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So you want to be a Medical Writer: Interview with Dr. Michael Fiedler

in Face à Face/Uncategorized by

Dr. Michael Fiedler (MF) shares his experience in the field of Medical communications with Imit Kaur (IK). He describes the job and also provides valuable advice on how to best transition from academia to industry.

IK: Please tell about yourself and your background.

MF: I am from Southern California. As a kid I loved animals and decided to study biology at UC San Diego. During my time at UCSD, I worked in an academic lab and learned techniques in Molecular Biology and Immunology. Unfortunately, after sophomore year, my PI lost his funding and had to let me go. That was a pivotal, enlightening moment in my life in that I realized I didn’t want to spend my life in the academic world where I would have to struggle for research money on a regular basis. I still loved science, however, and wanted to reach the pinnacle of academic achievement (i.e., earn a PhD). After completing my BS in Cell Biology, I attended graduate school at Yale University. While at Yale, I really wanted to challenge my mind and take advantage of any opportunity I could because I knew I wasn’t going to be in academia. I am naturally a talkative extrovert and writing was a way to harness that energy. During grad school I had multiple blogs and part time writing/editing jobs and was also on the board of the Yale Journal of Biology and Medicine. Towards the end of my PhD I strongly considered law school as a way to leverage my passion and skillsets, but ultimately decided against it because of fears related to work-life balance and student debt. At that point, I was 4 weeks away from my defense and had no idea what I was going to do. So I sat on the computer and wrote 2 words into Career Builder, “Science” and “Writing” as these were the two things I was most proficient in. That is how I came to discover Medical Communications (MC). Shortly thereafter I got my first job at Infusion Medical Communications, where I still am today.

IK: Explain Medical Writing (MW) and Medical communications (MC) in general. The field of scientific communications is expanding and are there distinct roles played by MW or MC in different organizations?

MF: Well there’s a difference in the type of content in MW. I like to explain MW using the analogy of DNA replication. There’s a leading edge, which is when new/private information becomes public (e.g., publication of clinical trial results) and there is lagging edge where published information is metabolized and leveraged for various purposes (e.g., slide decks).

There is also a difference in the type of communications. Proactive communications are the ones you see on TV, billboards, and Journal advertisements and they provide information that is strictly in the prescribing information or “on-label.” This type of communication is highly regulated and mostly done by sales and commercial people. Reactive communication on the other hand is in response to questions from healthcare providers (HCPs) and can be explained using a car dealership analogy. When you buy a car at a dealership you usually talk to the sales people and finance. However, if you have questions or car troubles after you buy the car, you don’t visit the salesmen who sold you the car, you go to the mechanic. In the pharmaceutical world, the mechanics are medical science liaisons (MSLs) that can talk about things outside the prescribing information to address specific questions. For example, if an HCP wants to understand how a drug works or if it is safe to use in an older or younger patient. In response to these types of questions, an MSL can discuss scientific information in a neutral, informative way with the HCP to help them feel more confident in their decisions. In this type of reactive communication, a medical writer will prepare materials that an MSL can use to facilitate the conversation (e.g., data summary slides, mechanism of action illustrations, etc.).

Another example of MC is with advisory boards, which are like committee meetings for pharmaceutical companies. Say a pharmaceutical company is interested in running a clinical trial for an approved drug, but for a new population (e.g., children). They will call upon experts in the therapeutic area who also have experience with pediatric populations. They will bring them to a central location for a meeting (e.g., Dallas, TX) to discuss the implications of using the drug in children (e.g., safety and efficacy) and what kind of patients would need to be included or excluded in a clinical trial. An MC agency will facilitate everything for the meeting to happen and capture the feedback. They will plan the event in terms of location, attendees and contracts, and create the content itself (e.g., agenda, discussion guide, slide development and onsite reporting). Afterwards they generate a report of who said what.

