Asia is a growing market for drug discovery
ephicacy lifescience Analytics Pvt. ltd., a clinical research organisation focusing on biostatistics and statistical programming services in the clinical domain, recently won an award at the ‘big Data, Analytics & Insights Summit’ in the ‘excellence in Industry Application Award (Pharma & healthcare)’ category. During his interaction with bio Spectrum, head of operations – India, Siva ramamoorthy, elaborates on ephicacy’s business plans and other details:
Apart from the US, how big is India and APAC market for Ephicacy?
Ephicacy has built its presence over the last seven years and has catered to the needs of several multinational and Indian customers. We have consistently increased our prominence in industry-wide conferences by presenting papers, posters etc. both in India and in the US.
Asia as a market for drug discovery is growing significantly in geographies such as China, Japan, Korea. We are excited about these markets and are engaging with prospective customers. Indian clinical industry is poised for a
bigger growth having being the second most preferred country after China for clinical trial conduct and services. The financial growth of clinical trials in India has increased from Rs50 to Rs5,000 crores during the last decade. And Ephicacy is excited about this growth and would look at this as an opportunity for creating more jobs and taking up challenging projects.
Recognition too has come to us as part of Ephicacy’s journey. Our papers and posters at conferences have won us accolades both in India and in the US. We have also been recognised recently by being awarded the ‘Big Data & Analytics Award’ for excellence in industry application – Pharma and Healthcare.
What are the key trends and factors driving your business in India and the US?
Pharmaceutical organisations depend on blockbuster drugs. And they team up with several service companies to achieve this goal. Being in the pharma domain, Ephicacy believes in the motto ‘bringing smiles’smiles on a pained lot. By joining hands with pharmaceutical organisations, biotechnology research firms, clinical research organisations we strive to achieve this motto.
The founding team, comprising Ganesh Gopal – entrepreneur and an expert in statistics domain along with Pratap Malik – thought leader, strategist and entrepreneur, sowed the seeds of this organisation. I am heading the India operations. I have worked with various firms and provided expertise in grooming start-ups. This team, coupled with technical and operation experts in the clinical domain, is laying the bricks of growth at Ephicacy based on a strong foundation of values.
Over the years, pharmaceutical development and service provision have been growing significantly in India thanks to economic liberalisation. Though the fruits of economic liberalisation reached our sector over a period of time, it has been relatively successful in creating job opportunities and has given birth to several business verticals. Talent pool in the region has significantly increased, giving opportunity for several multinational players to set up offices here. Cost-effective working models have created a win-win situation for all players in the domain.
At Ephicacy, highly qualified professionals, professionals with international pedigree and work exposure are forming part of the intellectual bank of the industry and are guiding our growth to the next level.
We have the ISO 9001 certification for quality management and ISO 27001 certification for information security management. With immense focus on compliance to regulatory and statutory needs of the industry, we have added several success stories to our cap and are continuing to grow with steady focus on timely and quality service to our customers.
Apart from services in the areas of biostatistics and programming, we have partnered with a US-based technology start-up firm working on launching products, which could add value to current working models of biostatistics and statistical programming. We are an extended arm of their product development, quality testing and interface design teams.
Ephicacy is strengthening its base in India and has offices in Chennai and Bengaluru. What is your overall strategy in the Asia-Pacific (APAC) region in general and India in particular?
We believe in organic growth; by this, we mean a robust, quality-oriented growth in the niche area of biostatistics and statistical programming, ensuring long-term partnership with our customers. We have been catering to the needs of organisations based out of the US and EU regions. Though FDA approved drugs have found acceptability in several countries, the regulatory framework varies country-wise. Ephicacy handpicks individuals who have global regulatory exposure, knowledge and skill.
We’ve seen growth in Hyderabad in the past year. We also have customer-facing offices at New York and New Jersey. We see India as a major playground in the APAC region and the opportunities here are yet to be tapped. Over the last few months, we’ve seen significant traction of customer requests in the Delhi-NCR and Mumbai regions.
We have been servicing studies/projects conducted in the APAC region in collaboration with other clinical research organisations. We have been receiving service requests directly from potential customers based out of this region and are in several phases of discussion. Hopefully, we should be directly serving APAC customers in the coming years.
Can you elaborate on some major differences between the clinical trial industry in the US and the APAC?
US, wielding high financial power and availability
of skilled and trained professionals, has been in the driver’s seat, followed by countries in EU.
The global clinical trials market has been estimated to reach USD14.2 billion in 2016 and is projected to reach around USD22 billion by the year 2021, growing at a compound annual growth rate of 7.5 per cent during the forecast period 2016 to 2021.
Cost for clinical labour is considerably low. For example, if the overall clinical cost is 1 unit, then in India it would be as low as 0.11 units. India stands fourth in clinical cost-maximisation after Russia, Argentina and China. Currently, top multinational pharma/biotech companies like Pfizer, Glaxo Smith Kline, Novartis, Astra Zeneca, Eli Lilly and others are conducting clinical trials in India. Amongst Indian pharma/biotech companies, Dr. Reddy’s, Piramal Healthcare and Cipla are also conducting major trials.
The number of contract research organisations (CROs) in the country is also growing; Quintiles, Parexel, ICON, Clinigene International, INC research, to name a few. Global CROs are reducing their presence in developed economies and are expanding in emerging economies like India to achieve greater overall profitability.
