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Every medicine in your pharmacy has a human story behind it. Real people doing real work and living real lives. We all have romantic ideas about scientists working late into the evening or doctors dropping everything to answer a phone call about a patient. You can almost envision the moment when one of those researchers finally solves an intellectual puzzle and leaps into action. Their eyes go from an empty stare to an alert laser-like focus. They sit a bit taller and start to read frantically. I am sure you’ve seen those movies too. But is it real? Is that how it really happens? That’s what we intend to explore in “Improbable Developments.” Each month we will talk to someone who was or is in the trenches of biopharma R&D and let them tell their story. We’ll be talking about medicines you may know and some that never saw the light of day. We’ll talk to people involved at the bench in the earliest stages through to those who run the clinical trials and present the data to regulators around the world. We'll even be talking to patients who have joined the effort. The science of drug discovery and development creates a rich landscape for all sorts of stories to unfold. The technical challenges, the urgency to help patients, career aspirations, the fight for resources, and many other factors all work together to produce a complex and enthralling human drama. In our monthly discussions, we will look at this from many different angles. Through our discussions, we hope to give you a real appreciation for the types of people behind the medicines you take and the medical devices you may use. You’ll get to know each of them a little bit and start to understand what they have in common and how different and unique they really are. We at Salem Oaks love to bring you these stories of people who are involved in the science, process, and profession of finding and developing new medicines. In our Emerging Researchers Series, we are even talking to people just entering the field and we hope you are enjoying their fresh energy and new ideas. But we need to ask for your help in continuing to bring you this podcast. As creators, we are looking for patrons who want to help us cover our expenses to bring you this service. We have established an account on Patreon that you can use to become a member of Salem Oaks at the Acorn or Sapling levels. Members receive exclusive benefits that you can read about at www.patreon.com/salemoaks. Thank You for your support. We truly appreciate it.

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Check latest episodes from Improbable Developments podcast

Amy Grover: Building Bridges Between Patients and Biopharma

2021/08/17

“Pharmaceutical companies sometimes have a bad rap of being, you know, big, bad pharmacy. But I learned that the patient or the people I am working with right now are just as passionate and just as dedicated to the patient community as I am.” Amy Grover, Director of Patient Advocacy at Catalyst PharmaceuticalsAmy Grover is a familiar face to the rare disease community. She spent 10 years at Global Genes before joining Catalyst Pharmaceuticals. At Global Genes she learned about rare diseases and the challenges they create for people. In her job now, she is working to bridge the gap between biopharma and the patients and families affected diseases like Lambert-Eaton Myasthenic Syndrome (LEMS). Sounds like a familiar mission. Amy moved from the patient side to industry much like I moved from industry to the patient world. We both were surprised by a few things that we saw as we passed through the looking glass between the two. We both recognize that one of the first steps to bridging this gap is mutual respect. If we work on this, the benefits of partnering will flow. I really enjoyed sharing insights looking at the problem from both directions. www.catlystpharma.com

Helping the Patients He Can. For Free. For Life. - Stanley Crooke, MD, PhD

2021/07/26

Imagine you are one of only 10 people in the world with a disease. People with ultra-rare conditions have little hope of attracting research funding to find treatments to work for them. The investments just don’t make sense to for-profit businesses. Our guest, Dr. Stanley Crooke, MD, PHD is leading an effort to change this. After an illustrious career in pharma and founding the RNA Therapy company Ionis Pharmaceuticals, he is blazing a new trail. He has founded https://www.nlorem.org/ (n-Lorem), a non-profit organization that works with families affected by these ultrarare conditions. N-Lorem works to find, develop, and provide new RNA treatments for free, for life. RNA therapy, which includes anti-sense oligonucleotides, has been a dream for researchers for decades. Dr. Crooke has been at the forefront of this work. Now that years of labor are starting to bear fruit, he is looking to a new chapter. A way to give back. The question has changed from, “Can We?” to, “How can we not?” https://www.nlorem.org/ (https://www.nlorem.org/) https://www.ionispharma.com/ (https://www.ionispharma.com/)

Alison Bateman-House, MPH, PhD: Not can we… but should we? Bioethics

2021/05/17

“I don't think a bioethicist is normally who people have come to their elementary school career day. So, we are a novel breed to many people.” Alison Bateman-House, PhD That is how our latest guest on Improbable Developments reflected on her chosen profession, bioethics. It is a field where scientists do not ask the questions about whether they can run an experiment or clinical study, but whether they should. Until recently, most people would not even know the field existed let alone give a good example of where it made a difference. But COVID has changed that. Who should be vaccinated first? How do we ensure equity in distributing the vaccine? If we run low on oxygen or ICU beds, who do we treat? Should we expand access to experimental or repurposed drugs before they have been tested? These are ethical questions that require considering multiple dimensions and perspectives. They are difficult questions. They are very human questions. Tune in to learn how Alison Bateman-House was led into this challenging field and the work she is doing today on policy, clinical trial design, and ethics consulting. Her career path is fascinating to say the least.

