Biotecnika magazine - Jan 2015

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Top 10 Astonishing Facts about Indian biotech sector INTERVIEW

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We realized very early in our journey that funding for this space was very difficult.”

Anand Kumar, CEO, Bugworks Research

GOOGLE enters sequencing space “ The huge variety is the biggest challenge we have to deal with.”

In Conversation Country Head Titan Biotech Ltd

Salary Special Cover Feature

Who pays you the best in

BIOTECH SECTOR?

SEE ALSO

Top 10 Politicians who stand for Biotechnology

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EDITORIAL When India was on the brink of crumbling under the merciless famine in the early 1960s, one man came to the rescue with his new and improved rice varieties, who later stood to be the proud reason behind “Green Revolution” across the world. Norman Borlaug, the Father of Green Revolution, today, takes the stage to advocate the acceptance of the much argued GM technology.

But the arguments among the consumers do not recede. The inception of GM was way back decades ago but the awareness is where it had gone amiss.

The technology had earlier presented us with its agricultural marvels but promotion is where it had got muddled. Is lack of promotion the only reason for the mounting fears and uncertainties over GM crops?

May not be the only one but certainly is one.

Mr. Shekhar Suman Chief Editor editor@biotecnika.org

While our very neighbor is planting and promoting the same then our country needs to question itself, Why not we? China, the most populous country, has been spreading the good word among the society to accept GM foods. They have engaged all forms of media to uphold the technology and promote awareness. This commendable step taken by the country instigates the ever persistent debate of either promoting or relegating GM crops. Should India follow the footsteps of China and foster GM technology or be adamant at its state of confusion towards the same? Analyzing the same, we have weaved our cover story around the issue, “GM crops- Promotion vs. relegation.”

Hoping to offer the best of bioscience industry to our readers, we are incomplete without the opinions, feedbacks and suggestions by our valuable readers. Put your thoughts into words and forward to editor@biotecnika.org

(Shekhar Suman)

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CONTENTS ents bioev

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WHAT’S ON BIOTECNIKA.ORG

Will Modi’s ‘Make in India’ turn the face of Genetically ‘Modi’fied technology?

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Dr. Anand, CEO, Bugworks Research

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Google enters sequencing space “Google Genomics” to store the sequences

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Antibiotics

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are they more than just ‘no-harm’ drugs?

How harmless bacteria became flesh-eating monsters

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INTERVIEW Country Head, Titan Biotech

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Top 10 Politicians who stand for biotechnology

CSIR takes the big decision

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Has it come too late?

Top 10 Astounding Facts

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about Indian biotech industry

Guest Corner

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“An emerging healthcare trend in India”

Mergers & Acquisitions

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helping or hurting the pharma sector?

Who pays you the

‘BEST’ in

BIOTECH SECTOR? Salary Special

>>COVER FEATURE

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BIONEWS

Promising Anti malaria compound to destroy malaria parasite

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n a study conducted by scientists at St. Jude Children’s Research Hospital, they have found a promising anti-malarial compound that can trick the immune system to rapidly destroy red blood cells infected with the malaria parasite and leave healthy cells unharmed. The safety trials of compound on healthy adults are already under planning.

Malaria, which is caused by a parasite spread through the bite of an infected mosquito, remains a major health threat to more than half the world’s population, particularly children. According to the World Health Organization (WHO), malaria killed an estimated 627,000 people in 2012, the majority of them sub-Saharan African children under the age of 5.

The compound, (+)-SJ733, destroys only infected red blood cells while leaving healthy ones alone. The compound has been developed from a molecule identified in a previous St. Jude-led study that helped to jumpstart worldwide anti-malarial drug development efforts. The researcher determined that (+)-SJ733 uses a novel mechanism to kill the parasite by recruiting the immune system to eliminate malaria-infected red blood cells. In a mouse model of malaria, a single dose of (+)-SJ733 killed 80 percent of malaria parasites within 24 hours. After 48 hours the parasite was undetectable.

“Our goal is to develop an affordable, fast-acting combination therapy that cures malaria with a single dose,” said corresponding author R. Kiplin Guy, Ph.D., chair of the St. Jude Department of Chemical Biology and Therapeutics. “These results indicate that SJ733 and other compounds that act in a similar fashion are highly attractive additions to the global malaria eradication campaign, which would mean so much for the world’s children, who are central to the mission of St. Jude.”

Whole genome sequencing of the Plasmodium falciparum, the deadliest of the malaria parasites, revealed that (+)-SJ733 disrupted activity of the ATP4 protein in the parasites. The protein functions as a pump that the parasites depend on to maintain the proper sodium balance by removing excess sodium.

Planning has begun to move (+)-SJ733 from the laboratory into the clinic beginning with a safety study of the drug in healthy adults. The drug development effort is being led by a consortium that includes scientists at St. Jude, the Swiss-based non-profit Medicines for Malaria Venture and Eisai Co., a Japanese pharmaceutical company.

Injectable 3D Vaccines to fight cancer and infectious diseases Researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard’s School of Engineering and Applied Sciences (SEAS) have developed a non-surgical injection of programmable biomaterial that spontaneously assembles in vivo into a 3D structure which could fight and even help prevent cancer and other infectious disease such as HIV. “We can create 3D structures using minimally-invasive delivery to enrich and activate a host’s immune cells to target and attack harmful cells in vivo,” said the study’s senior author David Mooney, Ph.D., who is a Wyss Institute Core Faculty member and Robert P. Pinkas Professor of Bioengineering at Harvard SEAS. Tiny biodegradable rod-like structures made from silica, known as mesoporous silica rods (MSRs), can be loaded with biological and chemical drug components and then delivered by needle just underneath the skin. The rods spontaneously assemble at the vaccination site to form a three-dimensional scaffold, like pouring a box of matchsticks into a pile on a table. The porous spaces in the stack of MSRs are large enough to recruit and fill up with dendritic cells, which are “surveillance” cells that monitor the body and trigger an immune response when a harmful presence is detected.

“Nano-sized mesoporous silica particles have already been established as useful for manipulating individual cells from the inside, but this is the first time that larger particles, in the micron-sized range, are used to create a 3D in vivo scaffold that can recruit and attract tens of millions of immune cells,” said co-lead author Jaeyun Kim, Ph.D., an Assistant Professor of Chemical Engineering at Sungkyunkwan University and a former Wyss Institute Postdoctoral Fellow.

Synthesized in the lab, the MSRs are built with small holes, known as nanopores, inside. The nanopores can be filled with specific cytokines, oligonucleotides, large protein antigens, or any variety of drugs of interest to allow a vast number of possible combinations to treat a range of infections.

Once the 3D scaffold has recruited dendritic cells from the body, the drugs contained in the MSRs are released, which trips their “surveillance”, trigger and initiates an immune response. The activated dendritic cells leave the scaffold and travel to the lymph nodes, where they raise alarm and direct the body’s immune system to attack specific cells, such as cancerous cells. At the site of injection, the MSRs biodegrade and dissolve naturally within a few months.

So far, the researchers have only tested the 3D vaccine in mice, but have found that it is highly effective. An experiment showed that the injectable 3D scaffold recruited and attracted millions of dendritic cells in a host mouse, before dispersing the cells to the lymph nodes and triggering a powerful immune response.

“ We can create 3D structures using minimally-invasive delivery to enrich and activate a host’s immune cells to target and attack harmful cells in vivo.

- David Mooney, Wyss Institute

The vaccines are easily and rapidly manufactured so that they could potentially be widely available very quickly in the face of an emerging infectious disease. “We anticipate 3D vaccines could be broadly useful for many settings, and their injectable nature would also make them easy to administer both inside and outside a clinic,” said David Mooney.

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An incubator for biotech startups by IITM… …fostering Indian biotech innovation

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IT Madras has initiated and established Bioincubator to help start ups and small and medium enterprises develop products for the global market. Biotechnology Industry Research Assistance Council (BIRAC) has supported the plan to buttress Indian biotech innovation and entrepreneurship.

According to Ashok Jhunjhunwala, co-chairman, IIT incubation cell, the government has allocated Rs. 10,000 crore for the development of entrepreneurship in India. These start-ups that sign up with IIT-M for research in biotechnology will be assisted with a start funding of 10 lakhs along with the mentorship and training programme.

The incubator offers lab and office space, equipment, centralised utilities for process and product development to aid technologies mature and accomplish commercialisation. The opportunity is open to all researchers with promising ideas and who want to develop processes and commercialise them.

“Even existing and less used technologies can be uplifted and rebranded to utilise it more,” encouraged Mr. Bhaskar Ramamurthy, Director, IIT-M’s Bioincubator.

The open invitation is extended to all entrepreneurs who can use this as a platform to gain technical advice from the expertise of the Institute’s faculty and researchers to realise business opportunities. Along with which support services such as accounts and tax, company secretary-ship, legal, HR, audit, IP, access to funds, investors, mentors, advisers and consultants, training programs, and networking events are also made available. The Bioincubator will also offer training through workshops to develop skills with help from IIT Madras Incubation Cell.

Four companies have been identified as the incubatees for the first phase and three among which have been started by doctoral students from the IIT Madras Biotechnology Department.

Identified companies are: Purius Nanosystems Pvt Ltd: Point-Of-Care Testing devices to conduct Single tests for Tuberculosis bacilli or multi-drug resistant TB, Malaria, Hepatitis B Virus or panel tests for HIV and Hepatitis B Virus FIB-SOL Life Technologies Pvt Ltd: Development of low-cost bio-fertilisers Vital Bio-scientific Solutions: Development of a model to simulate a system’s reaction to a drug Yaathum Biotech: Development of diagnostic test kits for make possible the identification of full range of drug resistant tuberculosis strains in a single test “The innovation space in biotechnology has expanded considerably in the last few years in the areas of computational and synthetic biology,” said Guhan Jayaraman, coordinator, IIT-M, Bio-incubator.

“Biotechnology, being a research-oriented subject requires a lot of time to emerge and is in its infancy yet. This incubator will enable more people to get on the right track with proper guidance in the field,” said D. Karunagaran, head of the department, Biotechnology.

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Another achievement in Synthetic Biology Scientists make synthetic enzyme

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n a first of its kid, scientists have achieved a major breakthrough by creating an artificial enzyme from artificial genetic material that does not exist outside the laboratory.

This milestone has come as a major achievement in the field of medicine by opening door to new ways of developing drug and medical treatments.

The research carried out by scientists at Medical Research Council (MRC) claim that the enzymes were made from artificial genetic material which does not exist in nature. These enzymes were found to be capable of triggering a chemical reaction in lab. The synthetic versions of DNA were created by using the same building blocks that are found in these nucleic acids and arranging them together. These molecules were called ‘XNAs,’ or xeno nucleic acid, and were found to be capable of storing and passing genetic information.

Using the lab made XNAs, the researchers have created ‘XNAzymes’ which power simple reactions, such as cutting up or stitching together small chunks of RNA, just like naturally occurring enzymes.

Dr Alex Taylor, the study’s first author said, “The creation of synthetic DNA, and now enzymes, from building blocks that don’t exist in nature also raises the possibility that, if there is life on other planets, it may have sprung up from an entirely different set of molecules, and it widens the possible number of planets that might be able to host life.”

The finding has lead the scientists to believe that the concept of enzymes being made just from proteins may not be true. Dr Taylor explains: “Until recently, it was thought that DNA and RNA were the only molecules that could store genetic information and, together with proteins, the only biomolecules able to form enzymes. Our work suggests that, in principle, there are a number of possible alternatives to nature’s molecules that will support the catalytic processes required for life. Life’s ‘choice’ of RNA and DNA may just be an accident of prehistoric chemistry.”

The XNAzymes are capable of catalyzing simple reactions like cutting and joining RNA strands in a test tube and can even join XNA strands together, which represents one of the first steps to creating a living system. Because their XNAzymes are much more stable than naturally occurring enzymes, the scientists believe they could be particularly useful in developing new therapies for a range of diseases, including cancers and viral infections, which exploit the body’s natural processes to take hold in the body.

They added: “Our XNAs are chemically extremely robust and, because they do not occur in nature, they are not recognized by the body’s natural degrading enzymes. This might make them an attractive candidate for long-lasting treatments that can disrupt disease-related RNAs

“ The creation of synthetic DNA, and now enzymes, from building blocks that don’t exist in nature also raises the possibility that, if there is life on other planets, it may have sprung up from an entirely different set of molecules, and it widens the possible number of planets that might be able to host life.

Dr Alex Taylor, Medical Research Council.

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“Pharma companies to suffer $65 billion loss by 2019 due to patent expirations” A GlobalData analysis

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study by GlobalData, a research and consulting firm, has projected that the pharmaceutical companies may suffer an estimated $65 billion drop in sales by 2019 due to the patent expiries of several leading drugs. Its report on pharrmaceutical market stated that the drug makers who are going to hit the hardest include Otsuka, Eli Lilly, and AstraZeneca (AZ), with a significant proportion of losses coming in the Central Nervous System (CNS) treatment sector.

