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Mitra Biotech – A Pioneer in Personalized Cancer Treatment

in SciBiz by

Editor’s Note

Finding a cure for cancer has been a daunting prospect for both physicians and scientists. Strides in various genomics technologies have revealed the mutational landscape of cancer and heterogeneity within tumors. Despite availability of therapies that target specific mutations, the biggest road-block has been the prediction of accurate biological response to these treatments. Riya Binil writes about a pioneering precision medicine technology called CANscript developed by Mitra Biotech that intends to overcome this huge obstacle. This company has developed a unique system of culturing tumor cells together with its microenvironment thus mimicking the cancer ecosystem within the body. Different combinations of treatment are tested with this system to identify those that work with greatest efficacy. With CANscript Mitra Biotech has taken a giant leap in the fight against cancer and we wish them great success.​- Shayu Deshpande

 

Mitra Biotech has expanded the horizons of cancer treatment by delivering a truly personalized patient-specific cancer care through their proprietary CANscript technology. CANscript is a fast, cost-effective, and powerful technology that predicts a patient’s response to cancer treatment with high correlation to the clinical outcome, thus aiding in the elimination of ineffective treatments. In an exclusive interview with Kirk Mundy, Senior Director, Worldwide Clinical Marketing at Mitra Biotech, he talks to us about Mitra’s CANScript technology and about their commitment to improving cancer care.

 

Mitra Biotech, spear headed by Mallik Sundaram and Pradip K Majumdar, was established in 2010 with a mission to develop and deliver ‘more efficient and effective’ strategies for cancer treatment. The company is headquartered in Woburn, MA, USA and runs an active laboratory arm in Bengaluru, India.

Need for personalized cancer care

Cancer is a devastating disease caused due to abnormal division of cells in the body. Aberrant cell growth in cancer can be a result of random mutations in DNA that are instigated by environmental and/or genetic factors. Cancer treatments are provided based on the type, stage (early or late) and grade (low or fast growth rate) of the cancer cells. Currently, available cancer treatments include non-targeted interventions like surgery, chemotherapy, radiation therapy, stem cell transplant as well as targeted therapies such as immunotherapy, hormone therapy and use of specific drugs to block the growth of cancer. These therapies are however, not free of drawbacks. While non-targeted therapies kill both cancerous and healthy cells leading to side effects, targeted treatments become ineffective over time as cancer cells become resistant to the drugs or re-grow utilizing alternate pathways. Therefore, it is important to deliver the right combination of therapies that kill cancer cells with high efficacy. This is very challenging as there is no defined approach for the use of combination treatments. Hence, there is a need to develop tools that will help physicians select appropriate patient-specific cancer therapy.

 

Precision medicine is a form of personalized cancer therapy, based on understanding of the patient’s genetic background. In this therapy, clinicians recommend treatments to a patient depending on population studies, where patients are grouped by factors such as similarity in the treatment history, genomic profile and tumor type or tumor progression. However, each cancer can be idiosyncratic due to differences in DNA mutation profile, tumor microenvironment, vasculature, and immune system. Therefore similar precision therapies may have low success rate in patients sharing common features. This calls for a stricter personalized cancer treatment approach that is specific for each patient and takes into consideration the characteristics of not only the tumor but also its microenvironment. This is where Mitra’s approach ‘CANscript’ falls into place. CANscript is currently the only available ‘truly personalized’ cancer therapy of its kind.

 

CANscript technology

The isolated cancer cells are grown under controlled conditions on culture dishes ex-vivo using a suitable matrix and patient serum for optimal cell growth. This recreated tumor microenvironment is then subjected to various combination of drug treatments following which the tumor response is scored.  The tumor response is measured through various parameters such as changes in morphology, metabolism, viability and necrosis.

 

via GIPHY

CANscript involves efficiently recreating a tumor’s microenvironment in culture (ex-vivo). The technology utilizes a tiny amount of tumor or cancer cells obtained via biopsy and blood of the patient. The isolated cancer cells are grown under controlled conditions on culture dishes ex-vivo using a suitable matrix and patient serum for optimal cell growth. This recreated tumor microenvironment is then subjected to various combination of drug treatments following which the tumor response is scored.  The tumor response is measured through various parameters such as changes in morphology, metabolism, viability and necrosis.  The data output obtained from these measurements is then subjected to analysis by a proprietary algorithm to predict clinical response to the respective treatments in the form of M-score. An M-score greater than 26 is indicative of high probability for that patient to respond well to the same treatment. The tumor microenvironment along with the algorithm forms the CANscript technology. The full procedure of CANscript testing is completed within seven days.

CANscript has been tested and validated in nearly 2000 patients with close to two dozen tumor types being included during the development. Moreover, CANscript has been tested for hundreds of drugs and drug combination across multiple drug classes. Data from clinical studies show that CANscript predicted treatments have greater than 90% correlation with clinical response. An important consideration here is that the therapies to be tested on the tumor are suggested directly by the patient’s oncologists, in which case, factors like therapeutic availability, cost, time, toxicity and other side effects have already been evaluated. Once results are generated, the physician considers the M-score for each of the tests and selects a therapy based on the experience and patient’s treatment history. Thus, CANscript aids in eliminating ineffective therapies thereby sparing patients from unnecessary toxicity from the failed treatments. CANscript saves time and is cost-effective for patients both of which are important factors, suggesting that it truly resembles a personalized form of cancer therapy.

 

Currently, Mitra Biotech works with clinicians from across 40 different institutions in India for CANscript testing. Kirk mentions that the patient has to go through their doctor to utilize the testing. One of the major challenges is that physicians are reluctant to shift from conventional treatment procedures to more innovative methods. Providing convincing data from controlled clinical study reports and clinical trials can soon change that. To facilitate this, Mitra Biotech is launching formalized studies in India, US and Europe aiming to capture on the clinical utility (do doctors prefer to choose the treatment with highest M-score or their first choice of treatment with high M-score) and patient’s response to these treatments.

 

Since CANscript technology is validated for thousands of different cancers and supported by clinical correlation studies, it forms a valuable platform for developing anti-cancer drugs in comparison to conventional cell lines or animal studies. Therefore, in collaboration with biopharmaceutical companies, Mitra is actively engaged in anti-cancer drug development. Above all, Mitra continues to explore basic cancer research in the area of tumor microenvironment through their R&D programs.

 

Kirk shares that Mitra is growing in size and will have job openings in the areas of Clinical testing, R&D, Business development, Sales and Marketing teams. He mentions that they have people with academic as well as industrial experience in the Clinical and R&D teams whereas their commercial team mostly consists of members with prior industrial experience. For open positions at MitraBiotech, you can either visit the company website or their LinkedIn page.

 

When asked about the company’s culture, Kirk describes it as caring, co-operative and committed to helping patients at a personal level to obtain effective cancer treatments. Mitra Biotech’s contributions towards helping physicians select the best cancer care is a true reflection of the name ‘Mitra’ (derived from Hindi word ‘Mitr’ meaning friend). We thank Kirk Mundy for his time and wish Mitra Biotech resounding success in their endeavor.

 

References:

  1. https://www.cancer.gov/about-cancer/treatment/types
  2. https://patient.info/health/staging-and-grading-cancer
  3. https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet
  4. http://www.mitrabiotech.com/
  5. https://www.nature.com/articles/ncomms7169

 

 

About the author:

Riya Binil is a science enthusiast and a creative scientist. She holds an MSc in Applied Chemistry (Cochin University of Science and Technology, Kochi, India), a PhD (National Centre for Biological Sciences, Bangalore, India) and Postdoctoral Research experience (Ottawa Hospital Research Institute, Ottawa, Canada) in Cell Biology. She currently works as a Biotech Analyst with SGS Canada. In addition to science, Riya enjoys music, traveling and experimenting different cuisines. She can be reached at here.

 

Editors:

Shayu Deshpande, PhD

Paurvi Shinde, PhD

 

Illustration:

Vinita Bharat, PhD

 

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

 

 

Starting up your idea – Face à Face with Kunal Kishore Dhawan, Founder of Navia Life Care

in Entrepreneurship/Face à Face/SciBiz by

‘Rome was not built in a day’ – as cliché as it sounds, it has stood the test of time even in this era of startups. Beyond the romance of building enterprises, one should take a reality check on challenges faced in building an idea from scratch and turning it into a reality. Somdatta Karak (SK) from CSG talks to Kunal Kishore Dhawan (KD), about his entrepreneurial experience while building ‘Navia Life Care’, a health tech company based in New Delhi, India. Navia Life Care builds customized mobile and software solutions for clinicians, medical providers and other players in healthcare ecosystem. Their goal is to provide easier and cheaper means of communicating, engaging and monitoring of patients.

