BioTecNika Magazine - June 2015 | India's fastest growing Biotech Magazine

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BT START UP SPECIAL Issue 6/ Vol 3 June 2015

CANCER CARE tops $100 bn threshold

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We have had great support from Malaysian VCs.

- David Lawrence CEO, Sentinext Therapeutics

Start-up Story LEUCINE RICH BIO

COVER FEATURE

Biotech & VC Funding Human Embryo Gene-editing HOW FAR ARE WE RIGHT?

can the MARRIAGE ever happen?

Top 10

Healthcare Devices for the coming years

Delayed Regulation on GM crops threatening agri-innovation

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Biotechnology sector is quite infamously famous for often receiving the new comers into the industry quite coldly. Be it in terms of infrastructure, getting required approvals or even fetching investors, a bio-preneur’s tale has many villains to overcome before they could actually celebrate a success story. The June issue is dedicated to all the start ups in the industry who have tried hard to make a mark and to those who are still in the rising. The cover story revolves around the ‘hide and seek’ between biotech start ups and the investors and how compatible do they stand out compared to other sectors. Though biotech sector stays ambitious in terms of reaching a top spot in the charts but do we have enough opportunities for its people? We talk about the profit, but is there patience to wait for the returns?

Quite sadly, no. Investors, who are mostly in a jiffy of looking for short term benefits often neglect on the huge profits that biotech could bring. There are a lot of strategies and improvements which if adopted could drastically change the scenario. Although in bits and pieces, we are heading towards that layout which is supportive of bio-preneur taking its step smoothly into the sector. Give a definite read to this biotech entrepreneur and investor relationship existing in India in the ‘BT start up special’ issue.

editorial editor@biotecnika.org

We also have the start up story of Leucine Rich Bio, a bioinformatics company based in Bangalore, India. Read their venture story and also how easy or difficult was it to make their dream a reality. We would like to thank Mr. Kumar Sankaran for his valuable time. Also featuring is a Malaysian biotech company, Sentinext which is slowly turning out to be a head turner in vaccine domain. Our sincere gratitude to David Lawrence, CEO, Sentinext Therapeutics without whose kind cooperation, the feature wouldn’t have been a success.

Other features covered in this issue are Human Embryo Geneediting, how far are we right? Which talks about ethical aspect of the recently conducted gene editing in human embryos in labs. Top 10 healthcare devices for the coming years, Cancer care topping $100 bn threshold are an interesting read to give. Do not miss on the power packed issue which has much read to offer.

Your valuable feedback and suggestions which constantly help us on improving and bringing out better content each time are always welcome. Keep in touch by writing to us at editor@biotecnika.org.

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A complex organ in the order of eye is going to be synthetically made by MHOX! The news on synthetic eyeball from May issue is quite an amaze.

Would it be a possibility soon?

- Vidya Sharma, Bangalore

LETTER OF THE MONTH

It is the era of 3D bioprinting. We are in the age of printing functional organs and vital parts of human body using bioprinting. But an organ as complex and serious as the eye was indeed challenging. The ground breaking research was from the Italian design firm, MHOX, who predict that the product will be on the market in early 2027. There is no further information on it as of now. We hope they come across all the hurdles in the coming years and make it a possibility as promised.

Mapmygenome has introduced India the concept of personal genomics. The interview by Anu Acharya was interesting to read through. I hope it garners good attention.

- Tejas Chauhan, Bangalore

Personal genomics promises better health to Indians through an affordable and valuable technology launched by Mapmygenome. It helps us understand our health needs and complications and combined with counselling, it turns out be a blessing. The market still needs to be mould around this new technology and we are glad that Mapmygenome is on its way to accomplish the task.

MAILBOX

When nature has made a GM crop all by itself, I guess its time people realize that scientists are not meddling with nature in the making of GM crops.

- Karthik R, Chennai

Ghent University (UGent) and the International Potato Institute’s suggestion that nature itself has been genetically modifying plants way before scientists was indeed appreciable. UGent researchers have come forward with an interesting discovery of sweet potato being a natural GM plant. While the concept of GM was never well conveyed to the people, it also lacks proper positive media attention. The perception needs to be accurate and people need to understand the pros and cons of the technology before revolting against it. However we believe in promoting the good behind GM technology and we are glad to know that we have support from readers like you.

The advent of H1N1 has created such havoc in India. I hope it is finally at rest.

- Priya Nair, Chennai

H1N1 had mercilessly claimed the lives of thousands across India. Though the numbers have come down eventually, researchers will still have to study the virus further and be aware of all the mutations that the virus might have undergone before making a vaccine for the same. It is always good to be ready.

It is always an insightful and a knowledgeable content that Biotecnika offers.

Much appreciation to the entire team of Biotecnika for the amazing work.

- Anu Sanghvi, Punjab

Thank you for your over whelming and kind words. We at Biotecnika sincerely work towards creating a content which is worth a read for our readers. With your support and feedback we hope to come up even better issue each time.

CONTENTS Issue 6 | June 2015

Human Embryo Gene-editing INTERVIEW

how far are we right?

POWER TWEETS

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Kumar Sankaran, MD Leucine Rich Bio

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Top 10

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Asthma is a complex condition. We are collaborating with RASP-UK to help make asthma personal.

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We clarify that Dilip Shanghvi has neither purchased nor agreed to purchase any shares of our Company in Daiichi Sankyo transaction.

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Thank you to our scientists for leading the development of two new malaria treatments.

Thanks to nanotechnology, we are closer to performing surgical operations that once sounded like science-fiction.

healthcare devices for the coming years

POWER TWEETS

INTERVIEW David Lawrence CEO, Sentinext

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Bionews Rasayanika Zone Whats on biotecnika.org Bioevents

Will Indian IP policy stand up with the us?

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COVER FEATURE

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Biotech & VC Funding can the marriage ever happen?

Trending technology 3D printing gets yet another utility!

Cancer care tops $100 bn threshold

Delayed regulation on GM crops

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threatening agri-innovation?

GUEST CORNER

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BIO-NEWS Human heart not all that sweet Bitter taste receptors found on it

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cientists have come across an astounding discovery of taste receptors being present on human heart. They are investigating the discovery of the presence of smell and taste receptors in heart that are normally found in the nose and mouth.

As a part of their on-going research, scientists from the School of Biomedical Sciences, University of Queensland were able to observe the presence of receptors on human heart. Dr. Simon Foster, who originally led the research, had found that around 12 taste receptors, particularly those that respond to bitter compounds, were expressed in human hearts.

“This is quite remarkable, as the human genome only has 25 of these bitter taste receptors, and we wanted to find out why half of them were located in the heart”, said Professor Walter Thomas, lead researcher. When we activated one of the taste receptors with a specific chemical that we all taste as bitter, the contractile function of the heart was almost completely inhibited” he added.

While the underlying physiology behind this phenomenon remains unclear, this is now a major area of ongoing investigation. The primary focus of the research team was to see how heart grows normally as well as abnormally in a disease. “After hypertension or a heart attack, the heart frequently undergoes compensatory growth in order to maintain the circulation of blood around the body,” Professor Thomas said. “But a common end result of this compensatory growth is eventual heart failure.”

“During laboratory tests, we were looking at all the genes that are regulated in the heart in this growth phase. And we found the rodent heart cells we were working with to be containing smell and taste receptors, which are normally considered to be only present in the nose and mouth.”

Professor Thomas said the project progressed from animal studies to human investigations. Using heart tissue from humans undergoing heart surgery, such as valve replacement and coronary arterial bypass, they replicated the rodent laboratory experiments and found taste receptors were also present in the human heart.

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One more interesting finding came with the discovery of 5th DNA base in late 90’s which was identified to be a derivative of cytosine called ‘methyl Cytosine’ (mC). It was known to be formed by methylation of cytosine to 5-methyl Cytosine and plays a key role in epigenetic mechanism of some genes, where it involves switching genes to ON or OFF states as per the physiological needs of the tissue.

Recent studies on this additional DNA base report that variation in mC results in the development of many human diseases, including cancer. What comes as an added surprise is the probability of existence of 6th DNA base pair by the researchers at IDIBELL. Manel Esteller, director of the Epigenetics and Cancer Biology Program of the Bellvitge Biomedical Research Institute (IDIBELL), ICREA researcher and Professor of Genetics at the University of Barcelona, unveiled the possible existence of a sixth DNA base, the methyladenine (mA) which also helps in determining the epigenetic mechanism of some genes “It was known for years that bacteria, evolutionarily very distant living organisms of us, had mA in its genome with a protective function against the insertion of genetic material from other organisms. But it was believed that this was a phenomenon of primitive cells and it was very static” describes Manel Esteller.

“However, recent study reveals eukaryotes such as the human body cells, also consisting of the sixth DNA base. These studies suggest that algae, worms and flies possess mA and it acts to regulate the expression of certain genes, thus constituting a new epigenetic mark. This work has been possible thanks to the development of analytical methods with high sensitivity because levels of mA in described genomes are low. In addition it seems that mA would play a specific role in stem cells and early stages of development, “explains the researcher.

Now the next challenge we face is to confirm this data and find out whether mammals, including humans have this sixth DNA base, and if yes, what role does it play overall?

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A 6th DNA base found !!

DNA the hereditary material is an alluring concept, a reason for existence of each individual and a ground factor of all research conducted in different domains of Biology. DNA, which is structured with string of base pairs attached to a phosphate sugar backbone, consists of four DNA bases - adenine (A), guanine (G), thymine (T) and cytosine (C). The order and sequential arrangement of these base pairs indicate the genes they encode, hence playing a crucial role in determining the key Information that controls growth and development of an individual organism.

Will it reveal solutions for many concealed confusions?

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n a recent scientific amusement, researchers have found out the probability of existence of a 6th DNA base pair.

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36 new drugs

marked essential by

WHO

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he World Health Organization (WHO) has added 36 new drugs/ treatments to the list of essential medicines which also include drugs that the agency believes should be made available and affordable through national and institutional health systems.

The WHO Expert Committee considered 77 applications and included 15 to the core list and 21 to the complementary list of EML, including five products for hepatitis C, four to target multi-drug resistant TB and 16 new medicines to the Essential Medicines for Children (EMLc) -- five to the core list and 11 to the complementary list.

The list includes five new HCV treatments such as Sovaldi sofosbuvir, Harvoni, ledipasvir/sofosbuvir from Gilead Sciences Inc., Viekira Pak ombitasvir/paritaprevir/ritonavir plus dasabuvir from AbbVie Inc. and ground-breaking new treatments for hepatitis C and multi-drug resistant tuberculosis (TB).

The core list represents the minimum medicine list for a basic health care system and the complementary list represents essential medicines for priority diseases.

WHO EML and EMLc list has a knock on effect on national governments where member states are expected to bring their national list in line with the WHO list.

The move opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally. The WHO’s Model List of Essential Medicines (EML), which is updated every two years, is used by governments around the world to help determine which treatments they should make available.

“When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them,” said WHO Director General Margaret Chan in a statement.

The UN agency has also said that there is a need to decrease the prices to make them accessible to patients in poorer countries. The treatment of hepatitis C has been transformed by the arrival of new drugs, including Gilead’s Sovaldi. The disease affects around 150 million people across the world, killing around half a million per year. Though these products can cure hepatitis C but they are out of reach at Western prices to patients in poor countries, as a single Sovaldi pill costs $1,000 in the United States.

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When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them.

- Margaret Chan, Director General, WHO

Biotecnika Magazine

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he Bill & Melinda Gates Foundation announced $75m to set up a network to investigate childhood deaths in developing countries. The Microsoft founder believes that the Ebola epidemic in West Africa was a “wake-up call” that highlighted the need for better monitoring of global health threats.

The foundation announced the launch of a disease surveillance network in Africa and south Asia aimed at gathering more accurate data about the causes of childhood deaths. Child Health and Mortality Prevention Surveillance Network (CHAMPS), a network of disease surveillance sites in developing countries will help gather better data, faster about how, where and why children are getting sick and dying.

This data will help the global health community get the right interventions to the right children in the right place to save lives. The network will also be invaluable in providing capacity and training in the event of an epidemic, such as Ebola or SARS. “The world needs better, more timely public health data not only to prepare for the next epidemic, but to save children’s lives now,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. “Over the past 15 years, deaths of children in developing countries have been dramatically reduced, but to continue that trend for the next 15 years, we need more definitive data about where and why children are dying. This will also better position us to respond to other diseases that may turn into an epidemic.”

