Archive for the ‘Life Sciences’ Category

Why Information and Speed Matters in Industry

Thursday, October 1st, 2020

We all know how competitive markets can be, especially when there are billions of dollars in stake. Both pharmaceutical and biotechnological sectors are indeed very competitive. Companies spend millions (sometimes billions) of dollars to get drug approvals and place a new medicine, drug or treatments in the market and it can take a decade to get the proper approvals. Regulation and approval are always a hurdle, but these are very important steps to evaluate a drug’s safety, toxicity, and the effects in the population in general, thus several clinical trials in different populations have to be done before any approval. We can see this going on with treatments and vaccine development for the coronavirus disease (for more information please check my previous blog posts). However, today in my blog post I will shift gears a bit to discuss about an area that has become very important for pharma companies: Immuno-Oncology (IO) and the drugs associated with cancer treatment. In fact, these drugs in a simple explanation, use the person’s immune system to attack cancer cells and shrink the tumor (sometimes even cure the patients). Thus, several tests and “facts” need to be checked before these types of treatment could be applied. I will discuss today about Business Intelligence (BI) and competitive advantage in life sciences. The example here will be two specific treatments that have been approved by the American Food and Drug Administration (FDA) to treat various cancer type. Immunotherapy combo drugs such as Opdivo or Nivolumab (developed by Bristol-Myers Squibb – BMS – NASDAQ: BMY) and Keytruda or Pembolizumab (developed by Merck – NASDAQ: MRK) have changed the cancer treatment landscape, but it’s becoming increasingly clear from clinical trial results that these potent therapies need to be targeted to the right patient populations to have the best clinical results; something named precision medicine. Both treatments use specific genetic profiles and background of the patient’s immune system to be successful, which is the expression of two proteins by patients’ immune cells: the so-called “check point” proteins PD-1 and PD-L1. These treatments actually block PD-1 with monoclonal antibodies (mAb) helping the patient’s immune system to kill cancer cells. That is the basic concept (for more information on the molecular biology of these treatments check “A molecular and preclinical comparison of the PD-1 targeted T-cell checkpoint inhibitors nivolumab and pembrolizumab”). In that regard, the brand names Keytruda from Merck and Opdivo from BMS mainly function by blocking the PD-1 ligand protein and have several structural similarities. In fact, both were approved in the same timeframe by the FDA in the end of 2014. However, Keytruda (Pembrolizumab) is projected to generate at least U$22.5 billion in revenue by 2025, according to an analysis by Global Data, a data and analytics company. In 2019, Keytruda generated more than U$7 billion in revenue and, based on more than U$5 billion it earned in the first half of 2019 it could hit U$10 billion or more by the end of 2020. Keshalini Sabaratnam, a pharma analyst at Global Data, said Keytruda has developed into Merck’s biggest product since it was first approved by the FDA in 2015. On the other hand, BMS’ Opdivo (Nivolumab), a rival checkpoint inhibitor to Keytruda, is expected to be in fourth place for global revenue and AbbVie and Janssen’s Imbruvica will take the fifth position, according to Global Data’s prediction. In 2018, Opdivo earned U$5.7 billion (for more information check “Keytruda Set to Become World’s Top-Selling Drug, Forecast Shows”). Why is that? Well, trying to understand why this market share change occurred in such a small timeframe (3 years or so) since both treatments were approved by the FDA in about the same timeline, I started digging in the approvals for both treatments since then. The main points I want to discuss in order to answer why Merck’s treatment is “winning” the competition now are: 1) Merck started combining biomarker identification to stratify groups of patients that would respond better to their drug, even in the clinical trials before approval, especially patients with high expression of both PD-1 and PD-L1; 2) big data analytics probably helped Merck to gain more information and faster approvals, so maybe people working for Merck were paying more “attention” to the advancement and developments of “targeted therapies” in immuno-oncology, which means that speed in getting information and data makes a big difference in business intelligence for big pharma and 3) it seems that Merck’s treatment can now be applied to several types of cancer and the one from BMS is a little more “restricted” to specific cancer types in terms of FDA approval. Thus, the take home message here is that we are in need of better tools, especially for life sciences’ companies, to get trustful information faster and use it smarter. There are already some solutions that can help big pharma in the market such as the Elsevier database (NYSE: RELX), Thomson Reuters Corp. database (NYSE: TRI), etc which are bringing revolutionary tools to speed this process. Indeed, sometimes being the first is not enough; keeping track of the information and the evolution happening in the scientific and biomedical fields are the differentiation factor to “win” in such a competitive market.

