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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.

Med-Ness: At the Frontier of Medicine, Healthcare and Pharma Business

in SciBiz by

This weekly blog will bring the major pharmaceutical and healthcare highlights. We all hate to move from blog to blog, post-to-post and website-to-website. Here, at Med-Ness we understand and value our reader’s time. Along with the major highlights, I will give you my opinion and my take for the week. 

     Med-Ness is for you if you are:

  • An inquisitive scientist and want to stay abreast in all the fields
  • Money minded and want to know business aspect
  • Medical Writer
  • Healthcare consultant

We will also focus on different sections each week. For example, next week will be the post-dated (or should I say, post-week?) section discussing the most coveted healthcare conference- JP Morgan 2017 (#JPM17)! Seriously, what is the fuss about this year’s conference? Never have I ever seen such hysteria about any conference! I hope one day my blog creates such a frenzy in the pharmaceutical field.

I will also brief you about the changing healthcare stocks and other market trends.

And how can I forget about political aspects? Did anybody say Trump’s take on Pharma industry? Where there is money, there is a political agenda. That is completely my take. Finally, I will bring in forefront any new policies or regulatory aspects that might or can affect the pharmaceutical business.

 

CNNMoney ranked healthcare stocks on number 2 position on their list, “5 stocks to buy in 2017”

So lets start with the simple and most commonly seen noun, “stock”. The dictionary spells out a very straightforward definition except; there is nothing simple about stocks. Moving on, stock is the capital that can be raised by any business firm when they issue and provide subscriptions for their shares. It basically defines and provides ownership rights to a company. So let’s say, you decide to buy stocks of a pharmaceutical company. With this stock you bought or rather own that part or percentage of the company. If the company makes profit or its net worth increases, so does the value of the stock increases. A Stock market aka equity market or share market enables such buying or selling of stocks.

  • Have you ever wondered about stocks, investments and equity research?
  • Have you ever thought of investing in healthcare market shares?
  • Have you ever felt speechless in the presence of colleagues talking about market forecast?

The most important question to ask is what determines the trends in stock market? Why should or why shouldn’t you buy a particular stock. The key to this question lies in research known as “equity research”. Equity Research involves analysis and forecast of company’s financials. The whole agenda behind such an exploration is to recommend a particular stock to buy or sell.

“Money has transformed every watchdog, every independent authority. Medical doctors are increasingly gulled by the lobbying of pharmaceutical salesmen”

– Thomas Frank

If you want to follow a particular stock market yourself, you will have to observe and understand the stocks in order to predict their future worth. This might take weeks or even months. All you need to keep is patience! In addition, if you are an amateur in healthcare stocks, you might have to consider previous historical trends to determine the worth of a particular stock. To learn more about stock market, I recommend you all two insightful articles published Forbes.

www.forbes.com/sites/…/01/…/10-things-you-absolutely-need-to-know-about-stocks

www.forbes.com/…/how-to-spot-the-stock-markets-trend-before-it-is-obvious-to-all/

The variability in the stock market due to drug introduction or rejection.

A pharmaceutical company invests in the drug much before it is available to the patients. The drug stays in the pipeline stage for years. The reason- it has to pass all the safety tests before it reaches the patient. Now, the success or failure of the drug’s safety or its use will determine the worth of its stock. Sometimes, small biotech start-ups or pharmaceutical giants announce the research of a particular drug against a disease or condition. The requirement and the need for that research will determine its initial stock worth and successful launch of the drug and Phase IV post-marketing analysis will determine the rise or fall of the stock. According to “Investopedia”, orphan drugs (drugs for the treatment of rare diseases or conditions) are most expensive drugs in the USA. Such drugs will often bring more revenue and hence increased stock value.

The information on new drug launches could be obtained from company’s website or from The Wall Street Journal or from Businessweek. You can also keep a check on the drugs entering clinical trials (clinicaltrials.gov) to follow drugs from the company.

With this, we wrap up our very first post on Med-Ness. Let the medicine and business madness continue. Have a great weekend!

 

 

 

 

 

 

 

Imit pursued her Ph.D. from the University of Utah, and is currently pursuing her Postdoctoral fellowship at the Albert Einstein Medical College in Bronx, NY. She has an expertise in preclinical drug development and regulatory protocol development and analytical chemistry focussed on Oncology. Her current work explores the signaling pathways involved in hematopoiesis and leukemia stem cells. She is passionate about medical and science communication.

NASDAQ Image Source:

https://secure.flickr.com/photos/bfishadow/3100369536/

Creative Commons License

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

 

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