-long course during which they are paid stipend and provided all the facilities. "Since 2011 Lupin has helped to create a total of 560 graduates with 181 students passing out this year (2018)," C Srinivasalu, senior vice president (HR) Lupin told reporters in Goa Thursday. "We expect to graduate more than 1,000 students by 2020 adding to the manpower resource of the pharmaceutical sector," Srinivasalu said adding that "most of these would be absorbed by Lupin." The company has initiated the 'Learn and Earn Initiative' at its facilities in Goa, Tarapur (Maharashtra), Indore (MP), Aurangabad (Maharashtra) and Sikkim, he said. During the course period, the candidate undergoes five days on-the-job training with one day of classroom session, Srinivasalu said. Further, the students have to compulsorily work with Lupin for two years, after completing their course before they have their options open to join any other pharmaceutical firm. Mumbai-headquartered Lupin has estimated that by the year 2020 they would be spending almost Rs 20 crore on this programme. This program will bridge the manpower requirement of pharmaceutical sector in a big way," he said. Addressing media, Yashwant Mahadik, president, global human resource, Lupin. said program was conceptualised in the year 2010 due an acute shortage of skilled manpower. "Historically, Lupin was recruiting 1,000 plus fresh graduates every year with no relevant job skill, and sensed that there was a need of job-ready graduates with appropriate technical and life skills," he said. Mahadik claimed that the main aim of this program was to "create a ready pool of talent in India to be part of the booming pharmaceutical sector.".


Regulators Hold Back ‘Golden Era’ of Innovation in Pharmaceutical Manufacturing
How can pharmaceutical packaging production executives prevent “innovation inertia”? A new report outlines key points in the issue and offers solutions from industry expert Girish Malhotra, who warns that regulators are holding back the pharma industry’s ability to innovate because of long approval times and short patent lives. Malhotra, president of Epcot Intl., an Ohio-based consultancy firm specialized in manufacturing and technology simplification for pharmaceutical and other industries, explains in the report, “The problem we have presently is that, for manufacturing technology innovations to be successful, pharma companies (brand and generics) need to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement. But the regulators—in particular the FDA [Food and Drug Administration]—are still dictating approaches to industry without asking what the commercial justifications are to support them.” He questions whether recommendations are developed by regulators who don’t have any hands-on experience in the development, design, commercialization and/or operation of pharmaceutical manufacturing facilities. If the dictating doesn’t stop, Malhotra says valuable process advances might never happen. For example, he believes guidelines for current Good Manufacturing Practices (cGMP) prompt pharmaceutical companies to focus on adhering to regulations rather than on innovating. Malhotra recommends that two paths—shortening the regulatory approval times and working closely with contract services worldwide—will usher in a new golden era of innovation and drug affordability for pharmaceutical companies producing patented products. He also thinks drug shortages will decrease and companies will realize maximum profits, without compromising product quality and safety, if industry takes these two actions. “Overall my prediction is that whilst the regulators are trying to improve the situation, we will again lose any major manufacturing improvements over the next one or two years. In the longer term however, I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation. But my fear is that we are still at least three years away from this,” concludes Malhotra.


Online Pharma Draft Triggers Over-Regulation Worries
The recently released draft guidelines for the online pharmacy industry have raised several questions for players operating in the burgeoning space, including on a possible overlapping role of state governments. The gazette notification, released on August 28, states that all e-pharmacies have to register with the Central Drugs Standard Control Organisation, the apex drug regulator and central licensing authority. But the rules also give state governments the power to cancel registrations, leading to fears of over-regulation in a space that has emerged as a sunrise sector over the last three years. “While the draft rules clearly mention a central licensing authority, as far as e-pharmacy marketplaces are concerned, there is also Rule 67T (3), which talks about the power of the state governments to cancel the registrations. The confusion lies around the question of where this power is coming from,” said Atul Pandey, partner at law firm Khaitan & Co. Additionally, it is yet unclear if offline pharmacy retailers selling on online platforms will also have to register with the central licensing authority, and if online platforms have to register with the states as well. “There is also a requirement under existing rules for each and every drug, retailers and wholesalers to obtain license from the state authorities. It is not clear if the online portals will have to register with the state authorities in relation with the drugs sold through the portal,” Pandey said. A 45-day period has been set by policy makers to receive recommendations and comments from the stakeholders and public on the draft rules, post which the rules will be notified formally. The e-pharma industry, thus far, has reacted positively to the draft guidelines, seen as the first attempt to bring it under regulatory oversight, having operated in what was perceived as a grey area since inception. “It is a very positive boost for the sector, because the notification is a clear intent of being supportive,” said Prashant Tandon, chief executive of online pharmacy 1mg. “What is still not fully clear are issues around data privacy. We are still waiting to understand what that means in some level of granularity, but that should be covered under the data privacy conversations, which are already actively on,” said Tandon, who also heads the India Internet Pharmacy Association. Tandon, however, shot down concerns relating to over-regulating the nascent space. “Regulations in this sector are much more poorly enforced than it needs to be. Pharmacy is a sector that deserves better compliance than it has today… We are anyway operating with high standards of compliance,” he said. India’s pharmaceutical sector was valued at $33 billion in 2017, according to the India Brand Equity Foundation. It is expected to expand at a CAGR of 22.4% over 2015–20 to reach $55 billion. The country is expected to be among the top three pharmaceutical markets by incremental growth and the sixth largest market globally in absolute size by 2020. The domestic e-pharmacy market has captured less than 1% of the overall pharmaceutical market but is projected to touch $3 billion by 2024, according to Kuick Research. “If you look at India’s growth, the two most important aspects are improving accessibility to healthcare and improving affordability. E-commerce can play a strong role in bridging that,” said Pradeep Dadha, chief executive of online pharmacy NetMeds