From a structure standpoint an MC agency has 4 parts:

  1. Business development: people going out and getting the business from Pharmaceutical companies.
  2. Account Services: people responsible for managing awarded projects, client interactions, leading calls, and ensuring completion of projects in a timely manner.
  3. Medical and Scientific Services: people like me who generate the actual content.
  4. Editorial and Graphics: they clean everything up and infuse graphics into the content.

IK: Considering MW for a fresh PhD graduate, is it a huge transition from regular academia? What advice can you give?

MF: Short answer yes, it is a huge transition. I liken it to your very first day in the lab.

Long answer, I would say every PhD or science professional has a general concept of science. As a PhD you are familiar with data, present in journal club, you are used to reading and writing, but as a professional MW, you are preparing material for a client. It can be somewhat of a culture shock in MC to leave your technical skills behind and focus exclusively on these “soft skills” like searching pubmed, creating powerpoint slides, and/or summarizing general research trends. As an MC professional, a pharmaceutical company will hand over their data and it’s your responsibility to present it in the most professional and coherent manner possible. Clients will ask you to research the available literature on their competitors and summarize it in a concise and cogent way.

For advice, the hardest and most critical thing when applying is demonstrating a genuine interest in the field. A company is looking for candidates who have a passion for writing. Can you and are you willing to do it on a daily basis? Another piece of advice is to keep working on your writing skills. I spent several years writing a non-science blog. Just writing will sharpen your skills and help you develop your own style. This is critical to your development as a MW. While applying for jobs, PhDs and post docs like to point out the techniques they know or publications they have, but can neglect the skills that are actually transferable. For example, publications often have multiple authors and the person who ties all of the data together in an eloquent manner has more to offer an MC company than the scientists who conducted the actual experiments.

IK: How did you gain your first writing experience? You mentioned blog writing but are there other avenues one should explore to gain experience? Is freelancing a good idea or is it frowned upon?

MF: It all depends on where you are at in the education process. If you are a 3rd or a 4th year grad student, a blog may be a good way to establish your own voice and portfolio (it doesn’t even have to be about science). If you are closer to finishing, you might want to be more focused. One recommendation I give is to write summaries of biomedical research articles. For example, I would pick a random article from the New England Journal of Medicine or The Lancet and write a 250-500 word summary explaining the findings and why they are important. You can also post these on platforms like LinkedIn. In MC you are often asked to write on areas outside your expertise. So by metabolizing an article and posting it, you are demonstrating your skill and showing that you are actually interested in the field.

Freelancing is also a good way to sharpen your skills if you can find the right opportunity. I found freelance writing and editing jobs in grad school and while I had no idea I was going to pursue MC back then, the skills I learned were completely transferable.

IK: How do you get noticed with your resume? There are a number of organizations like the American Medical Writers Association (AMWA), are these worthy? Also do certifications help obtain a job?

MF: Resumes should be 1-page and maximize use of white space (e.g., use columns); cover letters should be short, sweet and as specific to the job/company as possible.

AMWA is a good resource and I went to a workshop where I mingled with like-minded people. Also, they have good freelance resources, so if you have worked in an MC agency for couple of years and want to breakout on your own, you can make use of their freelance directory. If you don’t have a PhD and/or not a lot of writing experience, certifications from these organizations can be helpful to establish credibility. Publication writers also often pursue a CMPP credential that ensures good publication practice.

IK: Is it okay for a fresh graduate to jump right in or should they gain more experience (e.g., do a post doc)? Also, you started your career a couple of years ago, have expectations changed overtime?

MF: You definitely don’t need to do post doc. If you want a career in MC it is in your best interest to start as early as possible. For example I started at 28 and have seen a lot of growth in my position and salary. Had I done a post doc, I would have delayed my career development and not gained substantive transferable experience in the process.

As for the MC field, it has changed significantly in recent years with more and more professionals entering the space. But that doesn’t mean the market is saturated. The market is actually growing because pharmaceutical companies are being asked to be more transparent and they want to do so in new and clever ways. Compared to when I first entered the work force, new graduates are much more informed about MC and are booted up to make contributions right away.

