BioTecNika Magazine - December 2015 - BT Women Entrepreneur Special

Is the era of antibiotics nearing an end? | Reversing aging in humans | Transcriptic & Robotics in biology

Vol 3 | Issue 12

10 for 2016

TOP

India is slowly taking up to Genomics and Nutri-genomics..

Dr Amol Raut (CEO)

GeneSupport

Miracle Plant TO AID FOOD PRODUCTION IN SPACE

the first

women owned

biotech start-up In Conversation with Gayathri Thankachi & Aardra Chandra Mouli Founders, Aeka Biochemicals Pvt. Ltd.

December 2015

Bio-industry Trends

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editorial

Management team

chairman Mr Ajit Kumar Sinha

managing director Dr. Neha Suman

feature writers Sindhuri Chintakunta Srishti Deoras Preety K Ansu Abraham

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If the determination to be the next job creators in bioindustry was at one end, regulatory hurdles were also standing at the other. The challenges were many but the resolve was equally strong. The focus was on green solutions and the everyday objective was to create solutions that meet and satisfy social and environmental needs. What else do you need to turn a long cherished dream into a reality? The resilience to do some good to the community has taken the shape of “Aeka Biochemicals” led by women entrepreneurs Aadra Chandra Mouli and Gayathri Thankache.

Their entrepreneurial journey had virtually begun right after their graduation and resulted in the first women led biotech company in 2015. Their start-up undertakes the manufacture of biotechnological, biochemical & enzymatic products, chemical products or extracts of biological origin, which can be applied directly or indirectly in the development of products for relevant uses. With ideas on promoting women entrepreneurship they surely are an inspiration to a plethora of next-gen entrepreneurs. This December, we bring the story of Aadra and Gayathri, who stand to be the founders of the first wholly women led biotech company, based in Kerala. Their entrepreneurial take off is itself an inspiration and the idea of efforting for a green future is highly appreciable.

While these women entrepreneurs are busy racing with success, Biotecnika magazine has also interacted with Dr Amol Raut, the CEO of GeneSupport, who elaborates on the importance of Genomics and Nutrigenomics in India. This issue brings to surface the story of Theranos, a biotech company which had almost reached its zenith and had an unfortunate fall thereafter.

A special mention of gratitude to Mr Shiladitya Sengupta, for the insights on biotech industry and Ms Dorothy Lou, Business Development Lead, Transcriptic (USA), for her precious time dedicated for elucidating the importance of robotics and biology.

Other stories to keep up the interest are Reversing aging in humans, Miracle plants, Bioprinting and Top 10 bioindustry trends for 2016.

Don’t let them pass and Grab on a copy now!

Suggestions from our valuable readers are always a welcome. Pen your views to editor@biotecnika.org

branch office C-31, 1st floor, Sector- 2, Noida- 201301

Shekhar Suman Chief Editor

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CONTENTS page

Nutrigenomics & GeneSupport In Conversation with

06

Mailbox

24

Is the era of antibiotics nearing an end?

Dr Amol Raut CEO

28

Transcriptic

Concerns flow in from every corner of the world

32

Crispr cas9 in bio-agriculture Will it be crushed under the gmo regulations?

36

Power Tweets

Ms Dorothy Lou Business Development Lead

at the US firm details us on robotics and biology

Interview with

47

Mr Shiladitya Sengupta with insights on the biotech industry in India 56

How a biotech company’s success became a mess?

61

BIONEWS

Latest news updates from bioscience world

RASAYANIKA ZONE

BIOEVENTS

Events from biosciences to mark your dates without any going amiss

Industry and business news all at one place

50

Miracle Plant to aid food production in space

66

Printing bit of me to a newer me Bioprinting on a surge!

Top 1 0 BIOINDUSTRY

69

GUEST CORNER

TRENDS

Reversing aging in humans

for 2016

Reinstating youth through right anti-aging cellular targets

58

COVER STORY

The first women owned Biotech Start-up Making of Aeka Biochemical Pvt Ltd

37

R I am a biotech graduate and an all-time fan of Maggi. But the issues surrounding it has increased my doubts on it though it has cleared the court trial now. I wonder if it would be able to regain the confidence of public completely.

E Dear Kapil. The important derivation from the Maggi issue is that this incident, whether we favour Nestle or not, has underlined the importance of being wary when it comes to purchasing packaged food. Now that Maggi has cleared tests as told by the court, we should not be hesitating to give it another chance. For that matter, they were given a green by many other countries as well.

Kapil Kumar, Karnataka

Sandeep M, Bangalore

R The whitefly pest attack in Punjab and Haryana is a saddening incident. Whether because of GM or not, hope science comes up with solutions real quick.

E Dear Sandeep. The unfortunate pest attack incident in the two states has badly affected the cotton farmers. And experts aver that Bt cotton was made to fight bollworm alone. While the scientific community is working hard on researching the same, the public need to not lose their confidence in the concept of GM.

Letter of the Month R The cover story about Indian-American Vivek Ramaswamy's company Axovant which fetched the highest biotech IPO ever, that too from a failing drug was quite an inspiring story. I hope the product clears all the regulatory hurdles and cater to those millions who die out of Alzheimer's wrath. And I also congratulate Biotecnika magazine for bringing out a truly motivating story.

Look forward to read many such successful stories on entrepreneurship Rithika Patil, Pune

R I am Sathwika and I like the ‘technology trends’ part of the magazine where you bring in a blend of science, research and technology all together. I liked artificial intelligence the best, along with the pharma supply chain article.

E Dear Sathwika. Thank you for the much appreciation! We hope to keep up the good interests and bring in more informative and interesting technology trends to our readers.

Sathwika Reddy, Hyderabad

MAILBOX

BIOTECNIKA MAGAZINE

MAGAZINE

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BIONEWS receives FDA nod

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hough science and research is making appreciative efforts to make a progressive step towards curing cancer, it has still not reached the success point.

Almost close to eureka moment is the making of a virus which has been created to seek and destroy the cells that cause advanced melanoma skin cancer. The US FDA has now approved the first cancer-killing virus, called talimogene laherparepvec or T-VEC (brand name Imlygic).

Talimogene laherparepvec or Imlygic is a live oncolytic herpes virus whose genetic code has been modified so that it doesn’t harm healthy cells while eliminating cancerous melanoma in lymph nodes and in the skin. Fighting cancer cells with the help of viruses is not a new addition to the scientific knowledge but targeting only cancerous cells without hurting healthy counterparts was not very easy.

The biotech firm, Amgen, is behind the making of talimogene laherparepvec and though this particular treatment may not be completely effective, it highlights the fact that the concept may serve as the first step towards improving cancer therapies in the future.

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The US FDA has now approved the first cancer-killing virus, called talimogene laherparepvec or T-VEC (brand name Imlygic).

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First Cancer-Killing Virus

The virus particles are injected in a melanoma lesion where they invade the cell and essentially take over the cellular machinery leading the cell to rupture. The virus might not be an immediate cure to melanoma as a clinic study conducted with 436 patients showed that the virus was only able to extend survival by 4.4 months in patients with advanced melanoma, which is not a good sign. But hope is not lost as doctors believe that when combined with other treatments the virus could have a greater impact.

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University of Toronto have developed a $1 paper device that can analyze DNA to rapidly and inexpensively diagnose Hepatitis B.

Researchers introduce

“ONE DOLLAR” paper-based test

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for diagnosing Hepatitis B

T

he high prevalence of Hepatitis B in sub-Saharan Africa and East Asia, infecting between 5–10% of the adult population, is widely known. As diagnosis stands to be of importance in assessing the stage and prevent spread, researchers from University of Toronto have developed a $1 paper device that can analyze DNA to rapidly and inexpensively diagnose Hepatitis B and assess male fertility. This new paper based test could be of particular help diagnosing people in low-income areas, researchers said.

While DNA analysis has become a valuable tool in forensic science, genetics and disease diagnosis, carrying out such analyses requires expensive lab equipment, enabling efficient reach also is a problem to be highlighted. In March 2015, WHO launched its first “Guidelines for the prevention, care and treatment of persons living with chronic hepatitis B infection” and strongly recommended to promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment. This new product in making can meet this need.

As advances in nanomaterials could make analysis of genetic material possible at a much lower cost, David Sinton from the University of Toronto and colleagues wanted to see if they could come up with a new paper device with such nanomaterials to test DNA without the use of high-tech facilities. They succeeded in making a paper-based diagnostic test out of materials that cost less than $1 per device.

After only a 10-minute run, the device could detect the hepatitis B virus in blood serum at a level low enough to flag an early-stage acute infection, which is critical to help prevent its spread. It also could determine the DNA integrity of sperm - a predictor of fertility - from semen samples as accurately as current clinical methods.

Though there are number of tests available for diagnosis, the new low cost paper based diagnostic tool give hope to the people of low income countries.

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CSIR launches anti-diabetes herbal drug AFFORDABLE AND SCIENTIFICALLY VALIDATED

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mellitus.

edicinal plants are being looked up once again for the treatment of diabetes. An Ayurvedic based anti-diabetes drug christened ‘BGR34’ launched by CSIR gives hope to the patients with type II diabetes

The drug which has been made with natural extracts is scientifically validated and has no side effects along with 67% success in clinical trials. The drug, after effective animal testing, has found to be safe and effective.

“The drug has extracts from four plants mentioned in Ayurveda, and that makes it safe,” said Dr AKS Rawat, senior principal scientist, NBRI. Though there are other anti-diabetes herbal drugs in the market, BGR-34 ‘stands out’ as it is scientifically validated.

The drug will help maintain normal blood glucose levels, reduce chances of complications due to persistent high blood glucose levels and impart a good quality life to patients with high blood sugar levels. The drug boosts immune system, works as antioxidant and checks free radicals.

“We will manufacture it now and it will be available in market shortly, may be in the next 15 days,” said V S Kapoor, marketing head of Aimil Pharmaceuticals, the company which will be marketing the drug.

The drug which will be available in the form of tablets, may cost Rs 500 for 100 tablets. In India since 90% of cases of diabetes are type II diabetes it is likely to benefit the masses owing to its cost effectiveness.

The drug launched on the 62nd annual day of the NBRI for commercial manufacturing has been jointly developed by two CSIR laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (CIMAP). CSIR, India’s largest research and development (R&D) organization includes 37 laboratories and 39 field stations spread across the nation, with a total of over 17,000 people.

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“SUPER TOMATO” loaded with antioxidants

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esearchers from Washington University in St. Louis (WUSTL) have taken the assistance of nanoparticles to create a super tomato that produced almost 82 percent more fruit by weight, with the fruit also boasting higher antioxidant content.

The technique, developed by Ramesh Raliya, PhD and Pratim Biswas, PhD, from WUSTL’s School of Engineering & Applied Science, involves the use of zinc oxide and titanium dioxide nanoparticles to increase the tomato plant’s capacity to absorb light and minerals. The titanium oxide increases chlorophyll content in the plant’s leaves to improve photosynthesis, while zinc is an essential nutrient that also helps the function of enzymes within the plant.

“When a plant grows, it signals the soil that it needs nutrients,” Biswas says. “The nutrient it needs is not in a form that the plant can take right away, so it secretes enzymes, which react with the soil and trigger bacterial microbes to turn the nutrients into a form that the plant can use.

We’re trying to aid this pathway by adding nanoparticles.”

While comparing the use of nanoparticles as a spray directly depositing on the plant leaves and application of the nanoparticles to the soil, the former was observed to result in a much higher uptake of nutrients than latter.

“A plant can only uptake about 20 percent of the nutrients applied through soil, with the remainder either forming stable complexes with soil constituents or being washed away with water, causing runoff,” says Raliya. “In both of the latter cases, the nutrients are unavailable to plants.”

The plants which were nanoparticle treated showed 82 percent more fruit by weight than untreated and an increase of between 80 and 113 percent in levels of lycopene. Biswas says that the optimal concentration of nanoparticles that provide the maximum benefit still needs to be determined, but the plants and tomatoes used in the study had nanoparticle levels well below the USDA limit and were considerably lower than those found in conventional fertilizer.

The team is now developing a new formulation of nanonutrients that not just contains zinc, but all 17 elements required by the plant to grow, without extra worry for water and energy resources.

“In 100 years, there will be more cities and less farmland, but we will need more food,” Raliya says. “At the same time, water will be limited because of climate change. We need an efficient methodology and a controlled environment in which plants can grow.”

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Returning the sense of touch Artificial skin and medical bionics at work!

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he most complex sense of touch helps us successfully communicate, both physical and emotional, and science is right on its way towards the creation of an artificial skin product for bionic prostheses to restore the sense of touch in a person who has lost an appendage. The biggest breakthrough innovation by Stanford University scientists involves the making of an electronic artificial skin which is capable of transmitting pressure changes through nerve cells, triggering a response from the brain that the artificial skin is in contact with something or someone.

A new type of pressure sensor made from a thin, flexible material has been developed that can be placed over existing prostheses. The plastic material is embedded with a series of pure carbon nanotubes for conducting electricity. When the material is squeezed, pulses of energy from the carbon nanotubes are transmitted and those pulses grow more rapid as the pressure is increased.

In a recent case, a Dutch man received a prosthetic arm with sensory-stimulating electrodes. The device’s artificial tendons had sensors for tracking finger movement and tension data used to send translated signals to nerve electrodes implanted in his upper arm. He, with the prosthetic device, was able to sense touch for the first time in nine years since losing the appendage.