Coronavirus Pandemia: Why Science Matters Now?

Monday, August 3rd, 2020
Image Source: Chemical & Engineering Society

This is my fourth blog post on the coronavirus pandemia and I will focus on science and how general people are getting more interested in biomedical research. I’ve written in several occasions that the scientific system is broken, and I’ve criticized how the scientific funding system works, the peer-revision process, the low salaries and long hours of work, etc. In fact, let me just remind the readers how the scientific cycle works (I’ve already discussed this in an old post – check it here): First, when you want to get into academic research you need to do a Ph.D. in a very “famous” laboratory; this is the “business card” to get a Post-Doctoral Training in an even better laboratory (either in the US or in Europe); second you will need to publish your research after long hours of work (working like a “slave”, Pardon my French…) with a very low salary – not very exciting right?; third, with good publications in high-level journals you will need to bring in research money from well-respected funding agencies since this will enable you to start your own laboratory in a different Institution. If that does not happen you are already “out of the game”; fourth, if you are successful in all the first 3 steps, which are tremendously difficult, you can start your own laboratory and get funding  (the statistics are terrible: less than 5% of Post-Doctorates get to this stage, so what happens to the other ~95%? Do another Post-Doc, become jobless, change profession or go into the private sector). Thus, it is very competitive and the “big labs” always get the funding and grants. It is a very old-fashioned system. Another interesting fact is this: when you do experiments, draw an hypothesis out of them, write an article with your own intellectual skills, most times you will need to pay to publish (and a lot; we are talking depending on the publisher and journal at least 1,500 US Dollars) and give all copyrights to the publisher (well, there are some “open source” options, however it is not working well mainly because the big publishers are not happy, they want to keep getting their profits). Then, after giving the publisher all the rights for your work, paying a lot to publish, getting nothing in exchange financially – just “scientific prestige” (check my old blog post on this subject here), the publisher charges people to download the article (a range of 30-50 US dollars per article!). This is outrageous. Another fact: the private sector has full access to all these scientific articles (paying for downloads) and use them to develop “products” that they will come back and sell to Academic Centers and Laboratories for a very high price. It is a terrible cycle. Even Nobel Prize scientists are not happy at all with how science works (see my blog post about it here). It is a win, loose, loose, loose game. The only one winning here is the Publisher and eventually biotech and pharma companies. The most important aspect that will be the focus of my post: general people that pay taxes (part of it go to the funding agencies to finance research) have no clue how science and the scientific system works. Now, with the coronavirus pandemia, I believe everyone in the world is trying to understand how this system works. I always get questions like: Why there is not a medicine for the virus? Why there is no treatment? Why it took so long for governments all over the world to catch up and we are still in this mess? Simple answer: Scientific Systems are unprepared for any global pandemia. The system definitely has to change. Science communication has to come out strong after that (please stop the “fake news”!). Why is it so difficult to deal with the spread of the disease and lack of trustful information from the media and the governments? I don’t know. Lots of politics involved here. However, I think the positive point is that general citizens all over the world are trying to understand the scientific system, how we respond to pandemic situations such as this one and are demanding answers (true answers!). Now we see strong collaborations between Academic Centers and pharmaceutical companies (i.e.: University of Oxford and AstraZeneca) for a vaccine (this already happened before, but it not the rule). I will discuss the race to a vaccine for the coronavirus in my next blog posts (coming soon…). Let me give, as I always do, a personal example on how the scientific system is slow and old-fashioned: I just had an article accepted in a journal recently and we got the Cover of the Journal. I will not cite names here to avoid problems, but we (mainly my ex-Ph.D. student) took our creativity, time, resources and designed a “masterpiece cover” for the journal. We sent it to the Editorial Office and got the reply saying that the Cover was very nice and we would need to pay a fee of 1,700 US Dollars to have it published with our article. I said what? I wrote back questioning that we took our time, resources and creativity to design a cover and would have to pay to give them our copyrights – no thank you! The Editor wrote back apologizing and waiving 100% of the fee. This is a “toxic” business that is really affecting careers of young scientists. Another important fact: several if not most scientific articles published are already “old-news” since it takes an average of six months to a year if you are lucky to get your study published anywhere. Thus, now that this pandemia has impacted the globe, I see a “fast and furious” race both in academia and in the private sector to develop vaccines and treatments. I hope after we get an efficient treatment and/or vaccine the whole scientific system changes for the better. In addition, I defend that all the scientific community find better ways to communicate with the general public, mostly non-scientists, with trustful information in a way they can understand – no technical stuff, please. Science communication is key and it has to change for the better. People say that there is always a good side for every history and I hope this pandemia changes the whole scientific system for the better. We will see. I have my fingers crossed: to overcome this global pandemia and for changes in the way science is done everywhere!