In the forecasted global market, the developed countries will likely account for about 66.8 per cent by 2020, down from 76 per cent at present; whereas the emerging countries combined together will likely account for 25.2 per cent, up from 15.7 per cent at present.
Most companies are outsourcing the clinical trials of their newly developed drugs to various contract research organisations as this could save them the hassles of regulatory issues and patient recruitment burden from the research and development phase. Clinical trials allow the drug to be tested for safety by different ethnic populations. Due to the higher medical needs and increasing disease prevalence, developing countries are becoming a hub for clinical trial execution.
US and Canada have the highest market share in the clinical trials market, followed by Europe where Germany leads the market followed by Poland and Western Europe. Asia is one of the fastest growing markets. India, China, Singapore and South Korea are the major players.
The Indian government’s initiatives and vision for bringing in more investment in this space has been yielding results with many top CROs having made India their major base.
What is your business plan for 2017?
Ephicacy looks 2017 as a year of ‘five’ with focus on five major activities, viz, geographical expansion in new regions of India to tap the best talent everywhere; grow customer base significantly, especially emerging biotech companies; leverage our strength in statistics and analysis and help customers in other business; groom high performing talent and win a reputation as a great place to work; grow technical infrastructure, including a data centre. Also, customers in the pharma space require on-premise data centres due to data security needs. We shall look into that aspect.
How will the life science sector perform in 2017?
The life science sector in 2017 will continue adding value to the economic growth only next to IT sector. Origination of several innovative technologies converging with healthcare and application of these in the sector will continue having an impact on the field. Along with these, come the challenges of operating performance in a regulated and risky environment, supply chain management, changing political landscapes such as Brexit, cost and pricing pressures, changes in regulations, adoption of technological advances and most importantly, the quality of the product.
Achieving operational excellence across the organisations post-mergers/acquisitions, within their organisations and with several service providers would be an interesting aspect since it’s important to realise the complete value of synergies.
Employment opportunities will see an upward growth. Life science companies will have to work towards finding a fine balance between organisational efficiency and innovation.
Analytics will play a major role in the coming year, with experimentation on patient-centric models; analysing population behaviour using social media; analysing the data from electronic systems. Different business models to accommodate risk-based monitoring will come into vogue to meet the requirements of the ever-changing technological and research landscape.
How important are analytics and statistical methods for the pharmaceutical sector?
Pharmaceutical companies are subject to a variety
of laws and regulations regarding patenting, testing and marketing of drugs. It takes an average of 12 years (eight years remain from the 20 years’ patent granted) and over USD350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to a regulatory body such as FDA to begin testing the drug in humans. Only one in 1,000 of the compounds that enter laboratory testing will ever make it to human testing.
Current challenges in the pharma industry include shortening time to approval; identifying meaningful end points and criteria for treatment effectiveness; handling erroneous data; dealing with global regulatory environments. All of these have implications as to how statistics has evolved and continues to evolve in the drug industry.
Statisticians play significant role in designing and analysing the experiments (here, experiments mean clinical trials), thus ensuring the clinical study objectives are met, thereby reducing the likelihood of any repeat experimentation and hence reducing cost, time and any implied ethical considerations.
Please explain the importance of statistics while compiling clinical trials data.
Statistical methods provide formal accounting for sources of variability in patient responses to treatment. The use of statistics allows the clinical researcher to form reasonable and accurate inferences from collected information and to make sound decisions in the presence of uncertainty. Mastery of statistical concepts can prevent numerous errors and biases in medical research, define and quantify the objective, to use appropriate study designs and proper methods of analysis.
The journey of any drug has two important goals – to prove its safety and efficacy. Having been through the journey, the drug would have entered the last phases of the trial and with huge data in place, making sense out of this data is a daunting task.
Data presentation (tables, graphs) and appropriate interpretation of results play a key role in analysing the clinical trial data, thus forming an integral part of a clinical study report. Statisticians and statistical programmers’ role here in ensuring the right interpretation to be part of the final document is a crucial activity which decides the fate of the drug.
Please elaborate on the statistical support
services that Ephicacy offers.
Data analytics play a key role in enabling the drug discovery to drug approval by regulatory bodies. Ephicacy works with pharma companies and enables their structured data into knowledge. As such we work in three areas:
• Statistics - Our statisticians enable pharma companies in designing drug trials. During trials, they also assist the pharma companies decide what success would look like.
• Stats programmers - programme to structure the
data generated during trial.
• Data standardisation - pharma industry accepted standards for clinical trial data which are recognised by global regulatory authorities.
Ephicacy provides biostatistics and statistical programming services to its clients in the entire clinical development cycle - protocol development, study design, statistical analysis, and regulatory submission.
Our services include:
• Statistical Input to Protocol/Study Design Development
• Sample Size Estimation
• Randomisation Schedule
• Review of CRF and Data Management Plan
• Statistical Analysis Plan (SAP) and Mock-up Shells
• Analysis of Safety, Efficacy Data for CSR and Regulatory submissions
• SAS Programming - SDTM/Adam Datasets and Tables, Listings, Figures
• Design and Deployment of System-level SAS Macros
• PK/PD Analysis
• Integrated Safety and Efficacy Analysis (ISS/ISE)
• Analysis for BA/BE Studies, Meta-Analysis
• CDISC standards Implementation Service
• Support Safety Monitoring, Interim and Exploratory
Analysis, Manuscripts and Abstracts
• Patient Profiles/Safety Narrative
• Statistical Report Writing
India’s clinical trials industry has been through a trying phase for the past few years. In your opinion, what could be the major reasons?