Adam Dion, MS, GlobalData’s Analyst covering Healthcare Industry Dynamics, said that Eli Lilly and AZ have seen profits fall in the CNS therapeutics market since 2010, with the latter losing the greatest share over the past three years.

Dion stated, “AZ’s CNS segment has been bleeding sales as a result of the company losing its patent on Seroquel (quetiapine fumarate), a treatment for bipolar disorder, which led to the entry of cheaper generic alternatives from Teva and Sandoz. GlobalData estimates AZ’s share to have been around 9% in 2010, which has now fallen to only 3% in 2013.”

“Eli Lilly’s market share declined from 14.3% in 2010 to 11.2% in 2013, primarily thanks to decreasing sales of Zyprexa (olanzapine), the company’s dopamine antagonist used to treat schizophrenia and bipolar disorder. Zyprexa sales have plummeted from over $5 billion to $1.2 billion over the same period, as a result of the drug losing its US patent exclusivity in 2011,” the analyst added.

While Otsuka’s anti-psychotic drug Abilify (aripiprazole), which the company co-markets with Bristol-Myers Squibb, was the sales leader in the CNS arena with $9.5 billion in 2013, the drug faces a less positive future, commented Dion.

Dion also explains, “Otsuka benefited from higher annual sales across most major markets in 2013 due to reimbursement and label expansions. In the US and Europe, prescriptions increased for adjunctive therapy in major depressive disorder and manic episodes of bipolar disorder, while there were rising sales in China, where the drug was included in the national medical insurance system.”

“However, Abilify’s upcoming US patent expiration in 2015 means the drug will lose a massive $6.2 billion by 2019 as the result of generic competition, making it the biggest victim of the pharmaceutical industry’s current patent cliff.”

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Eli Lilly’s market share declined from 14.3% in 2010 to 11.2% in 2013, primarily thanks to decreasing sales of Zyprexa (olanzapine), the company’s dopamine antagonist used to treat schizophrenia and bipolar disorder.

- Adam Dion, GlobalData’s Analyst

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Researchers develop a new “F-class” stem cells Hopeful of speeding up the research

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anadian researchers have discovered a new class of stem cells- capable of transforming into nearly all forms of tissue- which are being dubbed as F-class cells because they cluster together in fuzzy looking colonies.

The discovery which sheds a new light on the process of cell reprogramming is been looked upon with a hope to be of a better use in medical research, which could eventually lead to new uses for treating illnesses. Since the discovery of stem cells by scientists in Toronto about 50 years ago, researchers have hoped the cells could be used to repair damaged or diseased tissue, thanks to their ability to create all of the cells in our body.

The pluripotent cells have enormous value to medical researchers as they have the extraordinary shape-lifting abilities. They allow scientists to study the effect of drugs and diseases on human cells and have given rise to the field of regenerative medicines, which seeks to restore the lost and damaged tissues.

The F-class cells were created using genetically engineered mouse cells, and may not occur naturally outside the lab, according to senior author Andras Nagy, a stem cell researcher at Toronto’s Lunenfeld-Tanenbaum Research Institute of Mount Sinai Hospital. “We think that if we have time, and money and hands to do it, we might find additional novel cell lines,” Nagy said.

Until now, stem cells have been either obtained from embryos or produced in the lab through a painstaking process called induced pluripotency, whereby a virus is used to alter an adult cell’s genetic information and return the cell to a pliable, embryonic state. Nagy and his colleagues, a consortium of international researchers called Project Grandiose, began their research by looking more closely at the castoffs of that process, or those cells that did not closely match the description of embryonic stem cells.

“We looked at it in an unbiased way,” Nagy said. “Instead of ignoring or discarding those cells that don’t look like embryonic stem cells, we thought we might find more than just one alternative cell type.”

Their hunch paid off when they identified half a dozen cells that were very similar to each other, yet very different from the gold-standard embryonic-like cells. These F-cells were engineered in a slightly different way than most induced pluripotent stem cells. They were designed so that the cell reprogramming process would only occur when they were exposed to the antibiotic doxycycline. Once the cells were no longer exposed to the medication, they either turned into an adult specialized cells or they died, Nagy said.

The newly discovered cells could reproduce quickly and were not “sticky”.“The adhesion is not that high, so they are amenable to bioreactor type of growth,” Nagy said. “We can put these cells into a big jar of media and grow them up in a suspension, which is much more efficient, cheaper, and less work to produce a huge number of cells.” It remains to be seen whether human cells can be converted into F-class cells, but researchers say it seems highly possible.

We looked at it in an unbiased way.

Instead of ignoring or discarding those cells that don’t look like embryonic stem cells, we thought we might find more than just one alternative cell type.

“

- Andras Nagy, Lunenfeld-Tanenbaum Research Institute

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23andMe gets a nod from UK regulators to sell ‘DNA TESTS’

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he U.K Medicines and Healthcare Products Regulatory Agency (MHRA) has given thumbs up to the Google backed company’s spit test, which has a CE mark clearing it for sale in Europe. It comes as good news for 23andMe which is always in limelight for hostile behavior of US FDA against it.

The DNA test would be available for the consumers in U.K who can buy the test for £125 ($196)--significantly more than it costs in the U.S.—and will also receive a report detailing 100 genetic health factors. The report is what landed 23andMe in hot water with the FDA, which issued a warning letter for making medical diagnoses without the necessary approvals or evidence. 23andMe said its tests aren’t diagnostics. It has also removed many of the risk factors that riled the FDA from U.K. reports.

Before the warning letter, 23andMe’s reports covered the risk of 254 diseases and conditions. The U.K. report includes more than 100. “Many of the drug responses, inherited conditions and genetic health risks that were of concern in the U.S. have been removed”, said a spokesperson for the Department of Health. The DOH and MHRA have both warned consumers to think carefully before using a personal genomics service, though.

The nod has given a fresh source of income to the company at a time when it is still working through its disagreement with FDA. The expansions could also swell the pool of people who contribute genetic information to the databases that underpin the research side of 23andMe’s business.

“It’s not entirely clear what their business plan is--whether they want to make money by selling kits to consumers, or whether they want to make most of their money by selling consumer data to other companies,” Professor Hank Greely, director of the Center for Law and the Biosciences at Stanford University, said.

It’s not entirely clear what their business plan is--whether they want to make money by selling kits to consumers, or whether they want to make most of their money by selling consumer data to other companies.

Professor Hank Greely, Director of the Center for Law and the Biosciences, Stanford University.

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Biochemize and Polyclone sign an MoU to offer enzyme engineering services

From L-R- Dr.Jaume Mir, CEO, Biochemize, Catalonia; Dr.Geetha Swamilingiah, Biotech Sector specialist, EBTC and Mr.Naveen Kulkarni, CEO, Polyclone (India).

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iochemize’ from Catalonia and ‘Polyclone’ from Bengaluru signed a Memorandum of Understanding (MoU) to collaborate in the field of Enzyme Engineering - an area with many applications across the interdisciplinary subsectors of biotechnology.

This collaboration came about as a result of the European Business and Technology Centre (EBTC) EU-India biotechnology mission last year, where a partnering session was organized to foster EU-India business and research relationships.

Dr. Geetha Swamilingiah (Biotechnology Sector Specialist, EBTC) recent said that “We at EBTC are more than happy to help both companies to seal the deal while helping them to address a few of the issues related to the regulatory frameworks, IPR issues and technology transfer hurdles moving forward.”

Biochemize S.L. is a biotechnology company focused on the design and development of processes based on biocatalysis and microbial fermentation for the manufacturing of active pharmaceutical ingredients (APIs).The MoU with Polyclone Bioservices Pvt. Ltd., will utilise Polyclone’s in silico enzyme engineering framework (eEF) to strengthen its core services.

“Through this collaboration, strategic synergies between activities and scientific-technological platforms of both companies are reinforced, in such a way that experimental results and the in silico models will boost the capacity for launching new, more specific, high performance engineered enzymes, to better fit the customers’ need for better, safer, more specific, stable and competitive enzymes” opined Dr. Jaume Mir (CEO, Biochemize).

Mr. Naveen Kulkarni (CEO, Polyclone) added that “computational tools have long since aided and accelerated discovery in the biotech pharmaceutical industry. Application of advanced techniques like Quantum Mechanics and Molecular Modeling has further revealed unprecedented data points giving a whole new dimension of knowledge to the mechanics of Enzyme substrate reactions. Our in silico Enzyme Engineering Framework precisely provides this bridge to develop better enzymes, and the partnership with Biochemize brings to the table the knowledge about enzymes and assays that are relevant and industrially important to embark on a journey to bring productivity to businesses”.

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Zydus Cadila launches “Exemptia” Biosimilar of AbbVie’s Humira

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ydus Cadila launched a biosimilar of Adalimumab, thereby becoming the first company to launch a biosimilar of the drug used for treatment of auto immune disorders, at a price much lower than the innovator drug in India. Developed by the researchers at the Zydus Research Centre, the biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name, Exemptia. The drug will be used to treat auto immune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis.

“The cost of the innovator product by AbbVie is USD 1,000 per vial. Our Exemptia will be available at one-fifth of its cost in India. It is the first biosimilar of Adalimumab,” Zydus Cadila Deputy Managing Director Sharvil P Patel said.

Exemptia is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product. The biosimilar of Adalimumab is a part of Zydus’ robust biologics programme which has the largest number of monoclonal antibodies under development in India. The group’s R&D pipeline which comprises 24 biologics includes biosimilars and three novel biologics. These biologics are being developed to treat auto immune disorders like arthritis, cancer, infertility and stroke.

Adalimumab was first approved globally in 2002 and has since then been the most preferred therapy to treat patients suffering from auto immune disorders. However, the therapy was not available to patients in India. It is estimated that more than 12 million patients in India suffer from these chronic conditions which progressively deteriorate and lead to lifelong pain and in some cases, even disability.

“At Zydus, we believe that innovations must bridge unmet healthcare needs and provide solutions to patients who are suffering from disease and disability especially in such chronic conditions. This therapy will offer a new lease of life to millions in India who did not have access to this therapy so far. We are happy to offer them hope, freedom from pain and better quality of life through Exemptia”, he added.

The company is also looking for approvals for three large indications - Crohn’s disease, ulcerative colitis and plaque psoriasis. When asked about the global sales of Adalimumab, Patel said: “The sales were around USD 12 billion worldwide.”

The therapy will be marketed by Zydus Biovation- a new division launched to exclusively market this ground breaking therapy.

Sharvil P Patel Managing Director, Zydus Cadila

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The cost of the innovator product

by AbbVie is USD 1,000 per vial. Our Exemptia will be available at onefifth of its cost in India.

It is the first biosimilar of Adalimumab.

An enzyme technology that converts

waste oil into biodiesel

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he first commercially available enzymatic solution to make biodiesel from waste oil has been launched by Novozymes under the name Eversa®. The enzymatic process converts used cooking oil or other low grade oils into biodiesel. Biodiesel producers can thereby reduce their raw material costs. The resulting biodiesel could be sold under same trade specification as biodiesel created through traditional chemical processing.

Growing demand for vegetable oil in the food industry has resulted in increased prices, causing biodiesel producers to search for alternative – and more sustainable – feedstocks. Most of the oils currently used are sourced from soybeans, palm or rapeseed, and typically contain less than 0.5% free fatty acids (FFA). Existing biodiesel process designs have difficulty handling oils containing more than 0.5% FFA, meaning that waste oils with high FFAs have not been a viable feedstock option until now.

“The idea of enzymatic biodiesel is not new, but the costs involved have been too high for commercial viability,” says Frederik Mejlby, marketing director for Novozymes’ Grain Processing division. “Eversa changes this and enables biodiesel producers to finally work with waste oils and enjoy feedstock flexibility to avoid the pinch of volatile pricing.”

Eversa can work with a broad range of fatty materials as feedstock, but initial focus has been on used cooking oil, DDGS corn oil and fatty acid distillates.

Making the change from a chemical catalyst to the enzymatic process requires retrofitting in existing plants. Biodiesel producers looking to utilize Eversa will therefore have to invest time and resources to make the switch to the enzymatic process. Novozymes’ engineering partners estimate that the resulting improved process economy indicates a payback time of three years or less, depending on the plant setup and feedstock savings potential in that region.

“The enzymatic process uses less energy, and the cost of waste oil as a feedstock is significantly lower than refined oils,” says Frederik Mejlby. “A small number of plants have been producing biodiesel from waste oils using existing technologies. But this has not been cost-efficient until now, broadly speaking, as the waste oils have had to be refined before being processed using chemicals. We hope that our technology can unleash more of the potential in these lower grade feedstocks.”

The enzymatic process eliminates the need for sodium methoxide, one of the most hazardous chemicals in traditional biodiesel plants. The radical reduction of harsh chemicals and by-products ensures safety for both Eversa enpersonnel and the environment.