Talking to us about his roller coaster journey from Navia’s inception to developing happy customers in market, Kunal opens up about the valuable lessons he learned while building his team, product, and skills that helped him sustain in the market.

SK: We would love to know about your journey so far – from having the first idea, to arranging funds, to developing your product and company into its current form.

KD: Healthcare is a traditionally fragmented space in India, with various stakeholders – medical practitioners, providers, pharmacists, pharma companies, insurance players and ultimately patients operating in silos. Getting them to work in tandem with each other, by exchanging information and interlinks, is any healthcare entrepreneur’s dream. I realized several critical issues plaguing the industry, ranging from the lack of essential quality health services, inaccessibility of healthcare institutions for differently abled, overall scarcity of medical professionals, to the quality of sub-standard medicines. My experience as an executive in the pharma industry made one issue particularly stand out – the patient’s adherence to drug regimens.

While we knew that technology can solve problems in this field, it was essential for us to first understand which problems we want to address, and for whom. Repeated interactions with different stakeholders prompted us, to develop a pill reminder system at Navia Life Care, that would function on a mobile device. Our first iteration of the app was based on a business-to-consumer model, i.e. by working directly with patients. The release of our app was well received, but could not open any avenues of monetization. That prompted us to further evaluate our company’s strategy.

We realized that it was imperative to consider drug adherence as a part of a holistic patient management process, so that our solution also adds value to the clinicians practice, and improves the relationship between patient and provider. Upon finalization of our product’s framework, we assembled an in-house team of developers, to improve work efficiency, reduce errors and turnaround time. Our second direct-to-consumer campaign consisted of roll-out and interaction with patients and providers, where they used our product for a certain period of time. It gave us useful information on the problems faced by both the sides, and compelled us to make the following changes:

  • Opt for a business-to-business (B2B) strategy, i.e., building the platform for healthcare institutions, ranging from individual practitioners, clinics, hospitals to health-focused social enterprises instead of working with patients directly.
  • Be flexible with the product we offer to the clients, instead of forcing one down their throat.
  • Understand first, needs of a client, and then put together a solution that best fits.
  • Be open to brand the product in name of the client, instead of pushing our brand to patients, which might give them incentive to pay for the product.

B2B strategy worked well in regards to generating a revenue and helped us get a small seed investment from Benori Ventures LLP – a private seed fund run by an industry veteran, Ashish Gupta – founder of Evalueserve, Gurgaon, India and co-founder of Ashoka University, Sonepat, India. We are now hoping to break even before the end of 2017.

The core Navia team (from left to right – Gaurav Gupta (Operations Strategy Lead), KD (CEO), Shourjo Banerjee (CTO)

SK: Tell us about the prominent challenges faced in an entrepreneurial journey. How did you work around yours?

KD: The biggest challenge was to identify the needs of customer and build our product around it, so that it gets adopted and paid for by consumers and customers. The only way, in my opinion, to achieve that was to keep the needs of customers in forefront of whatever we do. We have constantly gone back to the users to get their inputs on whatever we created. There is no point in making something, if there is no need for it. Another of our evident challenges was to identify and develop an in-house team who understands, appreciates this problem, and has the skillset to solve it.

Navia was bootstrapped from day 1 and we hired only freshers and trained them to fit the appropriate roles. Until Feb of 2017, we were not able to generate any revenue from our products. We re-designed our product and business strategy multiple times, so that users could see the real value of our product and we could monetize on it. This revenue generation has been very critical for our fundraising ability. Most investors look for a business model that works, i.e. has the ability to generate money, and not burn a hole in pocket of the company.

Meanwhile, there have been times when I felt like doing something else, although not necessarily giving up. I had decided to give myself a year to assess the business correctly, but based on advice given by several veterans, we decided to stretch it to year and a half. There were times during Jan and Feb of this year, where it seemed that we would not be able to pull our resources to last the entire time, but having a clear focus and time frame helped us tide over that period.

SK: How do you support your startup – in terms of funding, mentoring, etc.? Among the young entrepreneurs venturing into health technology in India, which ones do you recommend and why?

KD: I believe we are at a point in the Indian startup ecosystem, where a good support system exists for new entrepreneurs. Of course, it is not anywhere close to the “boom” of 2014-16, but in a way, that’s better. All business ideas are analyzed critically before they get funded. There is a continuous assessment going on from the entrepreneurs and stakeholders of products, which helps us improve the offering, and in better vetting of the business as a whole.

There are plenty of accelerators and incubators (some are associated with universities, which is good) that help the first-time innovators. But it is important to assess them for their merits, as there are always some bad apples. Some are just in business to make a quick buck from their struggling startups, and it is necessary to be wary of them. One has to also analyze the investor’s management team and success story as critically as they assess you as an entrepreneur – and remember – they need you more than you need them! The traditional VC’s are always good, but they come at a later stage. During initial stages, having a mentor from a similar field helps (and if they can fund you in a small way, all the better).

As for the list, I would suggest that every entrepreneur should do their research and identify a team that suits them. It helps not only to increase focus, but also improve one’s network, which is critical at all stages.

SK: According to you, what are some of the most important qualities an entrepreneur should have? Who would you recommend taking this path?

KD: I think an entrepreneur needs to embrace the “humanity” in them – the same qualities that make us human are amplified in entrepreneurship. Patience, diligence, grit, ability to repeatedly take a “no”, adaptability, ability to handle failures, and not being resistant to change, are just some of them. There are times when you might feel that this is the end, but you just need to dig in and get out of the rut. Customers, investors, stakeholders, even team members are often critical of the company and its products, so it is essential to listen, and imbibe what you think is beneficial for betterment of the business.

I think everyone should become an entrepreneur, and if not that at least an intrapreneur. Bring about a change in smallest of the ways, wherever you work or live – that itself is worthwhile. You don’t need to build a billion-dollar business, even the smallest gestures sometimes create a significant impact.

SK: What have been your most valuable learnings so far from entrepreneurship?

KD: This journey has been nothing, if not educational for me. From being a member of a 10,000+ employee organization, to taking the business idea to a 10-member group, it has been full of learning, both academic and intangible ones. Academics or educational apprenticeships have included developments in regulatory landscapes, company laws, human resource requirements, hospital systems, coding technologies/languages, and much more. Although, the intangibles have been more rewarding – such as handling teams and employees, ability to take rejections, adaptability, etc. Entrepreneurship is a long-term game, and one must be ready to slug it out for the long haul. Patience has been key, and not hesitating to seek feedback or help from people more experienced and connected to you, has helped. Lastly, don’t underestimate your network – collaborations, customers, even critics come from a network, and one should always be willing to expand that.

SK: How does the journey look for you in coming years? What are your next priorities? Where do you see yourself and your product in next five years?

KD: I sincerely hope that the coming years are rewarding. A saying goes “Entrepreneurship is the willingness to live for a few years like most people won’t, to enable yourself to live for rest of your life like most people can’t, and I hope it comes true for me. I will continue to build the company, add customers, improvise on products and services while focusing on innovation and differentiation. My aim is to create ten things during my lifetime – now whether it’s ten products or ten companies or a combination of the two remains to be seen. Navia Life Care is a first of these, and I hope in the next five years, I would be able to add to it.

 

Author: Somdatta Karak, PhD writes on science, business/ entrepreneurship and social challenges of education and global health.

Editorial team: Paurvi Shinde, PhD edited the article. Sushama Sivakumar, PhD and Akshaya Hodigere proofread the article.

Paurvi Shinde is a Post Doc Fellow at Bloodworks Northwest in Seattle, where she’s studying the mechanism of how alloantibodies are formed against the non-ABO blood group antigens. Apart from doing the actual science, she loves editing scientific articles, to help convey message behind it in a clear and concise form.

Sushama Sivakumar is currently postdoctoral scholar at UT Southwestern Medical Center, Texas, USA. She works in the lab of Hongtao Yu where she studies mechanisms that regulate proper chromosome segregation during mitosis.