India’s decision to become TRIPS compliant in 2005 and the amendment to schedule Y of the ‘Drug and Cosmetics Rules’ had an impact on the clinical trial industry. This is common across industries; initial hiccups, trying phases followed by a sustained
growth curve is the pattern seen in business. This is true to our industry too, since our regulatory and legal thoughts had to be re-looked into both at the intellectual and bureaucratic levels. This led to a slow start. Marred by few regulatory findings such as FDA audits on Indian companies, we have recovered extremely well and have shown the world that compliance and confidentiality with respect to data integrity is of high-importance and we adhere to it.
Today, global pharmaceutical companies, clinical research organisations are looking at the sub-continent as source of talent and man-power. With the growth of companies like Ephicacy, the prospect of growth is high in countries such as India. India boasts of resource advantages in the following areas:
• Specialists in different therapeutic areas
• English trained professionals
• Treatment protocols in-line with the West.
• ICH/GCP compliance
• Large diverse gene pool
• Disease segment
Clinical research infrastructure
• Over 250+ medical colleges
• Hospitals, diagnostic labs
• Skilled computer-savvy workforce
• India is known for its IT brains, IT support is another factor of importance.
In your opinion, which are the major countries in the world that lead in conducting clinical trials and why?
Undoubtedly, the United States is the leader in this space, followed by Canada and EU countries which have excellent R&D spending and relevant infrastructure. It ought to be clear then that when the Western multinational corporations are shifting the clinical part of drug development to countries like India, it is not for altruistic reasons, nor is it for their inability to recover their costs incurred in R&D in the western countries, but because they have been presented by the WTO Patent Regime an opportunity to maximize their profits by using the easy availability of patients from developing countries.
According to Pharmaceutical Research and Manufacturers of America (PHRMA), R&D expenditure of US pharma companies has been growing moderately since the year 2000 and currently amounts to around USD58.8 billion. R&D spending by Indian pharma industry has increased from around USD426 million in 2005 to 1013 million in 2012.
What are the emerging trends in bioscience/medtech/drug discovery/technology fields?
Technological trends such as wearables and electronic health management systems are on an upswing. Reduced source date verification practices using risk-based methodologies would continue to play a major role in revolutionising the sector.
Real-world evidence-based studies in concurrence with randomised control trials would gain prominence. Adaptive designs would continue to be of interest in the bio-statistical fraternity. Standardisation would also enter the list of trends to be looked into with respect to the clinical domain. Simulations and modeling would be another area of focus that could impact the clinical industry in the long run.
What are the new technologies and trends that the company is focusing on?
Ephicacy, known for its ethical and compliant business model, would focus on continuing the compliance levels. Data security and subject data integrity being important, our in-house data centre would undergo transformation by embracing cutting-edge technologies/solutions.
Focus on learning and development to sustain the competency level of our employees to have an edge in the competition will be one of the primary goals. Metricsdriven and flexible project management model implementation would be another area of interest.
Engaging with customers and delivering value to the world through innovative methodologies would be of interest too. Application of new trends and methodologies in biostatistics and statistical programming including using R, WPS softwares is on the anvil.
Sun Pharma to acquire Novartis’s cancer drug Odomzo for $175m
Sun Pharmaceutical Industries Ltd is planning to acquire Novartis AG branded cancer drug Odomzo for $175 million. Under the agreement, Sun Pharma will get global marketing rights for the product and Novartis will receive certain additional milestone payments.
Odomzo is used for the treatment of advanced basal cell carcinoma (BCC) that recurs for patients who are not candidates for surgery or radiation therapy. This drug has marketing approval in over 30 countries globally, including the US, Europe and Australia and approved by the US Food and Drug Administration in July 2015. The deal is expected to be finalised after getting clearance from the US antitrust agency.
Kirti Ganorkar, Global Head - Business Development Sun Pharma said, “Odomzo gives us an opportunity to meaningfully expand our already established branded dermatology business and support our expansion into branded oncology with a launched brand. We see meaningful global potential for Odomzo by leveraging Sun Pharma’s existing dermatology and oncology infrastructure to provide an innovative product to BCC patients worldwide.”
According to Jesper Jensen, Head - Biologics and Dermatology, Sun Pharma, “We look forward to collaborating with the medical community to bring this novel therapy to the market to patients suffering from locally advanced basal cell carcinoma. Odomzo complements and enhances our existing dermatology franchise. This acquisition has the potential to leverage and expand the relationships that our Levulan sales team have with the dermatologists that treat common pre-cancerous skin conditions.”
Symcel, Colzyx partner to test 25 novel, collagen VI derived anti-microbial peptides with calScreener
Symcel, the company behind the cell-based assay tool for real-time cellular bioenergetic measurements, calScreener, has partnered with Colzyx to test 25 different new collagen VI derived antimicrobial peptides analysing their capability to kill bacterial growth. These newly discovered, first-in-kind peptides each have the capability to kill bacteria in different ways. The technology will be used flexibly to test each peptide independently or in combination with others.
Testing the collagen VI derived peptides with Symcel’s calScreener, with the calorimetric measurement of heat generated by metobolism, provides rapid generation of unique information that can’t be acquired through other experimental methods.
The novel calScreener technology provides continuous kinetic data for bacterial growth and inhibition - making it a valuable tool for evaluating novel antibacterial compounds. These newly created peptides are of a type that has never been tested in this field of R&D before.
