Empowered Patient Podcast

Lindsay Mateo is the Chief Commercial Officer at Weave. This company has developed a platform to automate and streamline the regulatory documentation process for FDA submission for pharmaceutical and biotech companies. The regulatory lifecycle for drug development currently involves data from various sources in digital and paper formats. Weave Bio's tools are designed to automate and streamline administrative aspects of the regulatory process and create a living digital record of the development of the drug, which supports collaboration and saves time.

Lindsay explains, "I look at the regulatory life cycle for any given drug program, and experts are at the core of that. Those experts, who are scientists, strategists, and project managers, essentially put all the work into the documentation that goes to regulators like the FDA here in the US. And that information goes on to allow this drug to continue through various stages of development to ultimately get to market and obviously help patients."

"That is everything from early studies looking at how drugs are being handled in animals, in mice and rats, all the way through to clinical development. We start to get into humans and then again out through what gets drugs to market and even post-market expansion of various labels. So this is critical to getting any therapy to any patient with any condition. The process itself, the challenge with the process is that it's manual."

#Weave #WeaveBio #Pharma #Biopharma #WeavePlatform #AINative #AutoCT #AutoND #FDASubmission #RegulatoryDocumentation

Weave.bio

Listen to the podcast here

Lindsay Mateo is the Chief Commercial Officer at Weave. This company has developed a platform to automate and streamline the regulatory documentation process for FDA submission for pharmaceutical and biotech companies. The regulatory lifecycle for drug development currently involves data from various sources in digital and paper formats. Weave Bio's tools are designed to automate and streamline administrative aspects of the regulatory process and create a living digital record of the development of the drug, which supports collaboration and saves time.

Lindsay explains, "I look at the regulatory life cycle for any given drug program, and experts are at the core of that. Those experts, who are scientists, strategists, and project managers, essentially put all the work into the documentation that goes to regulators like the FDA here in the US. And that information goes on to allow this drug to continue through various stages of development to ultimately get to market and obviously help patients."

"That is everything from early studies looking at how drugs are being handled in animals, in mice and rats, all the way through to clinical development. We start to get into humans and then again out through what gets drugs to market and even post-market expansion of various labels. So this is critical to getting any therapy to any patient with any condition. The process itself, the challenge with the process is that it's manual."

#Weave #WeaveBio #Pharma #Biopharma #WeavePlatform #AINative #AutoCT #AutoND #FDASubmission #RegulatoryDocumentation

Weave.bio

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Aspen Noonan, CEO of Elevate Holistics, a company that helps patients obtain medical marijuana cards through a telehealth consultation with licensed doctors. The qualifications for obtaining a medical marijuana card vary by state, and Elevate Holistics helps patients navigate the regulatory landscape. Many doctors are hesitant to recommend cannabis due to the federal illegality and restrictions from employers, and Elevate Holistics is filling the gaps by connecting patients looking for alternative treatments for conditions such as anxiety, depression, PTSD, and chronic pain.

Aspen explains, "We are a one-stop shop for getting your online medical marijuana card. We connect doctors with patients 100% online in over 18 states to go through the process, which basically means book your appointment, fill out forms, join a video chat, call, and check for your emails because it's a hands-off experience. We really help people. I say A to Z, we don't just see you and get out. We ensure that your state application is filed correctly, so you ca your medical card at the end of the day."

"You have every right to ask your primary care provider for a medical marijuana recommendation. The problem is, and the reason we started, is that a lot of doctors do not want to sign their name next to something that says cannabis. They aren't allowed to go through their clinics. Let's say they work at a hospital, they work at a big organization, and they're not allowed to attach their name to the cannabis industry. And so that's where we come in and just take patients, take a provider, put them together."

#ElevateHolistics #Marijuana #Cannabis #MedialMarijuana #MedicalMarijuanaCard

elevate-holistics.com

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Aspen Noonan, CEO of Elevate Holistics, a company that helps patients obtain medical marijuana cards through a telehealth consultation with licensed doctors. The qualifications for obtaining a medical marijuana card vary by state, and Elevate Holistics helps patients navigate the regulatory landscape. Many doctors are hesitant to recommend cannabis due to the federal illegality and restrictions from employers, and Elevate Holistics is filling the gaps by connecting patients looking for alternative treatments for conditions such as anxiety, depression, PTSD, and chronic pain.

Aspen explains, "We are a one-stop shop for getting your online medical marijuana card. We connect doctors with patients 100% online in over 18 states to go through the process, which basically means book your appointment, fill out forms, join a video chat, call, and check for your emails because it's a hands-off experience. We really help people. I say A to Z, we don't just see you and get out. We ensure that your state application is filed correctly, so you ca your medical card at the end of the day."

