Biotecnika Times - 19th Nov 2019 Latest Edition

November 19th, 2019

Vol. 03

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NO 105

AGT CURE FOR HIV

POTENTIAL BREAKTHROUGH?

FSSAI

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INSULIN MADE WITH STEM CELLDERIVED THERAPY

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HEADLINES

November 19th, 2019 Vol. 03 NO 105

For First Time Insulin Made With Stem Cell-Derived Therapy Stem cell therapies have become increasingly versatile. Two presentations at this fall’s Cell & Gene Meeting on the Mesa in Carlsbad illustrated how the stem cell therapy field is maturing.

SAN DIEGO’S VIACYTE IS NOW DEVELOPING 2 VERSIONS OF EXPERIMENTAL DIABETES TREATMENT, USING INSULIN-PRODUCING CELLS GROWN FROM THE EMBRYONIC STEM CELLS. THE CELLS ARE ENCAPSULATED IN A DEVICE THAT IS IMPLANTED BELOW THE SKIN.

By Ria Roy

One of the versions, called PEC-Direct, shows intermittent signs of producing therapeutic levels of insulin, the first time this has been seen, said ViaCyte’s CEO, Paul Laikind.

And this was seen indirectly through the presence of a by-product of insulin production. However, the production is not reliable enough to substitute for injected insulin, Laikind said.

ViaCyte is now working to improve reliability.

PEC Direct is meant for the most severe cases of type 1 (insulin-dependent) diabetes. It allows the blood vessels to grow into the device to contact the cells. In order to prevent an immune reaction, the patients get immunosuppressive drugs.

The other ViaCyte product, PEC-Encap, shields the cells from direct contact. Immune-suppressing drugs are not required here. However, it did not work well in early testing, because scar tissues built up around the implant.

Athersys’s MultiStem is a propri- about weeks; And so the cells simply etary cell that can be given off the cannot respond fast enough to be able shelf to different patients. It is obtained from adult bone marrow. Gil Van Bokkelen, Athersys chairman & CEO, said MultiStem does not provoke an immune reaction.

The cells secrete various proteins & other substances that reduce inflammation and promote healing, Van Bokkelen said. They do not persist and eventually disappear from the body.

The healing potential of multistem got the attention of doctors at The University of Texas Health Science Center at Houston,& the Department of Defense, he added.

Now, Athersys is planning a midstage, or Phase II, the trial of MulViaCyte has worked on that problem tiStem in trauma patients. The goal with its partner W. L. Gore & Associ- here is to temporarily reduce inflamates– the makers of Gore-Tex. Gore- mation, which goes to excess in trauTex makes the implant material and ma. has been collaborating with ViaCyte to make it less likely to produce the He added if we can tip the scales in scarring. The early signs are that the favor of more constructive response, newly formulated material is meeting stop the bad stuff, that hyper-inflammatory tidal wave, we can really alter that goal. the trajectory of how the patient reAnother company Cleveland-based bounds.

Athersys, at the meeting, reported on its multi-purpose cell product, Mul- Van Bokkelen said while these cells tiStem. It is in late-stage or Phase III naturally exist in the body, there are testing for stroke, caused by blood not enough of them to take care of clots. It is also in testing for heart at- major injuries. tacks and being considered for brain It is all about kinetics, he added. In trauma. major trauma, we are talking about minutes or hours. We do not talk

to have the impact that we see that we can have.

HEADLINES

November 19th, 2019 Vol. 03 NO 105

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AGT Claims To Develop Cure For HIVPotential Breakthrough A Maryland pharmaceutical company- American Gene Technologies claims they may have created a potential cure for HIV.

AGT’S APPROACH DIFFERS FROM OTHER MEDICAL RESEARCHERS’ ATTEMPTS TO CURE HIV.

By Rahul Mishra

American Gene Technologies announced it filed a 1,000-page application with the FDA on Wednesday as scientists there believe they have created a gene therapy unlike any other.

American Gene Technologies (AGT), a Rockville-based medical research company, has submitted an Investigational New Drug (IND) application with the FDA to begin gene therapy trials that researchers believe could eliminate HIV in people alHIV-positive patients. ready living with the virus.

If approved, the company hopes to AGT Develops Cure For HIVbegin a Phase 1 clinical trial that will What is the potential treatment? examine the safety of AGT103-T in humans.

The drug—an HIV treatment program called AGT103-T—is a sinIn a statement, AGT chief science gle-dose, lentiviral vector-based officer C. David Pauza, Ph.D., said gene therapy that AGT says could the company’s objective is to treat remove infected cells from the body HIV disease with an innovative cell and decrease or eliminate the need and gene therapy. This new approach for lifelong antiretroviral treatment in

will reconstitute immunity to HIV and will control virus growth in the absence of antiretroviral drugs.

AGT Develops Cure For HIV- The Current Scenario

Pre-exposure prophylaxis (PrEP), a potentially life-saving HIV prevention drug is very popular in the US.

In the United States, PrEP is pretty much exclusively available as Truvada, its brand-name version manAs the fight against HIV/AIDS wag- ufactured by Gilead Sciences with a es on, communities at risk of con- very high retail markup. tracting the virus continue to take preventative measures against new infections—including daily use of

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HEADLINES

November 19th, 2019 Vol. 03 NO 105

Latest FSSAI Internship Scheme December 2019-20 – Apply Online The official notification for the FSSAI December Internship Scheme 2019-20 has been released. Interested candidates with a background in Life Sciences, Food Technology and Microbiology are encouraged to apply online for the Internship scheme.

CHECK OUT ALL OF THE DETAILS ON THE SAME BELOW:

By Diluxi Arya

F. No. Z-12020/01/2016-E&A Food Safety and Standards Authority of India (A Statutory Authority established under the Food Safety & Standards Act, 2006) (HR Division) FDA Bhawan, Kotla Road, New Delhi-110 002 Internship starting in the month of December 2019 under Internship Scheme 2019-20 in Food Safety and Standards Authority of India Food Safety & Standards Authority of India (FSSAI) is an independent statutory body established under the Food Safety & Standards Act, 2006 under the aegis of Ministry of Health & Family Welfare, Government of India. It is the apex body responsible for ensuring food safety and compliance with food standards throughout the nation. FSSAI invites application for the month of December 2019 for its Internship Scheme 2019-20, which will supply Interns with different learning opportunities via a well-designed training calendar.

Eligibility Criteria: Students pursuing a Complete time postgraduate degree/ diploma or higher level in the Recognized Institute in India/ overseas, in any of the following: A. Life Sciences, Chemical Sciences, Food Technology, Microbiology, Veterinary Sciences, Agricultural Sciences or some other related field B. Business Administration & Management including Policy Regulation & related disciplines C. Media & Communications Notice – Students in 3rd / 4thyear of the 4-year Bachelor’s program in Food Technology or related disciplines also can apply.

Tenure: The internship will be accessible throughout the year at various points of time. Internships offered will be for the length of 8 weeks, which might be extended to a maximum period of 6 months for reasons to be recorded in writing.

Place of Internship: • FDA Bhawan, Kotla Road New Delhi- 110002. (HQ) • FSSAI (NR), First Floor, NBCC Place, Bhisham Pitamah Marg, Pragati Vihar, New Delhi-110003.

• FSSAI, Hall Mark company plaza, Sant Dyaneshwar Marg Oppst. Gurunanak Hospital road, Bandra (East), Mumbai400051.

• FSSAI, Central Documentation Complex, (South Wing), Che1mai Port Trust, Rajaji Salai, Chennai 600001 • FSSAI, Benfish Tower, 6th floor,31 G N Block, SSectorV, Salt Lake, Kolkata – 91.

Working Space: Interns would be asked to get their own laptops. FSSAI shall supply their functioning area, net facility and other essentials but Shall not ensure local accommodation and travel facilities.

FSSAI won’t bear the costs of any Boarding & Lodging.

Application Process:

1. Interested and eligible students • FSMS can apply online in the specified for- • Training mat as per the timelines provided by • Imports FSSAI. Applicants, who have applied • Quality Assurance for an internship for previous months, • Risk Assessment & R&D need to apply afresh.

• IT 2. The shortlisted candidates may be • SNF Projects required to submit a short write up/ • Legal presentation for final selection.

• Food Fortification 3. The final list of selected candidates along with their date of joining Regional Offices (NR Delhi, Mumand Internship tenure would be de- bai, Chennai & Kolkata): clared online on FSSAI website.

Hands-on training in Food Imports In the time of joining, Intern will be Clearance and Licensing and Regisasked to carry a letter from their own tration of Food Business Only.

Institute indicating his/her status .in the institution as a student and “No Assignments: Objection” for allowing him or her to undergo Internship Program for the Interns will be attached to one of time for which he/she’s chosen, is rel- the many Divisions at FSSAI based evant. A character certificate from the on the technical and academic trainjurisdiction of the Institute, together ing and assigned project(s) associatwith evidence of educational quali- ed with different aspects of Food and fications as stated in the application Nutrition Management Processes. form would also have to be submitted Some attributes of the Program: at the time of joining for an internship.

• Orientation Program to easeon-boarding Areas/Domains Available for In- • Structured session for planning ternship: project outcomes and action plan with timelines The area mentioned in the applica- • Seminars/presentations to protion will be indicative of the prefervided required exposure ence rather than a confirmation of • Allocated ·’Buddy” to profesprotect allocation at the particular desionally encourage and empower partment. mentoring Sessions to improve learning and provide direction HQ New Delhi: • Standards • Regulations/Codex • Regulatory Compliance

Next Page>>>>

HEADLINES/NEWS

November 19th, 2019 Vol. 03 NO 105

• Smaller Projects to Give Important Dates: cross-divisional exposure • Routine review and supervision of conduct, adherence to func- Description tioning standards and project advancement Start date of receiving application They will be given a certificate from FSSAI only once the final report/ presentation is completed successfully, submitted and reviewed.

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Timeline 13th November 2019

Last date for submitting online application

24th November 2019

Announcement of Shortlisted Candidates

29th November 2019 (For the candidates who had apply for internship starting from 05th December 2019)

Date of Joining

05th December 2019

Mega Hike In Fellowship of CSIR-Senior Research Associates / SRA’s Under 7th CPC COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH / HUMAN RESOURCE DEVELOPMENT GROUP / CSIR COMPLEX, LIBRARY AVENUE, PUSA, NEW DELHI, NEW DELHI – 110012 OFFICE MEMORANDUM SUBJECT: REVISION OF PAY OF CSIR-SENIOR RESEARCH ASSOCIATES (SRAS) IN LINE WITH 7TH CENTRAL PAY COMMISSION & ENHANCEMENT OF CONTINGENCY GRANT FOR SRAS- REG

By Diluxi Arya

The Governing Body (GB). CSIR in its 192nd meeting held on 23-08-2019 considered and approved the proposal for revision of Basic Pay stages in line with 7th CPC plus allowances i.e.

DA and I-IRA as per GOI norms, with effect from 01-09-2018. Accordingly, the revised Basic Pay stages effective from 01-09-2018, arc as follows:

Rs 20,000 per annum to Rs 40,000 per annum. with effect from 01-042019.

The revised basic pay is fixed and no annual increments arc admissible.

The other terms & conditions will remain the same.

The GB has also approved the enhancement of contingency grant from

Hindi version will follow.

Sr. No.

Existing Basic Pay ( in Rs.)

Revised Pay (in Rs.)

1.

21000

56,100

2.

21310

56,100

3.

21820

56,100

4.

22330

57,800

5.

25200

67,700

6.