IK: Following up on this, how about competition in the field?

MF: There is competition and it will help to have a portfolio. You have to show some kind of commitment to writing. I would encourage people to write as much as possible. It just shows your passion and enthusiasm for your future occupation. As a field, a lot of MC agencies have historically relied on experienced writers to work on publications. However, in this era of digital communication, agencies now need to up their game to be competitive and are taking advantage of the army of new PhDs looking for fulfilling careers. These will be the innovators of the MC space and I feel fortunate to be part of the wave.

IK: What are the challenges in the field?

MF: One of the most difficult things is that you are developing content for someone else and thus have no ownership of it. From a publication perspective you have no authorship, you are just a mediator between HCPs and pharmaceutical companies. MC is also a service industry and working with clients is critical, but tricky. Executing someone else’s vision with quality and on time is not easy. Depending on the “deliverables” you work on there can also be some travel involved (e.g., advisory boards) and this tends to increase over time (i.e., you might travel 10% of the time to start, but that can grow to 30% as you take on more projects). Also, you have to learn to be cognitively nimble because you may have to jump from therapeutic area to therapeutic area within the same day.

IK: You are a career counselor; how can someone reach out to you? Why do you this?

MF: LinkedIn is a good resource. You can connect with me on LinkedIn but you need to follow the proper edict. People send connection requests all the time, but I won’t respond unless you include a message articulating why you are sending me a request. If you just send a connection request, I don’t know who you are and I can’t even respond to find out.

I like helping people for 2 reasons: 1) there is a huge population of PhD professionals trying to grab an opportunity, just like I was, and it is rewarding to help anyway I can; 2) self-interest, plain and simple. By exporting good will, if/when I ever need help in the future I can approach my contacts and hope someone returns the favor. People are usually willing to scratch your back if you have already scratched theirs.

IK: what is the growth potential in the field?

MF: It depends on the agency and work you do. I started 6 years ago and I have been promoted 4 times. There’s also a huge difference between publication work and non-publication work. Publications are commoditized (i.e., a primary manuscript is charged a flat fee) whereas non-publication work (e.g., advisory boards, slide development) is charged hourly. Because projects always take unanticipated twists and turns, non-publications tend to be more profitable and that is where I have spent my entire career.

IK: Before or during the interview process, should you try to get in touch with a recruiter?

MF: Yes if possible because you have nothing to lose. Finder’s fees are paid by the agency, so a recruiter can only help you. To do this, try and apply to as many positions as you can, which are often gated by recruiters. This will help you get on their radar and then you can pursue a relationship, should one manifest. Once you get into the field, recruiters will try and get you to change jobs because they get a commission. That is trickier to navigate and up to you based on your circumstances.

IK: Once you have the job, what do you need to do to stay in the field and keep loving your job?

MF: Maintain professionalism, focus on quality, and care about your team. If you help them do their job, they will help you do yours.

IK: Thank you so much for your time. I am sure our readers and prospective medical writers will benefit from this interview.

MF: I am happy to speak with you and I hope this is of some value.

About Dr. Michael Fiedler

Michael is the Scientific Director of Ashfield Healthcare for over 5 years and
is a dynamic and well respected presence within the company.

About Imit Kaur:

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 by Vinita Bharat

Editors:
 
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).

 

How to cut through the bullshit with Carl Sagan’s ‘Baloney Detection Kit’

in Sci-Pourri/That Makes Sense/Uncategorized by

A large fraction of the information that we come across online is quite possibly bullshit. The internet has made it very easy for us to access and disseminate unreliable information, transforming the society into an echo chamber of misinformation.  Democratization of publishing and social media have resulted in opinions being marketed as facts. In this era of  #fakenews and #alternativefacts, the ability to cut through bullshit and get to credible information has become an essential social skill.