Eskil Söderlind, CEO, Colzyx said, “We are delighted to have partnered with Symcel in what is an industry first in R&D on multiple counts. Their innovative calScreener technology is set to further test and validate the effectiveness of our novel collagen VI peptides which, for the first time in research history, are being put to use to combat microbial infection by destroying bacteria”.
Christer Wallin, CEO, Symcel commented: “We are very pleased to be working with Colzyx and very much look forward to putting our technology to use in measuring and evaluating the impact that their peptides have in killing bacterial growth. CalScreener was selected because of its ability to deliver unique data in real-time for these truly groundbreaking tests - the results of which
will be of high scientific and healthcare interest.”
“Our peptides have the potential to provide a new and unique form of antibiotics for treating infections in the future. Our highly natural solution - utilising the bodies own built in defence mechanism and developing that into a form of a pharmaceutical drug for targeting microbial infection - has great healthcare potential,” said Söderlind.
watson-Marlow Fluid Technology Group acquires Aflex Hose Ltd
Watson-Marlow Fluid Technology Group strengthens its product portfolio through the acquisition of Aflex Hose Limited. Watson-Marlow Fluid Technology Group, the world leader in niche peristaltic pumps and associated fluid path technologies, has acquired Aflex Hose Limited and its subsidiary Aflex Hose USA LLC through its parent company Spirax-Sarco Engineering plc, for £61.4 million.
Aflex, based in Halifax, England and with a sales/assembly operation in Pennsylvania, USA, specialises in the design and manufacture of PTFE lined flexible hose for the pharmaceutical, food and chemical process industries.
Aflex is highly synergistic with, and a natural extension to, the WMFTG fluid path product portfolio and further strengthens WMFTG’s already strong global presence in the biotechnology, pharmaceutical, industrial/chemical and food & beverage sectors. Aflex utilises patented, market-leading technology to produce PTFE lined flexible hose, which outperforms other PTFE and standard hose-types within the most demanding applications, ensuring the highest levels of chemical resistance, superior flexibility and sterility.
Aflex joins a fluid path product range comprising Watson-Marlow Pumps, Watson-Marlow Tubing, Flexicon Filling Systems, BioPure single-use tubing connector systems, Asepco aseptic valves, FlowSmart seals and gaskets, Alitea OEM Pumps, MasoSine Process Pumps
and Bredel Hose Pumps.
Jay Whalen, President, Watson-Marlow Fluid Technology Group said: “The strategic acquisition of Aflex further broadens our fluid path product range and strengthens Watson-Marlow’s position in across all our major market sectors. For example, in the biopharmaceutical sector we now have a complete and comprehensive product range to enable customers to source the world’s leading, most technically advanced products from a single trusted partner. Our range covers all aspects of technology required for fluid transfer from source to delivery point. This is another exciting milestone for WatsonMarlow and we are looking forward to accelerating our growth with our broadened product portfolio coupled to our process expertise. e are pleased that Rod Anderson, founder, will continue in a technical advisor capacity and that senior management will remain.”
Jeremy Hudson, Managing Director, Aflex said, “I am very excited to be part of the Watson-Marlow Fluid Technology Group and look to drive sales further with the expansive WMFTG sales network.”
New chikungunya vaccine brings in hope!
Bringing in a much-needed relief to millions of people suffering from chikungunya every year, researchers from The University of Texas Medical Branch at Galveston have revealed that they have developed the first vaccine for chikungunya fever that produces a strong immune defence and completely protects mice and nonhuman primates from disease when exposed to the chikungunya virus.
The vaccine is made from an insect-specific virus that doesn’t have any effect on people, making the vaccine safe and effective. The findings were published in journal of Nature Medicine. Chikungunya is a mosquito-borne virus that causes a disease characterised by fever and severe joint pain, often in hands and feet, and may include headache, muscle pain, joint swelling, or rash. Some patients will feel better within a week but many develop longer-term joint pain that can last up to years. Death is rare but can occur.
Senior author and researcher Scott Weaver from the University of Texas Medical Branch at Galveston, said,
“This vaccine offers efficient, safe and affordable protection against chikungunya and builds the foundation for using viruses that only infect insects to develop vaccines against other insect-borne diseases.”
Researchers used the Eilat virus as a vaccine platform since it only infects insects and has no impact on people. The UTMB researchers used the virus clone to design a hybrid virus-based vaccine containing chikungunya structural proteins. The Eilat/Chikungunya vaccine was found to be structurally identical to natural chikungunya virus. The difference is that although the hybrid virus replicates very well in mosquito cells, it cannot replicate in mammals.
Within four days of a single dose, the Eilat/Chikungunya candidate vaccine induced neutralising antibodies that lasted for more than 290 days. The antibodies provided complete protection against chikungunya in two different mouse models. In nonhuman primates, Eilat/ Chikungunya elicited rapid and robust immunity - there was neither evidence of the virus in the blood nor signs of illness such as fever after chikungunya virus infection.
Other authors include UTMB’s Jesse Erasmus, Albert Auguste, Huanle Luo, Shannan Rossi, Karla Fenton, Grace Leal and Tian Wang; Jason Kaelber and Wah Chiu from Baylor College of Medicine; Dal Kim and Ilya Frolov from the University of Alabama at Birmingham and Farooq Nasar from the United States Army Medical Research Institute of Infectious Diseases.
lonza to buy Capsugel for $5.5bn
Swiss pharma giant Lonza group announced that they have inked an agreement under which Lonza will acquire Capsugel from KKR for USD 5.5 billion in cash, including refinancing of existing Capsugel debt of approximately USD 2 billion, through a transaction that has been approved by the Boards of Directors of both Lonza and Capsugel. The transaction will be financed with a combination of debt and equity financing.
