1 min read

Why I Joined Medable: A Unique Opportunity To Change Lives

By John Walton on Jan 21, 2021 7:33:32 AM

When we see a pharmaceutical company’s drug pipeline, we are viewing a roadmap to a better quality of life for patients; however, the main obstacle we encounter is the time it takes to bring these drugs to market. In the world of disease progression, the average 10-12 year timeline to approve new therapies can mean the loss of hope for many.

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When I discovered Medable and their mission to bring effective therapies to patients faster by reducing clinical trial timelines by 50%, it was a statement that hit very close to home. Growing up with Cystic Fibrosis, I have been the beneficiary of medical breakthroughs that have advanced me from a life of predetermined struggle to enabling me to participate in collegiate athletics at the NCAA Division I level. What was once innovation, now necessity. Medable’s decentralized cloud-based platform enables high-risk patients, like me, simple and safe access to study enrollment while eliminating the risk of clinical on-site exposure. On the operations end, I cherish the challenge of providing a high-quality decentralized data capturing platform to
Sponsors and CROs to efficiently drive their studies to conclusion. This motivation comes knowing first-hand what it’s like to receive a next-gen therapy and the life changing benefits that go with it.

At Medable, we offer the once-in-a-lifetime opportunity to change the way clinical drug trials are conducted. Here you are not just another number in the system, but rather, an integral member of the project team. The teammates I have the privilege to collaborate with make it exciting to wake up every day and work towards that next therapeutic breakthrough.

While the Customer Success team operates under a remote setting, we have still found a way to develop a tight bond within the division. One of my first takeaways was the tight-knit family environment with a work-hard play-hard mindset. To any highly motivated individuals with a self-starter mentality, I encourage you to visit our career opportunities page and help our dream of bringing new treatments to market in half the time, become a reality.

Visit our careers page here: https://www.medable.com/company/careers 

Topics: decentralized trials medable careers life sciences clinical trials
5 min read

Fit for a King: Bending the Arc of Legacy Toward Action

By Allison Kalloo, MPH on Jan 18, 2021 12:07:19 PM

We are excited to announce the addition of Allison Kalloo to Medable’s Patient Advisory Council. She is the founder of Clinical Ambassador and iParticipate, and is a passionate advocate for diversity in clinical research.

More than ever, I am convinced that anyone who does anything has got to hold a deep and abiding belief that one person can actually make a difference in the world. Dr. Martin Luther King, Jr. clearly believed that. My mother believed that. I believe that also. I had little choice.

My mother was a spitfire who radiated warmth and grace, and she very deliberately instilled in me that I alone am enough to have an impact. That my unique talents and passion are actually supposed to be of service to the world. 

Both Dr. King and my mother had an abiding commitment to civil and human rights that stemmed from their fundamental belief that we are all called to take action…each of us. That being “created equal” also confers an equitable obligation—no matter who we are, where we’re from, or “what” we’re from—to use our talents for the greater good. 

My mother grew up in the racially hostile south, coming of age during the 50’s and 60’s where not having access to equitable health care easily set into motion poor health outcomes. My mother was class Valedictorian and the first to go to college in her family. She’d been an avid reader from early childhood and became enthralled by science. GIven her chronic health struggles exacerbated by discrimination and lack of access to health care, the fact that she did go to college was remarkable. 

I was recently granted a copy of her college admissions essay, which she wrote longhand in 1959 at the age of seventeen. My mother’s essay ends with the following passage: 

“In light of the above facts, I feel that North Carolina College is the institution which will prepare me adequately to adjust myself to the various situations of life as well as equip me in such a manner that I might make a definite contribution to society.”

—Marian Suitt

Among hundreds of other young, gifted and Black students who attended HBCUs and who remained somewhat insulated from the outside world, they were fully cognizant of navigating the segregated south. She and her classmates felt duty-bound to participate in the lunch counter sit-ins later credited with being catalysts of the civil rights movement. She would also attend the March on Washington in 1963, the summer she graduated. 

The civil rights struggle was not just an abstract captured in grainy black & white news footage. It was a vivid first-person experience that my mother lived. When she retold the stories, it was in riveting detail. For me, the earliest and most compelling images of who Dr. King was and what he represented came straight from my mother’s mouth. 

Armed early on with the prospects of not having a lot of time, my mother possessed a sense of urgency and decisiveness about everything. She would become a lead scientist for the District of Columbia Bureau of Laboratories as an expert on swine flu, rabies, and smallpox. My mother was a trailblazer and scientist and the context for my first superhero being depicted in a white coat.

In the wake of the coronovirus pandemic, not only have I thought of my mother for the scientist she was, but ironically, I’m reminded of her every time Dr. Anthony Fauci is mentioned or interviewed. You see, Dr. Fauci is my mother’s peer and was a colleague. My mother was a virologist, too. They attended the same scientific conferences and Dr. Fauci’s name was often the topic of dinner table conversation. 