25810

67,700

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NEWS

November 19th, 2019 Vol. 03 NO 105

Researchers Develop New CRISPR-Cas9 Enzyme With High Precision!

Highly precise CRISPR-Cas9 enzyme is developed by a group of researchers from the City University of Hong Kong (CityU) and Karolinska Institutet that can enhance the targeting accuracy in the genome editing process.

THE NEW CRISPR-CAS9 PROTEIN IS BELIEVED TO BE VERY USEFUL IN HUMAN GENE THERAPIES, WHICH REQUIRE HIGH PRECISION.

By Rahul Mishra

CRISPR (Gathered Consistently Interspaced Brief Palindromic Repeats) -Cas9 is a famous gene-editing modern technology that has a broad range of applications, from curing numerous genetic diseases to establishing drought-tolerant plants. Scientists are conducting clinical trials making use of CRISPR-Cas9 to treat cancers, blood problems, and eye diseases.

PR-Cas9 repair the genetic issues onCRISPR-Cas9 technology gives sci- site by getting rid of the malfunctionentists the ability to change an organ- ing genes or correcting it to recover ism’s DNA. This allows genetic ma- regular gene expressions. terial to be added, removed, or altered at particular locations in the genome. Cas9 enzyme locates the faulty The CRISPR-Cas9 system has gener- genes throughout the DNA as well as ated a great deal of excitement in the customizes the very same. clinical research since it is faster, less costly, a lot more accurate, and extra However, it has been observed that effective than other existing genome sometimes it does not have the preediting approaches. cision, and modifications of genes at undesirable places in the genome The CRISPR-Cas9 technique was might happen. Unintended alteraadapted from a naturally occurring tions of the genomes might potentialgenome modifying system in bacte- ly bring about serious consequences, ria. The microorganisms capture bits such as cancers, as occurred in the of DNA from the invading viruses preliminary genetics treatment trials and use them to produce DNA seg- years ago. ments called CRISPR varieties.

Therefore it is essential to develop a The CRISPR arrays enable the mi- highly precise CRISPR-Cas9 enzyme croorganisms to remember the in- to do the molecular modifying on the fections (or carefully relevant ones). genome with extreme precision.

If the viruses infect once again, the bacteria create RNA segments from Highly precise CRISPR-Cas9 enthe CRISPR arrays to target the virus zyme- More Information genome. The microorganisms then utilize Cas9 or a similar enzyme to There are two variants of Cas9, parcut the DNA apart, which disables the ticularly SpCas9 (significance Cas9 virus. nuclease from the microorganisms Streptococcus pyogenes) as well as Repairing the genetic defects SaCas9 (Cas9 nuclease from Staphyon-site by Highly precise CRIS- lococcus aureus), which are generally PR-Cas9 enzyme used in CRISPR. CRISPR-Cas9 is regarded as an effective method in gene editing because it has made genetic modifications or editing extremely straightforward.

Unlike standard genetics treatment where extra duplicates of a particular gene are introduced into cells, CRIS-

Both of them were discovered to have a certain degree of inaccuracy or off-target results.

The customized SpCas9 variants crafted to boost SpCas9’s targeting precision were large to fit in the tiny

shipment vector called adeno-associated viral (AAV) vector that is typically utilized for in vivo gene therapy.

However, SaCas9 is much smaller than SpCas9, as well as can be quickly packaged in the payload-limited AAV vectors for providing gene-editing elements in vivo. Nevertheless, no SaCas9 variation with high genome-wide targeting accuracy was discovered to date.

Highly precise CRISPR-Cas9 enzyme SaCas9-HF to increase the precision in genome editing Dr. Zheng Zongli, Assistant Professor of Department of Biomedical Sciences at CityU and the Ming Wai Lau Centre for Reparative Medicine of Karolinska Institutet in Hong Kong, and Dr. Shi Jiahai, Assistant Teacher of Division of Biomedical Sciences at CityU, efficiently crafted SaCas9-HF, a CRISPR Cas9 variant which reveals high precision in genome-wide targeting in human cells without compromising on-target per-

formance.

The research group’s finding was based upon a considerable examination of 24 targeted human genetic locations comparing the initial unmodified (wild-type) SaCas9 and also the new SaCas9-HF. For those targets having comparable sequences in the genome and thus prone to off-target adjustment by the wild-type enzyme, SaCas9-HF decreased the off-target task by about 90%. For those targets with rather much less off-target modifying by the wild-type enzyme, this highly precise CRISPR-Cas9 enzyme SaCas9-HF yielded no observable off-target activity.

The research findings were published in the scientific journal Process of the National Academy of Sciences (PNAS) labeled “Logically engineered Staphylococcus aureus Cas9 nucleases with high genome-wide uniqueness.”

NEWS

November 19th, 2019 Vol. 03 NO 105

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US Researchers Use Biomarker Blood Test To Reveal Heart Disease Risk Without occasionally looking under the hood, it is difficult to predict whether expensive car repairs lie ahead.

IN A SIMILAR WAY, PREVENTIVE CARDIOLOGISTS ARE NOW LOOKING FOR WAYS TO DETECT EARLY-STAGE HEART DISEASE IN PEOPLE WHO ARE NOT CURRENTLY UNDER TREATMENT.

By Ria Roy

Preventive cardiology scientists at UT Southwestern Medical Center believe that new blood tests for protein biomarkers could easily identify these individuals. And their new study is now published in Circulation.

The study pooled patient data from 3 major patient populations including multiple ethnicities and totaling nearlas Heart Study,& from the Multiethly about 13,000 people. The research nic Study of Atherosclerosis. team asked whether measuring levels of 2 biomarkers i.e, proteins in the Further researches are needed to blood would identify people in need determine whether informing blood of treatment. pressure treatment with these protein biomarkers has an effect on patient The scientists found that approxioutcomes. mately one-third of the adults with mild hypertension who aren’t curDr. Pandey explained one of the rently recommended for treatments proteins, high sensitivity troponin, have slight elevations of one of these measures injury to the heart muscle, 2 protein biomarkers; these individand the other, called the NT-proBNP, uals were more likely to have heart measures stress on the heart muscle. attacks, strokes, or even congestive The presence of these proteins is the heart failure over the next ten years. indication of subtle long-term cardiac In other words, these heart patients injury, like wear & tear over time, he are flying under the radar and do not added. know that they are at a greater risk of cardiovascular events.

The team thinks this type of test can help in the shared decision-making process for patients who are in need of information about their risk, said preventive cardiologist, Dr. Parag Joshi, Assistant Professor of Internal Medicine. Biomarker blood tests are easily accessible and are less expensive than some other tests for risk assessment, he added.

Led by Dr. Joshi & Dr. Ambarish Pandey, Assistant Professor of Internal Medicine, the scientists looked at data from about 12,987 participants (mean age 55 years, 55% female) who experienced 825 cardiovascular events, such as heart attacks & strokes, over a median follow-up time of ten years. This information was compiled from the Atherosclerosis Risk in Communities Study, the Dal-

High blood pressure (with other risk factors) is known to increases the risk of heart attacks, strokes & congestive heart failure. Treatment to lower the blood pressure reduces this risk factor. Other parameters that play a role in cardiovascular disease include high cholesterol levels, gender, age, smoking, poor diet, lack of exercise & diabetes.

The process of developing the cardiovascular disease can be difficult to pick up on based only on these risk factors. Now there are tests to detect markers of heart disease in people without any symptoms who are actually at higher risk, said Dr. Joshi.

Additional UT Southwestern cardiology scientists who contributed to the study include Dr. Kershaw Patel, cardiology fellow; Colby Ayers, Internal Medicine Faculty Associate; Dr. Wanpen Vongpatanasin, Professor of Internal Medicine; Dr. Jarett Berry, Professor of Internal Medicine; & Dr. James de Lemos, Professor of Internal Medicine. Dr. Vongpatanasin holds the Norman & Audrey Kaplan Chair in Hypertension and the Fredric L. Coe Professorship in Nephrolithiasis Research in Mineral Metabolism.

Dr. Berry is a Dedman Family Scholar in Clinical Care. Dr. de Lemos holds the Sweetheart Ball-Kern Wildenthal, M.D., Ph.D. Distinguished Chair in Cardiology.

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NEWS

November 19th, 2019 Vol. 03 NO 105

Getting Mood Swings?

Scientists Say This Brain Receptor Is Responsible!

A research team has now discovered a unique receptor in the brain i.e, believed to regulate negative moods.

THE STUDY FINDING IS THE CULMINATION OF 8 YEARS OF PAINSTAKING INVESTIGATION INVOLVING DR. YO OTSU, NOW WITH THE UNIVERSITY OF SYDNEY & KOLLING INSTITUTE, AND RESEARCHERS FROM FRANCE, CANADA & HUNGARY, UNDER THE DIRECTION OF DR. MARCO DIANA.

By Ria Roy

This small receptor was found in a little-studied region in the center of the human brain, the medial habenula.

The study has been published in the He further added that the psychiatric drugs often have side effects because leading journal Science. they are not specific and affect the The first author of the study, Dr. whole brain. This receptor discovery Otsu said he and his research col- offers the potential to create much leagues now believe the receptor more targeted medicines with lesser plays a role in regulating the negative side effects.

moods. This is called the glycine gated [N- methyl-D- aspartate receptor] The findings of the study may also have implications for future medicaNMDA receptor. tions to reduce pain with receptors The function of the medial habenula subunit found in a part of the brain region is not very well understood but known to contribute to the pain, he is thought to be related to the negative explained. motivational states, said Dr. Otsu.

He added the team knew there were GluN3A subunits in the adult medial habenula & NMDA receptors formed with these sub-units were likely to have very different characteristics.

The team didn’t expect to find the receptor that they did, said Dr. Otsu.

The NMDA receptors normally require two different neurotransmitter molecules i.e, glutamate and glycine, to bind and activate the receptor.

The receptor that Dr. Otsu & his colleagues found only needs one neurotransmitter i.e, glycine, to activate it.

The receptors direct brain function and are also the target of approximately 40 % of all current medicines.

Therefore, this discovery of the rare type of brain receptor and its role in modulating anxiety and its effects of negative experiences means it has the potential to be a highly specific target for mood-regulating drugs.

The team will be embarking on research within the Kolling Institute to further understand the role of this newly found brain receptor, with the ultimate goal of developing drugs to target it. This discovery could lead to advances in mental health & pain medications, he added.

Dr. Aubrey said Yo has brought such a depth of knowledge to the team. He interrogates every aspect of the data i.e, an approach that has enabled him to consistently produce data of the highest level & impact.

Dr. Otsu is a part of the Pain Management Research Institute and this Dr. Karin Aubrey of Pain Manage- is a research study affiliated with the ment Research Institute at the Uni- University of Sydney’s Faculty of versity of Sydney’s Northern Clini- Medicine and Health. cal School & Kolling said the study finding opens up a whole new area of brain research.

NEWS

November 19th, 2019 Vol. 03 NO 105

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Scientists Use CRISPR For Dose-Dependent Gene Activation A group of scientists affiliated with several institutions in the U.S. has developed a way to use the CRISPR gene-editing technique for dose-dependent activation of gene expressions.

THE TEAM OF SCIENTISTS DESCRIBES THEIR TECHNIQUE FOR ALTERING GENE EXPRESSION IN AN ALTERNATIVE WAY AND HOW WELL IT WORKED.

By Rahul Mishra

Prior studies have shown that gene expression can be suppressed or activated using the CRISPR/Cas9 gene-editing technology. But until now, the CRISPR technique had not been used to enable dose-dependent activation of gene expression.

