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Continuus Pharmaceuticals: Changing the rules of drug manufacturing

in Entrepreneurship/Face à Face by

Editor’s note: The innovative research and technologies bid adios to many diseases that posed a threat to us. However, with the boost in the population, one major challenge that the pharmaceutical industry confronts is to keep the balance between demand and supply. In the global market, it is no longer just about getting the right cure; it is about searching the fastest, economic, eco-friendly and sustainable alternatives. This face-to-face interview with Bayan Takizawa will throw light on ‘continuous flow model’ of manufacturing which permits the bio-pharma companies significant lead time in the drug production. Additionally, he discussed with Subhalaxmi Nambi how his company Continuus Pharmaceuticals is currently the best solution to bridge the gap between supply and demand.- Rituparna Chakrabarti

An efficient manufacturing process in any industry is the crux of the economic success and market sustainability. This article focused on one such success story. Traditionally, pharma industries focus has been on ‘batch manufacturing’, with multiple disconnected steps. Further, a large plant footprint, magnified the risk of human errors and contaminations, running the system into time crunches. Annually, it is estimated that on average the pharmaceutical industries suffer a loss of $50 billion during the manufacturing process alone. In contrast, other manufacturing sectors, such as the electronics industries implement ‘continuous flow model’ where raw materials are funneled through uninterrupted steps, delivering the final product/services. The Novartis-MIT Center were among the first ones to embrace this model successfully in 2007. Their prototype system circumvented the major roadblocks associated with the stages of manufacturing. Now, it is not any more a far-fetched dream, that a tablet can be produced from the raw materials, just within two days.

A few weeks ago, Subhalaxmi (Subbu) had the opportunity to interact with Bayan Takizawa, a co-founder and chief business officer at Continuus Pharmaceuticals, Woburn, MA; a spin-off company from the Novartis-MIT Center established in 2012, for Continuous Manufacturing.

During the course of the interview, Takizawa highlighted that Continuus is relentlessly moving forward with their cost/time efficient plans. They aim at better plant footprints and drug quality through implementation of plant-wide Quality by Design. Continuus’ modular manufacturing designs further allowed modification and adaptation of an existing process for a new drug.

Bayan Takizawa exclaimed that “The continuous flow technology is a game-changer! However, we have to acknowledge several challenges towards its broader implementation within the pharma industry.” No doubt that establishing this process is profitable but involves initial capital investments. Moreover, many companies are not enthusiastic about overhauling their established production processes, a phenomenon often termed as industry inertia. However, the situation is changing as there are some early adopters. Continuus has worked with several companies ranging from innovative pharmaceutical to generic companies, leveraging its novel continuous manufacturing technologies. Additionally, they are currently working with government agencies, including the NSF (through their SBIR programs) and the FDA.

In the future, the incorporation of Continuus’ flow technology will enable companies to reduce their cost structures. The modular and flexible nature of the process design makes this technology ideal for personalised medicine applications. Dr. Takizawa is also interested in exploring how this technology platform can be exploited for the development and production of biologic medicines (e.g. oligonucleotides). He emphasized the importance of the rich Massachusetts’ life science ecosystem and how it has contributed to Continuus’s success, as many of the advisors and employees are from this area. He added companies can benefit greatly from the fruitful collaborations with the thriving Massachusetts Life Sciences Center (MLSC) and the Massachusetts Biotechnology Council (MassBio) located in Waltham and Cambridge, respectively.

Continuus strength is the people with technical and regulatory expertise, who are flexible to work in a small company culture. Bayan explained they are always excited to welcome those future candidates aboard who are adaptable and willing to accept changes. He quipped “We appreciate someone disagreeing but not disagreeable”. When asked for advice for budding entrepreneurs, he laid stress on using one’s network to connect with interested and helpful people. He personally finds attending conferences to be a great connection-building exercise. Additionally, he believes that creating a competent management team is a key factor in building a successful startup.

 

Finally, he offered some advice for the budding entrepreneurs:

  1. Listen to others – we all think we’re pretty smart, but we have not done it all, and we can learn from listening to others
  2. Listen to your client
  3. Be ready to pivot (especially based on 1 and 2) above
  4. Be objective when picking advisors/directors – you don’t want to pick friends or people who you feel comfortable with – you need people who will provide good guidance and advice
  5. Be ready for tough times ahead – creating a business is not easy. It is important to be energetic, persistent, and resilient while being realistic (don’t be delusional!)