SCHOTT KAISHA Hosts Pharma Packaging Stalwarts at its Jambusar Plant, Gujarat
Jambusar: Leading pharmaceutical packaging company, SCHOTT KAISHA recently opened doors to its valuable industry partners for a plant visit, as part of the Parental Drugs Association’s (PDA’s) two-day conference on ‘Advancing Science In Drug, Device & Primary Packaging: A Primer to Containers, Closures & Integrity’. More than 60 delegates from the high-profile conference, took part in the half-day visit to SCHOTT KAISHA’s state-of-the-art facility in Jambusar, Gujarat, to enhance their know-how of best practices being followed by the Indo-German joint venture. “We are proud to have hosted such a high-profile delegation of PDA at our plant in Gujarat. It was not only a great experience for our workers, who felt motivated after meeting industry professionals, but also enriching for the visitors. Many of them represent our long-standing clients and they were extremely happy to see what happens inside the plant that delivers them high quality pharmaceutical packaging material,” said Eric L'Heureux, Director Operations, SCHOTT KAISHA Private Limited.


NSF International and IDMA Offer Pharmaceutical Quality Management Education in Bangalore
Ann Arbor, Mich., York, UK and Bangalore: NSF International, a global public health and safety organization, is partnering with the Indian Drug Manufacturers’ Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education program in Bangalore, India. Pharmaceutical industry professionals who complete the graduate-level, advanced education program will earn an internationally recognised certification in GMP compliance from NSF International and IDMA. The Advanced Program in Pharmaceutical Quality Management consists of five modules, each lasting four days. With the modules taught every other month, the program can be completed in 10 months. Classes will be offered at Acharya College in Bangalore with a planned start in September 2017. Pre-registration information sessions will be held in Bangalore, Hyderabad and Mumbai during the week of 12 February, 2017. The information sessions will be led by S.V. Veerramani, National President of IDMA, S.M Mudda, Chairman of the IDMA Regulatory Affairs Committee & Program Coordinator, and program tutor Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. The event in Hyderabad is sponsored by the Pharmaceutical Export Promotion Council (PHARMEXCIL) and organized by the Ministry of Commerce and Industry, Government of India. India has the highest number of GMP-approved manufacturing plants outside the United States and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. According to a report by Deloitte, 64 percent of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth. “India is one of the world’s largest producers of generic pharmaceuticals and IDMA is aware of the changing global regulatory expectations that require a focus on holistic management of quality rather than compliance with minimum regulatory standards. IDMA believes that education and development of quality leadership in the industry would serve as a foundation for continued compliance and for building a culture of quality,” said S.V. Veerramani, National President of IDMA. “We are pleased to partner with NSF International to customise its world-class pharmaceutical quality management education program for the Indian pharmaceutical industry.” NSF International’s Advanced Program in Pharmaceutical Quality Management is taught by world-recognised leaders in PQM. The course tutors each have more than 30 years of global pharmaceutical industry experience. Several are former Medicines and Healthcare products Regulatory Agency (MHRA) inspectors and others have authored guidance documents for the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). In addition to training pharmaceutical industry professionals, NSF International has provided training to regulators from eight regulatory agencies, including agencies in the United States and the European Union (EU). “This program provides the training needed to comply with GMP requirements in Europe and the United States,” said Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. “Together with IDMA, we’re going to change how course participants think about quality and give them the knowledge and tools they need to protect their company’s legacy, reputation and future.” The training program is designed to be highly interactive and includes modules covering best practices in PQM systems, change control and deviations, human factors in quality management, practical application of statistics, and process validation and technology transfer. The course also includes practical instruction on the leadership and communication skills required to improve business performance and regulatory compliance at pharmaceutical manufacturing operations and to successfully interact with regulatory agencies in the United States and the EU