CRISPR For Dose-Dependent Gene Activation- A New Approach In this new effort by scientists, they have found a way to do just that by making use of chemical epigenetic modifiers- (CEMs) that were skillfully designed to activate desired gene expression with the help of some parts of the endogenous chromatin-activating machinery — doing, so researchers eliminated the requirement of exogenous transcriptional activators.

The new approach involved using two components; the first was Cas9, which was catalytically inactive along with the binding protein FKBP.

researchers then performed cytome- The researchers closely observed try on the cells that were expressing the inactive Cas9 protein that was guide RNA (g-RNA) & the inactive treated with the Chemical Epigenetic Cas9.

Modifiers to confirm that it was the CEM systems that were activating They then tested activation of the the GFP in the desired manner. In so gene using a plasmid expression doing, they found that treatment with along with one of the three chosen CEM87 was the only test case that elChemical Epigenetic Modifiers. Then evated the expression of GFP. the researchers had to wait to confirm Together, the 2 parts were used to that GFP expression was increased The scientists suggest this new techactivate gene expression in desired compared to cells that had not been nique developed by them could be useful in situations demanding for ways treated. dose-dependent activations of gene This group of scientists tested their CRISPR For Dose-Dependent expression in validation studies. system by infecting HEK293T cells Gene Activation- Experiment Rewith a fluorescent green protein. The sults The second was a CEM developed with FK506. This was linked to a molecule that would interact with the desired cellular epigenetic machinery. To be more specific, they created CEM-activating molecules that would find the gene activating mechanism, including CEM114, CEM87, and CEM88.

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November 19th, 2019 Vol. 03 NO 105

Biologists Discover New Target For Small Lung Cancer Therapy MIT cancer biologists find a new pathway of treating small cell lung cancer using pyrimidine biosynthesis, which appears to be a promising treatment for the particularly aggressive type of lung cancer cells with limited options for therapy.

THE LEADING CAUSE OF CANCER-ASSOCIATED DEATHS IN THE UNITED STATES AND WORLDWIDE IS LUNG CANCER, HAVING LESS THAN 20 PERCENT SURVIVAL RATE FOR FIVE-YEAR SURVIVAL.

By Ria Roy

But while comparing the two major subtypes of lung cancer, between small cell lung cancer and the nonsmall cell, small cell lung cancer is a lot more aggressive and also has a much poorer prognosis. Small cell lung cancer proliferates and metastasizes early, thus causing 6 percent of a five-year survival chance. sitive to the loss of a gene inscribing dihydroorotate dehydrogenase Unfortunately, there are no new ther- (DHODH), a key enzyme in the Novo apies for small cell lung cancer cells pyrimidine biosynthesis pathway. as we have for various other lung Upon finding that the level of sensigrowths, claims Tyler Jacks, director tivity entailed a metabolic pathway, of the Koch Institute for Integrative the scientists looked for the collaboCancer Cells Research Study at MIT. ration of the Vander Heiden lab, proActually, people are treated today the fessionals in normal and cancer cells same way they were treated 40 or half cell metabolism who were already a century earlier, so clearly there is a performing studies on the function of huge need for the growth of new ways pyrimidine metabolism and DHODH of treatments. preventions in various other cancers cells.

A research study appearing in the Nov. 6 issue of Science Translation- Pyrimidine is among the significant al Medicine reveals that small cell building blocks of DNA and also lung cancer cells are specifically re- RNA. Unlike healthy, the cancer cells liant on the pyrimidine biosynthesis are regularly dividing and required to pathway and that an inhibitor enzyme produce new DNA as well as RNA to called brequinar is effective against support in producing new cells. The the illness in cell lines as well as in private investigators discovered that animal model system using a mouse. small cell lung cancer cells have an The senior author of this study is unexpected vulnerability: Regardless Jack, along with other MIT research- of their reliance on the availability of ers including Associate Professor of pyrimidine, this synthesis path is a lot Biology & Koch Institute member less active in small cell lung cancer Matthew Vander Heiden, and co-lead than in other cancer cell types exauthors postdoc researcher Leanne Li amined in the research study. When and graduate student Sheng Rong Ng. DHODH is inhibited, they found that small cell lung cancer cells were not Scientists in the Jacks laborato- able to produce adequate pyrimidine ry-made use of CRISPR to evaluate to stay on top of demand. small cell lung cancer cell lines for genes previously being targeted by When scientists dealt with a genetdrugs, or that are most likely to be ically engineered mouse design of drugged, in order to identify thera- small cell lung cancer growths with peutic targets that can be tested more the DHODH inhibitor brequinar, tuquickly as well as conveniently in a mor progression reduced, and the clinical setting. mice survived longer than untreated mice. Similar results were observed The team found that small cell lung for the small cell lung cancer growths cancer growths are especially sen- in the liver, a regular site of metasta-

sis in individuals.

In addition to mouse model studies, the scientists examined 4 patient-derived small cell lung cancer lump designs as well and discovered that brequinar functioned well for 2 of these models– one of which does not react to the conventional platinum-etoposide regimen for this disease.

These searchings for are significant since second-line treatment options are really limited for clients whose cancers no longer react to the first therapy, and they assume that this might potentially stand for a new option for these individuals, said Ng Brequinar has currently been approved for use in people as an immunosuppressant. A preclinical study has shown that brequinar and also other DHODH preventions might work for other kinds of cancers.

the future, said Li. There is a lot of work to do before the brequinar can be tested in the clinic as a therapy for small-cell lung cancer, the team is hopeful that this might happen more quickly now that they are starting with a drug that is known to be safe in humans, he added.

Further ahead, researchers need to optimize the restorative efficacy of DHODH inhibitors as well as integrating them with various other presently readily available treatments for little cell lung cancer cells, such as chemotherapy and immunotherapy.

To help with the treatment of each individual patient, researchers will certainly work to recognize biomarkers for tumors that are at risk to this treatment, as well as to identify those resistance mechanisms in the tumors that do not respond to this therapy.

The research study was funded, in part, by the MIT Center for Accuracy The team is excited because their Cancer Medicine as well as the Ludfindings could provide a new way to wig Center for Molecular Oncology help small cell lung cancer patients in at MIT.

NEWS

November 19th, 2019 Vol. 03 NO 105

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Do You Hate Vegetables?

You Might Be A ‘Super-Taster’ According to the researchers at The American Heart Association, vegetables may taste extremely bitter to those who inherit a particular gene. The Scientists termed these persons as ‘super-tasters.’

SUPER-TASTERS ARE EXTREMELY SENSITIVE TO BITTERNESS, A COMMON CHARACTERISTIC OF MANY DARK GREEN, LEAFY VEGGIES SUCH AS BROCCOLI, CAULIFLOWER, CABBAGE, AND BRUSSELS SPROUTS.

By Rahul Mishra

Vegetable Taste Related To GenesThe New Study With a gene to taste differently, such people are likely to experience extreme sensitivity to bitterness. According to the research, People with the “bitter gene” are approximately 2.6 times more likely to hate vegeta- Vegetable Taste Related To Genesbles. This could make it more diffi- The Major Cause cult for some to incorporate healthy vegetables into their diet.

A mixture of two gene variants is responsible for this called AVI & PAV. However, these vegetables are low Everyone receives two of these genes, in calories and high in fiber. Their about 50% of people get one of each, benefits are essential to a healthy diet, while the other half gets copies of one especially when it comes to tackling or the other. the growing heart-health concerns.

People who have both AVI & PAV Jennifer Smith, the research author are sensitive to bitter tastes, while and postdoctorate in cardiovascular people with two copies of AVI are science at the University of Kentucky not. Scientists named this as “taste School of Medicine, said that genetics genes” are variants of the gene called affect the way you taste, and the taste TAS2R38. is an essential factor in food choice.

To carry out the research, scientists

gave questionnaires to 175 people Vegetable Taste Related To Geneswho averaged 52 years in age and How Is The Study Helpful? comprised 70% females. They found that people with AVI & PAV gene var- Researchers say that the role of geiants experienced intense reactions to netics in taste will be essential to research further as people’s food prefbitter compounds. erences change. According to Smith, Scientists also found that people identifying healthy substitutes for with the gene may also react nega- bitter vegetables is the goal of the retively to dark chocolate, coffee, and search. sometimes beer.

Finding new ways in which genes The study could also be used to de- impact food choice and taste expetermine if there are certain vegetables rience will be relevant, stresses the that super-tasters accept. By finding American Heart Association. what foods people with the gene will eat, doctors will be better equipped to make nutritional recommendations.

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November 19th, 2019 Vol. 03 NO 105

How Zika Virus Can Spread? Transmission Risk Maps Developed By Researchers The spread of infectious disease, Zika, depends on many different factors. Even the environmental factors play a role, as do socio-economic factors.

RECENTLY, THERE WERE SEVERAL ATTEMPTS MADE TO PREDICT THE TRANSMISSION RISK OF THE ZIKA VIRUS AT A GLOBAL AS WELL AS AT A LOCAL LEVEL, BUT THE SPATIAL AND TEMPORAL PATTERNS OF TRANSMISSION ARE STILL NOT WELL UNDERSTOOD.

By Ria Roy

Now, scientists from Goethe University and the Senckenberg Society for Nature Research in Frankfurt were able to generate reliable maps for the transmission-risk of the Zika virus in South America. The study has been published in the scientific journal PeerJ. Based on the models southern areas of the continent. The for South America, researchers will following countries are some of the use the method to determine the Zika especially affected countries accordtransmission risk for Europe as well. ing to the model: Brazil, Columbia, Cuba, the Dominican Republic, El In most of the cases, mosquitoes of Salvador, Guatemala, Jamaica, Venethe genus Aedes transmit the Zika vizuela, Haiti, Honduras, Puerto Rico, rus to humans. The primary vectors & Mexico. In Europe, a risk of Zika are the yellow fever mosquito (Aedes infection exists mainly in the Mediaegypti) & the Asian tiger mosquito terranean region, but also in the in(Aedes albopictus). Both the mosquiland regions of France & in the Rhine to species are widespread in the South areas of Baden-Württemberg.

America region. Whereas the yellow fever mosquito is nearly absent in Europe, the Asian tiger mosquito is widespread in the Mediterranean region.

Sven Klimpel Professor for Parasitology & Infection Biology at Goethe University in Frankfurt and the Senckenberg Biodiversity and Climate Research Centre said with their new modeling approaches it is possible now to illustrate the risk areas for Zika virus infections in Latin America regions. Klimpel added that the models additionally allows illustrating Zika risk areas for Europe.

For example, their models indicate the 2 autochthonous cases in southern France in Département Var (see illustration). And at the end of October, French authorities announced the first Zika case in Europe; about a week later, a second Zika case was made public.

According to the scientists’ calculations, the Zika infection risk in South America is highest along the Brazilian East Coast & in Central America.

The infection risk is moderate in the Amazon region and the lowest in the

To determine the infectious risk of a specific area, the scientists Dr. Sarah Cunze & Professor Sven Klimpel modeled the potential spread of the 2 species of mosquito, Aedes aegypti & Aedes albopictus. Since the mosquitoes can only transmit this Zika virus in regions where the virus is present in the first place, the scientists included an Evidence Consensus Map in their risk model. This map could categorize the number of reported Zika

illnesses at the regional level. And the average temperature of the warmest quarter was also incorporated in the model since the temperature has a significant influence on whether the virus can survive and then multiply in the mosquito. Finally, the researchers added socio-economic factors such as population density and gross domestic product to their risk model.