The deal will help Lonza to accelerate growth and deliver value along the healthcare continuum by complementing its existing offerings and by opening up new market opportunities in the pharma and consumer healthcare and nutrition industries. The acquisition of Capsugel will add a trusted brand to Lonza with a large breadth of technologies and will expand the market reach of its contract development and manufacturing organisation (CDMO) and products businesses. It will also support Lonza’s strategic ambition of getting closer to the patient
and end consumer.
With approximately 3,600 employees and 13 facilities on three continents, Capsugel has a customer-centric, entrepreneurial and collaborative culture that closely aligns with Lonza’s corporate culture. Both companies focus on quality, operational excellence and delivering on promises.
“The acquisition of Capsugel meets Lonza’s strategic and financial goals. It accelerates our healthcare continuum strategy by giving us broader exposure to the fast-growing pharma and consumer healthcare markets,” Richard Ridinger Chief Executive Lonza said in a statement.
The combined business will be well positioned to benefit from the dynamics in these industries and to anticipate and address technology trends in order to support the evolving needs of its customers. It will provide additional value by offering an integrated portfolio of industryleading technologies, from active pharmaceutical ingredients (APIs) through excipients to dosage forms and delivery technologies.
The deal will strengthen Lonza’s position in consumer healthcare and nutrition as Lonza becomes a fully integrated and innovative service provider of active ingredients, oral dosage forms, development services and delivery technologies. As a result, Lonza will be well positioned to meet the increasing need for optimised consumer health and nutrition through a wide offering of next-generation dosage forms. The combined business will also be able to leverage its bioavailability technology to create a new dietary ingredient-ready offering, as well as capitalise on its formulation expertise to develop new ingredients and to market new combination products.
Guido Driesen, President and Chief Executive Officer,
Capsugel, said, “This transaction brings together two leading companies that share a common vision - to deliver real value to customers by accelerating their ability to develop and commercialise innovative pharmaceutical and healthcare products. The combination of our complementary technology platforms will put us in a strong position to benefit from evolving trends in the pharma and consumer healthcare markets.”
He added, “Both companies enjoy a strong quality and regulatory track record, and we believe that the combination enables us to provide the most complete set of tailored and integrated solutions for our customers. We look forward to bringing together our talented teams to deliver science- and engineering-based solutions to customers for the benefit of the patients and consumers who use their products. I am personally committed to making this integration a success.”
Trump promises to bring down drug prices
In a recent interview with a leading magazine, US President-elect Donald Trump said that he would bring down drug prices and reduce the cost of prescription drugs. Trump previously had also suggested that he was open to allowing importation of cheaper medicines from overseas.
In a cover story for Time magazine, which named him its Person of the Year, Trump said: “I don’t like what has happened with drug prices.” This might bring relief to many consumers who have been constantly affected with rising drug prices.
Recently a Reuters report stated that, top executives from large US drugmakers discussed for the first time possible changes for the industry under Presidentelect Donald Trump, and issues that have damaged the reputation of their industry.
Brent Saunders, Chief Executive, Allergan Inc said, “Though pharma companies are now breathing a sigh of relief, Trump could be more critical of drugmakers and their price increases than the industry expects.” Saunders predicted that Trump could be a “more vicious tweeter” against the drug industry than his former Democratic rival Hillary Clinton had been during the campaign.
Clinton’s tweets committing to a crackdown on exorbitant drug price increases weighed heavily on pharmaceutical shares since her first tweet in September 2015. Pharma shares jumped in the days after Trump’s election as Clinton’s proposed price controls fell off the table.
Saunders said Americans are rightly angry about price increases, and the industry needs to police itself or face government repercussions.
“I worry that the pharmaceutical industry has a very false sense of security because of the Trump administration and a Republican-controlled Congress,” Saunders said.
Regeneron Pharmaceuticals CEO Len Schleifer, speaking on a panel at the Forbes conference, said the industry will be seen in a bad light as long as it maintains the common practice of taking twice yearly, often doubledigit, price increases on widely-used medicines.
“We as an industry have used price increases to fill gaps in innovation,” he said. “You can’t say ‘I set the price based on the value of the drug’ and then have these egregious price increases,” Schleifer said, adding that the value of a drug to society does not increase each year.
Ian Read CEO Pfizer Inc took exception to Schleifer’s characterisation of the price hikes, arguing the cost of prescription drugs as a percentage of overall healthcare spending had not changed in two decades. In an overhauled US healthcare plan under Trump, Read said he would like to see financial risk shift from insurers to providers, such as hospitals, with an emphasis on prevention and wellness.
“Give them the tools and the freedom and the incentive to manage that risk,” Read said. Separately, Merck & Co CEO Ken Frazier said he thought one of Trump’s proposed healthcare reform policies - allowing the import of cheaper drugs from other countries - will not work. The US pays more than any other country for medicines, and current US law forbids importation of drugs from other countries that charge far less.
“I don’t think it’s going to be made possible,” said Frazier, during an interview on CNBC after an appearance
at the conference. “Every time we’ve tried to do that no FDA commissioner has ever been willing to certify the safety of those drugs.”