Gujarat to Set up India’s First biotechnology University
Ahmedabad: India's first Biotechnology University will take shape in Gujarat with the State legislative assembly set to pass a Bill for establishment of the country’s first such university. It will aim to boost research, innovation and entrepreneurship in the sector. The Gujarat Biotechnology University, to be made a world class research-focused academic institution, will train and prepare biotech scientists in product-focused research to create and deliver a strong pipeline of innovative products for the country. The University will have world-class infrastructure, an intellectual property base and skill sets for education, training, research, product development and technology commercialisation in biotechnology and allied sciences. The Bill for the new university provides a framework to facilitate intellectual property and matters related to technology commercialisation for product pipelines. It will also identify key issues and solutions by means of biotechnology and develop manpower with the knowledge and skills to meet industry needs. The act of the University has provisions to form an Advisory Council, for necessary directions on strategic changes, including its education system, research system and linkages to industries and with top ranking institutions abroad. This is aimed at making the university match global standards. Before coming out with a Bill for a dedicated university in biotechnology, the State government conducted a survey of more than 600 students. It was found from the survey that there is a need for practice based curriculum for the students in advanced biotechnology tools and techniques. For conceptualising such research-based and product-focused curriculum faculties, scientists of national and international repute were consulted, a State government statement said here. In order to create a strong Biotechnology ecosystem in the State, the government has established the Gujarat State Biotechnology Mission, Gujarat Biotechnology Research Centre and The Savli Technology and Business Incubator. These organisations already work towards accelerating research, human resource development, policy based start-up and entrepreneurship in the State, providing momentum to the biotechnology sector.


Waters and Restek Co-Marketing Agreement Created with Needs of International Food Safety Laboratories in Mind
MILFORD, Mass.--(BUSINESS WIRE): Corporation (NYSE:WAT) and Restek Corporation have entered into a co-marketing agreement in an effort to give food safety laboratories access to the GC-MS instrumentation and consumables they need to perform pesticide residue GC-MS analyses and support a safe, secure, sustainable and nutritious global food supply. “We are delighted to enter into this agreement with Restek. Like Waters, they are strongly committed to making customers successful and their market-leading GC consumables and technical support play an important role in helping our customers monitor for pesticides and other contaminants and meet the sensitivity requirements of global regulated methods,” said Jeff Mazzeo, Vice President, Marketing, Waters Corporation. “Restek is excited to work with Waters on this new venture because we both place great value in bringing exceptional service and quality to our respective customers. By collaborating, we can combine our unique expertise to help analysts around the world perform the vital job of ensuring the safety of a food supply we all share,” said Rick Lake, Vice President, Marketing, Restek Corporation. Under the terms of the agreement, Waters and Restek will work together to provide food safety laboratories with training and applications support of GC-MS methods and workflows for pesticide monitoring and screening. Shipping This September: The Waters Xevo TQ-GC Mass Spectrometer The Waters® Xevo™ TQ-GC Mass Spectrometer is a tandem quadrupole mass spectrometer with an electron impact (EI) ionization source. When paired with highly-inert Rxi columns and Topaz liners from Restek, the Xevo TQ-GC Mass Spectrometer allows laboratories to meet and exceed low part-per-billion limits of detection when quantifying pesticide residues and other contaminants in food using GC-MS/MS methods set forth by worldwide regulatory agencies/authorities. Waters is exhibiting the Xevo TQ-GC System at these international scientific conferences this week: 132nd AOAC International Annual Meeting & Exposition and the 22ndInternational Mass Spectrometry Conference (IMSC). Waters recently published a poster featuring a multi-residue analytical method titled The Determination of Pesticide Residues in Quechers Extracts of Fruit Commodities by GC-MS/MS. Download a copy here