Illustration: The cover picture is made by Ipsa Jain (follow her work as IpsaWonders at Facebook and Instagram) with assistance from Noun Project under CC license. The inset images are made by Somdatta Karak.

 

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Career Path from academic research to supporting social enterprises – Face a Face with Dr. Arun Venkatesan, Villgro

in Entrepreneurship/Face à Face/SciBiz by

Here is our second article in line as part of our two article series on Villgro, a social enterprise incubator. The article is based on a discussion between Dr. Reetu Mehta, Vignesh Narayan, Club SciWri (CSW) and Dr. Arun Venkatesan (AV), Chief Technology Officer, Villgro. We discuss here Dr. Arun Venkatesan’s successful and trendsetting journey from being an academic researcher to working in Villgro.

CSW: What is your story- how did you arrive at Villgro?

AV: My training has been in Chemical engineering. I was an undergraduate at RAC, Trichy that is now NIT, Trichy. I completed my masters & PhD at the University of Akron and a post doctorate at Case Western University in fuel cells & materials. While working at Mitsubishi housed in UC Santa Barbara, CA, I was engaged in developing a fuel-cell material. Then I worked with a small company on an electrochemical oxygen generator, reverse of the fuel cell and later contributed in a startup working on device development. I moved back to Chennai looking for projects and started working as head of R&D at Phoenix Medical Systems. One of the projects that came out during that period was Brilliance, a low-cost phototherapy product – arguably the first openly priced product at 400$ for India, Nepal, Pakistan and 500$ worldwide. Other projects Phoenix has been involved with are, one from IIT Delhi, a Wellcome Trust funded project called SmartCane – an ultrasound based navigation device for the visually impaired costing Rs 3000. Another one was a standup wheelchair called R2D2 that was funded by Wellcome Trust at IIT Madras, designed by Prof. Sujatha Srinivasan’s group. I consulted quite a bit afterwards and one of my consulting clients was Villgro.

As you can see, I already had a bent of mind for product development in the social space. Eventually whatever worked out was where my heart was – they all had a social angle. So when the Villgro role came it was a natural fit.

CSW: What goes into making a social entrepreneur?

AV:. Social enterprise is a difficult field. We, at Villgro, really empathize with the entrepreneurs because they have chosen to solve a difficult problem and dedicate a huge chunk of their lives to it. Openness to ideas, and commitment is what we look for at Villgro. The social entrepreneur is the one who owns the problem no matter what and wants to solve it. It takes time, a good amount of their life – about 5 to 7 years before any sizable revenue is generated.

CSW: What are the skills a life science PhD requires to work at places like Villgro or an investment firm?

AV: Flexibility or versatility – You can be a subject expert but you should be able to very quickly probe into and assess knowledge regarding the field in question. Identifying the problem and relating it to the business side of things is very important. Multifaceted assessment of an idea is also very important.

2. Openness – You cannot be very dogmatic about anything.

3. Networking and having soft skills – Regarding soft skills I think it is very important understanding how to practically apply the knowledge you have.

I believe PhD is only a proof that the person is capable of defining, analyzing and solving a problem. Problems will almost always be outside your core training. You will have to use the general skills that you have learned to get there. Scientific and technology development principles still apply. But an intuitive jump (to understand the problem) is required.

CSW: One of the things we notice in India is your educational qualifications are not given their due credit when you enter the job market, especially for PhDs. What is your opinion on that?

AV: The entire industry working space is moving towards a more efficient lean model. There are research institutes where the degree and sector expertise are valued. In the entrepreneurial sector, especially in social entrepreneurship, knowledge is definitely valued but you have to be very productive and very efficient. The approach we take is that you have to be relevant to your customer, which in this case is the entrepreneur. So anyone who can share knowledge in a way that is relevant and creates an impact is always respected, especially in India where a lot of things are relationship driven. I find that it is not the degree but the deployable knowledge that is valued. If you can translate your knowledge to something that is relevant to the customer, then your knowledge is valuable. There are western systems where there are very set roles – if the role is not effective anymore then you may also lose value. However, in the Indian context, I wouldn’t say that your degree is not valued. If you value your degree then you value the knowledge your degree has given you. There has to be balance of respect and relevance.

CSW: What are the career options that a life science specialist can explore at investment firms or organizations like Villgro?

AV: If you are flexible enough, technical mentors are always needed. Sector knowledge is respected because that leads to quick solutions. We call them senior advisors but you can call them technical advisors. These are very knowledge driven roles.

CSW: What sort of options exist for those who are fresh out of their PhDs?

AV: There are a lot of analyses that investors rely on, for instance, landscape analyses. In those sectors they can add value. But one should remember that the value of the person and their degree would be subsequently determined by the impact they generate.

About the authors: The article is based on an interview conducted by Dr. Reetu Mehta and Vignesh Narayan, and transcribed by Dr. Somdatta Karak.

Illustration: The inset image was made by Dr. Somdatta Karak. The cover picture is from Pixabay.

About the editors: Dr. Shayu Deshpande edited and Dr. Roopsha Sengupta streamlined the article. Dr. Manoja Eswara proofread the article.

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

 

 

Villgro – Supporting social entrepreneurs stand on their feet

in Entrepreneurship/Face à Face/SciBiz by

Gone are the days when social work was perceived by many, as mindless charity. Today many bright minds work on ideas and innovations in various fields to make lives of the marginalized better – by attempting to make quality education and healthcare accessible to all, by providing sustainable livelihoods, to name a few. We are talking about those entrepreneurs who cater to the poorest of poor. These out of the box thinkers, in helping one of the most critical customer segments are aided in their journeys by support systems such as Villgro.

We have a two article series based on discussion between Dr. Reetu Mehta and Vignesh Narayan from Club SciWri (CSW) and Dr. Arun Venkatesan (AV), Chief Technlogy Officer, Villgro, Chennai. They discussed the role of incubators and venture capitalists committed to social development in India, with a special focus on Villgro’s medtech and healthcare programs. This first in the series article briefs our readers on the functioning of Villgro and the niche that it caters to.

CSW: Please brief our readers about Villgro- who does it work with and how does it work?

AV: Villgro is a 16 years old non-profit social enterprise incubator (not an accelerator) which works like a venture capital firm. One of its core missions is to work towards poverty elimination by creating for-profit enterprises with ideas that could help the poor, mostly in rural India. We look for sustainable impact in areas where even the poorest will be willing to pay – three such areas are agriculture, education and health. The organization not only invests in but also provides mentoring support to these enterprises and sits on their board to hold the companies accountable.

CSW: How does Villgro take care of its expenses?

AV: Operational expenses are largely covered by donations from foundations that believe in our abilities and cause. We are also being entrepreneurial ourselves by performing equity investments and are slowly contributing to Villgro’s sustainability.

CSW: What is the difference between Villgro and a venture capitalist?

AV: We give grants. Venture capitalists take primary interest in equity. While Villgro also takes equity in some cases, we follow a very mentor-intensive model. A lot of times enterprises approach us not only for the seed funding but also because of our high touch mentoring model. Our portfolio managers check on enterprises every week if not more often, have monthly reviews and assign time to guide each enterprise by providing a mentor and a senior technical advisor. Villgro does virtual business incubation- when the science and technology is already developed; we help the enterprise get to a product version, post-validation of that proof of concept. The product is examined from the point of the problem(s) it addresses, the solution it is providing and the strength of the problem-solution fit, its market, scope, consumer, price, etc. ‘Fail early and fail often’ is what people say in entrepreneurship. We push the enterprises at least at the thought level to figure out which concepts are failing and move on to the next.

CSW: Tell us more about the process of selecting the enterprises that Villgro wants to incubate. Who checks with the numbers that the entrepreneurs come up with and how is it done?

AV: When there is an application made to us we have an internal process. We have an internal investment committee and an external investment committee comprising some of our board members, to eliminate all kinds of biases in the decision making process. When an entrepreneur first comes to us, we do a preliminary screen to assess if some of the following check boxes are crossed. The checkboxes include:

  • The contribution made by the organization must have a direct social impact primarily to the rural Indian poor who are at the base of the pyramid. For instance, Reliance Jio creates thousands of jobs, which indirectly impacts the rural society. However an enterprise providing content development on science education in tier 2 cities or developing very low cost machines for small, marginalized farmers who have 1 acre of land is more likely to cause direct social impact.
  • Sustainability and scalability – Sometimes they are separate and sometimes they are inter-linked.
  • Technology innovation –We mostly hear from startups developing products for agriculture or medtech due to Villgro’s product bias. Rarely have we supported startups providing services alone. We are funded by Lemelson Foundation to fund inventions that directly impact society.

