Thanks for visiting. I’ve been writing a blog since 2011, prior to my career shift to medical writing. The previous blog posts can be viewed on Blogger, and are informal and fun posts on a variety of pharmaceutical topics and give a hint to my personality. As I polish up those posts to a more professional style or create new ones, they will be posted here.
Here is a video with reviewer tips that I made for WI. If you often have to review documents in tracked changes, this 1-min video will help you navigate between Word’s editing views and provide you a shortcut that I use frequently.
Pharmaceutical professionals keep one foot in science and another foot in health authority regulation, both rapidly evolving fields that require consistent training to keep pace. In addition, new opportunities often entice scientists to widen their expertise to contribute to new areas of drug development, which may require an entirely new set of skills. At some point, you are likely to reach the limit of what your corporate or personal budget for training allows. This list is just what you are looking for: quality training that is either free or subsidized!
These courses are ones I have taken and felt were worth the time investment. This list is current as of February 2022.
This course (IPPCR) is offered by the NIH to train new clinical investigators from September to July of each year. It covers all aspects of clinical trials including design, analysis, reporting, budgeting, regulations, and ethics. The textbook is available for about $88 (with the promo code they provide) and the course is free, self-paced, and entirely online. If you pass the final exam you will earn a certificate of completion. This course is a significant time commitment, there are about 40 lectures and most are 60-90 minutes, and you will need to allow additional time to read the assignments and study for the exam. I highly recommend going through Statistics on Khan Academy (see below) to prepare for the biostatistics in this course.
This 6-week course offered by the Office of Regulatory Affairs and Quality (ORAQ) at Duke University is free and available online via WebEx. This course is not self-paced, there are 1-hour webcasts from 12-1 pm EST on Fridays. They take attendance and there is reading and homework.
ORAQ also offers free seminars on regulatory topics that you can join via WebEx.
This online course consists of 6 self-paced modules, which took me about 6 weeks (they estimate 8 weeks). It’s a great overview of the drug approval process and the history of the FDA. It’s presented by the Program on Regulation, Therapeutics, and Law at Harvard and Brigham and Women’s Hospital. It is free to audit, or $199 to get a certificate. It is self-paced, so you start anytime enrollment is open.
The FDA offers free online resources, including the online courses below.
If you are completely new to medical writing, this course will provide a complete overview of the field. It’s available online through ed2go and also through a partnership with community colleges (I took it through Wake Community College for less than ed2go charges).
When writing up adverse events, you need to learn a whole other language. If you are new to terms like pyrexia, dyspnoea, and tachycardia, take this brief online self-paced course on the Latin and Greek behind medical terminology. It takes about 2 hours, and is free if you don’t require a certificate.
Government communications are required to be written in plain language, but some writers are unclear what plain language means. This free online self-paced course from the National Institutes of Health (NIH) will help you understand federal requirements for plain language.
Membership to AMWA will cost you $199/year ($80 for students) but offers a lot of educational perks for medical, scientific, or regulatory writers. AMWA offers a variety of paid courses, but there are some that are free for members (search for “complimentary“), and they email out a monthly free webinar (one that is usually paid) for members as well. You also get an included subscription to the AMWA Journal and all back issues online. Membership in AMWA also includes free chapter events that are a great bargain if you live near an active chapter (if you live in NC or SC, check out @AMWACarolinas on Twitter!).
Membership in the North Carolina Regulatory Affairs Forum is only $40 and includes 6 seminars per year on regulatory topics that are available by WebEx. They also offer a summer workshop (at an additional very reasonable fee) to prepare for the Regulatory Affairs Certification (RAC) exam.
This podcast is provided by Emma Hitt Nichols of Nascent Medical to promote her business and her 6-week course. She has many interviews with medical writers, through listening you can learn about the many career paths available to medical writers as well as many tricks of the trade.
Take a whirlwind tour of the past, present, and future of cancer in episode #62 of Peter Attia’s podcast. I’ve listened to this one a few times because so much interesting detail is packed into every minute of this episode.
are well versed in experimental bias, which is why we address it by using
experimental controls, masking our clinical trials, and using the scientific
method to approach questions. However, how do we control for bias within our own minds? Cognitive bias refers to any number
of ways that our brain prevents us from making entirely objective
decisions. In an article that Harvard Business Review published in June
2011, “Before You Make That Big Decision…”, several
types of cognitive bias are defined and discussed along with case studies, and
a 12-step checklist to root out bias is defined.
decisions in pharmaceuticals are impacted
by cognitive bias. When developing a product, there are a million
decisions that can have a significant impact on the cost, timescale, clinical
success, and eventual marketability of your product. Many of these
decisions are originally made at the
bench level, and may not be able to be changed without considerable additional
time or expense as the project progresses through later stages of development.
example, a formulator may demonstrate a bias for a particular type of
formulation process because of previous experience and comfort, or the wish for
high visibility through the use of trendy new technology, or convenience
according to what equipment is on site and available. Decision makers
should recognize the potential for this bias and make sure the best formulation
is chosen regardless of the above
factors. Once this formulation makes it into human studies, there is
considerable inertia that makes change difficult, since the project team
doesn’t want to delay timelines by having to repeat animal studies or bridge
with additional human pharmacokinetic studies.
can be very costly to big pharma companies,
but attempts to avoid bias are not without cost. Multiple layers of peer
review, involving Marketing early in development where most compounds fail for
other reasons, and execution of checklists also take time, but could save
billions for that one “blockbuster in the rough.”