When her health began declining further, my mother made the bold decision to participate in a clinical trial. She signed up for a trial at the National Institutes of Health— led by Dr. Fauci. As she shared with the family, she knew participating would not save her life. Her participation would help somebody else, and that’s what mattered to her. And she was uniquely equipped to recognize how important representation was— even in the long shadow of the Tuskegee Experiment. 

It’s impossible to look around and not be taken aback by how far we’ve come in the last thirty years since my mother’s enrollment in that clinical trial, but also how far we still must go if we are to make good on Dr. King’s dream of equality. 

Despite profound medical and technological advances that have occurred even recently, racial and ethnic minorities have failed to achieve equal health outcomes. By virtually every measure, minorities experience higher morbidity and mortality rates than the general population— even when income, education, and other socioeconomic variables are controlled for. One doesn’t have to wonder what Martin Luther King would have thought about the disproportionate burden of disease among certain groups. He actually said it: “Of all the forms of inequality, injustice in health care is the most shocking and inhumane.”

Exactly a year ago on Dr. King’s birthday, I was leaving a study appointment for a trial I was participating in. As I walked through, I locked eyes with an elderly Black woman seated in reception. We both did ‘double-takes.’ I smiled at her. She smiled at me. (We could see each other smiling because it was pre-COVID and neither of us were wearing masks). Turns out, she wanted to accompany her niece to her study screening. She told me that while she had been a bit leery, they decided to show up anyway. I remember telling her that I thought minority participation in clinical trials is about  health equity and social justice. That on a personal level, I think of participating as an issue of awareness, empowerment and exercising options which include access to cutting-edge healthcare. I’ll never forget her response. She said, “You know, you're right. I hadn’t thought of it that way. It is important that we participate. I'm glad you took the time to speak with me.”

I felt emotional walking back to my car. It hit me that my encounter was infused with Dr. King’s spirit. I had also experienced validation that in our increasingly digital, tech-driven world, face-to-face connections (and virtual ones for these times) remain the holy grail of connecting with people and we need to make sure we give this brand of magic its due.

It’s hard to imagine that any of our high-tech modern conveniences could possibly have enhanced Martin Luther King’s profound impact on the world any more than he did. His movement was simply about connecting people. 

My mother and Dr. King both lived by an edict that we are all beholden to do something significant. That we all carry an obligation to do more than just dream. 

I’ve come to realize that the concept of legacy is not only something that remains of you after you have gone. Legacy is actually what you create daily. It’s what you’re actively building, and all of what you do pays homage to those who’ve invested in you. 

So, may it be for us today and always, that the best way to show respect for Martin Luther King’s principles—and that of our ancestors—is to DO SOMETHING of service to humanity.  Do something that MATTERS. Pay it FORWARD.

“Now, therefore,” wrote Barrows Dunham, “since the struggle deepens, since evil abides and the good does not yet prosper, let us gather what strength we have, what confidence and valor, that our small victories may end in triumph, and the world awaited be a world attained.”

Happy Martin Luther King Day 2021!  

Allison Kalloo, MPH



Topics: life sciences D&I Diversity Inclusion MLK
1 min read

Q&A With Medable PAC's Allison Kalloo On MLK Day

By Allison Kalloo, MPH on Jan 18, 2021 12:06:10 PM

We are excited to announce the addition of Allison Kalloo to Medable’s Patient Advisory Council. She is the founder of Clinical Ambassador and iParticipate, and is a passionate advocate for diversity in clinical research.

Each year, on the birthday of Dr. Martin Luther King Jr., the nation takes a moment to pause, reflect and think back on the life and impact of his work. 

Today, our own Patient Advisory Council member Allison Kalloo sat down with Medable CEO and co-founder Michelle Longmire to incite a moment of pause and reflection, by discussing the very real and continued issues and challenges that African American communities face in our own industry.

 

Allison has had a remarkable life shaped by the work of Dr. King, her mother, and trials and healthcare in general, and she presents the industry with a number of challenging thoughts and questions that should make us all stop, pause, and reflect on the work that we do everyday, as well as the lives we lead outside of Medable.

Topics: life sciences D&I Diversity Inclusion MLK
2 min read

Glaucoma Awareness Month: Educate Yourself on the Often Symptom Free Disease

By Richie Kahn on Jan 12, 2021 2:03:49 PM

January is Glaucoma Awareness Month which means it’s the perfect time to learn more about this often symptom-free cause of vision loss. As a patient with optic atrophy, one of the hallmarks of glaucoma, I’m intensely passionate about building awareness of the importance of routine exam eyes. Read on to learn more. 