“Switching to Eversa can lead to a safer working environment for plant operators. The enzymatic process does not use high pressure or high temperature,” says Frederik Mejlby.

“And when it comes to the actual enzymes, their organic nature and mild process conditions do not generate toxic components as in some chemical biodiesel processes.”

ables biodiesel producers to finally work with waste oils and enjoy feedstock flexibility to avoid the pinch of volatile pricing.

Frederik Mejlby, Marketing Director, Novozymes’ Grain Processing

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RANBAXY launches India’s first biosimilar of Infliximab drug, InfimabTM

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anbaxy Laboratories Limited (Ranbaxy), one of India’s largest pharmaceutical company, today announced the launch of InfimabTM, the first *Remicade® (Infliximab) biosimilar in India. The product was launched at the Indian Rheumatology Association Conference (IRACON), in the presence of over a thousand rheumatologists and doctors from around the country.

InfimabTM, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialization of biosimilar monoclonal antibodies. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai.

The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

InfimabTM marks Ranbaxy’s entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis. Talking about the significance of the newly launched InfimabTM, Rajeev Sibal, Vice President & Country Head-India Region, Ranbaxy, said, “InfimabTM offers a new opportunity in the management of conditions like rheumatoid arthritis. The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment.”

Dr. Arvind Chopra, Consultant Rheumatologist, Pune who was also the Principal Investigator of Clinical Trial conducted in India with InfimabTM (BOW015), stated, “There has been an inordinate interest among the medical fraternity in India regarding the launch of InfimabTM as it is an affordable therapeutic alternative to Infliximab with equivalent clinical effectiveness. The availability of the new drug has widened our options to treat several forms of arthritis. This will increase patient access and many more Indian patients will benefit from this biologic treatment. The drug will not only be able to stop progression of rheumatoid arthritis but effectively control several of its complications that include bone damage, deformities and osteoporosis. InfimabTM also has an excellent treatment potential to treat other crippling painful arthritis like ankylosing spondylitis and psoriatic arthritis”.

Amit Munshi, president and CEO of EPIRUS, stated, “We are delighted to partner with Ranbaxy to bring InfimabTM to India. InfimabTM represents an affordable solution for patients and may expand patient access to this important medicine”.

It is well established through studies that if a biologic treatment is started relatively early and patients adhere for the required duration as recommended by the physician, significant improvement in overall treatment outcome can be achieved. Along with the affordable pricing of InfimabTM, Ranbaxy has launched RAISE (Rheumatoid Ailment Infimab Support Endeavor) a patient support program for improving patient awareness and compliance on therapy. With a similar clinical safety and efficacy to Remicade®, a reduced cost of therapy, and patient support program, InfimabTM may encourage more patients to initiate and continue treatment, thus potentially improving the overall treatment outcome.

“

InfimabTM will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment.

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Rajeev Sibal, Country Head, Ranbaxy India

3D maps reveal ‘genomic origami’ responsible for cancer and other deadly diseases!

H

umans have been long aware of the genomes and their folding patterns with hidden switches that can turn on and cause deadly diseases including cancer. Now the researchers including Indian-origin scientist, have created a three-dimensional (3D) map of human genomes, sort of “genomic origami”, that allows the same genome to produce different types of cells.

The researchers set out to identify the folding pattern called loops using a technology called “in situ Hi-C” in the human genome. Loops form when two bits of DNA that are far apart in the genome sequence end up in close contact in the folded version of the genome in a cell’s nucleus. Researchers found thousands of hidden switches, which are vital in turning on diseases.

“More and more, we are realizing that folding is regulation,” said study co-first author Suhas Rao, a researcher at the Baylor College of Medicine in the US. “When you see genes turn on or off, what lies behind that is a change in folding. It’s a different way of thinking about how cells work,” Rao added.

The folding is able to regulate genetic expression by preventing transcription factors from gaining access to the DNA. Understanding where these loops occur uncovered thousands of regulatory points that were previously unknown. In the future, this information could be used to understand the underlying cause of cancer or genetic diseases.

“Our maps of looping have revealed thousands of hidden switches that scientists did not know about before. In the case of genes that can cause cancer or other diseases, knowing where these switches are is vital,” said co-author Miriam Huntley, a doctoral student at the Harvard School of Engineering and Applied Sciences.

The current finding is a continuation of the work Aiden’s lab has been doing over the last five years where the team developed Hi-C method in 2009. Named after the juice box, the Hi-C method investigates the 3-D structure of condensed DNA to find where genes are located relative to one another. The new study examines the genome with much greater detail, making it better suited for biological research.

“

More and more, we are realizing that folding is regulation.

When you see genes turn on or off, what lies behind that is a change in folding. It’s a different way of thinking about how cells work.

Suhas Rao, Baylor College of Medicine

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BIOEVENTS

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www.2015.bioasia.in

2nd Workshop on

‘Mechanical Manipulations and Responses at the Scale of the Cell and Beyond’ April 24 - May 7, 2015 Venue: National Centre for Biological Sciences, Bangalore

AND

Indian Cell Mechanics Meeting April 24-26, 2015

Venue: Raman Research Institute, Bangalore

INTRODUCTION The understanding of biological processes at a cellular and sub-cellular scale has made a big leap forward, thanks to the availability of new microscopy tools that enable sub-diffraction resolution and high-speed live cell / tissue imaging technologies that have made the advance from a qualitative to a quantitative description possible. Recently, the application of a wide variety of techniques to mechanically manipulate single molecules or multi-cellular cell composites has allowed scientists to begin addressing the question of how organisms react to controlled mechanical cues. This two weeks long program introduces a scope of techniques to gain quantitative information of responses of the biological material (at all scales) to perturbations of a mechanical nature, and explores how the combination of theory and experiments will lead to a systematic deciphering of the physics of how living material engages with mechanical information. In addition, a conference about cell mechanics will be held before the start of the workshop (see below for further description).

SCOPE OF WORKSHOP The practical part is intended primarily for early career scientists: PhD candidates and postdoctoral fellows at the beginning of their projects. Participants would choose three out of eight available modules. Instruction will consist of a set of basic lectures, hands-on practical sessions and research talks. The emphasis lies on the practical aspects of how to set up and run the presented devices. In addition, a strong theoretical thread in form of a theory module and the interaction with theoretical bio-physicists will accompany the experimental fabric of this two week engagement, both during the workshop and the conference.

LIST OF SPEAKERS • Optical tweezers Speaker: Roop Mallik (TIFR Mumbai)

• Shear stress/ cell rheology Speaker: Pramod Pullarkat (RRI)

• Atomic force microscopy (AFM) Speaker: ASR Koti (TIFR Mumbai)

• Micro-patterned surfaces and chemical treatments Speaker: Aurnab Ghose (IISER Pune)

• Micropipette aspiration Speaker: Darius Koester (NCBS) / Deepak Sinha (IACS)

• Stretchable surfaces Speaker: Bidisha Sinha (IISER Kolkata)/Feroz Menon (C-Camp)

• Glass needle Speaker: Pramod Pullarkat (RRI)

• Supported lipid bilayer Speaker: Thomas Pucadyil (IISER Pune)/Darius Koester (NCBS) mag.biotecnika.org

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“Moving towards Skin Perfection: Latest Innovations in Cosmetic Research” Event Summary CII- Center of Excellence in Nanotechnology, Ahmedabad organized One Day Seminar on “Moving towards Skin Perfection: Latest Innovations in Cosmetic Research” at CII House, Ahmedabad on 12 Dec, 2014.

Around 35 delegates from Cosmetic companies, Suppliers of raw materials and packaging, Research institutes and Skin Experts attended the seminar. Welcome address was delivered by Dr. Ajay Gupta, Senior Counsellor & Head, Centre of Excellence in Nanotechnology, Confederation of Indian Industry, Ahmedabad. Dr. Sanju Dhawan, General Manager-NDDS, Cadila Pharmaceuticals, Ahmedabad expressed her thoughts on Nanotechnology and its role in skin delivery. Dr. R.C. Raval, HOD, Dermatology & Leprosy, N.H.L. Medical College & V.S. Hospital, Ahmedabad talked upon the Topical Treatment Tips for Acne, Rosacea, AK (Actinic keratosis) and Eczema.

Dr. Vinay Kumar Singh, General Manager-Technical, Mikasa Cosmetic Limited, Ahmedabad discussed about the Advancement in technology for Skin Care. Dr. Seema Jain, Skin Specialist & Cosmetologist, Body care Clinic talked upon Skin aging prevention and treatment. She explained about the age related changes in metabolic functions, Structural age changes in skin & age related dysfunctions. Dr. Smita Nagpal, Skin Specialist & Cosmetologist, Anya Skin Clinic, Ahmedabad discussed upon the Emerging therapies for the management of psoriasis & their types.

Dr. Sanjeev Acharya, Associate Professor, Phytopharmaceutical & Natural products, Nirma University talked upon the Global Regulation in Cosmetics and difference in regulatory procedure of cosmetic product’s filing between USA, EU, Japan & India. He also explained about the current and future market growth of Cosmoceuticals, Nutraceuticals and Nutricosmetics. Dr. G.C.patel, Lead Biostatistician, Cliantha Research Limited, Ahmedabad talked on Statistical Analysis methods in Cosmetic Research & Statistics of Cosmetics Research by Category. Dr. Simran sethi, Director Operations – Personal Healthcare, Cliantha Research Limited, Ahmedabad expressed her thoughts upon Safety & Efficacy of Cosmetics. She also talked about the types of studies that are being performed for clinical testing of cosmetics.

Dr. Ajay Gupta gave presentation about the activities of Centre of Excellence in Nanotechnology. He also breifly explained about the ongoing R&D projects of Center of Excellence in Nanotechnology. Mr. Anil Pandey, Head, Intellectual property Facilitation Centre explained about the importance of intellectual property in research.

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What’s on biot ecn i ka .o

GlaxoSmithKline is all set to work towards setting up its advanced tablet facility at the Vemgal Industrial Area in Kolar district, Karnataka where it has slated to invest Rs. 994 crore for a Greenfield project. 50 acres of land was allocated... http://bit.ly/1zixJ7V

rg

GSK set its eyes on Karnataka | Plans to invest Rs. 94 crore for a Greenfield project

Europe says ‘no’ to Ranbaxy’s antibiotic drug made at its Dewas site!

Indian drugmaker Ranbaxy Laboratories has been barred from exporting the antibiotic cephalosporin to Germany for not complying with standard manufacturing practices.... http://bit.ly/1zUrMy7

James Watson to auction his Nobel Prize Medal due to monetary shortage!

James Watson, the world-famous biologist who was shunned by the scientific community after linking intelligence to race, said he is selling his Nobel Prize because he is short of money... http://bit.ly/1yUtdya

L&T inaugurates State-of-the-art anti-retroviral therapy (ART) center on World AIDS Day! Diversified conglomerate Larsen & Tourbo opened a state-of-the-art anti-retroviral therapy (ART) centre for the treatment of HIV/ AIDS patients at Kol Dongri in suburban.... http://bit.ly/1wqCj6u

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“

It is the first time that the NDA government has made public its stance on allowing field trials for GM food crops.

Would this make way to a new road for GM crops?!

Will Modi’s

MAKE IN INDIA turn the face of

GENETICALLY “MODI”FIED TECHNOLOGY?

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“

India has the potential to become a major producer of transgenic rice and several genetically modified or engineered vegetables.

- Modi’s campaign

W

hile Make in India initiative has already created a stir to be a potential magnet for investors and has raised the hopes high to be a game changer in improving the employability ratio in the country, it has brought some good news for the biotech sector as well. In what might come as a surprise to the biotech patrons, the most ambitious project by the Prime Minister Narendra Modi has pitched India as a potentially lucrative investment destination for genetically modified crops. Infamously surrounded by a mist of rebuttal and contention, would this change towards GM technology be accepted whole heartedly by the Indians or bring yet another criticism in the kitty, is for the time to see.

India has already marked a glory in being a self sufficient country when it comes to agriculture and it could even prove to be a major producer of transgenic rice and several other genetically modified or engineered vegetables if technology fetches the requisite support. The road to GM technology has never been a smooth ride, thanks to the perception that is created in the mass partly by the media and partly by improper marketing of the product. Every attempt to promote the GMOs has only drawn criticism, whether when it is the consumption of GMOs or the very recent approval to conduct GM trials. Despite the sharp criticism that the Union Government has faced from various Rashtriya Swayamsevak Sangh (RSS)-affiliated organizations for giving permission to conduct field trials for two varieties of GM crops in a few states recently, Modi’s signature campaign is quite hopeful on making India an investment hub and export powerhouse.

“India has the potential to become a major producer of transgenic rice and several genetically modified or engineered vegetables,” states the campaign website. It also states, “GM food crops are an investment opportunity for foreign players as they will offer “new business opportunities” in the country. Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield improvement.”