In another incident relating to bionics, researchers at Case Western Reserve University successfully grafted electronics to nerve cells in the upper arm of a man who lost his hand in an accident. The electronic cuffs provide a stimulation to nerve cells in response to signals from a series of 19 sensor locations. The sensors and the nerve stimulation system also help the person detect the texture of the material which they are holding.

Being able to analyse temperature is another aspect of touch and working on the same are researchers from a group of British universities, who designed bionic limb electrodes to wrap around nerve endings in a person’s arm. Both temperature and shear force information can be transmitted to the brain in real-time through this system. It also aids in analysing the position of the limbs and where they are being held.

With the rising innovations in the field of bionics future developments employing miniaturized sensors are expected to produce more robust inventions with positive implications.

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T

PC: Wisconsin University

aking a step towards regaining lost voice, researchers have introduced us with a breakthrough innovation. For the first time scientists from University of Wisconsin have made vocal cord tissue with cells from human vocal cords. This bioengineered tissue vibrates and even sounds similar to the natural thing. The making of vocal cords in lab is expected to aid many people with voice impairment and severely damaged vocal cords in regaining their lost voices.

Vocal cords in the making!

Restoring the lost voice

“It’s an exciting finding because those patients are the ones we have very few treatment options for,” says Jennifer Long, a voice doctor and scientist at the University of California, Los Angeles, head and neck surgery department, who wasn’t involved in the study.

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The speech process of humans is executed by forcing air over their vocal folds, residing in the larynx. The cords are like two flexible bands of muscle lined with delicate tissue called mucosae which resonate in response to energy from the airflow. The cords produce sound waves by vibrating against each other about 100 to 200 times a second. But a few deprived cannot even make sounds of 100 cycles per second.

Reason for voice impairment could be due to the repeated surgeries or radiation to remove cancerous and noncancerous growths, during which the cords are scarred or get stiffened.

“I can’t overemphasize just how negatively a severe voice problem can impact someone’s life,” says co-author Nathan Welham, an associate professor of surgery at the University of Wisconsin School of Medicine and Public Health in Madison. “If you have a really poor voice, it draws attention immediately when you open your mouth.” Procedures such as injecting collagen can add bulk to the vocal cords, helping them come together more easily. But some of the fold’s ability to vibrate is still lost. “It isn’t a real fix,” Welham says.

Welham’s team have engineered vocal fold mucosae in the lab using the two main cell types that make up the tissue, which are the connective fibroblasts, forming the main body, and epithelial cells, lining the surface. Unlike the previous experiments, the team collected epithelial cells and fibroblasts from human sources being one cadaver and four living people who had their healthy voice boxes removed during unrelated surgeries. They placed the two cell types in a 3D collagen matrix that mimics conditions in the body. Gradually the cells formed a more complex structure that quickly came to resemble natural vocal cords.

The research is an “admirable start,” says Robert Sataloff, a professor and the chairman of the ear, nose, and throat department at Drexel University College of Medicine in Philadelphia, Pennsylvania, who wasn’t involved in the research. “But there’s still a long way to go before we can replace someone’s scarred vocal fold mucosa with a new, essentially normally functioning one.”

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RASAYANIKA ZONE

‘BIOGEL’ FOR DRUG DELIVERY A novel way to treat cancer

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elivering anti-cancer agents directly into cancerous tumours and killing them can soon be a possibility using the latest development, a new injectable ‘biogel.’ Researchers from University of Montreal Hospital Research Centre (CRCHUM) have developed the technology and tested in the laboratory as well. If successful the therapy could one day revolutionize the treatment to many cancers.

“The strength of this biogel is that it is compatible with anti-cancer immune cells. It is used to encapsulate these cells and eventually administer them using a syringe or catheter into the tumour or directly beside it. Instead of injecting these cells or anti-cancer drugs throughout the entire body via the bloodstream, we can treat the cancer locally. We hope that this targeted approach will improve current immunotherapies,” said Réjean Lapointe, co-author of a study on the technology.

Unlike “jello”, the biogel is liquid at room temperature and gels at 37 degrees Celsius human body temperature. The biogel was effectively tested in several in vitro models such as melanoma and kidney cancer.

Biogel composition and making was developed by Sophie Lerouge, a researcher at the CRCHUM and professor in the Department of Mechanical Engineering at the école de technologie supérieure. “The compound is made from chitosane, a biodegradable material extracted from the shells of crustaceans, to which gelling agents are added. The formulation is liquid at room temperature, which facilitates its injection, but quickly takes on a cohesive and resistant structure at 37 degrees. We also needed a hydrogel that was non-toxic for the body and provided excellent survival and growth of the encapsulated cells,” said Sophie.

“The T lymphocytes in the gel are functional and can grow for two to three weeks, be released from the gel, and kill the cancerous cells,” explained Lapointe. Next in line is the testing of biogel in animals and humans and if successful, the therapy could land up in the list of current cancer therapies.

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Her leukemia was so aggressive that such a response is almost a miracle.

- Prof Paul Veys, Director, Bone marrow transplant, GOSH

An exceptional approach

towards cancer

Layla Richards

GENETICALLY ENGINEERED IMMUNE CELLS SAVE A LITTLE LIFE

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ayla Richards is a one year old baby girl who was diagnosed with Acute Lymphoblastic Leukemia, the most common form of childhood leukemia, when she was 14 weeks old. As chemotherapy and a bone marrow transplant turned to be of no help, doctors at the Great Ormond Street Hospital (GOSH) in central London offered an experimental treatment which was still under development. Fortunately it worked. A ‘cell therapy treatment’ that has never been tested in people earlier saved Layla who was close to dying from cancer. It also represents one of the first times that a novel “genome editing” technique has been used to treat someone. Though Layla has displayed cutback since few months only, her doctors consider it as a remarkable outcome as she has not been helped by conventional therapies.

“As this was the first time that the treatment had been used, we didn’t know if or when it would work and so we were over the moon when it did,” said Professor Paul Veys, director of bone marrow transplant at GOSH and Layla’s head doctor. “Her leukemia was so aggressive that such a response is almost a miracle.”

With reference to this incident, researchers consider cell therapies development to be important as they are witnessed to represent a new set of treatments with less time and money involved. They might not have to be customised as well as they present a “one size fits all” treatment, untested till now.

“We have only used this treatment on one very strong little girl, and we have to be cautious about claiming that this will be a suitable treatment option for all children,” said Waseem Qasim, professor of cell and gene therapy at the Institute of Child Health and consultant immunologist at GOSH. The therapy, developed by Cellectis, a French biotechnology company, had the cancer doctors surprised by the new approach involving genetically altered patients’ T cells so that they can better attack cancers. Cellectis’s therapy is meant to work for any patient with a particular type of leukemia. The therapy involved extracting the T cells from the patient, shipping them to a manufacturing plant where they can be altered, then sending them back and putting them back into the patient.

The experts recognise the therapy as a huge step forward in treating leukemia and other cancers.

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The biggest deal ever!

Pfizer to buy out Allergan for $150 billion

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harma industry’s biggest deal ever is supposed to be in the making. US drug giant Pfizer is reportedly gearing up to sign a deal with Allergan for $150 billion (Rs 9,88,000 crore). The takeover could allow Pfizer to escape relatively high US corporate tax rates by moving its headquarters to Allergan’s headquarters in Dublin. Allergan is the famous Boox maker, along with other aesthetic-medicine products and has been growing at a faster rate.

The deal as it gets closed, will out-beat Pfizer’s $90-billion buyout of Warner Lambert in 2000. It would be an on the top moment for Irish firm Allergan and its history of tens of acquisitions and selloffs and provide the $45-billion Pfizer the tax benefits of an Irish domicile.

Allergan believes that it could launch more than a dozen new products, including drugs for age-related macular degeneration and depression, over the next several years that could add more than $15 billion in sales. Also the companies together will have more resources to devote to drug research and development.

Allergen, led by CEO Brent Saunders, is looked by experts as a company fond of doing deals. “This bold action is the next chapter in the successful transformation of Allergan, allowing us to operate with greater resources at a much bigger scale,” said Saunders.

The merged business will be called Pfizer Plc. The companies said they expected the deal to be completed in the second half of 2016, considering the regulatory approval in the US and in Europe. “The proposed combination of Pfizer and Allergan will create a leading global pharmaceutical company with the strength to research, discover and deliver more medicines and more therapies to more people around the world,” said Mr Ian Read, CEO, Pfizer.

After the deal closes, the combined company is expected to evaluate splitting into two businesses, one focused on patent-protected products and the other on drugs that have lost their patent protection or are close to losing it.

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A portfolio of six drugs being introduced by Sanofi

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range of innovative products are being introduced by Sanofi including a dengue vaccine and a medicine to cut cholesterol. A portfolio of six innovative drugs is being built, an upsurge from the drug shortage prevailing in the Big Pharma space. The dengue vaccine, which has been under development for nearly two decades, Sanofi’s executive vice president, Suresh Kumar, stated that the prevalence rate of dengue in India is an example of how the problem is not being recorded properly and poorly understood.

“By the end of 2015, we will have submitted the regulatory file for approval in 20 countries. In case India has an urgent need to arrest the problem, we will do everything we can to try and make the product available here,” said Kumar who joined Sanofi from US management consultancy Oliver Wyman.

Investments of 1.5 billion have been put into the research and making of dengue vaccine with clinical trials on more than 40,000 people. The other top innovations Sanofi is expected to take up further include biologics such as the recently approved Praluent to cut cholesterol; Toujeo, an insulin for diabetes; dupilumab for atopic dermatitis and sarilumab, tested widely for treating rheumatoid arthritis.

Sanofi believes that their line of drugs, once available in the market, is going to strengthen the company and also provide effective treatment options for patients.

Kumar stated that, “Sanofi is present in India end-to-end from innovation to manufacturing to marketing products, and now it’s looking at what more needs to be done. Not only for the India business but over time we see how these capabilities can be honed as export hubs for the rest of the world.

Kumar said response about the product from patients remains positive but agreed that the company is aware of the slow demand for the drug and continued to look at what needs to be done to improve sales.

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Sanofi believes that their line of drugs, once available in the market, is going to strengthen the company and also provide effective treatment options for patients.

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FEASTING ON

a genetically modified fish!

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ore than five year since the genetically modified fish has been trying to reach our tables. And finally FDA has approved the human consumption of the GM salmon, the first genetically altered animal.

In the middle of consumer concerns about eating genetically modified foods it took time for the agency to declare that the fish is safe to eat. FDA said that there are “no biologically relevant differences in the nutritional profile of GM Salmon compared to that of other farm-raised Atlantic salmon.”

By name, AquAdvantage Salmon, the fish was created by the Massachusetts-based company AquaBounty. “The fish is a game changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats,” said Ron Stotish, the company’s CEO. Talking about the fish, it grows twice as fast as normal salmon and so reaches market size more quickly. It also has an additional growth hormone from the Pacific Chinook salmon that allows the fish to produce growth hormone round the year. Researchers who have worked on GM salmon have used another gene from an eel-like fish called an ocean pout to keep the hormone active. FDA has also said that the fish would cause no harm to the environment. It would be bred as female and sterile and a very small percentage might still be able to breed.

“The F.D.A. has thoroughly analyzed and evaluated the data and information submitted by AquaBounty regarding the AquAdvantage salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” Bernadette Dunham, director of the agency’s Center for Veterinary Medicine, said in a statement.

Though there is no evidence that the foods would be unsafe, ethical concerns do not stop from raising doubts. A few retailers have said no to sell the salmon and whether people would be open to accept the fish or not is still ambiguous.

Nevertheless, upwelling interest in developing genetically altered farm animals and pets because of the advancing technology, is letting scientists edit animal genomes too.

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Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once-daily, complete regimen for patients with HIV-1 infection.

- Edward Cox, Center for Drug Evaluation and Research

FDA nods at a new drug for HIV Indian pharma market awaits its launch!

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s we scroll through the list of illnesses which have been difficult to cage over decades, HIV infection stands to be on the top of the list. The recent research on confining HIV led to a new treatment, approved by USFDA, has no side effects associated with other drugs used to fight the virus.

The drug by name Genvoya is a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, and acts as a complete treatment for combating HIV-1 infection in adults and paediatric patients aged 12 and above.

India has the third highest number of HIV patients and over 20 lakh people live with HIV. There are around 1.5 lakh children infected with the virus.

Though the latest statistics indicate an overall reduction of 57% in the annual new HIV infections among adults, it still witnesses around 1.2 lakh new infections and 1.5 lakh AIDS-related deaths every year. With such high prevalence existing in the country the need for a complete treatment of HIV is also quite high. Though the drug is currently not available in India, experts say approval in the US is a major breakthrough and may initiate trials for the drug in India.

“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once-daily, complete regimen for patients with HIV-1 infection,” said Edward Cox, director of the Office of Antimicrobial Products at USFDA’s Center for Drug Evaluation and Research.

According to USFDA, Genvoya contains a new form of tenofovir that has not been previously approved. The new form provides lower levels of drug in the bloodstream, but higher levels within the cells, where HIV-1 replicates. “It was developed to help reduce some drug side effects,” the regulator said. The new drug also appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir-containing regimens based on laboratory measures.