For those who may not know, glaucoma is the leading cause of permanent blindness worldwide with over 76 million patients impacted. 

Technically speaking, glaucoma includes a number of diseases that result in damage to the optic nerve which connects the eyes to the brain. Damage is caused by increased pressure in the front of the eye which results from an increase in fluid build up. When left untreated, this can eventually damage the optic nerves and result in irreversible vision loss. 

Glaucoma is a chronic condition which means it stays with you for life. When properly treated, vision loss can often be prevented or slowed. Glaucoma often displays no signs or symptoms until the condition has significantly progressed. 

In order to accurately diagnose glaucoma, your eye doctor will perform a number of tests: 

  • Ophthalmoscopy: The shape and color of the optic nerve is reviewed for damage. After this exam, you’re eyes will be sensitive so you’ll want to wear sunglasses for a few hours
  • Tonometry: This test measures eye pressure. The average range is 12-22 mm Hg though it is possible to develop glaucoma when pressures fall in this range
  • Perimetry: This is sort of like a video game where you’re handed a clicker and asked to stare straight ahead. When a spot of light appears, you click
  • Gonioscopy: Here, your doctor will use a purpose-built lens to visualize the angle between your iris and cornea
  • Pachymetry: This test measures corneal thickness

 

If a diagnosis of glaucoma is made, your doctor will work with you to tailor the most appropriate course of treatment which may include eye drops; a variety of laser surgeries; and implantable products designed to reduce pressure in the eye and ultimately slow or potentially halt disease progression. 

Since there are relatively few outward signs and symptoms of vision loss, glaucoma is often called the Silent Thief of Sight. That's why it's so important to build awareness. Here are a few things you can do to help your friends and neighbors preserve their eyesight:

  • Talk, talk, talk! Both about glaucoma itself and the importance of getting screened for symptom-free vision loss
  • If your eyes are healthy, be sure to keep up on your routine eye exams. These typically happen every two years. They’re a great excuse for a new pair of glasses if that’s your thing
  • If you’re having trouble with your vision, be sure to tell your eye care professional as you may require specialized testing or treatment

 

For more information, be sure to visit the Glaucoma Research Foundation's website at www.glaucoma.org. If you'd like to read about optic atrophy from the patient’s perspective, please visit http://richiekahn.wordpress.com

Topics: life sciences glaucoma
3 min read

Medable Sets Stage for Broad Decentralized Clinical Trial Adoption in 2021

By Big Valley on Jan 11, 2021 1:36:48 PM

Shares Business Impact, Insights and Predictions for Patient-Centered Drug Development at JPM 2021

PALO ALTO, Calif. — Jan. 11, 2021 — Medable Inc, the leading cloud platform for patient-centered drug development, experienced record growth in 2020 as the COVID-19 pandemic drove demand for remote clinical trial technologies. By minimizing the need for in-person site visits, Medable customers have achieved unprecedented results – including 3X faster enrollment and over 90 percent retention rates.

Medable onboarded more than 50 new clients in 2020, as pharmaceutical, biotech, and clinical research organizations used Medable’s software to enable patients to participate in trials remotely — reducing their dependence on physical sites due to quarantines and social distancing. Decentralized trial adoption grew Medable revenues by more than 400 percent in 2020. Additionally, Medable launched five new products to support patient-centered research, and secured $118 million in total funding to accelerate digital and decentralized clinical trial adoption.  

“COVID-19 accelerated patient-centered research by five years,” said Dr. Michelle Longmire, CEO and co-founder of Medable. “2021 will be marked by the democratization of access to research. Leveraging Medable, partners can provide remote access to new investigational medicines to patients worldwide. We are driving radical transformation in clinical trials through patient-centered technologies that remove traditional bottlenecks and transform key processes. In 2021, Medable will continue to drive the emergence of a global ecosystem that truly enables research anytime, anywhere and for every person.”

Digital and mobile technologies played a pivotal role for clinical trials in 2020, enabling the continuation of in-flight research efforts via remote care while also accelerating development of vaccines and therapeutics for COVID-19. Building on that experience, Medable executives will share lessons learned from 2020 and predictions for 2021, via five sessions at this week’s Fierce JPM Week 2021 and Digital Medicine & MedTech Showcase events:

Rerouting: How Real-Time Patient Data Will Drive the Future of Healthcare

Moderator: Dr. Michelle Longmire, CEO, Medable

Panelists: Andy Coravos, CEO, Elektra Labs | Maria Fotiu, Executive VP of Decentralized Solutions, Syneos Health | Thomas Switzer, Digital Health Scientist, Genentech | Dr. Priyanka Agarwal, Director and Head of Digital Health, Myokardia