This network of disease surveillance sites in areas with high childhood mortality rates like in Sub Saharan Africa and South Asia will offer a long-term approach to information management, laboratory infrastructure and workforce capacity – vital resources in geographies lacking sufficient public health infrastructure. This network could be repurposed quickly in the event of an epidemic, as in Nigeria where the national polio program’s Emergency Operations Center was mobilized to fight Ebola.

“We are excited by and committed to this extraordinary opportunity to make a major contribution to children’s health,” said Dr. Jeffrey Koplan, vice president for Global Health at Emory University.

“A disease threat anywhere is a threat everywhere,” said CDC Director Tom Frieden, M.D., M.P.H. “Strong networks such as CHAMPS will help us find, stop, and prevent outbreaks and will not only save children in Africa and Asia, but will help to make the world a safer, healthier place for everyone.”

Disease Surveillance Network in Asia & Africa

GATES Foundation to Fund

CHAMPS is a minimum twenty-year project to gather more accurate data about how, where and why children are dying in developing countries. It will help ensure that the right vaccines and treatments are delivered to the people who need them most and that the global health community invests in crucial new drugs and health tools.

The world needs better, more timely public health data not only to prepare for the next epidemic, but to save children’s lives now.

- Bill Gates,

Co-chair, Bill & Melinda Gates Foundation

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If it works, this method opens great prospects.- Nathalie Rives, Director, Centre for assisted

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reproduction, University Hospital of Rouen

ARTIFICIAL SPERM created in lab for the first time in history

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n a first successful attempt that the scientists have witnessed with growing sperm artificially in lab, they are quite hopeful of providing treatment for infertile men. Kallistem, a company based in Lyon claimed to have created human sperm in vitro, a feat which would be world’s first.

Isabelle Cuoc, the CEO of the Kallistem laboratory, said: “Kallistem is addressing a major issue whose impacts are felt worldwide: the treatment of male infertility.”Our team is the first in the world to have developed the technology required to obtain fully formed spermatozoa in vitro with sufficient yield for IVF.”

If the pre-clinical trials are a success, the company claims to be in a position to assist the birth of baby in clinical trials. The procedure will involve removing a sample of immature spermatogonia from a man’s testicles in a simple biopsy, transforming the genetic material into mature sperm and using it in traditional IVF procedures. The sperm could also be frozen.

This research paves the way for innovative therapies to preserve and restore male fertility. However Professor Allan Pacey, an expert in male fertility at the University of Sheffield, warned couples not to get their hopes up. “This is a bold claim to make and we have had our fingers burnt before with people making this claim,’ he said. ‘Until I see a peer-reviewed scientific publication showing unequivocally that this has been done, I have to remain sceptical, he added.

Spermatogenesis, the process through which the basic reproduction cells develop into sperm, is an extremely complex one. The procedure usually takes 72 days to take place in the human body, where basic cells transforms into mature sperm. Some men may however suffer from non obstructive azoospermia or abnormal sperm production, rendering them infertile.

The lack of scientific findings published in a peerreviewed journal has led to experts from around the world calling for caution to be exercised while further work is conducted. “Claims like this can often cause heartache for infertile couples who see them as hope only to have their hopes dashed later when it doesn’t translate into an available procedure”, said Professor Allan.

For more than 15 years scientists have been trying to develop a procedure to extract immature spermatogonia from infertile men, transform it into mature men and then use IVF to produce a child.

Supporting the finding, Professor Nathalie Rives, director of the centre for assisted reproduction at the University Hospital of Rouen said “If it works, this method opens great prospects”.

The scientists have successfully replicated the procedure in mice earlier but this is the first time that they have been successfully shown to work using human cells. The next step in the success story is to demonstrate that the procedure is safe in pre-clinical trials which will take place by next year.

The company hopes to begin human clinical trials within two years and is hoping to eventually treat 50,000 men a year which is estimated to be of worth £1.7bn a year.

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Artificial muscles now made from Onion

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nions have till now been used to flavor your culinary world, garnish your dish, keep an avocado from turning brown, and no wonder make you cry when you aren’t sad. But have you ever thought of vegetables being used as a constructing element for an artificial muscle which can reversibly contract, expand and rotate within one component due to an external stimuli like voltage, current, pressure or temperature? Well, now you can.

Researchers from National Taiwan University have come up with a new idea of using onions as a source material for devices that can either expand or contract to bend in different directions depending on the driving voltage applied. “The initial goal was to develop an engineered micro-structure in artificial muscles for increasing the actuation deformation (the amount the muscle can bend or stretch when triggered),” said researcher Wen-Pin Shih. “One day, we found that the onion’s cell structure and its dimensions were similar to what we had been making,” he added.” When we were in elementary school, we studied plant cell structure by observing onion cells under the microscope,” Shih said. “So, when we recently searched for plant cells to replace our engineered artificial muscles, we thought about onion cells again.”

Previously artificial muscles were known to be made out of various types of polymers that could contract or expand, but none that could also bend at the same time. Here researchers define an artificial muscle as one that bends in response to an external stimulation and is made by easily accessible and significantly cheaper biomaterials.

The first onion muscle prototypes are very small -- just a few onion cells long. They were created from thin, translucent layer of epidermal cells that lie just below the dry outer skin of the average store-bought onion. But it turns out that if you freeze-dry these cells, coat them in gold, and then hook them up to an electric current, they will contract or elongate depending on how much voltage you use. As the cells contract or elongate, they cause the entire length of cells to bend.

The researchers found that when an electrical current between 0 and 50 volts was applied to the onion cell muscle, it causes the top part of the cells to elongate, in turn making the whole muscle bend downward. When the current was between 50 and 1,000 volts, the cell walls become concave and the muscle bends upward.

“Overall, the cells contract and bend like human muscle,” said lead researcher Wen-Pin Shih of National Taiwan University. “Gold electrode and onion muscles are both biocompatible, so this work could be applied for biomedical manipulations,” he said. He added that in the future, these artificial muscles could be bundled for use in robots.

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Overall, the cells contract and bend like human muscle. Gold electrode and onion muscles are both biocompatible, so this work could be applied for biomedical manipulations.

- Wen-Pin Shih of National Taiwan University

RASAYANIKA ZONE A Rs 100 crore investment coming to India Taiwan’s Apex Medical Corporation announces

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aiwan based Apex Medical Corporation which is mainly into manufacturing of respiratory therapy and supporting surface products have announced foraying into India with plans to invest around Rs 100 crore initially. The company will initially import its products and sell them in the country through local dealers, hospitals and tenders to the government.

The three product verticals that the company will focus in India are respiratory, support surface and autoclaves, Apex Medical Chief Executive Daniel Lee told. “The Indian healthcare market is growing at 1215 per cent, we expect Apex in India to grow at least by 5 times in the next five years,” said Daniel Lee. Founded in the year 1990, Apex Medical Corp is headquartered in Taiwan and is one of the leading support surfaces product manufacturers in Asia with its own brand of respiratory therapy products. The company caters to Europe, United States, Asia and other international markets through an established network of international subsidiaries and partners. The company has made its mark in the industry with its superlative, ultra advanced and innovative technological solutions. The company has a very strong R&D team that has driven innovation to continuously deliver world-class products. Apex invests 5 per cent of its annual revenue on R&D. With an ambition to focus on three of its best products, they intend to offer quality at affordable prices.

“We intend to offer best quality products at best and most affordable prices to medical personnel, care givers and consumers in the sub continent,” Lee said.

The company is planning on only marketing the products in India. Manufacturing of the products will follow later as told by Lee. “The company will adopt three routes to sell products in India. Through local dealers, through hospitals and through tenders to government,” Apex Medical India President Puneet Sahai said.

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The Indian healthcare market is growing at 12-15 per cent, we expect Apex in India to grow at least by 5 times in the next five years.

- Daniel Lee, Apex Medical Chief Executive.

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Kiran Mazumdar-Shaw Ranked No. 2 in the Global ‘Medicine Maker Power List’ 2015

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iran Mazumdar-Shaw, Chairperson of Asia’s premier biopharmaceutical enterprise Biocon Ltd., has been ranked No. 2 on ‘The Medicine Maker Power List’ 2015, an index of the 100 most influential people across the globe in the field of medicine.

Ms Mazumdar-Shaw appears on the list alongside global leaders from the industry, including CEOs, Professors, Nobel Prize winning researchers and many other celebrated scientists from the pharmaceutical world.

The Top 5 on ‘The Medicine Maker Power List’ are: 1. Anthony Fauci , Director, National Institute of Allergy and Infec tious Diseases, USA 2. Kiran Mazumdar-Shaw, Chairperson & MD, Biocon 3. Sir Andrew Witty, CEO, GlaxoSmithKline 4. Arthur D. Levinson, CEO, Calico 5. Heather Bresch, CEO, Mylan The prestigious list also includes names like Pascal Soriot, CEO, AstraZeneca; Robert A. Bradway, Chairman & CEO, Amgen; Ian C Read, Chairman, Pfizer; Prof. Tyler Jacks, Koch Institute for Integrative Cancer Research; Prof. Charles Cooney, Massachusetts Institute of Technology, USA; Prof. Harold Varmus, Weil Cornell Medical College and many more.

Ms Kiran Mazumdar- Shaw is the only India based business leader featuring on the list. The Medicine Maker is a UK based publication that is distributed worldwide to a targeted European and North American industry professionals. The power list has been compiled from reader nominations with the help of expert judges and is based entirely on merit.

It was developed in three stages. In stage one, The Medicine Maker invited readers to nominate those who they thought deserved recognition. In stage two, a jury of four noted medicine makers selected their top 100 from the slate of nominees: the results were consolidated into a list of 100 names. In the final stage, the jury ranked the list, and the average rankings were combined to provide the final Power List.

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Ms. Kiran Mazumdar Shaw is the only India based business leader featuring on the list.

SYNGENTA rejects MONSANTO’s takeover offer Monsanto to increase its initial bid

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arlier this month, agrochemical giant Syngenta had rejected Monsanto’s offer to takeover the company for $45 billion citing that the offer undervalued the Swiss firm. “The offer fundamentally undervalues Syngenta’s prospects and underestimates the significant execution risks, including regulatory and public scrutiny at multiple levels in many countries,” Syngenta stated.

Monsanto, which initially approached Syngenta last year, has long been interested in its Swiss rival and the potential to base itself in Switzerland and benefit from lower taxes. The US giant hasn’t given over its plan as it made another move to press ahead with Syngenta takeover after it rejected it $45 billion offer.

The company is working on the deal and could increase its initial bid which valued the firm at 449 Swiss francs a share. Monsanto, which dominates the market for seeds and genetically-modified crops, will have access to lucrative crop protection chemicals once the deal is locked. It could give the company mammoth combined sales of more than $31 billion.

Although the Swiss firm rejected the cash-and-shares offer, saying it undervalued its prospects and did not fully take into account regulatory risks, the company has not considered the deal dead. Major investors in Syngenta were confident that a deal with Monsanto would come off if the U.S. firm upped its initial $45 billion bid by at least 10 percent.

“Monsanto is likely to come back relatively soon, and not with a modest price,” said a source, who has worked with the U.S. company in the past. Monsanto may need to pay a premium of up to 40 percent to Syngenta’s shareholders to make the deal attractive. To ease antitrust concerns, it may also team up with an industry partner to acquire Syngenta’s U.S. seeds business, as the two groups are already seen as market leaders in the American seeds industry, according to a source.

Monsanto foresees strong benefits from a takeover of Syngenta, which makes heavy research and development (R&D) investments in crop technology to increase the average productivity of crops such as corn, soybeans, sugar cane and cereals. “There is a clear strategic logic to a deal,” an industry source said. “Syngenta is the only available target in crop protection. It’s no wonder Monsanto continues to circle the company.”

“The production of seeds is a concentrated industry. Both companies overlap in crop protection and seeds and there is a lot of R&D in this space, which would raise additional concerns,” said Andre Barlow, an antitrust expert at Doyle, Barlow and Mazard PLLC.

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The offer fundamentally undervalues Syngenta’s prospects and underestimates the significant execution risks, including regulatory and public scrutiny at multiple levels in many countries.