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FDA Authorizes NGS Test Marketing For Detecting HIV-1 Drug Resistance The FDA has approved the for marketing the Sentosa SQ HIV Genotyping Assay, which is the first HIV drug-resistant assay used in next-generation sequencing technology.

THE CAPABILITY TO LOGICALLY CHOOSE THERAPIES FOR PATIENTS READY TO START OR ALREADY TAKING ANTIVIRAL TREATMENT OFFERS AN ADDITIONAL DEVICE IN OUR ONGOING FIGHT VERSUS HIV,” SAID PETER MARKS, M.D., PH.D., SUPERVISOR OF THE FDA’S FACILITY FOR BIOLOGICS EXAMINATION AND RESEARCH STUDY.

By Ria Roy

“Today’s consent offers healthcare providers a brand-new tool in helping to choose treatment choices for their patients.

The best combination of antivirals can lower viral tons, or the quantity of virus in the bloodstream, and also aid keep patients with HIV healthy for several years. Nonetheless, according to a recent record from the Centers for Disease Control and also Avoidance and also the World Health Organization, the percent of individuals dealing with HIV around the globe that have resistance to some HIV medications has boosted from 11% to 29% given that 2001.

FDA Authorizes HIV-1 drug – What Causes AIDS? When HIV infection is untreated, it can cause acquired immunodeficiency syndrome (AIDS) disease. It is transmitted through direct contact with Human Immunodeficiency Virus-infected bodily fluids such as blood, and the majority of Human Immunodeficiency Virus infections in the U.S. are from Human Immunodeficiency Virus-1.

According to the Center for Disease Control, there were more than 1 million Americans with Human Immunodeficiency Virus in the year 2016.

The present standard of care for patients with Human Immunodeficiency Virus-1 is ART, also known as antiretroviral therapy, the daily combined usage of drugs to treat Human Immunodeficiency Virus by suppressing it.

Traditionally, monitoring a patient’s viral lots has been done to evaluate the effectiveness of therapies. Increasing viral loads indicate that the virus might have mutated and that a

patient’s present regimen is not effective at suppressing the virus. Once the virus has mutated or altered, and drug resistance develops, a person should generally change medications intake as different drugs will help to keep the virus from multiplying.

FDA Authorizes HIV-1 drug- Why Did FDA Approve It? Food and Drug Administration Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., said the public health agency, the FDA is precise, aware of the danger of drug-resistant infections and are focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections. This diagnostic provides a new way to select effective treatment options, he added.

The Sentosa SQ Human Immunodeficiency Virus-1 Genotyping Assay detects Human Immunodeficiency Virus-1 drug resistance mutations in patients taking to start antiviral treatment. This assay will detect mutations in genes of the Human Immunodeficiency Virus-1 virus from a sample of a patient’s blood using New Generation Sequencing or NGS technology.

Understanding the mutations in the virus will help healthcare providers to select a very useful combination of drugs in an ART regimen and indication in which drugs may no longer be effective against the mutated HIV-1 virus.

The US FDA reviewed data from

performance studies, which demonstrated a greater than 95 percent sensitivity and specificity in detecting 342 HIV drug-resistant mutations and determined the Sentosa SQ HIV-1 Genotyping Assay provides a reasonable assurance of safety and effectiveness for its intended use.

FDA Authorizes HIV-1 drug- The Research Data The Sentosa SQ HIV Genotyping Assay is for use only in patients with HIV-1 who are about to start or already taking antiviral therapy and is not intended for diagnosing infection with HIV. Results of this test are intended to be used in conjunction with clinical observations, patient history, and other laboratory evidence to make patient management decisions.

The Food Drug and Administration or FDA have reviewed data for the Sentosa SQ HIV Genotyping Assay through the de novo premarket review pathway, a regulatory pathway for devices of a new type.

Along with this authorization, the Food Drug and Administration is establishing criteria, called special controls, which is the requirement that test developers must meet for demonstrating accuracy, reliability, and effectiveness of tests intended to identify the virus mutations.

These unique controls, when met along with general controls, provide a reasonable assurance of efficacy and safety for tests of this type. This action will also create a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the Food and Drug Administration’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The Food Drug and Administration agreed on marketing authorization of the Sentosa SQ HIV Genotyping Assay to Vela Diagnostics USA Inc.

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November 19th, 2019 Vol. 03 NO 105

Roche’s Human Alzheimer’s ProjectThe “Brain Shuttle” Approach Roche- the Swiss drugmaker is testing its “brain shuttle” in humans hoping to prove the theory correct that removing amyloid plaques from the brains of patients suffering from Alzheimer’s disease will prove useful despite repeated failures.

AZAD BONNI, HEAD OF ROCHE’S NEUROSCIENCE TRANSLATIONAL MEDICINE AND RARE DISEASES, SAID THAT PHASE I CLINICAL TRIALS HAVE STARTED WITH A VERSION OF ITS EXPERIMENTAL GANTENERUMAB MONOCLONAL ANTIBODY DESIGNED TO CROSS THE BLOOD-BRAIN BARRIER.

By Rahul Mishra

Roche’s Human Alzheimer’s Project- The Technology Used The technology called the Brain Shuttle aims to deliver a more-efficient payload than that possible with a systemic medicine, where only a broader access to the target. Mr. Bonsmall fraction of the drug may reach ni said this during a presentation about Roche’s Swiss pRed research the central nervous system. group’s pipeline.

Roche’s work on the brain shuttle began more than five years ago, first Roche’s Human Alzheimer’s Project- Can Alzheimer’s Be Treated in mice and finally now in humans.

With This Approach?

The company further said that the technology would lead to faster and In the Roche Human Alzheimer’s

Project, the company aims at faster amyloid-beta removal throughout the brain tissue. Mr. Bonni termed this project to escalate Alzheimer’s research ‘exciting.’

Many varieties of drugs based on clearing amyloid plaques from Alzheimer’s patients’ brains to slow or halt the fatal form of dementia

have failed.

However, Roche’s continuous effort with gantenerumab, as well as Biogen’s move last month to revive a drug previously judged to have flopped in two clinical trials, shows scientists have yet to give up hope to cure Alzheimer’s.

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NASA’s Curiosity Rover Detects Strange Oxygen Behavior On Mars The Curiosity Rover by NASA landed in Gale Crater in 2012. Since then, it has been the Martian surface beneath its wheels to learn more about the planet’s history.

ALONG WITH THE SURFACE EXAMINATION, CURIOSITY ALSO COLLECTED DATA ABOUT THE PLANET’S ATMOSPHERE.

By Rahul Mishra

Curiosity’s tunable laser spectrometer, called SAM, which stands for Sample Analysis at Mars, detected the most significant amount of methane ever measured during its mission.

SAM has also discovered that over time, oxygen behaves in a way that can’t be explained by any chemical process researchers currently understand.

Sam has revealed the following data about the Mars atmosphere- 95 percent of the atmosphere is carbon dioxide, followed by 2.6 percent molecular nitrogen, 1.9 percent argon, 0.16 percent oxygen, and 0.06 percent carbon monoxide.

Earth, microbial life is a crucial source of methane. NASA also warned that expectations of life should be managed since interactions between rocks & water can also create methane, and Mars has water as well as the abundance of rocks.

Curiosity Detects Mars OxyCuriosity Detects Mars Oxy- gen-Behavior- The Previous Findgen-Behavior- What Is The Reason ings For Fluctuation?

This is not the first time methane has Similar to Earth, Mars goes through been detected on Mars by Curiosity. its seasons; over a year, the air pres- Throughout its mission Curiosity has sure fluctuates. This happens when detected methane several times, and the carbon dioxide gas freezes in win- studies have been written about how ter at the poles, consequently low- the gas levels appear to rise & fall deering the air pressure. It rises again pending on the season. It can spike as during spring & summer, redistribut- much as 60 percent during the suming across Mars as the carbon dioxide mer season. evaporates.

The researchers wanted to share Surprisingly, the oxygen rose by their findings in the hopes that experts a peak increase of 30 percent in the studying the mars atmosphere may be spring and summer before dropping able to help discover what process is creating these fluctuations in the atback to normal in the fall. mosphere.

Given the amount of time Curiosity has been monitoring the martin’s atmosphere, it was able to detect that this pattern repeated.

The variation suggests that oxygen is being created by something, then taken away.

Regarding methane, the June 2019 reading indicated 21 parts per billion units of methane by volume or ppbv.

So why is this unusually huge amount of methane so exciting? On

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NEWS

November 19th, 2019 Vol. 03 NO 105

Microsoft Uses AI To Diagnose Cervical Cancer Faster In India In some cases, Artificial Intelligence assisted cancer detection might be more than a convenience where it could be the key to getting a diagnosis in the first place.

MICROSOFT & SRL DIAGNOSTICS HAVE DEVELOPED AN ARTIFICIAL INTELLIGENCE TOOL THAT HELPS DETECT CERVICAL CANCER, FREEING DOCTORS IN INDIA AND OTHER COUNTRIES WHERE THE SHEER VOLUME OF PATIENTS COULD PROVE OVERWHELMING.

By Ria Roy

The research team trained an AI to spot signs of cancer by feeding it with “thousands” of annotated cervical smear images to help it spot abnormalities -including pre-cancerous examples- that warrant a closer look.

Doctors would only have to look at those slides that justify real concern. of the latest examples of Microsoft’s ongoing research work in India. The A framework for using Artificial In- world’s second-most populous nation telligence is now ready for an “internal preview” at SRL. It is not in use in the field just yet, then, but that is considerably better than other Artificial Intelligence cancer screening methods that typically don’t exist as more than experiments.

There is an incentive to put this into use quickly. TechCrunch noted that roughly about 67,000 women die of cervical cancer in India each year or more than a quarter of the deaths worldwide.

At the same time, there is just a handful of doctors that can process pap smears and help women take action. SRL diagnostics alone receives over 100,000 samples per year, and 98 % of those are normal. Microsoft’s Artificial Intelligence would let doctors focus on just the two percent of samples that are problematic and help women start treatment sooner.

SRL Diagnostics– Microsoft consortium said they are very hopeful about their APIs and it could find application in other fields of pathology such as in the diagnosis of kidney pathologies and in oral, pancreatic & liver cancers. The consortium aims to expand its reach with more collaborations with private players & governments to expand the reach of the model even in the remote geographical areas where the availability of histopathologists is really a challenge.

The announcement this week is one

has become a testbed for many American technology companies to build new products & services that solve

local challenges as they look for their next billion users worldwide.

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Data Science Startup Elucidata Uses AI To Accelerate Drug Discovery Drug discovery in the pharmaceutical industry & academic laboratories is often a challenging process.

THIS PROCESS IS TIME SENSITIVE AS THERE SEVERAL INDIVIDUALS WHO SUFFER FROM CHRONIC TO LIFE-THREATENING DISEASES.

By Ria Roy

One such startup is riding the wave of data-led drug discovery and that is Elucidata. It was founded in August 2015 by two IIT alumni, Swetabh Pathak (IIT-Delhi) & Abhishek Jha (IIT-Bombay), The startup Elucidata accelerates drug discovery through its Artificial Intelligence (AI) enabled platform, Polly. It uses data science to reduce the time taken to discover life-saving drugs that impact human Co-Founders of Elucidata; Swetabh lives significantly.

