Empowered Patient Podcast

James Graham is the CEO of Recce Pharmaceuticals, a biotechnology company focused on the global antibiotic-resistant patient population. This new class of synthetic antibiotics takes a broad-spectrum approach to kill bacterial infections, which continue to mutate, rendering existing antibiotics ineffective. The founding inventor of Recce is Dr. Graham Melrose, the grandfather of James, who has grown this idea into one of the top-performing biotech stocks in Australia.

James explains, "As you may know, by my accent, I'm an Australian. I think Australia found the first penicillin, which worked well for everyone around the world for a number of years. But it's time for a new penicillin, penicillin 2.0, or one entirely synthetic, not reliant on existing natural processes. And that's what we've fundamentally started with, beginning with the end in mind that is Recce antibiotics. So I really say the challenge, the silent pandemic is right upon us. You only have to look at the AMR resistance rates. I think raising at about 10% each year, certainly in certain antibiotic or indication groups. If we don't do something, we're just going to have these useless drugs that no one will pay the price for anyway. The business model will be broken, and everybody will be out of options. It's really the pandemic before us."

"I hinted that R327 is synthetic. It's entirely synthetic when all existing antibiotics to date are naturally derived. So the way antibiotics and bacteria have always worked is that you find something in nature by way of the antibiotic. The bacteria are too smart. They evolve too quickly, and let's begin with the end in mind and create something that will work against all types of bacteria, gram-positive gram-negative in their hypercellular mutated forms, and keep on working with repeated use."

"And in the case of my origins with Recce, the inventor, Dr. Graham Melrose, is actually my grandfather. He turned 90 years old about a little over a month ago, and he's the guy who was the head of Johnson & Johnson Australasia for about a decade. He is the foundational inventor of this compound. And he and I started this company. He's the inventor. I just gave him a bit of money, and off we went. That's the easy part. He started identifying the ideal compound in his garage in Perth in Western Australia. If anyone knows where that is, it's actually the most isolated city in the world."

@ReccePharma #AntimicrobialResistance #AMR #SuperBugs #Sepsis #UTIs #Urosepsis #SyntheticAntiInfective #Antibiotics #AustraliaBioTech

recce.com.au

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James Graham is the CEO of Recce Pharmaceuticals, a biotechnology company focused on the global antibiotic-resistant patient population. This new class of synthetic antibiotics takes a broad-spectrum approach to kill bacterial infections, which continue to mutate, rendering existing antibiotics ineffective. The founding inventor of Recce is Dr. Graham Melrose, the grandfather of James, who has grown this idea into one of the top-performing biotech stocks in Australia.

James explains, "As you may know, by my accent, I'm an Australian. I think Australia found the first penicillin, which worked well for everyone around the world for a number of years. But it's time for a new penicillin, penicillin 2.0, or one entirely synthetic, not reliant on existing natural processes. And that's what we've fundamentally started with, beginning with the end in mind that is Recce antibiotics. So I really say the challenge, the silent pandemic is right upon us. You only have to look at the AMR resistance rates. I think raising at about 10% each year, certainly in certain antibiotic or indication groups. If we don't do something, we're just going to have these useless drugs that no one will pay the price for anyway. The business model will be broken, and everybody will be out of options. It's really the pandemic before us."

"I hinted that R327 is synthetic. It's entirely synthetic when all existing antibiotics to date are naturally derived. So the way antibiotics and bacteria have always worked is that you find something in nature by way of the antibiotic. The bacteria are too smart. They evolve too quickly, and let's begin with the end in mind and create something that will work against all types of bacteria, gram-positive gram-negative in their hypercellular mutated forms, and keep on working with repeated use."

"And in the case of my origins with Recce, the inventor, Dr. Graham Melrose, is actually my grandfather. He turned 90 years old about a little over a month ago, and he's the guy who was the head of Johnson & Johnson Australasia for about a decade. He is the foundational inventor of this compound. And he and I started this company. He's the inventor. I just gave him a bit of money, and off we went. That's the easy part. He started identifying the ideal compound in his garage in Perth in Western Australia. If anyone knows where that is, it's actually the most isolated city in the world."

