trialsitenews's podcast: Recent Episodes
TrialSite News
TrialSite News Podcast Series is a segment where we talk with patients, doctors, CROs, nurses, clinical researchers and investigators, and clinical site representatives, to give you a full view of healthcare. We want our audience to know the good and the bad happening with clinical trials and research, and to see what is working and what is not.
In the last few weeks, the mainstream media ran with stories about Ivermectin, most noticeably referring to it as "horse medicine" or "horse dewormer" while, for some reason, leaving out the fact that Ivermectin is a WHO essential medicine for HUMANS.
At the same time, the mainstream media and social media ran with a specific story about Oklahoma hospitals having to turn away gunshot victims because of a surge of people overdosing on Ivermectin. The bombshell story turned out to be false, forcing magazines, like Rolling Stone, to issue a correction, but not before popular news outlets shared it widely on social media, without Big Tech's "disclaimer of shame" for spreading misinformation. Dr. Kory Responds.
An interview with Kelly McKee from Medidata on transforming the patient clinical trial experience.
Join the Conversation! | https://trialsitenews.com/ In the first edition of CATalyst, Shabnam Palesa Mohamed engages Advocate Dipali Ohja (IBA), Dr Pierre Kory (FLCCC), and Dr Tess Lawrie (EBMC) about the Indian Bar Association's decision to issue legal notice on WHO chief scientist, Dr Soumya Swaminathan. The 51 page notice, served 25th of May, claims as its legal basis alleged WHO's 'disinformation and censorship' on the Ivermectin issue. #CATalyst #TrialSiteNews #TrialSiteNewsAfrica #TSNA
We sit down with Ralph Lorigo, of the Law Office of Ralph C. Lorigo to discuss NY court cases regarding Ivermectin and Covid-19.
His firm have represented a number of elderly patients who have taken on their respective hospitals who refused to continue to administer doctor prescribed Ivermectin for the treatment Covid-19. This episode does not discuss the efficacy of the drug in relation to the virus, but rather, the legal fight surrounding it. Watch the video to hear the whole story!
Join The Conversation, Visit us at:
www.trialsitenews.com
Check out the Law Office Of Ralph C. Lorigo:
https://www.lorigo.com/
We sit down with Ralph Lorigo, of the Law Office of Ralph C. Lorigo to discuss NY court cases regarding Ivermectin and Covid-19.
His firm have represented a number of elderly patients who have taken on their respective hospitals who refused to continue to administer doctor prescribed Ivermectin for the treatment Covid-19. This episode does not discuss the efficacy of the drug in relation to the virus, but rather, the legal fight surrounding it. Watch the video to hear the whole story!
Join The Conversation, Visit us at:
www.trialsitenews.com
Check out the Law Office Of Ralph C. Lorigo:
https://www.lorigo.com/
Shabnam Palesa Mohamed: Activist. journalist, mediator (LLB). Founder of SAHARI and THJ CEO, discusses state of Ivermectin in South Africa. We discuss the twists and turns of the legality issues of the drug, to a campaign to bring awareness through-out the country and beyond.
Petition Link:
https://www.change.org/p/president-cyril-ramaphosa-south-africa-has-a-right-to-ivermectin
We talk with Dr. Kedar about rural research initiatives and the impact Covid-19 has had in bringing advanced research to them. Dr. Kedar specializes in autoimmune diseases that effect the musculoskeletal system, such as rheumatism, arthritis, and other disorders of the joints, muscles and ligaments.
Dr. Kedar's Website:
https://www.ruralamericaandcovid19.com/
Google podcasts:
https://www.google.com/podcasts?feed=aHR0cHM6Ly9hbmNob3IuZm0vcy8zZTM0NjM1Yy9wb2RjYXN0L3Jzcw==
Spotify:
https://open.spotify.com/show/41OxseQXTDxL8Zbru2YUNg
Apple podcasts:
https://podcasts.apple.com/us/podcast/rural-america-and-covid-19/id1552461945
Today we’ll be touching on a tough subject, Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord.
Essentially, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. Eventually, the disease can cause permanent damage or deterioration of the nerves.
So, what does this mean? Symptoms range from numbness or weakness one your limbs, electric-shock sensations that occur with certain neck movements, tremors, lack of coordination, and can cause visions like partial, or complete loss of vision.
Melanie Rice who herself is suffering from Multiple Sclerosis. She was diagnosed Sept 20 2019 at the Mayo Clinic in Jacksonville Florida. Since then she has uncovered an entire community, or more appropriately, a family of thousands of people struggling with this autoimmune disease. She has become an advocate for MS patients, and so we have brought her on to talk with us about her illness.
Related Links:
http://www.wheelchairkamikaze.com/2015/03/national-ms-society-decision-makers.html
We sit down with Sam Searcy to talk about his Company Clinistart, and innovative cloud-based service providers designed to accelerate clinical trial site activation and study start up. The goal: accelerate each step of the clinical trials process to accelerate the availability of medicines sooner for patients.