Pathak and Abhishek Jha. It was at Agios pharmaceuticals that In a research conducted by the MIT Abhishek realized that data generaLaboratory for Financial Engineering, tion has been modernized and techit was discovered that only 13.8% of nology has advanced over the years. drug programs make it from phase I But, making sense of this large data to the approval phase, a much higher still lagged way behind. The wealth figure when compared to the regular of huge data was being under-utilized estimates of 5 to 10%. by limited capability & technology to analyze it. Hence, they started EluciThe figure is even higher if the can- data with the idea to bridge the gap cer trials are excluded as cancer drugs and impact human lives, Swetabh have the lowest success rate. The said. research was conducted through an automated algorithm that draws data Polly helps in drug discovery by from nearly 1,86,000 unique trials of collecting data, giving insight by runover 20,000 compounds from January ning statistical and machine learning 2000 to October 2015. models, visualizing it in charts to be shared with one’s team and discussAbhishek Jha and Swetabh Pathak ing further through collaboration. co-founded Elucidata in the year 2015with offices in New Delhi, Ben- Polly platform has a number of feagaluru & Boston. tures such as processing raw medical data in minutes, delivering pathAbhishek who is an IIT graduate did way-level insights, tools for quick his postgraduate from the University customization, among others. of Chicago & Postdoc at the Massachusetts Institute of Technology. On Polly, you can analyze omics and Before co-founding this startup, he phenotypic data. The cloud platform worked with Agios Pharmaceuticals. Polly platform helps in deriving insights from diverse publicly available Swetabh Pathak, on the other hand, datasets. The workflow allows users did both his M Tech & B Tech from the to cut the data analysis from days to Indian Institute of Technology, Delhi. hours and produces comparable data He worked as a product manager with output that is easier to manipulate Avanti Learning Centres as a product and plot. Polly reduces time, hassle, manager. Swetabh also worked with & significantly increases throughput.

Opera Solutions as a business ana- These workflows are currently being lyst before co-founding Elucidata and used by scientists at organizations moving into the bio-medical data & like Pfizer, Cygnal Therapeutics, the tech space.

NIH, & Yale to cut down the time span required for its end-to-end analAI to accelerate drug discovery ysis, said Swetabh.

This software can be purchased as an annual subscription with 3 types of offerings: • Polly Pipelines: It is a suite of customizable pipelines for analytical chemists or biologists to analyze and process a variety of biomedical data.

• Polly Compute: It is a robust, scalable, secure computational infrastructure or bioinformaticians to build, manage and operate custom pipelines.

• Polly Discover: It is an AI-enabled technology for the integration of biomedical data to enable biologists to discover therapeutic assets.

This runs on a software-as-a-service, SaaS, based licensing model. Elucidata has partnered with some of the core

facilities such as VIB Center for Cancer Biology, University of Louisville, Lorkiewicz Laboratory, Van Andel research institute, among others.

Bootstrapped for the first 2 years, the startup raised $1.7 million in seed funding from Hyperlane Venture Capital in 2017. It has utilized the fund to expand its operations in New Delhi, as well as, build the Cambridge team in New England.

This startup is currently collaborating with top universities in both the US & UK, such as MIT, Yale, and UCLA, where the laboratories are of state-of-the-art, and helps the startup provide solutions.

Now, Elucidata is close to raising its Series A round of funding. Apart from the existing offices in Bengaluru & New Delhi, it is looking to expand to more places in the US & Europe.

Co-Founders of Elucidata; Swetabh Pathak and Abhishek Jha.

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November 19th, 2019 Vol. 03 NO 105

Google’s AI Based Search Tool For Analyzing Millions Of Health Records Google, the ever-growing technology company, has been revolutionizing the world since 1998.

FROM THE MOST USED SEARCH ENGINE TO THE RECENT DRIVERLESS CARS, GOOGLE CONQUERED ALMOST ALL THE TECHNOLOGICAL INDUSTRIES.

By Namitha Thampi

The most prominent players in the world, like Google, Facebook, Amazon, and Apple had been trying to invade the $3 trillion healthcare industry. Among them, Google’s dream is going to come true soon.

On November 12, Google declared a partnership with ascension, one of the leading non-profit health systems in the United States.

Tariq Shaukat, President, Industry Products, and Solutions of Google Cloud announced that Google would support Ascension with technology to deliver better healthcare across the US. Ascension will provide Google with personal health datasets to develop Artificial Intelligence-based tools for medical providers.

This alliance, named “Project Nightingale” was announced one week after Google bought Fitbit for $ 2.1 billion.

The announcement of the partnership confirms the earlier reports that Google is working on a search tool for doctors to find medical records easily.

The deal of sharing data Google will be acquiring detailed personal health data of people across the US, which would include patient names, dates of birth, doctor diagnoses, lab results, and hospitalization records, along with the medical histories of 50 million patients of Ascension.

Google confirmed that it would abide by the HIPAA regulations to protect the privacy and security of the patients.

According to the HIPAA regulations, hospitals can share the patient data with its business partners without the consent of patients on the condition that the data will be used only

for clinical purposes.

for personalized healthcare.

Google stated that the data from Ascension would not be used for any purposes other than the mentioned services, and they will not be combined with the Google consumer data.

This is not the first time Google is interested in the health sector. Google has close relationships with other health institutions like the Chilean Health Ministry, Mayo Clinic, Dr. Agarwal’s Eye Hospital, as well as the American Cancer Society.

It is noteworthy that Ascension is not paying Google for these services. They believe that the application of Artificial Intelligence will improve the quality of the health sector by developing machine learning models

Still, there are queries concerning the privacy of patients considering that 150 employees of Google will have access to these medical records.

That’s not all!

In 2016 Google was accused of violating patient privacy for DeepMind health move after it’s a partnership with Britain’s National Health Service regardless of it’s earlier vow to keep the health industry separate.

Despite the privacy concerns, let’s hope that this initiative by Google would improve healthcare immensely.

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Guide For Becoming a Programming Biologist Have the idea of becoming a biology programmer ever stricken your mind? Is it so that you tried but later found yourself standing nowhere near to start? If the answer to both of these questions is yes, you are encouraged to give a try to the following resources.

COMPUTER SCIENCE IS ONE OF THE SUBJECTS WHICH NEEDS LEAST CERTIFICATION AND GUIDANCE AND MORE OF SELF-LEARNING AND PRACTICE, ALONG WITH MOTIVATION AND A COMPUTER CONNECTED TO THE INTERNET!

By Dr. Preeti Saini

As artificial intelligence and computers are becoming an important part of our lives, having knowledge only about biology theory is not going to help out. Skills should be combined with experimental design and interpretation that also requires an understanding of the analytical approach.

While academic knowledge can aid in the implementation, computational literacy seems non-replaceable. In fact, the dry lab is getting more popularity compared to wet labs these days. So, hereby 10 simple steps are being mentioned to get acquire a computational skill set to become a perfect Programming Biologist.

Get Introduced To The Basics It is always better to take a step back to learn the fundamentals of computer science first. Before you learn the syntax of the language of your choice, you need to understand basic concepts such as data types, variables, conditionals, loops, arrays, functions, etc as well as the languages including C, PHP, JavaScript, SQL, CSS, and HTML. Also, it may be needed to increase your typing speed if you are not a regular user of the keyboard.

Some of the learners also take a step further and ensure to write/run programs in a simple web-based IDE. Choose The Language Related To Your Work Of Interest While selecting your primary language, consider the type of work being implemented. What exactly you want to achieve through this course: programming, designing, implementation, analysis? Advisable languages for biology researchers to become a Programming Biologist include: Python, followed by Julia, Pearl, R, Ruby. Python is especially easy to learn, contains multiple capabilities, and also includes a well-developed li-

brary of tools. To name a few Biopython, Galaxy, and Pygr. Python is also smoother to implement in a relatively shorter amount of time, as compared to C++ or Java.

If you’re unsure which program is right for you, do some research online, Spend some time reading up on the different pros/cons of the languages you have filtered as well as how steep the learning curve is. One can always learn multiple languages.

However, it is advisable to master the first language before setting out to learn a second.

Don’t Hurry It, Take Baby Steps!

Once you’ve begun, specialize in one task at a time and apply your thinking and problem-solving expertise. This needs tackling a problem stepwise. Analysis of the overall information could sound challenging, however taking the baby steps will help a lot. e.g., First scan your information, decide on a way to interpret missing values, do the scaling, establish comparison conditions, calculate fold change, etc. Tackle these tasks one at a time. Iteratively edit for potency, flow, and conciseness. Don’t be afraid of committing mistakes, the more important thing is to notice, correct, and learn from them.

Immersion Is The Best Learning Tool Do not sew along an analysis by shifting between or among languages, this is going to make the task more

difficult. If possible, complete the job in one language or environment.

Like, importing a spreadsheet of data (like you would view in Excel) is not necessarily straightforward; Excel automatically determines how to read a text, but the method may differ from conventions in other programming languages. If your date is not being read properly (misread), it is suggested to take the help of Excel.

However, these issues are fastened by correctly reading the information and by understanding the language’s data structures. Additionally, transferring across programs induces error.

See References for additional Excel or word processing–induced errors.

Eventually, you’ll establish tasks that don’t seem to be well matched to the language under consideration. At that time, it should be helpful to choose can build will make it easier to find out a second.

Practice Makes Perfect Once you’ve started onto something, what comes next is relentless practice.

Like any other field – a Programming Biologist career will also take lots of practice of constantly writing programs is going to make you perfect in this particular field. I hope you have learned of the famous fact “if you are going to spend 10,000 hours onto the subject of your choice, it will make you a Master of the same”. While doing the same, you’ll be handling certain small techniques, learning to think programmatically, and will eventually feel confident enough to

apply your knowledge to real-world issues.

Take Help There may be a whole lot of online resources in the form of documentation, sites, and tutorials as well as the communities to discuss the problems viz. Biostars, StackExchange, StackOverflow, etc., but nothing can substitute for a friend or colleague’s help.

You may find one in your own university. If your lab or university does not have a community of programmers, take the help of certification courses online. Thereby, it will also be possible to get mailing lists for connecting with members. One can also get in contact with the help of events organized by language-specific user groups or interest groups focused on big data, machine learning, or data visualization in one’s city.

But before asking for help as well, you need to be clear about the problem yourself. First, interpret the error message. The process of understanding the problem is called “debugging”.

Before starting the work go through previous papers, check experiments, get code from your friends, implement and interpret that code, discuss your queries with them, take their help in editing.

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Do not start from the beginning if pretations and details of the programyou are a complete newbie to this ming. Develop a habit of organizing a field. drawer with relevant files for all the experiments handled by you in the Copy and paste is something which past for quick access in the future. does not earn due respect in the scien- This saves a lot of time and boosts eftific field. However, it becomes your ficiency. Also, note down the modififast friend with regard to program- cations or changes in experimental or ming. Try all the resources available, computational protocols. which include cool snippets of code your labmate shared, examples in the Get Better Exposure language’s documentation, online tutorials, published code, and your own Try to collaborate with scientists in past work. Read widely to identify your research specific field. Together these resources. It is also advised to you can carry out a project, discovgive due credits and references. er something new, that suits the taste of other people as well. It may help Maintain Good Data Maintaining you get a publication in the form of Habits research papers and review articles, that will, in turn, boost your credibilAs a Programming Biologist, you ity. You may also apply the new apwill be dealing with loads & loads proach in already existing data from of data in terms of codes, theories & your past experiments that will imdata collected. It is also advisable to prove the chances of the manuscript maintain a computational lab note- getting accepted in the best journals. book which will include protocols, codes, inputs, outputs, figures, inter- Specialization in Bioinformatics –

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Is Programming Knowledge Necessary For Career In BioinformatAfter learning the basics and lan- ics? guage selection, one must attain a Give It A shot! specialization in Bioinformatics. Bioinformatics and computational biolo- These pieces of advice might help gy are the fields every programming you judge the path ahead, though biologist must be acquainted with. Ei- these may not be applicable to all of ther you can pursue a full-time degree you. You will learn new facts and dein it or go for certification courses. velop new skills well-suited to yourThere exist tonnes of bioinformat- self. ics algorithms including Sequence Alignment, Motif Searching, Genome Science is all about learning. The reAssembly, Evolutionary Tree Recon- spect you earn in the scientific comstruction, Hidden Markov Models, munity is always proportional to the Peptide Sequencing, and many more quality of research which is credible which comes in very very handy as a to you. Computers are not only for programming biologist. Additionally, word and excel now. Softwares are an next-generation sequencing tools and impeccable part of regularly upgradother methods in computational biol- ing researchers or learners. The resources and opportunities are endless. ogy must also be known.