 

Continuus Infoshell….

 

 ———————————————————————–
This interview was conducted by Subhalaxmi (Subbu) Nambi (MS, Ph.D.) She is  a business development associate for Innovation and Business Development at the University of Massachusetts Medical School (UMMS). Her responsibilities involve collecting competitive intelligence and market analysis to determine commercial viability and competitive advantage of technologies invented/discovered in UMMS. She is also involved in understanding the IP of the ongoing projects in UMMS. Prior to this position, Subbu did a post-doc with Prof. Chris Sassetti on developing new approaches to understanding the role of genes of unknown function in mycobacterial pathogenesis and validating their products as potential drug targets. She obtained her Ph.D. in Biochemistry at the Indian Institute of Science (IISc) in India. Her graduate research focused on understanding the role of cAMP signaling in mycobacteria.
About the author:
 Anisha Zaveri recently graduated from the Indian Institute of Science and is presently a postdoctoral associate at Weill Cornell Medicine, New York. She works on the human pathogen M. tuberculosis while also dabbling in effective altruism, behavioral economics and data science.

 

 

About the editors:

Rituparna Chakrabarti pursued her Ph.D. in Neuroscience from Georg-August University (Göttingen, Germany) and is currently a post-doctoral fellow at the Center for Biostructural Imaging of Neurodegeneration (BIN), Göttingen. Over years, she has gained technical expertise in electron and high-resolution light microscopy, in order to study the nanostructures of specialized chemical synapses in the sensory systems. She likes to have a bird’s eye view of her undertakings and gets excited with analytics. Passionately believes in, correct simplification of science, therefore engages in different scientific communication and public outreach projects. To unwind herself she plays mandolin and eagerly looks for a corner at a coffee house to slide herself in with a good read or company.

 

 

Uma Turakhiya, Ph.D. About herself Uma says “I currently work as a regulatory medical writer, having previously completed my Ph.D. in biochemistry from the University of Freiburg, Germany. I enjoy writing about science and believe that simplification of science and communication are the key to creating a scientific temper in the society. Apart from having a voracious appetite for books, I am enthusiastic about learning new languages, meeting new people and occasionally playing the piano.”

Featured image: Pixabay


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.

From Oklahoma to Manhattan- The Genesis of Sevengenes

in Entrepreneurship/Face à Face/Medness by

Where there is a will there is a way. This is the mantra followed by scientist-turned-entrepreneur Ayyappan Subbiah. Ayyappan started his journey in the field of Material Science, obtained PhD in 1997 from IISc, Bangalore, India under the supervision of eminent Professor C.N.R. Rao. Introvert by nature, Ayyappan had a desire to bring about some kind of impact in people’s lives. This passion was rekindled during his job at ConocoPhillips where he was working as a Senior Scientist. Ayyappan did not want to entangle himself in the rut of routine work and confine himself to the realms of bench experiments. This prompted Ayyappan to break the traditional norms and set forward his journey of entrepreneurship. With the help of two friends, Ayyappan founded LivePet LLC. The first product from LivePet was an anti-inflammatory supplement for the pets. In order to take the product from the bench to over-the-counter veterinary product, Ayyappan and his mates tested their product at Liberty Research Institute, NY and carried out a couple of small trials on 50 dogs. The dogs were administered a set dose of the supplement for 30 days and were tested successfully for the safety and the change inflammatory markers. All the tested dogs were safer and healthier at the end of the study.

After developing the novel anti-inflammatory supplement for the dogs, Ayyappan started questioning himself to go further beyond pet supplements. By now he also realized that as a responsible human being, the best job he can do is to help “towards making 7 generations of human beings living together healthily/happily!” But the bigger question was what will be the source of funding for his next project? There comes a point in life of every scientist when they look for their next career move. “I just knew that after LivePet, I couldn’t go back to the monotonous life of being a lab scientist. I wanted to make an impact in people’s lives and this was the right time” reminisces Ayyappan. Ultimately, he thought of self-funding his own project. He did not know how far his self-funding will take him, but decided to begin the journey. With this dilemma being resolved, the next question was the kind of project he should start.