Waters Sponsors New Research Centre to Address Global Food and Water Safety Challenges
Singapore, (Business Wire): Waters Corporation (NYSE:WAT) recently opened the doors of the new International Food and Water Research Centre (IFWRC) in Singapore to address the growing challenges of food and water security and safety. Led by a Scientific Advisory Panel, the IFWRC will support scientists throughout the world working in areas such as food authenticity, food fraud discovery, water contamination research, food quality enhancement and new ingredient/formulation studies. The Scientific Advisory Panel will identify meaningful, innovative projects by working with academic and industrial leaders globally. As world populations grow, it has become increasingly important to ensure food and water supplies are safe, healthy and plentiful. However, all over the globe, new challenges are arising — environmental contamination, food adulteration, access issues and more are putting people’s futures at risk. To find solutions, it’s critical to gather the leading food and water scientists together in collaborative environments. “In past decades, Singapore has become a major hub for food and water research that has far-reaching impacts around the globe. The country has long had well-established academic laboratories where scientists have done significant work,” said Mike Harrington, Senior Vice President of Global Market at Waters. “Based on that, along with Waters’ storied history in Singapore, we are thrilled to open the IFWRC, a model for scientific collaboration between industry, government and academia that will ultimately drive significant advances in food and water quality.” “As an innovation-led economy, Singapore values strong partnerships that accelerate the development of new, differentiating capabilities for our industries. The unique collaboration model of the International Food and Water Research Centre will build upon Singapore’s strong academic base, while bringing together regional and global researchers within the food and water domains, to co-create and implement innovative solutions with a global impact,” said Ms Thien Kwee Eng, Assistant Managing Director, Singapore Economic Development Board. Researchers will gain access to IFWRC’s state-of-the-art facilities outfitted with the latest advanced analytical instrumentation from Waters. In addition, the laboratory will be staffed with scientists and researchers who will work closely with project owners throughout implementation.


Verseon Unveils New Blockchain Technology
Fremont, Calif.: Verseon today unveils transformative blockchain technology for tokenized securities, developed by its wholly owned subsidiary, BlockRules Ltd. Since its founding in 2002, Verseon’s mission remains to develop disruptive technologies and products that advance global health. As part of this goal, the Company is challenging traditional drug development funding models through the process of tokenization of securities. BlockRules technology supports the sale, launch, and trading of securities on a public blockchain complete with multi-jurisdictional regulatory compliance integrated and enforced directly on the blockchain. This breakthrough permits fully regulated, secure, and transparent support of securities, including decentralized trading. Current blockchain technology has the potential to transform the global investment landscape. To accomplish that, token offerings need to comply with existing security regulations if they are to become ubiquitous. The technology developed by BlockRules is designed to overcome these regulatory hurdles. “We founded Verseon with the goal of developing new technologies to advance the discovery and development of new medicines,” said Adityo Prakash, CEO of Verseon. “By democratizing investment access with blockchain technology, we will change the way new medicines and other life-science innovations are funded and how the resulting proceeds are shared.” BlockRules Ltd. plans to offer its technology to innovative companies ready to embrace the rapidly developing blockchain community. By bringing regulatory certainty to the blockchain, BlockRules aims to provide the global investment community with safer and more relevant opportunities for investment. “Recent advances in the blockchain space have the potential to narrow the gap between innovative companies and investors,” said Neil Woodford, founding partner of Woodford Investment Management. “Verseon’s innovations in this space address some of the traditional choke points in capital flow and should lead to a more efficient market.”.


NeuroVive Reports First NeuroSTAT Clinical Efficacy Signal in TBI
LUND, Sweden, (PRNewswire): NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) today announced the successful completion of biomarker analyses of samples from its clinical study in severe traumatic brain injury patients (the CHIC study) using the company's investigational compound NeuroSTAT. The results provide an early signal of efficacy derived from time-based changes in biomarker levels that correlate with NeuroSTAT drug administration. Patient samples from the previously completed CHIC study have been analyzed in a research collaboration with Kevin K.W. Wang, Ph.D., at the University of Florida. The aim of the collaboration is to develop innovative endpoints for NeuroVive's clinical traumatic brain injury (TBI) program. The GFAP, UCH-L1, NF-L and Tau biomarkers, which reflect different aspects of the ongoing brain cell damage following TBI, were measured in repeated samples of cerebrospinal fluid from the severe trauma patients in NeuroVive's CHIC study. The results show a time-based change in biomarker levels correlating with NeuroSTAT drug administration for all four biomarkers. These biomarkers are being developed with the aim of improving diagnosis, enhancing short and long-term patient care and assisting clinical trials developing new treatments for TBI. "This early efficacy signal indicates that NeuroSTAT suppresses the secondary brain injury cascade and clearly supports our continued development of NeuroSTAT for TBI. The results from this fruitful collaboration are very promising in relation to our efforts to optimize efficacy measurement in TBI drug development and bring the much-needed treatment options to these patients," commented Magnus Hansson, Chief Medical Officer and VP of Preclinical and Clinical Development at NeuroVive. The company plans to use these innovative biomarkers as outcome measures together with other new endpoints to establish proof of concept for NeuroSTAT in its next larger randomized, placebo-controlled phase II efficacy study, planned to start in 2019.