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6th Annual International Conference on Advances in Biotechnology (BIOTECH 2015) 26th - 29th March 2016 | Singapore

Conference Theme passes a wide range of procedures for modifying living organisms according to human purposes going back to domestication of animals, cultivation of plants, and "improvements" to these through This multi-disciplinary conference aims to provide a challenging forum and vibrant opportunity for researchers and industry practitioners to share their original research results and practical develop-

Keynote Addresses Prof. Liu Yu Professor of Environmental Engineering, Director of Advanced Environmental Biotechnology Centre, School of Civil and Environmental Engineering, Nanyang Technological University, Singapore

Prof. Christopher Franco

Head of Department, Medical Biotechnology, Flinders Medical Science and Technology AU, Assistant Dean (International), School of Medicine, Flinders University Australia

Prof. Sanjay Kumar Verma

Professor, Biological Sciences Department Dean, Academic Research Division Birla Institute of Technology & Science Pilani India

Conference Venue Hotel Fort Canning [Website] 11 Canning Walk Singapore 178881

CMCGS CONFERENCE SECRETARIAT Global Science & Technology Forum (GSTF) 10 Anson Road, International Plaza, Singapore 079903

BIOEVENTS 20

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In Patnership with:

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Government of India

February 8-10, 2016, Hyderabad, IndIa.

Time to Hurry, Early Bird Offer connecting the dots

action packed conferences

With increasing pressure to reduce healthcare costs globally, emerging markets particularly India is gaining further prominence with its scientific and tech talent pool, contract research and manufacturing activities, process reengineering and innovative R&D capabilities serving as key enablers. under this backdrop, the thirteenth edition of bioasia will be organized with the theme of leveraging india to Succeed globally and shall focus on connecting the dots to build stakeholder consensus and draw a distinct road-map to propel the sector growth.

BioAsia 2016

Drug Discovery conference

February 09, 2016 | HICC, Hyderabad, India

BioAsia 2016

rapiD Diagnostics conference

February 09, 2016 | HICC, Hyderabad, India

BioAsia 2016

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Showcase your brand and connect with C-level Executives and influential delegates from 50+ Countries

100+ most innovative companies’ research, products, services and technologies to be showcased

Focused Conferences Keynote Talks CEO Conclave Networking Receptions Biopark Visit

One-to-One Meetings with 800+ corporates

HealtH & access conference

February 10, 2016 | HICC, Hyderabad, India

BioAsia 2016

Digital HealtH & HealtHcare it conference

February 10, 2016 | HICC, Hyderabad, India

BioAsia 2016

clinical researcH conference

February 10, 2016 | HICC, Hyderabad, India

13th bioasia - bigger & better!

50+cOuNtrieS 70+high prOfile SpeakerS 800+cOrpOrateS 1000+ partNeriNg MeetiNgS Offer open until: November 30, 2015

For more info contact Ms. paridhi gupta paridhi@bioasia.in +91 (40) 3000 4005 / 4006

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22 – 24 March 2016

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nearing an end?

The time may come when penicillin can be bought by anyone in the shops. There is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.”

– Alexander Fleming at his 1945 Nobel Prize lecture

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Is the era of ANTIBIOTICS

ave we just pushed a miracle drug into an ‘overly used and hence ineffective’ drug category?

Looks like the predictions of Alexander Fleming have not gone wrong! It was only a few decades ago when a patient could be treated of bacterial infections and major bed sores by a few doses of antibiotics. But now the same disease condition and same treatment and still no relief! Even the strongest class of antibiotics are failing to deliver required results. Is it because we have been prescribed a higher and longer dose where a little for a day would have been sufficient?

Where have things gone wrong?

We have earlier featured coverage on antibiotics and its losing credibility as a no harm drug. Since the time antibiotics have paved way into the pride list of doctor’s prescription, whether required on not, it has stood out to be the most popped up pill over the period of time. So much that India alone has witnessed a 62% increase in the consumption habits. The number of these pills consumed annually by Indians is recorded as 13 billion compared to the 10 billion in China and 7 billion in the US. “If we are not careful, we will soon be in a post-antibiotic era,” says Dr. Tom Frieden, director of the CDC.

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Are the concerns being given heed?

While the concerns of growing intolerance, unemployment, terrorism etc are constantly making headlines with the furious junta expressing their medley of expressions, a worry that should mark an equal rage in the “bio-world” is the resistance against the biggest serendipitous blessing to the society- Antibiotics!

There are concerns flowing from every corner of the world about its overuse and neglected use turning it into a useless one for forever. Yes, it is as scary as it sounds but every evidence points towards an era where antibiotics are nearing an unfortunate end. While we come across campaigners for anti-vaccination and anti-GMO’s, there are a very few anti-antibiotics cries being raised. We have comfortably settled in our little tiny world around antibiotics and hardly peep outside the cocoon.

Diving into the kind of damage that might surface due to antibiotic overuse, our researchers have pointed out issues surrounding obesity, antibiotic resistance, bacterial mutations, internal organ damage, disturbances in the intestinal microbial environment and hence aggravating the growth of unwanted bacterial growth. The intimidating emergence of NDM-1 (New Delhi Metallo-beta-lactamase-1) cannot be forgotten easily. Though it was long back in 2009 that the bacteria had begun to display extreme mutations, its consequences need to be kept in mind.

There are concerns flowing from every corner of the world about its overuse and neglected use turning it into a useless one for forever.

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Inspite of well understanding the role of antibiotics and the imminent troubles due to their over usage, physicians have not changed their age old habit of scribbling cephalosporins or fluoroquinolones on their notepads.

“When antibiotics are needed, we select ones that are stronger than necessary and give them longer than required. We are learning that most common bacterial diseases require fairly narrow-spectrum antibiotics for a much shorter amount of time, such as three days to treat outpatient pneumonia and even one day for urinary tract infection,” says Susan Huang, MD MPH, Professor, Division of Infectious Diseases at the University of California Irvine School of Medicine.

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class of antibiotics are failing to deliver re-

quired results. Where have things gone wrong?

STATS AT A GLANCE • Over 700,000 deaths each year are due to drug resistance • 75% accepted that antibiotic resistance is one of the biggest problems currently • In India, an additional two million lives could be at stake by 2050 due to drug resistance.

• 53% patients use antibiotics with no valid prescription • 18% save unused antibiotics for later use • 25% physicians prescribe antibiotics to children with any fever, and 23% not aware of antibiotic use in such cases • 25% doctors tell patients to stop antibiotics as they get better, leading to increased in antibiotic resistance • 47% switch doctors when antibiotics are not prescribed • 72% believe that experts will bring in a solution to the problem soon

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Even the strongest

Antibiotic resistance- what is the government doing?

Realizing the increasing antibiotic resistance to infectious diseases like tuberculosis, malaria, urinary tract infection and even HIV, Indian Government is soon is going to issue restrictions on the prescription and sale of antibiotics. This might inturn compel physicians to follow certain rules and guidelines.

The initiative is part of the new global strategy, adopted by all member countries of the World Health Organization, to fight drug-resistant diseases. India is well ahead with the making of standard treatment protocol and DCGI all set with the guidelines in place, yet to be released.

“India is ready with the standard treatment protocol,” said Rajesh Bhatia, chief scientific advisor to the regional director, WHO SEARO. If government has the responsibility to set guidelines and protocols on the purchase and sale of antibiotics, even consumers and physicians have a role in keeping antibiotic

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FIVE KEY OBJECTIVES set by WHO’s global plan • Increase awareness and understanding • Reinforce surveillance and research • Lessen incidence of infection • Augment use of anti-microbial medicines • Guarantee sustainable investment in combating antimicrobial resistance

resistance at bay. While patients need to avoid self-medication, physicians ought to prescribe antibiotics in minimal dosage after proper analysis of antimicrobial resistance.

Further….

We are standing in an exclusive self-inflicted situation where antibiotic resistance is looming fast with new mutations in bacteria taking shape, and also a fear of illnesses and deaths rising. A recent survey by WHO highlights that around 75 per cent of Indians who took part in the survey think that colds and flu can be treated with antibiotics which is inappropriate. After the multi-country survey by WHO, involving 12 nations, 58 per cent of the respondents from India said that they should stop taking antibiotics when they finish the course as directed.

Further analysing the stats from India, 75 per cent nodded at antibiotic resistance being one of the biggest problems in the world and 72 per cent consider experts to solve the problem before it worsens.

According to the survey, almost 64 per cent of 10,000 people covered across 12 countries expressed they are aware of antibiotic resistance could be an issue affecting them, but how and what they can be done to avert it are not well understood.

Since the quality of life and treatments of modern medicine are hugely dependent on the antibiotics, people need to realise the consequences of the situation. We need to step in the right direction averting any further dire concerns. It is apparent from the statistics that India need to boost its awareness regarding antibiotic resistance. Since any misunderstanding about antibiotic resistance would pose a threat to the public health and as many also do not understand how to prevent it from growing, awareness seems to be a strong solution to rein in the situation.

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uman beings are basically constructed by a complex combination of genetic information. Taking this idea further, GeneSupport is an India-based company that aims to find solutions to various health related problems through the study of Nutrigenomics. Nutrigenomics tests are aimed at assessing the genetic make-up of individuals in order that they can then take steps to lead healthy and productive lives. The first most comprehensive panel is a combination of uniquely devised tests to create a genetic profile of the individual and to check its correlation with diet and effects on bodily functions. Gene Support is a collaborative venture of GeneOmbio Technologies Pvt. Ltd., DNALife, South Africa and Resilient Cosmeceuticals Pvt. Ltd. GeneSupport brings to you India’s first-ever Nutrigenomic Testing services.

Dr. Amol Raut embodies a scientist with one clear focus, helps to understand and prevent human diseases. It is his core belief in this domain that gives him a sense of gratitude for the chance to give people the gift of life through science. Dr. Raut’s deep understanding and vast experience of genetics has led him to be an expert understanding of the human body.

In conversation with Dr Raut, we have excerpts as;

Nutrigenomics is predicted as the dietary science of tomorrow. The technology of DNA analysis and Nutrigenomics is very well established and proven.

Dr Amol Raut

INTERVIEW Chief Executive Officer GeneSupport

Q. Could you tell us about GeneSupport in brief?

How are you connecting the dots between gene and diet?

A. The idea of Nutrigenomic services at GeneSupport was

born with the research we started in the field of predictive genetics around 4 to 5 years back. This was the time we started to develop the molecular diagnostics tests which could tell us about the presence of a particular disease in an individual and help to identify and diagnose the same. Having worked for a long time with illness we thought we should utilize this concept and strength of genomics and genetics in the field of wellness and that’s how we started working on genetics tests which could help us identify risk or predisposition of an individual to different lifestyle disorders. After working on this concept we then came up with few tests which could help us predict the typical association of genetic makeup of

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an individual and his risk to conditions such as diabetes type II, osteoporosis, cardiomyopathies or other lifestyle disorders. However, only detecting the strong association of an individual’s genetic makeup may not be sufficient, hence apart from understanding the risk and predisposition it is also necessary to understand which type of lifestyle or dietary modification would be helpful in avoiding lifestyle disorders. This is how the idea came into existence. The whole process is now followed by Analyze. Transform. Evade.

Analyzing the problem by understanding the genetic makeup, transforming the lifestyle with the help of diet, exercise and nutrient modification and Evading the situation.

Q. Could you brief on your association with Denmark and South Africa for bringing in GeneSupport to India?

A. We initiated Nutrigenomic testing almost

2 years back and we also launched a few panels; after getting a good response, we then thought of associating with a company who were already into Nutrigenomics in order to provide a wide array of Nutrigenomics services in collaboration in India. That is when the collaboration between with Denmark and South Africa with GeneSupport came in the picture.

Q. What is the importance and profundity of the concept at large?

A. Nutrigenomics is predicted as the dietary

science of tomorrow. The technology of DNA

analysis and Nutrigenomics is very well established and proven. It is being practised for a long time and is trusted to give practical solutions leading to tangible results. Medical professionals and patients can trust Nutrigenomics, as its emphasis is on dietary advices; based on combination of experience, routine analysis and strong genetic research and not on personal judgement. There is a strong association with Nutrigenomics concept and its relevance with lifestyle habits. This is actually the primary reason why we thought it is the right time for people to start utilizing the Nutrigenomic testing in order to modify one’s lifestyle. We all know that in today’s world the lifestyle has been shifted to a different category where we can see a clear difference in lifestyle in metros and lifestyle in other parts of the country. A lot of stress, mismanagement, lack of exercise and all these things are making a huge impact on human body in terms of affecting the different systems of human body; even rise in male as well as female fertility has been observed. Thus, lifestyle has a major role to play in the terms of stimulating us to launch Nutrigenomics which helps modify the lifestyle with help of tailor made diet. Hence it becomes very critical for everyone to understand this concept in the busy lifestyle everyone is going through.

Q. Since Nutrigenomics is new to India,

how well has the Nutrigenomics based solutions by GeneSupport been accepted by the Indian masses?

The idea of Nutrigenomic services at GeneSupport was born with the research we started in the field of predictive genetics. mag.biotecnika.org

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A. Nutrigenomics as a concept though not so

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well known, I am sure our well read Indians would surely pay a lot of attention to this upcoming field of health care. Indian population is affected by lifestyle disorders like diabetes, obesity and cardiac diseases on a large scale.

Thus, it becomes very important to educate people about Nutrigenomics and its power in tacking these lifestyle disorders. Talking about the acceptance of the technology, Indians are very receptive about the new concepts that come up, majority of the population shows positive response towards the concept, leaving very few that are not.