You can check out Clinistart by clicking here:
https://clinistart.com/
We sit down for an interview with Dr. John Boockvar, vice chair of neurosurgery at Lenox Hill Hospital, who started a first-in-human clinical research study involving a new surgical technique to treat glioblastoma multiforme (GBM) - the most aggressive form of brain cancer.
Dr. Boockvar was one of the neurosurgeons featured on the highly praised Netflix series, Lenox Hill. See link here:
https://www.netflix.com/title/80201728
About the Procedure:
After standard tumor resection, the patient's own scalp tissue is harvested, rotated and engrafted and used to line the resected tumor cavity. It is our hope that by doing tissue autograft, it will allow to bypass the blood brain barrier so chemotherapeutics and immune cells can better reach the tumor site, improving treatment for GBM patients.
The study entitled, "Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme," is being led by John Boockvar, MD, the hospital's vice chair, neurosurgery and director of Lenox Hill's Brain Tumor Center. To be eligible for the study, participants must be 18 years of age or older and plan to undergo resection of known or suspected GBM.
Press release about the first patient for further background:
https://www.northwell.edu/news/lenox-hill-first-to-study-using-tissue-autograft-for-gbm-tumors-in-humans
Lenox Hill's neurosurgery department webpage:
https://lenoxhill.northwell.edu/neurosurgery
Social Media:
Instagram: lhh_neurosurgery
Twitter: @LenoxNeurosurg
Dr. Boockvar, background link:
https://www.northwell.edu/about/leadership/john-andrew-boockvar-md
Dr. Boockvar's research at the Feinstein Institutes for Medical Research:
https://feinstein.northwell.edu/institutes-researchers/our-researchers/john-boockvar-md
An interview with Dr. Gerald Maguire about the Phase 2 Speak Freely Study, which is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, exploratory study in adult subjects with childhood onset fluency disorder. Essentially a study directed at adults with stuttering.
About Gerald A Maguire, MD, DFAPA
Professor and Chair, Psychiatry and Neuroscience
University of California, Riverside School of Medicine
Study Link:
https://speakfreely.researchstudytrial.com/
World Stuttering Network:
http://www.worldstutteringnetwork.net/
We discuss "Smart" Natural Killer Cells for Cancer Treatment, Sonny Hsiao of Acepodia. A clinical trial targeting HER2-expressing solid tumors with “smart” NK cells.
Sonny Hsiao is the founder and CEO of Acepodia. Founded in 2016 the company seeks to develop new therapies in immune-oncology and cell therapy medicine. Put another way Acepodia is a novel technology platform that serves to arm immune cells with antibodies to cure cancer.
Company Website: www.acepodia.com
LinkedIn: https://www.linkedin.com/in/sonny-hsiao-83199956/
An Interview with Dr. Ian Smith, Founder, Director and Chief Medical Officer of Panthera Biopartners and CEO of Panthera Biopartners Stuart Young discussing the Lessons from Covid-19 and the differing strategies for recruiting and retaining patients in oncology and chronic diseases including CNS, Rheumatoid arthritis, Nash and cardiovascular.
About Panthera:
An independent site management organization run by a world-class team of experts, finds patients and runs clinical trials on behalf of CROs and pharma companies across multiple therapeutic areas.
https://www.panthera-bio.com/
About Dr. Ian Smith:
Dr. Ian founded Synexus, the world’s first independent clinical trials organization, whilst practicing as a GP. He went on to build the Synexus model into the foremost SMO with sites across the world.
Today Ian is a non-executive director of several healthcare companies. Ian was awarded an MBE for services to health research.
About CEO Stuart Young
Stuart previously managed the UK division of Synexus overseeing nine dedicated research sites. Stuart is particularly focused on the use of technology to reduce costs in clinical trials, provide a first rate patient experience and ensure that Panthera is at the cutting edge of clinical research.
Stuart, holds a degree in Mechanical Engineering from University of Strathclyde in Glasgow, has had extensive experience in data management and the introduction of new technologies into organizations.
Claudia Christian of FHI Clinical discusses Covid-19 impact on Clinical Trials. The challenge of patient recruitment in Clinical Trials
Claudia Christian is the Senior Vice President, Clinical Operations of FHI Clinical. FHI Clinical has, among other things provided clinical operations services for ACTT-1 trial of remdesivir for treatment of COVID-19. Claudia Christian has held positions in pharmaceutical, biotech and CROs across multiple indications. Since 2014, she has devoted her expertise full-time to infectious disease research, including managing multiple study protocols and developing sites in support of outbreak responses.
https://www.fhiclinical.com/the-elusive-covid-19-patient-subject-recruitment-remains-challenging-despite-increasing-case-numbers/
We sit down and talk to Dr. Abribat about Amolyt Pharma, which is developing therapeutic peptides to treat rare endocrine and metabolic diseases. The company recently announced that it has dosed the first patient in a Phase 1 clinical trial evaluating its experimental therapeutic peptide, AZP-3601, for a life-altering rare disease called hypoparathyroidism. This is Amolyt’s first clinical trial as a company. The trial, being conducted at sites in Europe, will test whether AZP-3601 will benefit patients with hypoparathyroidism by restoring lasting levels of calcium in their blood. Thierry Abribat, PhD can discuss why therapeutic peptides may provide better treatment options for patients with rare endocrine and metabolic diseases, the unmet need in hypoparathyroidism, AZP-360 and the ongoing trial
Dr. David Horn Solomon, CEO of Pharnext discusses PXT3003 which is currently focused on the treatment of Charcot Marie-Tooth (CMT) disease Type 1A.