Dr. Neil Bacon Appointed New President and CEO of ICHOM
Boston: The International Consortium for Health Outcomes Measurement (ICHOM) announced recently. that physician-entrepreneur Dr Neil Bacon has been appointed as its new President and CEO, effective October 1, 2018. Dr Bacon succeeds Dr Christina Akerman, who has returned to her native Sweden after four highly successful years as President. Dr Bacon’s mandate is to take ICHOM, the world leader in developing and supporting implementation of global outcome standards across the disease burden, to the next level. Outcome measurement must spread across every health care delivery organization and nation. ICHOM is also in the initial stages of establishing the first platform for benchmarking outcomes across countries that will enable unprecedented innovation in health care. Dr Bacon, a nephrologist trained at Oxford and Harvard, is a distinguished academic clinician and health information technology entrepreneur. He is an internationally recognized leader in quality measurement and engaging patients in their health. Dr Bacon founded Doctors.net.uk in 1996, now one of the world’s largest online medical networks used by nearly one quarter of a million physicians worldwide to rapidly obtain clinical information, education, medical news, and career opportunities. In recognition of his ground breaking contributions utilizing the Internet to improve healthcare, he was named a Fellow of the Royal College of Physicians in London in 2015. In 2008, Dr Bacon founded iWantGreatCare, an independent organization enabling patients to rate and review their doctors, dentists, hospitals, after-care facilities, and medications where he was CEO. With reviews from more than 5 million patients in 23 countries, iWantGreatCare has become a powerful tool for driving health care improvement worldwide. Harvard Business School Professor Michael Porter, ICHOM Co-founder and Chairman of the Board, commented: “Dr Neil Bacon is a pioneer and entrepreneur in use of information technology to enhance quality measurement and change health care. Universal measurement of outcomes that matter to patients, medical condition by medical condition, is the most powerful single tool to change health care.” Dr Bacon said: “The worldwide need to measure quality and value in healthcare through standardized outcome measures by condition that matter most to patients is greater than ever. The benefits to patients, providers, and payers of measuring the ultimate quality of care is irrefutable. The opportunity to lead ICHOM to drive such a transformation is truly exciting and creating and comparing patient outcomes will accelerate the importance and influence of ICHOM’s pioneering work worldwide.” ICHOM is an independent non-profit organization with offices in Cambridge, Massachusetts and London, England. It was founded in 2012 by Professor Michael E. Porter of Harvard Business School, and Dr Stefan Larsson of the Boston Consulting Group in partnership with Sweden’s Karolinska Institute with the mission of driving the adoption of value–based health care worldwide. In addition to Professor Porter ICHOM’s board includes Dr Larsson, Professor Martin Ingvar of Karolinska Institute, and Dr Donald Berwick, founder of the Institute for Healthcare Improvement and former Administrator of the Centers for Medicare & Medicaid Services. ICHOM’s mission is to catalyse the global movement to transform health care worldwide through creating international standards for the outcomes that matter most for patients by using medical conditions. Outcome standards are developed and updated over time by international teams of leading clinicians, investigators, and patients in a rigorous process including publication in peer reviewed journals. ICHOM standard sets have been developed in 26 conditions including stroke, diabetes, and ischemic heart disease, representing 25% of the global disease burden. ICHOM also assists providers on how to implement outcome measures and utilize outcomes to improve patient care. To date, ICHOM has worked with over 600 provider organizations, 15 national registries, and across 30 countries.


FIP Adds Biosimilars to Policy on Pharmacists’ Right to Substitute one Medicine for Another
The Hague: Pharmacists’ authority to use their expertise to substitute one medicine for another should also apply to biological medicines, the International Pharmaceutical Federation (FIP) made clear today. The federation has published a revised Statement of Policy on “Pharmacists’ authority in pharmaceutical product selection: Therapeutic interchange and substitution”, which has been updated to account for the emergence of biological medicines and their biosimilars onto the medical landscape. The core principles that were in the original statement remain, and include: that generic substitution is recommended as part of the pharmacist’s dispensing role; that pharmacists should be provided with bioavailability data by regulatory authorities and manufacturers; and that a medicine should only be substituted with a product containing a different active ingredient in agreement with the prescriber. The use of generic names is still encouraged, but the revised statement gives focus to the use of international non-proprietary names in particular. The revision also recommends that, to ensure safety, information about excipients should be taken into account when making decisions on substitution. “To date, no major safety issues with the use of biosimilars as alternatives to the original biological medicine have been reported,” the statement says. However, the new text calls for “adequate pharmacovigilance” to ensure identification of a biological medicine should any product-specific safety (or immunogenicity) concerns arise, as well as for post-marketing safety studies by companies marketing generic medicines or biosimilars, with safety updates to be made publicly accessible. “Pharmacists are key stakeholders in product selection and evaluation. The purpose of this policy is to guarantee quality and good pharmacy practice in this area of pharmacists’ activities. FIP supports well regulated processes in product changes where goals of safety, positive patient outcomes and economic benefits can be achieved with a good collaboration of all parties,” said FIP Vice President Eeva Teräsalmi.