Although the internet and social media have catalyzed the spread of falsehood, our relationship with bullshit is not new. We’ve encountered it time and again in science, politics, religious philosophies and social practices; however, the current state of affairs warrant the use of skepticism and critical thinking for busting bullshit more than ever.

The art of systematically and logically challenging the socio-political claims and getting to the logical conclusions was perfected by one of the brilliant philosophers of his time – Carl Sagan. In his marvelous book about the philosophy of scientific thought The Demon-Haunted World: Science as a Candle in the Dark, Sagan dedicated a chapter to ‘The Fine Art of Baloney detection’. In this chapter, Sagan advocates the need for critical thinking and maintaining a balance between acceptance and skepticism.

In Sagan’s own words, “In science we may start with experimental results, data, observations, measurements, ‘facts’. We invent, if we can, a rich array of possible explanations and systematically confront each explanation with the facts. In the course of their training, scientists are equipped with a baloney detection kit. The kit is brought out as a matter of course whenever new ideas are offered for consideration. If the new idea survives examination by the tools in our kit, we grant it warm, although tentative, acceptance”.

Image Source: Wikimedia (CC)

This approach of baloney detection used by scientists is equally effective in the hands of the general population and can help us fortify our minds against propaganda, falsehood and manipulation. Sagan emphasizes the indispensability of healthy skepticism in everyday life by saying, “when governments and societies lose the capacity for critical thinking, the results can be catastrophic”.

In his baloney detection kit Sagan proposed 9 tools to recognize the fallacious or fraudulent arguments, and to reach to conclusions which follow a true premise. The 9 tools from the kit are as follows:

“Wherever possible there must be independent confirmation of the ‘facts’.”

Facts are the foundation of any argument or claim. When you are presented with an argument, try to gather facts related to it. Something that you read on social media does not qualify as a fact, because it may just be someone’s opinion and hence may be biased. Check for the credibility of your sources. Make decisions based on verifiable evidence and not gut feelings or opinions.

“Encourage substantive debate on the evidence by knowledgeable proponents of all points of view.”

Debate allows for all point of views to be expressed and relative strengths of evidence, for and against the claims, to be evaluated. A healthy debate challenges the nature of the evidence, methods of data collection, inherent biases in study design, logical progression of thought and the validity of conclusions. Limit the debate to the evidence on the table without introducing personal opinions.

“Arguments from authority carry little weight — ‘authorities’ have made mistakes in the past. They will do so again in the future. Perhaps a better way to say it is that in science there are no authorities; at most, there are experts.”

If your boss tells you something is true, it is not actually so unless data supports it. Evidence is superior to all opinions irrespective of rank, position or authority of the person.

“Spin more than one hypothesis. If there’s something to be explained, think of all the different ways in which it could be explained. Then think of tests by which you might systematically disprove each of the alternatives. What survives, the hypothesis that resists disproof in this Darwinian selection among ‘multiple working hypotheses’, has a much better chance of being the right answer than if you had simply run with the first idea that caught your fancy.”

This one is my favorite.  It essentially means stringing up multiple hypotheses in front of you and trying to poke holes in each one of them based on the theoretical evidence and experimental results. This approach makes you think unconventionally and out of the box. You have the opportunity to put forward your craziest and the most counterintuitive hypothesis. If it stands the rigorous scrutiny of the evidence, it may emerge as the right answer. Approaches like this result in paradigm shifts in science.

“Try not to get overly attached to a hypothesis just because it’s yours. It’s only a way station in the pursuit of knowledge. Ask yourself why you like the idea. Compare it fairly with the alternatives. See if you can find reasons for rejecting it. If you don’t, others will.”

Keep an open and fair mind and do not try to keep a hypothesis alive in the face of contradictory evidence. Try to avoid personal bias. We learn something new when a hypothesis is shot down by evidence, seek that knowledge.