Chimeric Bio (CBC) and Genomic Enterprise join forces to tackle big data

Tuesday, January 21st, 2020

This blog post will focus on the announcement of the two life sciences’ companies that will start to work together to provide new, user-friendly, and revolutionary mobile access of big data to biotechnology, pharmaceutical, life sciences and technology companies. There is a new trend highlighting the need for new technologies to address the big data challenges and associated opportunities at pharma right now in drug development, biomedicine and healthcare. This is mainly because there is a need to develop and use big data analytics tools’ from hundreds of thousands to millions of patients and samples throughout the drug development process. That is what the CEO of Novartis (NYSE: NVS), Vas Narasimhan, started to implement at the company when he became CEO. This new trend is important to accelerate drug discovery, the development of new treatments and target identification applied to complex and rare diseases. However, there are several challenges associated to the current tools’ in the market and changes in the pharma “culture” to adopt new technologies as discussed by him and others at the JP Morgan Conference in San Francisco in January of 2020 (check the article at Forbes “Novartis CEO Who Wanted To Bring Tech Into Pharma Now Explains Why It’s So Hard”). Thus, Chimeric Bio (CBC) and Genomic Enterprise will start a “joint venture” called MobileBiOS to provide the best in class scientific solutions, services and support to customers identifying specific medicines and treatments to various diseases combing it to the development of solutions for mobile devices. “I think this will be a very nice opportunity for clients that are looking for state of the art consulting services in biomedicine and healthcare. Tristan’s expertise and my experience after founding and co-founding four companies and being the Head of one of the Apple Labs Program in Brazil, South America will definitely make a difference that the market needs right now” said Fabricio Costa about joining forces with CBC. “ModbileBiOS will allow biopharma professionals to have immediate access to new big data analytics tools’ and the corresponding actionable results culminating from these analysis. CBC already offers a number of powerful big data solutions across various types of data including curated scientific and biomedical content, patient data, single cell data, clinical trials’ information, biomedical conferences, publications, regulatory information and patents.” remarks Tristan Gill about the new Joint Venture.

Genomic Enterprise’s mission is to provide consultancy services in several different fields involving STEM (Science, Technology, Engineering and Math) for the government, academic centers, universities, start ups, mid-size companies and big corporations globally. In addition, Genomic Enterprise creates awareness on the new scientific discoveries and technologies that will impact society worldwide or even locally. Fabricio Costa is the founder and CEO of Genomic Enterprise and he has more than 20 years of experience in top academic labs and companies such as The Ludwig Institute for Cancer Research, Harvard University, Northwestern University, University of Chicago, Start Up Health Academy, Singularity University, 1871 Chicago, MATTER, Shire Pharmaceuticals (acquired by Takeda – NYSE: TAK), Google (NASDAQ: GOOGL) (Ventures, Higher Education and Start ups), Apple (NASDAQ: AAPL) and others. Fabricio is also a serial entrepreneur (co-founded and founded four startups; two were successfully sold).

Chimeric Bio (CBC)’s main mission is to support a complimentary set of innovative life science offerings and deliver first class consulting services to customers. CBC accomplishes this by understanding the pharmaceutical customer’s challenges and offering solutions to help customers’ achieve these critical needs. CBC can define unique solutions that best meet the scientific and business needs for customers.  Chimeric Bio’s founder and CEO Tristan Gill is an accomplished life sciences professional. Prior to founding CBC Tristan has 25 years of experience in top labs and companies including Cold Spring Harbor Laboratory, California Institute of Technology, Paracel (a subsidiary of Celera Genomics acquired by Quest Diagnostics – NYSE: DGX), Rossetta BioSoftware (a subsidiary of Merck & Co.- NASDAQ: MRK), Ingenuity (acquired by of Qiagen – NASDAQ: QGEN), Bejing Genomics Institute (BGI), and Thomson Reuters (NYSE: TRI).