@ReccePharma #AntimicrobialResistance #AMR #SuperBugs #Sepsis #UTIs #Urosepsis #SyntheticAntiInfective #Antibiotics #AustraliaBioTech

recce.com.au

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Jennifer Jones-McMeans, Divisional Vice President of Global Clinical Affairs at Abbott, discusses Abbott's new diversity initiative to help address mistrust and societal barriers that underrepresented populations face in receiving healthcare and participating in clinical trials. Through partnerships, clinical research coordinators from diverse backgrounds working in smaller institutions are trained to work with these populations. Norton Health with the Institute for Health Equity is putting funding and infrastructure in place to build a research program model for historically Black colleges and universities to attract more diverse participation in trials and build more vital research institutions.

Jennifer explains, "I had a good conversation with a physician today from the New York area, and we talked about one barrier that is translation. We discussed that the clinical trial this individual is working on did not have the resources for translation services. And so, if you think about something as simple as that, it means that patients who are non-English speaking, their family members, and researchers cannot even approach them because they may not have the translated material. That's one very simple barrier. We can go back to also time - patient time is critical. If you think about individuals who are working and who have family obligations, how do we actually reduce the barrier of time?"

"Well, this is where when we think about race and ethnicity, race is not biologic. Remember, it's a social construct. Ethnicity is a social construct. Yes, if you look geographically, we're 99.9% similar when it comes to human genomes. Who I am as an African-American female, I may have far more genetic similarities to someone who is not of African descent. We first have to dispel that. Yes, there can be genetic elements. We do know that geographically you may see a higher frequency of certain genetic associations and whatnot. But I think it becomes less about this because genetics and race are not biologic."

"When you think about who do I need to include? You have to bring in this whole concept of social determinants of health, or also concepts where people, cultures, groups, individuals are impressed not only by the biology but what their surroundings are."

#Abbott #ClinicalTrials #DiversityinClinicalTrials #DiversityResearch #Healthcare #SDOH #SocialDeterminantsofHealth

Abbott.com

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Jennifer Jones-McMeans, Divisional Vice President of Global Clinical Affairs at Abbott, discusses Abbot's new diversity initiative to help address mistrust and societal barriers that underrepresented populations face in receiving healthcare and participating in clinical trials. Through partnerships, clinical research coordinators from diverse backgrounds working in smaller institutions are trained to work with these populations. Norton Health with the Institute for Health Equity is putting funding and infrastructure in place to build a research program model for historically Black colleges and universities to attract more diverse participation in trials and build more vital research institutions.

Jennifer explains, "I had a good conversation with a physician today from the New York area, and we talked about one barrier that is translation. We discussed that the clinical trial this individual is working on did not have the resources for translation services. And so, if you think about something as simple as that, it means that patients who are non-English speaking, their family members, and researchers cannot even approach them because they may not have the translated material. That's one very simple barrier. We can go back to also time - patient time is critical. If you think about individuals who are working and who have family obligations, how do we actually reduce the barrier of time?"

"Well, this is where when we think about race and ethnicity, race is not biologic. Remember, it's a social construct. Ethnicity is a social construct. Yes, if you look geographically, we're 99.9% similar when it comes to human genomes. Who I am as an African-American female, I may have far more genetic similarities to someone who is not of African descent. We first have to dispel that. Yes, there can be genetic elements. We do know that geographically you may see a higher frequency of certain genetic associations and whatnot. But I think it becomes less about this because genetics and race are not biologic."

"When you think about who do I need to include? You have to bring in this whole concept of social determinants of health, or also concepts where people, cultures, groups, individuals are impressed not only by the biology but what their surroundings are."

#Abbott #ClinicalTrials #DiversityinClinicalTrials #DiversityResearch #Healthcare #SDOH #SocialDeterminantsofHealth

Abbott.com

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Que Dallara, Executive Vice President and President of the Diabetes Operating Unit at Medtronic, is enthusiastic about the MiniMed 780G system, a recently FDA approved solution for people with type 1 diabetes. This system has a continuous glucose monitor, insulin pump, and mobile app that connects with CareLink, which allows the physician and family members to follow the patient as well. This automated insulin delivery eliminates the need to count carbs and calibrates to each individual's eating habits for more accurate dosing.

Que explains, "It's the first of its kind that has automated adjustments and corrections to insulin delivery without needing the patient to do anything. The existing systems on the market have automated basal delivery, which helps to some degree, but we've introduced this concept of meal detection technology. It can figure out that you're having a meal. For example, if you're undercounting your carbs, it can notice that you're actually having a meal and then provide order corrections so that you don't go too high. It can do that in a safe way without increasing the risk of hypoglycemia."

