Calorify’s Role in Clinical Trials: A Q&A with Advisor Ellen Weiss
Calorify is excited to welcome Ellen Weiss as our Clinical Strategy Advisor. Ellen has an extensive background in business development and decentralized clinical trial management. She brings a wealth of experience from working in family offices to palliative care and clinical research. Most recently she was with PCM trials, and carried them to the head of a burgeoning industry. While building relationships with all of the big pharma companies, she became rather familiar with rare disease and the inner workings of the clinical trial space, including the ins and outs of the FDA. Ellen brings knowledge and expertise capable of propelling Calorify forward, and we’re excited to see what she helps us accomplish!
Q: Tell us more about your career. You started out working in finance, in family offices, and in 2014 made a switch to hospice and palliative care, ultimately leading you to clinical trials. What drove this change, and what insights has this journey given you?
A: Work in Finance taught me that the underlying value of anything, really, is how useful that thing is to furthering your goals. In Finance, it was striving to attain, grow and ultimately protect the financial security of a family or a business. Often, it was not how much money was held, it was working to ensure that the assets were being deployed in the pursuit of the family’s intended goals. Some clients had amassed significant assets but had seen a degradation of familial relationships. For some, their original goals (and friends and family) were discarded along the journey and they entered old age isolated and essentially alone.
At the very end, some were bereft of loving support and company. Hospice, specifically non-profit hospices, entered my view as they showed up at home and offered palliative care and end-of life services to everyone. The old saying ‘you can’t take it with you’ resonated deeply with me and by extension, wealthy clients, planning their last months and days. I became enamored of the very human work hospices do, and saw connections between providing a needed service at home, rather than a hospital setting. If crucial and effective pain relief could be brought home at end of life, what other medical-grade services could be delivered with the patient at the center? At home. Where people want to be.
Q: A lot of your clinical trial work has focused on decentralized trials, aiming to serve people at home. What drove this focus? Why is at-home testing uniquely valuable?
A: Funny thing about people....when you evaluate or test them in the typical care setting they show up having made an appointment, traveled to that site and otherwise disrupted their routine to keep that appointment. And somehow researchers expect that the result of any testing done at the typical site will show up as an indicator of their ‘normal’ performance. Blood tests, cognitive screening, strength tests: all are collected in an atypical setting. Maybe subjects have taken more care with diet or fluid intake, or avoided certain foods or behaviors to ‘prep’ that can skew the results. And results that are uneven or unexpected become unrealistic or even deceptive benchmarks.
From observing hospice work I saw first-hand that fragmented attention and anxiety were far more manageable in a patient’s most familiar location - their home. If we expect compliance to protocols and treatment regimens, perhaps home is where that should be happening. My fascination with decentralizing clinical trials was born right then and there. Over more than two decades, research with wearables, remote observation and remote dosing and testing have carried hundreds of treatments across the approval line. I am delighted to have played a small part.
Q: Why did you join Calorify?
A: Calorify represents a new level of at-home testing to bring covered treatments, both already approved and those in pursuit of approvals by FDA and EMA, to people across the globe struggling with obesity. As a first case, the burgeoning obesity market is fueled by direct-pay customers searching for weight loss solutions. Well and good for those who can pay out-of-pocket. But millions of others must rely on employer-paid insurance or federal-paid coverage that does not currently cover GLP-1 or newer combination treatments. These payers may be hesitant to cover these expensive regimens if they cannot accurately and objectively measure a patient’s metabolism or body composition. Attempts to maximize results from these expensive regimens have fallen short. Subjective measurements equals spotty adherence and spottier results.
I see Calorify’s role in this drug class as providing clarity and precision at pegging energy intake and expenditure ahead of treatment, mid-point in a treatment or trial protocol and at goal weight attainment to inform future needs. Be it researcher, or payer Calorify provides an objective measure of a patient’s commitment and compliance over time. If the level of adherence is just not there, an expensive course of treatment can be withdrawn.
Secondary cases for metabolic testing really light me up – beyond obesity, science struggles to unmask the mysteries of cachexia. Cancer patients, sufferers of HIV, COPD, CHF, and on and on....all would benefit from an accurate measure of metabolic rate. Especially a measure that does not inflict a burden of travel to a care setting or research site to collect it. A simple at home urine test is what Calorify can deliver. No needles, no inconvenient and risky travel for an already weakened patient. At scale Calorify can make a real difference!