My first instinct was to learn about the bottle-necks in pharmaceutical industry and look for the potential problems. I wanted to find solution to the biggest challenge of the pharmaceutical industry

says Ayyappan proudly. His research yielded him the answer for his quest. He decided to work on the solubility issues of the hydrophobic drugs. He says “About 40% of drug candidates filed with FDA and 90% in the discovery pipeline are hydrophobic and possess solubility/bio-better issues. Therefore there is an immediate need for a safe and better solvent (excipient) in the pharma industry.” He wanted to test one of his novel excipient/solvent technology idea from his materials science background with a hydrophobic molecule preferably a novel molecule for the first time in the pharma industry.  Literature search yielded an ideal hydrophobic molecule called triptolide which is notoriously known to possess solubility (and toxicity) issues but never became a drug just for those reasons.

Ayyappan took it as a challenge to solubilize triptolide in the novel excipient (7GEN) or the solubilizer. That’s the birth of Ayyappan’s successful start-up called Sevengenes (www.sevengenes.com ). Since then, there has been no looking back. 7GEN significantly enhances the solubility and bioavailability of hydrophobic molecules.  7GEN is very effective compared to existing drug delivery strategies (such as lipid and nanomaterials based) used for approved drugs.

So how does he fund his start-up projects? Ayyappan is deeply passionate about his project and he used up his 401 savings to fund his project. When asked about grant funding, Ayyappan did not want to divulge the details of his idea to the federal agency before gaining patent approval. He pitched in the idea to family and friends and they acted as amazing sources of funding. His MSc classmate wanted to help him and became a co-founder. Similarly, couple of his PhD colleagues from IISc also wanted to jump in and help and they have become co-founders too.  In addition, Ayyappan’s project was also screened by a non-profit organization, i2e (www.i2e.org) that provides funds to small scale biotechs in Oklahoma. With limited funding but tons of passion and zeal, Ayyappan and Sevengenes’ cofounders outsource their experiments to CRO’s and University of Oklahoma.

They are a pre-clinical company and would like to file their Investigational New Drug (IND) application on their first drug product 7GEN-TDTM when they get their first round investment.  They would like to use their 7GEN excipient (as a platform) for many other hydrophobic drugs and take 505(b)(2) approach for a particular combination.  Meanwhile, Sevengenes recently got selected by Alexandria LaunchLabs for an incubator space in Manhattan, New York from June-2017. Their might be restricted funds but there isn’t dearth of passion inside Sevengenes.

Infoshell…..

When asked about advice he will give to aspiring entrepreneurs, Ayyappan suggests that one should chase their dreams regardless of worrying about the outcomes. He believes that once someone sets his or her brain and heart to a project, the brain will work at its best to find resources to complete the project. Ayyappan has his background in Material Science and is yet a founder of Biological Science start up. He believes in working hard and fair. He credits his spouse and family for their support. He believes that it is a two way street. He saved up enough 401(k) so as to provide secured life to his family while his family understood and supported his dream of a start-up and his project. When asked about his mantra for relieving stress, Ayyappan says he enjoys yoga and believes in the power of prayers!

Ayyappan with Ananda Ghosh (Founder of PhD Career Support Group for STEM PhDs).

About the Author:

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)

 

Featured image: Ayyappan in the auspices of Alexandria Launchlabs

Blog design: Abhinav Dey

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

 

Gaurav Mittal brings technology to deprived

in Entrepreneurship/That Makes Sense by

Gaurav Mittal is an innovator, entrepreneur, hacker and in some ways a social worker determined to impact the lives of millions of visually challenged people. His latest work on a device called EyeD is already creating a measurable impact on almost 5000 users and counting many more with each passing day. The journey from an engineer to innovator is very interesting as well as inspiring and sharing this with CSG community is a pleasure.