Patient-Driven Therapeutics: Charting the Future of Healthcare

Presented by: Dr. Michelle Longmire, CEO, Medable

Interviewed by: Sari Kaganoff, General Manager, Rock Health

The Digitalization of Clinical Trials

Moderator: Maria Fotiu, Executive VP of Decentralized Solutions, Syneos Health

Panelists: Dr. Michelle Longmire, CEO, Medable | Cathy Gao, VP, Sapphire Ventures | Juliet Moritz, COO, Illingworth Research 

Hindsight is 2020: Lessons Learned from DCTs and 2021 Predictions

Presented by: Allison Holland, Head, Decentralized Clinical Trials, Medable | Craig Lipset, Industry Founder and Advisor

User Experience: From the Patient, Site and Sponsor View

Presented by: Rasmus Hogreffe, VP of DCT Innovation, Medable

Interviewed by: Karina Marocco, EBD Group

Please click here for more information about Medable’s presence at JPM 2021, or to schedule a meeting with Medable’s executives. For ongoing insight about decentralized trial adoption, advice and best practices, and patient-centered research, follow Medable via our blog, LinkedIn, Twitter and Facebook channels.

About Medable

Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company’s digital platform streamlines design, recruitment, retention and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution. Medable connects patients, sites and clinical trial teams to improve patient access, experience, and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California.

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Media Contacts:

Lisa Barbadora, Big Valley Marketing for Medable, +1 (610) 420-3413, media@medable.com

Topics: decentralized trials remote trials medable Hybrid Trials DCT life sciences
9 min read

Mental health coping mechanisms for caregivers with Dr. Lindsey Matt

By Jennifer McNary on Dec 23, 2020 1:12:43 PM

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The following text is a truncated version of Medable Patient Advisory Council Chair Jenn McNary’s interview with psychologist and Patient Champion Member Dr. Lindsey Matt. Jenn and Lindsey were kind enough to film parts of their conversation for inclusion with this blog. Thus, we're pleased to present and recommend viewing the remaining portion of their interview using the videos placed throughout the article. 

 

2020 has been a tough year for us all, with many spending time away from their families and feeling isolated this holiday season. This is especially true for caregivers of chronically ill children. In fact, research indicates that 40% to 70% of caregivers have had clinically significant symptoms of depression with nearly a quarter to half meeting the diagnostic criteria for major depression. Additionally, 35% of parents with chronically ill children meet criteria for clinical depression with 57% meeting criteria for what is considered anxious symptoms. .

With that in mind, Medable Patient Advisory Council Chair Jenn McNary (JM) spoke with Patient Champion Network member and licensed clinical psychologist, Dr. Lindsey Matt (LM), to discuss coping mechanisms and considerations as a caregiver for chronically ill children that can benefit many of us and our relationships with others this holiday season. 

LM: I would love if you could start by introducing yourself and telling folks a little bit about you.

JM: Sure. I’m Jenn McNary. First and foremost, always in my introduction is that I’m a mom because I became a mom at 18. That is what I always introduce myself as. I have three sons that live with rare diseases of different kinds and I also have a healthy nine year old daughter. 

LM: Thank you! Speaking to that piece, when you think about becoming a caregiver, how was that for you or can you speak a little bit more to that process or transitioning to mom and to caregiver? 

JM: Yeah, so, it’s interesting because I’ve always been a really responsible person. I was a nanny; I was a babysitter, and, so, the transition to mom was pretty easy for me surprisingly...even at 18. I found that my mental health status of sort of dealing with a lot of anxiety and dealing with depression and things like that actually made me a better and more understanding parent. I understood when my kids were throwing tantrums. There were no pre-existing expectations for behavior. So, when I had a colic-y infant, I could really empathize with him. I found, even for me transitioning as a caregiver to sons with a rare disease...my sons were diagnosed when I was 21. Austin was three years old and Max was three months old. I didn’t have any preconceived notions of what it was going to be like to raise children so I just became the person who was raising children who were fatally ill.

LM: Speaking to that piece, just coming into motherhood and then learning it sounds about the illnesses that were going on with your children, what does the road of a caregiver look like for you from diagnosis and then over the years? Being in their lives and through that process?

JM: It’s interesting because, at first, it didn’t look any different than just being a mom. Very quickly it becomes being a protector. Being an advocate. There are doctors that don’t necessarily mean well or maybe they mean well but they’re just not having your child’s best interests in their mind. I had a lot of doctors say that there’s nothing you can do; just take them home and love them. All the way to doctors saying you may not want to get attached. You’re looking at a newborn baby and they’re saying, “That child is going to die. Don’t get attached.” So, I became an advocate for them to find the best care and a lot of it was external. In my mind, you know, just standing there blocking bad things that were gonna happen and then also moving into schools and being protective about what was gonna happen to them physically; whether they were being treated kindly; whether they were being picked on...and, so, it was a lot of defense. That was really our early years. As they’ve gotten older, it’s been raising them to be decent human beings so that other people will want to be around them because it’s harder to make friends; and have friends; and be in relationships when you’re disabled. When you need somebody to take care of you and it’s not your mom, that person doesn’t have to take care of you. And, so, teaching them really how to behave towards caregivers and how to be respectful. Sometimes, it’s tough love and really teaching them to be good citizens first and I think that that’s rare. I think that, a lot of times, these folks that depend on care can be really difficult to care for and I didn’t want that because I’m also a human and so, even though I have the best of intentions, I get irritated if I get woken up in the middle of the night over and over. 

