Image for post
Image for post
Scan of an Alzheimer’s Disease brain versus a non-AD brain

Last week another potential blockbuster Alzheimer’s drug failed and two late Phase 3 clinical trials have had to be cancelled. Aducanamab, an antibody drug designed to target beta-amyloid, a pathological hallmark of Alzheimer’s disease, has failed to meet its clinically significant endpoint. Biogen and Eisai, the sponsoring companies behind this latest Alzheimer’s endeavor has suffered a great loss with its stock prices plunging. But the human cost to Alzheimer’s patients, communities and their clinicians, who were expecting to see a cure, will be even greater as they pick up the pieces of another failed promise. …


Image for post
Image for post
ELN Figure (from Nature)

When I first started working in my current job at this biotech startup I wanted to see if I could bring something new to the way I organized my experiments and shed some of my old academic habits of doldrum. I decided to jump onto the bandwagon of Electronic Laboratory Notebooks (ELNs). I quickly signed onto SciNote, one of the leading ELNs and, after talking with the management team, decided to stay with using it for the duration of my time in the lab.

ELNs are essentially online cloud storage platforms that are set to replace the traditional lab notebook — think of them as Dropbox for the lab. Instead of writing down protocols, large amounts of data and administrative rules for the lab in a physical book you can now upload everything onto the cloud. This allows everyone who has secure access to be able to see your lab book instantly. Potentially this could help share data between lab personnel and between collaborators more quickly and accurately. Online reviews of ELNs have hailed them as the future of knowledge-sharing platforms. But traditionalists and labs that have settled into a fixed way of managing projects will probably detest the idea. …


Image for post
Image for post

“You have a problem with something and it needs to be solved. I will show you where your problem is and provide you with a solution!”. That, according to Larry McEnerney of the University of Chicago, is how we should all start a piece of writing in order to be effective. Looking back at all of my previous blogs I am kicking myself and realizing that although I have constructed some interesting, well-written articles about science, law, policy and healthcare, it has all been written primarily for myself. I have disregarded you, the audience (whoever you are), and am being punished with having relatively few readers. But the problem goes deeper than that and it affects many writers from all areas of society. A lot of people write blogs, papers and even grant proposals expecting everyone to read it and expecting the world to change. In fact the world ignores these articles or just rejects them out right because no one actually cares. We, the ineffective writers, have forgotten the principle rule of writing — to cater to the right audience with things they care about. It turns out that while writing is done by ourselves, locked away in a room, the purpose of writing is to start a relationship with the audience, continuing an interactive dialogue. Only then do we present a possibility of providing value, giving them a sense that the article is worth reading on. With that I will jump straight into what I have learnt from watching a couple of McEnerney’s videos on how to write effectively. …


Image for post
Image for post

A lot of hype and pomp has been thrown around about the cost of gene therapy treatments recently. The current costs are truly staggering, ranging from over $300,000 up to $1 million for a one-time treatment. The truth of the matter is that every new technology that comes on the market will be expensive at first due to supply and demand as well as the costs for initial development. With time and with technology to improve manufacturing the costs will change (hopefully) for the better. When the automobile came on the market in 1900 the average cost was over $1000 while the average family earned $750 a year. …


Image for post
Image for post
Scream by Edvard Munch, 1893, epitomizes mental illness

As I sat in at a small church group last Friday evening listening to people discuss their anxieties and their struggle to find meaning, two people started talking about their emotional stress stories of dealing with failed experiments in their laboratories. One person recounted a near mental breakdown at one point and how they cried in that moment of despair. Another described a feeling of loneliness when pushed to over work at the bench. Both were biomedical scientists in the early stages of their careers perhaps facing turmoil within the academic system. During my drive back home I pondered about how I could relate to their situation. I remember feeling the same way when I was in graduate school and during parts of my postdoc. …


Image for post
Image for post

Over the last 10 blog chapters I have summarized a few interesting topics I learnt about pharmaceutical and biotech patents back when I was doing my Food and Drug Law class. At the end of that class I realized that the pharmaceutical industry puts a great deal of effort into applying for and maintaining eligible patents. The US Supreme Court has repeatedly struck down many patent validity appeals for biotechnology products in the past years after they arrived at the US Patent and Trademark Office (USPTO). …


Image for post
Image for post

A pharmaceutical company named The Medicines Company (MDCO) made news in 2015 when it lost a court battle for the rights to its patented drug. This is a warning story that has been told many times before by patent lawyers regarding inventions, even serving as a punch line in books such as “Don’t File a Patent!” The saga began way back in December 2000 when MDCO filed a patent term extension (PTE) request for its anticoagulant drug Angiomax (bilvalirudin) U.S. Patent №5,196,404.

The right to file a PTE is codified under the Hatch-Waxman Act of 1984 to help companies retain market exclusivity for their products because of time lost in the early years developing and testing a new drug as well as time taken at the end of drug development waiting for NDA review approval. Since a patent only lasts 20 years and it takes up to 15 years to bring a drug to the market, companies often require patent extensions to remain competitive. Under the patent term extension rules of the US Patent and Trademark Office (USPTO) 35 USC 156, a company can file a PTE within 60 days of receiving FDA approval for a drug. However, MDCO’s PTE request arrived at the USPTO on the 61st day (Feb 2001) by a stroke of bad luck. After many years of appeal to the District Courts for the recognition of the PTE, MDCO repeatedly got denied. …


Image for post
Image for post
Patent Troll Cartoon from Inc.

Over the years the Supreme Court has become more favorable to biotech companies in patent litigation cases where a patent is attacked either by bogus companies or by plaintiffs trying to reduce the costs of drugs. Just last year, Kyle Bass, the famous hedge fund manager of Hayman Capital Management, lost a litigation case where he tried to invalidate Biogen’s Tecfidera patent. In the same month, Kyle Bass also lost a similar patent case against the Acorda Therapeutics multiple sclerosis drug, Ampyra. …


Image for post
Image for post

I am often reminded of how quickly the biotech world moves as I look back at my FDA law blogs from 3 years ago. This week I am re-publishing my article about Direct-to-Consumer (DTC) genomics testing. DTC genetics testing and counseling is now a veritably large industry, having been given an increasingly and has grown up from its controversial beginnings a few years ago. DTC companies essentially market genetics tests on TV, print advertisements or the internet. Customers can send the company a sample of their DNA and a short time later they receive results. …


Image for post
Image for post

In the past few months the Supreme Court of the United States has been in the headlines for all the wrong reasons. With the swearing in of Brett Kavanaugh as the newest justice and the bitter battle that raged through his confirmation hearings, I have to conclude that the partisan politics of Washington DC and the polarization of America’s citizens are preventing the Supreme Court and the government from making actual policy decisions that affect real change. In spite of this backdrop it is important to remember that the Supreme Court has been quietly and conscientiously making non-partisan (or less partisan) decisions on healthcare and technology lawsuits that influence how we do science and business. The Supreme Court has made judgements on a long list of patent litigations over the years. Three years ago I wrote about one such case, AMP v Myriad, Naturally occurring isolated DNA is not patentable subject matter; cDNA is (2013 case). This case had wide ranging consequences and stood out for me as a landmark because it drew the line in biotechnology between what is patentable (a gene that has been altered in the lab) vs what is not patentable (a naturally occuring gene in its native unaltered form). …

About

Shen Lin

Gene Therapy Research Scientist working at a small biotech company. Blogging all things life and science since 2013.

Get the Medium app

A button that says 'Download on the App Store', and if clicked it will lead you to the iOS App store
A button that says 'Get it on, Google Play', and if clicked it will lead you to the Google Play store