Kangstem Biotech Selects MaSTherCell for GMP Manufacturing of FURESTEM-AD(R) in Europe
Seoul, Korea and Gosselies, Belgium: Kangstem Biotech, a biotechnology company specializing in developing cell therapies using mesenchymal stem cells derived from human umbilical cord blood, today announces the selection of MaSTherCell as its contract manufacturing partner for its European clinical trial of FURESTEM-AD(R). MaSTherCell, a subsidiary of Orgenesis Inc. (NASDAQ:ORGS) through Masthercell Global Inc. is a cell therapy dedicated Contract Development and Manufacturing Organization (CDMO). MaSTherCell will perform a technology transfer of FURESTEM-AD’s process and manufacture FURESTEM-AD for Kangstem’s European clinical trial. Kangstem is moving into late phase clinical trials in Korea and strengthened by this expertise, now takes the opportunity to enter into Europe with its innovative cell therapy products. “The European clinical trial of Furestem-AD will be a milestone for our company. We believe that MaSTherCell's expertise and experience will be the key to enable it,” said Mr. Tae Wha Lee, CEO of Kangstem. “Kangstem’s allogeneic human umbilical cord blood-derived stem cell based project fits perfectly in MaSTherCell’s long term strategy to provide services across all segments of the cell therapy field,” said Romain de Rauville, Business Development Manager and Head of Europe at MaSTherCell. “Being selected by a Korean cell therapy company really portrays MaSTherCell’s expertise and agility in assisting our partners with their globalization. Kangstem’s efficient manufacturing process will further increase MaSTherCell’s expertise and skills to broaden the impact of both companies on the cell therapy field.” The partnership provides Kangstem access to MaSTherCell’s cell therapy manufacturing expertise, capabilities and commercial state of the art new facility. The Agility by Design facility will provide Kangstem with the most efficient clean room set-up for its unique and high-value large-scale manufacturing process. If desired, MaSTherCell’s global facilities further allow Kangstem to easily expand to other continents. This puts Kangstem in a fast-track position to provide its innovative cell therapy products to more patients


AstraZeneca Well Placed to use Medtech to Expand in Chinese Healthcare Market, Says GlobalData
AstraZeneca is well positioned to use artificial intelligence (AI), robots and apps (Medtech) to expand its market share, and transform diagnosis and disease management in the world’s second largest pharma market—China, says leading data and analytics company GlobalData. The company’s CEO Pascal Soriot has recently announced plans to use Medtech in China, which has the highest incidences of several chronic diseases in the world, such as cancer and diabetes. They are expected to increase as a result of the westernized lifestyle and the rapidly aging population. Recognizing the importance of the rapid development of biotechnology in addressing challenges faced by the country’s healthcare system, the government aligned biotech development with the pharmaceutical sector under its 13th Five-Year Plan (2015–2020), the ‘Healthy China 2030 Plan’ and the ‘Made in China 2025’ plan. According to a recent survey ‘Digital Transformations and Emerging Technologies in the Healthcare Industry – H2 2018’ by GlobalData, AI, APIs, and the Internet of Things (IoT)—including smart apps and devices—are the three most popular emerging technologies that healthcare organizations are looking to invest into in the near future. Several independent companies are seeking to break into the healthcare industry by offering their ever-expanding and improving devices and services to aid patient data collection and aggregation, screening and diagnosis, and personalized medication decision-making. However, implementation of these fast-evolving technologies in healthcare is not easy. According to the survey, insufficient funding and lack of specific skills and talents are the most critical barriers that hinder digital transformation within healthcare organizations. Edit Kovalcsik, Managing Pharma Analyst at GlobalData, says: “Although digital transformation holds promise to build a more efficient and cost-effective healthcare system, its adaptation in healthcare is slowed by concerns such as patient data protection, regulatory issues, cybersecurity, and even work overload on the already low supply of trained experts if innovative devices and services are used incorrectly.” AstraZeneca established its initial presence in China in 1993. The country was AstraZeneca’s second largest market in 2017, according to AstraZeneca’s Annual Report. Earlier this year, the company announced partnerships with Alibaba and Tencent to provide a broader health service in China than simply selling drugs. The Chinese Internet giants will develop smart health services, AI-assisted screening and diagnosis tools for the British pharma giant. Kovalcsik concludes: “Investing in Medtech underlines AstraZeneca’s commitment to remain a leading pharma player in China. Effective management of chronic diseases will drive the Chinese pharma industry in the coming years, in which the use of smart app-, AI-, and robotics-assisted diagnosis and patient care will be critical components to overcome current issues of insufficient supply of doctors to meet growing demand, potentially facilitating China’s journey to become the world’s largest pharmaceutical market.”