We classify graduation or exit as “when the company is able to raise subsequent rounds of funding on their own and stand on their own feet”.

Once all the three criteria are satisfied, we generally get a feedback from the sector leads, portfolio managers, and the investment committee. The sector leads take the decision if we should engage in detailed diligence for ensuring a bias free decision. The process of due diligence takes about 4 to 6 weeks and is a very iterative process. We talk to subject experts such as clinicians working in medical technology, practicing teachers, content developers, agricultural entrepreneurs, ecosystem stakeholders, distributors, businessmen and scientists from research institutes to get the facts and numbers verified. We do detailed analyses so that it validates as well as exposes gaps in the entrepreneurs’ armor. The due diligence is done iteratively till a solid case is built. If it cannot be built it gets rejected. Iteration happens every week or every two weeks. When a critical amount of evaluation is done for a case, it is pre-tested in an internal committee (IC) meeting, which is held every week. In this meeting, we discuss the new things that we have learned about the enterprise and decide if we should dig deeper into issues such as – size of the problem, potential customers, market size, cost of the product, regulations around the product and so on.

We also identify where subsequent funding will be available from and how it can be leveraged. We build a solid relationship with the entrepreneur especially via portfolio managers. A lot of feedback is also given during the diligence itself, which benefits the entrepreneur.

CSW: Why do you restrict the product to only the rural setup?

AV: That is where the toughest problem lies. If that is sorted, it can thrive in a private market very easily.

Healthcare related products catering to rural market that we look at, must:

  • Improve the quality of healthcare
  • Increase access to healthcare
  • Reduce cost of quality healthcare

There is an enormous need for these in the rural context. The three themes, which we have in healthcare, are Maternal and Newborn Child Health (MNCH), Communicable diseases and Non-communicable diseases (either therapeutic or diagnostic solutions). This is also in alignment with the millennium goals or now called sustainable development goals.

Some ideas may not satisfy all of our requirements of direct impact or sustainability or innovation, but we listen. We want to make sure that no novel model is missed out.

CSW: How long is the incubation period?

AV: Since this is not a physical incubation there is no ‘get out’ date. It is company and sector dependent. Life sciences/ medtech enterprises have long incubation periods of around 3 to 5 years. Ideally 2 years is sufficient but this is difficult in the medtech sector.

CSW: How do entrepreneurs support themselves during this mentorship period?

AV: A seed capital of 20-60 lakhs is given to them. Then we prepare them to raise other funds. A lot of funding in life sciences is also available from DBT, BIRAC and DST. Typically, if an enterprise passes through the detailed diligence in Villgro they are well considered elsewhere too.

CSW: What do enterprises gain from Villgro and how do they fare once they exit Villgro?

AV: Villgro takes on very early enterprises. Today’s average profile is a tech savvy person with a technology or engineering background who has a technology solution and is trying to launch a product. Some of them are pre-proof of concept. So business-wise, a lot of learning is required. We identify the gaps and when they exit Villgro they usually have a product, which may still be pre-revenue. Although Villgro has been around for 16 years, how enterprises fare post Villgro is still experimental.

One of the enterprises mentored by Villgro, Biosense, started off with two physicians who wanted to make a difference in tackling anemia in women. They developed a low cost solution providing other parallel diagnostic tests. They have glucometers and a noninvasive anemia-screening device. What is amazing here is that for sustainability a lot of companies go through public-private pivot. All get started with the government but they move to private sector for sustainability where margins are better. In public sector the numbers are large but the turnaround times are huge. Government is a tough customer but it is a great customer. Long-term sustainability can be achieved if you can crack the market. So, a lot of the companies pivot very easily towards private sector for immediate returns. We have a mandate for them saying that they cannot completely move towards private. Biosense has kept its primary focus on penetrating government channels to deploy devices at appropriate levels and quality and they have been in business for quite some time.

We realized there is a funding gap between enterprises coming out of Villgro and a mainstream investor picking them up, so Villgro principals launched a for-profit SEBI registered fund for social impact called Menterra. Menterra also focuses on sustainability, scalability and, tech based innovations. The fund has a size of 50 crores and provides a funding between 2 to 4 crores. Menterra was launched exclusively to bridge this funding gap.

CSW: So does Villgro now have two verticals; one for not-for-profit social enterprises, and the other for profit?

AV: Actually these two are separate organizations launched by the same core group of people that share a common mission and beliefs. Both are partner organizations and each believes in the others’ due diligence and mandates.

CSW: Can somebody who has been incubated at Villgro look forward for a funding from Menterra?

AV: It is not taken for granted. Both have the mandates of serving rural India but each has its own investment committee (IC). Some of the members might be shared on both ICs, but each organization has an independent voting process to avoid any conflicts of interest.

CSW: Apart from Villgro what are the other incubators in India, which provide such mentorship?

AV: Each one is unique in their approach, mandate and the sectors that they focus on.

For life sciences – there is CIIE, Ahmedabad that is sort of our competitor (But well, we work with social enterprises, it is not called competition, however geographical locations do matter). BIRAC has Bionest program. There are 20 Bionest incubators. Different incubators focus on different kinds of enterprises. Some focus on more mature enterprises whereas others focus on nonprofits, like Aavishkar. There is Venture Centre – an off shoot of NCL in Pune with a lot of focus on polymer chemistry, C-CAMP in Bangalore, KIT in Bhubaneshwar, FITT at IITD, IKP (ICICI Knowledge Park) at Hyderabad, to name a few.

Stay tuned for part-2 in this series that will discuss the career trajectory of Dr. Arun Venkateshan from academic research to working with a social enterprise incubator.

About the authors: The interview was conducted by Dr. Reetu Mehta and Vignesh Narayan, and was transcribed by Dr. Somdatta Karak.

About the editors: Dr. Shayu Deshpande edited and Dr. Roopsha Sengupta streamlined the article. Dr. Manoja Eswara proofread the article.

Illustrations: The cover image was made by Ipsa Jain (follow her work at Ipsawonders on Facebook and Instagram). The inset image was made by Dr. Somdatta Karak.

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

 

 

Hey, DNA – what can you tell me?

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DNA. A mere three-letter word. The power that lies within though is beyond phenomenal, and we have only started to unwind the marvels of its intricacies. We have come a long way since the discovery of the DNA in 1953. We undertook the ambitious human genome project in 1990[1], which took us 13 years and 3 billion dollars to complete. Only 20 years have gone by and today, we are already planning $100-$1000 genomes.

The tiny 0.1% difference that exists between you and me is the magic that makes you, you and me, me. It defines the colors of our eyes, the different shades of our skin, our differing hair tones and whether we have that little dimple when we smile. Isn’t it remarkable that this tiny difference is all that makes us so distinctly different and so beautifully unique?

So much packed within the DNA. So much we know about it and yet so little do we.

But what use is all this sequencing and technology if we can’t use it to better our lives and of those around us? This article is a modest attempt to condense and highlight the various types of genetic tests and how we can use them. Isn’t it time to listen to what our DNA is telling us?

There are different things our DNA can tell us, as we grow within the comfort of our mother’s womb, and as we grow through adulthood and become parents ourselves. At all these stages, we can ask our DNA different questions – and get different answers.

Even before we plan to conceive a baby, we can choose to check whether we are “carriers” of a specific genetic mutation, one that we might pass on to our children (carrier testing)[2]. Carriers may not be symptomatic of the disease, and hence, these traits can secretly pass through generations without ever being detected, much like a silent volcano under the sea. Carrier testing is relevant to individuals with a family history of a certain genetic disorder. Even though there are hundreds of recessive genetic disorders, most of them are very rare. However, certain ethnic groups have an increased risk of specific genetic conditions[3]. Individuals who are carriers have a 25% chance, in each pregnancy, of having a child with that specific autosomal recessive disorder[4].

If DNA gives a discomforting answer in the carrier test, a couple can opt for preimplantation testing[5] or preimplantation genetic diagnosis (PGD)[6]. PGD is a specialized technique used during embryo selection during in vitro fertilization (IVF). IVF involves removing egg cells from a woman’s ovaries and fertilizing them with sperm cells in vitro (outside the body). In preimplantation testing, genetic mutations are tested for in a small number of cells taken from these embryos. Only unaffected embryos are implanted in the uterus to initiate a pregnancy, lowering the risk of having a child with a particular genetic or chromosomal disorder[7].