He belongs to a small town in UP named Anpara. His father being an electrical engineer realized the importance of technology and obtained a computer with Windows3.0 installed in his office. Gaurav immediately took liking to the concept of computers and it became his passionate interest. However, he got his PC or ‘personal computer’ a desktop computer with Windows 95 after 3 years of persuasion.  Soon, he immersed himself in the world of computers and found a destination for his passion at IIT BHU. While at IIT, he developed and honed the skills of hacking and aspired to be a professional hacker. His dream got fulfilled very soon with an assignment as hacker at CITRIX technology. He thoroughly enjoyed the job of hacking the codes written by software developers and providing insights for securing and strengthening the software.  This experience enabled him to participate and win many innovation competitions while the ‘intrapreneurial’ environment of the organization helped in understanding the process of shaping an idea into a product. He was allowed a sabbatical of 3 months to work on such ideas and feels very fortunate to get that experience while working. These experiences positively sowed the spirit of entrepreneurship in him and the thought process.

A visit to the National Association for Blind (NABD) Bangalore in 2012 marks a turning point in Gaurav’s entrepreneurial journey. There he learnt the blind way of life (literally speaking) through experience for example, he was blindfolded and asked to go to main gate and come back to the room inside. He instantly recognized the fact that seemingly trivial tasks for people with vision translated into big challenges for the visually impaired. What impressed him most was the determined attitude of blind individuals in overcoming these challenges. His interactions with the NABD associates made him realize that some of them were extremely bright and could write software codes as well.  He could appreciate the challenges these students faced and how they could succeed in overcoming those to create something as complex as software codes.

During his visit to the association, there was another incident that set him up on the current journey. A senior official from a reputed company, who had lost his vision at an age of 30 years entered the room and greeted everyone but received no response from the 15 odd people present there. Everyone had an awkward feeling of confusion but patiently, he greeted once again. This time everyone responded and upon hearing the response, he turned himself to the crowd and faced them. During the first greeting, he was facing the audience backwards creating a slight awkward moment which got resolved subsequently. This particular incident left Gaurav pondering on the engineering solutions that could help visually challenged people feel the presence of people they are interacting with or their surroundings.

He turned these thoughts into a hobby project and created seven prototypes for seven different problems, including a glove with a camera and so on.  But he was shocked at the response received during the demonstration of these prototypes at NABD. His target audience rejected his prototypes as they did not address the ‘real’ challenges from a visual impaired perspective. He learnt an important lesson in innovation that day: always understand the needs of the target audience. He shares this piece of wisdom with all the budding entrepreneurs that to arrive at a solution with wide acceptance, it is important to communicate with the target and approach the problem with real world insights rather than embarking upon an intellectual pursuit. He now interacts very frequently with the staff and students at NABD to assess and understand their needs that require a solution and then designs the technology around those needs. He is motivated to come up with technologically superior solutions for the visually impaired life every time he interacts with his audience.  During one such interaction, he was asked a very interesting question on whether he can develop a technology that will enable identification of colors. The person had never seen colors but read about them in books and shared that he is dependent on family and friends to achieve even small tasks such as wearing color coordinated dresses and wishes to make these decisions independently without help. He understood that the most pertinent applications of technology in the visually impaired world are towards creating a self-reliant world where basic life activities can be conducted and enjoyed without help from others.

He decided to quit his job and make the hobby project into a professional goal that he is truly passionate about. He now works with a team of three to develop an app based on Artificial Intelligence (AI) for visually challenged that helps them identify objects in their surroundings, colors of these objects, find nearest hospital, store, read printed text on labels  and documents (which is free at this point of time). A blind person walking on Indian roads might not realize they are going to step into a puddle but with this app, they can. They currently support 5000 plus monthly users and their goal is scaling up to a million users in the next 5 years.

App interface

The astounding response from the users who could read the label on aspirin bottle at night without anyone else’s help and could sleep well, add red bell pepper in their food as opposed to a green bell pepper and many other stories of self-reliance keeps them pacing towards the goal and motivated against all technological odds. To keep this communication alive, the users of the app can interact with the developers directly via SMS/call/live chat that is a distinguishing feature and a direct translation of the first lesson in innovation learnt by Gaurav.

Their interest in transforming the visually impaired life does not end with an app but continues with  designing more products and solutions such as an adaptable keypad that can be pasted to the keypad of smart phones and uses audio feedback for typing.This improvised device and app together allow usage of Whats App, Email and SMS by visually impaired. They are hoping to launch this product soon and recognized nationally by Government agencies to win an award called ‘best innovators of 2016’.