to the article, it is nearly impossible to detect your own bias, but through
learning about bias, we can better detect it in our peers and use this knowledge
to better challenge decisions. For example, when performing due diligence,
you must be alert for bias from the company under scrutiny, the fellow members
of your team, and in how your team prioritizes and reports the findings.
are some types of bias from the article and how they could come up in pharma:
This type of bias is hard to avoid. Almost every person on a project team is heavily vested in the success of their project. Part of this is due to corporate culture, which tends to reward those people who happen to be on successful projects. This bias can be minimized by shifting the focus from project success, which can be largely due to the luck of being assigned to a safe and effective compound, to excellence in contributing to the project. Another similar bias is loss aversion, a fancy business term for “fear of failure.” Pharma is understandably already risk-averse, but it is also disadvantageous to have people avoiding difficult projects, or killing projects that are a deviation from the norm without sufficient basis. If people on failing projects are rewarded for swiftly contributing to clinical evaluation and cost-effectively killing their project, there is less motivation to “succeed at all costs” or “run for the hills.”
a similar vein, even when project members’ fates are not tied to a project outcome, a project team can fall in love
with a concept after expending a lot of hard effort, which also makes an
objective analysis of the product’s value difficult. In this case, it is up to the peer reviewers or
due diligence team to make sure that they are getting a clear picture and not
an overly positive projection based on the best subset of data.
is the result of insufficient diversity on the team or strong dominant members
that quash all dissent before it can be fully
explored. If you have a group of scientists from similar
backgrounds, who have been working together in the same field for a long time,
groupthink can occur. Most Big Pharma companies indirectly solve
groupthink by aggressively promoting diversity and reorganizing fairly often, so you aren’t working with the
same people for more than a few years. Groupthink can be challenged
head-on in peer review by considering the people making up the team- was there
enough varied expertise? Were all voices heard?
There is a whole book devoted to this
type of bias. Where does it come up for pharma? In audits of
suppliers and due diligence for in-sourcing, this bias can be difficult to
avoid. A related bias is the saliency
bias, where a previous success casts a rosy glow on a new, similar
project. The halo effect can come up in decisions regarding outsourcing.
If you have a company that you love and frequently use for analytical
capability, that positive association may bias you to choose them for
formulation work, even though it may turn out that their capabilities for formulation are
insufficient. As common as this bias is, at least it is easier to spot
than some other types of bias. Auditing and due-diligence teams will benefit
from reminding themselves of this potential bias before visiting a favorite
supplier, as tempting as a shortened visit would be.
bias may be the most insidious for pharma. In confirmation bias, the team
generates one path forward and seeks only data to support the chosen path,
disregarding all else. In drug development, each decision builds over a
thousand smaller previous decisions. A
common pitfall in oral formulation development is dose. Early in development, a high dose is required, so you develop a melt granulation. Later in
development, when the dose has dropped to
10 mg, did the project team scale down the melt granulation, or evaluate a
cheaper dry blend process?
is much scientific information to evaluate in the early stages of product
development. Even still, many times you have to move forward with less info
than you would like. Analytical testing is a bit like exploring a cave
with a flashlight, where the light cast by the flashlight
is the capability of your test. Is there anything lurking in the
shadows? It’s important to do a risk assessment based on what data is
missing at the time of the decision and evaluate “what
ifs.” What if the drug substance supply was not an issue? What
if you had another month to develop? How would the decision
change? Should a contingency plan be in place in case a critical factor
example, many times your first formulation is
developed while your salt program is ongoing. For now, you are
assuming your compound is insoluble, but what if a soluble salt is found? How will this change your
approach? Do you have a workable backup plan?
Sunk Cost Fallacy
is very susceptible to the sunk cost fallacy because it is just so expensive to
develop a drug. The sunk cost fallacy is when you, for better or worse,
factor in past cost/resource into a decision for the future.
the simplistic hypothetical case where
you have a drug that you have already spent $500 million developing. The
Food and Drug Administration (FDA) then restricts your patient population,
driving the market forecast from blockbuster level to only $5 million a year
over a projected remaining patent life of 7 years. You have $5 million in
expected future costs prior to
launch. If you consider the sunk costs, this project is a loser, and you
may be tempted to cut your losses and save $5 million. However, if you
ignore the past money spent and focus only on the future, the return on
investment is pretty good.
sunk cost fallacy can also work in the opposite
way and be a powerful companion to the self-interest bias and related biases above, also known as the
“We Have to Make This Work Because We Have Already Spent Ungodly Sums on
the impact and cost of bias to Big Pharma, an organizational assessment to
determine how susceptible you are to bias
may be in order:
How aware are your project teams of cognitive bias and how to recognize
it? Is this awareness only at the executive level, or does it reach to
your bench-level decision makers?
How are your decisions controlled? Is there peer review? Are the peer
groups involved sufficiently diverse?
Is your corporate or departmental culture breeding bias? Are people
rewarded based on only project success? Have you ever rewarded a “positive failure”? Are
dissenting opinions welcomed?
Are there physical or process factors that could create bias in your
decisions? For example, scientists may have a bias toward equipment housed
in the same building as their office. If ordering a new excipient requires
multiple forms and a six-month auditing process, there will be a strong
preference for what’s already in the warehouse.
employees weather a perfect storm of conditions that promote bias: high
financial stakes, a strong scientific drive
to produce successful results, considerable time pressure, and a highly
regulated environment resistant to change. A pharma company that promotes
awareness of bias and implements effective counter-measures at all levels of
the organization can sail through this storm toward better outcomes.