- Syngenta

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Mapmygenome India awarded CE Certificate for Spoligo TB™ in vitro diagnostic test kit

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apmygenome India announced that their Spoligo TB™ in vitro diagnostic test kit for speedy detection and typing of large number of TB samples has been awarded the CE Certificate. With this move, the kit is all set to enter the Global market as a diagnostic device. Until now, the kit has been used extensively in Africa, South America, and Europe as in vitro research use only device.

Anu Acharya, CEO of Mapmygenome, said, “Spoligo TB™ has been one of our most consistent performers and now we can take this further to diagnostic labs across the globe. CE certification is a key milestone in achieving our vision of better health for India (and globally) using technology.”

About CE Certified Spoligo TB™ Kit CE certified Spoligo TB™ is an effective PCR-based method to simultaneously detect and categorize Mycobacterium tuberculosis complex. Spoligo TB™ utilizes the technology of DNA polymorphism present at a particular chromosomal locus, the Direct Repeat region, which is unique to Mycobacterium tuberculosis complex bacteria.

Researchers have proven that this test is superior to traditional tests such as Southern blotting, IS6110 fingerprinting, tuberculin skin test, culture, and sputum smear microscopy in terms of one or more of the following – accuracy, sensitivity, specificity, simplicity, throughput, costs, scale, and diagnosis time.

This kit finds applications in clinical samples, urban and rural labs for TB surveillance, and in large scale epidemiological control – in prison outbreaks, hospitals, and other closed communities. Information obtained from Spoligo TB™ is useful in the therapeutic management of tuberculosis. This test can also be used to screen TB infections in HIV patients.

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Researchers turn iPhone to DNA testing kit

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pple Inc. is teaming up with health researchers to develop a series of app that will enable the users to analyze their DNA. The phone would no longer be just a tool to click selfies or to make calls. All it need would be to spit in a cup to test the DNA.

The current development is a part of Apple’s ResearchKit which had already created five apps as a part of the programme. Launched last March, ResearchKit has already been used to develop apps to advance medical research on diabetes, breast cancer, asthma, cardiovascular disease and Parkinson’s disease. mPower which is used to monitor the development of Parkinson’s disease has arguably received the largest response till now. ResearchKit enables hospitals and scientists to create apps to track and diagnose patients’ conditions in real time using information collected by iPhone sensors.

An extension to the development, the phone can now offer us the luxury to know about our genetic lineage or probability of developing serious inherited conditions. Apple is recruiting academic partners for two initial studies as part of this new wave of research apps, which will analyze an iPhone user’s DNA and then send it to the researchers in one enormous database. The University of California at San Francisco and Mount Sinai Hospital in New York are working on the first two DNA testing apps. UCSF will use the iPhone to collect DNA info and other data from pregnant women to determine the causes of premature birth.

“Apple launched ResearchKit and got a fantastic response. The obvious next thing is to collect DNA,” Gholson Lyon, a geneticist at Cold Spring Harbor Laboratory said.

Rather than mapping your entire genome, Apple’s vision of DNA testing would instead focus on 100 or so medically significant genes. The test would require you to spit in a cup and mail it to an approved laboratory. Testing would cost “no more than a couple hundred dollars each” and be performed by University of California at San Francisco and Mount Sinai.

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Apple launched ResearchKit and got a fantastic response. The obvious next thing is to collect DNA. -Gholson Lyon

Geneticist, Cold Spring Harbor Laboratory

ResearchKit can also work in tandem with other devices to facilitate medical and genetic data collection. For example, the app developed to measure asthma levels relies on data collected using both an iPhone and a Bluetooth-enabled inhaler. In the same vein, DNA testing apps will incorporate a date from “spit kits,” similar to the kits used by genetic testing service, 23andMe. Although Apple has claimed that it will not have access to patients’ genetic data, the iPhone maker is very involved in the DNA data collection process. Apple has to approve the studies being conducted by medical researchers using ResearchKit. Even the gene-sequencing labs analyzing the “spit kits” have to have Apple’s stamp of approval.

Considering Apple has sold over 750 million iPhones to date, DNA testing and “gene-sharing” could become a common practice—providing medical researchers with more accurate data to help treat and prevent serious genetic diseases and conditions.

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Biocon-Mylan Programs Make Progress PEG-G-CSF and Adalimumab enter Phase 3 clinical trials; Patient recruitment for one Insulin Glargine Phase 3 study completed

B

iocon, Asia’s premier biotechnology company, announced that it has made clinical progress in its partnered programs with Mylan. The partnership has a strong portfolio of generic insulin analogs and biosimilars including Monoclonal Antibodies (MAbs) and recombinant proteins at various stages of development.

Biosimilars

Two molecules Pegfilgrastim (PEG-G-CSF) and Adalimumab have entered global Phase 3 clinical trials. While the PEG-G-CSF trial is well underway the Adalimumab trial has been recently initiated.

In addition, the Phase 3 global clinical trial for Trastuzumab is progressing in more than 100 sites around the world. An initial ROW focused Phase 3 trial for Bevacizumab is also underway.

Generic Insulin Analogs

Two global clinical trials for generic Insulin Glargine initiated in 2014, have also made significant progress. The patient recruitment for Type-1 diabetes study has been completed ahead of schedule, while the recruitment for Type-2 diabetes study is expected to be completed by July 2015.

Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon, said, “The advancement of these programs in the clinic represents significant progress towards providing these high quality biologics to patients across the world. I am confident that, together with our partner Mylan, we can build a strong global presence in generic Insulin analogs and biosimilars like monoclonal antibodies and recombinant proteins to address the need for affordable access to these biologics.”

As part of a shared commitment to provide access to high-quality and affordable biopharmaceuticals, Biocon and Mylan have established a strong collaborative R&D partnership for both generic insulin analog products and a high-value portfolio of biosimilars for oncology and autoimmune indications.

Biocon today has one of the largest generic insulin analogs and biosimilars portfolio in advanced stages of development with five molecules in Phase 3 clinical trials, viz. Glargine, Pegfilgrastim, Adalimumab, Bevacizumab and Trastuzumab.

As we move into FY16, we clearly see our biosimilar strategy playing out with greater clarity, credibility and traction visible across our portfolio of Biologics as they advance in clinical development.

We continue to make investments in R&D as a strong future value driver for Biocon.

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“

The advancement of these programs in the clinic represents significant progress towards providing these high quality biologics to patients across the world.

- Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon

BIOEVENTS Recent Developments Developments in in Medical Medical Recent Biotechnology and and Structure Structure Biotechnology Based Drug Drug Designing Designing Based [RDMBSBDD- 2015] 2015] [RDMBSBDD-

December 6-7, 6-7, 2015 2015 December

Department of of Biosciences Biosciences and and Bioengineering Bioengineering Department Indian Institute Institute of of Technology Technology Guwahati Guwahati Indian Assam-781039 Assam-781039

Patronand andAdvisor Advisor Patron Prof.Gautam GautamBiswas, Biswas,Director, Director,IIT IITGuwahati Guwahati Prof.

Chairman Chairman Prof.V.V. V.V.Dasu, Dasu,Head Headof ofthe theDepartment Department Prof.

OrganizingSecretary Secretary Organizing Prof.Vikash VikashKumar KumarDubey Dubey Prof.

OrganizingCo-secretary Co-secretary Organizing Dr.Shankar ShankarPrasad PrasadKanaujia Kanaujia Dr.

2nd International Conference & Exhibition on Biotechnology on August 03-04 2015 Hyderabad, India

About the event:

Bright International Conferences & Events Organization invites all the Academicians, Industrialists to attend the 2nd International Conference and Exhibition on Biotechnology. Biotech-2015 will be held during 03-04 August, 2015 at Leonia International Centre for Exhibitions & Conventions, Hyderabad, India. The conference theme will focus on “Harnessing the current research in Biotechnology”.

Biotech–2015 is well organized with the support of world class Organizing Committee and Editorial team of International refereed Journals.

Our Mission:

BRIGHT International Conferences & Events with a mission of organizing various global conferences with a sincere dedicated approach to provide extensive platform in the field of life sciences & technology, inviting global scientific fraternity, industries, students community to share their valuable, latest developments in the relevant core subjects.

Conference Highlights:

Abstracts will be published in International Journal of Microbiology and Allied Sciences (IJOMAS) • • • • •

Presentations from renowned speakers Accepted abstracts will published in the conference souvenir Certification from the international organizing committee International Workshop and training on drug Designing Best Speaker and Poster awards

Venue: Leonia International Centre for Exhibitions & Conventions Hyderabad, India Last Date for registration: July 15, 2015

Save the Date July 19-22, 2015 Montreal

World Congress on Industrial Biotechnology The BIO World Congress on Industrial Biotechnology is the largest international industrial biotech event. Taking place on July 19-22, 2015 in Montreal, the event will bring together 1,300+ leaders in advanced biofuels, biobased products and renewable chemicals.

Networking BIO knows that networking and initiating new partnerships is key to driving the industry forward. Networking at BIO World Congress will be powered by One-on-One Partnering™. This system enables you to quickly identify potential business partners, initiate contact and request 30-minute meetings held on-site in rooms provided by BIO. Over 1,000 meetings facilitated by One-on-One Partnering™ were held in 2014. In additional to this sophisticated networking tool, BIO provides over nine dedicated networking opportunities during the conference. Plus, throughout the conference you can connect with over 70 exhibitors from around the globe to discover new products and solutions.

Conference Highlights: -

1,300+ attendees from 680 companies and 45 countries 1,000+ BIO One on One Partnering Meetings 5 Plenary Sessions 8 Breakout Session Tracks BIO GreenTech Investor Sessions 60+ Poster Presentations 70+ Exhibitors Presentation of the George Washington Carver Award and Rosalind Franklin Award - Taking place in vibrant Montréal- remember the Just for Laughs Festival will be taking place during World Congress. The line up will be released in spring 2015.

Date: July 19-22, 2015 Location: Montréal

What’s on biotecnika.org

Ebola Vaccine by Bharat Biotech shows positive results in Mice Bharat Biotech's Ella Foundation has successfully tested a preliminary vaccine for Ebola on mice. The company has been trying to find a suitable vaccine to check the deadly viral disease that shook the world recently. The vaccine from adenovirus and glycoprotein was tested on mice and the results were found to be promising for developing a full-fledged vaccine…

Read More @ http://bit.ly/1AzwTnn

Know well up to 13 years in advance if you would develop cancer or not!

In a recent breakthrough, scientists have developed a new test that can predict with 100 percent precision if someone will develop cancer up to 13 years in the future. The discovery of tiny but significant changes taking place in the body more than a decade before cancer was diagnosed helped researchers at Harvard…

Read More @ http://bit.ly/1FKoJON

Making of jet fuel from black fungus || Washington State University researchers innovation!

Washington State University researchers have found a way to make jet fuel from a common black fungus found in decaying leaves, soil and rotting fruit. The researchers hope the process leads to economically viable production of aviation biofuels in the next five years.

Read More @ http://bit.ly/1EjIiIr

KM Shaw approaches PMO to take a call on GM Crops Shaw, who is also chairperson of ABLE, wrote a letter to the principal secretary to Prime Minister Nripendra Mishra saying that the failure to hold GEAC meetings and the consequent breakdown of the regulatory process had forced many to shut or scale down research programmes in agri biotechnology in India…

Read More @ http://bit.ly/1FR9AeQ

Human Embryo Gene-editing How far are we right?

T

he news swooped in as a storm raising scientific, ethical and moral questions across the biotech research world. The first ever paper on gene-editing of human embryo has created a pandemonium in the scientific world. Unethical, immoral, wrong, illegal and unprincipled, were the responses gathered on the world’s first theory of human embryo gene editing. The controversial study led by Chinese researchers gave rise to a severe debate across the world. Though the underlying intension of embryo gene editing were not vicious but to slice off the flawed bits of genes to eliminate certain inherited diseases, the response was not quite well received or encouraging. At one end lies the theory of editing human embryo to do away with incurable genetic diseases and at another end are the ethical implications. And the ultimate question of, how long can we go ahead and play on, still lingers.

The controversial Chinese study, where the research spoke about genetic editing techniques to avoid certain serious inherited diseases, was first time attempted on early human embryos. The study was published by a team of scientists from the Sun Yat-sen University, Guangzhou. And was vigorously questioned by the experts, that if it is ethical and moral enough to work on embryos.