Q. What are your marketing strategies on taking “gene-based” counselling to people?

A. Before we started offering Nutrigenomics tests we did a strong

survey whether these kinds of services are available in the market today and how the response has been. The idea of Nutrigenomics was not very well known in the medical fraternity and hence in terms of gaps, it definitely was regarding the awareness and lack of information. For filling these gaps we initiated by publishing several newsletters circulated amongst medical practitioners, doctors, fitness experts by making them familiar with the idea of Nutrigenomics. We also conduct meetings by introducing this concept to the doctors, dieticians and fitness experts. The other gap was making other people aware of this concept and hence we have started arranging different camps and general lectures for different groups like social society & gatherings or corporate by making the process and concept simple.

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Q. Could you tell us more on how GeneSupport aids in alleviating the functional and chronic illnesses of individuals’?

A. GeneSupport helps in preventing lifestyle disorders like obesity, diabetes, cardiac diseases, breast cancer, food sensitivities (gluten and lactose intolerance). Genomics is also of great help in the sports field. Please find below the panels offered by GeneSupport.

GeneSupport Nutrigenomics prices vary with the number of genes analyzed and complexity of the condition for which the analysis is being done, as it would rope in multiple experts.

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> Weight Loss (DIET) Support – This panel is designed for people with weight maintenance issues, this panel enables individuals to optimize weight management approaches (weight loss or weight gain) > SPORTS Support – This panel is aimed at all the professional athletes and sports person, this panel helps the individual to devise training programs suited to their body backed by a highly focused nutrition program > HEALTH Support (For Heart diseases, diabetes, osteoporosis and other issues) – This “must-do” panel for every individual provides in-depth information from 29 unique genes to help make well informed dietary and lifestyle choices. Health Support also help us in understanding the possibility of reducing the risk of lifestyle disorders like Obesity or Diabetes or manage them in individuals already suffering from the same. > Female infertility and cancer (OESTROGEN) Support – Specially designed for women to manage risk of cancers through diet modifications related to Oestrogen metabolism. This panel also helps females to manage and infertility related issues based on correcting the oestrogen metabolism, and dietary and simple exercise interventions required for the same. > Gluten Intolerance The adverse effects of gluten can vary from simple or stubborn acne to severe infertility related complications. The test provides an understanding on whether a person has a genetic tendency towards sensitivity to gluten. It helps in understanding the correlation between gluten and associated (though lesser-known) issues such as infertility, PCOS, acne, etc > Lactose Intolerance People who are lactose intolerant suffer from bloating, pain or cramps in the lower belly, diarrhoea, gurgling or rumbling sounds in

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India is slowly taking up to Genomics and Nutrigenomics.

the lower belly, vomiting. Around 70 percent Indians are lactose intolerant. This panel helps in identifying, analysing and in curing this food sensitivity.

Q. How affordable are the plans and packages offered by GeneSupport?

A. GeneSupport Nutrigenomics prices vary

with the number of genes analyzed and complexity of the condition for which the analysis is being done, as it would rope in multiple experts. Hence the price range varies from Rs 4500 to Rs 26000 depending upon the test panel to be analysed, where the Rs 26000 is the most comprehensive panel that covers almost all health related issues in all age groups.

We are also working on optimizing alternative technology forms for genetic testing, so that the prices can be brought further down as it would benefit many people.

Q. What are your future plans and strategies for the upcoming products?

A. We are planning to launch a PCOS (Poly-

cystic Ovarian Syndrome) panel soon.

One in every 10 girls is suffering from PCOS in India. There is not much knowledge about PCOS. In fact, there is a lot of misinformation that is spread regarding PCOS.A proper diet and lifestyle can help control PCOS effectively. We are working towards launching a PCOS Panel and educating the masses about PCOS.

Q. Do you have any competitors in this field currently in India?

A. India is slowly taking up to Genomics and

Nutrigenomics. Companies like Map my Genome, X code and Adam’s Genetics are also working towards spreading the importance of Nutrigenomics in India.

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CRISPR CAS9 IN BIO-AGRICULTURE Will it be crushed under the GMO regulations?

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n India, Sukhlal is worried of his mildew filled wheat; In Africa, Waldo is fearful seeing the blight affected potatoes; In Chili, Mike is crying holding his rotten sugarcane! Have you ever listened to these farmers? Most of them are visibly anxious at their crop loss. Their worries have no end as crop disasters are increasing with rising global warming and subsequent climate change. Crops are drought stunted, flood affected, and insects and pests are feasting on these susceptible plants. And, if we allow this crop loss to continue, the situation might become horrific. If we don’t feed the world, the world will feed on us!

Though agriculture experts are trying ways to increase the productivity with better production techniques, the rapid human population growth stands as a stumbling block. The United Nations experts say global food production will have to double by 2050, as the world population is expected to go well beyond 9 billion. And looking ahead the diminishing arable land, growing conditions will only get harsher.

Then! Is there a way to feed the growing population? Among the many solutions which keep coming up from the research table, one appears to be on its way. The so-called CRISPRCas9, the ‘knock out’ and ‘knock in’ gene editing technology, the latest storm in bio-agriculture is very close to being on the market. This could be the key to feeding the planet. The tool invented by the scientists of Unites States and Sweden in 2012 revolutionizes the way scientists can examine and manipulate the plant genetic processes.

A miraculous second green revolution on its way!

It’s easy, it’s fast, and it’s efficient! It’s highly specific, allowing scientists to zero in on a single gene and turn it on or off, remove it or exchange it for a different gene. It’s a wonderful technique for rewriting the genome. Its speed and simplicity

Norman Borlaug took two decades to come out with a better hybrid wheat variety; but this new genetic engineering tool is simply fast!

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have momentous implications for agriculture. We are talking about making of plants that can withstand what an increasingly overheated nature has in store.

“Researchers have glommed on to it and already published more than 150 related scientific papers, and the publication rate is accelerating”, says Jennifer Doudna, one of its inventors from University of California. Biologists and geneticists are confident it can help us build a second Green Revolution—if we’ll let them in.

During 1940’s, Norman Borlaug, regarded as the father of green revolution took two decades to come out with a better hybrid wheat variety; but this new genetic engineering tool is simply fast! With CRISPR Cas9, we can compress the development cycle to a few days or weeks, as we can now process, store and compare vast quantities of genetic data quickly and cheaply. Researchers at Kansas State University have sequenced the first and toughest of wheat’s 20 chromosomes and that one chromosome is far more complex than the entire rice genome. They say they’ll be able to do the next 19 in three years. It’s quick!

CRISPR Cas 9 has to be seen as an alternative to classical plant breeding and transgenic (GMO) methods to improve crop plants.

Is CRISPR Cas9 a transgenic GMO? Under current regulations, a GMO is a living organism that has been altered by a novel combination of genetic material, including the introduction of a transgene.

GM crops are plants used in agriculture, the DNA of which has been modified using genetic engineering techniques. But it is to be noted that, GMO is a regulatory definition than a ‘science term’. The science literates should also understand that all agricultural crops have had undergone genetic modifications at one time or the other. A recent study describes how the agrobacterium naturally altered the genome of sweet potatoes, making them edible, some 8000 years ago. Techniques like artificial selection for breeding and mutagenesis do this very randomly and at the whole genome level. Hence, genetic modifications need not be seen ‘just artificial’, as propagated to the public.

It is also critical to note that CRISPR Cas 9 is not a transgenic GMO. It has nothing to do with creating a new species. Hence, this new tool has to be seen as an alternative to classical plant breeding and transgenic (GMO) methods to improve crop plants. It is to be seen as a tool

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The new tool is revolutionary, as genetic modifications look just like genetic variations resulting from the selective breeding that farmers have been doing for millennia. that helps plants adapt to new environments by fine-tuning their own genetic traits, using their own genes from plants they would naturally breed with. As the tool targets a tiny segment of a plant’s DNA, the plant stays the same species, technically, even the same genotype.

It will only accelerate the natural plant processes. The new tool is revolutionary, as genetic modifications look just like genetic variations resulting from the selective breeding that farmers have been doing for millennia.

Will CRISPR-Cas9 be regulated under the GMOs? CRISPR Cas9 uses a single guide RNA (sgRNA) to identify and edit the target gene and Cas9 (a protein) then cleaves the gene, resulting in site-specific DNA double-strand breaks (DSBs). When the cell repairs the DSB, the resulting fix is the intended genetic edit. But the process can introduce bits of foreign DNA into plant genomes.

If in any case, the CRISPR Cas9 introduces bits of foreign DNA into plant genome, some jurisdictions, such as the European Union, could decide to classify such plants as GMOs, making their acceptance by regulatory bodies debatable. Similarly, using agrobacterium to deliver the CRISPR-Cas9 system into cells automatically requires the legal GMO designation in America, as the Cas9 gene and fragments of the Agrobacterium’s genome can end up in the final crop.

However, there are latest developments in the field. The IBS researchers of Center for Genome Engineering, South Korea have elevated the process, and no longer uses DNA. Kim and his team tweaked the technique so that it can delete specific plant genes without introducing foreign DNA, creating plants that he and his colleagues think “might be exempt from current GMO regulations”. Bioethicist Tetsuya

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Ishii at Hokkaido University in Sapporo, Japan, who has extensively studied the framework of regulation surrounding genetic engineering in plants depicts it as a milestone work for plant science, The IBN researchers wants to use the technique to edit the Cavendish variety of banana, which is struggling to combat a devastating soil fungus, and at the fear of extinction. The IBS team’s technique of genome editing without inserting DNA could be revolutionary for the future of the seed industry. The process will enable us to produce plants that are heartier and more suited to climate change.

The application of the Cas9 RNP gene editing technique could be the next step in ending food shortages, being unshackled from GMO regulations.

A proposal for new regulatory models CRISPR/Cas9 raises a regulatory issue by creating indistinct boundaries in GMO regulations because the advanced genetic engineering can simply pluck out a short DNA sequence or add a mutation to an existing gene. Considering the development with the new tool, the scientific community shall propose new regulatory models for genome-edited crops and declare a call to action for clarifying the issues associated with such genetically engineered crops. It is unclear what stance regulatory authorities will take on CRISPR-edited plants. But if there is a way to genetically modify plants using CRISPR-Cas9 without the addition of DNA, the resulting genome-edited plants need to be exempted from current GMO regulations and given a warmer reception by the public.

But, do we let them in?

It’s a question to the consumers. An agricultural technology will be successful only if the consumers buy in. Indeed, it is produced for them! But the public and scientists are at odds over the safety of genetically modified food. The activists have created the erroneous perception on transgenic GMOs to the public. In this context, will the scientific community be able to convince the public that CRISPR Cas9 is not a transgenic, or in their words, not a ‘GMO’. Will the pro-environmentalist allow the scientific community to make it reach the market? Or will it be crushed by the anti GMO campaigners, as happened with other GM crops? Let’s cross our fingers; let’s see what defines our regulations--fear or science?

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An agricultural technology will be successful only if the consumers buy in.

Indeed, it is produced for them!

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Approx 75% of breastcancer is hormone-receptor positive meaning their growth may be fueled by female hormones.

Did You Know that healthcare cost associated with obesity is €59 billion a year in Europe?

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India is the 3rd largest producer of chemicals in Asia & the 6th largest in the world.

Kudos to the CSIR for launching an affordable herbal drug that helps in the management of Type 2 Diabetes.

POWER TWEETS

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COVER FEATURE

the first

Making of Aeka Biochemicals Pvt. Ltd.

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WOMEN OWNED BIOTECH START-UP

THE EVERYDAY OBJECTIVE IS TO CREATE SOLUTIONS THAT MEET AND SATISFY SOCIAL AND

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ENVIRONMENTAL NEEDS.

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Cover

Aardra and Gayathri are racing the success bandwagon with a mission to promote women entrepreneurship and provide a platform for the development of young talent in biotechnology, biochemistry and life sciences

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feature

the first

women owned Aardra Chandra Mouli Director, Aeka

Aeka is a long-cherished dream that began from our second year at Sree Chitra Thirunal College of Engineering, Trivandrum

BIOTECH START-UP

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long cherished dream and passion of a duo which had begun to take shape four years ago after their graduation in Biotechnology, has today turned into the first fully women-owned biotech company in India.

“Along with the idea to start a company of our own, the lack of placement opportunities after graduation via campus recruitment was a contributing factor to our determination to become job-creators instead of job seekers,” says Aardra Chandra Mouli, one of the founders at Aeka Biochemicals. Aardra Chandra Mouli and Gayathri Thankachi V. are the two biotechnologists who have laid the cornerstone for the making of a biotech company involving biochemical manufacturing in Trivandrum (Kerala). It was in 2014 that Aeka took shape, and in a span of one year the

Aardra and gayathri with Kris Gopalakrishnan

Gayathri Thankachi V Director, Aeka

There was not exactly one single big challenge, but a series of smaller challenges that we had to face....

Making of Aeka Biochemicals Pvt. Ltd. EXCLUSIVE INTERVIEW WITH

Aardra Chandra Mouli & Gayathri Thankachi V company already has many accolades in its bag. Aeka was shortlisted and selected for the Kerala State Entrepreneur Development Mission scheme of the Government of Kerala in association with the Kerala Financial Corporation (KFC).

Science and technology might be on its heels, but when it comes to women entrepreneurship, we would definitely, at least once, come across raised brows, with questions on competency being raised often. Proving it wrong are Aardra and Gayathri who are racing the success bandwagon with a mission to promote women entrepreneurship and provide a platform for the development of young talent in biotechnology, biochemistry and life sciences.