"You have every right to ask your primary care provider for a medical marijuana recommendation. The problem is, and the reason we started, is that a lot of doctors do not want to sign their name next to something that says cannabis. They aren't allowed to go through their clinics. Let's say they work at a hospital, they work at a big organization, and they're not allowed to attach their name to the cannabis industry. And so that's where we come in and just take patients, take a provider, put them together."

#ElevateHolistics #Marijuana #Cannabis #MedialMarijuana #MedicalMarijuanaCard

elevate-holistics.com

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Mark Goddard, Vice President of Clinical Services at Infobionic.AI, describes the remote cardiac monitoring system that provides near real-time monitoring of patients with potential cardiac irregularities. The benefit of continuous monitoring allows for early detection of arrhythmias like atrial fibrillation, a growing concern driven by an aging population and factors like obesity and high blood pressure. AI-driven algorithms are used to analyze ECG data and identify potential issues, enabling proactive treatment and prevention of complications like stroke.

Mark explains, "The focus of our monitoring system is to provide near real-time monitoring of patients who are reporting maybe cardiac irregularities. The whole idea is to provide that near-real-time access to cardiac information so that arrhythmias can be identified relatively quickly. Additionally, the treatments for those arrhythmias are relatively quick as well, providing better patient outcomes. Just related to the fact that the data is always there, and it comes in maybe a minute or two behind live."

"We are partnered with a major health system that has an AI engine that is basically developing AI tools that can be utilized in cardiac monitors. And just looking at the patient's ECG, they're able to determine the potential for arrhythmias that may not have occurred yet. And that's kind of what we're focusing on. The ability to review ECG and understand those little nuances that may indicate, hey, this patient's going to have an event like atrial fibrillation, which is the most common irregular rhythm there is, especially for an aging population. Identifying those folks early can really help with not only the outcome for the patient, in that they're not going to run into the problems you may have if you don't recognize you have atrial fibrillation, but it'll also decrease healthcare costs, which in the end helps everybody."

#InfobionicAI #MedAI #Cardiology #AFib #HeartMonitor #CardiacTracking

infobionic.ai

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Mark Goddard, Vice President of Clinical Services at Infobionic.AI, describes the remote cardiac monitoring system that provides near real-time monitoring of patients with potential cardiac irregularities. The benefit of continuous monitoring allows for early detection of arrhythmias like atrial fibrillation, a growing concern driven by an aging population and factors like obesity and high blood pressure. AI-driven algorithms are used to analyze ECG data and identify potential issues, enabling proactive treatment and prevention of complications like stroke.

Mark explains, "The focus of our monitoring system is to provide near real-time monitoring of patients who are reporting maybe cardiac irregularities. The whole idea is to provide that near-real-time access to cardiac information so that arrhythmias can be identified relatively quickly. Additionally, the treatments for those arrhythmias are relatively quick as well, providing better patient outcomes. Just related to the fact that the data is always there, and it comes in maybe a minute or two behind live."

"We are partnered with a major health system that has an AI engine that is basically developing AI tools that can be utilized in cardiac monitors. And just looking at the patient's ECG, they're able to determine the potential for arrhythmias that may not have occurred yet. And that's kind of what we're focusing on. The ability to review ECG and understand those little nuances that may indicate, hey, this patient's going to have an event like atrial fibrillation, which is the most common irregular rhythm there is, especially for an aging population. Identifying those folks early can really help with not only the outcome for the patient, in that they're not going to run into the problems you may have if you don't recognize you have atrial fibrillation, but it'll also decrease healthcare costs, which in the end helps everybody."

#InfobionicAI #MedAI #Cardiology #AFib #HeartMonitor #CardiacTracking

infobionic.ai

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Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics, is dedicated to addressing unmet needs in breast cancer prevention and treatment. Dense breasts are a significant risk factor for breast cancer, and Atossa's lead drug candidate has shown effectiveness in reducing breast density and lowering the risk of cancer. This dual-action drug blocks estrogen receptor signaling and induces programmed cell death in cancer cells, potentially offering a more effective and more tolerable treatment option.

Steven explains, "So we are very focused on breast cancer to the point that Princess of Atossa, the company is named after, was the first woman in recorded history with breast cancer about four 50 BC. She was the wife of Darius the Great, who had the Persian Empire, the largest piece of real estate before the Roman Empire. And she had a breast lesion. It was documented that her slave cauterized it with a hot poker from the fire. We didn't get a follow-up from that, but anyway, we are dedicated to all the women, including her, and since then, who have been dealing with breast cancer."

"So it's a very interesting molecule. We call it a Janus molecule. Janus is the two-faced goddess. In this case, it is two-faced in a positive fashion because she addresses two different ways that cancer cells control themselves to drive the growth. Its major activity is to block estrogen binding to the estrogen receptor. So, as I said at the beginning, if 75% of all breast cancers are driven by estrogen, our drug is going to really nail 75% of all breast cancers. But then it gets even more exciting because it also has a second activity in another pathway in cancer driving called PKC beta."