DuPont Nutrition & Health Research Study Demonstrates a Role for Nasal Microbiota in the Host Response to Viral Respiratory Infection
KANTVIK, Finland: A collaborative clinical study between DuPont Nutrition & Health, the University of Virginia and 4Pharma Ltd indicates that nasal microbiota may influence the viral load, host innate immune response and clinical symptoms during rhinovirus infection. The DuPont Microbiome Venture and Global Health & Nutrition Science teams have worked in collaboration with the University of Virginia and 4Pharma Ltd in an experimental rhinovirus challenge to understand the role of nasal microbiota clusters and their association with inflammatory response, viral load and symptom severity. The study has been published recently in Scientific Reports, available at www.nature.com/articles/s41598-018-29793-w.


Knowledge About Current Contraceptive Options is Still A Problem in Highly Developed Countries, Says GlobalData
Women in the US are still not fully aware about the available choices of contraceptives and receive outdated or incorrect counselling as their general providers are not familiar with currently available options, particularly the long-acting reversible methods, according to GlobalData, a leading data and analytics company. September 26 marks World Contraception Day (WCD), which aims to improve awareness of all contraceptive methods available and enable young people to make informed choices. Dr. Edit Kovalcsik, Managing Analyst at GlobalData, comments: “According to interviewed Key Opinion Leaders (KOLs) there are two main problems with access to contraceptives in the US. Firstly, it is a financial problem for those without a medical insurance, and second, provider and patient knowledge about the current contraceptive options is still not sufficient. “Education of both general providers and patients about contraceptive choices will likely increase the use of the long-acting reversible contraceptive methods, such as the hormonal IUDs, in the coming years. In particular, the American College of Obstetricians and Gynecologists (ACOG) recommends that physicians counsel patients about the long-acting reversible methods first. “Increased knowledge about the long-acting formulations will mean more sales for contraceptives such as Allergan’s Liletta and better adaptation of the launching novel long-acting formulations, such as The Population Council and TherapeuticsMD’s extended-release vaginal ring, Annovera.” Contraceptives in late stages of clinical development, which are likely to launch within ten years, will provide women with options that could reduce side effects, another problem that causes many women to discontinue treatment. These include The Population Council and Antares Pharma’s transdermal gel, NestraGel; Mithra’s combined oral contraceptive, Estelle; and Evofem’s non-hormonal vaginal gel, Amphora. Dr Kovalcsik concludes: “In order to optimize uptake of the launching new contraceptives however, raising awareness about the new contraceptive options and educating providers and women about the benefits of the new products will be essential.”


Apceth to Manufacture First Potential One-Time Gene Therapy for Transfusion-Dependent β-Thalassemia
Munich, Germany, (B3C newswire): apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, congratulates its partner bluebird bio on the acceptance and validation of its market authorization application by the European Medicines Agency (EMA). bluebird bio has applied for market authorization of its investigational LentiGlobin™ gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. “We congratulate our partner bluebird bio on this recent success”, commented Dr Christine Guenther, CEO of apceth Biopharma. “These are exciting times also for apceth, as we are now in the position to become one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use.” apceth has supported and will continue to support bluebird bio for obtaining the market authorization for LentiGlobin™. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for LentiGlobin, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy..


