The Four Phases of Clinical Trials Before Market ApprovalRobert Hindes MD
Trek Therapeutics co-founder Robert Hindes, MD was previously a member of the faculty at Yale University in Connecticut. A consultant with a strong background in the pharmaceutical industry, Robert Hindes, MD consults with drug manufacturers on clinical trials for new drugs.
What Non-Opioid Treatment Options are Available for Chronic Pain?Robert Hindes MD
Robert Hindes, an expert in internal medicine and infectious diseases, discusses non-opioid treatment options for chronic pain. These include over-the-counter medications like ibuprofen and acetaminophen, which are generally not effective enough for long-term chronic pain. Non-drug therapies include electrical stimulation, nerve blocks, and injections of drugs that block or destroy pain fibers, such as capsaicin and resiniferatoxin. Spinal cord stimulation and cryoneurolysis (freezing nerves) can also help reduce chronic pain but tend to be more expensive. Stem cell research may lead to additional non-opioid options in the future.
Robert Hindes, MD, formerly of Trek Therapeutics and Sorrento Therapeutics, helped develop resiniferatoxin (RTX), an injectable treatment for chronic pain from conditions like arthritis and cancer. [RTX] targets and permanently disables the nerve endings that transmit pain signals locally, potentially revolutionizing pain treatment. It specifically targets pain nerves without affecting other sensations, and eliminates chronic pain without the side effects of opioids by disabling oversensitive pain neurons and removing dependence on opioids.
The vice president of clinical research at Sorrento Therapeutics, Robert Hindes, MD, develops innovative therapeutic approaches in the treatment of autoimmune disease. Robert Hindes, MD, also serves as the chief medical officer of Trek Therapeutics in Cambridge, Massachusetts, where he supports the company’s mission to create affordable, accessible treatments for people with diseases such as hepatitis C (HCV).
PSI-7977 is a nucleotide analog polymerase inhibitor being studied for the treatment of HCV. A Phase 2b trial found that once daily PSI-7977 plus pegylated interferon and ribavirin achieved a 98% rapid virologic response rate in treatment-naive HCV genotype 1 patients. A separate trial found that all 24 treatment-naive HCV genotype 2/3 patients achieved undetectable viral loads by week 4 of once daily PSI-7977 plus pegylated interferon and ribavirin therapy, and all patients maintained an undetectable viral load through week 12. Preliminary viral dynamic modeling of PSI-7977 data suggests a relationship between drug exposure levels and antiviral response
The World Health Organization’s Pharmacovigilance ProgramRobert Hindes MD
Formerly based in Connecticut where he worked with Bristol-Myers Squibb, Robert Hindes, MD, has served Trek Therapeutics as chief medical officer since 2014. In this role, Robert Hindes, MD, directly supervises Trek’s pharmacovigilance (PV) program.
Robert Hindes, MD is the chief medical officer and cofounder of Trek Pharmaceuticals. He works with the Trek team to develop affordable treatments for viral infections like hepatitis C. Trek brings together medical researchers to help patients worldwide access low-cost treatments. Currently, Trek is conducting trials of the drug Faldaprevir combined with other antivirals to treat hepatitis C. Phase 2a studies showed all patients achieved a sustained viral response when treated with Faldaprevir plus two other drugs. Further clinical trials aim to create treatment affordable for most patients globally.
Trek Therapeutics' Work as a Public-Benefit CorporationRobert Hindes MD
The former group director of virology at Bristol-Myers Squibb in Wallingford, Connecticut, Robert Hindes, MD, co-founded Trek Therapeutics in September 2014. As the organization’s chief medical officer, Robert Hindes, MD, is responsible for the development of clinical strategy.
The Four Phases of Clinical Trials Before Market ApprovalRobert Hindes MD
Trek Therapeutics co-founder Robert Hindes, MD was previously a member of the faculty at Yale University in Connecticut. A consultant with a strong background in the pharmaceutical industry, Robert Hindes, MD consults with drug manufacturers on clinical trials for new drugs.