#AtossaTherapeutics #BreastCancer #Cancer #DenseBreasts #Estrogen

atossatherapeutics.com

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Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics, is dedicated to addressing unmet needs in breast cancer prevention and treatment. Dense breasts are a significant risk factor for breast cancer, and Atossa's lead drug candidate has shown effectiveness in reducing breast density and lowering the risk of cancer. This dual-action drug blocks estrogen receptor signaling and induces programmed cell death in cancer cells, potentially offering a more effective and more tolerable treatment option.

Steven explains, "So we are very focused on breast cancer to the point that Princess of Atossa, the company is named after, was the first woman in recorded history with breast cancer about four 50 BC. She was the wife of Darius the Great, who had the Persian Empire, the largest piece of real estate before the Roman Empire. And she had a breast lesion. It was documented that her slave cauterized it with a hot poker from the fire. We didn't get a follow-up from that, but anyway, we are dedicated to all the women, including her, and since then, who have been dealing with breast cancer."

"So it's a very interesting molecule. We call it a Janus molecule. Janus is the two-faced goddess. In this case, it is two-faced in a positive fashion because she addresses two different ways that cancer cells control themselves to drive the growth. Its major activity is to block estrogen binding to the estrogen receptor. So, as I said at the beginning, if 75% of all breast cancers are driven by estrogen, our drug is going to really nail 75% of all breast cancers. But then it gets even more exciting because it also has a second activity in another pathway in cancer driving called PKC beta."

#AtossaTherapeutics #BreastCancer #Cancer #DenseBreasts #Estrogen

atossatherapeutics.com

Download the transcript here

Dr. Alex Meves, distinguished dermatologist at the Mayo Clinic and a spokesperson for SkylineDx, discusses the challenges in diagnosing and treating melanoma and how a new molecular test called Merlin can help improve risk stratification and treatment decisions for patients with early-stage melanoma. Diagnosis and treatment have traditionally used tumor thickness as a primary risk factor. This molecular test measures the expression of genes in the tumor biopsy and can help determine the extent of surgery needed and whether additional therapies may be beneficial.

Alex explains, "My department, when I started to work here at Mayo, wanted me to do some translational research, and I had just come back from a postdoc in Germany, at the Max Planck Institute, and I was tasked to get some research going. And so I focused on melanoma because I thought at the time there wasn't a lot of molecular research going on in melanoma that could be translated to patients. And so we started to develop biomarkers, sort of molecular tests that we could apply to tissue, and then help patients with."

"Yes, so the problem that our research is focused on is what to do once you're diagnosed with a melanoma. What you want to do is to match the right therapy to the right patient. That's the goal. There are lots of melanomas that might not be very aggressive, and you don't have to do a lot of treatment. And then there's some melanoma that's very aggressive, and you want to do lots of treatment, but it's not always obvious which melanoma is low risk and which melanoma is high risk. And so this idea of risk stratification at diagnosis becomes very important to match therapy to patients."

#skincancer #melanoma #SkylineDx #PersonalizedMedicine #PrecisionDiagnostics

skylinedx.com

Listen to the podcast here

Dr. Alex Meves, distinguished dermatologist at the Mayo Clinic and a spokesperson for SkylineDx, discusses the challenges in diagnosing and treating melanoma and how a new molecular test called Merlin can help improve risk stratification and treatment decisions for patients with early-stage melanoma. Diagnosis and treatment have traditionally used tumor thickness as a primary risk factor. This molecular test measures the expression of genes in the tumor biopsy and can help determine the extent of surgery needed and whether additional therapies may be beneficial.

Alex explains, "My department, when I started to work here at Mayo, wanted me to do some translational research, and I had just come back from a postdoc in Germany, at the Max Planck Institute, and I was tasked to get some research going. And so I focused on melanoma because I thought at the time there wasn't a lot of molecular research going on in melanoma that could be translated to patients. And so we started to develop biomarkers, sort of molecular tests that we could apply to tissue, and then help patients with."

"Yes, so the problem that our research is focused on is what to do once you're diagnosed with a melanoma. What you want to do is to match the right therapy to the right patient. That's the goal. There are lots of melanomas that might not be very aggressive, and you don't have to do a lot of treatment. And then there's some melanoma that's very aggressive, and you want to do lots of treatment, but it's not always obvious which melanoma is low risk and which melanoma is high risk. And so this idea of risk stratification at diagnosis becomes very important to match therapy to patients."

#skincancer #melanoma #SkylineDx #PersonalizedMedicine #PrecisionDiagnostics

skylinedx.com

Download the transcript here