While pursuing bachelors in Biotechnology and Biochemical Engineering at Sree Chitra Thirunal College of Engineering, Trivandrum, Aardra, Gayathri and their classmates from Biotechnology and Biochemical Engineering had then conceptualized Aeka, the first fully women-owned biotech and biochemical start-up venture. Aardra and Gayathri moved on to gaining some work experience in biotech and biomedical product management and marketing respectively.

While Gayathri joined a leading stem cell banking company, Aardra worked at a currently one of the largest transfusion manufacturers in the world and later completed her master’s degree in management from Warwick Business School in UK. It was in 2014 that the duo had finally taken the plunge and founded Aeka Biochemicals Pvt. Ltd. With a dedicated, passionate and innovative team to support the effort and create a friendly work environment, the start-up took off with much confidence and optimism. Experienced guidance and mentoring came in the form of Dr. V.P. Potty along with his 42 years of research experience and over a hundred published papers. Leading the team in the right direction were Nidhin Sreekumar, head of Aeka’s scientific team and Jayaram K, the lab head.

The scientific team, under the able leadership of Nidhin Sreekumar, takes every effort to develop and manufacture products that are

aimed at being useful to the common man.

This social dedication is the basis for the choice of areas in which Aeka plans to be active.

Challenges and further…

Though the state of Kerala happens to be a place with very few start-ups and quite a few challenges in store, it did not dampen the spirit of the team from moving ahead.

Kerala has not treaded much on the biotech road but Aardra and Gayathri looked at it as an opportunity to explore the wide-spread options on the road untaken. Aeka’s broader goal was also to help in establishing and developing Trivandrum and Kerala as strong biotech and bio-related industrial centres.

As we move onto the challenges faced by a biotech start-up, “There was not exactly one single big challenge, but a series of smaller challenges that we had to face during the initial phase of starting up Aeka,” says Gayathri.

Lack of a single portal of comprehensive information regarding statutory, regulatory and legal procedures stood to be a major obstacle while setting up the company.

Fostering Aeka’s presence: Aeka’s prime focus is on building green solutions. The company is into manufacturing biotechnological, biochemical and enzymatic products, chemical products or extracts of biological origin, to be applied directly or indirectly in the development of products for

We at Aeka aim to establish ourselves as a company that addresses current needs that are relevant to local as well as global consumers.

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Team Aeka:

Aeka’s first product range, the Sasya series of microbial plant growth promoters, for safe and chemical-free farming was launched in October 2015, by Shri. Kris Gopalakrishnan, co-founder of Infosys.

The Sasya range of microbial plant growth promoters from Aeka Biochemicals Pvt. Ltd. is a series of microbial consortia of selected species of naturally occurring soil microorganisms developed and tailored towards the needs of different scales and types of farming. With organic farming and food security movements gaining momentum in India, the Aeka team believes that the Sasya series holds much significance. .

What’s in store for the future?

Aeka envisions to be a global player in the next 25 years. The company also aims to diversify and spread wings into agriculture support, and environmental remediation.

With the unfaltering support extended by the team, along with their experience, Aeka has plans to develop customized plant growth promotion products and to develop an

As a very young organisation with young talent on board, the vibe at Aeka is dynamic and open.

‘

relevant uses.

It was in January 2015 that Aeka’s laboratory and small-scale production facility at Vazhuthacaud were established. Followed by this, Aeka Labs, the marketing wing of the company, for market research and promotion, was launched.

And in July the initiation of lab-scale production and testing for Sasya range of products had taken off, standing to be a major milestone.

“Our newly revamped website was launched in September of this year, which helped us establish our online and social media presence more concretely,” says Aardra

Maximising our contribution to the community while staying green forms the bedrock of all our efforts.

innovative and eco-friendly technique for small-scale waste water recycling based on biochemical and microbial methods that employ the application of indigenous materials.

Gayathri and Aardra are proud to be handson entrepreneurs, and are passionate about creating a friendly work atmosphere that fosters creativity, teamwork, innovation, and unity. They are determined on making a contribution to Indian manufacturing and on promoting research for the betterment of mankind. The “environment-first approach” is laudable and hope the duo succeeds in their objectives very soon.

Biotecnika Magazine had an exclusive conversation with these two women entrepreneurs and the excerpts are as;

Q

Aeka Biochemicals Pvt. Ltd. has been addressed as the “first only women biotech start-up.” What inspired you to conceptualize Aeka?

Aardra: Aeka is a long-cherished dream that began from our second year at Sree Chitra Thirunal College of Engineering, Trivandrum.

The idea of starting a company of our own was something a group of us from the 200711 batch of Biotechnology and Biochemical Engineering had been extremely interested in, and the lack of placement opportunities after graduation via campus recruitment was a contributing factor to our determination to become job-creators instead of job seekers.

Q

‘

Could you briefly tell us about your journey from Sree Chitra Thirunal College of Engineering to Aeka Biochemicals Pvt. Ltd.?

Gayathri: After completing our B. Tech., Aardra and I worked in biotech and biomedical product management and marketing respectively.

I joined a leading stem cell banking company.

Aardra was a part of what is now one of the largest transfusion manufacturers in the world, before going on to complete her masters in management from Warwick Business School, UK, where she attended with a full scholarship. In 2014, we decided to take the plunge, and start Aeka.

Q

What is Aeka Biochemicals exclusively into?

Aardra: At Aeka, our focus is on green solutions. The everyday objective is to create solutions that meet and satisfy social and

environmental needs. We undertake the manufacture of biotechnological, biochemical & enzymatic products, chemical products or extracts of biological origin, which can be applied directly or indirectly in the development of products for relevant uses. We believe in putting the environment first - in the heart of the city, Aeka’s Vazhuthacaud facility is optimised so as to be eco-friendly, pollutant-free, and a green, zero-effluent zone. The lab and manufacturing unit are equipped for microbiology, biotechnology, quality control and chemical (wet lab) work.

Our efforts are centred around meeting the needs of the local community, and then broadening the focus outwards to adapting the products and solutions developed at Aeka to wider areas of application. We have taken a conscious decision to start small, and to do all that is in our power to minimise waste and energy loss at our facility. Maximising our contribution to the community while staying green forms the bedrock of all our efforts.

Q

What was the one big challenge that you had to overcome to make Aeka a success?

How did you overcome it?

Gayathri: There was not exactly one single big challenge, but a series of smaller challenges that we had to face during the initial phase of starting up Aeka. A significant challenge was the lack of a single portal of comprehensive information regarding statutory, regulatory and legal procedures to be followed while setting up a biotech company.

Women in Kerala are highly intelligent, educated, and capable, so the concept of women pursuing their dreams is definitely well-accepted in our state.

Another difficulty we faced is due to the expansiveness of biotechnology and the life sciences, and the lack of public awareness regarding our field – the one-size-fits-all approach in regulatory requirements to be fulfilled seen sometimes does not take into consideration the distinctive nature of the activities of a biotech and biochemical company. With the help of expert advice from our mentors, guides and supportive local authorities, we were able to successfully overcome these and similar obstacles.

Q

Was being “just two girls” an obstacle while setting up your company?

Aardra: As you know, women in Kerala are highly intelligent, educated, and capable, so the concept of women pursuing their dreams is definitely well-accepted in our state. Due to our gender and relative young age, we have on occasion been asked hilarious questions like “who’s your manager?”, “who actually runs the company?”, and “why aren’t you girls married instead of running around like this?”.

However, on the whole, we would say that we have received encouragement, kindliness and consideration in the majority of our interactions with authorities, clients and the general public.

Q

Could you tell us about Aeka’s revenue model?

Gayathri: As mentioned earlier, Aeka is a smallscale manufacturer of biochemical and microbial products. The revenue model adopted is the production model, wherein the company manufactures and sells its products to target customers, thus generating revenue.

Q

It has been a year since Aeka had taken shape. How has the progress been till now?

What plans are in store to keep moving on the success road?

Aardra: Aeka Biochemicals Pvt. Ltd. was incorporated in June of 2014. On 3rd October 2014, the Princess of Travancore HH Aswathi Thirunal Gouri Lakshmi Bayi inaugurated the official start of Aeka’s operations. In November of last year, Aeka was shortlisted and selected for the Kerala State Entrepreneur Development Mission scheme of the Government of Kerala in association with the Kerala Financial Corporation (KFC).

In January of 2015, we began the establishment of our laboratory and small-scale production facility at Vazhuthacaud, Trivandrum. February of this year witnessed the introduction of our marketing wing – Aeka Labs – that handles the marketing activities and market research. Aeka Labs is also responsible for the market promotion of our bioproducts.

On the first of June 2015, scientific work at the company’s newly established laboratory was flagged off.

July 2015 marked another major milestone for Aeka – the initiation of lab-scale production and testing of what has evolved into its Sasya range of products.

Our newly revamped website was launched in September of this year, which helped us establish our online and social media presence more concretely.

And, in October 2015, celebrating the first anniversary of Aeka’s inauguration, Aeka’s first product range, the Sasya series of microbial plant growth promoters – for safe and chemical-free farming – was launched. The product range was launched by Shri.

Kris Gopalakrishnan (Co-Founder, Infosys) at a function attended by luminaries of the business and scientific communities of Kerala.

Q

Could you tell us more about Sasya series of microbial plant growth promoters for safe and chemical-free farming?

Gayathri: The Sasya range of microbial plant growth promoters from Aeka Biochemicals Pvt. Ltd. is a series of microbial consortia of selected species of naturally occurring soil microorganisms developed and tailored towards the needs of different scales and types of farming.

The range consists of the following products, each being specially formulated and tested for specific target crops and modes of application: • Sasya Sutra - for nursery and garden use, via seed and root treatment • Sasya Mitra - for kitchen, home or terrace gardens, and small farms, via foliar application • Sasya Raksha - for gardens, and farms, via foliar application • Sasya Poshak - large farms, via seed, root and foliar application • Sasya Poshak+ - plantations, via seed, root and foliar application The Sasya range of products are now available at Agro Bazaar (opposite Fort Mission High School, Trivandrum), a unit of Kerala Agro Industries Corporation. They can also be purchased directly from Aeka Biochemicals Pvt. Ltd. (Contact: +91 94976 99919 / aeka.care@ aekabiochem.com)

Q

Could you give us an insight on the future projects in store by Aeka? What are your plans for scaling up?

Aardra: As mentioned earlier, we at Aeka aim to establish ourselves as a company that addresses current needs that are relevant to local as well as global consumers. With organic farming and food security movements gaining momentum in India, the Sasya series holds much significance.

Aeka’s first year was focused on the successful set-up of our facility and the development of

our MB-PGP range. The Aeka team, with excellent input from our scientific head, Nidhin Sreekumar, and our lab head, Jayaram K., and the expert guidance of our mentors Dr. V. P. Potty and Shri. G. Ravichandra Mouli, has some interesting plans for the next two years.

Our R&D pipeline for 2015-17 includes plans for more custom-made plant growth promotion products, and a green solution that we are highly enthusiastic about - the development of an innovative and eco-friendly technique for small-scale waste water recycling based on biochemical and microbial methods that employ the application of indigenous materials.

Q

What is your mantra for an efficient, hassle-free running of the organization?

Gayathri: As a very young organisation with young talent on board, the vibe at Aeka is dynamic and open. We believe in actively striving towards developing and maintaining a happy and positive workplace. The Aeka team is passionate about creating a friendly work atmosphere that fosters creativity, teamwork, innovation, and unity. This in turn helps our efforts to manufacture products that are aimed at, and useful for, the common man.

Q

Would you like to say something about Kerala being the home for starting up Aeka Biochemicals Pvt. Ltd.? How supportive was the Government?

Most people were of the opinion that we were stacking the odds against ourselves, starting our company in Kerala. We are both from Trivandrum, and we believe everything needs to start somewhere! Why not Kerala?

The start-up environment in Kerala for biotech and bio-related companies may not not as conducive as it may be in cities like Bengaluru, Hyderabad, Mumbai or Pune, and the support available is less than it is in places where the domain of biotech is well established. We are just waking up to the possibilities of biotech here in Kerala. But that means that we can do

something different, try out innovative ideas, and forge our own paths. We like to see this as an advantage.

The Government of Kerala has several schemes in place for the benefit of young entrepreneurs and women entrepreneurs. For example, we were selected for the Kerala State Entrepreneur Development Mission scheme of the Government of Kerala in association with the Kerala Financial Corporation (KFC), which helped us add to the equipment that we required in setting up our laboratory. This was definitely beneficial, as this field is comparatively quite capital-intensive. The Women Entrepreneur (WE) Mission of the Kerala State Industrial Development Corporation (KSIDC) is another programme launched by the Kerala Government for women entrepreneurs aiming to start micro and small enterprises. We were selected by KSIDC to showcase our start-up and our products at the WE Summit 2015, under the WE Mission.

Q

What do you think are the major roadblocks faced by Biotech Startups in the country?

Funding, availability of trained, qualified and skilled talent, intellectual property protection, and a clear and conducive regulatory system for the establishment of innovative biotech ventures are all areas which have major impact in promoting the biotechnology and allied sectors in India.

Q

Do you think there is a decreasing interest among students to opt for biotech or biosciences?

We believe that those who are interested in biotechnology and life sciences are still

opting for courses in their preferred fields.