LM: And you had mentioned, I think, something so important. At some level, having some anxiety, things like that, coming into motherhood, coming into parenthood, can actually make you well suited for the job. I’m curious, for you, as you added on this caregiver role, what were some of the, I suppose, advantages and disadvantages of that? You mentioned the irritability. Sometimes it can be a little bit much. You’re a human being. I wonder, for you, some of the ways this impacted your mental health over the course of time.

JM: A lot of times I have said in the past, and I maintain, that having the boys really saved my life. For some people, it can be a pet; it can be a plant that you have to water at least once a week. Just knowing that I really don’t have the option of just losing it, especially as a single mom. Even on the days where, and certainly with bipolar disorder, I have days where I’m super mom and I’m super functional and our house looks amazing and immaculate and I’m playing boardgames and I’m really, really good. Then, there are days where I’m like, “I don’t even want to leave my bedroom.” I don’t have that option. So, in a way, being forced into reality has been good for me and I think that also having realistic expectations about moods has made me a better parent sometimes. We yell. We’re a family of yellers. I’m a yeller. My kids are yellers. We all swear but we’re all pretty good at apologizing. Being somebody with a mental illness, you become pretty good at apologizing. You apologize for forgetting something; you apologize for not showing up; and you apologize for being irritable. So, all of my kids know that forgiveness is an option and they know that people are human. I think sometimes that takes the pressure off of the people in your life.

 

 

LM: You mentioned your boundaries, things you do to look after yourself and I think that’s a very, very important part about this conversation about what it means to be a caregiver. I wonder are there resources you have found helpful for supporting your mental health or areas where it’s been hard to have the support you’re looking for?

JM: I guess the resources--Facebook and support group, please where people get it--and that doesn’t mean that everybody with a child with a rare disease gets it--and so I have an ongoing chat group with about six women that have children with Duchenne of varying ages and we’re in constant contact every day. We have Zoom calls. We live across the country but that’s where I go when I want to vent so, making sure you find your people. Also making sure you find your people that don’t have anything to do with rare disease, totally don’t get it, don’t understand it, don’t want to understand it, and so you don’t have to talk about it. I have a couple of those friends and, in fact, I have friends without children. Those are my favorite friends because we can be really selfish and self-centered and they don’t even know that it’s happening. Those are the resources. Also, of course, advocacy organizations and things like that are great if you’re struggling. For me, the biggest thing I’ve done for myself is keep myself strong since I have to do a lot of lifting. My kids are heavy. So, I’ve invested in exercise. I don’t love exercise but yoga; Peloton; treadmill; you name it is here and it’s in my face staring at me in my room and in my office. Making sure that I’m taking care of my health has been incredibly important.

 

LM: Thank you so much for speaking to all these different areas. Is there anything else that you would want to add or other things that we haven’t talked about already that are really important in this area?

JM: I think that it’s just important for everybody to realize, again, if I were speaking to caregivers or to people who both struggle with their own mental illness and then also are trying to take care of another human being, I’d say what I just said to a mom who wrote in a chat group about completely losing it on her kid in the middle of the night. Like, completely losing it. We’re talking screaming; crying; she may have even punched a hole in the wall. I remember that the comments were so unkind. “Get help. Get help. Get help. You’re a psycho.” Even from our community. I remember commenting and saying, “If these people are saying that they’ve never felt that way, they’re lying to you.” I really want to remove the stigma of struggling and that martyrdom, you know? None of us is built to care for people exclusively forever. That is not the way that we are made. We’re not those kinds of people. We’re not superhumans. I really want to work to removing that barrier, you know, to feeling what you feel.  

LM: That’s an excellent point. Thank you so much.

JM: Thank you!