Computational expertise also makes To get more details on the list of Bi- a biologist much more marketable & oinformatics Skills Required and Ed- presentable in terms of better job & ucational Qualifications for becom- career opportunities. ing a Programming Biologist visit the below link : A Must

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How To Make A Career in Next Gen Sequencing?

Current DNA sequencing methods cannot differentiate between the 2 states of genes i.e; when they are turned on or off.

THE NEXT GEN SEQUENCING TECHNOLOGIES CAN DIFFERENTIATE BETWEEN THE SAME.

By Dr. Ankita Trivedi

With the help of this technology, we can accurately identify cures for diseases !! There were certain misconceptions and drawbacks of Sanger sequencing methods that laid the foundation of these new and much more advanced sequencing technologies collectively termed as NEXT GENERATION SEQUENCING. What is Sequencing?

You all are aware of the fact that our body is made up of DNA – A Hereditary material. DNA is made up of a nucleic acid sequence. In order to determine the nucleotides in DNA, sequencing was performed. Sequencing includes any method or technology that can be helpful in any way to determine and analyze the order of the four nucleotide bases: Adenine (A), Guanine (G), Cytosine (C) and Thymine (T). DNA sequencing is mostly performed by using the Chain Termination method of Frederick Sanger.

This was the simplest technique that implies sequence-specific termination of a DNA synthesis reaction using modified nucleotide substrates.

Nevertheless, certain new technologies of sequencing are acquiring a high share of the sequencing methods. Pyrosequencing is one of those that is generating more genome data than Sanger DNA sequencing method/technology.

What is NGS- Next Gen Sequencing?

Next-gen sequencing alludes to non-Sanger-based high-throughput DNA sequencing technologies. Many strands, almost Millions or billions of DNA strands can be sequenced in parallel, generating substantially more throughput and minimizing the need for the fragment-cloning methods that were used for Sanger sequencing of genomes. NGS has transfigured nearly most of the area of Biotechnology.

NGS allows the sequencing of nucleic acids like DNA and RNA much more quickly and in a cheaper man-

ner than the older version of sequencing technologies. With the use of these technologies study of various branches of Biology such as Genetics and Molecular Biology are revolutionized. Next-gen sequencing includes different types of sequencing methods. Let’s have a look at these Sequencing methods and how they are far ahead from Sanger-based sequencing technology.

NGS utilizes vast numbers of short reads that are sequenced in a single stroke. To achieve this, the input sample is first chopped down into short sections. The various section lengths produced will depend on the fact that which particular sequencing methodology has been used.

Based on this NGS can be of three types described below: Illumina (Solexa) Sequencing: This method works by simultaneously analyzing DNA bases as each base emits a unique fluorescent signal, and adding them to a nucleic acid chain.

In this method: 100-150 bp reads are used. Longer fragments are ligated to generic adaptors which are then annealed to a slide with the help of adaptors. To amplify each read and to produce a spot with multiple copies of the same read, PCR is used. In the final step, multiple copies are split into single strands that are subjected to sequencing.

Roche 454 Sequencing: The second type of NGS is based on pyrosequencing that notices the release of

pyrophosphate once nucleotides are subsumed by polymerase to a new DNA strand with the help of fluorescence. This method can sequence much longer reads than Illumina (up to 1kb), but the sequencing method remains the same. The read ends are attached to generic adaptors and are annealed to beads. Finally, PCR is used to amplify these fragments by adaptor- specific primers. Each well of a slide contains a single bead covered in multiple PCR copies of a single sequence in addition to Sequencing buffers and DNA polymerase.

Ion Torrent: Proton / PGM sequencing: This NGS method is unique in its own way. This sequencing method measures the direct release of H+ by the incorporation of individual bases / dNTP by DNA polymerase and thus shows the difference from the previous two methods as it does not measure optical signals. In this method, the read size is about 200bp. Adaptors are added and a molecule is deposited on a bead. With the help of emulsion PCR, molecules are amplified. Single well on a slide contains a single bead.

Applications of NGS : Next-Generation Sequencing has an allied group of applications. With the advancement in various sequencing methods, the way to carry out various studies on molecular and genomic levels has been changed and modified. NGS has given us so much power to sequence and interprets genomes quickly and accurately. NGS is used to study various variations,

DNA-binding as well as expression at a genome-wide level. With more advancement based on various research studies, one can get an idea of the immense potential of Next Gen Sequencing in numerous fields and the different tools that can be used for the analysis purpose.

Some of the Applications of NGS are listed below : • Next generation sequencing techniques are applied to different aspects of Biological Sciences such as Plant Biotechnology, Animal Biotechnology, and Human Biotechnology.

• The plentiful information generated by NGS assists in analyzing genomic variations, various disease mechanisms, and its resistance.

• NGS has its applications in forensic genetics- NGS contributes to offering new possibilities for forensic genetic casework.

• This method of sequencing can be combined with various types of markers like STRs, SNPs, insertion/deletions, mRNA -to gather more information from unique samples in a single experiment.

• All these sorts of applications of Next generation sequencing help

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applied techniques for most of the research studies. So, it is always better to be a part of a bright and famed future. If you have a golden path in front you, why not have a walk on it!

Career Options And Job Pros- If you are confused regarding your career options after your graduation pects: or post-graduation, you can have this You should always choose a field, field as an option. I would rather say which you are interested in. Always you should go for it as opportunity find out what you like doing best. knocks only once.

Don’t go behind the crowd; Career choice should always be yours, What If you are an aspiring researcher, makes you happy -Choose that! If the academician or a student, this is the details thus far given about NGS have golden opportunity to learn about this enticed you then you probably must technology, glance at the research prospects in this avenue, and become go for a career in this field. aware of career opportunities in this NGS with its speed, ultra-high field. Get the participation certificate throughput, extensibility enables re- (hard copy as well) and highlight your searchers to experiment and establish new skills on your resume. a variety of applications and also to study various biological systems at a Who must attend: Students in their level that was never possible before. B.Sc / B.Tech / M.Sc / M.Tech who NGS will remain as one of the most aspire to work on cutting-edge rein development as well as the advancement of better diagnostic tools, breeds, and numerous therapies.

CAREER ADVICE search technologies of the FUTURE. Where to apply for jobs after learning NGS Skills?

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are various openings for talented candidates in Commercial, R&D, Corporate, Software and Operations sections of highly reputed industries and institutes. You can also choose a career in research where you can join for a Ph.D. program in NGS.

Today’s research world is all based on your knowledge and experience.

After enrolling yourself in any one of the above-mentioned courses, you Companies & Institutes Carrying can easily apply your knowledge and out NGS Research : skills of NGS in research. You can search for jobs in areas related to • National Centre for Biological Sciences (NCBS) Personalized medicine, Preventive medicine, Gene Therapy, and Drug • Illumina.

Development. You will be enriched • Thermo Fisher Scientific. with various skills after completing • Roche. training courses in NGS- Literature • Qiagen. mining, Sequence Alignment, Phy- • Agilent Technologies • Macrogen logenetics, Gene prediction.

• Medgenome Job Prospects: You can work as • Mapmygenome Field Applications Scientist, Scien- • Xcelris tist II, Associate Scientist, Sr Scien- • SciGenom tific Researcher, Program Manager, • BGI Genomics Microarray and NGS Curator. There

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CAREER ADVICE

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Medical Writing As A Career – Eligibility & Job Prospects If you master those writing skills which can leave the readers into a state of contentment where the most complicated fact or data is explained in a technical but tranquil language, this exhilarating career of medical writing might be waiting for you.

NOT ONLY THIS CAREER OPTION HAS TOUCHED THE HEIGHTS DURING RECENT YEARS IN TERMS OF PROVIDING CAREER OPTIONS BUT ALSO IT IS OFFERING ALLURING SALARY PACKAGES TO THE EMPLOYERS.

By Dr. Nidhi Hukku

What is medical writing and what does it contribute?

Medical writing is an art of creating well-articulated scientific documents that may include clinical research documents, content for healthcare websites, health magazines, health care journals, and health-related news. It also encompasses writing documents for clients in media, industries, government, clinical research organizations (CROs) and medical device manufacturers.

The Two arms of Medical writing!

Medical writing can be broadly categorized into regulatory medical writing and Educational medical writing.

1.Regulatory medical writing: Contributes to getting the approval of drugs/cosmetics/food products/ medical devices!

This form of medical writing involves writing the documents that are required to be submitted to the regulatory agencies to get approval for drugs, devices, and biologics.

Usually, each country owns its national authority whose approval is required for medicine, drug, cosmetic products, processed food, biologics to be marketed and sold. Regulatory documents remain huge and are required to be created complying with the standards of technical writing. For drug approval, regulatory documents comprise of all the details and data initializing from the clinical trials.

These documents include clinical study protocols, clinical study reports, patients’ consent forms, investigator brochures and the most significant Common Technical Document [CTD] in prescribed formats. These documents are created to summarize and interpret the data gathered by the

company in the course of developing a pharmaceutical or cosmetic product.

The audience for these documents remain ethical committees and regulatory authorities.

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2. Educational medical writing: Assists in facing the general audience!

Any information which has been collected from various sources and shaped in the form of the technical regulatory documents, when needs to be presented to the general audience or health care professionals should be done in a captivating and illuminating manner. Addressed for the general public, these documents are written in simple, non-technical language.

This subset of medical writing helps in developing drug-related educational and propagative literature, journal manuscripts, abstracts. Besides, writing content for healthcare-related journals, newsletters, magazines and healthcare websites will share canopy under educational medical writing.

What a medical writer does?

• A medical writer creates, proofreads, finalizes protocols, investigator brochures, synopses, regulatory documents, and clinical documents.

• A medical writer contributes to the development of product dossiers for a company aimed at regulatory authority submissions.

• A medical writer coordinates with clinicians, clinical scien-

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tists, biostatisticians, and pharma professionals to transcribe study results.

A medical writer ensures clinical or research studies results and statistical interpretations are precisely reflected in the final documents.

A medical writer works in collaboration with scientists, doctors and subject matter experts to design and outline the framework for the essential documents.

A medical writer helps doctors or a medical organization to write research articles, abstracts, reviews and monographs on health-related topics.

A medical writer works for a pharmaceutical or medical device manufacturing company to design educational materials and informational material for kits or package inserts to be used by the doctors and the nurses.

A medical writer may produce documents for the press release for a company or website content for it.

A medical writer writes about the research discoveries for any medium or means to reach the general public.

A medical writer fortifies that medical writing documents comply to International Conference on Harmonization(ICH) or other relevant regulatory guidelines A medical writer develops standard operating procedures for the preparation and maintenance of compliant medical writing deliverables for a company.

• A medical writer inspects that appropriate documented quality control (QC) checks are being implemented on medical writing deliverables.