What Non-Opioid Treatment Options are Available for Chronic Pain?Robert Hindes MD
Robert Hindes, an expert in internal medicine and infectious diseases, discusses non-opioid treatment options for chronic pain. These include over-the-counter medications like ibuprofen and acetaminophen, which are generally not effective enough for long-term chronic pain. Non-drug therapies include electrical stimulation, nerve blocks, and injections of drugs that block or destroy pain fibers, such as capsaicin and resiniferatoxin. Spinal cord stimulation and cryoneurolysis (freezing nerves) can also help reduce chronic pain but tend to be more expensive. Stem cell research may lead to additional non-opioid options in the future.
Robert Hindes, MD, formerly of Trek Therapeutics and Sorrento Therapeutics, helped develop resiniferatoxin (RTX), an injectable treatment for chronic pain from conditions like arthritis and cancer. [RTX] targets and permanently disables the nerve endings that transmit pain signals locally, potentially revolutionizing pain treatment. It specifically targets pain nerves without affecting other sensations, and eliminates chronic pain without the side effects of opioids by disabling oversensitive pain neurons and removing dependence on opioids.
The vice president of clinical research at Sorrento Therapeutics, Robert Hindes, MD, develops innovative therapeutic approaches in the treatment of autoimmune disease. Robert Hindes, MD, also serves as the chief medical officer of Trek Therapeutics in Cambridge, Massachusetts, where he supports the company’s mission to create affordable, accessible treatments for people with diseases such as hepatitis C (HCV).
PSI-7977 is a nucleotide analog polymerase inhibitor being studied for the treatment of HCV. A Phase 2b trial found that once daily PSI-7977 plus pegylated interferon and ribavirin achieved a 98% rapid virologic response rate in treatment-naive HCV genotype 1 patients. A separate trial found that all 24 treatment-naive HCV genotype 2/3 patients achieved undetectable viral loads by week 4 of once daily PSI-7977 plus pegylated interferon and ribavirin therapy, and all patients maintained an undetectable viral load through week 12. Preliminary viral dynamic modeling of PSI-7977 data suggests a relationship between drug exposure levels and antiviral response
The World Health Organization’s Pharmacovigilance ProgramRobert Hindes MD
Formerly based in Connecticut where he worked with Bristol-Myers Squibb, Robert Hindes, MD, has served Trek Therapeutics as chief medical officer since 2014. In this role, Robert Hindes, MD, directly supervises Trek’s pharmacovigilance (PV) program.
Robert Hindes, MD is the chief medical officer and cofounder of Trek Pharmaceuticals. He works with the Trek team to develop affordable treatments for viral infections like hepatitis C. Trek brings together medical researchers to help patients worldwide access low-cost treatments. Currently, Trek is conducting trials of the drug Faldaprevir combined with other antivirals to treat hepatitis C. Phase 2a studies showed all patients achieved a sustained viral response when treated with Faldaprevir plus two other drugs. Further clinical trials aim to create treatment affordable for most patients globally.
Trek Therapeutics' Work as a Public-Benefit CorporationRobert Hindes MD
The former group director of virology at Bristol-Myers Squibb in Wallingford, Connecticut, Robert Hindes, MD, co-founded Trek Therapeutics in September 2014. As the organization’s chief medical officer, Robert Hindes, MD, is responsible for the development of clinical strategy.
What Are the Different Phases of Clinical Trials?Robert Hindes MD
Clinical trials are broken down into five phases. Phase 0 involves limited exposure to human subjects for exploratory purposes. Phase I tests new treatments on a small number of people to evaluate safety and side effects. Phase II expands trials to more people to generate data on effectiveness at different doses and durations. Phase III further expands trials to large and diverse populations to demonstrate safety and efficacy compared to approved treatments. Phase IV occurs after approval to obtain additional data on effects in the general population.