“Quantify. If whatever it is you’re explaining has some measure, some numerical quantity attached to it, you’ll be much better able to discriminate among competing hypotheses. What is vague and qualitative is open to many explanations. Of course there are truths to be sought in the many qualitative issues we are obliged to confront, but finding them is more challenging.”

Quantification produces a standardized way of measurement and allows for measurements made by different individuals or groups to be compared using statistical tools. It increases precision and minimizes ambiguity, guesswork and prejudice. By relying on quantitative data, you will be able to make more informed decisions.

“If there’s a chain of argument, every link in the chain must work (including the premise) — not just most of them.”

A chain is as strong as its weakest link. Similarly, if your argument has multiple points, each one of them should stand up to scrutiny, else the whole argument may fall apart. You should carefully analyze the argument and try to strengthen the weakest link.

Occam’s Razor. This convenient rule-of-thumb urges us when faced with two hypotheses that explain the data equally well to choose the simpler.”

A simpler theory is preferred over more complex ones because simple theory can be tested relatively easily.

“Always ask whether the hypothesis can be, at least in principle, falsified. Propositions that are untestable, unfalsifiable are not worth much.”

If a hypothesis can be tested and can be refuted in light of evidence, it is called a falsifiable hypothesis. And a falsifiable hypothesis is a good thing. An untestable hypothesis is one which cannot be practically or ethically explored with controlled experiments. Falsifiable hypothesis allows you to learn something new when disproved whereas unfalsifiable are not worth much.

Sagan further writes, “In addition to teaching us what to do when evaluating a claim to knowledge, any good baloney detection kit must also teach us what not to do. It helps us recognize the most common and perilous fallacies of logic and rhetoric”. He warns against the 20 most common fallacies and examples for each.

This timeless wisdom by Carl Sagan has been guiding scientists and nonscientists in their pursuit of knowledge and critical thinking for the past two decades. I hope it will help you cut through the culture of bullshit and reach the knowledge you seek.

About the Author

Gaurav is a biomedical scientist trained in multidisciplinary and multicultural settings. He is currently working on electrical conduction through single DNA molecules in pursuit of developing quantum tunneling based DNA sequencing platform.

Pooja: When a film maker becomes a science communicator

in Biodiversity and Environment/Uncategorized by

I have wondered if there is psychological factor driving one to work hard towards making their aspirations come true. Our society is mainly fuelled by the notion of success and growth.

Pooja started painting while she was in third grade. Her passion for painting and sketching continued every summer. She obtained her formal education in fine arts. She always felt that studying fine arts in school robbed the real art space. Nevertheless, by the time she graduated from high school, Pooja Gupta was a water-color queen (and revered for the same in her undergraduate).

Maria Papova, thinker of the modern times has taught that one should be always allowed to change their mind. I have been fortunate interacting with such people. Pooja also switched from commerce to film making. At present she is working on wildlife conservation and related projects, she made a remarkable insight, while paintings invites attention and appreciation, film making captures the real emotion thereby enabling a direct call to action. Unlike painting, film making invites participation towards a solution.

Pencil work by Pooja

The end product of her degree was a film on caged birds that questioned the concept of captivating birds and animals. This work provided positive reinforcement and she extended her niche covering nature and animals. Through extensive networking, she got the opportunity to make a movie on mangrove trees in Andaman Island after tsunami.

She has gone back to science with love for it than she ever had at school. Her story is yet another reminder to the society questioning how education ruins curiosity. Fortunately, she found her way back. She is instilling the same interest in young kids by organizing educational field tours. Traditional school is not for everyone, she observes. This resonates with sentiments expressed by Abhisheka. Hence this effort made by her in the direction of alternative education will hopefully bring a new of generation of truly learned individuals.

She believes Art is a practice and not an exam. She is on a mission to use art of film making for science. She works towards the goals of creating awareness, spreading education, inciting appreciation (for nature), and satisfying curiosity. I sincerely hope that her work spirals a butterfly effect that culminates in rescuing an ecosystem from destruction.