Where medical writers could be placed for Job? Nowadays Medical Writing Career is booming, demand for medical writers is tremendously growing. Medical writers could find a job option in an array of niches like: • CROs( Contract Research Organizations) or BPOs and KPOs • Functional service providers i.e companies involved in Scientific content and healthcare communication • Media & Publishing companies • Reputed Medical Journals • Academic medical institutions engaged in providing education to healthcare professionals.

• Medical/scientific societies • Pharmaceutical/healthcare product companies including medical device companies • Food processing/ cosmetics manufacturing companies • Healthcare Websites Top Companies Hiring Medical Writers: • Paraxel • Novo Nordisk

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• • • • • • • • • •

Accenture Eli Lilly TCS Novartis Cognizant inVentiv Health ICON HCL PPD Covance

The sequence of steps to be followed while writing an absolute document!

-The aim of the project must be apparent!

You must undergo the details of the project before initiating the writing project.

For any assignment provided by the sponsor, the foremost requirement remains the purpose and the aim of the document being written. After getting the apparent idea about these the framework of the document must be designed.

-The right approach to search the literature!

Precise keywords should be used while searching for genuine literature. Do not hesitate to spend ample time on the literature survey as it will form the foundation of your document build up.

-Making a draft!

er, an individual must possess a few qualities which can shove the career of a medical writer towards the rising trend:

the correct keywords to search for the most authentic information and then it should be framed in a pre-planned strategy.

• He/ she should have a complete acquaintance of the drug development procedures.

• He /she should have been aware of the ICH/GCP guidelines/protocols regarding drug development phases, clinical research and medical writing standards and be able to interpret and implement these guidelines to document writing.

• Nevertheless, he/she should have an unmatched command on written English, must be able to read, write, and speak fluent English.

• Multitasking ability will help to coordinate data and reports from various sources to develop an influential and accurate deliverable.

• He/ she should be rich in active listening and must have influencing skills as establishing and maintaining professional and productive working relationships with team members will remain part of the job • Ability to work independently with minimal supervision and work efficiently under pressure (as usually targets are given to complete the projects) • He/ she should have the knowledge of basic word and data processing software tools and software.

How you are going to present your data?

Begin with designing a draft and then continue with the final compilation of the document. This is the moment where you need to apply all of Besides the above-mentioned qualyour linguistic skills applied accord- ities, a competent medical writer for ing to the client’s style or the regula- a Medical Writing Career should postory standard. sess general knowledge and language skills.

-Review, format, and edit!

Use of correct grammar Checking for spelling mistakes, grammar, punctuation marks, and In addition to the understanding of other editing measures is absolutely the scientific aspects, the ability to essential. correctly incorporate grammar, use of short sentences written preferably in Providing an electronic copy of the an active voice, correct implementadocument! tion of the punctuation marks can turn any technical document into a more After getting your document ap- virtual and simple piece of writing to proved by the authorized personnel, the readers. time to apply the digital skills to make your article or document go air. you Internet searching for genuine litdefinitely need to have acquittance erature and references about the recent e. publishing tools being in use these days.

To source the medical data genuine e.Books, e.journals, databases like What skills can make you a com- PubMed, MedLine are used commonpetent medical writer? ly. Nevertheless picking up correct information from the widespread data is For a successful Medical Writing like grasping at straws. So, the right career, to be a skilled medical writ- approach should be used by choosing

There is an amazing quote saying “ The most beautiful things in the world must be felt with the heart” Presenting the research data or interpretation of it in the text form should comprise of graphs and tables to make it easy for the readers to understand effortlessly. This is just like embellishing yourself before going to attend a public meeting.

Don’t forget to consider the ethical /legal issues!

Medical writers should be utmost careful about the ethical and legal concerns which may stand up in relevance to the research studies. Complete knowledge about copyright laws, patent laws, plagiarism, and other ethical laws is mandatory.

Has the Idea of becoming a medical writer been rooted inside you? let’s check out the eligibility to be a medical writer!

Although the minimum requirements or eligibility criteria to be a medical writer / Medical Writing Career varies from organization to organization, we can review some eligibility criteria to hold a medical writer position.

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• Bachelor or Masters degree in any life science-related field is recommended but not mandatory.

• A Bachelors’s or Master’s degree in the English language is also acceptable provided the candidate has a basic knowledge and understanding of medical terminologies.

• An individual with relevant medical writing experience is preferred for many openings.

• Openings for Scientific medical writers, including regulatory medical writers who write proposals and applications for new FDA drug and medical device approvals by regulatory authorities prefer advanced training certificates from AMWA (American Medical Writers Association) in the medical field.

• Many organizations prefer only PhDs or MDs who are competent in putting their specialized field related knowledge to work in writing.

Medical writing can be considered as an art. A medical writer career definitely involves becoming an artist who can actually put his writing skills into an amazing piece of document which not only has a technical significance but also makes the concepts or the facts live in the readers’ minds.

Demand for medical writers is fiercely on an increasing trend. Nevertheless, it can provide exhilarating career options to a life science graduate/ postgraduate/Ph.D. individual having the right kind of aptitude and skills.

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CAREER ADVICE

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Career In Regulatory Affairs – Job Opportunities, Eligibility & Skills Required Regulatory affairs is a profession within regulated industries such as pharmaceuticals, biopharmaceuticals, medical devices, cosmetics and consumer health, natural health, and veterinary products.

REGULATORY AFFAIRS IS A DEPARTMENT WITHIN THE COMPANY THAT INTERACTS WITH THE GOVERNMENT AUTHORITIES WHO REGULATE THE ACTIVITIES OF THE COMPANY.

By Divya

Their aim is to protect public health in terms of safety, quality, and efficacy of products like medical devices, pharmaceuticals, veterinary medicines, pesticides, cosmetics & complementary medicines, agrochemicals, etc. These professionals keep a check on how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed in order to ensure that the products being supplied are safer for public health-wise as well as in providing a profitable contribution to the welfare of the public.

Although regulatory affairs specialists work in a wide variety of disciplines such as public policy, health, science, economics, and law but the majority of them work in industries such as biotechnology, food science, pharmaceutical as well as medical device sectors. Few others work as consultants in marketing, research, or law entities in their Regulatory Affairs Career. Some are also employed by healthcare, clinical research organizations, and hospitals as well as in academic settings and government agencies. Thus one can say that it’s a combination of science and management in order to achieve a commercially important goal within a drug development organization.

Regulatory Affairs Career is a profession within the healthcare industry namely, pharmaceutical, healthcare, medical device, biologics, and functional food. It forms a bridge between drug regulatory authority, the pharmaceutical industry, regulatory affairs professionals. It is a centralized department for communication of registrations, queries associated with a product in FDA as well as the ministry of health of various countries.

Main objectives in Regulatory Affairs Job Profile includes: • Keeping track of changing legis-

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lation in regions where the company distributes its products.

Interpret and apply regulations.

Advise internal colleagues on legal and scientific requirements.

Develop and implement regulatory strategies.

Collect, collate and evaluate scientific data.

Participate in product development programs to ensure adherence to international regulations and guidelines.

To give strategic and technical advice to R&D, production, QC department, etc right from the beginning of the development of the product, making an important contribution both commercially and scientifically to the success of a development program and a company as a whole.

Prepare submissions to regulatory agencies such as Health Canada, EMA(Europe) and other jurisdictions.

Helping the company in order to avoid problems that may be caused due to improper scientific thinking or due to poor presentation of data.

Regulatory Affairs professionals interact with numerous functional areas which include: • Pre-clinical research : Pharmacology and toxicology testing to evaluate new drug candidates.

• Clinical Research: Conduct of clinical studies, data collection, statistical analysis, report writing

• Manufacturing: High levels of controls for the production of safe and efficacious products.

• Quality control: Analytical testing of all products in terms of purity, safety, potency, and quality.

• Quality assurance: Oversight of operations related to failure investigations, auditing, complaints and documentation management.

Qualifications Required To Become A Regulatory Affairs Professional / To Make Career in Regulatory Affairs: • A Bachelor’s degree in the field of science especially pharmacy, biology, pharmacology, microbiology, biochemistry is a must for getting into as RA. • For junior positions, undergraduates or postgraduates is sufficient but for senior positions • In the field of clinical research, it is mandatory for a person to have a doctorate degree.

• In order to get very good success in this field one must start his/her career with a related field like for example, laboratory testing, production, quality control, quality assurance, etc. with this he/she will get a good practical experience in drug development and its related process.

• However, professionals with essential skills in biology, clinical sciences, management, engineering, and writing are also highly desired candidates for this diverse field.

Additional Skills required for Regulatory Affairs Career: • Good analytical skills so that they can pay close attention to all the details review process and data and identify the issues if any.

• Good negotiating skills • Judgment skills and presentation skills • Good communication skills since they need to interact with clients, staff members and other regulatory authorities.

• Good computer skills, since certain tasks like preparation of reports and analysis of data, are done with the help of a computer.

• Project management skills are of utmost importance since one has to do different types of work and time also less so they must know how to shuffle multiple tasks efficiently.

• Ability to keep up to date on current regulations Regulatory Affairs employment opportunities exist in the following sectors: Pharmaceuticals : The newly graduated Pharmacist have the best opportunity to start their careers as regulatory professionals in regulatory affairs department of a pharmaceutical industry. The function of Regula-

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tory Professionals in Pharma industry is to provide all legal information like updates in amendments in the law, new drug inventions and drug development designs, patent, trademark, and copyrights. Information about Biological and Pharmaceutical drugs and guidance regarding rules and regulation of drugs, latest good manufacturing practices, science and Technology updates and their regulatory aspects, post-marketing surveillance of the product to compile the documentation of pharma industry.

It is a rapidly growing department of pharma industry because most of the stakeholders are now interested in the export of their pharmaceutical products in other countries but international markets demand strict regulation and legal requirements in terms of allowing marketing authorization of pharmaceutical products. Internationally many countries require pharmaceutical Dossier or Common Technical Document(CTD) format for registration of the drugs or marketing authorization of the products.

CTD is the set of documents ensuring quality, safety, and efficacy of the pharmaceutical or biological products which should be prepared according to the requirements of regulations prescribed by the governing authority of India.

Medical devices: The medical device industry plays a critical role in the department of healthcare by providing ingenious solutions that will improve the patient end result. RA professional in the field of medical serves a very important role in the lifecycle of the product like for eg: he/she can advise the team regarding regulatory strategies in order to ensure that the product is legally marketed. Once the design of the product is complete the team of product development experts RA to make a successful marketing submission. And finally, these companies will rely on them for post-marketing surveillance in order to confirm it to FDA if any malfunctioning them.

Biotechnology companies: Biotechnology and Regulatory affairs are the areas that are creating opportunities for us to build networks across the world and to work collaboratively together. Depending upon the individual’s experience one can make a good career here.

Biological products need to be readdressed by means of scientific advances and it is needed to put a hold in the initiation of new quality control procedures without sufficient discussion. There is a growing demand for

preclinical testing of Biotechnological products. With the development of Biotechnological industries, it has catalyzed various changes in the regulation of drugs worldwide with major blow on the regulation of unnatural products.

Clinical research: In the field of clinical research Regulatory Affairs Professional has a vital role in making safe and good quality products related to healthcare. Their responsibility begins with the research and development phases of each product.

They keep themselves updated in terms of procedures, regulatory policies, and trends. One can enter as a clinical research coordinator or Drug Safety Associate at their entry-level.

In their mid-level, they can enter as a Clinical Research Associate or Investigator. And at the senior level, they can be appointed as a Data Manager, Director of Regulatory Affairs.