In our opinion, the availability of a fresh and talented pool of new graduates as well as experienced recruits is a strength and advantage that India has not yet been able to fully tap.

Q

Would you like to comment on the employment opportunities in the biotech industry?

A disadvantage that we face in our country is the constant comparison of all fields with the mainstream, “safe” choices of employment that are currently available. The vastness of the biotech industry, the amazing range of opportunities and focus areas present within this particular field, and the complexity of each of these areas are not appreciated by the majority of us. These characteristics of the biotech and allied industries often cause them to be viewed as a ‘risky’ option for a longterm career, and may have led the general public to label biotech as a “trend”, and predict a short lifespan for it. After all, the issue of insufficient employment opportunities for the constantly growing number of graduates is not just restricted to the biotech industry.

Q

Do you wish to give out a message to the young entrepreneurs of biotech industry?

There is a quote by a truly great Indian that has been an inspiration to entrepreneurs everywhere: “My message, especially to young people, is to have courage to think differently, courage to invent, to travel the unexplored path, courage to discover the impossible and to conquer the problems and succeed. These are great qualities that they must work towards. This is my message to the young people.”

- A. P. J. Abdul Kalam

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In Conversation with

Dorothy Lou

Business Development Lead

Transcriptic

T

ranscriptic is a robotic cloud laboratory for molecular and cell biology. Their cloud-based platform enables experimenter’s everywhere to design, test and run experiments via their laptop. These experiments are then executed on high-end, standardized hardware with real-time control and feedback. Transcriptic has become a key platform for biotech companies in the Bay Area and around the world. The company has been particularly successful at reducing the average time and money that is spent to bring a product to market. Currently, it takes approximately 12 years and billions of dollars to get a new drug through the FDA and into the market. According to Transcriptic, its services enable scientists to work remotely with a wide range of data and its automated equipment can produce low-cost results in just a few days. While there’s a lot involved in getting a life-saving drug on the market, this could greatly reduce the time and cost involved, which means faster, cheaper cures for you and me.

Transcriptic recently moved into a new 22,000 square-foot facility in Menlo Park, California which gives it a bit more room to grow and the ability to introduce additional services like BSL-2 workflows, more cell-based assays and eventually medicinal chemistry.

‘

We, at Biotecnika had the opportunity to talk with Dorothy Lou Bailey from Transcriptic, the excerpts of which are listed as below:

Transcriptic was born out of a frustration with the current lab model.

‘

Our mission is to enable two post-docs with a laptop in a coffee shop to start a drug company.

Dorothy Lou has led Business Development at Transcriptic from January 2015 until September 2015. She focuses on building relationships in the BioPharma and Synthetic Biology sectors and draws from her extensive experience in the life science industry. Previously, Dorothy Lou led business development at Science Exchange where she brokered strategic partnerships across corporate, government, and medical organizations. She continues to advise companies out of QB3, Rock Health, Janssen Labs, and Indie.Bio in addition to being a founder herself. Dorothy Lou graduated with Distinction from Duke University with a BS in Molecular Biology & Biochemistry.

Q. How did the idea of Transcriptic conceptualize?

A. Transcriptic was born out of a

frustration with the current lab model. Grad students spend 60-70% of their time executing experiments and only 20-30% of the time on design and analysis. Automation is an excellent way to shift the time spent on low value tasks and make that time available for high value tasks. Additionally, automation can remove some of the irreproducibility

of manual execution, thus providing higher confidence in results.

Q. How smooth was the journey from an idea to the implementation of Transcriptic, which currently works with dozens of prestigious customers?

A. Like all company origin myths, this is kind of a long

story. The trivial answer (“we raised a $1.2M seed round in 2012 to build a prototype”) is not the interesting one.

I will say that we didn’t spin out of a university and we didn’t come into the company with significant contracts or IP, so we looked more like a web start up than a biotech one in the early days. - Direct from MH Q. Could you tell us more about how Transcriptic stands out from the other biotech/ life science companies in the market?

A. Our mission is to enable two post-docs with a laptop

in a coffee shop to start a drug company. We believe that the high costs of research and barriers to entry radically constrain the kinds of questions we’re asking and the quality of results that we’re getting. Our modular, scalable platform enables organizations of all sizes to do more discoveries at lower cost with substantially higher reproducibility.

Q. Will the robotic automation take a toll on the employment opportunities?

A. We don’t believe so, with what companies are able to

save in capital equipment and other fixed costs they now have the ability to ask more questions. Automation enables humans to solve problems faster and will create better and higher value employment opportunities.

Q.. Does Transcriptic outsource its Robotic automation technology?

A. Transcriptic’s in-house innovation is around in-

creasing the functionality of lab tools. We do not have in-house life science research and thus will never have a conflict of interest with our clients.

Q. Are there any plans of global expansion?

A. Transcriptic currently works with scientists and

companies across the globe from Singapore to Germany.

The beauty of a cloud-based platform is that we have been global-ready from day one. That being said, you may see new operational locations coming online as we continue to grow and meet the logistical needs of our partners.

‘

Automation enables humans to solve problems faster and will create better and higher value employment opportunities.

BIOTECNIKA MAGAZINE

Miracle plant to aid food production in space

Inter Bio

I

f an astronaut, accidently left behind on Mars, subsequently growing potatoes on the red planet for survival (Ridley Scott’s movie “The Martian”) sounds convincing, so does the work of Peter Waterhouse, a plant geneticist, who also believes in taking food production to outer space. Far from harvesting on land but on a similar mission, were a team of Australian scientists, who have recently discovered a gene from a magical plant with potential to change the face of agriculture. To be precise, agriculture in space!!

The gene identified in an ancient plant is believed to pave way for food production that too in outer space, specifically during longer human space missions.

Professor Peter Waterhouse, a plant geneticist at the Queensland University of Technology, discovered the gene in the ancient Australian native tobacco plant Nicotiana benthamiana. The discovery was made while he was trying to trace the history of the plant, which has been used by geneticists as a model plant upon which to test viruses and vaccines, for decades.

“This plant is the ‘laboratory rat’ of the molecular plant world. We think of it as a magical plant with amazing properties,” he said. “By sequencing its genome and looking through historical records, we have been able to determine that the original plant came from the Granites area near the Western Australia and Northern Territory border, close to where ‘Wolf Creek’ was filmed,” he explained.

This ancient plant was identified to have survived in the wild for around 750,000 years.

“What we found may have a big impact on future plant biotechnology research. We have discovered that it is the plant equivalent of the nude mouse used in medical research,” added lead

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stell ar o tec hnology

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The recent film “The Martian” which involved an astronaut stranded on Mars growing potatoes while living in an artificial habitat, had a bit more science fact than fiction than people might think

researcher Julia Bally.

The plant has the ability to germinate and grow quickly, rapidly flower, and set seed after even a small amount of rainfall. “Its focus is on creating small flowers but large seeds and on getting these seeds back into the soil in time for the next rain,” Bally noted. The plant also has figured out how to fight drought in order to survive through generations.

With this discovery in hand, scientists wanted to use it to investigate other sterile growing environments where plants were protected from disease and the leading option was ‘space’.

“The recent film “The Martian” which involved an astronaut stranded on Mars growing potatoes while living in an artificial habitat, had a bit more science fact than fiction than people might think,” professor Waterhouse informed.

The discovery also holds importance for future genetic research on Earth as well.

“Scientists can now know how to turn other species into ‘nude mice’ for research purposes. So just as nude mice can be really good models for cancer research, ‘nude’ versions of crop plants could also speed up agricultural research,” he said.

Since N. benthamiana variety from central Australia had doubled its seed size, it made way for investigations into how N. benthamiana could be used commercially as a biofactory, as seeds were an excellent place in which to make antibodies for pharmaceutical use.

Be it agri-research on land or in space, it is apparent that future plant biotechnology research is going to witness changes in leaps and bounds. All we have to do is wait and watch!

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Be it agri-research on land or in space, it is apparent that future plant biotechnology research is going to witness changes in leaps and bounds.

some of the ‘out of space’ experiences include:

>> If colonizing other planetary bodies is what our space research is up to then one major hindrance stands to be the basic life support systems. Recycling of air, water, and food is what we are talking about. Replenished the same through microorganisms and plants has recently hit news. The concept might be well discussed over years but what’s new today is the application of synthetic biology.

Scientists based at NASA Ames Research Center and the University of California at Berkeley came in with the concept of placing synthetic biology at centre stage for the making of food and air and placing other activities like synthesis of polymers, and production of pharmaceuticals also in line for further examination. >> Another potential application of biotechnology for space include the research as done by Leo Marcelis and Sander van Delden. They started with the setup of a cultivation system for fundamental plant research on the ISS (International Space Station) to enable plant growth either without gravity or with the gravitational conditions found on the moon, Mars and on earth. With an objective to provide the scientists of ISS with good food, these Wageningen scientists are exploring into consistent ways of providing the plant with the correct ratio of water and nutrients in space like conditions. It is difficult to search for the perfect substrate in which the roots can grow as materials behave contrarily in space than on earth. >> Wieger Wamelink, also from Wageningen, working on another project, efforted on cultivating plants on soil which is similar to that found on moon and mars.

Though various crops managed to flower on the Mars soil, Moon soil was not a hit.

Further with the help of organic material, both were successful. Also importance of worms and bacteria for the breakdown of organic material and nitrogen fixation in the air was noted to have a greater implication. >> Tom Dueck from Wageningen will be determining the right cultivation systems and conditions along with analysing the optimal temperature, moisture and CO2 required for cultivation. >> Earlier in 2014, a plant growth chamber by name “Veggie” was designed by NASA and ORBITEC to expand in-orbit food production capabilities in space. It is considered to be a resource for the food growth and consumption by astronauts.

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Co-founder:

In Conversation with Dr. Shiladitya Sengupta

• • • •

Invictus Oncology Mitra Life sciences Vyome Biosciences Cerulean Pharmaceuticals

D

r. Shiladitya Sengupta, an assistant professor in Harvard Medical School is many of those innovators who believes in bringing a successful experiment to the utility of a patient than being left out as a mere research abstract or a publication. Standing on the same belief he has co-founded various start-ups such as Invictus Oncology, Mitra Life sciences, Vyome Biosciences and Ceulean Pharmaceuticals. He also serves as the co-chair of the Center for Regenerative Medicine at the Brigham and Women’s Hospital.

An alumnus of AIIMS, India, University of Cambridge and MIT, he is the man behind “nanocells”, an innovative step towards cancer treatment. This drug delivery device developed during his postdoc at MIT consists of a lipid sphere about 200 nanometers wide surrounding smaller, biodegradable polymer spheres. These nanocells have been proved to be effective in mouse models of melanoma and lung cancer.

Since the polymers and drugs utilized to design these nanocells are already approved for human use, doctors can quickly move them to clinical trials.

Apart from this, he also holds many esteemed recognitions such as being listed in the top 35 young innovators in the world by Technology Review Magazine, recipient of the Indus Technovator

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The major challenge was the lack of ecosystem. I was lucky that there were people who were willing to listen and try taking the risk. We worked together to create the ecosystem.

Award, featured on the cover page of many internationally proclaimed magazines etc. He has also been awarded the $4M Era of Hope Award by the US Department of Defence, and more recently selected for the US DoD Innovator Collaborative award with Erkki Ruoslahti and Roger Tsien (Nobel Prize winner). In conversation we have;

Heading the helm of a series of start-ups, how do you take along such large responsibilities?

A. Its all about getting the right team. It does mean a lot of hard work, but then my co-founders and everyone in the start-ups have rolled up their sleeves and are making it happen. There are not many companies in the world that can take a drug from an idea to the clinics in just a year. Vyome, for example, did that for a product for treatment of acne that is not responding to antibiotics.

How did you take a leap towards entrepreneurship?

A. It’s a continuation of the science I do. The idea of research is to help mankind in the end.

For me, research doesn’t end with a publication, it ends with curing a disease one patient at a time, and the only way that can be achieved is by starting companies that can advance the product to the patients.

It is certainly a huge amount of achievement with recognitions such as innovator of nanocell and many awards under your belt. What keeps you inspired and motivated?

A. There are so many diseases that need a cure. Awards and acheievements are nothing compared with the satisfaction of helping people who are suffering. I go after questions and problems that others haven’t tackled, and the exhilaration that one gets from solving a tough problem is enough.

What were the major challenges you had to deal with in the initial stages of setting up the industries? How did you overcome those?

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Awards and acheievements are nothing compared with the satisfaction of helping people who are suffering.

A. The major challenge was the lack of ecosystem. Such innovation-driven start ups in the healthcare space was non-existent in India, and nobody, including investors understood the space. I was lucky that there were people who were willing to listen and try taking the risk.

We worked together to create the ecosystem, sometimes spending months and years to get something approved. We are viewed as how Genentech was viewed in 1970s in US. We have been able to achieve all our milestones, and also positively impact the ecosystem.

Talking about cancer which is your major area of interest, how far have we been able to deal the deadly disease? What are the recent breakthroughs in the field of cancer diagnosis and treatment? Have there been major contributions from India?

A. Well 70% of all cancers are curable, especially if detected early. The challenge is that people hide it thinking the worst. Recent breakthroughs have been in the area of technologies that ensure the chemotherapy goes only to the tumor or reprogramming the body’s immune system to kill the cancer cells. Unfortunately, there has been no contribution in these advances from India. This is why I started Mitra Biotech (predictive medicine) and Invictus Oncology (next generation drugs that only target the tumor).