Digital work by Pooja

Her story, along with several others is a reminder for me that, certainly amongst us, will find our way to do things that we really want despite having been fed to the education factory.

The destruction in natural resources and environment are often justified by causes of growth and development. People like Pooja might train a new, more sensible generation, which understands the value of preservation in development of society and economy.

Here is the link a team initiative she is involved in: https://http://www.facebook.com/earthcolab/

 

About the Author:

Ipsa Jain is Ph.D. student at IISc. Wants to gather and spread interestingness. Prefers drawing and painting over writing. Posts on Facebook and Instagram as Ipsawonders.

 

 

 

MedNess- Immuno Oncology, Precision Medicine and more….

in SciBiz/Uncategorized by

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).

 

MedNess-Pill for Alzheimer’s?

in ClubSciWri/SciBiz/Uncategorized by

Hello and welcome to yet another exciting week of MedNess. We bring the news from medicine and healthcare with greatest impact. It seems like; year 2017 will be the year of neurology! It is just the second month of the year and treatment strategies for various neurological disorders are making headlines.

Merck halts Phase 3 study on Alzheimer’s drug- another setback for amyloid theory

Clinical trials on Verubecestat- a small molecule BACE 1 and BACE2 inhibitor were called off after an interim analysis on Phase 2/3 studies did not show promising results. The analysis team concluded that there was “virtually no chance of finding a positive clinical effect”. However, another trial on patients with early symptoms of Alzheimer’s will continue. It has been speculated that the drug was too weak, or was dosed inadequately or the disease had progressed too far in patients for the drug to show concrete effect. The failure of this trial is another blow to the famous “amyloid theory”. According to this theory, the amyloid plaques are believed to be cause of the disease. Verubecestat is a beta secretase inhibitor. This disappointing cessation of clinical trial came months after Eli Lilly’s Alzheimer’s drug; Solanezumab failed in Phase 3 clinical trials in November last year. Unlike Verubecestat, Solanezumab targets plaque rather than beta secretase enzyme. This brings in disappointment not only for the patients but also for the researchers. The evidence suggests that once the disease has advanced and patients have established dementia, the removal of amyloid plaque might not yield effective outcome.

                              Do we have a pill to cure Alzheimer’s? Some quick facts:

  • Alzheimer’s is an irreversible brain disorder causing cognitive impairment
  • More than 5 million Americans are expected to suffer from Alzheimer’s
  • Sixth leading cause of death in the USA
  • No new drug has been introduced to provide symptomatic relief or to halt its progression since last decade

Picture source: https://unsplash.com/search/brain?photo=rmWtVQN5RzU

There are couple of drugs at various stages of trial that are being tested under the amyloid plaque hypothesis. These drugs either act on the plaque or beta secretase enzyme (BACE inhibitor) or available as amyloid immunotherapy. These candidate drugs are from Biogen, AstraZeneca, Eli Lilly, Amgen and Novartis. Apart from BACE inhibitors, hopes are also high for Axovant’s intepirdine. Intepirdine is believed to improve cognitive symptoms by targeting receptor 5-HT6 that stimulates the release of a neurotransmitter. Interestingly, intepirdine was abandoned by GSK in 2010. The drug failed when compared to placebo. However, one study showed tangible effect on cognitive symptom when intepirdine was paired with the approved Alzheimer’s drug Aricept.

MedNess: Merck’s stock suffered severe blow after the announcement of cessation of clinical trial. On the contrary, shares of Eli Lilly, AstraZeneca, Biogen and Roche, the fellow Alzheimer’s drug makers, increased. (Fierce Biotech, Business Insider, STAT news, The Boston Globe)

Axovant’s nelotanserin passes phase 2 study for Lewy body dementia

Axovant Sciences declared successful completion of phase 2 study of nelotanserin. The company is now setting its foot forward for phase 3 study that is expected to initiate later this year. Axovant Sciences reported preliminary results from the first small group of 11 patients.