What does the initiative promise? Why is it being speculated to be the next big thing in the GM world? In a time equivalent to forever since the inception of the genetic engineering, it is the first time that the National Democratic Alliance gov-

GM food crops are an investment opportunity for foreign players as they will offer “new business opportunities” in the country.

“

- Modi’s campaign

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The Union government is of the view that research in GM and confined field trials for generating bio-safety data with all due precautions should be allowed to continue in the national interest.

“

Prakash Javedkar, Environment Minister

ernment has made public its stance on allowing field trials for GM food crops. And this acceptance of the field trial has opened the door to new “business opportunities” for the foreign players. The experts believe that Hybrid seeds, including GM seeds, could represent new business opportunities in India based on yield improvement.

The biotech regulator of the country, GEAC had earlier approved the field trial of 13 GM crops, including those of mustard, cotton, brinjal, rice and chickpea which were strongly opposed by the Sangh Parivar organisations such as Swadeshi Jagaran Manch (SJM) and Bharatiya Kisan Sangh (BKS). Under the pressure there were speculations of the trials being put on hold by the Union Government but it had not stated any ban on the field trials in the Parliament.

The environment minister, Prakash Javadekar has come forward in supporting the technology by stating that there is no scientific evidence to prove that GM crops are harmful to soil, human health and environment. Supporting the point he claimed that GM corn, canola, soybean and cotton are being cultivated and consumed by human beings as well as animals in many countries as food, feed and processed products with no harm being reported on them.

Promoting the field trials of GM crops and to allow them across the country, the Union Environment Minister had said, “The Union government is of the view that research in GM and confined field trials for generating bio-safety data with all due precautions should be allowed to continue in the national interest.”

“In view of various concerns related to the safety, efficacy and agronomic performance of transgenic seeds, extensive evaluation and regulatory approval process takes place before any GM plant is approved for commercial cultivation,” said Prakash Javadekar, Union Environment Minister.

The minister further said that GM crops have beneficial traits such as insect resistance and herbicide tolerance, stress tolerance, fungal resistance, disease resistance, salt tolerance, drought tolerance, enhanced yield and nutrition that may help in food security. The outright support from the minister and the decision to put no ban on GM crops either by government or Supreme Court has added to the hope on an increased interest in attracting investors towards this dreaded technology.

While the support is flowing in to promote GM crops in the country, complete acceptance by public is still a far cry.

It might take another few decades to create awareness and see the light of acceptance by public. Amidst the uncertainty surrounding it, would the high expectations of attracting investors sustain the market or succumb to the heat of controversy? Is Make in India stated to revolutionize and ‘Modify’ the popular perception towards GM? The promises in store are many but would it meet the desired expectations? While Make in India has indeed made a lot of space in the headlines, whether it has the nerve to change the fate of genetically modified crops remains the most awaited question!

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“

The availability of government funded world class bio-incubators like CCAMP, coupled with the mushrooming Accelerator ecosystems in cities like Bangalore, are making for a conducive environment for entrepreneurship in the Bio/Lifesciences domain.

Tete-a-tete with a drug discovery start-up

A

n infection drug discovery startup focusing on Antibiotics, which has been making its mark since its inception in early 2014, is Bugworks Research Inc (www.bugworksresearch. com). Bugworks uses an unprecedented approach to design Antibiotics to combat drug resistant hospital acquired infections, currently causing havoc all over the world!

Bugworks is a spin-off from Cellworks Group Inc (www.cellworksgroup.com), a therapeutic design company that uses proprietary simulation technology to both design novel combinations for Oncological indications and is also pioneering the use of Systems approach in personalizing Onco-therapies.

As part of Cellworks, the Infection team (which later went on to start Bugworks) had developed an insilico model of Mycobacterium tuberculosis (MTB) that was

Dr. Anand AnandKumar, CEO mag.biotecnika.org

25

funded by the Wellcome Trust and EU Framework program 7 grants.

This model of MTB was used to identify novel combinations for the treatment of MDR-TB and XDR-TB. Insilco predictions of novel combinations for TB were successfully validated in animal models that were run by Astra-Zeneca India. A highly successful program in TB, provided the momentum to the spinoff process.

“

Pharma has gestation periods that are much longer than for any other tech-investments and requires ‘patient monies’. Typical VC’s in India also lack domain expertise in Bio-Pharma, further exacerbating the funding situation for this sector.

Bugworks aims to discover novel treatment options for Drug resistant bacterial infections (Hospital acquired Infections is the focus area), via pharmaceutical assets designed using their proprietary Systems Biology platform and through its Proof of Concept strategy by wet-lab experimentation. Bugworks scientific team has over 100 man-years experience in the anti-infective space and brings together orthogonal skill sets ranging from Microbiology/Biochemistry to Mathematical modelling of biological systems to Semiconductor engineering in truly differentiated and novel fashion. This unique scientific approach has been leveraged by being awarded several national and international research grants within the first 6 months of the company’s formation.

The company is trying to solve a globally massive problem of Hospital acquired infection using approaches very different from those that have been tried by big-pharma!

We had a conversation with Dr. Anand AnandKumar, CEO of Bugworks, who is a serial entrepreneur, working initially in the semiconductor industry before switching gears to enter the Biotech arena.

Anand is also the co-founder of EVA Accelerator, Gen-Sec of ABLE (association of Biotechnology led entrepreneurs), and co-founder of the India Semiconductor Association.

In conversation with Dr. Anand, we have; Q. Tell us about Bugworks, its association with Cellworks Group Inc. and the success so far.

Q. Bugworks is a spinoff from Cellworks. The infection portfolio from Cellworks is a part of this spin out. While there are some commonalities in the DNA, the problem space (Antimicrobials) and specific approach taken by Bugworks is different from that of Cellworks. Though very early days in our journey, Bugworks has been able to come up with interesting assets to deal with Drug Resistant bacteria in the Hospital Acquired Infection space.

Q. Hailing from Electrical & Biomedical Engineering arena, what was the inspiration behind landing up in Bio-pharma space?

A. Whether it is electrical engineering or biology it is all about the behaviour of complex networks. The only difference is that in electrical engineering the behaviour can be precisely simulated whilst in biology the predictions are somewhat gross. The massive success that simulation/emulation has had in Electronic product design and the poor success rates in conventional pharma industry, were the inspiration behind us using orthogonal thought process to solving complex issues in Bio-Pharma.

Q. Has Bugworks signed up any contracts or agreements putting out its products and services into utilization?

A. We are in the early stage so we are a couple of years away from putting our products or assets in for licensing or co-development

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Q. What is the USP of Bugworks? Who are your

biggest competitors?

“

We realized very early in our journey that funding for this space was very difficult and that Bugworks initial funding would have to come from Govt. grants and angel monies.

A. The USP of Bugworks is that it uses insilico model driven wetlab experiments that is not only cost effective but also reduces the massive search space to effectively and efficiently hone-in on vulnerable targets and pathways. Apart from elucidating new mechanisms of bacterial kill, we are also able to study bacterial populations which forms the basis for our assets targeting Bio-films, which are at the heart of hospital acquired infections. There are many SME’s and MNC in this space, however none to our knowledge is following the path that we have decided to traverse.

Q. How difficult is it for a start-up to funds or VC investments in India?

A. Extremely difficult. Concept of early or seed investment is quite non-existent in India, particularly in the Bio space. Most VC’s are going after ‘predictable investment spaces’ such as E-commerce where the time to garner profits or fail is short. Pharma has gestation periods that are much longer than for any other tech-investments and requires ‘patient monies’. Typical VC’s in India also lack domain expertise in Bio-Pharma, further exacerbating the funding situation for this sector. Most early stage funding comes via grants from DBT/BIRAC, and from angel investors who are willing to bet on the team.

Q. In the journey of establishing Bugworks, from blueprint to building, what was on the whole concern causing period?

A. We realized very early in our journey that funding for this space was very difficult and that Bugworks initial funding would have to come from Govt. grants and angel monies. The problem that we are attacking is a very complex one that has global implications, yet poorly funded. So challenges on the technology front in parallel to lack of funding where the two huge impediments that we had to face in the early days, and still continue to face!

What motivates us is the opportunity posed by the global threat of Antibiotic resistant bacteria, and the unique and unprecedented approach we are taking to solving the problem.

“

Bugworks Research Labs

What motivates us is the opportunity posed by the global threat of Antibiotic resistant bacteria, and the unique and unprecedented approach we are taking to solving the problem.

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Q. What are your future expansion plans in the coming years?

A. Next steps will depend on how the animal proof of concept pans out for our Antibiotics assets. Within the next 12-18 months we will have a better understanding on which assets to further ourselves, and which to out-license or co-develop in partnership with pharma companies. Early results in taclking gram negative hospital acquired infection looks very promising!

Q. There have been fingers pointed out on the Indian regulatory system, saying that it takes forever to get through approvals? Be it for land or environment or others. What would you say?

A. Since we are in the pre-clinical space, we are yet to be faced with the regulatory hurdle. We keenly understand the issues in this space, and our current thinking is to do clinical trials outside India, unless tectonic changes come about in India’s regulatory framework.

Q. What is your opinion on the employment or salary structure of the Indian Biotech scenario?

A. Most of the students that come out of Universities in Biotech have minimal wetlab and insilico experience. It takes more than a year to train them to industry needs. In general we find that Biotech salaries are lower than those in Engineering/IT. We have tried our best to pay our employees at par with IT-industry.

Q. Do you advocate bio-graduates to try their hand in entrepreneurship in the bio/pharma sector?

A. Only few have the skill and courage to get into this area as the domain is fraught with many hurdles. It is my feeling that only after some years of industry experience should one get into a start-up mode. In the Bio entrepreneurship arena, IT/Mobility for healthcare, Data-analytics, devices and diagnostics are areas that lend themselves to start-ups better than classical Biosciences/Biopharma companies do. All of us in industry are very appreciative of the proactive approach being taken by DBT-BIRAC to support start-ups in this space. The availability of government funded world class bio-incubators like CCAMP, coupled with the mushrooming Accelerator ecosystems in cities like Bangalore, are making for a conducive environment for entrepreneurship in the Bio/Lifesciences domain.

“

In the Bio entrepreneurship arena, IT/Mobility for healthcare, Dataanalytics, devices and diagnostics are areas that lend themselves to start-ups better than classical Biosciences/Biopharma companies do.

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“Google Genomics” to store the sequences

enters

GOOGLE

SEQUENCING SPACE

W

hen Google was chalking out its ambitious plans from its secretive Google X R&D division such as developing nanobots to sniff out cancer or tremor negating spoons for Parkinson’s patients, what went amiss and overlooked was the deeply ambitious project by Google under the name “Google Genomics” which is an effort to store genomes of the clients in a cloud. The goal of the system, Google says is to “explore the genetic variation interactively”.

This would mean allowing researchers to access millions of genomes and run batch analyses easily. Google’s plan to store entire copies of the human genome online is edging closer to reality. With 3,500 genomes already stored on its servers and more medical institutes jumping onboard, the blueprint of every person on Earth could soon be in the cloud.

“

Currently, decoding a single human genome can take a few hours or more and the size of resulting data amounts to about 100 gigabytes of raw data.

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Currently, decoding a single human genome can take a few hours or more and the size of resulting data amounts to about 100 gigabytes of raw data. Although storing it with Google costs $25 for a year, but once the raw data is cleaned up, a human genome can amount to less than a gigabyte of data. At that point, storing that information in Google’s cloud computing system cost $0.25 cents a year. Google itself was quick to point out that at the inception of the human Genome project; it took 15 years and $3 billion just to do the first human genome sequence. Today, it can all be done in a day, and for about $1,000.

“We saw biologists moving from studying one genome at a time to studying millions,” David Glazer, the Google software engineer who led the effort, said. “The opportunity is how to apply breakthroughs in data technology to help with this transition.”

Earlier this year, announcement of Google’s association with Global Alliance for Genomics and Health, a big consortium of research organizations created a stir as it could host public genomic data on its cloud platform. Till date, 3500 genomes have been uploaded to Google’s servers. “Cancer genome clouds” is a central goal of such repositories, said Sheila Reynolds, a research scientist at the Institute for Systems Biology in Seattle. “Not everyone has the ability to download a petabyte of data, or has the computing power to work on it.”

Facing a competition in the market from Amazon, Microsoft, and IBM for storing genome sequence data, the programming interface of Google Genomics has an extra edge over its competitors as it allows the users to focus on science rather than tech details such as servers and file formats and also store data securely so that the private data remains private and public data is available to the community anywhere and process as much data as one needs.

David Glazer said that making the act of comparing genomes as easy as possible is becoming increasingly important; because the way researchers study genetics has shifted. People used to study a single genome, but now they’re looking at many at once. This, he says, is something Google can help with. With Google Genomics, researchers will get a chance to compare millions of genomes — and multiply their discoveries in the process, he says.

“

Making the act of comparing genomes as easy as possible is becoming increasingly important; because the way researchers study genetics has shifted. People used to study a single genome, but now they’re looking at many at once. This is something Google can help with.