Eye-D keypad on a smart phone

We hope that their story encourages some more people to come forward and innovate for challenged sections of society. Gaurav says that there are millions of problems waiting to be solved. You, my reader, pick one and solve one. If not, fail at one?

 

About the Author

Ipsa is a Ph.D. student at IISc. She wants to gather and spread interestingness. She prefers painting and drawing over writing. She posts her work on Facebook as Ipsawonders.

Edited by Dr. Satya Lakshmi

 

 

Finding antibodies in the haystack…

in Entrepreneurship by

Face to Face with Thomas Leung, CSO, BenchSci.

 

The first day I started my postdoc in the Bremner lab, I remember talking to Tom, a graduate student working in the “Epigenetics” wing of the lab. Being fun-loving and most importantly coffee loving, we instantly bonded and formed a team…doing Science and talking non-sense. I witnessed the BenchSci growth closely…it is amazing how Tom took his idea forward, pursued relentlessly and now successfully launched his startup, raising money from both angel investors and VCs. Within a short span, the BenchSci team won University of Toronto Banting and Best Centre for Innovation and Entrepreneurship (BBCIE) Fellowship 2016, Ontario Centre of Excellence (OCE) Smart Seed 2016 and the Brightlane Entrepreneurship Award (BEA) 2016. To inspire potential start up seekers in CSG, I interviewed Tom recently about his journey with BenchSci.

 

ME: Tell me about BenchSci?

TL: BenchSci is a machine learning software that analyzes and decodes scientific papers to extract antibody usage data in the form of figures. These figures are then further indexed and aggregated to make them easily accessible to the research community.

ME: So, how did the idea get started?

TL: During my PhD, one day I was planning a new experiment, which required a lot of new antibodies for this huge Western blot. I was sitting in front of my computer, using conventional search engines and looking through PubMed to search for antibodies that have been validated in peer reviewed papers. After many hours, I thought to myself, “wouldn’t it be nice if there was a database somewhere that I can just input my favorite protein and I will be able to see all papers produced with different commercial antibodies against that protein?”. I started looking online and realized that such database does not exist, so I decided to build one on my own.

ME:  How did you go about it? What’s the process involved and how did you form a team?

TL:  To build this massive database, I know that I am going to need someone with superb programming expertise. My whole academic career was in Life Science and I do not know many people in Computer Science. I know that UofT is a great place with awesome ComSci talents, so I logged into my LinkedIn account and typed in “UofT, programming”. The first result was David Chen, who became our Chief Technology Officer. Amazingly, David is both an adept programmer and a PhD researcher in Neuroscience. I invited him out for a drink and we chatted for many hours and that’s how the team got started. I continue to look around UofT and assembled an awesome team right here, including our Chief Executive Officer, Liran Belenzon, MBA from Rotman, our Chief Database Officer, Elvis Wianda, PhD from Medical Biophysics, and our Community Architect, Maurice Shen, PhD from Pharmacology.

ME: How did your exposure in University of Toronto (U of T) help you in this pursuit, from a lab to a startup?

TL: UofT has many incubators aiming to nurture and support new ideas. We took advantage of this great opportunity and went to a few of these wonderful incubators such as the Hatchery at the Department of Engineering, the Creative Destruction Lab at Rotman Business School, and H2i at the Faculty of Medicine. Also, being a research scientist myself means I was able to talk to many professors and researchers to get valuable feedbacks and comments. For instance, our scientific advisors Dr. Jim Woodgett, Director of Research at Mount Sinai Hospital, Dr. Ruth Ross, Chairwoman of the Pharmacology Department and Dr. Ioannis Prassas, Staff Scientists at Mount Sinai, gave us many great suggestions that helped us develop and improve the BenchSci platform to better serve the scientific community.

ME: How is your platform different from the several antibody validation websites that already exist, like Antibodyreview, Biocompare, etc…?

TL: We are a true validation platform, meaning that we directly showcase experimental usage validation of antibodies in peer-reviewed journals. As a researcher, I realize the importance of seeing a figure more than anything, that’s why BenchSci is designed to show scientists antibody evidence-of-use directly in the form of figures, and not just a mere citation number.