Once in the 1st or 2nd trimester of pregnancy, prenatal testing[8] may be performed, if there is an increased risk that the fetus might have a genetic or chromosomal disorder.  Prenatal tests can help identify whether your baby is more or less likely to have inherited genetic disorders[9].

9 months later, a baby enters the world. As precious as it is, so much more important is to do newborn screening[10]. Internationally recognized as an important preventative health program, newborn screening aids in early detection, diagnosis and treatment of certain genetic, metabolic and even infectious congenital disorders, significantly reducing disease development, associated disabilities and mortality rates. Although the newborn disorders being screened varies between hospitals, these four most common genetic diseases are often included:  1. Phenylketonuria (PKU), 2. Congenital Hypothyroidism (CH), 3. Galactosemia (GAL) and 4. Sickle Cell Disease.

The answers we get from prenatal and newborn screening have helped dramatically reduce the rates of morbidity and mortality of babies with genetic disorders all around the world.

Disorders sometimes only appear after birth, often at later stages in life. Predictive testing[11] can help identify mutations that increase a person’s risk of developing genetic disorders, such as certain types of cancer. Presymptomatic testing[12] may aid in determining whether a person will develop a genetic disorder before any signs or symptoms appear. These tests are not to be taken lightly due to the implications of their results. The answers from these DNA tests can provide information about a person’s risk of developing a particular disease and help to make informed decisions about future medical care.

Sometimes, particular conditions can only be predicted or suspected based on physical signs and symptoms. That’s when diagnostic testing[13] can act as an additional tool to identify and confirm a diagnosis. The results from this type of testing can help one make informed choices about health and management of the disorder, much like carrier testing.

Talking about health and management, DNA testing like pharmacogenomics (PGx) testing[14] is challenging our current medical paradigm of “one size fits all”. Naturally, not all of us react the same way to medications (think alcohol or caffeine). In fact, drugs can be ineffective for up to 95% of patients (for example. high cholesterol medications)[15]. Knowing our DNA and what it encodes for might just be a step closer in personalizing medicine specific to any individual. Optimizing treatments based on our DNA eliminates the need for the long and tiring “trial and error” methods of prescribing, reduces the risk of potential side effects and improves therapeutic efficacy.

As much as our DNA can guide us in planning and managing our lives better, it also offers some playful information, making us connect with our past – centuries of our past, embedded somewhere in the DNA we carry within. Genetic ancestry testing[16] offers great predictions about where an individual’s ancestors might have come from and about relationships between families. As smart as it is, DNA can sometimes leave traces too – specific patterns of genetic variations are frequently found in people of similar backgrounds and the more closely related we are (families, populations, etc.), the more patterns of variations we would share. However, there are various limitations as well due to a limited database of genetic variants on specific ethnicities and human migrations, for example.

All these give an idea of how serious answers may be as we seek our genes.

However, DNA certainly has a fun side to it too. Why not have fun with some “Recreational DNA testing”? The triple helix is not always serious, for it is able to tell if you might have athletic genes, can recommend a great wine for you, guide your fat loss and even help in optimizing your sleep, to name a few.

Throughout our lives, we can keep asking our DNA for answers. Some of which we might get and some of which we will not. Some of which are serious, some of which are silly, some of which are just reflecting its playful nature and some, it’s secret side. DNA is after all, only a part of us and we are what it is.


About Mathura:

Mathura Shanmugasundaram, PhD is a geneticist who is deeply passionate about personalized medicine and believes in using advances in science and technology to optimize and improve healthcare.

 

 

Editors: Sayantan Chakraborty, PhD, Rituparna Chakrabarti, PhD and Sushama Sivakumar, PhD

Illustration: Fuzzy Synapse


[1] https://www.genome.gov/10001772/all-about-the–human-genome-project-hgp/

[2] “Genetic Screening Tests – Autosomal Recessive Diseases”. OB/GYN Specialists of Palm Beaches, P.A.

[3] The American college of Obstericians and Gynecologists, Carrier Screening for Genetic Conditions, Number 691, March 2017

[4] NIH Genetics Home Reference: https://ghr.nlm.nih.gov/

[5] Brezina PR and Kutteh WH (2015). Clinical applications of preimplantation genetic testing. BMJ 19:350, 7611.

[6] Harper JC. Introduction. Harper JC, Delhanty JDA, Handyside AH, eds. Preimplantation Genetic Diagnosis. London, UK: John Wiley & Sons; 2001. 3-12.

[7] American pregnancy association: http://americanpregnancy.org/infertility/preimplantation-genetic-diagnosis/

[8] Latendresse G and Deneris A (2015). An update on current prenatal testing options: first trimester and noninvasive prenatal testing. 60: 24-36.

[10] Centers for Disease Control and Prevention: https://www.cdc.gov/newbornscreening/

[11] Mitchell PB et al., Predictive and diagnostic genetic testing in psychiatry. Psychiatr Clin North Am. 2010; 33(1): 225-43

[12] Genetic Diagnosis and Testing in Clinical Practice. 2006. Clinc Med Res (4): 123-129.

[13] http://emedicine.medscape.com/article/773832-overview

[14] Relling MV and Evans WE (2015). Pharmacogenomics in the clinic.  Nature (52): 43-350.

[15] Schork, N (2015). Personalized medicine: Time for one-person trials. Nature. 520, 609-611.

[16] Kirkpatrick BE and Rashkin MD (2017). Ancestry Testing and the Practice of Genetic Counseling. J Genet Couns. 26: 6-20.

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Global oncology – Equitable global health

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  • 19749360_1493159330748408_1042093450_o-1.jpg?fit=1280%2C1047
    Diagonal Solution to the Problem by Michail Serebrjakov, a photograph by Supriya Pratihar

Cancer care – not only for the rich

Keeping the key numbers in mind

On addressing cancer control, the WHO’s website says: “The key mission of WHO’s work in cancer control is to promote national cancer control policies, plans and programs that are harmonized with strategies for noncommunicable diseases and other related health concerns. Our core functions are to set norms and standards for cancer control including the development of evidence-based prevention, early diagnosis, screening, treatment and palliative care programs as well as to promote monitoring and evaluation through registries and research that are tailored to the local disease burden and available resources.”

A quick look at cancer control and therapies

Cancer – a disease that can arguably be called as one of the most complex enigmas in medical science – has been a challenge in many different ways. Not only has it been extremely difficult to elucidate the molecular causes of the disease to develop cost-effective treatments but also training and development of medical professionals in the field, provision of timely and appropriate therapeutic interventions and public education to ensure possible prevention and control of the disease.

This matter warrants an immediate reality check in the lower and middle-income countries (LMICs) where a huge disparity exists compared to high income countries. Nearly 80% of cancer cases occur in LMICs where the infrastructural support is dismal in most regions of these countries. Without public health insurance system, the enormous cost of present day cancer care is beyond the reach for majority of population, especially in the LMICs. As population in these countries is on the rise, without a proper tab on the cancer care in these countries, we risk a huge part of human population suffering without access to medical health care – that will directly affect economic and social development in these regions.

Diagonal approaches to cancer care – Educating masses on the prevention and providing therapeutic interventions go hand in hand

Cancer care is now a global issue that invokes organizations like WHO to enable local governments to deal with cancer care effectively. But in line with the WHO objectives, local and government structures in India, North east Africa, Mexico and Middle eastern countries have developed diagonal approaches to strengthen the health system by improving human resource development, drug supply, service provision, quality assurance, financing – of which a few are cited below (5).

Most of the cancer incidences in LMICs are due to cancers that are highly preventable but with limited awareness amongst masses. Various liberating structures and community events have now been in use in combination with didactic education to impart awareness on cancer prevention. While working with people directly, it is imperative to be aware of their lifestyles and cultures to be able to impact the most – a learning useful for the local health workers.

– Better communication between specialist oncologists and primary care providers – doctors and nurses, in local Indian hospitals via WhatsApp based interfaces to consult on complex chemotherapy protocols and management of side effects has enabled easier access to better treatments at local district hospitals.