 

Resources

  • If you or a loved one is receiving medical treatment, start by asking your hospital, center, clinic, or provider if they are aware of mental health resources for patients and/or caregivers. 
  • If cost or provider availability is a concern:
    • Search “university counseling center” to locate low cost clinics in your area where therapy is provided by graduate students. These students are supervised by licensed professionals and often provide evidence-based care supported by current research.
    • Search “sliding scale therapy near me” to locate therapists whose session cost is negotiable based on income. Many therapists are also currently practicing via telehealth, so consider searching outside of your town or city on sites like Psychology Today or Good Therapy to access a greater number of available providers.
  • If therapy feels out of reach or you prefer the support of a group, robust communities for patients and caregivers alike exist within organizations and  across Facebook, Meetup.com, and Instagram. These can be found by searching for “support group” or “caregiver support group” along with the name if you or or your loved one’s condition. Examples include:
    • Family Caregiver Alliance - A list of support groups for adult and young adult caregivers of those with chronic health conditions
    • The Cancer Patient - An Instagram community that takes a satirical look at life as a cancer patient or survivor 
    • The Dinner Party - A peer community for those in their 20s or 30s who have lost someone close to them 
Topics: life sciences caregivers mental health
2 min read

The First Step is Education: Medable’s Jennifer McNary nominated by Reuters for Her Work in Rare Disease Advocacy

By Dan Horsey on Dec 21, 2020 10:31:17 AM

“The reason the Master Class is happening is because advocates like myself were not given a roadmap when our children were diagnosed with rare diseases,” states Jennifer McNary, Rare Disease Advocate. She’s flanked virtually, by her peers and fellow patient advocates for Reuter’s Events 2020 Pharma awards.

Jennifer, alongside three other nominees, is being honored for her work in furthering patient advocacy. Jennifer supports the Patients Rising Master Class she mentions as a faculty member, which is facilitated by fellow Reuters nominee, Lilly Stairs, and is simply a part of her everyday work in furthering the education that exists for patients who suddenly find themselves at the tail end of a rare disease diagnosis.

For Jennifer, and many advocates like her, proper education is the first step in creating a roadmap towards treatment. “Really, the key is that when you have success, instead of keeping that to yourself, share it.”

Thankfully, Jennifer has been instrumental in creating roadmaps for rare diseases for years, most notably with Duchenne Muscular Dystrophy (DMD).  In fact, her work as the Director of Outreach and Advocacy at a Massachusetts based non-profit foundation is the reason for what was the largest FDA advisory committee hearing in history for DMD.

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Jennifer’s end goal? Better access to treatment and greater speed to cures.

“Approved doesn’t mean accessible,” Jennifer says. “There are so many disparities around who can participate in a trial. When my son was in a trial we were flying back and forth across the country every week for blood work.”

Thankfully, Jennifer acknowledges that those days are starting to change. Companies across the globe, such as Medable, where Jennifer chairs the Patient Advisory Council for 2020, are helping to bridge the gap between patients and trials. Home measurements, remote assessments and other technologies greatly increase access to trials that were previously only available to a select few.

Recently, advancements in DMD treatment have given advocates like her hope.  Yet, she acknowledges there is still much work to be done, not only in DMD, but in rare diseases with little to no treatment plans.  

“My hope for all the rare disease community is that we continue enhance flexibility at companies like ours, enhance education, and be prepared to provide access and reimbursement for these kinds of therapies,” Jennifer notes, “So that when someone is born with a rare disease in five years there’s a pre-established treatment plan to help them.”

To learn more about the Master Class, please visit the Patients Rising Now website here

 

About Jenn:

Jenn McNary is a trusted voice in the rare disease community, as a mother, public speaker and fierce advocate. Her work in the rare disease space as a thought leader earned her the Ryan’s Quest Ryan’s Hero award in 2013, a nomination for the Global Genes Champion of Hope award in 2014, and the prestigious 2017 Meyer- Whalley instrument of change award. Formerly as the director of outreach and advocacy at a Massachusetts based non-profit foundation, she was responsible for the organization of the largest FDA advisory committee hearing in history, with over 1000 Duchenne Muscular Dystrophy (DMD) advocates, families, clinicians and researchers in attendance.

Topics: life sciences DMD rare diseases
2 min read

Medable named “Life Sciences Innovation Champion” in the 2020 Accenture HealthTech Innovation Challenge

By Dan Horsey on Dec 17, 2020 12:48:07 PM

Medable is proud to announce we have been named “Life Sciences Innovation Champion” in the 2020 Accenture HealthTech Innovation Challenge. Accenture has recognized Innovation Champions since 2016, by inviting healthtech startups across the globe to demonstrate how they can bridge the gap between startups and life science companies to put innovation at the heart of their business and patents. This year, they invited life science startups to showcase their businesses and answer:

“How can we transform the patient experience prior, during or after care (at-home, outside of clinics)?”

Accenture selected Medable as Life Sciences Innovation Champion for the 2020 Accenture HealthTech Innovation Challenge for providing patients with an integrated digital and physical experience during clinical trials, allowing them to access clinical care sites and clinical trial teams from their mobile phones.