Ucima Goes to Teheran and Mumbai to Promote the Excellence of Italian Technology
Modena: The Italian Automatic Packaging Machinery Association Ucima has chosen the two important processing and packaging trade fairs PacProcess Teheran (Teheran, 11-14 October) and PacProcess India (Mumbai 24-26 October) as the next events for promotion of the Italian packaging industry and its cutting-edge technology. Iran and India are two strategic markets that are showing strong interest in Italian technology due to its high degree of customisation and innovative characteristics in terms of automation, sustainability, predictive maintenance and robotics. In 2017, Iran imported a total of 210.7 million euros of packaging machinery, an increase of 14.2% on the previous year. Italy was the country’s second largest trading partner after Germany with sales of 60.3 million euros (up 16.3% on 2016) and a 29% share of the total. For the three-year period 2018-2020 the Ucima Research Department is forecasting annual average market growth of 1.7% and a 5.2% increase in Italian exports. In 2017 India imported a total of 427.8 million euros’ worth of packaging technology (down 3.1% on 2016), a contraction caused by the growth of local machinery manufacturers which hold a 60% share of the domestic market. Italy is the country’s second most important trading partner with exports worth more than 100 million euros (-3.9%, in line with the market as a whole) and a 23.8% share of total imports. For the three-year period 2018-2020, the Ucima Research Department is forecasting annual average market growth of 6.9% and a 4.5% upturn in Italian exports. The Italian participation in PacProcess Teheran and PacProcess India is part of the partnership agreement signed in 2017 between Ucima, Ipack-Ima and Messe Düsseldorf. Under the terms of the agreement, the organisations provide mutual support with each other’s trade fairs and Ucima offers its assistance for international events organised by the German trade fair management company as part of Interpack Alliance. The aim of the partnership is to create a reference network for companies operating in the processing and packaging industry in a number of key markets for Italian technologies. During the shows, Ucima will hand out promotional materials and provide detailed information on the sector and on the association’s member companies.


CPhI Annual Report Warns Trade and Patent Changes Could Increase Healthcare Cost by $100bn Over Next 5-Years


China is harmonizing to ICH standards at feverish pace and will force poor quality manufacturers out of market
Amsterdam: CPhI Worldwide the world’s largest pharma event – taking place in Madrid October (9-11) and organized by UBM (part of Informa plc) – has released the second part of its annual report, which evaluates the effects of regulatory divergence, trade agreements and IP rights over the next 5-years. Two annual report experts, Dilip Shah, CEO of Vision Consulting Group, and Bikash Chatterjee, President and Chief Science Officer at Pharmatech Associates review the impact of ‘IPRs and trade agreements’ and ‘regulatory divergence’ respectively, suggesting the implications of both could have profound impacts globally. Dilip Shah argues strongly in his paper that the global trend towards patent term restoration and extension will result in patients needing to wait an extra 5 or 10 years to access generic versions of medicines. In many cases Regional Comprehensive Economic Partnership (RCEP) texts seek to redefine the protection period to 20 years from the date of marketing approval. “For example, ‘Patent linkage’ under Comprehensive and Progressive Trans-Pacific Partnership Agreement (CPTPP) will require [generic company] to gain consent from patent holder prior to use of data in (generic) marketing approval. CETA between the EU and Canada has similar patent restoration as does EU-Japan economic partnership agreement.” commented Shah.
However, Shah believes this may, in fact, result in longer term consequences for the industry with consumers and governments ultimately forcing a fundamental reform of how medicines are reimbursed. Over the course of the next 5-years, he forecasts that healthcare costs could potentially rise globally by as much as $100bn[1]. The implications for the patented pharma industry is that it is likely to come under sustained pressure in the medium term (5-10 years hence) to reduce prices. Bikash Chatterjee in his paper on ‘regulatory philosophy divergence and innovation convergence in the next decade’, predicts China’s rate of advancement is still accelerating and that we can very quickly expect full harmonization with ICH standards. The next result will be that China’s overall standards will improve quickly and poor quality manufacturers will drop out of the market in the next two to three years. Globally, he foresees that whilst regulators are actively diverging in their philosophies, technology and innovation is simultaneously converging – with frameworks grounded in scientific tools and analytical techniques. For example, process validation in the future will be completed for individual patients, not batches. CAR-T and NGS have opened a potential regulatory pathway for even 3-D bioprinting of organs to follow.
“We have seen groundbreaking drug therapies and diagnostics approved in the last five years that position regulatory bodies to embrace these new innovations. Whether risk is managed via enhanced control and oversight, such as with the EUs GDPR legislation, or is a by-product of intelligently gathered real-world data, as provided under the US’s 21st Century Cures Act, the regulatory evaluation in each framework required to evaluate these new technologies will be grounded in today’s scientific tools and analytic techniques. Technology is playing an increasingly large role in improving rates of attrition. Over the next five years, big data will catalyse drug discovery with R&D leading to quicker advancement of more targeted therapies” added Chatterjee.
The full findings of the CPhI Annual Report will include more than 10 in-depth expert contributions as well as the CPhI manufacturing and bio leagues tables, which will evaluate the relative reputations of each major pharma country.

For a list of onsite content, please visit: https://www.cphi.com/europe/agenda






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