The research led by Junjiu Huang, a gene-function researcher at Sun Yat-sen University in Guangzhou, said that they had collected and worked on faulty human embryos (non-viable embryo) incapable of leading to live births, from discarded stores at fertility clinics. Using a gene-editing technique known as CRISPR/Cas9, the team attempted to modify the gene responsible for β-thalassaemia, a potentially fatal blood disorder. The results were said to reveal serious obstacles to further use of the method in clinical applications. The procedure failed in many cases. In some cases, it gave rise to new genetic mutations (off-target effects). The conclusion provided was that these off-target effects require further investigation before any more attempts are carried on to take the procedure to the clinic.

“I believe this is the first report of CRISPR/Cas9 applied to human pre-implantation embryos and as such the study is a landmark, as well as a cautionary tale,” says George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts. “Their study should be a stern warning to any practitioner who thinks the technology is ready for testing to eradicate disease genes.”

There were ample reactions on this particular study on various grounds. Questions flared on what would happen as you implant the edited embryo in womb and give it a chance to develop. There was rising concern on passing of genetic changes to further generations. Another argument was regarding the misuse of the technology for cosmetic purposes. Then there were questions on how legal the technology was? There were also calls for issue of a moratorium on such practices, till scientists and authorities take an appropriate decision.

24

I believe this is the first report of CRISPR/Cas9 applied to human pre-implanta-

“

tion embryos and as such the study is a landmark, as well as a cautionary tale.

George Daley, Stem-cell biologist, Harvard Medical School

“

In theory, replacing the defective gene with a healthy one would be the ideal solution. Researchers have been working on developing techniques to accomplish this for many years.

However, altering genes in human embryos can have unpredictable effects on future generations..

- Dr Yalda Jamshidi, St George’s University Hospital

Dr Yalda Jamshidi, at St George’s University Hospital, stated, “In theory, replacing the defective gene with a healthy one would be the ideal solution. Researchers have been working on developing techniques to accomplish this for many years. However, altering genes in human embryos can have unpredictable effects on future generations.”

Studied but never attempted…

The system was well studied earlier, but practical application was always feared. As the study articulates, embryos are injected with the enzyme complex CRISPR/ Cas9, which bind and splice DNA at specific locations.

CRISPR/Cas9 can be programmed in a way to target a faulty gene, and replace using another sent in at the same time. The well described report on its execution is old but its use in human embryos is very new.

At the Sun Yat-sen University, the team injected 86 embryos and then waited 48 hours. The time was sufficient for the CRISPR/Cas9 and the molecules used to replace the DNA to act and also for the embryos to grow to about eight cells each. Out of 71 embryos that survived, 54 were genetically tested. The results showed that just 28 were successfully spliced, and only a few of those contained the replacement genetic material.

“If you want to do it in normal embryos, you need to be close to 100%. That’s why we stopped. We still think it’s too immature,” said Huang.

There were also a number of ‘off-target’ mutations introduced by the CRISPR/Cas9 complex acting on

If you want to do it in normal embryos, you need to be close to 100%. That’s why we stopped. We still think it’s too immature.

- Junjiu Huang, Sun Yat-sen University

26

“

“

Equally, some will ask if the procedure is safe, do we have a moral imperative to make sure that we do it?

- Prof Darren Griffin, University of Kent

other parts of the genome. This stands to be the chief concern regarding germline gene editing as these unwanted mutations could cause harm. Such mutations frequency was higher than those observed in the study on mouse embryos or human adult cells.

“We wanted to show our data to the world so people know what really happened with this model, rather than just talking about what would happen without data,” says Huang.

A few yeses..

Prof Robin Lovell Badge, at the Crick Institute, said, “Such procedures could be legal in the UK if granted a license after careful considerations by the Human Fertilization and Embryology Authority. But it would be illegal to then implant the embryos into a woman for further development. Meanwhile in the US, it would not be possible to do this with federal funding. But finances from private companies and charities could be used in states that do not ban the procedure.”

Not everyone is saying no to the study. An argument that a technology, if can, introduce us to a solution to the dangerous genetic diseases prevailing, then it should be allowed to continue. Prof Lovell Badge says, “I am fully supportive of research being carried out on early human embryos in laboratory settings - especially on embryos that are not required for reproduction and would otherwise be discarded. If the techniques work, there are many questions that could be asked about the role of specific genes in early human development.”

Prof Darren Griffin, at the University of Kent, states that if these obstacles are overcome, the next consideration is whether it crosses a moral boundary to apply it to patients. “Equally, some will ask if the procedure is safe, do we have a moral imperative to make sure that we do it?” he says.

It is well understood that the genetic changes to embryos, known as germline modification, are heritable and could have an unpredictable effect on future generations. Concerns are raised that any gene-editing method or study on human embryos could always lead to unethical use of the technology.

Oxford bioethicists Chris Gyngell and Julian Savulescu argue that there is a moral imperative to research editing embryos.

The research by Chinese is important as it helps us understand about some of the risks involved in working on humans with current gene editing technique.

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NIH says ‘no’ National Institute of Health has outright rejected the idea. They have said no to any kind of funding involving human embryo gene editing.

Francis Collins, Director of the National Institutes of Health, has issued a statement regarding the use of the technology as, “…NIH will not fund any use of geneediting technologies in human embryos. The concept of altering the human germline in embryos for clinical purposes has been debated over many years from many different perspectives, and has been viewed almost universally as a line that should not be crossed. Advances in technology have given us an elegant new way of carrying out genome editing, but the strong arguments against engaging in this activity remain. These include the serious and unquantifiable safety issues, ethical issues presented by altering the germline in a way that affects the next generation without their consent, and a current lack of compelling medical applications justifying the use of CRISPR/Cas9 in embryos.”

The study goes on..

Huang is planning to work on decreasing the number of off-target mutations using adult human cells or animal models. Many strategies are being considered such as altering the enzymes and guiding them to the target location effectively, or introducing the enzymes differently to help regulate their lifetime, or changing the concentration of enzymes and repair molecules. He would want to consider other gene-editing techniques as well.

Oxford bioethicists Chris Gyngell and Julian Savulescu argue that there is a moral imperative to research editing embryos. They say that the research by Chinese is important as it helps us understand about some of the risks involved in working on humans with current gene editing techniques.

It is estimated that at least four groups in China are pursuing gene editing in human embryos. The debate would go on for quite a while. Those who are in pro would continue working, creating various technologies and experimenting on anything they want. It all depends on how a science mind perceives it. If it is looked at as a technique to help save your future generations from life-threatening diseases, it would sure see a well laid acceptance path. If it is considered as to be playing God, then the world would never get to see its true potential.

Nevertheless, the good and the bad effects need to be equally measured and considered carefully before taking it any further.

28

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START UP STORY Mr. Kumar Sankaran, Founder Before starting the company I was working with a lot of proteins which had lots of Leucine rich repeats in it, and it sounded unique enough.

A bioinformatics start-up based in the Silicon Valley of India, specializes in Next Generation Sequencing (NGS) Data Analysis & Interpretation.

LEUCINE RICH BIO Located in Bangalore, Leucine Rich Bio, though a beginner, is making its mark in Human Genome Interpretation, especially for clinical and research use. The company makes use of advances in the area of Computer Science, Information Science, Data Management, Statistics and Systems Biology to solve complex problems in Genomics.

W

“

ith a vision to delve deeper into the understanding of the human genome and develop novel solutions to drug discovery, Leucine Rich Bio employs cutting edge big data approaches along with machine learning algorithms. Leucine Rich Bio’s proprietary platform AGIS (Advanced Genome Interpretation Suite) based customized report translates complex genomic data into clinically relevant and actionable biological information. The company’s dynamic genome interpretation service provides researchers in pharmaceutical industry and top research labs worldwide with choice of bioinformatics suite to interpret, analyse and act on relevant information derived from ever evolving NGS data.

Finally we got some courage to head the entrepreneurial road and we collected some funds and started over.

An in-depth knowledge on Cancer Genomics, Genetic Conditions caused by Rare Variants and Drug Response and collated information on Genetic Variants, Mendelian Inheritance, Genome Wide Association Studies and Pharmacogenomics data provides the company a strong foundation. Leucine Rich Bio has joined hands with NextGen Life sciences recently for promoting its products and services.

In conversation with Mr. Kumar Sankaran, Founder and CEO of Leucine Rich Bio, we have excerpts as;

L-R: Prabhat Manjappa & Kumar Sankaran Founders, Leucine Rich Bio

30

Leucine Rich Bio Team Biotecnika Magazine

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Q. The name Leucine Rich Bio is quite intriguing. What is the story behind the name?

A. Before starting the company I was working with a lot of proteins which had lots of Leucine rich repeats in it, and it sounded unique enough. Most of the companies have some genome related names to it and at that time it sounded right so we went ahead with naming the company Leucine Rich Bio. Q. Can you tell us more about Leucine Rich Bio and what the company is majorly into?

A. At present Leucine Rich Bio is looking at clinical interpretation of NGS data. We have built the platform which analyzes and interprets genomic data. We have built a report for the doctor with clinically actionable mutations. For researchers we also have services and analytic pipelines ready which will be usable for researchers both in academia and industry.

Q. Can we know about your education and how did you head towards the entrepreneurial road?

A. I finished my Masters in Biotechnology and did a small course in Bioinformatics. I have about 10 years of experience in Systems Biology. I have always been in this domain. My co-founder Mr. Prabhat and I had been talking about it for about a year and over.

Finally we got some courage to head the entrepreneurial road and we collected some funds and started over.

31

“

One challenge that we faced was in getting the right computational power for doing Bioinformatics. Being a start up when we needed bootstrapping, we did not have enough funds and to get machines which could do high end computational work was the biggest challenge for us.

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mote our products and services in India. We are also looking for similar collaborations in future but nothing has materialized yet.

Q. Being Bioinformatics start up what were the challenges that you had to initially face?

A. One challenge that we faced was in getting the right computational power for doing Bioinformatics. Being a start up when we needed bootstrapping, we did not have enough funds and to get machines which could do high end computational work was the biggest challenge for us.

Q. Talking about collaborations could you tell us what GA4GH is all about?

A. It is global alliance for genomics. They basically are platform which helps company in responsible sharing of data. Since there are a lot of privacy concerns around genomics data, they have come up with good API to share genomics data with hospitals and companies. So we are basically following their guild lines in sharing data.

Q. Did you get any VC funding?

A. We didn’t go after Venture Funding. We did meet a few VC’s to understand what the game was all about but we didn’t go after it. Right now we are self funded.

Q. Do you believe that Next Gen Sequencing could change the face of disease diagnostics and treatment in the future?

Q. You have been in the sector for the past one year. In the coming 10 years where do you see the company going?

A. We want to be the company that does analysis for personalized medicine. So we want to tie with both diagnostic companies as well as with pharmaceutical companies and be global leader for personalized medicine.

A. It’s going to bring a definite shift in diagnostics.

A lot of first tests for any disease is going to be sequencing based.

Q. The initiative by Leucine Rich Bio to seek crowd funding to make gene mutation information accessible is commendable. Could you tell us how successful has it been till now?

Q. Talking about personalized medicine, are there enough attempts in India towards that direction?

A. Right now there is a lot of attention towards life style diseases. There is not yet any kind of push especially in the area of cancer. I think cost is biggest factor right now but I surely see India in the coming 2-3 years as a big player in personalized medicine.

cost is biggest factor right now

Q. What projects are you currently involved with?

A. We are currently doing projects related to research in academia and we are hoping to get into clinical market soon.

Q. Do you think there is a gap between academia and industry when we talk about the biotech sector?

A. There is surely a gap. But with the amount of information that is available right now, people understand what the academia is doing and what the industry is doing. At least they recognize that there is a gap now. There was a time when people didn’t recognize the gap and it was much more difficult.

Q. You have collaborated with NextGen Life Sciences for promoting your products. Can we know more about collaboration?

A. The crowd funding wasn’t successful. We could not turn out enough interest to get sufficient amount of money to make it publicly accessible. But we have developed the mutation database and we

A. We have just initiated the collaboration with NextGen life sciences and they are going to pro-

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are looking at other possibilities in sharing that data right now.