– While financing cancer care remains a huge challenge worldwide, especially in LMICs, Mexico made a remarkable health reform by introduction of a publicly funded health insurance scheme that covers an increasing list of cancers and encourages preventive measures like timely mammograms.

From educating masses and medical professionals to better health insurance policies – these local experiments serve useful lessons to implement on a larger scale to address disease remediation by combining treatment with preventive measures and better care. While we still await more effective and affordable cancer treatment, there are millions out there who can benefit from the existing pool of knowledge and infrastructure. Let’s at least make sure that we use it equitably without restricting cancer treatment to those born in the first world countries.

References:
1. Cancer Care and Control as a Human Right: Recognizing Global Oncology as an Academic Field, Alexandru E. Eniu, MD, PhD, Yehoda M. Martei, MD, Edward L. Trimble, MD, MPH, and Lawrence N.Shulman, MD, ASCO Eductional Book 2017
2. World Bank definition of 2016
3. Global Health Initiatives of the International Oncology Community, Sana Al-Sukhun, MD, MSc, Gilberto de Lima Lopes Jr., MD, MBA, FAMS, Mary Gospodarowicz, MD, FRCPC, FRCR(Hon), Ophira Ginsburg, MD, MSc, FRCPC, and Peter Paul Yu, MD, FACP, FASCO, ASCO Educational Book 2017
4. Need for Radiotherapy in Low and Middle Income Countries – The Silent Crisis Continues, E.H.Zubizarreta, E.Fidarova, B.Healy, E.Rosenblatt, Clinical Oncology, 2015
5. Thinking Differently in Global Health in Oncology Using a Diagonal Approach: Harnessing Similarities, Improving
Education, and Empowering an Alternative Oncology Workforce, Natalia M. Rodriguez, PhD, Jeannine M. Brant, PhD, APRN, AOCN, FAAN, Dinesh Pendharkar, MD, PhD, MBA, Hector Arreola-Ornelas, MSc, Afsan Bhadelia, MS, Gilberto de Lima Lopes Jr., MD, MBA, FAMS, and Felicia M. Knaul, PhD, ASCO Educational Book 2017

Featured images are by Fuzzy Synapse (on Facebook, Twitter and Instagram) and Supriya Pratihar.

About the author:

Somdatta Karak works with Club SciWri as a project coordinator and Corporate Liaison. She is a doctorate in Neuroscience from Georg August University, Göttingen, Germany and has been a Teach for India fellow (2014-16). She loves putting her analytical skills to build newer and more sustainable solutions, enjoys traveling and communicating and takes every opportunity to expand her horizon.

You can reach her here.

About the editor:

Imit Kaur, Ph.D. is a freelance scientific advisor, medical writer, editor, and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development. Follow Imit on LinkedIn (Imit Kaur) or Twitter (@imit_kaur)

 

 

 

 

 

© The contents of Medness are the copyright of the PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs)

Creative Commons License

This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

MedNess – Bringing the latest in cancer treatment from the ASCO meet Part I

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Following the American Society of Clinical Oncology (ASCO) annual meeting at Chicago from 2nd to 5th June 2017, here is a comprehensive list of studies presented that are funded by leading pharmaceutical companies worldwide. We hope to provide an overview of what is the state of art therapeutic developments in cancer treatment. Know the leaders in oncology and what molecular targets and techniques they are most interested in for the prevalent forms of cancer.

From discussing development of newer drugs for the well-known targets in cancer therapy to CAR-T therapy, here is a collation of all the ground-breaking research from the pharmaceutical companies.

Content Idea: Imit Kaur, Ph.D

Content development and execution: Somdatta Karak, Ph.D., Vinita Bharat, Ph.D.

Edited By: Imit Kaur, PhD.

Illustration: Vinita Bharat, Ph.D

About the Authors:

  Imit Kaur, Ph.D. is a freelance scientific advisor, medical writer, editor, and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development. Follow Imit on LinkedIn (Imit Kaur) or Twitter (@imit_kaur)

Somdatta Karak, PhD is interested in pharma and healthcare sector in Asia. She also works with PhD Career Support Group / Club SciWri as its project coordinator. She aims to make a more and better informed world for all, and hence experiments with making effective platforms of education. She can be reached here.

Vinita Bharat Ph.D., is currently a postdoctoral research fellow at European Neuroscience Institute, Göttingen, Germany and had been an International Max Planck Research School (IMPRS) student here. Her research area focuses on cellular and molecular neuroscience. Other than enjoying ‘being a scientist’, she has also been working on science education. Presenting science in easy and fun way is what she loves doing through her platform “Fuzzy Synapse” (one can find fuzzy synapse on Facebook, Instagram and Twitter). She is a fun, enthusiastic and curious person, passionate about traveling, loves celebrations and bringing smiles around her.

MedNess: At the Frontier of Healthcare Business/ March For Science- Special Report

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Cover Design: Ipsa Jain

Hello everyone and welcome to MedNess: At the frontier of healthcare news. The month of April was pretty crucial for Gilead Sciences and Novartis. Read below to find out more.

Also, this issue of MedNess is special as we are covering a report on March for Science from Club SciWri’s “Reporting from the lab” led by Radhika Raheja, Ph.D. Why are we covering March for Science on MedNess? Science affects us; the scientists, science affects our decisions and perspectives..still need more reasons? Check out our section on March for Science.

To stay on top of major scientific advancements, subscribe to ClubSciWri (www.sciwri.club)

Gilead’s NASH candidate clears early proof concept study

Gilead Sciences presented the first clinical trial data for GS-0976, an acetyl–CoA carboxylase inhibitor in patients with non-alcoholic steatohepatitis (NASH) at the 2017 International Liver Congress. The results are very preliminary but hopeful.

Gilead acquired GS-0976 from Nimbus Therapeutics in a billion-dollar deal last year.

This chronic liver disease affects around 15 million Americans. It is manifested by fat deposition in the liver and can cause scarring and liver fibrosis leading to liver failure (FierceBiotech, SeekingAlpha).

The clinical trial consisted of only 10 patients treated with 20mg dose OD for 12-weeks. GS-0976 blocked the formation of new fat in the liver by 29% and reduced liver fat by 43%. There was also a statistically significant decline in liver stiffness, marker for liver fibrosis, from 3.4 to 3.1kPa.

MedNess: Although on Friday, April 21, 2017, we did not see Gilead stocks soaring after the news, based on 19 analysts polled by TipRanks, majority approve buying Gilead stock while 7 maintain a hold and 0 recommend selling (SmarterAnalyst).

 FDA issues new warnings against the use of opioids in kids and nursing mothers

The Food and Drug Administration (FDA) issued a consumer safety alert on April 20, 2017, ordering major label changes on prescription drugs containing codeine and tramadol. Codeine is found in some prescription pain, and cough medicines and some over-the-counter cough medicines and tramadol is found in some prescription pain medicines. The opioid drugs are metabolized rapidly by children which can lead to breathing problems.

The FDA listed 15 medications and their generics that will be affected by this warning ranging from J&J’s Tylenol with codeine and Ultracet with tramadol, Vertical’s ConZip with tramadol, and Allergan’s migraine medication Fiorinol with codeine (FDA.gov)

FDA approves Roche’s Tecentriq as first line treatment for certain patients with advanced bladder cancer treatment

Roche’s Tecentriq gained accelerated approval from the FDA as a first-line treatment in patients with advanced bladder cancer who are ineligible for cisplatin chemotherapy. Tecentriq was earlier approved for treatment in patients with advanced or metastatic bladder cancer whose disease worsened within one year of standard chemotherapy.

MedNess: This immunotherapy was approved earlier for the treatment of non-small cell lung cancer (Roche.com). The current approval enables label expansion of this immunotherapy. As per Zacks ranking list, Roche stocks are strongly recommended for buying (Zack.com)

Novartis’ CAR-T CTL019 receives FDA “Breakthrough” Tag for the treatment of most common form of lymphoma

Novartis received the US Food and Drug Administration (FDA) Breakthrough Therapy designation for CTL019, an investigational chimeric antigen receptor T-cell (CAR-T) therapy. Last month, CTL109 received the breakthrough designation for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.

This is the second indication for which CTL019 has received this designation for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) for the treatment of adults who have failed two or more prior therapies.

The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study. The results from JULIET study are expected to be presented soon (Novartis.com).