- David Glazer, Google software engineer

David Glazer

We saw biologists moving from studying one genome at a time to studying millions.

The opportunity is how to apply breakthroughs in data technology to help with this transition.

“

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GOOGLE GENOMICS

in a nut shell

• STORE alignments and variant calls for one ge -

nome or a million.

• PROCESS genomic data in batch by running prin-

cipal component analysis or Hardy-Weinberg equilibrium, in minutes or hours, by using parallel computing frameworks like MapReduce.

• EXPLORE data by slicing alignments and variants

by genomic range across one or multiple samples -- for your own algorithms or for visualization; or interactively process entire cohorts to find transi- tion/transversion ratios, allelic frequency, genome- wide association and more using BigQuery.

• SHARE genomic data with your research group,

collaborators, the broader community, or the public. You decide.

WHY IS THERE A BIG STIR AROUND GOOGLE GENOMICS?

A genome sequence even if completely sequenced by itself is of no use. Only when studied in comparison with others can it be of some worth. Taking at least two or more than two genomes can only reveal what is mutated and what is normal. And with a database of dozens, hundred, thousands of genomes, there always is a better chance of analyzing.

The bigger is the database, the better it is. Moreover, sequencing of genome over a period of time has become cheaper and easier but sharing those many terabytes of data has not. Google Genomics provides the user with a wide range of sequences to carry out the comparison and also allows systematic arrangement of the huge amount of data. Google is efforting towards building a centralized database where a researcher can query millions of genome sequences at once.

This is the infrastructure for personalized medicine.

Suppose your child turns out to have a rare and mysterious genetic disease. Or suppose you come into the hospital with cancer. By comparing one genome sequence to millions of others in a database, one can begin untangling how to find out the best treat individuals.

HOW MUCH MEMORY MIGHT BE NEEDED?

We talk about saving a mammoth of information in the drivers which we know would be needing a huge memory but just how much memory is needed to save all 6 billion of the nucleotide letters that comprise a single genome sequence? Google estimates it’s around 100 gigabits, which might not seem like a lot, until you consider just how many of us there are.

For example, if you wanted to read the DNA of everyone officially living in a city, it would take more than 1.2 million terabit hardrives. While that is obviously an enormous amount of information to process, Google’s current search index stands at 100 petabyes – 100,000 terabytes. The average search query, however, takes 0.25 seconds.

And it is applying this self-same search technology to the Google Genomics which is viewed as the key. At the inception of the project, scientists began hammering out an application programming interface (API) which would allow them to move DNA data into Google server clusters and conduct experiments using the company’s renowned web-indexing technology.

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“

If you wanted to read the DNA of everyone officially living in a city, it would take more than 1.2 million terabit hardrives.

Google’s current search index stands at 100 petabyes – 100,000 terabytes.

The average search query, however, takes 0.25 seconds

And as scientists have expanded their studies beyond individual genomes, hammering out a synthesis between data science and life science could propel the pace of medical advancement over the coming years.

“We saw biologists moving from studying one genome at a time to studying millions,” said David Glazer, “The opportunity is how to apply breakthroughs in data technology to help with this transition.”

PRIVACY ISSUES...THE ULTIMATE BLOCKAGE

When the technology is offering many perks to interest our readers, there might be certain issues which come along with the string. With big data comes the privacy issues and once it is addressed, it might prove to be an absolutely reliable and threat-free technology. To maintain the security issues, genome database have to carefully calibrate how much information they provide along with the DNA sequences. The more is the information displayed such as age, sex, location, habits etc, the more useful it becomes for the researchers to access information and compare. However, the more is the information, the easier it becomes to identify to whom the genome belongs.

A study last year, for example, could identify several men from the publicly available 1000 Genomes Project based on their Y chromosomes and age, location, and family tree data. While Google Genomics’ data seem to be aimed at researchers and not the general public, enabling the wide sharing of genome makes these concerns much more depressing.

Another scenario displaying the privacy concerns may be a situation in which you express your consent to sequence your genome for a cancer study. Your genome gets uploaded to a central database, where other researchers working on other studies accidentally find out you have a newly discovered rare disease or an unknown sibling.

Should they tell you? These ambiguities and worries are not only limited to or unique to Google Genomics, but looking at the huge expectations that it has roared in the scientific community, the unlikely impact of it cannot be neglected. The sheer scale of the envisioned database magnifies the potential problems.

Although every technology has its own set of problems, finding out solutions to deal with it makes it a success. The researchers have already advocated for central genomic data centers to at least standardize privacy policies for a hassle free utilization of services, although not necessarily maintained by Google. With Google Genomics ensuring storage of genomic data, what would set it apart from other contemporaries is the ease with which it deals with the privacy issues, if it could. If all goes well, Google Genomics could provide an API to store, process, explore, and share DNA sequence reads, reference-based alignments, and variant calls, using Google’s cloud infrastructure.

“

Although every technology has its own set of problems, finding out solutions to deal with it makes it a success.

With big data comes the privacy issues and once it is addressed, it might prove to be an absolutely reliable and threat-free technology.

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. .

S IC

T O I IB

T N A

? g u r D rm”

a

oh N “ t s an ju

h

th e r o ey m

t e r a . . ..

“

Despite a word of caution by the scientists, we constantly kept marching towards an era where people are dying of previously treatable bacterial infections. Can it be brought back to normal?

I

n today’s world, where the medical advancement is much advanced, even a minor hitch in the health seeks the mercy of the miracle drugs ‘antibiotics’. Whether or not prescribed by physicians, our intuitive mind tends to self proclaim antibiotics as the best treatment for that ailment. Are we doing a right thing in doing so? Won’t the little knowledge prove deadlier than the actual disease? Are antibiotics all that ‘merry’ we perceive them to be? Undeniably, antibiotics are one of the magical marvels of medical world; the popular views seem to have marked them over-rated. It has more surprises in store than what we usually know. Let’s explore the flip side of these “no harm” drugs!

mag.biotecnika.org

33

“

It is a high time that doctors and patients practice lesser use of antibiotics and that the activists create awareness on over use of antibiotics than protesting baselessly for GMOs.

According to a data, four out of every five people get prescribed with antibiotics in an interesting regional prescription patterns which might not necessarily be linked to any disease. Since their discovery, antibiotics have been thought to be a miracle cure without any downside. So much confidence into the medication that even viral infections receive doses of antibiotics without analyzing the detrimental effects it might have. Whether it cured the disease or worsened the condition even more, we hardly care?

In experiments conducted by scientists at NYU, Martin Blaser and his colleague Laurie Cox fed mice with antibiotics quite early in life and they found the bacterial balance of their guts shifting enough to make them twice as likely to have obesity as adults. They also tested the effect on mice who received antibiotics their whole lives and also on mice who received short courses of the drugs. In both the cases microbiomes of these mice bounced back to normal after eight weeks, but they still showed the obesity effect because of the temporary bacterial balance disruption. In the most affected case, female mice that had antibiotics and a high-fat diet, the microbiome disruptions caused them to weight 25 percent more than their peers. Even the ‘short bursts’ of antibiotic use in mice was the equivalent of a human taking the drugs from birth to adolescence.

Apart from being a link to obesity and other personal harms, the profligate over use of broad-spectrum antibiotics is gradually obliterating the healthy microbial communities in our guts and spurring the evolution of dangerous antibiotic resistant germs. These have given rise to the popular super bugs- the most dreaded reality of the medicine world.

There are many bacterial infections such as Methicillin-resistant Staphylococcus aureus (MRSA), that don’t respond to any commonly available drugs. If we remain ignorant, the future may witness many antibiotics that would no longer be useful.

In spite of the fear of the unlikely, the US FDA gets frail in changing the regulation towards usage of antibiotics in the livestock, thanks to intensive lobbying by the industry. Although FDA is persistent on careful usage of antibiotics, their efforts go bleak. It is a high time that doctors and patients practice lesser use of antibiotics and that the activists create awareness on over use of antibiotics than protesting baselessly for GMOs. The popular view on GMO consumption being harmful is more of a perception than a proof but a drug resistant super bug kills 23,000 people per year, according to the CDC. The wraths of antibiotics would only multiply with time so if people really insist on knowing what they are eating, if they are really insisting on labeling, they should be shown whether the food animals that they are eating were raised ‘antibiotic free’. People, who worry about eating healthy food, should really worry about eating “antibiotic-free” food than a “gene-modified” food.

Despite a word of caution by the scientists, we constantly kept marching towards an era where people are dying of previously treatable bacterial infections. Can it be brought back to normal? While many would be worried about going back to square one and start over again, the advancement in antibiotics have reached such advancement that the only feasible cure is the reduction in usage of antibiotics. Doctors should be cautious while prescribing them and people should avoid unnecessary consumption of them.

It’s high time that people be communicated about the risks involved with antibiotics. How could it be done? Whether educating people about the difference between virus and bacteria do the needful? Would it be an easy deal to educate general mass about what a villain antibiotic resistance could be? Well, certainly it would not be the easiest thing to do but the only option that can be adopted in the given scenario. In short creating awareness about antibiotics not just being the ‘hero’ of the story could only save antibiotics from being the next big ‘bio-villain’ of the future.

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biotecnika magazine

Biotecnika Magazine

page

57

Are you still doing PR for your company?

Introducing VPR!! presents

Video Press Release

Visit www.biotecnika.tv for more news Contact 1800-200-3757 35 mag.biotecnika.org

POWER TWEETS China’s decision to scrap drug price caps is a move in the right direction.

Finding a cure for Cancer: It will be the biggest discovery of the 21st century, if it happens.

-Kiran M Shaw, CMD, Biocon

India is amongst the top 12 Biotech destinations in the world & ranks third in the Asia-Pacific region.

India is the largest producer of recombinant Hepatitis-B vaccine - Make in India

Protein that rouses the brain from sleep may be target for Alzheimer’s prevention.

- Thermo Scientific

Lungcancer causes 1.59 million deaths each year, more than breast, colorectal and prostate cancers combined.

- Novartis

On any given day there are roughly 170,000 clinicalstudies going on around the world.

Too many compounds are making it to late phase trials before they’ve shown a robust proof-of-concept.

- Quintiles

36

The development of laser devices to combat cancer will be a critical innovation in the fight against Cancer.

- Biocon biotecnika magazine

Who pays you the BEST in

BIOTECH SECTOR? Salary Special

COVER FEATURE

mag.biotecnika.org

37

E AT UR FE R CO VE

Who pays you the BEST in

BIOTECH SECTOR? (Salary Special)

SA 38

L

RY A

biotecnika magazine

C

reate a crop variety, enhance the produce, preserve food with greater safety, make a better pharmaceutical drug, engineer a healthcare device, or break into a scientific maze.

Well. Sounds like an appealing and phenomenal profile. But how rewarding would such herculean profile be? The very prospect of efforting for a cause and researching to spin out a breakthrough is lucrative. Guess every individual hailing from life sciences domain can just not wait to grab onto such jobs.

Common Career Paths

• Advertising & Marketing • Business Development & Sales • Purchase & Finance

• Medical & Healthcare • Research & Development • Production & Manufactur- ing

But biotechnology is one such field where skill profile happens to weigh more than education profile. One of the fastest growing industries in India and considered to be a lifesaving domain, is Biotechnology, which has grown by 15.1% in 2012–13. Be it biotech or pharma, the salaries totally rely on skill profile, proficiency and experience. Professionals need to get a grip over the practical skills and enhance expertise before stepping out into the job world. According to the Academic Director of Biocon Academy, it is important to build up the talent to fill the gap between academia and industry. Rigorous, industry-relevant training is imperative to equip the graduates and postgraduates with the skills needed to make them employable in the pharmaceutical and biotech industry.

• IPR & Regula- atory • Education & Teaching • Analytics • Creative & Design

“

The biotech sector has grown by 15.1% in 2012–13 and salaries, they rely on one’s skill profile, proficiency and experience.

Popular Employers* • Cipla

• Micro labs

• Dr.reddy’s

• Torrent

Belonging to life science domain, the common career paths that a graduate might consider to try and pursue is no small list. Based on your interest and skills one may choose to pursue fields in the likes of Medical and Healthcare, Research and Development, Production and Manufacturing, Advertising and Marketing, Business Development and Sales, Purchase and Finance, IPR and Regulatory, Education and Teaching, Analytics, Creative and Design.

• Ranbaxy

pharma

• Lupin

• Cadila

• Zydus

• USV panacea

• Aurobindo

• GSK

• Glenmark

• Pfizer

• Abbott

• Novartis

As you garner the requisites and move out in pursuit of a job, the first thing to cross your mind would be ‘salary.’ An analysis on how much a trained biotech professional would earn after graduation or post graduation across private organizations is coming next.

• Torrent

• Biocon • Wockhardt • Sun pharma • Intas

* This is just a glimpse. There are more companies with mag.biotecnika.org opportunities for biotech and pharma.