Q. Being a start up in biotech sector, what message would you like to send across the budding entrepreneurs who want to venture in biotech sector?

A. I would like to say that especially if you are venturing into biotech sector, you have to be very patient and tenacious. Not everybody is going to understand what you are doing. It is very easy to walk up to someone and say I am going to follow “flipkart model” or some other model, but biotech/ bioinformatics is a technical sector so patience is a key. And perseverance is definitely needed.

“

We want to tie with both diagnostic companies as well as with pharmaceutical companies.

Q. What are the three musts that a person venturing into biotech sector should have?

A. First and foremost is patience. It is going to take a long time to build a company so be patient. At the same time you should be flexible. The product that you start off with may not the one that you end up with so you need to be flexible and understand what marketing is.

Thirdly you just need to be determined.

The three musts before venturing into Biotech: •

Be patient

•

Be determined

•

Be flexible

“

33

Especially if you are venturing into biotech sector, you have to be very patient and tenacious. Not everybody is going to understand what you are doing.

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Asthma is a complex condition. We are collaborating with RASP-UK to help make asthma personal.

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We clarify that Dilip Shanghvi has neither purchased nor agreed to purchase any shares of our Company in Daiichi Sankyo transaction.

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Thank you to our scientists for leading the development of two new malaria treatments.

Thanks to nanotechnology, we are closer to performing surgical operations that once sounded like science-fiction.

POWER TWEETS

COVER FEATURE

Biotech & VC Funding can the marriage ever happen?

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Biotech & VC Funding can the Marriage ever happen?

Investors come to India with an expectation to exit in five years. This is because of our services history, but in life sciences they need to have more patience.

“

- Vijay Chandru, CEO, Strand

A

n idea to travel from the blueprint to industry stage needs a road map of opportunity, growth and most importantly, financial accountability. The road to entrepreneurship is bumpy. And narrowing down to the one leading to a biotechnology start-up is like taking a rough ride. Biotechnology in India is predicted to touch $100 billion by year 2025. And the growth rate is estimated to be 30% per year to reach the desired target. With investments touching Rs. 30,000 crores annually in the next five years can only help the country reach the designated target. The goal of standing on par with IT industry with respect to income and employment is challenging but not impossible. For which India needs to work on certain basic issues of investment and regulatory policies, and encourage VC funding. But how do we garner investors’ interests?

The current size of the biotech industry is about $5-7 billion and needs to grow in terms of entrepreneurship by encouraging the establishment of more biotech companies and also improve the scenario for bio-business. With venture capitalists mostly preferring short term profits, it is getting difficult for biotechnology start-ups to find a suitable angel investor. Start-ups from India which have received VC funding can be counted on fingers. There are many more that are on the lookout.

But today’s PE investors seem to be in a hurry. Venture capitalists are looking for quick profits in a short period, and hence biotech is not qualifying to meet their interests. While biotech industry is where patience becomes a virtue, the time taken by the sector to mint appreciable profits is not fetching good VC funding.

“Investors come to India with an expectation to exit in five years,” says Strand CEO Vijay Chandru.

“This is because of our services history, but in life sciences they need to have more patience.”

“For India, during the first three quarters of 2014, investments approach $1 billion for the same (biotech, healthcare and medical devices) industrial categories, but this include money invested by private equity funds and reflects mostly health services. While it would be extreme to say that biotech is an orphan in terms of venture financing in India, however that wouldn’t be far from the truth. This situation is definitely a drag when it comes to the growth of India’s biotech industry. In the case of India, there are not many forces at work that are driving that number upwards,” says Stephen M Sammut, Senior Fellow, Health Care Management, Wharton School, University of Pennsylvania and Visiting Faculty, Indian School of Business.

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Partnerships giving a push:

With investments touch-

Exiting the company might always interest the venture capitalists is what, Ramaswamy Subramanian, biologist and CEO of the incubator C-Camp, believes.

annually in the next five years can only help the

Though there have been very few exits so far, such as, Shantha Biotech being bought by Sanofi for $783 million, and bioMerieux acquiring a 60% stake in RAS Life Sciences for 1.6 million, more deals need to be in the order. “This is a critical period for the biotech industry,” says Ramaswamy Subramanian, biologist and CEO of the incubator C-Camp in Bangalore. “If there are some big exits one after another in the next few years, nothing can stop this industry.” He believes that repeated exits are necessary to interest the venture capital community in the country’s biotech and diagnostics industry.

ing Rs. 30,000 crores

country reach the designated target of $100 billion by year 2025.

Like Curadev, after serious attempts to search for funding in India and abroad, signed an agreement with Roche, to bag on the biggest deal ever, $25 million in upfront payments and $530 million for future objectives in research and developing two anticancer molecules. “We went through difficult times,” says Arjun Surya, Chief Scientific Officer, Curadev “but now we can plan our future with confidence.”

“With respect to the pharma industry providing more investment in Indian biotech, there have been a steady number of strategic alliances between European, the US and Japanese companies with Indian pharma and biotech companies, but there is need for these to occur more frequently and in larger amounts of financing,” says Stephen.

• French pharmaceutical company Sanofi SA, acquired Shantha Biotechnics through its vaccines division, Sanofi Pasteur SA, and invested Rs 460 crore to build a facility with a capacity to produce 60 million Insuman cartridges annually.

• Bristol-Myers Squibb and Syngene International announced a five-year extension of their drug discovery and development collaboration in India.

• Cancer Genetics Inc (CGI) acquired genomics services provider BioServe India for US$ 1.9 million. This will enable CGI to better position themselves globally in personalized cancer care.

Such deals have not gone unnoticed- both by start up entrepreneurs and venture communities.

“

The Indian biotech system has become so friendly over the years that any individual with an innovative idea can now start a company.

- Nidhi Adlaka , PhD grads from ICGEB (who bagged a grant of Rs 50 lakh from DBT)

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Success stories: Nidhi Adlaka and Neha Munjal, PhD grads from ICGEB, have tasted the good side of generous VC funding, to give their idea a solid shape. After bagging a grant of Rs 50 lakh from DBT, they set to work on proving the commercial worth of their idea (to make 2, 3-butanediol from agricultural waste). “The Indian biotech system has become so friendly over the years that any individual with an innovative idea can now start a company,” says Nidhi.

Biotechnology Industry Research Assistance Council (BIRAC) set up by DBT three years ago and its Biotech Ignition Grant (BIG) scheme now provides entrepreneurs Rs 50 lakh and mentorship over 18 months to prove technology ideas before seeking angel investment. From the past three years, 140 entrepreneurs have made use of this grant, promoting lifescience entrepreneurship in India.

Another on the same lines, IKP Knowledge Park has incubated or provided research grants to 150 companies. A few turned out to be big like Laurus Labs, which is now a Rs 1,000-crore company. GVK Bio and Sai Life Sciences are also huge companies. “There has been a big change for life sciences start ups in the past three years,” says Deepanwita Chattopadhyay, CEO of IKP Knowledge Park in Hyderabad. “The energy in the system has gone up significantly.”

Shiladitya Sengupta, came to India to pursue his commercial ideas and set up companies like Vyome Biosciences, Mitra Biotech and Invictus Oncology. All three have raised venture capital of more than Rs 150 crore, without much difficulty. “It is not much difficult if you have good science with IP protection,” says Sengupta, Assistant professor at the Massachusetts Institute of Technology (MIT). “I think it’s possible to raise money and build a strong team”, he added.

Connexios, a drug discovery company raised more than Rs 200 crore from an investor, Nadathur Holdings. Strand Life Sciences has managed to raise Rs 20 crore.

A few incubators for biotechnology start-up support: •

The Amity Innovation Incubator

•

Wadhwani Centre for Entrepreneurship Development

It is supported by DST, Ministry of Science & Technology, GOI. Startups with pioneering ideas and innovations are largely supported by Amity Innovation Incubator. Focus areas also include food and allied technologies, biotechnology and life sciences, nanotechnology and material sciences.

The initiative educates and assists young entrepreneurs in the area of business planning, and promotes entrepreneurship as a career option. It has supported a biotech startup by name Richcore Lifesciences.

Others such as: •

IIT Madras

•

IIT Bombay

•

Hyderabad Central University

•

University of Delhi

•

NCL Venture Centre

•

IKP Knowledge Park

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A few venture capitalist firms supporting Biotech/ Biopharma/ Healthcare

Fidelity Growth Partners India

Fulcrum Venture India

A PE arm of Fidelity International Limited is focused on making investments across sectors including Healthcare and Life Sciences, Technology, Consumer and Manufacturing. FGPI on an average invests between $10 Mn and $50 Mn for a minority stake in the company.

Fulcrum is a PE investor which prefers to invest in like-minded entrepreneurs with solid principles and objectives. Healthcare is of interest and has funded Shield Healthcare Private Limited.

New Enterprise Associates

It’s one of the largest and most active VC Firms which helps entrepreneurs build businesses across multiple sectors, one being agriculture sector.

Qualcomm Ventures

An investment arm of Qualcomm Inc., a Fortune 500 company with operations across the globe invests in Indian healthcare sector.

Unitus Seed Fund

Warburg Pincus

It is a leading global private equity firm focused on growth investing. And healthcare is one of their industries of interest for investment.

Global venture capital firm

A seed stage venture fund which investing in developing markets with primary focus on rural startups with investment between Rs. 50 Lakh and Rs. 1 Cr. Venture Fund Advisors India Ltd

India based investment company it is involved in multi stage investing, with preference towards early stage startups. Industries for investment are biotechnology, healthcare Infrastructure, agribusiness, biogas, pharma, food, life science, clean technology, healthcare.

The firm invests in people with creative ideas. Interested in all stages of development, seed financing, start-ups, growth and early stage investments.

Usually invests between $0.05 Mn to $80 Mn Ascent Capital

With investments in healthcare ranging from $10 Mn to $30 Mn, it is an India-focused independent PE firm and the most experienced teams on ground.

Unilazer

Axon Partners Group

Nadathur Group

It is a PE and venture fund specializing in early stage and late stage investments. Investing industries include healthcare and agriculture.

The Group prefers to invest in technology focused companies in countries like Latam, Spain and India and biotechnology is their interest sector.

Invests from 100,000K to $25 Mn.

A private investment firm interested in healthcare and life science platforms.

Aarin Capital

Seed investors who engage in bio-nanotechnology and other sciences.

Bain Capital professionals

The group is the largest investor in every fund raised. Healthcare investment included.

Sabre Partners

It is an India focused private equity fund interested in healthcare.

Basil Partners

A Venture Capital fund involved in Early Stage Venture Investments focusing on Indian investments. It has backed Karmic Lifesciences earlier.

Kalaari Capital

It is a $160 million venture capital fund investing in early stage technology oriented companies in India.

Forum Synergies India (PE) fund

A unique, ethical PE fund management model in India that provides investors with a best-in-class private equity model. Forum Synergies invests between $2 – $10 Mn in firms with revenues between $3 – $50 Mn.

Navam Capital

It is a venture capital firm focused on making seed and early-stage investments in energy, technology and healthcare.

Source: InFocus

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Not everyone get the same: But that is not all. Listing around ten companies with successful capital gaining stories doesn’t reiterate the same for all start ups. There are many start-ups in India and entrepreneurs who come to India to give their ideas a commercial stage but go disappointed. After searching a lot in India, Anand Anandkumar, from Bugworks, had to go back to US for financial help. He set up his company in Silicon Valley, but did not get successful with VC funding.

“VCs in India want to invest in areas they already know,” says Anand Anandkumar, founder and CEO at Bugworks Research. “In the US they want to be first in an area and want to learn with the company.”

He raised $700,000 for his company, and is in the middle of raising larger VC investments from the US. For difficult and risky businesses like drug discovery, most of the startup entrepreneurs opt for foreign help.

Though very few, they frequently look towards abroad funding agencies, for capital, market and partnerships. Abgenics Life Sciences, incubated inside NCL, received $100,000 from Gate Foundation to prove its idea.

Incubators to the rescue- are they enough?

Unlike setting up a software company, starting a life science company is much complex and requires sophisticated and expensive infrastructure. Favorably, a fair number of incubators are coming up by universities and research organizations, to aid these startups. Segull Biosolutions and Abgenics were incubated in the NCL Venture Centre, Pune.