TREK Therapeutics is developing affordable treatments for hepatitis C using two licensed assets - Faldaprevir (FDV, a protease inhibitor) and TD-6450 (an NS5A inhibitor). TD-6450 has shown potent viral load reductions in genotype 1 patients in clinical trials. The company aims to develop low-cost regimens using these assets for global markets and is currently conducting a phase 2a trial of FDV+TD-6450 for genotype 4 patients in the US. TREK is uniquely positioned with these well-characterized assets and an experienced management team to rapidly develop and commercialize regimens for major global markets.
Robert Hindes, MD is the chief medical officer of Trek Therapeutics, a company seeking new treatments for hepatitis C virus (HCV). Doctors at Monash University are urging the Australian government to subsidize new direct-acting antiviral drugs that can cure HCV to prevent thousands of avoidable deaths from liver disease. The new drugs work by disrupting HCV replication and infection. Researchers cited the drugs' high cure rates but noted that without subsidies, their high cost puts them out of reach for most patients and could lead to over 22,000 HCV-related deaths in Australia by 2030.
Dr. Robert Hindes published numerous articles on infectious diseases like hepatitis B and C after completing a research fellowship at Harvard Medical School. The document discusses the co-infection of hepatitis C virus (HCV) and human immunodeficiency virus (HIV), noting that HCV is transmitted through contact with an infected person's blood, often from sharing needles, and this increases the risk of co-infection with HIV. It states that co-infected patients experience accelerated liver disease according to the National Institutes of Health.
American Liver Foundation Rallies Support for Liver Life WalksRobert Hindes MD
Robert Hindes, MD founded Trek Therapeutics in 2014 to develop more affordable treatments for hepatitis C and other infectious diseases. The CDC estimates that over 4 million Americans have chronic hepatitis B or C, which can lead to liver disease, cirrhosis, and cancer. While current antiviral treatments are effective for many patients, barriers to treatment still exist for some. The American Liver Foundation holds annual Liver Life Walks across the country in May and June to raise funds and awareness for hepatitis and other liver diseases.
Research Examines Combination Treatment for Hepatitis CRobert Hindes MD
A study examined the combination of sofosbuvir, ribavirin, and pegylated interferon alfa-2a to treat genotype 1 hepatitis C infection. Researchers divided patients into three cohorts receiving different treatment regimens and found patients tolerated sofosbuvir well over 12 weeks. The study concluded further trials should examine sofosbuvir therapy for people with hepatitis C and cirrhosis.
Robert Hindes, MD helped develop sofosbuvir, a potent nucleotide analogue, while vice president of clinical development at Pharmasset. Sofosbuvir inhibits HCV polymerase and is currently the most effective drug being tested to treat hepatitis C. After Gilead Sciences acquired Pharmasset, they conducted Phase 3 clinical trials of sofosbuvir alone and in combination with other agents like ribavirin. These combinations resulted in high sustained response rates up to 12 weeks post treatment.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central19various
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
What Are the Different Phases of Clinical Trials?Robert Hindes MD
Clinical trials are broken down into five phases. Phase 0 involves limited exposure to human subjects for exploratory purposes. Phase I tests new treatments on a small number of people to evaluate safety and side effects. Phase II expands trials to more people to generate data on effectiveness at different doses and durations. Phase III further expands trials to large and diverse populations to demonstrate safety and efficacy compared to approved treatments. Phase IV occurs after approval to obtain additional data on effects in the general population.
TREK Therapeutics is developing affordable treatments for hepatitis C using two licensed assets - Faldaprevir (FDV, a protease inhibitor) and TD-6450 (an NS5A inhibitor). TD-6450 has shown potent viral load reductions in genotype 1 patients in clinical trials. The company aims to develop low-cost regimens using these assets for global markets and is currently conducting a phase 2a trial of FDV+TD-6450 for genotype 4 patients in the US. TREK is uniquely positioned with these well-characterized assets and an experienced management team to rapidly develop and commercialize regimens for major global markets.