Lewy body dementia or LBD is the second most common form of dementia. The hallmark characteristic of this form of dementia is the build up of abnormal proteins i.e. Lewy bodies thus affecting cognition, movement, behavior and alertness.

The study included patients with either LBD or Parkinson’s disease dementia. These patients experienced frequent hallucinations as assessed by mini mental state examination (Pharmaceutical Business Review)

CRISPR battle of patents: The Broad institute and MIT wins!

The scientists who first demonstrated the use of most powerful gene editing technology in biotech suffered a major blow on Wednesday, February 15, 2017, in their fight to gain exclusive rights on their invention. CRISPR gene editing system has revolutionized the field of biotechnology enabling scientists to make changes in DNA. Jennifer Doudna, a UC Berkely biochemist and her European collaborator Emmanuelle Charpentier first published this gene editing technology in prokaryotic system (type of bacterial system) in 2012 in Science. UC Berkely and University of Vienna filed for U.S. patent in March 2013. There were 155 broad claims to the CRISPR-Cas9 technology. Feng Zhang, a biologist at the Broad Institute, demonstrated the use of this technology in eukaryotic cells (type of plant cells, animal cells and human cells). The Broad Institute filed their patent in 2013; months after Berkeley group filed their patent. Since the patent claims by Broad Institute were fewer than Berkeley’s, the Broad Institute’s patent was issued on April 15 2014 through accelerated approval while Berkeley group is still awaiting their approval. After the Broad Institute was granted their patent, UC Berkeley filed an interference claiming that the Broad Institute should not have been granted the patent since Doudna’s and Charpentier’s CRISPR research outlined in 2012 paved the way for Zhang’s research in eukaryotic system. The Broad Institute argued that the research was not obvious and the patent claims from both the institutes were different. The federal Patent Trial and Appeal Board ruled out UC Berkeley’s claims and sided with the Broad Institute. With this decision, UC Berkeley plans to move forward with their patent application, which if approved, will provide them right on the use of CRISPR on all cells. This would also mean that if the technology will be employed commercially, the companies would have to get licenses from both the Broad and the Berkeley group.

MedNess: The patent decision in the favor of the Broad institute increased the stocks of Editas Medicine by 30%. Editas Medicine licenses Broad’s patents for human genetic disorders. (Fierce Biotech, STAT News, The LA Times, NPR, Wired)

Are pharmaceutical industries in favor of Trump’s FDA pick? The story so far….

Donald Trump is pushing deregulation of FDA in order to accelerate the drug approval process. His ideology: drug costs are higher, drug approval process through FDA takes forever, drug companies are involved in “unfair foreign trade”, drugs should be manufactured in the USA and finally, drug companies should add the innovation factor for the better cure of the diseases. This recipe will work in favor of patients to bring the overall drug costs down and patients can have quicker access to the newer agents. Not to forget, drug manufacturing in the USA brings back jobs and the “fair trade” promotes revenue generation. This all sounds good, except, the pharmaceutical industries have opposing views. The most common complaint of every patient and every healthcare researcher is the never-ending drug approval process by the FDA. So suddenly, when we might be able to overcome this hurdle, why is everyone (read the researchers, pharmaceutical companies and informed patients) so anxious? The truth is bitter sweet. Even though we rant over the FDA, we still knew, the FDA has best interests at heart and such a tight screen is probably important for the safety of the patients. In addition, a 2011, study found that the FDA usually approves cancer drugs before Europe does. Moreover, the researchers at Yale found the FDA’s drug review is at least a month faster than Europe’s or Canada’s.