Emerging Researcher: Shandra Trantham

2021/03/16

In the last of our Emerging Researchers Series, I speak with Shandra Trantham, a Ph.D. candidate at the University of Florida. Shandra was destined for a life in science. As a young child, science and math were her favorite subjects. She and I share the childhood dream of becoming an astronaut. I never followed my dream, but Shandra didn’t even have the choice. When she was 9 years old, she began to lose her balance and things got progressively worse. When she was 12, she was diagnosed with Friedreich’s Ataxia. Our regular listeners may be familiar with Friedreich’s Ataxia because we have talked to other’s about the rare disorder (Kyle Bryant in episode 2 way back in 2019, and Layne Rodden in episode 013). For Shandra, her diagnosis gave her a focus on science, a reason to study, and a purpose. Her story is informative and inspiring. You can contact Shandra at [email protected] Plese support us a https://patreon.com/salemoaks

Emerging Research: Emily McIntosh

2021/02/23

In the latest episode of our Emerging Researchers Series, we talk to Emily McIntosh (@MCINTOSE) a recent Ph.D. from the University of Guelph in Guelph, Ontario. Living less than an hour from Toronto, she is a big Leafs fan (that is the Maple Leafs for all you non-hockey listeners.) Emily earned her doctorate in biomechanics after studying age-related muscle loss and how that influences balance and mobility. As she says, it seems so intuitive, but she wanted to know why this happens. Emily began her work with elderly people as part of a summer research project just before her senior year in undergrad. She went on to get her master’s and eventually started her Ph.D. studies. And that’s when the story got quite a bit more interesting. Emily had gotten a piercing headache that went away in a day or so. It was bad enough that she was worried but not so bad to call the doctor. She attributed it to dehydration and stress. When it happened again, she did call a doctor and was referred to a neurologist who found what he thought was a benign tumor in her brain. After getting a somewhat different and scarier second opinion, Emily used her well-earned scientific skills to start learning as much about this type of tumor as possible. It was this initiative and her ability to think clinically about her own condition that may have saved her life. You’ve just got to listen to hear what happened. You can reach Emily on LinkedIn (https://www.linkedin.com/in/mcinsite) and via e-mail ([email protected]) Please help support Improbable Developments at www.patreon.com/salemoaks

Emerging Researcher: Robin Powers

2021/01/14

We continue our Emerging Researchers series with an interview with Robin Powers, a student just starting her master’s degree work. Robin is an enigma. She has a wealth of energy and a very fast-moving mind. She has dreams and aspirations that will change the world. Yet she has yet to find the right experiences and coaches to refine her approach. She most certainly has not come from a place of privilege. Robin is a patient who has been managing and advocating for her own Ehlers-Danlos Syndrome for 17 years now, including identifying the issue and securing the genetic testing required to confirm the diagnosis. She has presented at conferences, been a PCORI Ambassador, and volunteered with other rare disease organizations. She has done all this independently without the luxury of programs or an organization paving the way. Robin talks about how she came to Buffalo State College and designed her own degree program, Biochemical Pharmacology of Rare Diseases. She also discusses her work to earn a degree in patient advocacy and public policy. The goal of our Emerging Researchers series is to highlight people like Robin who are full of potential but lacking the experience our other guests may have. These younger people have fresh ideas and the freedom to be bold. For Robin, her life depends on it.

Emerging Researcher: Layne Rodden

2020/12/15

We are excited to introduce our Emerging Researcher Series. Over the next 4 months, we will be talking to some people who are at various stages in their education. Each of them is excited about the research they are doing now and are looking forward to promising futures. We thought it would be interesting to hear what motivated them to pursue science and what they have learned so far. We also thought this would be a great way to showcase some diamonds in the rough. Our first emerging researcher is Layne Rodden who is studying for her Ph.D. at the University of Oklahoma Health Science Center under the mentorship of Dr. Sanjay Bidichandani. Layne is currently looking at the contribution of DNA-methylation to the silencing of the frataxin gene in Friedreich’s Ataxia. Layne has a unique ability to communicate about the science she is doing to non-scientists. Layne hopes to earn her Ph.D. in early 2021 and begin looking for her first “real job.” She has a curious mind and is open to many different possibilities. Hearing her talk about this crossroads will throw you right back to those times when you were about to take the leap into a new chapter. If you would like to connect with Layne, you can reach her at [email protected]. You should follow her on LinkedIn linkedin.com/in/layne-rodden-57877b74 Sound Design: Jake Tompkins Graphics: Heather McCullen