Vitas Pharma is incubated in IKP Knowledge Park and University of Hyderabad. “I don’t think we could have done this kind of work here if there was no incubation,” says Radha Rangarajan, CEO, Vitas Pharma.

IIT Madras and Bombay are also home to many start-ups. University of Hyderabad and Delhi have incubation centres too.

“

VCs in India want to invest in areas they already know. In the US they want to be first in an area and want to learn with the company.

-Anand Anandkumar Founder and CEO at Bugworks Research

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While compared to the growing bioeconomy, the number of incubators dedicated for biotech is quite less.

Looking at Tata Elxi’s incub@TE, started to encourage and support aspiring entrepreneurs and icreate developed by Narayana Murthy of Infosys, and many more incubators lined up to aid software firms, biotech sector is looking forward to more such initiatives aiding entrepreneurship in all ways possible.

Changing times India does not fall behind in terms of talent, skill, infrastructure and scientific manpower which form the basis for a growing bioeconomy. In recent developments, India surfaced as partner country at the world’s biggest industrial fair, Hannover Messe, portrays its effort to make India a global biotech hub.

The industry is heading onto growth and success and is in phase of rapid acceleration. Indian industry is beaming with potential and is more than ready to receive investors’ attention. But that is not all. More of Scitech park, Nano park and AcE funding is what the start up scenario is looking forward to. And to transform the sector into a major player in the biotechnology sector across the world!

Just for Laughs!

While we have seen what the persisting scenario is and what are the changes that are slowly getting adapted, we still have to ponder on a bigger solution to deal with the problem. The underlying fact is, while the investors from other firms might not be well assured of the success that biotech company can affirm and hence they refrain big time investing in BT, it is the bigger fish in the pond that has to support the industry and it’s people.

The bigger organizations who have already made a mark and are big shots in the industry would be the best people to understand the short comings. The industry biggies need to support and encourage the upcoming companies, with potential to change the sector at large. More incubators need to be seen in the rising when more of start-ups would, in parallel, seek encouragement as well. Efforts will pace along with opportunities and support extended, hence helping the sector thrive and succeed.

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The number of telehealth patients globally is predicted to increase twen fold between 2013 and 2018 Digital Healthcare Funding In 2014, it was over $4B In 2015 (Q1), it was $630B

Activity trackers outnumbered smartwatches 4 to 1 in 2014.

Digital health startups in 2014 received $4.1 billion in funding

Top 10 Healthcare Devices for the com BlueStar

TempTraq Blue Spark Technologies

1 The only wearable Bluetooth thermometer to continuously monitor body temperature for 24 hours in the form of a soft comfortable patch.

Robohand

2 The Robohand is a set of replacement fingers, made using a 3D printer. Robohand now has a 3D printer farm to keep up with custom orders.

BioSport

WellDoc

Intel

4

3 Bio Sport headphones track your heart rate and monitor your fitness levels without needing a charge. Data is send to your smartphone.

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4

The first "Mobile Prescription Therapy" for people living with type 2 diabetes.

Sweat Sensor strips

Electrozyme

5

It is a strip sensor that in into the back of your wea device and measures metabolic substance secreted in your sweat.

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* Stats covering eight countries

Today’s doctors are going digital!

Use continuously

Use rarely

s

Use sometimes

nty-

Interested in using

Percentage of Digital doctors globally who access clinical data

24%

15%

47%

6%

ming years

e

nserts arable the es

Smart pills AliveCor

6 It is a heart monitor on your smartphone which fits on most mobile devices and rests on your chest or fingers to record an ECG.

77 Smart pills with RFID technology allow health care providers to monitor whether a patient is taking the pills or not.

Smart patches

BitBite

Senso TRACK Sensogram

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10

The first ear-based device that automatically tracks your eating habits and helps you improve It is a device that fits them with real-time snugly on your ear, dietary advice. where it measures heart rate, It is a type of patch, which blood pressure, oxygen is worn on the body, saturation and respiration which constantly monitors vital rate. signs, like heart rate, that connects with their ingestible pill.

Proteus Digital

8

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David Lawrence CEO, Sentinext Therapeutics

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Raising money for early stage companies is always challenging – however, we have had great support from Malaysian VCs.

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S

entinext Therapeutics, a vaccines biotech company, based in Malaysia, holds a very strong foundation based on research spanning over 20 years carried by eminent Malaysian scientist Dr Jane Cardosa.

Dr. Jane is renowned for her extensive research on diseases and viruses including Hand, Foot and Mouth Disease (HFMD), Dengue and viral encephalitis. The company employs cutting edge VLP technology to develop superior vaccines that protect against infectious viral diseases where there is a significant unmet medical need.

Headquartered in Penang, Malaysia, it has a global network of development partners/advisors in the US, Europe and Australia.

In 2011, Sentinext was awarded a “Grand Challenges Explorations” (GCE) grant from the Bill and Melinda Gates Foundation (BMGF) to test whether its enterovirus platform technology for making VLPs would also be a possible option for a new and safe vaccine for protecting the world’s population from Poliovirus infection whether natural or introduced by bio-warfare.

Sentinext’s vision is to be a significant player in the field of vaccine and immune research in the next ten years and be recognized for its expertise regarding the infectious diseases of the region. Sentinext is focusing on developing vaccines and therapeutics for EV71, polio, influenza and dengue and its goal is to have a product in phase II within five years.

In conversation with David Lawrence, CEO of Sentinext Therapeutics, we have excerpts as;

Q. The company has been designing and constructing virus-like particles for its vaccine which is known to trigger production of necessary antibodies to fight off the virus infection. Can you elaborate on these virus look a like particles and how far have you been able to achieve it?

A. We have constructed a number of different virus-like particles containing 60 copies of 3 different proteins that assemble naturally into a sphere. These VLPs do not contain rDNA and this is what makes them different to the virus itself.

These virus-like particles are stable and able to convince the host’s immune system to make antibodies directed against the virus, thus enabling the host to kill viruses that enter the body. Most vaccines use a killed or weakened version of the virus itself.

Our challenge now is to establish how much of these particles are needed to fully protect a child for a number of years.

Q. What are the company’s flagship products? What more are in pipeline (under trials)?

A. Our lead product is a bivalent HFMD vaccine covering EV71 and CVA16 viruses. We will commence our first clinical trial in less than 12 months from now. We are working on VLPs for Polio as part of a wide project funded by the Bill & Melinda Gates Foundation. We have a potential candidate for EV68 in research.

Q. Was garnering VC funding for the company a hurdle?

A. Raising money for early stage companies is always challenging – however, we have had great support from Malaysian VCs and hope to attract non-Malaysian VCs as we advance our products.

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Team at Sentinext

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The role of synthetic biology continues to evolve and emerge; I foresee this having an increasing influence in drug/vaccine design as well as production and, in turn, regulatory standards.

Q. Are there any plans of expanding the global presence of the company?

A. We already have external partners in Europe and Australia in particular to support the development of our products. The largest HFMD market is China so we are looking for a partner there to undertake development and commercialization in China.

Q. What do you see happening in biotech and the life sciences sector globally over the next 10 years?

A. China, India and Asia are all likely going to continue to grow faster than US and Europe, we will see the advance of more companies from the region and Chinese companies will start to look beyond China. More new technologies will be developed and get to the regulator; we already see many VLP vaccines in development and a few are now on the market; immunotherapies for cancer such as the Juno approach will advance and are extremely interesting; synthetic biology will take hold and provide many advantages to current approaches including drug/vaccine design.

Q. Does Malaysia have a flexible regulatory body when it comes to execution of clinical trials?

A. Not for Phase I, Malaysian MoH is working with others and the ASEAN initiative. We plan to conduct Phase I in Australia (where HFMD has been reported in recent years).

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“

Malaysia is still at an early stage but is committed to trying to build lifesciences capacity and competence. I see the government and agencies trying to find ways to support the growth of the industry whilst acknowledging that this cannot be an overnight success.

Q. As investing in biotech is always a risky play, what trends are going to take a big stance in the coming era?

A. Neil Woodford, now that he has his own fund, will play an influence in the UK and beyond; the success of some of the new technologies and companies such as Juno will set the tone going forward.

Big Pharma are going to have to continue to acquire products and companies; they may also reorganize and adopt some new strategies – ViiV by GSK and the Abbott/Abbvie strategies are examples; we may also see a few new large players evolve. The role of synthetic biology continues to evolve and emerge; I foresee this having an increasing influence in drug/vaccine design as well as production and, in turn, regulatory standards.

Q. What kind of opportunities are emerging in Malaysia and is there a biotech boom in the country yet?

A. Malaysia is still at an early stage but is committed to trying to build lifesciences capacity and competence. I see the government and agencies trying to find ways to support the growth of the industry whilst acknowledging that this cannot be an overnight success. The development, for example, of an ASEAN regulatory capability would be helpful. There are some good links to the Middle East and this can also help as evidenced by the establishment of AJ Pharma/AJ Biologics. If Sentinext can help be a pioneer for the first VLP Polio, for example, then this will help build credibility quite widely.

Q. What interests you the most apart from work?

A. My family, I have kids of 8 and 12 years old so being away from them regularly can be tough; we enjoyed a holiday in Borneo last year which was great and gave them a taste of the culture and weather that I live/work in for about 30% of my time. I hope to have the opportunity to live and work in a new environment in the next few years. Rugby – I love watching and I coached youths until taking this role on, sadly the travel and so on meant I had to stop.

Quote to Inspire!

“

Don’t think what’s the cheapest way to do it or what’s the fastest way to do it...think what’s the most amazing way to do it.

-Richard Branson Founder, Virgin Group

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will Indian IP policy stand up with the US?

I

t was the summer of 2013 when Supreme Court of India had dismissed the plea of Swiss Drug maker Novartis to patent its cancer drug- Glivec.

The reason was simple- the court had not found any substantial improvements in the product to ignite a patent for it. India continued selling the cancer drug at cheaper prices which sure was a victory for public health in India but led to a major furor in European and US pharma market. Why was it received with such opposition? Is Indian IPR policy not in place?

The strong patentability criteria of India has long been the opposing factor for the US and Europe. US following the liberal patent criteria allow the company to file for a fresh patent even for a slight change or modification in the content of the medicine unlike in India. This usually leads to having a long patentability for most of the companies, usually reaching out to not less than 20 years. The drawback is that it creates monopoly in the market and hence pushed up prices of the drugs is the usual outcome of it which eventually leaves the treatment inaccessible to millions of people particularly in Asia and Africa.

With Modi introducing various crucial policy changes through the ordinance route, the draft National Intellectual Property Rights policy was looked upon with great interest in the US since it holds the major potential of determining the size of profits that American pharmaceutical companies can make by selling medicines to Indians. For long India has been on the “priority watch list” in America’s special 301 report that identifies countries which do not provide “adequate and effective” protection of intellectual property rights or “fair and equitable market access to

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Report on Intellectual Property Rights

• The Office of the US Trade Representative has refrained from imposing an out-of-cycle review of India’s IPR laws, unlike last year • The annual report on IPR lauded the efforts of the NDA government towards “increased bilateral engagement” between India and the US • India’s draft IPR policy, announced last year, was silent on the issue of compulsory licensing in pharmaceuticals, for which Indian IPR laws were criticised by the West • It also did not pay heed to the long-pending demand of a separate court for IPR cases

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India has its own economic compulsions. We are trying to revive industry and manufacturing, and pharma brings about $8-9 billion into this country. So you cannot just give it up.

-Gopakumar Nair Patent attorney and Past President of the Indian Drug Manufacturers’ Association

United States persons that rely upon intellectual property rights”.

The government’s approach to IPR has always been the subject of intense discussion, especially in the context of USTR (US Trade Representative) putting Indian and some other countries on the mat over the alleged weakness in IPR regime including in the area of pharma, IT and publishing. But is really Indian IPR policies really not in compliance with the global policies? Or is it just the fear of losing the monopoly in the market and an eventual drift from the profit sector that triggered US to put India in the priority watch list?

In a recent comment, Prime Minister Narendra Modi had said that India needs to fashion a policy that could be in tune with the global standards at the same time protects special Indian strengths. “India should align its IPR laws with global standards.” It is going to be an extremely challenging task to stick to a position that favors both economic and technological developments. Especially in pharma sector that faces maximum pressures from extremely well funded lobbies set up by big pharma from the U.S. and other developed countries.