39

Research & Development

Business Development & Sales > Sales Executive- Retail

> Research Scientist 4.7

Best Paid Employer

Best Paid Employer

2.9

Ranbaxy,

4.0

5.5

Advertising &

Lupin

Dr.Reddy’s

3.0

5.4

Best Paid Employer

Best Paid Employer

Ranbaxy

3.2

3.3

2.7

4.6

> Sales Executive- Corporate > Clinical Research Scientist

Abbott, Cipla,

Best Paid Employer GSK

> Direct Marketing Executive

Novartis, Ranbaxy

> Sales Executive- Institutional

> Formulation Best Paid Employer

Scientist

3.3

Novartis,

Best Paid Employer Abbott, Ranbaxy

4.6 3.2

4.7

Ranbaxy

3.3 2.8

> Sales Manager- Retail > Biopharma Informatics Scientist

4.1

2.5

Best Paid Employer Ranbaxy

Best Paid Employer

5.5 1.3

Regional ManagerCorporate

5.1 3.3 2.4

5.8 9.6

Biostatistician

4.0

> Assistant Marketing Manager

Institutional Sales Manager

Education &

R&D Executive

Analytics

Research Associate

1.6

Abbott

Cipla

8.0 13.9 4.0

Best Paid Employer

GSK, Novartis,

3.5

Production & Manufacture

> Data Scientist

5.5 4.3

Best Paid Employer

3.0

Novartis

6.1 3.3

2.5 4.2

> Data Analyst Best Paid Employer

> QC Executive- Manufacturing

3.4

Indegene

3.3

Best Paid Employer Reddy’s, Intas, Biocon

2.5

4.7

40 3.5

> Data Analytics Manager

> Product Development Executive- Manufacturing 10.0

> Other Managerial Positions

biotecnika magazine

6.5

9.4

Best Paid Employer Novartis

2.2 2.0

IPR & Regulatory

Medical & Healthcare

Marketing

> Pharmacist 4.5

Best Paid Employer Cipla, Intas, Lupin

Best Paid Employer Pfizer, Novartis

2.5

> Market Research Executive

> Patent Agent/ Analyst/ Associate 4.0

> Microbiologist

5.3

Best Paid Employer Biocon, Lupin, Ranbaxy

3.7

3.9

2.5

4.0

2.4

3.0 Best Paid Employer

Best Paid Employer Macleods, Zydus,

Novartis

> Medical Writing

Emcure

> Product Marketing Executive Best Paid Employer

3.0

> IPR/ Regulatory Affairs Manager

4.8

Best Paid Employer

6.7

Biocon, Novartis

3.8

Novartis

Purchase & Finance

> Clinical Researcher

4.5 3.3

> Purchase Executive

3.5

Creative & Design

3.0

Best Paid Employer Ranbaxy, Cipla

Teaching

> Purchase & Vendor Development Manager

> Designer 5.6

Best Paid Employer

9.4

3.2

> Assistant Professor

Ranbaxy

6.2

> Material Management > Professor

Best Paid Employer

> Editor

2.0

8.9

Dr.Reddy’s

5.0

2.0

> Other teaching roles

11.0

> Other Managerial roles

13.3

SALARY INFOGRAPHIC41 mag.biotecnika.org

* Experience in years and

Salary in lakhs/annum

* Reference: Various job sites and Biotecnika job portal

HOW GENEROUS IS THE GOVERNMENT?

Pr Sc inc ie ipa nt ist l

40

15

0

60

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91

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00

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Heading towards the famous organizations out there, like CSIR, DBT, ICAR, ICMR and UGC, they recruit life science candidates for various posts beginning from JRF to Director. Analysing the salary structure, we have;

37

CSIR

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Sen 00

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70 –6

374

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Grade Pay

0

0 750

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40

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67

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fessor

67000

Associa te Professo r

67000

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-3

91

-3

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0

00

0

biotecnika magazine

Scientist 6000 Principal Scientist 10000 Asst. Pro

00

00

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Scientist 6000 Senior Scientist 9000 Principal Scientist 10000

Grade Pay Asst Professor 6000 Associate Professor 9000 Professor 10000

91

40

37

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39100

37400 –

60

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37400 –

IIT/ I

GOVERNMENT ORGANIZATIONS

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Lecturer 7000 Asst Professor 9000 Associate Professor 10000 Professor 11000

STUMBLING BLOCKS OF THE BIO-SECTOR

The industry is estimated to grow 20 per cent CAGR and attain a size of $100 billion by 2025. The potential is certainly on the rise but several issues pertaining to the prevailing skill deficit needs to be addressed. Among the 40,000 biotechnology students who graduate every year from various colleges, not many end up finding a place in the 500 odd biotech companies and the reason being lack of requisite skills. Although quality research institutions and universities are flowing into the field, India still lacks significant and well-trained manpower.

Recruiting faculty who are proficient and trained is another barrier. Many Indian institutes and universities falter while trying to keep up the quality of teaching and hence the quality of education is affected.

Indian biotech students who can afford the fees choose to go abroad for higher studies, attracted by the possibilities of working in high-tech labs and the aspiration of working for leading biotech innovators. And there arises the question of brain drain.

HOW JUSTIFIABLE IS BRAIN DRAIN?

More than 60% of biotechnology graduates are moving abroad either in search of work or to pursue study. Brain drain has been increasing gradually and the reasons attributed are infrastructure, facilities and salary to begin with.

Other reasons maybe persisting reservation system, corruption, politics and fewer available opportunities. While America has been the first in the list of applying for jobs, UK, Germany, Europe and Australia follow.

100 90 80 70

Considering an example of Research Scientist, their average pay in biotechnology is $74,160 per year in USA. The highest paying skills associated with this job are Product Development and Stem Cell. They must be familiar with tools such as electron microscopes, computer-based analytical software, and sometimes research with live animals. Pay for this job does not change much by experience, with the most experienced earning only a bit more than the least.

Popular employers being Amgen Corporation, 89 Bristol-Myers Squibb Company, Life Tech83 nologies, Novartis Institutes for Biomedical 77 Research, Illumina, and so on.

71

Analysing the pay scale by experience level, we can see that at entry level with 0 to 5 years of experience, the average salary would be $71,000 and reaching almost to $80,000 in the next 10 years.

60 50 40 Entry Level (0 - 5 yrs)

Mid Level (5 - 10 yrs)

Experienced (10 - 20 yrs)

Late Career (>20 yrs)

The next in line being UK, a biotech research scientist earns an average salary of ÂŁ29,080 per year and AUS $ 71,925 in Australia.

A HOPE STILL LINGERS

Indian pharma industry is positioned as a leader, being the third largest in terms of volume, growing at a CAGR of more than 15% over the last five years. Biotech, healthcare and pharma verticals are roaring with potential and considered to be holding opportunities on par with any other domain. While the sectors are improving admirably and while the big pharma is minting money on large scale, correspondingly, big salaries and large benefits ought to be a part and parcel of the story. Employees or prospective workers often crib saying that the money is limited in this particular region. Be it research or manufacturing or production or marketing. Huge salaries are indeed witnessed at certain places but the general notion that the industry does not offer much to its employees still prevails.

Biotech and pharma, being the largest money makers, and successfully garnering appreciable amounts of investments recently, need to dedicate a sumptuous portion to its workers. Instead of taking the labour for granted, a six figure salary can be made a default number in the employment sector. Only then the biocommunity would articulate some hope in the sector. We might even be able to pull back the big brains flying off to other countries looking out for greener opportunities and the industry would continue to flourish on the same accelerating path.

mag.biotecnika.org

43

How harmless bacteria became

flesh-eating monsters

B

acteria, a fast evolving species with a short life cycles means that generations come rapid-fire, adapting through natural selection into the monster pathogens that are currently shrugging off our finest antibiotics.

Bacterial diseases cause millions of deaths every year but the situation is alarming when we are dealing with the flesh eating variety. One such strain group A Streptococcus which wasn’t always so virulent and aggressive (Early 1980s) suddenly ramped up into epidemic, which continues to this day.

So a new kind of disease called Flesh-eating disease came into limelight which can spread through human tissue at a rate of 3 cm per hour. Twenty-five percent of its victims die, and in severe cases, the patient is dead within 18 hours.

The medical name for this disease is necrotizing fasciitis (NF) and Streptococcus pyogenes, or Group A streptococcus (GAS) is the bacterial culprit behind this deadly disease. Necrotizing fasciitis is a serious bacterial infection that spreads rapidly and destroys the body’s soft tissue.

The tiny bacterium spherical cell with a diameter of 0.6 – 1.0 nm is often found in human throats or skin but exhibit no symptoms of illness. Sometimes S. pyogenes is responsible for diseases like strep throat, rheumatic fever and minor skin infections. These infections are often referred to as “non-invasive GAS disease.”

Scientists are puzzled as to why the normally mild GAS bacteria can sometimes become deadly, as in the case of necrotizing fasciitis (NF). In cases of necrotizing fasciitis, bacteria spread rapidly once they enter the body. They infect flat layers of a membrane known as the fascia, connective bands of tissue that surround muscles, nerves, fat, and blood vessels. The infection also damages the tissues next to the fascia.

RESEARCH Researchers have discovered that Bacteria that can cause deadly ‘flesh-eating’ infections evolved in just 35 years.

These bacteria appeared to have affected humans since the 1980s, and researchers have previously been unable to work out why they developed so quickly.

To go into the root of problem, genome sequencing of thousands of strains of group A Strep was done in the biggest bacterial study of its kind. The results were amazing as they found that only four tiny modifications to group A Strep caused it to explode into a worldwide epidemic.

According to James Musser of the Houston Methodist Research Institute, one of the authors of the paper, “The first

44

biotecnika magazine

“

This whole process ultimately resulted in two important character changes to the organism, which were, the ability to cause an increased number of infections, and an increased severity of infection

- James Musser, Houston Methodist Research Institute

two events were the acquisition of two bacterial viruses”. Sometime in the 1980s, these viruses infected a single bacterial cell of group A Strep, transferring genes to the bacterium that allowed it to produce novel toxins. This is known as horizontal gene transfer.

This was followed by regular mutation event in the genes of the bacteria, which produced an upgraded variant of one of the toxins. The fourth and final event that immediately preceded the epidemic was horizontal gene transfer from another virus. The crucial gene transfer from the virus to epidemic strain encoded two additional toxins and caused the strain to churn them out in massive quantities.

“This whole process ultimately resulted in two important character changes to the organism, which were, the ability to cause an increased number of infections, and an increased severity of infection,” Musser said. Then you’re off and running with an epidemic.”

WHAT CAUSES NECROTIZING FASCIITIS? Bacteria cause most cases of necrotizing fasciitis; only rarely do other organisms such as fungi

“

Researchers have discovered that Bacteria that can cause deadly ‘flesh-eating’ infections evolved in just 35 years.

These bacteria appeared to have affected humans since the 1980s, and researchers have previously been unable to work out why they developed so quickly.

mag.biotecnika.org

45

“

No vaccine is available to prevent GAS infections. Early diagnosis and early medical treatment are the keys to surviving NF. The first line of defense against this disease is strong antibiotics given through a needle into a vein.

cause this disease. Group A Streptococcus and Staphylococcus, either alone or with other bacteria, cause many cases of necrotizing fasciitis although Clostridium bacteria should be considered as a cause especially if gas is found in the infected tissue.

In general, the bacteria that cause necrotizing fasciitis utilize similar methods to cause and advance the disease. Most produce toxins that inhibit the immune response, damage or kill tissue, produce tissue hypoxia, specifically dissolve connective tissue, or do all of the above. In polymicrobic infections, one bacterial genus may produce one toxic factor (for example, E. coli causing tissue hypoxia) while different types of coinfecting bacteria may produce other toxins that lyse damaged tissue cells or connective tissue. In general, this disease is not contagious, but the organisms that may lead to its development are contagious, usually by direct contact between people or items that can transfer the bacteria. People usually need a break in their skin (cut, abrasion) for these flesh-eating bacteria to cause disease TREATMENT No vaccine is available to prevent GAS infections. Early diagnosis and early medical treatment are the keys to surviving NF. The first line of defense against this disease is strong antibiotics given through a needle into a vein. But because the bacterial toxins can destroy soft tissue and reduce blood flow, antibiotics may not reach all of the infected and decaying areas. This is why the rapid surgical removal of dead tissue – in addition to antibiotics – may be critical to stopping the infection. Surgical intervention can range from removing flesh, subcutaneous tissue, and fat in early stages, to major limb amputation in advanced stages.

A number of articles have been published on flesh-eating bacteria amputee Aimee Copeland. The 25-year-old Georgia, USA resident was on a vacation with friends in May, 2012 when she fell in a river while zip lining and wounded her leg. While Copeland was receiving stitches to close the wound, a doctor noticed necrotizing fasciitis in the wound. The flesh-eating infection that robbed her of her left leg, right foot and both hands. The survivor has battled her life for two years and able to walk and hold things with new prosthetics.