MedNess: Novartis is competing with Kite Pharma over CAR-T therapy. Kite already has breakthrough designations for DLBCL, transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma. After the announcement, Kites shares dropped by 1% and Novartis’s by 0.3% (FierceBiotech)

MedNess # March for Science by Radhika Raheja Ph.D

While we look at FDA approvals and how they affect pharmaceutical companies, it is important to acknowledge the science coming out of academic institutions that steers translational discoveries. Here is a brief report on how science impacts lives and why it is necessary to support scientific research.

Reporting from outside the lab – #marchforscience #Boston

This week we are not ‘Reporting from the lab” but from outside the lab where most of the excitement was happening. Thousands of scientists all over the world took to the streets to “March for Science” on April 22, usually observed as Earth Day.

Why do we march for science? We march for science because “ Science is real, denial is deadly”, “ No science, no beer”, “ Progress in science = progress in humanity”, “Climate change is real” and several other reasons. Here in Boston, the research community in the Longwood medical area marched under the motto “ Science is good for your health“. Our rally kick-started with a lineup of extremely eloquent speakers, faculty, students, patients and the Dean of Harvard Medical School (HMS) who spoke about the impact of science on our lives and the ramifications that reckless changes in science policy can have on all of us.

Why do we march for science? Science gives us the opportunity to give back to the community. The Dean for Students at HMS, Fidencio Saldana, emphasized that science affects all of us. “Science is for people who want to invest in the future of our children” he said, as science education creates awareness, teaches our children to think critically, ask questions and creates opportunities for them in the future. Fidencio Saldana ended by saying that there is, “too much at stake for us to remain silent anymore”. On a similar note, Senan Ebrahim, an MD-PhD student at the HMS reminded us, “to raise our voices and speak the truth, because we are blessed with knowledge and it is our responsibility to act on it and share it.” It is our duty to leave behind a legacy of advanced engineering, improved medical care and to safeguard the future for young and bright scientists.

Why do we march for science? Science gives us hope when we are afflicted with disease. This was further exemplified by the stories of patients and doctors on the innovative cures for various diseases including sickle cell anemia, acute lymphoblastic leukemia, neuroblastoma, lymphangioleiomyomatosis that have saved lives, thanks to fundamental scientific research conducted in laboratories within Boston and the nation. In order to continue fostering the promise of scientific discoveries, it is important to ensure our voices are heard. “Scientific research is one of the fundamental pillars of our society, … this is not a fight for our livelihoods, this is a fight for human lives “ said Elorm Avakame, an MD/MPH student at Kennedy School of Public Health.

Why do we march for science? “We march because we are facing a threat to humanity “. The proposed budget cuts within federal agencies like the National Institute of health itself will be dramatic as it has an annual budget of $32billion and propels scientific progress not only in the United states but in the world. “Such budget cuts, if applied, will have tragic consequences that will haunt us for generations, destabilize our economy and pose an existential threat to America’s preeminence as a world leader in biomedicine”, said George Daley, Dean of HMS. He also added that NIH funding supports over 380,000 jobs nationwide and over 31,000 jobs in the state of Massachusetts alone. Research funded by the NIH drives an economic activity of over $65 billion a year. “Scientific progress, scientific discovery is an enduring symbol of what is best and what is most noble about this great nation. Cutting biomedical research funding will eviscerate our ability to relieve suffering here and around the world. It threatens the very core of our mission”.

Boston plays a historic role in creating and nurturing some of the best scientists and physicians trained to alleviate human suffering caused by disease. Nearly half of new cancer drugs in the last 5 years emerged from the hard work and curiosity of scientists in the laboratories at Harvard University funded by grants from the National Institute of Health. In this era of phenomenal advancements in science, it is terrifying to envision the therapeutic landscape for various diseases without support for scientific research.

It was a cold, rainy day in Boston, with temperatures as low as 3oC (37oF) , yet this did not deter the spirit of the students, scientists, physicians, patients and people whose lives have been positively impacted by science to get out and stand up for science. We marched to reaffirm the importance of science and how it benefits our lives, our country, and our planet. We marched because science truly matters!

About the Authors:

Imit Kaur is a freelance medical writer, editor and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.

 

Radhika completed her PhD from Cornell University and is currently a Postdoctoral fellow at the Brigham and Women’s Hospital. Her research interests have centered around oncology and neuroimmunology. Among other things, she is striving to effectively communicate scientific discoveries to the community.

 

 

MedNess: FDA approvals,rejections, M&A and more…

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Illustration: Ipsa Jain

Hello and welcome to MedNess where we bring you the news from healthcare market. We are excited to announce the brand new section known as MedNess Focus, led by Abhinav Dey, Ph.D. that will be published every alternate week. Stay tuned for that next week where he will “Focus” on Novartis’ CAR-T therapy BLA! We are also excited to introduce MedEurope this week, led by Czuee Morey, Ph.D. For other in-depth coverage, please subscribe to @Club SciWri (www.sciwri.club)

FDA grants approval to Gilead Hep C drugs for pediatric patients
The U.S. Food and Drug Administration granted approval to supplemental applications for two Hep C drugs; Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for use in pediatric population ages 12 to 17 or weighing at least 35 kg. The drugs are approved to treat hepatitis C in adolescents without cirrhosis or with compensated cirrhosis. Harvoni gained approval for treating pediatric patients with genotype 1, 4, 5 or 6 hepatitis C virus (HCV), while Sovaldi was approved for treating pediatric patients with genotype 2 or 3, in combination with ribavirin. Both of these drugs were previously approved to treat hepatitis C virus (HCV) in adults. The supplemental approval came in as a win for both the medical field and business investment field. These two drugs are the direct-acting antiviral agents approved for the pediatric patients. Direct acting antivirals are efficient in curing HCV in most cases. These agents prevent the virus from multiplying thus reducing the amount of HCV in the body. Alternatively, the supplemental approval of Sovaldi  and Harvoni  also came in as a relief to the slumping Gilead sales (Fierce Pharma)

MedNess: Gilead Sciences tops HCV and HIV treatment market. However; recently, the patent battles and competition from the rivals has given tough time to Gilead’s stocks. While investors have been worried about Gilead’s cranking cash flow, the expanded label approval of Gilead Sciences star HCV drugs; Sovaldi and Harvoni should provide a sigh of relief. There was a slight increase in the stock price after the expanded drug approval use (seeking alpha and The Motley Fool).

FDA rejects Merck’s plea to drop cardiovascular risks from sitagliptin label
The FDA sent a complete response letter to Merck rejecting the drug maker’s appeal to include outcomes from its TECOS trial. This heart study showed that Merck’s drugs used for the treatment of diabetes; Januvia and its related combos Janumet and Janumet XR had “no signal” of heart failure (FiercePharma).

MedNess: Merck has been facing competition with Eli Lilly’s and Boehringer Ingelheim’s SGL2 medicine Jardiance and Novo Nordisk’s GLP-1 Victoza which have shown to reduce the combined risks of heart attack, stroke, and death from the cardiovascular disease. Amongst these rivals, Merck wanted to follow suit. The stock prices of Merck fell after the letter on Friday (Investor’s.com).

FDA authorizes 23andMe Personal Genome Service Genetic Health Risk tests
The FDA approved the marketing of genetic health risk analysis. The results of these tests will provide information directly to customers without requiring physician’s prescription.
The genetic health risk tests can detect a genetic predisposition to 10 diseases including Parkinson’s disease, late-onset Alzheimer’s disease, and Gaucher disease. But there are certainly gray areas with the testing system. The tests are designed to provide information on genetic predisposition that can help make lifestyle changes, but the results are not expected to be entirely valid or “fully penetrant.” This implies, even if a person is shown to be at higher risk genetically, he or she might never develop a disease in their lifetime and vice versa. In addition, the reports provided by these test results will be independent of the family history. This is particularly concerning as for some diseases; family predisposition might increase the risk in general. Therefore, customers are advised beforehand to not to rely on the test results completely and not to get emotionally upset with the unfavorable test results (STAT).