The pharmaceutical industries on the other hand are concerned about the high drug costs. In addition to the limited patient safety, deregulation in the FDA might not provide enough time for pharmaceutical companies to justify high costs of the drugs to patients and to insurance companies. The pharmaceutical companies will not be able to account for high costs of the drugs owing the limited safety and efficacy analysis that ultimately affects both the patients and the companies. President Trump said last month he has a “fantastic person” lined up for the role of the FDA commissioner. A survey conducted by Mizuho Securities of drug company executives indicated that 72 percent agreed Scot Gottlieb should be Trump’s pick to head the FDA. Until then, we all wait! (Reuters, The New York Times, Forbes)

 

              

MedNess- At the frontier of Medicine, Pharmaceutical and Healthcare Business

in Poli-Scie/SciBiz/Uncategorized by

Hello and welcome to the biweekly roundup of Healthcare business top stories. Please follow us on Twitter and LinkedIn

MedNess 

BMS’s injectable Opdivo approved by FDA for bladder cancer

FDA approved intravenous use of Opdivo (nivolumab), a PD-1 checkpoint inhibitor for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have not benefitted from platinum-containing chemotherapy or in cases where the disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. Last year, FDA approved Roche’s Tecentriq, a checkpoint inhibitor, for the treatement of bladder cancer.

From the business standpoint, this was much awaited good news for BMS as the Opdivo did not make the cut as first line monotherapy study in non small cell lung cancer (NSCLC) in 2016. However, Merck’s Keytruda gained FDA approval soon after Opdivo failed in NSCLC study (Fierce Pharma).

 

The battle of patents: bad news for Teva Pharmaceuticals

Genric drug maker giant: Teva Pharmaceuticals lost the patent challenge in U.S. District Court, safeguarding their star drug Copaxone against generic competition. Copaxone, approved in 1996, became the most prescribed drug for the treatment of multiple sclerosis. The patents protecting Copaxone against generic competition expired two years ago for 20mg dose. Novartis and Momenta launched their 20 mg alternative (Glatopa) in 2015. To recuperate, Teva launched a 40 mg formulation of Copaxone. However, this week, U.S. District Court invalidated Teva’s last and fourth key patent protecting 40 mg Copaxone from generic drug competition. Teva lost other 3 patents last year (Madison.com).

Trump pledges to bring drug costs down

Pharmaceutical industries were told by Trump that the drugs should be manufactured in the USA and the foreign countries buying US manufactured drugs should pay “fair share”. These changes in addition to “better innovation” will help bringing prices down for the US patients (CNBC).

MedNess from MedPol: Amgen CEO Robert Bradway announced that soon nearly 1600 jobs will be added. Bank of America Merrill Lynch predicted that Trump’s policies could help Amgen recover their stocks by 23% in the next 12 months (CNBC)

MedPol

US President’s executive order on immigration: the aftermaths

This is not a political blog, but the executive order has a very significant impact on the scientific, medical and healthcare community. In the following paragraphs, I will brief you with the sectors that have been affected.

  • NRMP issues the statement for the upcoming Match

Nearly 260 people from seven nations affected by travel ban, applied through National Resident Matching Program (NRMP) for medical residency in the USA (Association of American Medical Colleges, AAMC). Both the applicants and the hospital programs are concerned and affected by the travel ban. However, NRMP has urged the programs and the applicants to be discrete in their decisions that are in the interest of healthcare. The official statement issued by NRMP on their website states, “The medical education community must support all international medical graduates and their families during these difficult times. As for the current Match cycle, NRMP encourages applicants and programs to make the best decisions they can under current circumstances. For its part, NRMP will be liberal in granting waivers to applicants and programs if they cannot meet their respective Match obligations because of the effects of the Executive Order” (NRMP.org).

  • Dark times for the US hospitals and patients from seven nations affected by travel ban

Ill patients scheduled for treatment at the USA’s premier healthcare centers, John Hopkins Medicine and Cleveland Clinic are uncertain of their treatment options. Hopkins is taking a step ahead by either urging the patients to postpone their travel or sending their staff abroad for their treatment (STAT News)

We wrap up our biweekly MedNess and MedPol news section. Have a great weekend!

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