"So it's very difficult with a CGM alone and with just the patient to make all these decisions throughout the day. What the MiniMed 780G does is automates all of that. There's a CGM, and with the specific algorithm that we have on the 780G. It knows when you're going low, when you're going high, how much insulin on board, the rate of change of all of this, when you might have under-counted carbs, when you may have missed a bolus. And it helps you make the decision automatically. You don't have to be involved. It's truly a hands-off system."

@Medtronic #MiniMed780G #Diabetes #Type1Diabete #TypeOneDiabetes #CGM #ContinuousGlucoseMonitoring #MealDetection

medtronicdiabetes.com

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Que Dallara, Executive Vice President and President of the Diabetes Operating Unit at Medtronic, is enthusiastic about the MiniMed 780G system, a recently FDA approved solution for people with type 1 diabetes. This system has a continuous glucose monitor, insulin pump, and mobile app that connects with CareLink, which allows the physician and family members to follow the patient as well. This automated insulin delivery eliminates the need to count carbs and calibrates to each individual's eating habits for more accurate dosing.

Que explains, "It's the first of its kind that has automated adjustments and corrections to insulin delivery without needing the patient to do anything. The existing systems on the market have automated basal delivery, which helps to some degree, but we've introduced this concept of meal detection technology. It can figure out that you're having a meal. For example, if you're undercounting your carbs, it can notice that you're actually having a meal and then provide order corrections so that you don't go too high. It can do that in a safe way without increasing the risk of hypoglycemia."

"So it's very difficult with a CGM alone and with just the patient to make all these decisions throughout the day. What the MiniMed 780G does is automates all of that. There's a CGM, and with the specific algorithm that we have on the 780G. It knows when you're going low, when you're going high, how much insulin on board, the rate of change of all of this, when you might have under-counted carbs, when you may have missed a bolus. And it helps you make the decision automatically. You don't have to be involved. It's truly a hands-off system."

@Medtronic #MiniMed780G #Diabetes #Type1Diabete #TypeOneDiabetes #CGM #ContinuousGlucoseMonitoring #MealDetection

medtronicdiabetes.com

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Joe Todisco, CEO of CorMedix, is developing a product that has broad spectrum activity against bacteria and fungus to impact the safety of receiving hemodialysis through a central venous catheter. With the recent acceptance by the FDA of the submission for DefenCath, CorMedix is hopeful of obtaining FDA approval for this therapeutic to prevent bloodstream infections. Since the active ingredient is not an antibiotic, the drug does not further the problem of antibiotic resistance.

Joe explains, "The lead indication for the product is for the reduction in risk associated with catheter-related bloodstream infections in hemodialysis patients undergoing hemodialysis with a central venous catheter, CVC. Catheter-related bloodstream infections, or CRBSIs, are one of the most severe adverse consequences associated with getting hemodialysis through a CVC. The incidence rate in the general population is about 25% to 33%, and they can be fatal up to 25% of the time. So it's a critical unmet medical need. There is no current FDA approved therapeutic for the prevention of bloodstream infection in this patient population or any population, and we're hopeful to obtain FDA approval as a first-in-class therapy."

"DefenCath is what's called a catheter lock solution. As I said, it's investigational. It has not received FDA approval yet. But it is designed to sit in the catheter between dialysis sessions or times that a catheter is accessed. We're pursuing our initial approval for the hemodialysis patient population. Still, the hope is to expand the label post-approval into some other therapeutic areas where patients have high levels of infection and high rates of catheterization. But the product sits in the catheter in between dialysis sessions. It's a combination of heparin, which is an anticoagulant, and our proprietary molecule, Taurolidine. Taurolidine is a molecule with the unique properties of being a non-antibiotic antimicrobial with broad-spectrum activity."

#CorMedix #CRBSI #CLABSI #Dialysis #Infections #BloodstreamInfections #HealthcareInnovation

cormedix.com

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Joe Todisco, CEO of CorMedix, is developing a product that has broad spectrum activity against bacteria and fungus to impact the safety of receiving hemodialysis through a central venous catheter. With the recent acceptance by the FDA of the submission for DefenCath, CorMedix is hopeful of obtaining FDA approval for this therapeutic to prevent bloodstream infections. Since the active ingredient is not an antibiotic, the drug does not further the problem of antibiotic resistance.