At Medable, we believe that healthcare works best when it’s designed to improve the lives of patients everywhere. Thus, we’re excited, humbled, and grateful to be recognized as a leading company that’s working to simplify clinical trials through decentralization, while providing greater access to patients across the globe. 

Our own Tyler Pugsley, VP of Life Science at Medable expresses our commitment to improving the clinical trial experience:

“We are extremely honored to receive this recognition from the Accenture HealthTech Innovation Challenge. Clinical innovation is only possible through the great contributions of patients. This recognition from Accenture allows us to further improve the patient experience so that any person, anywhere, can participate in a clinical trial.”

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The Accenture HealthTech Innovation Challenge also showcases the breadth of advances happening every day across the life science ecosystem and recognizes more than just the hard work of Medable. It also honors the work of every startup in life sciences and the greater healthcare industry who has brought and inventive patient solutions to our market. This is especially true in 2020, as the industry works tirelessly to react and adapt to a world faced with new challenges and adversity as a direct result of the COVID-19 pandemic.

We’re also proud that so many of our peers have taken new and novel approaches towards solving the issues that continue to afflict our industry. So, if you have a moment, please take a second to recognize the following companies!

  • Cardiolyse, a cloud electrocardiogram (ECG) & heart rate variability (HRV) analytics platform that enables real-time remote heart health monitoring, providing plain-language personalized reports, detection and up to two months data-based prognosis on dangerous heart events;
  • Donisi, a global company at the forefront of contact-free health monitoring that works to change lives without changing lifestyles;
  • Particle Health, which is helping healthcare companies by offering simple, secure access to vital medical data by breaking down data silos that stunt innovation; and
  • Sidekick Health, which operates a patient-centric digital care platform driven by gamification and is scalable across a wide range of chronic illnesses.
Topics: decentralized trials DCT life sciences Innovation
2 min read

Why I Joined Medable: An Inspiring Mission to Improve Patients' Lives!

By Michelle Paulin on Dec 9, 2020 3:37:13 PM

Impacting something bigger than myself has always been part of my philosophy. So, the day I met Michelle Longmire and she talked about Medable’s mission, I knew I wanted to be part of the team. Imagining that my job contributions could change the lives of patients waiting for a cure fit my idea of making my work life meaningful. Little could I have imagined how relevant and tangible Medable’s impact into the lives of the world population could be. At the time, the era of COVID-19 was not on the horizon and the race to achieve our company BHAG (to cut trials timelines in half with the use of technology) seemed far away. Fast forward to 2020, just two years after I joined, and I witnessed that in a matter of three weeks Medable was able to develop and deploy a TeleVisit solution. Our solution kept clinical trials running while patients remained safe and socially distanced in their houses as the world went into lockdown.

Now more than ever, we understand that making patients the center of everything is top priority. At Medable we work relentlessly to leverage technology, and provide engaging, high-quality data capture systems that enable sponsors, patients, and sites to feel confident about adopting Decentralized Clinical Trials (DCTs). In fact, this is how we materialized our mission of “enabling effective therapies to reach patients faster”. Thankfully, market adoption has made us leaders in the DCT space. With this leadership comes the commitment from all of us who work at Medable, to work as a unified team and empower one another to reach new heights every day.

Joining Medable has been a fascinating life experience for me. It has shown me how the passion of an engaged group of individuals can go beyond frontiers and make a remote team feel as driven and connected as if we were all collocated. It has taught me to stop at nothing and find a way to make it happen. It has made me feel like an integral part of a company where we work hard, while still making the time to connect as a team to celebrate victories and promote wellness. 

Medable is a dynamic place where I can see the impact and value of my work on a daily basis, not only within the “company walls” but in real life. It’s wonderful knowing that thanks to my work someone is finding a cure, and little by little we are improving the quality of life for millions while making the world a healthier place. If you are looking for a compelling reason to wake up everyday feeling energized about your work, please consider joining us at Medable!

Topics: decentralized trials medable careers DCT life sciences
4 min read

Ready for Remote: eCOA Adapts to a Hybrid World

By Big Valley on Dec 8, 2020 4:46:38 AM

COVID-19, for all of the pain and suffering it has wrought, has driven some positive change. In the life sciences industry, for example, necessity has been the mother of adoption—spurring a notoriously risk-averse industry to shift from in-patient visits to remote interactions by embracing mobile and digital technologies. In a matter of months, researchers started to decentralize clinical trials by adopting remote consents and clinical outcome assessments (COAs) through a variety of digital applications. 

One such tool is the new Medable TeleCOA application, which allows patients and researchers to harmonize outcome assessments captured remotely in the clinic and home. Medable TeleCOA works with Medable’s TeleVisit and TeleConsent applications to improve the trial experience for patients, sites, and sponsors. 