ME: So right now what’s the design of your BenchSci website?

TL: It is very straightforward. All you need to do is go to our platform, type in the protein you are interested in and press, “enter”. We will show you a list of figures produced by commercial antibodies that target your protein of interest. You can continue to narrow down your search to fit your experimental criteria by applying multiple layers of filter including technique, tissues, cell lines, and disease models. We have a demo video on our website at www.BenchSci.com. For one minute of your time you will immediately realize how simple it is to use BenchSci.

ME: Do you plan to move to other reagents, other than antibodies?

TL: Yes for sure. BenchSci is a powerful software that can decode scientific papers, and we are also planning to target other experimental reagents that require validation information before making a purchasing decision.

ME: Is the software the end product that you will sell, if so, what is your future direction after that?

TL: We are offering BenchSci free to use for all research scientists. We truly believe that BenchSci would be helpful for researchers around the world. Many PhD students that we talked to had one recurring comment: “oh how I wish I have something like this earlier in my career!”.

ME: You mentioned to me that you are the CSO, but not the CEO of the company, although the idea is yours. For scientists like me who do know much about startups, can you describe how these titles work out? What or who decides these things?

TL: Each of our founders plays very specific role in the company. As the Scientific Officer, I am responsible for all things life science and biology related during product development, from backend data collection logic to frontend user interface search mechanics. I am not directly involved in the coding (which is done by David and Elvis), I design the scientific reasoning behind the code. Our CEO Liran is responsible for all things on the business side of our company. It is a triangle: Science, Technology and Business, each of the founder’s specialties in each of these components makes the team strong.

ME: There are two types of people who are getting into startups. One kind, like you, start with your own idea. On the other hand, I was attending a talk recently and the guy wanted to start a startup and he did some research on what’s hot right now and came up with an idea and went about it. According to you, which type is more sustainable? Or do you think both will work the same?

TL: The story that you build from the idea is the important element. A good story will resonate with people and bring more impact to the idea. However, the idea can either be something that took place in your dream, or something that was triggered after hearing another person’s seminar. The only difference is that, if you are creating a solution to a problem close to yourself, it is easier to convince others the value of your solution. It is more credible for a cell biology scientist to create a solution for the reagent problem than, for instance, an outsider from mechanical engineering. Let’s say I realized this terrible traffic problem on the highway and wanted to build a transportation system to solve this problem. This idea itself might be very good, but since I have no computer or engineering background, it would be more difficult for me to convince people about this idea.

ME: Finally, do you have any advice for beginners, who want to start a startup?

TL: Imagine a road parked full of cars, looking for a parking space is not going to be possible. If your car is your idea and the road is the market, with so many other solutions already out there, it would be tough for your idea and product to develop and grow. To build a startup, good “product-market” fit is important. Do not try to find parking space on a road already filled with cars. Instead, create solutions for problems that do not yet have a good solution. Maurice, our Community Architect, wrote a very good article for students who are thinking about startup, you can read more here.

 

 

You can find more information about BenchSci, see the following:

Company info: http://www.benchsci.com/about/.

Demo/Introduction video on www.benchsci.com

Company statement: http://blog.benchsci.com/2016/09/15/the-benchsci-story/ “The BenchSci Story”

http://www.theglobeandmail.com/report-on-business/small-business/science-startups-make-research-faster-cheaper-more-accurate/article32270645/ “Science startups make research faster, cheaper, more accurate”

 

About Thomas Leung:

 

Tom Leung completed his MSc in Virology and PhD in Epigenetics at the University of Toronto. For his PhD thesis, he investigated the molecular mechanism of repressive genetic bookmarking during cellular division and the potential application of reversing these bookmarks as alternative cancer therapeutic approaches. As a molecular biology research scientist, Tom experienced first hand the inefficient organization of biomedical publications.

Tom is very passionate about the development of a solution to better organize the vast amount of data in scientific literature in order to bring the most relevant information to scientists to facilitate the next big biomedical breakthrough.