Ethan Perlstein: Scientific Coaching for Rare Families

2020/11/16

We first met Dr. Ethan Perlstein on our other podcast Raising Rare. Dr. Perlstein is a biotechnology entrepreneur. Dr. Perlstein has nearly two decades of experience in biomedical research and over five years in biotech company formation and executive leadership. He holds a doctorate in molecular and cell biology from Harvard University and was a Lewis-Sigler Fellow at Princeton University from 2007-2012. In 2014, Dr. Perlstein founded Perlara PBC, the first biotech public benefit corporation with a legal mandate to co-develop drugs in collaboration with families and communities affected by genetic diseases. During that time, Dr. Perlstein served as a member of the Medical and Scientific Advisory Board of Global Genes, the leading rare disease community-led advocacy organization. Prior to becoming a biotech entrepreneur, Dr. Perlstein conducted and led cross-disciplinary academic research in genetics, cell biology, neuroscience, pharmacology, and drug discovery. In 2019, Ethan joined the Christopher & Dana Reeve Foundation as their first Chief Scientific Officer, but due to unexpected COVID-related financial constraints, his team was let go in Spring 2020. Dr. Perlstein currently advises https://cureGPX4.org and a few other small foundations. His story is one of a relentless pursuit of ways to help families affected by rare disease. https://www.perlara.com/

Lynne Becker: Re-empowering TBI Patients

2020/10/13

Put me in the game coach. These six simple words can be putting athletes, soldiers, and employees at great risk. Lynne Becker knows this from her experience building a database of traumatic brain injuries (TBI) for the department of defense. A bit closer to home, both of her daughters have experienced TBI. She has dedicated her life to helping these patients find their way back. Despite her work as a clinical researcher and biostatistician, Lynne found herself struggling to make sense of her daughter’s signs and symptoms the first time this happened. Because of her work experiences, she was ready to do something about it. She has used all these experiences to create an AI-powered TBI dashboard that helps patients get a correct diagnosis, track their progress, and regain some control of a very scary situation. In this Episode of Improbable Developments, you will hear Lynne’s story and how a series of events has shaped her career. Ultimately, this journey has led to the establishment of Power of Patients, an organization dedicated to supporting the victims of TBI. https://powerofpatients.com/

Mike Wenger: Improving Clinical Trial Data Transparency

2020/09/15

Mike Wenger is Vice President of Patient Engagement at TrialScope. A brain tumor patient and software developer, Mike is passionate about patient access to clinical trials. He is spearheading TrialScope Connect, the industry’s first patient referral collective. This initiative is creating a paradigm shift for patient recruitment, focusing on collaboration vs. competition. Previously, Mike worked at the Michael J. Fox Foundation where he helped develop the Fox Trial Finder, a clinical trial matching platform that educates patients on trials and helps them locate trials best suited to their needs. He also was a lead software developer at Epion Health, transforming the doctor’s appointment into ¬a personalized digital experience where patients could share information with their doctor and take ownership of their own health management. Mike was named one of the 2020 PM360 ELITE 100 in the Patient Advocates category and a 2020 Force for Change Illuminator. He also was a finalist in the Patient Advocate of the Year category in the 2020 Medigy HITMC Awards. Mike became interested in working in healthcare when he had a health scare himself. Because of this scare, he started keeping a headache diary, which helped him learn to manage those headaches. He felt very fortunate to have been able to use these data to improve his condition. This, in turn, motivated him to find ways to help others.

Mary Rofael, MD: Helping Companies Communicate Complex Data in Ways that Matter

2020/06/29

“I think it is really important for the public and the patient Community to learn a little more about FDA advisory committees because these are public meetings and they're accessible for anyone to attend and learn from.” Mary Rofael, MD An FDA Advisory Committee is one of the biggest moments in the development of a new treatment. As a drug developer, I consider the FDA Ad Comm as the pinnacle of my career. During these hearings, a company is given a short time to make the case for the approval of their New Drug Application (NDA) and answer questions from a panel of independent experts. The FDA has a similar opportunity to present their concerns and question to that panel of experts. And all this is done in public. Needless to say, consolidating 12-15 years of collected data into a couple of hours is daunting. Over the past 20+ years, Mary Rofael, MD has built a business, ProEd Communications, that helps guide companies through this major event. In this episode were learn how those companies prepare, what ProEd Communications brings to the table, and why Mary finds this work so fulfilling.

Rob Lambkin-Williams: Mapping Out the Quest for a COVID Vaccine

2020/05/07

The impact of COVID-19 is literally being felt around the world. Humanity has been racing to find weapons to fight this invisible enemy. We know so very little about how the virus is operating. This can leave us feeling confused and isolated. We speak to Dr. Rob Lambkin-Williams from his home where he is locked down for three months because he is vulnerable to complications of COVID. Rob is a UK-based virologist who has been studying influenza for most of his career. His expertise applies directly to the COVID pandemic. We talk to Rob about the scientific and regulatory steps that must be taken to bring an effective vaccine to the millions who need it. He lays out a map of these steps and gives us insight into the challenges each one brings. Join us on this look into what is likely to unfold in the next year or two. You can follow Rob's work and his blog at VirolologyConsult.com (Note: We recorded this conversation at the end of March 2020. The situation is constantly changing, and some details may already seem out of date.)