The company recently hosted a webinar to talk about the shift to remote collection of outcomes, hosted by CEO and co-founder Dr. Michelle Longmire, along with Dr. Robert Bissonnette (CEO of Innovaderm, a specialist in dermatology clinical research), and Richie Kahn (a patient advocate and member of Medable’s Patient Advisory Council).

While decentralization is a major industry trend, Dr. Longmire and the panelists reinforced that it doesn’t necessarily mean all trials will be 100% remote. Biotech and pharma sponsors need flexible and modular solutions to enable the unique needs of a given protocol. That requires additional digital technologies to connect with a patient as early as possible to engage in the trial, from recruitment to study close.

Dr. Bissonnette noted that some clinical outcome assessments—specifically patient reported outcomes (PROs)—have often been captured remotely and electronically in many clinical trials. Before COVID-19, though, most of the other assessments were almost exclusively done in a physician’s office. Bissonnette believes many more assessments can be done remotely, and “we’ll see more and more assessments being done remotely” over time, even after the pandemic.

Factors that Determine Feasibility for Remote eCOA

The feasibility of eCOAs depends on many factors. Dr. Longmire said understanding the disease and the condition is first and foremost, followed by evaluating which COAs are needed for the protocol—and then determining which COAs are suitable for remote.

Of the four kinds of outcome assessments—patient reported outcomes (PROs), performance outcomes (PerfO), clinician-reported outcomes (ClinRO), and observer-reported outcomes (ObsRO)—PerfOs and ClinROs have traditionally been most dependent on onsite clinics.

Dr. Longmire shared that more PerfOs and ClinROs are transitioning to eCOA, but many factors determine feasibility: therapeutic area, disease, disease stage, disease prevalence, patient preference, access to technology, privacy, safety, and so on.

Screenshot 2020-12-07 at 20.09.37

The panel discussed specific factors that determine remote activity, including:

Therapeutic area: Different areas of medicine require different levels of onsite care. PerfO assessments in dermatology, according to Dr. Bissonnette, can use telemedicine to a greater extent than neurology.

“Some research in dermatology should ideally be done 100 percent remote. For example, non-drug studies looking at quality of life or resource utilization or impact on work. At the other end of the spectrum, you have Phase I studies with an intravenous medication that obviously will need to be done in the research setting or environment. In between, we have many options.”

Kahn knows this firsthand from participating in research for his optic atrophy. “There are ways to collect information on visual fields to actually perform remote visual field exams at home. But every now and then you’re going to have something that cannot be done electronically.”

The need for physical contact doesn’t automatically require an onsite visit. There’s also the possibility of local nursing agencies stepping in to do things like blood work. And wearables can track a patient’s vitals even more comprehensively than less frequent onsite visits.

Disease prevalence: Finding patients with rare diseases may require more remote activity because of the difficulty recruiting. On the other hand, common conditions can often be researched onsite due to the broader pool of potential participants. For example, acne is so common that it’s easy to find patients near a research site.

Said Dr. Bissonnette: “If you do a study on a rare genetic disease, most of your patients will have to travel hours. That’s where one needs to try to do everything that is possible to avoid site visits and replace them with telemedicine visits.”

Disease stage: A patient’s condition can also determine the feasibility of remote care. “Typically in phase II-III studies, patients in the past had to come to the office for every visit,” said Dr. Bissonnette. “I would favor a hybrid model, where some visits are done at the site, some are done remotely, specifically for primary and endpoint visits where it’s a subjective evaluation.”

Customizing to Meet the Needs of Patients and Protocols

Regardless of modality, an important requirement of eCOAs is that they provide valid, reliable and meaningful endpoints equivalent to onsite COAs. This is happening more and more, while research on equivalence is still ongoing. Dr. Longmire reinforced the importance of a hybrid model that adapts to both patient needs and protocol needs. “Medable TeleCOA can connect with a patient as early as possible, on any device, to engage and enable participation in the clinical trial, from recruitment forward.”

Dr. Bissonnette noted that patients “want more and more telemedicine.” They would rather stay home than go to the physician’s office because it’s easier for them. “In the future, given the choice between two similar studies, if a study has 10 visits at the site versus another one with three visits at the site and all the other visits remotely, patients will probably favor the second study.”

Whatever COA strategy is used by a trial, focusing on patient needs should be a central design philosophy to ensure successful and sustainable studies. Said Kahn: “We are finally at a point where there’s all this momentum to decentralize trials and bring them to patients where they are and how they want to participate. … There’s going to be some stuff we get right and some stuff we get wrong. When in doubt, always incorporate the input of the patients early and often.”

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For more information about capturing outcomes in a decentralized world, check out the full Medable TeleCOA webinar on demand (here) or reach out to our team of experts to schedule a meeting (here).

Topics: decentralized trials remote trials DCT TeleCOA life sciences