 

About Manoja Eswara:

Manoja did her PhD from University of Guelph, Canada, where she worked on unraveling nuclear cytoplasmic transport pathways for transfer RNAs (tRNAs). Currently, she is doing Postdoctoral fellowship at LTRI, Canada, on Cancer Molecular biology and Epigenetics. Her work is focused on understanding the epigenetic factors involved in regulating replication and gene expression in Cancer cells and the potential use of small molecule inhibitors targeting them as Cancer therapeutics.

 

Featured image source: Pixabay

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

The different hats of technology transfer officers

in Entrepreneurship/Sci-IP by

business-561387_1920

With the establishment of Bayh Dole Act in 1983, US universities started establishing “Technology Transfer Offices”, whose main job was to evaluate inventions coming out of their laboratories. This helped universities to protect their intellectual property (IP) and license it out to startups or established companies. Technology transfer begins as soon as inventors disclose their technology to technology transfer offices. A technology transfer officer then wears different hats- an inventor’s, an attorney’s, an entrepreneur’s, an industrialist’s or a consumer’s to weigh various aspects of the technology before he/she consents to file a patent. As simple as it sounds, it requires a sound knowledge of the science involved and the rules and laws of patent prosecution. It also requires the business acumen needed to license a technology after filing a patent. Let us go through these steps one by one:

Determining prior art: The first and the most important hat worn by a technology manager is that of a patent agent. He/she asks the most important questions on the disclosed technology that a patent office will also ask: Does the technology have “utility” in the real world? Is the technology “novel”? Given all the previous knowledge or literature in the field, is the technology described by the inventor “obvious”? A patent will be granted by a patent office only if the answer to the first two questions is affirmative, and the answer to the third question is negative. Based on literature and patent database searches for the disclosed technology and judgment from experience, technology transfer officers decide whether to proceed forward with the technology and file a patent.

Freedom to operate (FTO): Wearing an attorney’s hat, the tech transfer officer asks another crucial question: Assuming that a patent is issued for the disclosed technology, can the owner or licensee of the patent practice the invention without infringing upon other patents? In other words, how much “freedom to operate” does the patent actually confer to its inventor/owner/licensee when compared with other patents that have been granted in the same area. A patent that cannot be practiced is as good as not having the patent. It is like investing in a dead technology. No business will buy or license out the technology. Patent prosecution being a very expensive process, a technology transfer officer evaluates the FTO very carefully to decide whether or not to invest university’s money to protect the technology. In my future blog, I will discuss FTO in detail.

Market: The next hat that a technology transfer officer wears is that of a marketing analyst. A tech transfer officer is not only involved in protecting the IP but is also instrumental in supporting the development of the technology. The whole idea of protecting the technology is to incentivize the companies to license out the technology from the university to make it useful to the society. To attract industries to invest in the technology many important questions are asked in advance: 1. What is the current market for the technology? 2. What is the market landscape (what other companies are involved in the technology space?) 3. If the technology enters the market, how much market penetrance will it get? In other words, will the industry see the return of investment if they license the technology from the university? Stage of development: A crucial factor in marketing university-owned technologies is to gauge the stage of development of the technology. Most of the university-based technologies are very embryonic or in other words, very early-stage technologies. Such technologies, especially in biotechnology, need a lot of investment from companies who are licensing it, both in terms of money and product development. Remember, an issued patent has a term of 20 years from the date of filing in

Stage of development: A crucial factor in marketing university-owned technologies is to gauge the stage of development of the technology. Most of the university-based technologies are very embryonic or in other words, very early-stage technologies. Such technologies, especially in biotechnology, need a lot of investment from companies who are licensing it, both in terms of capital and time investment. Remember, an issued patent has a term of 20 years from the date of filing in USA. A technology that requires a long incubation time will eat up the patent term (number of years of the patent rights). Losing the patent term means losing the competitive advantage. Therefore, the technology transfer officer needs to ascertain that there will be sufficient patent term remaining for the company, to recover its invested dollars and generate a considerable return of investment on the product.