Top Companies Hiring For Regulatory Affair Jobs are: • • • • • • •

ITC Parexel Medtronic Novartis Novozymes IQVIA Bharat Serums and Vaccines Ltd

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Amgen Reckitt Benckiser Jhonson & Jhonson Lupin PPD Apotex Dupont Genpact Merck Covance

Regulatory Affairs is ever-changing legislation thus one can always keep on learning new things and keep on taking up new challenges and at the same time, you will have a good salary package. A career in Regulatory affairs is one of the versatile professions one can ever come across because it provides diversified employment opportunities that too at various levels.

Even though Regulatory Affairs is one of the most interesting and rewarding careers but still it has its own challenges. So there are a lot of things to be considered when you think of Regulatory Affairs as a Career. You need to evaluate the goals both personally as well as professionally in order to have a better understanding of how our career can meet your goals.

stores.biotecnika.org

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VOICE OF BIOTECNIKA

November 19th, 2019 Vol. 03 NO 105

Overpopulation – The Human Explosion Explained

Humans are considered as the most powerful species on earth. They are the most intelligent and have the power to control everything that exists on earth.

But what, if we tell you, that this super-intelligent human race is controlled by tiny organisms that live within or exists inside the human body. They not only influence the human brain but behavior too.

Episode 56

By Dr.Tanushree

Scary right! Welcome to the next episode of Voice of Biotecnika, where we will tell you about who these tiny organisms are and why as well as how these tiny organisms control humans or more precisely “RULE OVER YOUR BODY”.

Bacteria are everywhere, the air you breathe, the water you drink, food that you eat, on and inside your body, things you use like mobile phones, laptops, tabs, even washed clothes as well as utensils, everywhere, you can think about it. In recent years, the term “microbiome” has sought the attention of researchers and scientists all-round the globe. So you must be thinking what is this Microbiome?

Microbiome describes the genome of all microorganisms including bacteria, viruses, fungi and archaea in a particular environment, like the microorganisms in our gut environment are known as the gut microbiome.

These microbes can be symbiotic or pathogenic, living in and on all vertebrates.

Talking about bacteria in the gut, these are key to many aspects of human health including metabolism, immune, and neurobehavioural traits which have been supported by evidence from the animal models and human studies. But how our relationship with these bacteria begins? It is assumed that humans develop their relationship with bacteria inside the mother’s womb. The innumerable bacteria present inside the mother’s womb, cover every single part of our body. Pregnant mothers release some molecules that make their way in the fetal brain and seed their babies with these microbes during childbirth.

After birth, special sugars that are present inside the mother’s milk feed and support these bacteria. During the first few years of infant life, both the brain and microbe rapidly develop. These bacteria help in the development of our immune system and develop a healthy community inside

the human body. Once the solid diet is introduced to babies, it becomes an important factor that has a stronger impact on subsequent maintenance and maturation of gut microbiota organization throughout the lifespan.

These bacteria are considered to play an important part in human health, therefore, our body not only accepts their invasion but we also welcome it.

What does this gut microbiota do for us?

There are several categories of bacteria inside our bodies. There are some whom we learn to live, the one which is present in our mouth and can harm our teeth if we do not brush daily.

Next is, friendly fellows who live in our gut. The bacterial microbial communities present in the human gut are essential for maintaining the intestinal ecosystem as well as play an important role in gathering energy from foods and producing micronutrients.

The gut microbiota performs fermentation of non-digestible substrates like dietary fibers which in turn supports the growth of short-chain fatty acids and gases producing microbes.

Several enzymes produced by these gut microbes contribute to the metabolism of bile acid that acts as metabolic regulators and signaling molecules to affect important pathways in the host. In return, we provide food to them and an appropriate environment for growth. Thus, we not only live with them but also depend on this vast army of bacteria to stay alive.

Every human has a distinctive mi-

crobiome. In the last few years, understanding of the influence of gut microbiome goes much deeper. The gut microbiome is considered an area of great assurance for a better understanding of human health and related diseases. It is considered that the bacteria that are part of our microbiome encodes millions of genes that can manufacture thousands of metabolites, which has the potential to replace many of the functions in the host which affect the host’s phenotype, fitness, as well as health. Whether it’s a craving for a specific food, immune system protection, regulation of behavior or role in several disorders such as depression, autism, dementia, and many others, in all these, our body’s bacterial community plays a very important role. Therefore, the microbiome is now considered a virtual organ of the human body.

So, how do these microbiomes communicate with us?

There are several pieces of evidence that indicate the human immune system and microbes communicate with each other and produce a specific response. Different disease results in changing of the composition of these bacteria in the gut. Several researchers are working on how our body’s immune system interacts with these tiny travelers and how that relationship may function in a particular disease. For example, certain bacteria that are present in the lining of the gut excrete excessive quantities of antibodies into the gut, which can help in understanding what are the antibodies

types being made, and how the body tries to regulate the interaction between ourselves and bacteria on the outside.

It is interesting to know that microbes can even talk to our brain, they not only interact but affect our nervous system or maybe our mood too.

In the gut, several neuroactive compounds are synthesized which have a major impact on mental well-being.

Studies have reported the production of DOPAC, a metabolite of the neurotransmitter dopamine in humans is related to the healthier mental quality of life. Dopamine and serotonin have composite roles in the brain and imbalances related to it. About 90% of serotonin which is an important messenger for the immune system, produced in the gut. Scientists believe that the microbiome does this to communicate with the vagus nerve, which connects about 100 million nerve cells from the digestive tract to the base of the brain. The vagus nerve sends these signals from the gut to the brain, where they alter the production of a hormone called oxytocin that promotes social bonds. Some chemicals communicate through the bloodstream with the brain. Since the brain decides what to eat, the microbe is interested in a healthy brain.

Bacteria in the gut have the ability to manage behavior and mood through altering the neural signals in the va-

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gus nerve, changing taste receptors, producing toxins to make us feel bad, and liberating chemicals to make us feel good. However, the microbes, that live outside the human body, like those present in the soil are not able to synthesize some kind of neurotransmitters. The reason might be that these microorganisms have not co-evolve with humans and therefore, have not learned to gain advantage from invading into the host nervous system.

Although there is a heritable part of gut microbiota, several environmental factors such as related to diet and drugs decide the composition of gut microbiota which in turn can affect our health. Antibiotics entered indirectly in our body through the food chain have various metabolic consequences that vary from person to person. Antibiotics are used for livestock farming in many countries. Several human studies, as well as many rodents studies, have provided an obesogenic effect of antibiotics in humans in minute doses found in food.

Therefore, extensive research on the gut microbiome is required to better understand the effect of antibiotics, chemicals such as pesticides sprayed on crops on them.

Several animal studies have shown that sugar substitutes such as aspartame, sucralose as well as saccharin and food additives such as emulsifiers which are present in processed food have negative effects on the animals’ gut microbiota. The production of trimethylamine from carnitine and dietary phosphatidylcholine (dairy and meat products) by gut microbiota varies between people depending on the food they consume. This trimethylamine oxidized in the liver to trimethylamine N-oxide, which is associated with an increased risk of atherosclerosis (buildup of plaque inside arteries) and major adverse cardiovascular events. Some people follow restrictive diets like raw food, the vegan, gluten-free diet which may also raise some concern as these may have some side-effects on gut health. So, there is a strong relationship in what you eat decides what type of bacteria you breed or what type of bacteria present in your body decides what to eat.

These microbes initially come from our mother but how they develop and change depending on what we eat. For example, some bacteria like fibers whereas some like cheese. If we eat a lot of fast food we breed fast food-loving bacteria that take up space for vegetable eating bacteria and also send signals to the brain

to eat fast food. Thus, gut microbiota seems to play an important role in the development and progression of obesity. So we can reverse fast food or cheese liking bacteria with vegetable liking or fiber good bacteria and this intensifies the strong connection between diet and microbiome.

Also, it’s not just about the bacterial numbers but their diversity too.

It has been observed that the people suffering from inflammatory bowel disease, type 1 or 2 diabetes, obesity, and atopic eczema have lower bacterial diversity than in healthy individuals. This indicates that the gut ecosystem which is rich in microbe species is more robust against environmental influences. If any microbe species is missing, its function is been performed by a more related microbe.

Thus, “diversity” seems to be a good indicator of a “healthy gut”. However, an increase in dietary fiber or a specific type of diet may temporarily reduce the diversity as the microbes related to digestion of fibers increases, leading to change in a composition via competitive interactions. It has been reported that the people who lack certain bacteria in their gut are more likely to undergo depression.

Studies have provided evidence that the bacteria Dialister and Coprococcus, were uncommon in depressed people. It might be possible that the people suffering from depression may have different eating habits that have led to changes in their gut flora, resulting in their low levels and in turn responsible for depression.

Some researchers also believe that bacteria living within our bodies may cause stomach or other cancers. Thus, the evolution of tumors and bacterial communities are linked. There are several pieces of evidence where minor changes in microbiota can result

in major changes in immune-chemotherapy treated cancer patients, autoimmune disorders and bone marrow recipients. For example, studies have shown that phytoestrogens have a protective effect on breast cancer which depends on the presence of several intestinal bacteria such as Lactonifactor longoviformis, Clostridium saccharogumia, and Blautia producta, Eggerthella lenta that can convert isoflavones into bioactive compounds.

Targeting the microbiome, there is a possibility for preventing a variety of diseases such as diabetes and gastrointestinal tract cancers. The treatment is possible by using probiotics that increase the populations in gut treatment.

Probiotics are live microorganisms that when given in an appropriate amount have health benefits on the host. Among probiotics, mostly Lactobacillus species and Bifidobacterium species are included in of products such as dietary supplements, drugs, and food. There are concerns that most microbe supplements are unable to set themselves in the gut and in turn, do not exert any effect on the resident community. However, they have a direct effect on the host through the production of bioactive compounds or immune modulation.

But, prior to probiotic treatment, it is important to know about the substances synthesized by these bacteria followed by their testing. This is a challenging task as this diverse and complex bacterial community of gut microbiome keeps on changing during different stages of life. The human microbiota undergoes the most prominent fluctuations during infancy and old age. This is the time when our immune health is most unstable and weakest. The elderly people have different bacterial gut microbiota profile than healthy adults. There are ev-

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idence that suggests, the association of gut microbiota with age-related chronic conditions of health and inflammation, and hence could be exploited as a presumed target to improve the aging process.

Understanding the functional role of the human gut microbiome, the researchers have come up with fecal microbiota transplantation. It’s not yet clinical practice but has been explored where feces from a healthy donor is transplanted to recipients with metabolic syndrome resulting in better insulin sensitivity. Fecal microbiota transplantation (FMT) provides support in the treatment of recurrent Clostridium difficile infection with cure rates reported up to 90% in clinical trials. However, the FMT use in other conditions such as obesity, inflammatory bowel disease, metabolic syndrome, and functional gastrointestinal disorders is still controversial. Thus, more studies are required to fill in gaps in understanding microbiome composition, function and bacterial prebiotics, probiotics or fecal microbiota transplantation to assess changes in microbiota composition and in health outcomes. The extensive catalog of human gut bugs will help scientists to recognize the specific bacteria in patients’ bodies and lead research into new treatments for conditions such as psychiatric, neurological, allergies, obesity, aging, bowel syndrome and many disorders.

So, now you might have understood better, that your diet plays an important role in the development of healthy bacteria inside your body. Your microbiome not only indicates what is going inside you but also keeps you healthy as well as happy, because after all it’s not you but your “microbiome- that rule over your body”.

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