During the Prime Minister meet with Obama, it had allowed the United States to place its demands on the table. Speculations were that for once India should not play the good host as not only the cost of healthcare for Indians but also the competitiveness of the Indian pharma industry was at stake. “India has its own economic compulsions,” Gopakumar Nair, Patent attorney and past president of the Indian Drug Manufacturers’ Association said. “We are trying to revive industry and manufacturing, and pharma brings about $8-9 billion into this country. So you cannot just give it up.” The US government has always raised concerns on India’s IPR policy, saying it discriminates American companies. However, India has maintained that its patent policy is in compliance with global obligations.

When we have a close look on to the policies, they seem to be quite in sink with the established norms of the WTO. Nirmala Sitharaman, Commerce and Industry Minister to the US said “the report issued by the US is a “unilateral measure to create pressure on countries to enhance IPR protection beyond the TRIPS agreement, Under the WTO regime any dispute between two countries needs to be referred to the dispute settlement body of the WTO and unilateral actions are not tenable under the regime. Special 301, which is an extra territorial application of the domestic law of a country, is inconsistent with the established norms of the WTO.” The earlier released draft on IPR policies spoke lengths on using IP for incentivizing research and rewarding innovation without laying adequate provisions on how a stronger intellectual property regime could contribute in fetching larger foreign direct investments. “The draft policy was inadequate in finding a

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Drawbacks of current IP policies:

IP-driven innovation models have failed to alleviate health crises in developing countries, like antibiotic resistance and the shortage of tuberculosis medicines, says Leena Menghaney, South Asia head of MSF Access. Research in new drugs has stalled because companies don’t want to invest in creating drugs they will have to sell cheap.

“Countries like India are in urgent need of innovation models that do not depend on IP,” said Menghaney. “The IPdriven innovation model is not one that India has endorsed in international fora till now. The IPR think tank has reversed this most important policy stance.”

For instance, Gilead, which produces an extremley expensive drug for hepatitis C, produces the pill for $ 1000 in the US, while it can be produced locally at $ 1 a pill.

balance between market access and trade. The draft also failed to address the concerns on compulsory licensing with regard to pharmaceuticals. There have to be specialized courts to hear intellectual property-related cases, which was also not discussed in the draft policy,” said Bipul Chatterjee, deputy executive director, CUTS International, a consumer rights lobby.

However the latest draft on National IPR policy has been welcomed by US pharma sector while regretting the consistent barriers posed by the country’s pharma sector to US companies. The representatives of Pharmaceutical Research and Manufacturers of America told the USTR that barrier still remains. “Despite these potentially positive signs and sustained industry engagement, PhRMA and its member companies remain negatively impacted

by India’s barriers to US trade and investment, including its failure to respect IP rights”, said Amiee Aloi, associate vice president, Pharmaceutical Research and Manufacturers of America (PhRMA).

Although changes have been done, significant unpredictability in IP protection and enforcement in India remain as no progress has been made in terms of meaningful policy change to address the challenges faced by the innovative biopharmaceutical industry in India or in tackling the true barriers to patient access to new medicines. According a SPAG Asia survey of Indian companies, as many as 67 per cent of the respondents in the survey said India lacked a sound IP policy.

Despite these potentially positive signs and sustained industry engagement, PhRMA and its member companies remain negatively impacted by India’s barriers to US trade and investment, including its failure to respect IP rights.

-Amiee Aloi, Associate vice president, PhRMA

While there are two sided talks on whether to change the policies in place and make it more complaint with what the developed countries want, we are definitely amidst a pool of changes that are taking place swiftly in this direction. With new administration and positive indicators, the hope raises high that a fair decision on policies will be brought as intellectual policies are an important part of the overall economic future. If everything is set in place, it could act as a game changer for creating new market opportunities for the right holders.

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DELAYED REGULATION ON GM CROPS threatening agri-innovation?

W

hen it comes to genetically modified plants, the reception of Indian consumers has been quite hostile. In spite of the fact that Indian public researchers have been deploying investments in genetic engineering for over more than a decade and that India has largest number of scientists who are well trained in crop improvement and safety assessment, testing and growing of GM crops has only had apprehension and negligence in store. Whether growing a biotechnologically modified cotton or brinjal, furor and opposition from every corner had been a definite must. The scenario becomes even duller and mundane when not just the people but governing bodies start resisting the technology.

Despite the demonstration on affordability and scientific compliance of the crop improvement techniques by the Indian scientists, not much has been done to actually ease the implementation of GM technology in the country. What worsens the situation even more is that stance on genetically modified crops still

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remains a question mark. Despite all the credibility in the sector we are still indecisive of where do we stand on our take on GM technology. If nothing else, what is largely impacted by this uncertainty is agri-innovation. A country like India which largely depends on the income from agricultural inputs, a constant innovation in the sector plays a huge role in improvising the sector. But the bad luck with GM still revolves and the question is till when?

It is a surprising fact to note that the Indian private sector follows the best regulatory protocols adopted by the world and the exponential increase in the use of BT cotton in India has made the country leapfrog from a laggard to a world leader. India also holds the stand of being the number one global exporter of cotton and the second largest producer of cotton in the world. Indian cottonseeds go far and wide with its cultivation being witnessed in countries such as South Asia and South East Asian countries. If BT cotton could show a result so effective, why are we lacking in adopting similar technologies in other

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The Supreme Court’s technical expert committee has said no, the parliamentary standing committee has said no, whole Europe has said no. Then why should India be holding field trials.

-Ashwini Mahajan, National Co-convener, Swadeshi Jagran Manch

crops?

During the last 8 years, several Indian public sector research organizations and industry players have developed a number of biotechnology derived seeds that could bring enormous advantage to Indian agriculture specifically to small and marginal farmers and consumers. But the effort is time and again been threatened by vigorous efforts of few NGOs and anti-GMO organizations that swear by the downfall of this technology. But now is the time to put the case in rest.

In a recent event, Biocon head, Kiran Mazumdar Shaw had written to the PMO urging a speedy decision on GM crop issue. Though the Modi government has raised our hopes quite a high by moving swiftly on a range of environmental issues, approving long-delayed projects, clearing the backlog inherited from the UPA and bringing in processes to simplify green clearance, the one area where it continues to be indecisive is that of genetically modified crops.

Though transgenic crop field trials got a nod in eight Indian states allowing trials of a range of crops such as rice, cotton, maize, mustard, brinjal and chickpea, this relaxed attitude towards GM crops saw misty breeze of satisfaction when the decision faced criticism from all corners. It all came back to square one and we still await a stand on GM. The decision of Prakash Javadekar-led government had managed to fetch the attention by allowing field trials of GM crops in various states; it was again received with an eye of suspicion. Following the turn of events, a meeting reconsidering the decision was scheduled in which Genetic Engineering Appraisal Committee (GEAC) was to take a stand on laws stating the usage of GM crops in the country. But was the meeting conducted? Did it fetch a notable result?

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Quite disappointingly- no.

What is disheartening to see is that despite the urgency in the situation, we still lack a confidant and stable stand on where we are heading towards the acceptance of genetically modified crops. The dangling uncertainty has put the industry under scanner and the science innovators are worried that it might pose hindrance in the generation of newer ideas and innovation in the agriculture sector. The concerned industry is now turning every stone to materialize a step on GM. The letter of KM Shaw to the PMO emphasizes on calling meetings of the GEAC as the “entire agriculture biotechnology sector in great difficulty” and seeks a quick fix of the problem.

The failure to hold GEAC meetings and the consequent breakdown of the regulatory process has forced many to shut or scale down research programs in agri-biotechnology in India. Kiran pointed out that the GEAC, a statutory body required to meet at least once in a month has only conducted the meetings eight times in the last three years and has not considered any agri biotechnology applications since August 2014. She also raised concerns that the upcoming kharif season may be lost which is widely considered suitable for field testing. . “If the field trials approvals are not given in April for certain parts of the country and by May for the other parts, the kharif trials cannot take place,” Shaw said. “We will

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If the field trials approvals are not given in April for certain parts of the country and by May for the other parts, the kharif trials cannot take place. We will be losing again one year.

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- Kiram Mazumdar Shaw, MD, Biocon

be losing again one year. As you know, once GEAC gives the permission, we have to get NOCs from each state, which is also a time-taking process. It is very important that GEAC meets immediately and approves trials for this kharif season” she said.

If we have a look into the scenario, close to 20 applications for field trials of six crops- cotton, corn, brinjal, chickpea, rice and wheat are pending with the GEAC currently. While Andhra Pradesh, Maharashtra, Karnataka and Punjab have granted no objection certificates to the field trails, they are still awaited from others. Citing the same, a letter also has been written to Javdekar intervening on the same issue. The ministry has largely remained noncommittal with only one comment that the matter was being examined.

“GM crops are not a new thing what we are doing...

Some is legacy, some are earlier decisions, trials are on,” said the minister. “You can’t stop science... safe trial is what we want... Whatever we have allowed is only in the public sector and universities and I think it’s a limited number... But you can’t stop research...

There may be applications pending but GEAC meeting will happen soon” he added.

If not just the government negligence, the delay in materialization of GEAC meeting could also be attributed to the strong opposition from anti- GMO organizations. While the government is bestowing its support to the technology, there are a few in the crowd such as the Swadeshi Jagran Manch- who completely oppose the field trials of GM crops. The opposition has been ignited on the fact that when the technology has faced such a cold response in

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Europe and other countries across the globe, why should India be favoring it acceptance and promotion? There have also been accusations of all of it being hoopla of garnering profit by the MNCs. Ashwini Mahajan, national co-convener of the Swadeshi Jagran Manch, stated that “the BJP manifesto was clear in its objection to GM crops, the Supreme Court’s technical expert committee has said no, the parliamentary standing committee has said no, whole Europe has said no. Then why should India be holding field trials. We are not against science but these are MNCs pitching for GM crops without due scientific studies on the ill effects of GM crops on humanity and the environment.”

The hurdles raised by a few organizations are inevitable, but it should be justified with a suitable reason.

“Our appeal to you is that the regulatory process for evaluating the technology should not be stopped because of such concerns,” Ram Kaundinya of ABLE said in the communication with the PMO. “The best way to answer any concerns regarding the technology would be to allow its testing and take the decisions based on the results” he added.

There is no denying in the fact that despite of decade of existence in the scientific world; GM technology is still looked upon with a qualm. In the wake of criticizing the technology we often tend to forget that genetic modification is just a more precise form of breeding that plant breeders have long been using to ensure the best of features from various plants. We only hope that the regulatory guidelines on GM crops see a positive response and that mere ignorance of the understanding of the technology does not take a toll on a huge road of agri innovation that lies ahead.

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Trending Technology

3D printing gets yet another utility!

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D printing technology since the beginning of its existence has been a reason of awe in the scientific community. And why not? It makes it possible to grow liver, heart, kidney and what not in a condition as good as they would be in vivo. While many organizations are adapting to 3D printed version of organs to carry out their research, this would first time when a cosmetic company would take a leap in printing 3D skins. When you think of L’Oreal, you probably think “cosmetics” not “3D-printed skin. But L’Oreal, the French cosmetic giant which has long been producing skin has now taken a step ahead to automate the process.

The company needs skin and that too a lot of it. Further advancing towards ensuring best results in compliance with the human skin, it recently announced partnership with bioprinting startup Organovo to figure out how to 3D print living, breathing derma that can be used to test products for toxicity and efficacy. “We’re the first beauty company Organovo has worked with,” says Guive Balooch, global vice president of L’Oreal’s tech incubator. The work has huge implications. Most obviously, it will enable L’Oreal to lab test the safety and performance of cosmetic products on 3D bio printed skin.

Although being the first cosmetic giant adapting to 3D printing technology, it is not new to producing skins. Way back in 1980s the company started farming skin to avoid testing of

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cosmetics in animals. In France, it runs lab facilities the size of three Olympic swimming pools dedicated solely to growing and analyzing human tissues. A dedicated team of more than 60 scientists grow more than 100,000 skin samples annually which roughly equals to five square meters of skin per year—or 54 square feet, about the equivalent of one cowhide.

Each sample is 0.5 square centimeter in size. The fattest are 1 millimeter thick.