Tradeoff analysis: One of the primary objectives of technology transfer offices, as I have already mentioned, is to see the university technology get developed into a product that is directly useful to the society. Therefore, the tech transfer officer evaluates pipeline products of companies, their business and development plans, their market share and capital as well as their past performance in developing the licensed technologies. The question whether the technology is suitable for a startup or an established companies is very crucial. A startup will have a vested interest in developing a technology. Therefore, it will have a focused approach towards the development of the product. In the case of established companies, they will have several products in their pipelines. Therefore, their focus, and hence, the development plan my change with changing priorities that is heavily shaped by the market. At the same time, startups are risky, and their product development pipelines are not as well charted out as an established enterprise. Therefore, an important challenge for tech transfer officers is to do a tradeoff analysis to narrow down the companies that will provide the best opportunity for the technology to get developed into a viable product.

Technology valuation: This is perhaps the most difficult part of the technology transfer process in the universities for which there are no easy answers. In general, the technology transfer officers rely on past deals (also known as comparable deals) for similar technologies and market analysis to come up with a value. There are complex quantitative ways to estimate the cost of the product 5-10 years from the present day for a thorough evaluation. One can easily imagine the difficulty in predicting the market a decade in advance. The two most important aspects of valuation are license issue fee and royalty. The latter is most important for universities, as it is their return of investment for their innovation. It is through royalties that universities can pump back money into the basic research and infrastructure. They can also incentivize inventors by giving them a part of the royalty.

Salesman: A tech transfer officer also needs to be an excellent salesman. Like a prudent salesman the officer has to win the best possible deal (in terms of royalty from the sale of the technology (also known as consideration) and due diligence (DD) terms for the technology development) for the universities. This is the most challenging hat worn by a tech transfer officer. It starts when a company shows interest to license a technology for making, using and selling it as a product. The tug-of-war involved in coming to a perfect term for a licensing deal is a thesis on its own. It will be sufficient to stress that this step requires the wizardry of a technology transfer officer to win a profitable deal for the university to support everything that a tech transfer office stands for. During the negotiation process, the officer always makes sure that the interest of the university and its IP is given the supreme interest. Once, the negotiation is done, the deal is formalized in a license agreement and is then bound by the law of the state.

Police Officer: Following license agreements, tech transfer officers monitor the strict DD terms. DD is very crucial for technology transfer officers, because it acts as an instrument to make sure that the technology gets developed in a timely manner. Breaching DD leads to termination of the license agreement.

The final goal is to see that the technology gets developed and is transferred to the masses for their consumption, thereby advancing the society through cutting-edge science and technology.

Ananda Ghosh

https://www.linkedin.com/in/ananda-ghosh-3238a716

Entrepreneurship Experience in Bangalore

in Entrepreneurship/Face à Face/SciBiz by

 

I have been asked to put down my experience of starting and running a business in Bangalore. All of us have lived in Bangalore for at least 2 years inside the IISc campus. Our view of Bangalore is heavily skewed by our experience at IISc. My view of Bangalore was that it is a very settled, slow moving, high-tech and amazingly green city.

I graduated from IISc in December 2008 and returned to Bangalore only in January 2015. This time I was in a different part of Bangalore, the startup region – south Bangalore. I was pleasantly surprised to see the speed of development here. Everywhere you go, you will find boards of companies hanging over houses, buildings and shops, new buildings being constructed to house more and more companies. No street is left untouched by the startup buzz.

We started our company at a coworking space. The concept of cowork space is pretty amazing as it gives you a feel of office without being too hard on your budget. Most companies are bootstrapped at least in the initial period of their existence, our case was no different. Companies providing cowork spaces most often convert big houses into workspaces, where they charge you per seat (~5k) and also provide you with a registered address for your company. You can also get a dedicated room or cabin for your team at a slightly higher cost per month.

Being in a cowork space you get to interact with other startups and participate in their journey. I will often see a 3 member founders team suddenly getting a lot of funding and increasing their team to 30-40 in a matter of a week and then moving out of the coworking space. Others will remain stable and work on their product. Some will stop coming as their startups were not going anywhere.

Our company is now 1 year old, unofficially (0.5 years, officially). We are now incubated at IISc. Instead of putting everything in one post, what I have decided is to write to you in intervals as I go through more experiences.

 

Neha Satak Astrome Tech

 

Neha
Astrome Technologies (www.astrome.co)
(An Indian Space Technology Company)

 

 

 

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