Apart from Cancer, what is the other area of concerns according to you that needs immediate attention?

A. Development of resistance to antibiotics is a major challenge. We need newer antibiotics that retard the development of resistance. This is what we have developed at Vyome.

How technologically equipped is India in dealing with medical problems?

A. Well India does have all the latest technologies. However, accessibility is the major challenge. I don’t see any other solution but universal health insurance.

There is often a saying in biotech sector that popular re-

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searchers cannot be popular leaders and hence there is a dearth of enough start-ups in the country. Do you agree with it?

A. Yes, lack of leadership talent is a major challenge in India. Leadership isn’t about hierarchy, its about conceptualizing new ideas and empowering the team to enable those ideas. We completely fail on both these parameters.

What is the basic difference between the biotech start-up culture in India and the US? A. The biotech space is mature in US, you get the talent pool as well as investments. Unfortunately, the space is still nascent in India. People need to realize that there is an opportunity to build Genentechs in India, which returned a lot of money to the investors.

Could you tell us something about India Innovation Research Centre?

A. It is a not for profit organization that I started to facilitate young innovators to flourish. If say someone has a very creative idea, they can pursue that at IIRC and can potentially start a company with the technology if it matures. We also have employees of the start-ups who are doing PhDs through IIRC, which has tie-ups with PhD awarding universities. The vision is to pursue blue-sky globally-competitive research from India.

Talking about employment in the sector, do you think young India posses required skill set to stand on par with the world’s bioscience excellence?

A. No, the institutions in India are completely failing to impart the right education. We are training people to do experiments but not think. The world is moving towards a knowledge economy, and biotech/lifesciences are knowledge economy. If we don’t train people to be creative while being rigorous workers, we are going to lag behind.

Any words of inspiration for young bio scientists aiming to plunge high in the bio-sector?

A. This is nothing to do with biosector. What I tell young students is to follow their passion. Don’t get into a sector just because the pay is good, because if one doesn’t have the talent in the space it is unlikely that the person will ever succeed. On the other hand, if one is passionate about the subject, then the chances of rising to the top is very high. It is very important to follow your passion.

The institutions in India are completely failing to impart the right education. We are training people to do experiments but not think. mag.biotecnika.org

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BIOTECNIKA MAGAZINE

Top 10 Bioindus Quick Stats • The biotech industry is expected to experience significant growth amid favourable business conditions—

By FY25, India’s biotech industry is estimated to reach USD100 billion from USD7 billion in FY15.

• Increasing government expenditure is likely to augment growth of biotech in its 12th Five-Year Plan— Government aims to spend USD3.7 billion on biotechnology compared to USD1.1 billion in the 11th Five Year Plan.

• Growing pharmaceuticals market is estimated to aid growth of the biotech industry— India’s pharmaceuticals market is expected to grow to USD35.9 billion by 2016F and USD45 billion in 2020

Top10 Trends as per CAGR

Top10 Trends as per Revenue

• • • • • • • • • • •

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Synthetic biology CRISPR BioIT Big Data NGS Biosimilars Bioprinting Biomarkers Bionics Genomics

• • • • • • • • •

Personalized Medicine Big Data Biomarkers Synthetic biology Bionics Genomics Molecular diagnostics BioIT NGS Biosimilars mag.biotecnika.org

BIOTECNIKA MAGAZINE

stry Trends for 2016 Biotrends & Global Market Forecast Forecast period

PM BD BM SB

6.2

8.7

9.1

BN GEN MD BI NGS BS

Global CAGR in %

44.2

Synthetic Biology

9.3

2015-2020

19

Biomarkers

20.5

2014-2019

45.5

Big Data

48.6

2014-2022

38.7

Market Forecast (revenue in $ US bn)

Personalised Medicine

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Bioapplication

2014-2020

25.4 23.1

Bionics

2015-2021

11.8

13.2

13.5

PM Genomics

23.1

12

BD BM

SB

BN

22.1

9.3

GEN

MD

BI NGS BS

2013-2018 Top 6 Trends in India

Molecular Diagnostics

Biomarkers Bio-IT

2015-2020

2012-2018

Growth Drivers Bio IT

Rich biodiversity & Outsourcing bioinformatics to India Rising awareness of bionics & Good income levels of Indians

Bionics Biosimilars

NGS

2014-2020

Genomics NGS

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how a biotech company’s

Success Became a Mess?

“

30 tests from a single drop of blood” was the objective and “needle-less, speedy and accurate blood tests” was the intention.

Putting an end to the standard practices of phlebotomy and introduce the usage of nano-diagnostic technology for blood-tests was the sole idea.

A tiny drop was supposed to change everything, but it did not quite end the way it was imagined.

The story of THERANOS led by Elizabeth Holmes mag.biotecnika.org

Holmes denied accusations but the company is still under the scanner, with people under a confusion of who to believe and what to trust.

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Theranos established 2003

Draper Fisher Jurvetson makes seed investment in Theranos

The company raises $16 mn in 2 rounds of initial fundraising and $28.5 mn in a 3rd round fundraising

2004

2006

Theranos raises an additional $45 million from a single unnamed investor 2010

A 19 year old Stanford drop-out had adorned the grand stage recently for being a young entrepreneur with enthusiasm, dedication and remarkable ideas. But the lime light did not turn out to last long. The story of the blood-testing biotech company started twelve years ago, which had hit every cover story recently, is now raising doubts within a few months of its success story hitting newsstands.

Elizabeth Holmes, Founder and CEO of Theranos, had conceptualised the company with ideal intentions of revolutionizing the world of blood tests. But the big feat has very speedily turned into a fiasco with the company currently facing accusations of misinterpretation and cheating in its test applications. Holmes denied accusations but the company is still under the scanner, with people under a confusion of who to believe and what to trust.

BRAINS BEHIND THERANOS:

Theranos authorizes the sale of 11.7 mn shares at $17 a piece Feb 2014

29 Oct 2015 Theranos quietly reduces its board from 12 members to 5 as most of the board members were of high stature but only 2 were with medical training

Holmes had become a praised and celebrated icon in the media world in a very short span. Holmes holds more than a dozen patents and is financed by prominent venture investors, standing at the financial acme. Theranos was started by her in 2004 and is averred to be worth $9B, of which Holmes would own about $4.5B. The billionaire entrepreneur has decorated the cover picture of many magazines and success stories with glory and success in each hand.

Making of less painful and cheaper blood tests was her objective for which she had picked inspiration from her research work at Standford. Based on work that she had been doing on testing blood for the SARS virus, she concluded that technology can be adapted to make way for multiple tests to be executed on smaller quantities of blood along with enhanced speed and efficiency with the results.

This became the basis for the Theranos Naotainer, a half-an-inch tube containing a few drops of blood that would replace the multiple blood containers used by the conventional labs.

The technology was very quickly adored and adopted by the healthcare system making Holmes the youngest, self-made, female billionaire in the world and also the recipient of “The Horatio Alger award� in 2015.

As it is said that the speedily gathered success and fame also brings in a speedy disruption, imminent trouble was lurking right around the corner.

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Theranos declares that the company had raised around $400 million in total funding (at the $9 billion valuation) June 2014

Theranos authorizes new shares that would value the laboratory startup at more than $10 billion

A prestigious newspaper accuses Theranos that their procedures are faulty and lab results are inaccurate

Theranos denies accusations but fails to prove it

A report made public on FDA’s stopping of Theranos ‘nanotainers’ from further usage

12 Oct 2015

15 Oct 2015

15 Oct 2015

16 Oct 2015

RUNNING THROUGH THE TIMELINE 24 Oct 2015

23 Oct 2015

21 Oct 2015

18 Oct 2015

18 Oct 2015

Walgreens states it will not open new Theranos blood-testing centers in its pharmacies till it receives information on current issues

Theranos claims to have done business with Pfizer and GSK which the big pharmas companies decline

Holmes states that the share authorization was not intended to raise funds

Jean-Louis Gassée’s questions went unanswered

Jean-Louis Gassée, head of Apple engineering in late 1980s, narrated his personal experience with Theranos product

THERANOS MAKING AND BREAKING: Right after six months of successful entrepreneurship, accusations started lining up. A media report stated that Theranos was overplaying the potential of the Nanotainer and that it was not being used for the bulk of the blood tests. The report also highlighted that senior lab employees at the company realised that the nanotainer’s blood test results were not consistent. This highly raised doubts on the science behind the concept.

As the doubts started mounting, FDA explored into the issue, inspected Theranos, and asked the company to stop using the Nanotainer on all but one blood test (for Herpes) as concerns regarding the data supplied and the product’s dependability were raised and were yet to be investigated. Also FDA mentioned that GlaxoSmithKline, a giant drugmaker for which Theranos has claimed to have done tests, has actually not done any business with the company in the past two years.

LESSONS TO BE LEARNT: As in the story of theranos, the potential of the science behind its product was greatly highlighted but reality went amiss. Experts believe that a regulatory loophole is responsible for companies like Theranos entering the market with unreliable tests being executed on patients without

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proper FDA approval. “Lab developed tests” or LDTs are diagnostic procedures which can enter hospital usage without FDA’s consent. This loophole which has been prevailing from many years is making way for companies like Theranos end up making costly mistakes. Since this loophole is raising concerns more than helping, FDA has recently brought in an amendment that that would require developers obtain approval before they start marketing their tests to patients.

The FDA wants to make sure that these tests “are accurate, reliable and that they do, in fact, identify a disease,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Right now, this form of verification isn’t conducted by FDA or federal lab inspectors. And that’s a problem,” Shuren said. “If diagnostic tests return inaccurate results, physicians can make the wrong decisions and patients can get hurt.”

A recent FDA report talks about 20 LDTs that caused harm to patients. Among them was a genetic breast cancer test that gave out inaccurate results in 20 percent of cases, indicating that some patients might not have received correct therapy. There is also a mention of prenatal tests based on controverted scientific concepts which might have led women abort a normal pregnancy.

The FDA’s proposal to validate test results before launching diagnostic tests into market is still under consideration and not into full effect yet. The FDA plans to release the finalized guidance for the regulation of LDTs sometime in 2016.

A recent FDA report talks about 20 LDTs that caused harm to patients

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Every start-up faces troubles and in a sector as intricate and intense such as health care, ruling the business with diligence is not a piece of cake. Every company has to go through ups and downs to reach its success acme. But how far do you go to get a hold onto the trophy. Theranos had made promises beyond its competences. There are doubts raised on the technology, the investment rainfall and also the integrity of the company. Whether Theranos would be coming out of the mess clean or not, we may have to wait and see but FDA certainly has considered the entire issue as a wakeup call. They are going to clearly regulate tests with premarket analyses to avoid such costly mistakes. Let us hope this new task taken up by FDA would ensure comprehensive drug/ tests analysis and hence patient safety.

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“Go Green” Initiative

By Biotecnika Magazine “Go Green” Switch to Biotecnika Magazine App Available on Playstore & App Store

“Go Green” initiative by Biotecnika Magazine is to promote greenery in the city of Bangalore.

We seek assistance from all the biotech/pharma/ healthcare organizations to join hands with us and aid in promoting the same. Biotecnika crew would wish to plant a sapling in the premises of your organization and make environment go green.

Join hands with us!

Write to us at editor@biotecnika.org or Call Us at 1800-200-3757 for more details. mag.biotecnika.org

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PRINTING bit of me....

3D

bioprinting is advancing at an astonishing rate, moving from the top of our head down to our feet. Technology can now print anything from bone to blood vessels to heart tissue, and it hopes to one day produce entire organs that could be implanted in humans. Are we heading towards the 3D printing of the whole human body?! Though it might not happen anytime soon, the innovations currently making news could one day bring us closer to it! Is the very thought amazing but crazy? Well. Maybe. But have you thought of its implications? Is it ethically right? Is it indeed required?

Bit of me is already printed!

• An 83 year-old Netherland woman got her jaws replaced by an artificial one.

• RMIT University in Melbourne has successfully created 3D printed vertebral cage for a patient with severe back pain.

• Tessa, a two year old born without nose and sense of smell got a 3D nose in UK. • Princeton scientists have created an ear that can pick up radio waves.

• A UK company can print 150 prosthetic eyes an hour!

• If we want to fill the jaw with teeth, dentists can print a tooth in 6.5 min.

• A Toronto based company has printed episkin that could be used to treat people with large scale burns

• US company gained FDA approval for its 3-D printed spinal implants.

....to a NEWER ME

Bioprinting has made quite an astonishing progress till date!

With advancing technology, we no more remain physically challenged. 3-D printed prosthetics of legs, feet, hands and fingers are becoming very common, with added convenience to order customized ones as well! They are perceived as lifesavers. While a two year old receives a bioengineered trachea, a three infant was saved with printed throat implants. It does not stop there! The technology moved much further into the area of printing complex organs as well. As we name a few;

‘

Are we heading towards 3D printing the whole human body?!

• Liver tissues are being sold and printed to pharmaceutical laboratories to use in early-stage drug testing. In August 2014, scientists at the Hangzhou Dianzi University in China unlocked the possibilities of printing kidneys and printed a small working kidney that lasted four months.

• Bioengineers are getting closer to intestines • University of Texas scientists have demonstrated for the first time the ability to create fully functioning "bio-artificial" tissue grown from intestinal stem cells in the bowels of laboratory rats.