But everybody is not as lucky and determined as her.

We hope that with further advances in medical research, “flesh eating disease” may be able to move from the pages of science fiction and bacteriology into the pages of ancient history.

46

biotecnika magazine Aimee Copeland

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READERS CORNER I have been following Biotecnika since long and it has always been introducing interesting products. Being a researcher, I find Magazine very excellent to read and would love to see more.

- Prakash R, Chennai

Dear Prakash. We highly regard your appreciation for the magazine. And we would definitely effort to keep up your interests in the magazine intact. Thank you.

I am Srinidhi from Noida and I work in Bioinformatics sector. I read the article by Dupont that the awareness regarding green and biobased products is highest in India. It was interesting to get to know that. I liked the edition a lot.

- Srinidhi Sarkar, Noida

Dear Srinidhi. Thank you for the appreciation. The survey indeed confirms that India has increasing awareness and becoming more environment conscious. The younger generation of the country is leading the way and that is commendable.

I am a lecturer at a biotechnology college in Delhi. Going thorough the November edition, I was thinking if only our society was a little more open toward genetically modified food, the second green revolution would be much easier.

- Shefali Pathak, Delhi

Dear Shefali. Thank you for the much appreciation. Accepting the much debated technology of genetic modification without any hesitation would take a lot of effort from every vertical of the society and administration. We only hope it paves way for some good soon.

I am Sreeja pursuing biomedical engineering in Hyderabad. I was indeed shocked to read about the antibiotics usage in chickens. I wonder how many litres of antibiotics I am storing in my system right now. It was quite informative though.

- Sreeja R, Hyderabad

Dear Sreeja. Thank you for writing to us. Unlike other countries there are no set rules for antibiotic usage in India. Such rampant usage might hamper the resistance to diseases and it needs an immediate check by surveillance organizations.

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49

INTERVIEW In conversation with Mr. J. Balasubramaniam Country Head, Titan Biotech Ltd.

T

itan Biotech Limited (an ISO 9001:2008 Certified Company & cGMP faciliated) established in the year 1992, located in Bhiwadi, Rajasthan-60 k.m. away from Indira Gandhi International Airport, Delhi, India has been established with an objective of serving scientific community and mankind. It is one of the leading manufacturers & exporters of the biological products which are used in the field of Pharmaceutical, Nutraceutical, Food & Beverages, Biotechnology & Fermentation, Cosmetic, Veterinary & Animal Feed, Agriculture Industries, and Microbiology Culture Media & Plant Tissue Culture Media etc.

It offers a wide range of quality Biological Products in the form of Protein hydrolysates, Peptones, Malt extract, Yeast Extract, Liver Extract, Bile Extract and their derivates, Dehydrated Culture Media & Media Bases, Laboratory Chemicals, Plant Tissue Culture Media, Plant growth promoters & their basic ingredients for soil nutrition and Food additives. All their products are certified by ISO 13485:2003 and finds utility in the field of Clinical diagnosis, Vaccine production, Antibiotics, Agro- biotechnology, Animal feed.

Continuous development of newer products and exports to more than 60 countries all over the world in short span of time is an exceptional achievement of the organization.

50

In conversation with Mr. J. Balasubramaniam, Country Head, Titan Biotech Ltd., we have excerpts as; biotecnika magazine

“ We have designed training modules for easy induction of the new employees in the company. Employees take on their responsibility efficiently after successful completion of their training program.

Q. What are the recent projects that Titan Biotech is involved in? What is the USP of the company?

A. Titan Biotech Ltd. is in the process of revamping its Bhiwadi manufacturing unit. This was the first plant setup by the company in 1994. The new facilities would incorporate additional space to meet the growing demand from various segments like Readyto-use, Plant Tissue Culture Media, Media Plates & Supplements. The plant is being refurbished on the guidelines of WHO GMP, incorporating the latest state of the art machinery & equipments.

“

Titan Biotech Ltd. is also one of the few companies who manufacture media bases. Building the product from scratch is our USP. This enables us to have complete control over our product.

Another recent successful project has been the introduction of Antibiotic Discs. The product has been well accepted in the domestic as well as global market. Titan Biotech Ltd. is also one of the few companies who manufacture media bases. Building the product from scratch is our USP. This enables us to have complete control over our product.

Q. Among various industry verticals of Titan Biotech, which is the major area of focus in India?

A. Titan Biotech has various industry verticals like prepared culture media; culture media bases; food preservatives & ingredients; animal feed supplements & ingredients and other biological growth enhancing products. Titan is equally focused on both its culture media segment as well as bulk segment. Dedicated teams are working round the clock to make each segment a success. All our products are well received in the market.

mag.biotecnika.org

51

Q. As the organization grows and becomes more diverse, what are the challenges that you have to deal with?

A. Diversity & growth would require us to setup separate facilities for each product we focus upon. In addition, we would have to work hard on associating the right manpower with us. Most of our products are designed by keeping in mind the end user and many a times customized. Dehydrated culture media segment itself has more than 1700 products. The huge variety is the biggest challenge we have to deal with.

Q. How satisfying is the quality of manpower that approaches Titan Biotech? How can it be enhanced?

A. India has a vast array of talented microbiologists but ours is a unique industry.

It is very hard to find people who have worked in the same field as ours. Hence, we have designed training modules for easy induction of the new employees in the company. Employees take on their responsibility efficiently after successful completion of their training program.

Q. How do you drive a sustainable growth of the company? Where do you see the company’s growth in the next 5 years?

A. Titan Biotech Ltd. is one of the few companies who have been able to drive growth consistently. Focus on quality & successful efforts of the R&D Department have been the two pillars of company’s strength.

With more awareness among the new age customers, we foresee a major rise in the demand of our products in coming years. In the next 5 years, we shall setup separate manufacturing unit for each of our industry vertical.

52

biotecnika magazine

New updated agenda

23 - 25 March 2015 Suntec Singapore Convention & Exhibition Centre, Singapore

Navigating the future of Asia’s biopharmaceutical industry www.terrapinn.com/biopharmaasia

mag.biotecnika.org

53

s 0 n 1 a i TOP Politsitacnd for who

y g o l hno

ec t o i B

Prakash Javadekar

1

“

GM crops are being cultivated and consumed by human beings as well as animals in many countries across the world as food, feed and processed products. No scientific evidence to prove that GM crops would harm soil, human health, environment.”

Union Minister of state for Environment, Forest and Climate Change

Narendra Modi

2

“

“Make in India” initiative, proposed in the Independence Day speech promises to attract investors from across the globe and help in biotech boom. Prior to the speech, the speculations were even high that State-funded research in areas such as biotechnology, pharmaceuticals and automobile would receive the necessary support from government.

Indian Prime Minister

3

Veerappa Moily

Former Environment Minister

4

Hillary Clinton

54

Former US Secretary of state, US Senator

biotecnika magazine

“

When the trials for GM crops were given a nod, he supported the decision by claiming approval by the GEAC (genetic engineering approval committee) was within the bounds of law so we have approved it. He said that subject to conditions and a no-objection from states, companies can go-ahead with restricted field trials of GM crops.

“

I stand in favor of using seeds and products that have a proven track record” and that “there’s a big gap between the facts and what the perceptions are.” She further added genetically modified’ sounds Frankensteinish,” and thus turns people off to GMOs, “Drought resistant sounds really like something you’d want”

I N F F L A U C E T N O R C E 1

2

3

4

5

6 7

8

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Whether the GM food is safe or not should not be decided by departments or individuals, it should be decided by scientists following strict standards and procedures. Chinese soybean oil is mainly processed from imported GM soybean, which has passed the safety assessment of producing country and strict validation Han Changfu of Chinese National Security Committee of Genetically Modified China Agriculture Organisms.

Minister

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As such agricultural biotechnology will play a significant role in increasing quality production in these states.”

Also highlighting the benefits of biotechnology, Singh said crops can be made climate resilient and drop in production can be addressed with use of biotech crops.

6 Radha Mohan Singh India Agriculture Minister

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”While safety must be ensured, we should not succumb to unscientific prejudices against Bt crops. Our government remains committed to promoting the use of these new technologies for agricultural development. Use of biotechnology has great potential to improve yield.” (at 101st Indian Science Congress)

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Manmohan Singh Former Prime Minister, India

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Owen Paterson

James C. Greenwood,

UK Department of Environment, Food, and Rural Affairs (former)

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While I acknowledge the views of other Member States, I want British researchers and farmers to be able to reap the economic and environmental benefits of the latest technologies. We have a world class science and research base and the expertise to play a leading role in feeding a rapidly increasing global population.” He relented that “Despite having the most robust and comprehensive safety system for GM in the world this, GM products which have passed the safety assessments remain stuck in the pipeline.

Only one crop has been approved for cultivation in the last 14 years

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10 Niu Dun, Vice Minister of Agriculture,

American Politician in the Republican party

“

With the United Nations forecasting the global population reaching 9.6 billion by 2050, Mr. Greenwood sees genetically modified crops as an important tool in keeping humans fed, suggesting that food production must double to meet this looming demand.

“Biotechnology helps companies across the supply chain to meet these goals,” said Mr. Greenwood.

“I understand that people have a great interest in the food that they feed their families. I’m a father and a grandfather. But that’s not an excuse to let anti-science, antiGMO activists distort or misconstrue the role that biotechnology can play in feeding a growing planet.”

China

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China does not allow commercial production of any genetically modified staple foods, but China needs to stay on top of GM technology. We should draw a clear distinction between GM research and GM production. The GM technology, an advanced technology that is valued greatly across the globe, should be taken seriously by us. GM is not just about science. GM wheat R&D of the US sets a good example, demonstrating the nation’s research capability and state competitiveness. To be competitive and enhance the soft-power, China must take the high ground in technology.

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CSIR takes the BIG DECISION! Has it come too late?

T

en years of complain, dissatisfaction and struggle could finally breathe some fresh air of contentment as the government finally addressed the long abandoned science community by increasing the fellowship amount. The step which came after a massive protest by researchers and associates working in different institutes across the country sent a wave of excitement and has every reason to be celebrated as not only did the government give “some� hike but an outright increment of 50% was witnessed! The Union Minister of State (Independent Charge) for Science & Technology and Earth Sciences, Dr. Jitendra Singh announced over 50% hike in the fellowship amount which would be received by various categories of young Research scientists after a constant dig to offer a better pay package.

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The news which came as Diwali dhamaka for more than one lakh science professionals in the country would not only provide a more secure future to them but also help in dealing with one of the most dreadful situations that India has been long trying to find solution for- i.e brain drain. The lack of funds, basic amenities, and facilities often forced the ingenious minds of science to try their fate in the western countries such as US and Europe. It certainly led to fulfillment of their dreams and aspirations but took a major toll on the righteousness of India.

Now that the CSIR fellowship is hiked, let’s have a look into who got what? Science students undertaking PhD and post-doctoral studies are expected to receive better stipend from the government along with other facilities such as house rent allowance and medical benefits as per the central government norms or the norms of host institutions whichever applicable. “This is the biggest ever increase in the scholarship for research students,” said Union Science Minister Jitendra Singh.

The post doctoral students will see a hike of 50% for every vertical of the research from junior research fellow to research associate. The increment would be from Rs 22, 000 to Rs. 36, 000 if they are research associate I, from Rs 23, 000 to Rs 38,000 for research associate-2 and from Rs 24, 000 to Rs 40, 000 for research associate-3. While research associate 1 and 2 are generally for one year, research associate-3 can continue the work till the person gets a position in a research institute. For comparison, the entry-level salary at the Council of Scientific and Industrial Research is about Rs 50,000.

The government also issued directions to the science & technology ministry to put in place a “web-based fellowship assessment and disbursement mechanism” so that delays in disbursement of fellowship amount could be avoided. Announcing the decision, Union minister of state for science and technology Jitendra Singh said, “Each ministry and agency can now use the guidelines to make requisite changes over their specific fellowship pro-

Previous fellowship: Rs. 24,000

Research Associate III Previous: Rs. 23,000

Current fellowship: Rs. 40,000

What would the hike do?

- A starting fellowship of Rs 32,000 brings a CSIR NET

Research Associate II Current: Rs. 38,000

JRF at Par with any Regular IT professional who gets an equivalent salary

Previous: Rs. 22,000

- Brain Drain will reduce by 30-40% - Students switching between fields after their Post Gradua-

Research Associate I

Previous: Rs. 18,000

Current: Rs. 36,000

Senior Research Fellow Current: Rs. 28,000

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tion will come down - CSIR Labs as well as BT Companies will get quality manpower/ researchers in the coming years

Previous: Rs. 16,000

Junior Research Fellow Current: Rs. 25,000

- More such initiatives and encouraging entrepreneurship could do wonders to the life science domain

“

Each ministry and agency can now use the guidelines to make requisite changes over their specific fellowship programmes.