Strides Shasun acquires Perrigo’s us FDA approved API facility in India
Bengaluru-based pharmaceutical company Strides Shasun Limited have signed an agreements to acquire the entire shareholding in Maharashtra based Perrigo API India for INR 1000million. Perrigo API India got access to two US FDA AOI facilities having a combination of API’s for captive consumption and commodity APIs. Post-merger with Shasun Pharmaceutical Limited in 2014, the Company has significantly scaled up its API practice through upgrade of infrastructure and quality standards with a focus on building a portfolio of backward integrated small molecules and catering to high entry barrier markets of Japan and South Korea.
Under the terms of agreement, Strides Shasun will acquire 100 per cent of the issued capital of Perrigo API India. Also, Perrigo parent or affiliates will continue to source few products from the facility under a long-term supply agreement.
Perrigo API India’s facility brings into the fold a US FDA approved API facility located at Ambernath, Maharashtra, to be used for captive consumption and will augment the Company’s resources to handle high velocity of new product development and commercial launches in the formulations portfolio. The facility with a potential capacity of 600 tons per year had zero 483s during its last US FDA inspection.
Commenting on the development, Shashank Sinha, Group CEO of Strides Shasun stated “With this acquisition, we bring into our fold a manufacturing facility designed to handle multipurpose small batch productions and accelerates our time to market. This augurs well for the Strides’ stated strategy of building a backward integrated portfolio of niche and small volume products for the regulated markets.”
Japan’s Takeda to invest €40 million in Irish facility
Japanese drug giant Takeda is planning to invest nearly €40 million in a new facility in Dublin in a move that will lead to the creation of 40 jobs. The company first invested in the country about 20 years ago, in 1997 and is now planning to build a production facility, dedicated to manufacture its oncology product NINLARO (TM) for global markets from Dublin. The move is set to further expand Takeda’s Irish footprint.
Takeda is the largest pharmaceutical company in Japan employing more than 400 people at its three sites in Dublin. Plant Director at Takeda Ireland Grange Castle, Paul Keogh said in a statement that the additional investment in Ireland “demonstrates the confidence and commitment” Takeda has in its Irish operation.
Keogh said, “We are delighted that Takeda has chosen
Ireland for this investment and proud that we have been entrusted with the responsibility to produce and deliver this very important treatment for cancer patients worldwide. We have a great team here in Ireland and are committed to continuing to put patients first through the timely manufacture and supply of high quality products from our site.”
Welcoming the investment, Mitchell O’Connor, Minister for Jobs, Enterprise and Innovation said, “The pharma industry makes a huge contribution to the Irish economy in terms of jobs and exports, and is one of the fastest growing sectors. Takeda’s decision to manufacture their new cancer treatment in Ireland is a great win and vote of confidence in Ireland and it builds on our ongoing expansion of the sector here. I’m delighted that this investment will bring a further 40 jobs to the com-
pany’s existing Clondalkin facility.”
Martin Shanahan CEO IDA Ireland commented on the investment and said, “Ireland is globally recognised as a centre of excellence in life sciences due to the country’s regulatory track record and talent availability.”
Korea’s pharma workforce up by 27 per cent
With the South Korean pharma industry expanding, the size of the local pharma workforce grew by 27 per cent compared to four years ago reported the Korean Herald. According to the Korea Pharmaceutical Manufacturers Association, a total of 94,500 people were employed at some 842 pharmaceutical companies as of 2015, a sharp increase from 2011, when 74,000 people were employed at 822 companies.
The association pointed out that though the number of pharmaceutical companies rose just 2 per cent during the four-year period, the number of people employed in the field rose 27 per cent. KPMA said in a statement that, “Despite deepening unemployment, Korea’s pharmaceutical industry appears to be actively contributing to continued job creation.”
The biggest growth came from the drug manufacturing and research and development arenas. The number of manufacturing personnel rose 34 per cent from 23,500 in 2011 to 31,700 in 2015. The number of R&D personnel grew 26 per cent from 8,800 to 11,000 during the four-year time frame.
Meanwhile, the change in the size of the pharmaceutical sales and marketing workforce was smaller but still significant - growing from 24,500 people in 2011 to 25,700 people in 2015, according to the association.
On the whole, manufacturing personnel took up the biggest share of the pharmaceutical workforce in 2015 at 33.5 per cent, followed by sales and marketing at 27.24 per cent, administrative roles at 20.23 per cent, R&D at 11.7 per cent and others at 7.33 per cent.
APAC pharma market to see modest growth in 2017
According to BMI Research, Singapore’s pharmaceutical market will see a modest growth of around 6 per cent in 2017. The firm also said that the whole APAC region will see a rise of 5 per cent. The firm said that the Asia Pacific pharmaceutical market will see modest growth in 2017, as ongoing trends such as the roll out of universal healthcare and advances by private healthcare providers is seen to continue.
The firm further elaborated that two themes will define 2017 in APAC, one of which is the demise of Trans-Pacific Partnership. “The TPP had the potential to reshape the operating environment for multinational drugmakers. This includes strengthening the intellectual property regime with patent adjustments to a more transparent procurement process,” the firm noted.
It added, “Notably, the impact of the TPP would have extended beyond the seven APAC signatories’ markets, as leaders from countries such as Indonesia, Thailand and South Korea had expressed their interest in eventually participating in the trade deal.”