NIH’s Zika vaccine enters Phase 2 trial amongst budget cut frenzy
The Phase 2 trial testing a Zika vaccine, developed by scientists at the National Institute for Allergy and Infectious Diseases (NIAID), began at Baylor College of Medicine in Houston. The phase 2 study results are expected by the end of this year.
The clinical trial involves a DNA-based vaccine, lacking a live Zika virus, but from which proteins are placed into small pieces of DNA. NIAID is a part of the NIH and is obviously affected by President Trump’s recent budget proposal cut. However, given the importance of this study, the institute has dedicated $100 million funding for the Phase 2 work. If the Phase 2 study is successful, NIAID will partner with commercial sources to bear the costs of larger Phase 3 trials (STAT)

Novartis CAR-T therapy BLA granted FDA priority review
Novartis announced that the US Food and Drug Administration has accepted the company’s first Biologics License Application (BLA) filing and granted the priority review for CTL019 (tisagenlecleucel-T) in relapsed and in relapsed and refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). CTL019 is an investigational chimeric antigen receptor T-cell (CAR-T) therapy.  The priority review designation is expected to shorten the anticipated review time to six months.

In the Phase II ELIANA study, 82% (41 of 50) of patients infused with CAR-T cells achieved either complete remission or complete remission with incomplete blood count recovery after three months. The study enrolled patients globally across the US, EU, Canada, Australia, and Japan.

CAR-T therapy, one of the most controversial treatments involving gene therapy, utilizes reengineered patient’s T cells. These T cells (immune system’s killer cells) are filtered from patients blood and altered in the lab and injected back intravenously making it a “living drug.”(Novartis.com)

MedNess: After the announcement, Novartis shares were little changed but the shares of the company making CTL019 raw materials, Oxford BioMedica, rose by more than 4.5 percent. Alternatively, Kite Pharma, Novartis’ rival in CAR-T race, also submitted a rolling application for their chimeric antigen receptor T cell candidate. Rolling applications are allowed for promising new drugs. Kite’s application could be accepted early putting behind Novartis’. Therefore, the winner of the CAR-T race will set the price of the therapy and subsequently the stocks (Reuters and Nasdaq).

MedEurope by Czuee Morey, Ph.D.

Astellas Pharma expands its portfolio to women’s health by acquiring Belgian biotech Ogeda
Japanese Astellas Pharma announced its plans to acquire privately owned, clinical-stage drug discovery company Ogeda. The acquisition comes three months after Ogeda achieved positive results from a Phase IIa study of fezolinetant (ESN364), its lead drug candidate. Fezolinetant is a potential non-hormonal treatment for menopause-related vasomotor symptoms (MR-VMS) such as hot flushes and night sweats and is an antagonist of the GPCR known as tachykinin receptor neurokinin3 (NK3). The phase II data showed statistically significant reduction in both frequency and severity of menopausal hot flushes versus placebo in 80 women.
Astellas’ offer consists of €500 million ($530 million) upfront followed by an additional €300 million ($318 million) if Ogeda meets its development and regulatory milestones. Astellas will also benefit from a few pre-clinical assets under investigation for autoimmune diseases and ulcerative colitis. The companies expect the deal to close in the second quarter, at which point Ogeda will serve as an Astellas subsidiary. This acquisition will help to expand Astellas’ pipeline that is primarily focused on oncology.

MedNess: The global MR-VMS market was valued at US$3.77 bn in 2014 and is projected to grow at a CAGR of 3.7% from 2015 to 2023 to reach US$5.28 bn by 2023. Ogeda is also running Phase II trials with the lead candidate to treat polycystic ovary syndrome (PCOS) and uterine fibroids. Other companies developing neurokinin antagonists are UK based NeRRe Therapeutics for a range of conditions from sex hormone imbalances to opiate use and US-based Millendo Therapeutics for polycystic ovarian syndrome, both in Phase II.
Astellas stock, which trades on the Tokyo Stock Exchange, was up about 2% to ¥1,492 ($13.39) on Monday morning after the announcement.
(PRNewsWire, Labiotech.eu, Seeking Alpha)

About the author:

Imit Kaur is a freelance medical writer, editor and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.

 

MedNess- Immuno Oncology, Precision Medicine and more….

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Picture Illustration: Ipsa Jain

CAR-T therapy- a step closer to precision medicine?

Kite Pharma’s CAR-T candidate axicabtagene ciloleucel (previously referred to as KTE-C19) might be the first gene therapy to gain approval from FDA. The candidate therapy attained primary endpoints in a major study. The study encompassed patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma. The study showed that out of 101 patients enrolled in ZUMA-1 trial, 82% had their cancer shrunk at least by half after six months. In addition, 41% had partial response while 36% of patients went on complete remission. The therapy comes with its own share of risks. 3 patients in the study died and 2 of the deaths were attributed to the treatment.

CAR-T therapy, one of the most controversial treatments involving gene therapy, utilizes reengineered patient’s T cells. These T cells (immune system’s killer cells) are filtered from patients blood and altered in the lab and injected back intravenously making it a “living drug”.

Novartis and Juno Therapeutics are also in the race for CAR-T therapy. However, Juno Therapeutics announced the discontinuation of their experimental product early this month. This is because thirteen percent of patient deaths were reported, majorly due to cerebral edema and brain swelling. Kite Pharma’s CART-T cell product is safer in this regard. Kite Pharma’s axicabtagene ciloleucel was granted Breakthrough Therapy Designation status for diffuse large B cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma by the FDA and by the Food Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

MedNess: Although Kite Pharma has not presented formal results of the trial and is expected to present their report at the annual conference of American Association of Cancer Research in April this year, the reports of axicabtegene ciloleucel meeting primary endpoints raised the stock prices by 13% of this California-based biopharmaceutical company. Kite Pharma’s CAR-T product might be first in line to gain approval from FDA by the end of this year leaving behind the products from its competitors. Therefore, stocks of Kite Pharma hold a lucrative future. However, a lot can change in further studies and it all comes down to safety and efficacy of the final product (FiercePharma, STAT).

Barclays analyst’s stern advice to Gilead Sciences

Geoff Meacham, Barclays senior analyst apparently lost patience with Gilead Sciences, urging it to “do something”. He sent an open letter to the management prompting the company to either make an acquisition or take strict measures to improve sales and profit growth. Meacham suggested measures including Gilead’s orphan drugs diversification, cost cutting in Hep-C business due to declining market, HIV franchise clarification and/ or in-licensing deals in order to gain trust of its investors (Seekingalpha)

MedNess: Gilead Sciences sales and profit growth have eroded as its hepatitis C franchise has declined, the shares have slipped by 1% and profits have declined in each of the past five quarters.

Scott Gottlieb to lead FDA under Trump administration

Scott Gottlieb who has served as a practicing physician, clinical assistant professor at New York University and health information technology adviser for the department of Health and Human Services, has been selected as Trump’s nominee to lead FDA. The president’s selection is expected to yield support from biopharma industry. Gottlieb, if confirmed, is likely to hasten the drug approval process that might have earned him Trump’s support. He was a former deputy commissioner for medical and scientific affairs at the FDA under George W. Bush (FiercePharma).

Earlier this month, Club SciWri initiated a new section on Science and Policy, emphasizing on the involvement of scientists in the healthcare policy decisions. Gottlieb’s nomination to lead FDA will serve as a perfect example, underscoring the relevance of this sensitive subject.

BMS appoints Thomas Lynch as its new Chief Scientific Officer

BMS has been in news for quite a while now and that too for all the wrong reasons. Amongst the turmoil and speculations of its buyout, BMS appointed Thomas Lynch as its new Chief Scientific Officer (CSO) while the former CSO Francis Cuff made the exit this Wednesday. Thomas Lynch, an oncologist, was a former board member of BMS. With the new appointment, hopes are high on the Opdivo front as well. Recently, Opdivo fell short in a major clinical trial when tested on previously untreated lung cancer patients. Opdivo is PD-L1 checkpoint inhibitor and therefore its efficacy is expected to be better in patients with higher levels of this biomarker. However, BMS lost its non-small cell lung cancer lead to rival Merck’s Keytruda that succeeded in patients with a PD-L1 score of 50% or more. Also, earlier this year, BMS decided to not to seek accelerated approval for their Opdivo-plus-Yervoy combination in lung cancer. These two events combined with new checkpoint inhibitors expected from Roche, AstraZeneca, Merck and Pfizer have put BMS’s shares down. However, analysts suggest, BMS share might still be a great bargain if the drug succeeds in other arms of the trial, testing Opdivo as a monotherapy in first-line lung cancer. The company also awaits readouts from Phase 2 and Phase 3 studies evaluating Opdivo and Yervoy in other types of cancer (FiercePharma, The Motley Fool).

 

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