- Jitendra Singh, Union minister of state for S&T

grammes�. Suggestions were also made that a hike in the fellowship amount should be undertaken periodically after due assessment and for this purpose the ministry would put in place a proper mechanism.

The decision will put an additional burden of about Rs 750 crore on the exchequer. Research scientists from premier institutions, including the Indian Institute of Science, IITs, JNU, CSIR institutes, NIT and AIIMS, have been demanding the hike for long.

While the step taken is highly commendable, there are a few questions that need immediate attention. The first and the foremost concern is why it took 10 years for the government to come with something substantial for the science community? Should there not be a policy fixed at place which takes care of hike, funds and other facilities on timely basis? Should the long waiting years be made definite ones? With these and many more dubiety still surrounding the life science sector, to achieve a scenario as perfect as in western countries is still beyond vision, but the step has surely increased the ray of hope that we were long waiting for.

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TOP 10

Astounding facts about

India & Global Bioindustry

Indian Biotech Companies

The Indian biotech industry holds about 2 per cent share of the global biotech industry. With the growth in the customer base and more investments taking place in the biotech sector, the biotech industry is expected to grow to around US$ 73.73 billion by the year 2020.

India is among the top 12 biotech destinations in the world. Out of the top 10 biotech companies in India (by revenue), six focus their expertise in biopharmaceuticals and four specialize in agri-biotech.

India’s GMO beats Canada India had recently overtaken Canada to emerge as the fourth largest country to grow biotech or genetically modified (GM) crops.

Vaccine Leader India is a leader in vaccine production and carries the tag of being the largest producer of recombinant Hepatitis B vaccine.

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Largest GM Crop Producer Farmers in India have planted BT cotton in about 11 million hectares. The global acreages under GM crops increased to 175.2 million hectares in 2013, about five million hectares more than the previous year

Indian Biotech Industry...

Superbug was created by an Indian, Dr. Ananda Chakrabarty. He developed the multi-plasmid hydrocarbon-degrading Pseudomonas and patented it. This was the first time anyone had patented a living organism.

India Ruling Pharma World India is known as “PHARMACY OF THE DEVELOPING WORLD.”

First Living Organism Patent

Biocon’s Kiran Majumdar Shaw is world’s 14th Most powerful social Media influencer among the top hundred.

Most Influential Person Clinical Trials, CRO & Manufacture India has emerged as a leading destination for clinical trials, contract research and manufacturing activities owing to the growth in the bioservices sector, which accounts for revenue generation worth about US$ 636.73 million.

The Chairman of Sun Pharma is among the Top 5 Richest Entrepreneurs of India.

Richest Pharma Entrepreneur mag.biotecnika.org

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t s e u “g ” r e n r co

dia n I n i d n Clinics e r d t n a e ls r

ita ca h t l r Hosp a e t e n h e lti-C erging lty Mu

An em

Single

Specia

I

t is a known fact that 80% of India’s healthcare needs are provided by the private sector as the government spends as little as 2% of the GDP on Healthcare expenditure and over 90% of Indians pay out of their pocket to meet their healthcare expenses. India will sustainably have the largest number of people suffering from noncommunicable diseases such as Hypertension, Arteriosclerosis and Diabetes. But with the rising population is the increase in disposable incomes, patient awareness and health insurance penetration. Patient’s aspirations too are fast changing and they demand quicker response times, lesser waiting periods and better health outcomes.

A recent trend emerging in India to meet this huge gap of healthcare demand is the mushrooming of multiple single specialty hospitals and clinics under a single corporate entity. Take a look around your neighbourhood and you would notice the branded eye care centers or mother and childcare facilities or specialized day care surgery centers, small and mid-sized hospitals, dialysis centers, dental clinics etc. The business model thrives on rolling out several centers simultaneously across Tier-I and Tier-II cities in India under a corporate entity bringing healthcare to your door-step. In fact Private equity firms and Venture Capitalists have jumped on to the bandwagon funding these corporatized healthcare services with millions of dollars as they see these single specialty

“ A recent trend emerging in India to meet this huge gap of healthcare demand is the mushrooming of multiple single specialty hospitals and clinics under a single corporate entity.

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“

Healthcare IT companies have come up with solutions which can integrate data across these centers such that a patient’s EMR is available at the corporate level across multiple locations.

centres to be profit generating centres in shorter gestation periods. Even the investment required in setting up these specialized centers is much lower in comparison to the large multi specialty tertiary care hospitals.

This emerging trend is at a nascent stage in healthcare but seems exciting considering that healthcare seems to be learning from the manufacturing sector. Concentrate on your core competence, achieve a favourably higher number of expected patient outcomes i.e. higher quality, better customer satisfaction, brand recognition, employee retention and eventually profits.

Healthcare IT companies are also rising to this emerging trend. They have come up with solutions which can integrate data across these centers such that a patient’s electronic medical record (EMR) is available at the corporate level across multiple locations/cities. So if a patient walks into XYZ Clinic in Location X, his medical records should be accessible even if he goes for a follow-up visit to any of the XYZ Clinics at any of its available locations. The Healthcare IT vendors are also offering EMR applications as a Software as a Service (SaaS model) which are web-based and some with a cloud offering, allowing no requirement from a clinic to invest in an in-house server, a dedicated IT Team or any networking equipment. All the clinics would need to invest in is a dedicated internet connection or a leased line or a 3G dongle and they are up and running live with a hospital/clinic management software.

One of those advantages of this business model is it is less capital intensive and highly scalable wherein a new center can be opened in a location under the same brand in a short period of time. The key to implementing the right EMR product is also to ensure that the application that the corporate decides to purchase is also scalable such that the addition of a new clinic should be technologically feasible. A lot of inefficiency in operational and clinical processes stems from the lack of quality reporting. With an effective HIS/EMR system in place, the risk is eliminated as data flows in a seamless fashion across various centers nation-wide and hence the availability of improved analytics. With a web based application, the clinician can instantly pull a patient’s medical record remotely and securely from the comfort of his home on a tablet and revert on a case immediately. The managers have a better tab on the statistics of their respective department real time such as Turn-Around-Times in a Laboratory, Patient Stats for a Hospital Administrative, Inventory status alerts for a Store Manager, real time Bed Occupancy Rates etc.

Quick access to patient medical record helps improve the coordination of activities within the work/process flow of the hospital. Imagine the time saved for discharging the patient if all the information regarding to the

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“

In earlier days the patients would flock to receive services from a specific doctor but today that reputation is slowly shifting to the brand image of the corporate.

patient’s treatment is well documented and in place for the billing user as well as the clinician who prepares the discharge summary.

This model is also seeing a shift in patient behaviour where the patient walks in to a particular clinic or hospital due to its brand perception and not just on the competence of the doctor. In earlier days the patients would flock to receive services from a specific doctor but today that reputation is slowly shifting to the brand image of the corporate.

The model has also evolved into franchising models, where the corporate only lends its franchise but the subsidiary is still privately run. Some of them are looking to penetrate further into the Tier –II / III and even the rural markets and roll out 100s of such centers.

About the Author

The government understanding that privatization of healthcare is inevitable seeks to leverage the PPP (Public Private Partnership) model as is seen in the running of Primary Healthcare centers in rural areas.

Arun Joseph Varghese Arun Joseph Varghese works as Product and Marketing Manager at Insta Health Solutions. He is a Bioinformatics Engineering graduate from VIT (Vellore Institute of Technology) University, an alumnus from IHMR, Bangalore as a Post Graduate in Hospital Management (PGPHM) and an MBA in International Hospital and Healthcare Management from the Frankfurt School of Finance and Management, Germany (in collaboration with HEC Montreal, Canada). He also has the experience of having worked with Tata Consultancy Services.

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Mergers and Acquisitions

I

s big pharma industry on the shrinking lines with respect to employment? Or is the industry blooming like never before? How responsible are the increasing mergers and acquisitions? Every year, with more than more than $100 billion in deals, how has it been helping or hurting the pharmaceutical domain?

It all began with the big unisons back in 2009. Pfizer acquiring Wyeth, Merck and Schering-Plough and Roche merging with Genentech. Following which were Valeant bidding for Allergen, Novartis, GSK and Astra Zeneca. As these million dollar deals hit the news stand, the stock prices escalate dramatically, irrespective of the completion of the deal.

The merger activity ascended in the fourth quarter of 2013 to the year end, with total deal value 45.8% higher than in 2012. The entire year 2013 has witnessed 49 deals with a total value of $113.9 billion in the pharmaceutical sector, compared to the $33 billion across 41 deals in 2012.

When asked to comment on the recent deals in trend, Sanofi CEO, Chris Viehbacher, said, “The company has no intentions in getting involved in this recent trend. It is in pretty good shape and these mega-merger deals are simply a trend. There’s lots going on in the environment. That doesn’t mean it changes our strategy on M&A. Just because an asset becomes available doesn’t mean you can acquire further businesses.”

A MERGER involves two business entities joining forces and

forming a new business, with a new name. It generally involves two companies of same size and stature joining hands.

An ACQUISITION involves one bigger business taking over a smaller company which either is absorbed into the parent company or run as a subsidiary. The company being taken over is referred to as the ‘target company’ in the corporate world.

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Preparing for a merger is more like prepping up for a weak year. Increased regulatory scrutiny, escalating prices and expiring patents are the famous hurdles for producing a breakthrough.

They add up to the consolidation taking shape. The average cost of developing

Helping or hurting big pharma? and marketing a new drug has been estimated at $5 billion in 2013 when compared to $1.1 billion in the late 1990s.

Teaming up is a way to cut costs and maintain profits.

One side of the M&A story also includes the “employment segment”. Between 2003 and 2013, statistics read that many companies and their employment capacity have reduced in numbers largely. The figures include pharma industry’s big players like Pfizer, Merck, BMS, Lilly and Astra Zeneca. As these big names take a step ahead and acquire neighbouring pharma companies, their overall head count disturbingly goes down. The employment capacity of pharma industry has come down by 3% in the last decade, with a fear that merging and reshuffling would direct the industry to drastically reduced employee numbers and payroll.

Analyzing the changing workforce numbers in Big Pharma companies between 2003 and 2013, apart from the mass laying-off and dismissal, the employee count has been declining over the decade. For instance;

• Pfizer had 122,000 employees (2013) and Wyeth had 52,385.

Four years after acquiring Wyeth, Pfizer’s employee base had

shrunk to 77,700.

• Merck (63,200 employees in 2003) took over Schering-

Plough(30,500 employees) in 2009 and by 2013 the Merck stood

at 76,000 employees.

• Lilly with 46,100 employees stooped to 37,925.

• Astra Zeneca fell from 62,900 to 51,500 and • Bristol-Myers Squibb came down from 44,000 to 28,000.

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“

Bristol-Myers Squibb and Pfizer topped the list with respect to the declining number of employees. Each company fired 36% of their employees.

The reason that the past ten years witnessed the company downsize the workforce is that it acquired Pharmacia and Wyeth.

Bristol-Myers Squibb and Pfizer topped the list with respect to the declining number of employees. Each company fired 36% of their employees. As we look at Pfizer’s workforce, the numbers have been reducing drastically. The reason that the past ten years witnessed the company downsize the workforce is that it acquired Pharmacia and Wyeth.

Biotech, though analysed to be better off when compared to pharma, has a few downsides as well. Though the sector is considered to be partially immune to rationalization, the recent Novo Nordisk’s rheumatoid arthritis drug, failed a clinical trial. As a result, the company not only stopped the development of the drug but also closed all efforts in inflammatory R&D. On the same road, the Biotech company, Exelixis, after finding out that its cancer drug failed a Phase III trial, it was forced to suspend 70% of its workforce.

While the diminishing employee count and lay-offs stand to be the negative effects of mergers, benefits are also a part of the story. They include a wider assortment of products, eliminate duplication and overlap and hence bring down costs, and improved availability of capital. And above all it is not strange to say that the stock prices would push up high when an acquisition is declared. A median acquired company contributed around 37 percent of total pharmaceutical revenue and 10 percent of new-product revenue for the combined company five years after the deal’s announcement. Consolidation deals created maximum economic profit for acquirers through both cost synergies and accelerated revenue growth.

“Unlike deals in many industries, big mergers and acquisitions among pharmaceutical companies generally have resulted in positive returns for shareholders,” says a well-known business advisory firm. It is considered that bigmergers generate shareholder value and hence consolidation deals produce greater economic growth.

While pharmaceutical megamergers have increased share holders revenues, they also had a few downsides. Not all the deals look or result positive. However, as drug pipelines are better understood, given the track record of consolidation deals generating high economic profit, we would not be surprised to see them continue merging and acquiring.

“

Unlike deals in many industries, big mergers and acquisitions among pharmaceutical companies generally have resulted in positive returns for shareholders.

- McKinsey & Company, Business Consulting firm

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A median acquired company contributed around 37 percent of total pharmaceutical revenue and 10 percent of new-product revenue for the combined company five years after the deal’s announcement. biotecnika magazine

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