BMI also cited that in 2017, cost containment in the APAC region will become more acute as governments seek to contain rising healthcare spending amid a more uncertain economic outlook. “While the broader trend
of controlling costs has been an ongoing theme within the region, we expect 2017 to mark a key inflection point as governments adopt additional measures to further reduce spending. Notably, 2017 will see a more targeted approach being adopted, as authorities seek to mitigate the financial pressures stemming from the use of high value pharmaceuticals,” BMI said.
Asia to replace europe as the secondlargest healthcare market by 2025
Research firm Frost & Sullivan said that Asia is all set to replace Europe as the second-largest healthcare market in the world by 2025. The new analysis, “Vision 2025 - Future of Healthcare,” which is part of Frost & Sullivan’s Advanced Medical Technologies Growth Partnership Service program, sees the global healthcare industry growing at a compound annual growth rate (CAGR) of 5.6 per cent to reach revenue of $2.69 trillion by 2025.
The report states that though North America is the largest healthcare market in the world today, it may only retain this lead until 2028. With growth in healthcare expenditure as a percent of GDP set to be higher than North America and Europe, Asia is poised to take the lead. The analyst firm also predicts that by 2025, Latin America is set also forecast to overtake Japan to become
the fourth-largest healthcare market globally.
Meanwhile, aging populations worldwide are challenging and will continue to challenge existing healthcare systems financially and require improved healthcare outcomes. Frost & Sullivan expects this to cause a shift towards value-based care and require national policies to change dramatically. The rise of consumerisation as well will lead to patient-centric healthcare.
“With an aging population and increasing chronic disease prevalence, the focus on prevention and monitoring will be enforced. This is reflected in rising shares of healthcare expenditure for prevention, monitoring, and diagnosis, while the share for treatment will decline,” noted Siddharth Shah, Frost & Sullivan Transformational Health Research Analyst.
“Emerging technological advances to help alleviate the situation will enable several new billion-dollar opportunities to arise in all sectors. The combined effect of transformational shifts and new opportunities will facilitate the emergence of new business models in the industry,” Shah said.
ultrasound devices market to reach $10,476mn globally by 2022
A new report published by Allied Market Research, titled, “Ultrasound Devices Market - Global Opportunity Analysis and Industry Forecast, 2014 - 2022”, projects that the global ultrasound market would reach $10,476 million by 2022. Diagnostic ultrasound system would continue to be the highest revenue-generating segment throughout the forecast period. Europe accounted for almost one-third of the market share in 2015, and is expected to dominate the overall market during the study period.
The major factors boosting the market growth include technological advancements (such as advent of 3D and 4D ultrasound that provides detailed information about a known abnormality from different angles), rising incidence of chronic diseases, and increasing geriatric population worldwide.
The rising number of application areas of ultrasound coupled with increasing adoption of ultrasound systems in obstetrics and gynaecology field, is set to boost the growth of the ultrasound market worldwide. Cost effectiveness, safety, high accessibility, and clinical value in preliminary diagnosis are strengthening the technologies value proposition in technological advancements in the ultrasound market. In addition, increase in number of diagnostic imaging procedures, and rising awareness for early diagnosis of clinical disorders are anticipated to further drive the demand for ultrasound devices. However, dearth of skilled and experienced sonographers and technological limitations of ultrasound systems are some of the factors restricting the market growth.
The radiology/general imaging segment accounted for the major share of 30 per cent of the overall ultrasound market in 2015. This is primarily due to the wide adoption of ultrasound devices in the diagnosis of rising number of abdominal diseases. Urology has emerged as the fastest growing segment, registering a CAGR of 11.3 per cent during the forecast period, due to the growing incidences of urinary tract infections coupled with the rapidly aging patient population.
Diagnostic ultrasound devices such as 2D ultrasound, 3D & 4D ultrasound, and Doppler devices have given rise to new applications (such as biopsies and imageguiding interventions) across different clinical specialties.
The growing demand for both ultra-portable and portable diagnostic ultrasound systems in diagnostic and image guidance area at points-of-care have further boosted the market growth.
The advent of portability in ultrasound has built a strong path for the increased demand of these devices for point-of-care applications such as emergency medicine, anaesthesiology, musculoskeletal, and critical care medicine. The trolley/cart-based ultrasound devices segment accounted for the major market share of the total ultrasound market in 2015, whereas, the compact/ handheld ultrasound devices segment is expected to grow at a higher CAGR during the forecast period.
Geographically, the European region accounted for the majority share in the overall ultrasound market in 2015, and is expected to maintain this lead throughout the
forecast period. The growth in the ultrasound market is attributed to the increased adoption of ultrasound for diagnosis, increased procedure volumes resulting from rapidly aging population, and increased prevalence of chronic diseases.
However, regulatory framework concerns and dearth of experienced and skilled sonographers in various countries in Europe are expected to hamper the market growth. In addition, the growing momentum of HIFU in European countries for the treatment of prostate cancer is further set to drive the ultrasound market.
Asia-Pacific is projected to be the fastest growing region throughout the analysis period. This is mainly due to the improving healthcare infrastructure and healthcare expenditures in the emerging markets (such as India and China) to overcome the unmet medical needs in these countries. Technological advancements for cost-effective devices in these nations offers a lucrative opportunity for the growth of the ultrasound devices market.
• In the year 2015, 2D imaging systems was the leading segment, accounting for almost half of the overall market revenue, and is projected to grow at a CAGR of 3.3 per cent during the forecast period.