Robert Hindes, MD is the chief medical officer of Trek Therapeutics, a company seeking new treatments for hepatitis C virus (HCV). Doctors at Monash University are urging the Australian government to subsidize new direct-acting antiviral drugs that can cure HCV to prevent thousands of avoidable deaths from liver disease. The new drugs work by disrupting HCV replication and infection. Researchers cited the drugs' high cure rates but noted that without subsidies, their high cost puts them out of reach for most patients and could lead to over 22,000 HCV-related deaths in Australia by 2030.
Dr. Robert Hindes published numerous articles on infectious diseases like hepatitis B and C after completing a research fellowship at Harvard Medical School. The document discusses the co-infection of hepatitis C virus (HCV) and human immunodeficiency virus (HIV), noting that HCV is transmitted through contact with an infected person's blood, often from sharing needles, and this increases the risk of co-infection with HIV. It states that co-infected patients experience accelerated liver disease according to the National Institutes of Health.
American Liver Foundation Rallies Support for Liver Life WalksRobert Hindes MD
Robert Hindes, MD founded Trek Therapeutics in 2014 to develop more affordable treatments for hepatitis C and other infectious diseases. The CDC estimates that over 4 million Americans have chronic hepatitis B or C, which can lead to liver disease, cirrhosis, and cancer. While current antiviral treatments are effective for many patients, barriers to treatment still exist for some. The American Liver Foundation holds annual Liver Life Walks across the country in May and June to raise funds and awareness for hepatitis and other liver diseases.
Research Examines Combination Treatment for Hepatitis CRobert Hindes MD
A study examined the combination of sofosbuvir, ribavirin, and pegylated interferon alfa-2a to treat genotype 1 hepatitis C infection. Researchers divided patients into three cohorts receiving different treatment regimens and found patients tolerated sofosbuvir well over 12 weeks. The study concluded further trials should examine sofosbuvir therapy for people with hepatitis C and cirrhosis.
Robert Hindes, MD helped develop sofosbuvir, a potent nucleotide analogue, while vice president of clinical development at Pharmasset. Sofosbuvir inhibits HCV polymerase and is currently the most effective drug being tested to treat hepatitis C. After Gilead Sciences acquired Pharmasset, they conducted Phase 3 clinical trials of sofosbuvir alone and in combination with other agents like ribavirin. These combinations resulted in high sustained response rates up to 12 weeks post treatment.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central19various
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
2. Extensively involved in research on the treatment of
Hepatitis C (HCV), Robert Hindes, MD, serves as the chief
medical officer of Trek Therapeutics, a B (benefit)
corporation that he cofounded. Robert Hindes, MD, and his
team at Trek Therapeutics are developing novel, affordable
therapies for curing HCV.
The cost of existing HCV therapies has generated
significant controversy in recent years. Gilead Science,
which offers the leading curative regimen, priced its drug
Sofosbuvir at $1,000 per pill. A single course of treatment
with Sofosbuvir costs $84,000. That cost covers only one
drug that may be part of a larger curative regimen. For
patients treated in one New York City hospital, the cost of
a cure averaged more than $171,000.
3. Kian Bichoupan, PhD, of Mount Sinai Icahn
School of Medicine has pointed out that this
cost, overwhelming as it is, is still lower in
total than the cost of treatment with earlier
HCV regimens, since the newer drugs have
such a higher rate of successful outcomes.
Thus, while the individual cost of treatment
may be higher, the per-cure cost is actually
lower because more patients actually reach a
point where the HCV becomes undetectable.
4. While Bichoupan makes a valid point, the cost of
treatment is still prohibitive for many people in
the United States, and makes paying for curative
treatments extremely difficult in developing
nations, where they are desperately needed. In
the United States, most insurance companies
have developed algorithms which prioritize
treatments for patients with more advanced liver
disease, leaving the majority of HCV infected
patients without access to the marketed
regimens from Gilead and Abbvie.