Joe explains, "The lead indication for the product is for the reduction in risk associated with catheter-related bloodstream infections in hemodialysis patients undergoing hemodialysis with a central venous catheter, CVC. Catheter-related bloodstream infections, or CRBSIs, are one of the most severe adverse consequences associated with getting hemodialysis through a CVC. The incidence rate in the general population is about 25% to 33%, and they can be fatal up to 25% of the time. So it's a critical unmet medical need. There is no current FDA approved therapeutic for the prevention of bloodstream infection in this patient population or any population, and we're hopeful to obtain FDA approval as a first-in-class therapy."

"DefenCath is what's called a catheter lock solution. As I said, it's investigational. It has not received FDA approval yet. But it is designed to sit in the catheter between dialysis sessions or times that a catheter is accessed. We're pursuing our initial approval for the hemodialysis patient population. Still, the hope is to expand the label post-approval into some other therapeutic areas where patients have high levels of infection and high rates of catheterization. But the product sits in the catheter in between dialysis sessions. It's a combination of heparin, which is an anticoagulant, and our proprietary molecule, Taurolidine. Taurolidine is a molecule with the unique properties of being a non-antibiotic antimicrobial with broad-spectrum activity."

#CorMedix #CRBSI #CLABSI #Dialysis #Infections #BloodstreamInfections #HealthcareInnovation

cormedix.com

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Jeff Hackman, CEO of Comera Life Sciences, recognizes the need to find a more efficient, patient-friendly solution for receiving biologics rather than being administered by IV therapy. Using the SQore platform, a proprietary technology, Comera is reformulating IV biologics to Sub-Q utilizing small molecule chemistry and an understanding of excipients. Seven out of ten global medicines are biologics, and most are administered by IV, providing a tremendous opportunity to expand access to biologics using Sub-Q technology.

Jeff elaborates, "Our mission is to transform these biologic therapies into a different form, a subcutaneous form. That form takes on the ability of these patients to administer these medicines for themselves, at home, at school, and at work. So really, what the summary of this mission is, through the freedom of self-injectable care, we hope that these patients can live a life without the burden of this therapy and the ability to be able to make their lives more livable."

"Excipients have been around for decades. They often fail to reduce the viscosity necessary to get these high-potency biologics into these small spaces, these small syringes, as you said. Our technology, which is called the SQore platform, allows this to happen more often, and it's such a significant impact that we have had multiple partnerships and collaborations with large pharma over the years to work with them to be able to do this."

"The issue you have around the science and the platform is that by taking and putting large molecules like this and these biologics into small spaces that are very potent, these biologics and antibodies stick together. So what our technology does is it's viscosity-reducing. That viscosity, you can think about it as when you put these biologics into a small syringe, they almost look like oil or glue."

"The ability to be able to stabilize these and to be able to get them to flow around each other and to be injected at these high potency levels is what our SQore platform does."

#ComeraLifeSciences #Biologics #IVInfusion #Subcutaneous #SubQ #Immunotherapy #SQore #Excipients

Comeralifesciences.com

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Jeff Hackman, CEO of Comera Life Sciences, recognizes the need to find a more efficient, patient-friendly solution for receiving biologics rather than being administered by IV therapy. Using the SQore platform, a proprietary technology, Comera is reformulating IV biologics to Sub-Q utilizing small molecule chemistry and an understanding of excipients. Seven out of ten global medicines are biologics, and most are administered by IV, providing a tremendous opportunity to expand access to biologics using Sub-Q technology.

Jeff elaborates, "Our mission is to transform these biologic therapies into a different form, a subcutaneous form. That form takes on the ability of these patients to administer these medicines for themselves, at home, at school, and at work. So really, what the summary of this mission is, through the freedom of self-injectable care, we hope that these patients can live a life without the burden of this therapy and the ability to be able to make their lives more livable."

"Excipients have been around for decades. They often fail to reduce the viscosity necessary to get these high-potency biologics into these small spaces, these small syringes, as you said. Our technology, which is called the SQore platform, allows this to happen more often, and it's such a significant impact that we have had multiple partnerships and collaborations with large pharma over the years to work with them to be able to do this."

"The issue you have around the science and the platform is that by taking and putting large molecules like this and these biologics into small spaces that are very potent, these biologics and antibodies stick together. So what our technology does is it's viscosity-reducing. That viscosity, you can think about it as when you put these biologics into a small syringe, they almost look like oil or glue."

"The ability to be able to stabilize these and to be able to get them to flow around each other and to be injected at these high potency levels is what our SQore platform does."

#ComeraLifeSciences #Biologics #IVInfusion #Subcutaneous #SubQ #Immunotherapy #SQore #Excipients

Comeralifesciences.com

Download the transcript here