• HIFU segment is expected to grow at a remarkable CAGR of 22.5 per cent, owing to the non-invasive nature and high accuracy of technology for the treatment of prostate cancer.
• Asia-Pacific accounted for about one-third share of
the global ultrasound market in 2015.
• The obstetrics/gynaecology segment is projected to surpass the ultrasound market for radiology/general imaging during the forecast period.
• China and Japan are the major shareholders in the Asia-Pacific region, jointly accounting for about twothirds share of the regions ultrasound market.
The key players in the ultrasound market are highly focused on expanding their business operations in the fast-growing emerging countries and new product launches as a preferred strategy. The companies profiled in this report include Analogic Corporation, Esaote SPA, Fujifilm Corporation, General Electric Company, Hitachi, Ltd., Koninklijke Philips N.V., Mindray Medical International Limited, Samsung Medison Co. Ltd, Siemens AG, and Toshiba Corporation.
Agilent Technologies collaborates with Transcriptic for innovative biology solutions
In order to foster innovation and to develop novel synthetic biology solutions, Agilent Technologies have recently collaborated with Transcriptic. Transcriptic’s automated discovery biology enables scalable life science research through a convenient and simple web interface. This platform can be used by biologists to control their science and generate data remotely via the cloud.
This collaboration will add multiple Agilent Genomics product lines for mutagenesis and cloning to the protocol library within the Transcriptic robotic Cloud laboratory like QuikChange Lightning which will accelerate the generation of multiple mutants for large protein function projects and providing cutting-edge Agilent bioreagents in a robotic laboratory setting allowing a global customer base to automate and optimise workflows for rapid and efficient research discoveries.
Herman Verrelst, Vice President and General Manager of Genomics Solutions Division and Clinical Applications Division, Agilent said, “We’re excited to combine our genome engineering tools with automated experimentation. Transcriptic’s services are validated, scalable, and accessible from anywhere in the world, which will enhance the market for our industry-leading reagents.”
Yvonne Linney, Chief Operating Officer, Transcriptic said, “By bringing these products to Transcriptic, we will make it extremely easy for customers to scale up their research, using many mutants to produce very large datasets for exploring protein function.”
Hemocue launches world’s first realtime anaemia monitoring system
Hemo Cue, the global leader in point-of-care diagnostics, launched Hemo Cue Health Trender Anemia, the new-age anaemia screening and monitoring system at an event held on November 30, 2016 at Embassy of Sweden, New Delhi. The event was graced by important stakeholders including policy makers, government officials, bureaucrats, health administrators, public health experts, doctors.
Anaemia presents a formidable public health challenge,
affecting nearly half of all Indian women, a fourth of all men, 79 per cent of children aged 6-59 months and causing 20 per cent maternal deaths.
Speaking at the event, Dr. Ajay Khera, Deputy Commissioner, Ministry of Health and Family Welfare, emphasised the need of technological interventions to support and strengthen government efforts to eradicate anaemia. Dr Khera pointed out, “Anaemia has become a burgeoning health concern not just in India but across the world. The Government of India acknowledges the urgency of the situation and is committed to battle out the epidemic.”
He added, “While we are doing our best, we face formidable challenge, especially vis-à-vis quick and reliable diagnosis of anaemia. Technology-based interventions can deliver fast results in terms of speedy and accurate screening as well as data collation.
Early and accurate diagnosis can play a key role in improving treatment outcomes in anaemia. Employing detection methods that are fast, accurate and reliable promises to be a significant step forward in meeting the challenge anaemia poses. Moreover, manual collation of data associated with these methods takes months and is error-prone, which in turn means that anaemia management policies often have to be based on either insufficient or unreliable data.
Bjorn Christ, President - Hemocue AB said, “To diagnose anaemia and make early crucial decisions related to managing anaemia in patients and to monitor response to therapy, haemoglobin measurement remains the prime focus. And that is where Hemocue can make a difference with its technology-enabled products. We have been able to achieve great results in other countries as well. Continuing with our mission of improving lives through innovation, we have developed Hemocue. Health Trender, an innovative system that ensures optimal usage of resources to secure maximum outcome of healthcare programme.”
“Hemocue Health Trender Anemia is an innovative device that when integrated with community health programmes, especially in rural areas, can help address the issues of delayed and incorrect diagnosis. We strongly believe that the real-time data that it helps generate and analyse can be instrumental for decision makers to create policies around anaemia management,” said Deepak Sharma, Regional Sales Director Asia Pacific, Hemocue. Numbers reveal that the physical and cognitive losses due to iron deficiency have a significant effect on the Gross Domestic Product - in some developing countries up to as much as 4 per cent.
The Government of India is relentlessly involved in carrying out programmes to fight anaemia. Many of the programmes are executed by village clinics, healthcare centres and NGOs in rural areas under harsh conditions with limited access to electricity, pure water combined with a poor infrastructure.
Under these conditions, it becomes virtually impossible to collect data, to review, act or evaluate the programmes in a timely and effective way; something that has been requested for a long time but never adequately solved.
Hemocue Health Trender Anemia is a Cloud-based solution can help overcome these challenges as it offers immediate insight using real-time data captured from the Hemocue Hb201+ analyser in the field. A stream of data over time can help policymakers manoeuver the direction of programmes and also facilitate consistent monitoring of haemoglobin levels in the target groups.
Head of India Operations,
Ephicacy Lifescience Analytics Pvt. Ltd.
Head of India Operations,
Ephicacy Lifescience Analytics Pvt. Ltd.