• Researchers at Kyoto University used 3D printers to help surgeons complete a living donor lung transplant on a Japanese woman.

• If we want a beating 3D printed heart, researchers of Dr. Frankenstein’s lab have figured out how to create one.

• Fraunhofer Institute has unveiled their breakthrough discoveries in bioprinting artificial blood vessels. Possibly even more impressive is that these printers can even create cells. While nerves are not yet printed, scientists have figured out how to at least spur re-growth and reconnection in damaged ones.

The innovations are still on. Netherland doctors have successfully replaced most of a human’s skull with a 3-D printed plastic. And while not quite as complex as a real human brain, scientists are moving closer to constructing the complex tissue. Using a handheld 3D printer, researchers at Australia developed a method for constructing layered biological structures that closely resemble cerebral cortex tissue. Though they are still a long way from printing a brain, but the ability to arrange cells so as they form neuronal networks is a significant step forward.

With the technology advancing at such an astounding rate, entire organs and bodies produced by 3D printers will become a concrete reality, rather than a strange science fiction. Yes, we are inching towards whole body printing.

Inching towards a newer me!

Researchers are only steps away from bioprinting organs to solve a myriad of illnesses. But if to predict the timeline of ‘whole printed organ’, scientists are of different opinion. Some are talking about print-on-demand hearts or kidneys in five to ten years; some see it unrealistic, but hope to have it in 20 to 30 years. But all are optimistic of the realization of the whole organ printing.

San Diego-based company, Organova which made the first liver tissue for testing purpose estimates it would currently take 10 days to print an average sized liver and lobe, but hopes that the speed and efficiency with which they could create such tissue structures will greatly advance in the future. In its current form, it takes 1,690,912,929,600 hours to print a liver for every member of the human race!

“If one can bioprint functional human organ constructs, then bioprinting a whole human or whatever will be the name for such a creature is just a logical extension”, says Dr. Vladimir Mironov, Scientist, 3D bioprinting solutions, Russia.

With the advancement in 3Dbioprinting, sooner or later someone might mastermind the 3D printing of an entire human body. But is the anatomy that easy? As we are aware, for the proper functioning of a human body, thousands of tiny pieces are to be fit together in perfect places. And that requires a huge amount of biotechnological advancements. So what to conclude? It sounds like, ‘the printing of whole human body remain science fiction’. But is it really? Not so, as there are many happenings in this world which we couldn’t imagine a decade ago, or were considered fictions. Indeed reality exceeds even the most imaginative science fiction writers. When one looks at the history of science, very few, if any, predicted the scientific future correctly. But the advancements in science has made many ‘science fictions’ a reality.

The Ethical and Moral dilemma The printing of whole organs, if approved, could be a reality within the next few decades. It will also console those who are waiting for an organ transplant. But as per reports of Gartner Inc., the information-technology research and advisory firm, ‘3-D bioprinting will spark a major ethical debate by 2016. It is indeed important to reflect the ethical, moral and spiritual implications!

‘

Is cell mixing of Human--Animal acceptable?

Will patients turn guinea pigs?

The mixing of animal and human cells in the inkjet printing technology can trigger a debate among people who have ethical, moral, religious and political concerns.

A report of Gartner research revealed the use of human amniotic fluid, canine smooth muscle cells, and bovine cells in one University.

Is everyone comfortable with such human-animal bioprinted spare parts?

3D printing might be used in combination with stem cell derived cell lines. Unlike the case of developing a new drug, a stem cell therapy can’t be tested on a sizable number of healthy people prior to being tested on patients and then, finally, being made available as a standard treatment. In such cases, how can we know in advance that these treatments are safe? Will the first patients to undergo transplants with 3D-printed organs serve as guinea pigs?

How about regulations concerning the technology?

Thought science is for saving the lives of people, industries might turn unethical in a move to increase their business, especially in the sectors of cosmetics and sports.

As enhancement of beauty and physique will give people an edge in their respective work areas, the chances of unethical practices will be more.

As these are not part of pharmaceutical sector, will government be able to control the misuse of this technology? Will it lead to unethical organ replacements?

If one can bioprint functional human organ constructs, then bioprinting a whole human or whatever will be the name for such a creature is just a logical extension.

- Dr. Vladimir Mironov, Scientist, 3D bioprinting solutions, Russia

Will the poor be able to access?

The new technology will be more expensive than the existing. “The functioning organs will likely be only accessible to those willing to pay for personalized treatments; poor will be left on the organ transplant waiting lists”, says Kirstin Matthews, Fellow in Science and Technology Policy at Rice University. Will this expands the access divide between the rich and the poor?

Will the regulations be amended for the good?

Currently, there are no distinct regulations for bioprinting, so researchers at academic institutions, research laboratories, and private are experimenting with bioprinting until they are told otherwise. But this will create moral challenge, even if one scientist is ethically wrong. Will the regulations be amended?

Every new and advancing technology comes with plethora of speculations and uncertainties. The idea is not to ignore them but to properly address the same. But these doubts should not lead to the curbing or slowing down of the science. When it is thousands who are going to be benefitted with the help of bioprinting, the need of the hour is to take it in a straight and controlled pathway.

As we keep the speculations aside for a while and consider the good bioprinting research keeping in mind its ethical, moral, religious and political implications, there should not be any controversy if scientists are producing good data and helping people with health conditions.

Moving on….

3D printing itself was a science fiction until recently! Who would have ever though that in the near future we will be able to print body tissues? Hence human body printing can be a reality; but a far-off reality. Either we or our next generation will be able to see it. But it might happen one day! And once succeeded, this would become the most significant ‘science’ in the history of mankind. But will that science lead to the welfare of the humanity or to the warfare? One has to wait and watch!

If only good could come from such medical applications, why should we be skeptical of the technology? What do you think? Do we really need to ‘create’ people? Will scientists be able to ‘play god’ keeping the ethical considerations? Share your thoughts with Biotecnika!

BIOTECNIKA MAGAZINE

G U E S T C O R N E R

Abhishek Mohanty is a Biotech Professional with Ph.D. from IISc, Bangalore and Post doc Fellow from Ottawa Heart Institute, Canada. He is curently working as a Research Associate at INSTEM-NCBS in Bangalore. Being a passionate researcher and writer, Abhishek has contributed a write-up on aging and its reversal for Biotecnika Magazine.

The modern era medicine in concert with the rejuvenation biotechnology is aiming at treating the underlying causes of aging.

Reversing Aging in Humans

Reinstating youth through right anti-aging cellular targets “There is a fountain of youth: it is your mind, your talents, the creativity you bring to your life and the lives of people you love. When you learn to tap this source, you will truly have defeated age.”

A

s rightly pronounced by the Italian actress Sophia Loren, throughout history, human beings have always dreamed of being able to cure aging and diseases, looking for the discovery of a “fountain of youth”. This dream has never become reality because, human aging and its basis still remains a largely mysterious process and one of the open biomedical challenges of the 21st century. Thus, the only way to achieve increase in human longevity is by understanding the cellular and molecular basis of aging and by discovering ways to retard the aging process itself. Till date, serious scientific efforts by present day rejuvenation biotechnologists is underway to understand and intervene in the aging process - not just to prevent associated illhealth and disease, but to also repair and reverse the root causes of aging.

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the only way to achieve increase in human longevity is by understanding the cellular and molecular basis of aging and by discovering ways to retard the aging process itself.

AGING: A SIDE EFFECT OF BEING ALIVE Aging has been assumed to be an inherent, universal but a progressive natural phenomenon of life ever since it was created. Through a biomedical gerontologist perspective both the comprehension and the intervention to deal with the complexities of aging is surely a challenge. However, the modern era medicine in concert with the rejuvenation biotechnology is aiming at treating the underlying causes of aging and alleviating age-related ailments for providing a healthy life span of humans having youthful characteristics. In other words, inspite of nutrition and exercise being well known to delay the aging process the intrinsic root causes are still elusive and that is why the approach is towards reversing the cellular and molecular changes or damage accompanying the aging process in humans.

Scrolling through the theories associated with aging, Free Radical Theory (Oxidative cellular Stress due to Free Radicals) stands to be the most widely accepted one. Though several theories of aging such as the immunologic theory, the inflammation theory, neuro-endocrine theory, the telomere theory and so on and so forth have been put forward to explain the fundamental mechanisms mediating these age-related diseases and are all specific of a particular cause of aging, the free-radical theory of aging is by far the most popular and long standing.

Owing to multiple factors involved in aging, the different theories of aging are not mutually exclusive, but complement each other for the onset of normal aging process. The free-radical theory first formulated in the fifties and later revised by Harman in 1972, proposes that cumulative damage to biological macromolecules by oxygen radicals (reactive oxygen species) results in irreversible cell damage and an overall functional decline. The theory principally renders a central role for mitochondria in the cells - known as the powerhouse of the cell - as the principle source of intracellular reactive oxygen species (ROS) leading to aging-associated mutations and deletions in Mitochondrial DNA (mtDNA or mDNA).

Any form of damage to the mitochondrial DNA causes mutations in the DNA sequence ending up in the progressive impaired function of the respiratory chain and thus affecting ATP synthesis thereby triggering the process of early aging in many species, including humans.

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The free radical theory of ageing claims that the mutation rate of the mitochondrial DNA is estimated to be 15 times more than that of the DNA present in the nucleus of the cells. Hence, due to an increased awareness of the origin and natural history of mitochondrial mtDNA mutations in aging, important steps forward have been made in better understanding the nature of mitochondrial aging with respect to an increased ability to link the mitochondrion with other cellular pathways of aging and a better chance of effective intervention over the next decades. Put together, defects in the cell’s mitochondria leads to DNA damage that is linked to age –related hair loss, weight loss, spine curvature, osteoporosis and a decreased life span. Nevertheless, there still remain quite a number of unresolved controversies and contradictory observations within the field.

REVERSING THE AGING PROCESS

The free radical theory of ageing claims that the mutation rate of the mitochondrial DNA is estimated to be 15 times more than that of the DNA present in the nucleus of the cells.

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For instance, in one of the break through discovery carried out by David Sinclair and his group at Havard Medical School, it has been seen that aging associated changes seen above can simply be reversed in mice which can be driven towards youth by putting back a certain group of genes called sirtuins particularly the SIRT1, gene. It has also been observed by Sinclair and his colleagues that the SIRT1 gene can be activated by a compound called resveratrol, found in grapes, red wine and certain nuts. Hence , the secret of anti-aging properties in nuts can be attributed to the presence of the compound Resveratrol.Interestingly cells isolated from mice, stay healthy as long as coordination between the mitochondria and nucleus in these cells is maintained due to the activity of SIRT1 gene and contrastingly these cells start showing aging phenotype in absence of SIRT1 gene which disrupts mitochondria-nucleus communication.

“The aging process we discovered is like a married couple— when they are young, they communicate well, but over time, living in close quarters for many years, communication breaks down,” said Harvard Medical School Professor of Genetics David Sinclair.. Therefore, researchers have generally been skeptical of the idea that aging can be reversed, due mainly to the prevailing theory that age-related ills are the result of mutations in mitochondrial DNA and the myth that age-related ills cannot be reversed is not true as has been seen in the above findings.

Furthermore, in a very recent study by Professor Jun-Ichi Hayashi, a researcher from the University of Tsukuba in Japan, has found that the process of aging can be delayed or reversed in human cell lines. He and his team were also able to find that the two genes which regulate the production of the amino acid

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glycine have a role in the process of aging. Hayashi, while analysing the controversial issues surrounding the popular mitochondrial theory of aging, made this exciting discovery.

While contradicting the postulates of this theory, Hayashi and his team found that the mutations in the mitochondrial DNA are not the ones to be blamed for onset of early aging but another form of genetic regulation. By comparing the functionality level of mitochondria in the fibroblast cell lines in children below 12 years to those of people 80 to 97 years, the researchers came to the conclusion that the older cells did not show any more damage to the DNA than those in the children.

This indicates that reduced cellular function is related to epigenetic regulation, the type of changes which alter the physical structure of the DNA and not the DNA sequence on the molecular level. The epigenetic changes in the DNA lead to switching on and off of certain genes responsible for aging.

Genetically reprogramming of the cells to embryonic stem cell-like state can possibly reverse these epigenetic changes in the DNA which ultimately can prove to be effective in turning back of the human body clock. These findings published in the journal Scientific Reports reveal that, contrary to the mitochondrial theory of aging, epigenetic regulation controls age-associated respiration defects in human fibroblast cell lines. However, it still needs to be confirmed if epigenetic regulation can also control aging in humans? And if proven, could result in glycine supplements giving our older population a new lease of life.

FUTURE PERSPECTIVES FOR A YOUNGER AND AGEFREE LIFE Not just these two above mentioned studies but many other tangential literature studies have been established to reverse the process of aging and as the future awaits, as time ticks away unlike our ancestors, we all are likely to live to enjoy to be determined by the ability of clinical medicine to revert and repair the causes of aging, and not by lifestyle choices.

Thus when we reach for longer, healthier lives, it is vital that we lend our support to the research and development of therapies capable of treating the causes of aging. We must ensure that the public is educated, the fundamental longevity science is funded, the clinical applications of that research fully developed, and the resulting rejuvenation biotechnologies made available and all this as soon as possible. The clock is ticking, after all, and this is the only approach that will allow us live for significantly longer than our ancestors.

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The clock is ticking, after all, and this is the only approach that will allow us live for significantly longer than our ancestors.

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