The current technique involves growing skin samples from tissues donated by plastic surgery patients in France and then cutting it into thin slices and breaking down into cells. Those cells are placed in trays, fed a special, proprietary diet, and exposed to biological signals that mimic those of actual skin.

“We create an environment that’s as close as possible to being inside someone’s body,” says Balooch. It takes about a week for the samples to form, he adds, “because the skin has different layers and you have to grow them in succession.” Roughly half of the skin that company produces is used by them and the rest it sells to the pharmaceutical companies and rivals in the cosmetic industry.

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We create an environment that’s as close as possible to being inside someone’s body.

-Guive Balooch Global Vice President, L’Oreal’s

The step to seek partnership with San Diego-based Organovo’s is aimed towards speeding up and automating skin production within the next five years. The research will take place in Organovo’s labs and L’Oreal’s new California research center.

L’Oreal will provide skin expertise and all the initial funding, while Organovo, which is already working with such companies as Merck to print liver and kidney tissues, will provide the technology.

L’Oreal which is more of a tech company than many people realize, spends not less than 3.7 percent of its revenue—more than $1 billion annually—on research and development which is about twice the industry standards.

An army of about 3,800 L’Oreal scientists in more than 50 countries are dedicated towards creating beauty breakthroughs and boosting up the confidence of those millions of girls across the globe. The highly techie company has various machines under its disposal that do stuffs such as washing hair over and over to test the compatibility of products in humans or 3D imaging the cells which shows off different materials such as collagen and keratins. The company also launched an app called Makeup Genius that lets you see yourself in real time wearing products that are not actually on your face.

The cosmetic pro will have exclusive rights to the 3D printed skin so developed for uses related to non-prescription skin care products. Organovo will retain rights to the tissue models for efficacy testing of prescription drugs, toxicity tests and the development and testing of therapeutic or surgically transplanted tissues.

If we talk about the applicability of 3D printing technology outside of L’Oreal, the current areas of business involves in being a cosmetic surgery potential which is already extensively studied and discussed amongst the surgeons. 3D printed skins could be a blessing to those injured or with badly affected skin. And the time is not far when it would be commonly used to achieve the desired result in cosmetic procedures. With the advances that are shaping up in medical technology, we only hope to see a future of being able to 3D print entire organs and help deal with donor shortages or other requirements during the surgery. Wouldn’t the world be a better place to live where no one died of organ shortage or no animals were killed for selfish motives of humans? With 3D printing on the rise we hope so.

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Cancer care tops $100 bn

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n a report from UK cancer research on the world cancer statistics, 14.1 million adults were diagnosed with cancer in the year 2012 and there were 8.2 million deaths from cancer in the same year. The International Agency for Research on Cancer (IARC) under WHO report shows that as a single entity, Cancer cases worldwide are forecast to rise by 75% and reach close to 25 million over next two decades.

threshold

The word Cancer grabs everyone’s sight because of its uncontrollable and immortal nature of existence. More than 100 types of cancer exists which entraps at least one person from every individual’s life and each one has a sad story to relate to. The global cancer burden is increasing quite markedly, predominantly due to ageing of the population and unscrupulous population growth.

• 14.1 million cases diagnosed with cancer • 8.2 million deaths from cancer

In India, life expectancy at birth has risen from 45 years in 1971 to 62 years in 1991 to 71 years expected by 2021-25 and so has the risk to harbor cancer. India with a population of 1.27 billion has 70-90% incidence of cancer per 1 billion populations. If we talk about the deadly disease taking lives, about 6% of all deaths in India are due to cancers which contribute to 8% of global cancer mortality.

The prevalence of cancer in India reaches 2.5 million cases with 8 lakhs new cases and 5.5 lakhs deaths occurring every year. More than 70% of the cases present are in advanced stage accounting for poor survival and high mortality.

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A look on the figures of cancer statistics perks our internal geek that do we really lag in appropriate and promising therapies and medications for treating tumor? Does the existing care for tumor fail to cure the growing percentage of populations diagnosed with cancer? Do we still require to find the promising treatments for curing cancer; if so, what would be the gross rate of research and investments dedicated for this clinical landscape?

Here are the answers for all the rising questions and confusions. In recent years the pace of treating the malignant tumor has accelerating drastically at a global level. The clinical landscape is leaping ahead in terms of oncology related pharmaceuticals and a wide range of new therapies and drugs are being introduced. IMS Institute for Healthcare Informatics released a Global Oncology Trend Report 2015 where it says that Global spending on cancer medication in 2014 rose to $100 billion, up from $75 billion four years ago. The global market for oncology drugs increased 10.3 percent last year and may reach $147 billion by 2018, according to IMS Health. The figures clearly are suggestive of increasing chances of survivals in a cancer struck sole.

Of all the spending that has amounted, 42.2 % of the global spending is contributed by US followed by European markets like Germany, France Britain, Spain and Italy which stay close behind. The total drug spending in the US was 10.7% in 2012 and has increased to 11.3% in 2014. Similarly in European market 13.3% of investments for cancer care in 2010 have increased to 14.7% by 2014. The report also said that a range of new, more complex and better drugs are on the rise. Pharmaceutical companies have produced 45 new drugs from 2010 to 2014 for 53 uses. 10 new drugs, including five biologic therapies, have been launched globally last year.

Investment Statistics for Cancer Care in 2012 and 2014

Investment rate in US Investment rate in Europe

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Reason for rapid dynamics in the oncology therapeutic market

There is a huge progress from a scientific perspective in understanding of cancer and as a result of which scientists have been able to achieve major breakthroughs in terms of cancer treatment. The survival rate of the disease has steadily improved over past 20 years. While two out of three individual in developed countries now survive for at least five years after diagnosis, in the early 1990s only half lived that long. The recent modifications in cancer care like earlier diagnosis, long treatment duration and increased effectiveness of drugs are resulting in a change in market dynamics. Spending is raising due to better medicines for cancer care and higher survival rates.

However, patient access to cancer drugs varies widely across the major developed countries. In 2014, patients in Japan, Spain and South Korea had access to fewer than half of the new cancer drugs launched globally in the prior five years. Newer drugs which are majorly produced by the developed nations may not be reimbursed evenly amongst the countries and as a result reaches out only a limited number of patients. In emerging markets the availability of newer targeted therapies remains low but nevertheless is increasing comparatively.

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When it comes to India, according to Boston Consulting Group study, 60-80% cancer cases are diagnosed quite late and 60% of patients do not have quality treatment.

There are only 300+ cancer centers in India while 600 more are suggested to meet the demand. Moreover about 40% cancer centers are not equipped with all modern facilities. Doctor patient ratio is one in 2000 and the aim is to achieve one in 100 by 2021. We can say that the delivery of equitable, quality and affordable cancer care

When it comes to India, 60-80% cancer cases are diagnosed quite late and 60% of patients do not have quality treatment. There are only 300+ cancer centers in India while 600 more are suggested to meet the demand.

in India is quite challenging.

A look on the scenario of cancer care in developing and under developed countries suggests that the percentage of people diagnosed with cancer are increasing rapidly with population explosion and there is an urgent need to improve the existing methodologies and therapeutic system for treating cancer. Not just this, there is a need to replace existing ones with the newly updated treatment strategies.

Well, the immense research on the outset and propagation of cancer and the advancement in technologies to identify tumor in its earlier stages has laid cancer cure in a more promising position, we have to head a few more hurdles to reach the destination.

Development of cancer specific drugs is on a rise which is being developed at different pace in developed, developing and underdeveloped countries which has sure enhanced the survival rates.

Looking at the pace with which the cancer cure is elevating and total investments in clinical landscape shaping, we are very hopeful of cancer being a treatable disease in the coming years.

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Top Biotech breakthroughs in the year 2015

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Guest Corner - Dr. M Swetha Vinay

iotechnology has always been an innovative sector, with immense potential to change the world into a better living place. Though once considered to be impossible and out of reach are now on the research desk trying to take shape and dazzle the world beyond imagination. A perfect blend of technology with knowledge is aiding our research minds in creating miracles. Biotechnology is where the knowledge of biology fuses with technology and thereby enhances the quality of life and eases human sufferings. The milestones, when listed, in the field of biotechnology, the top breakthroughs would be as below:

Designing babies according to your choice is what we are talking about. Blue eyes or green eyes, tall or lean, black hair or brown hair.

CRISPR can do it all. Want your kids to be more intellectual? It gets a little complicated there. That’s not all. We can as well get genetic diseases removed, and add genes which provide immunity to diseases such as HIV. We are well aware that some genes can contribute to cancer and heart disease and dementia. We also know that mental disorders like depression and schizophrenia have strong genetic components.

CRISPR can answer them all. In a way, we can design our babies just like the way we want.

Make way for designer babies

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The greatest of all is the ability to see. For those who are deprived off their power to see, good news is in store. Scientists might be able to change the cells in a blind person’s eyes, restoring their vision. People who have lost their vision due to injury or illness to the photoreceptors of the eye, scientists hope that through gene therapy, they can transform nerves in the eye to replace the lost/damaged photoreceptors.

A new field of study called optogenetics uses molecules from algae or other microorganisms. These molecules respond to light and when put into the nerve cells to transform them, they can receive light as well. The technique is developed by Zhuo-Hua Pan of Wayne State University in Detroit. This new field of study has also provided some understanding on the working of brain. It can also be used to alter memories.

Researchers believe that this technique can be used to restore vision to blind people. While the technique has already proved to be successful on animals, human trials could begin next year.

Optogenetics to restore vision

The astonishing breakthrough by scientists at Australia-Sino collaboration might pave way to a single universal flu shot immunizing people for lifetime.

Scientists have discovered how human immune cells retain information on earlier encounters with strains of influenza. It shows how CD8 and T cells remember the various virus strains they bump into.

“We’d never seen anything like H7N9,” University of Melbourne’s Associate Professor Katherine Kedzierska said. “The virus was infecting more people rapidly and nobody had immunity. Thankfully, we did manage to contain the virus but we knew we had come face-to-face with a potential pandemic that could kill millions of people around the world if the virus became able to spread between humans. After collecting samples from infected patients we found that people who couldn’t make these T cell flu assassins were dying. These findings lead to the potential of moving from vaccines for specific influenza strains towards developing a protection, which is based on T-cells,” she said.

“From the 30 per cent mortality rate in China we knew the clock was ticking on the situation. Had the contagion spread broken out globally, we’re talking about a history-altering event on the Spanish Flu scale. As it turns out, boosting the T cell adaptive memory capacity is our way in,” Kedzierska said.

“Our extraordinary breakthrough could lead to the development of a vaccine component that can protect against all new influenza viruses, with the potential for future development of a one-off universal flu vaccine shot,” she said.

A universal flu shot

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Though widely debated over, the research breakthrough by Chinese on gene editing at human embryo level was quite astonishing. The scientists from Sun Yat-Sen University led by Junjiu Huang, wanted to edit a gene that causes beta-thalassemia, a blood disorder. Also called germ-line modification, the purpose was to find out the efficiency of CRISPR in editing genes of human embryos, so that the babies are born disease free. The corrected gene will be passed down to subsequent progeny.

The researchers have used CRISPR gene-editing tool to change the genomes of 86 human embryos collected from IVF clinics which were non-viable and cannot grow further. Oxford bioethicists Chris Gyngell and Julian Savulescu argue that the Chinese research is “important precisely because it increases our understanding about some of the risks involved in targeting humans with current gene editing techniques.”

Gene editing in the next level

Transplantation of retinal tissue derived from human stem cell, which is found in the back of the eye and is responsible for sight are currently under clinical trials. Many other types of tissue of different shapes and sizes are also being looked at a possible tool for improved patient outcome.

About the Author Dr Swetha Vinay The author is into dental practicing, however her fervor for the recent developments and technologies in medical/ biotech field led her to write for Biotecnika Magazine. Tech-savvy by nature, she likes to keep updated with the latest trends in biomedical field.

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3D retina tissue structures

Scientists have produced crude 3D tissue structures from induced pluripotent stem (iPS) cells under current good manufacturing practices (cGMP), an important step for eventual large-scale use in human patients. Simplified 3D structures of the retina were produced using a variety of cGMP-compliant culturing procedures and sources of iPS cells. iPS cells from “super donors,” individuals who provide beneficial immune matches to significant portions of the U.S. population, were also successfully generated.

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