Charcot-Marie-Tooth is a degenerative nerve disease that usually appears in adolescence or early adulthood. CMT affects the Peripheral Nervous System. It is a progressive nerve disease. Nerves weaken over time, causing progressive disability starting in the toes and fingers and working toward the center of the body.
You can visit Pharnext by clicking on this link: https://pharnext.com/
About:
Dr. Solomon is a leader in the life sciences industry with a 30+ year track record. Prior to joining Pharnext, David served as the CEO of Silence Therapeutics (NASDAQ:SLN), Akari Therapeutics (NASDAQ:AKRI), Bionor Pharma (OSLO:BIONOR), and Zealand Pharma (NASDAQ:ZEAL) guiding Zealand through approval of Adlixin for Type II Diabetes. He was Managing Partner at Sund Capital in Denmark and also headed healthcare investments at Carrot Capital Healthcare Ventures in New York City. A former Board member of TxCell (acquired by Sangamo Therapeutics), Onxeo, and Promosome, David is currently Chairman of the Board for Advicenne Pharma (PARIS: ADV) and Rexgenero in London. David was earlier a Professor of Pharmacology and Neurology at Columbia University’s College of Physicians and Surgeons in New York City.
Dr. Lenze discusses a clinical trial conducted by Washington University School of Medicine in St. Louis which evidences the potential that fluvoxamine, an antidepressant, may prevent COVID-19 infections from worsening. This trial is based on recent research that originates from the University of Virginia School of Medicine.
Website: https://stopcovidtrial.wustl.edu/
Phone: 314-747-1137
Email: stopcovidtrial@wustl.edu
Dr. Ragen discusses X4 Pharmaceuticals, which is currently developing therapies for rare genetic diseases that result from dysfunction of the immune system and is currently undergoing a global Phase 3 trial for WHIM Syndrome and two Phase 1b trials for Waldenstrom macroglobulinemia (WM), a type of rare lymphoma, and severe congenital neutropenia (SCN).
We sit down with Dr. CJ Barnum, Director of Neuroscience at Inmune Bio, Inc. to talk about the recently announced grant from the NIH for $2.9 million to test a new hypothesis that #neuroinflammation plays a major role in treatment resistant depression (TRD).
This money will support a first-of-its-kind phase 2 study that will be conducted at two sites in the U.S. – Emory University School of Medicine in Atlanta and University of Alabama in Birmingham. Patient enrollment will be based on levels of inflammatory biomarkers and anhedonia, rather than being an all-comers study which is the standard in today’s psychology trials.
We also discuss INmune Bio Inc.'s developing novel therapies targeting distinct parts of the patient's immune system to fight disease. This includes drug candidates to treat #cancer, and #Alzheimers disease.
To find out more about Inmune Bio Inc. you can check out there website:
https://inmunebio.com/
Hartmut Ehrlich and Philippe Pouletty discuss Abivax Pipeline of Clinical Programs involving Covid-19, Ulcerative Colitis, Crohn's Disease and more.
https://www.abivax.com/pipeline/
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COVID-19
https://www.abivax.com/pipeline/abx464-for-covid-19/
Ongoing Phase 2b/3 trial with ABX464 in Covid-19 (miR-AGE trial), the unique properties of the lead candidate (antiviral, anti-inflammatory, tissue repair) to treat elderly and high-risk Covid-19 patients, the rial is ongoing in Europe and Brazil (Mexico, Peru and Chile to follow shortly)
-#Cancer
https://www.abivax.com/pipeline/abx196/
ABX196 has been developed as a synthetic agonist of iNKT cells from a proprietary platform technology that identifies agonists of these types of cells that demonstrate immune enhancing effects in cancer models.
Preclinical data showed that ABX196 enhanced anti-tumoral activity when used alone and in combination with anti-PD1 antibodies or doxorubicin.
-
Ulcerative Colitis
https://www.abivax.com/pipeline/abx464-ibd-uc/
ABX464 in Inflammatory Bowel Diseases (Abivax development priority), excellent two-year efficacy and safety data for ABX464 ulcerative colitis Phase 2a maintenance study and ongoing ulcerative colitis Phase 2b trial in 15 countries, the US and Canada -
Crohn’s disease
https://www.abivax.com/pipeline/abx464-for-crohns-disease/
Planned pivotal Phase 2b/3 trial with ABX464 in Crohn’s disease (FPI Q1 2021) and ngoing clinical trial with ABX464 in rheumatoid arthritis in 5 European countries -
HC
Ongoing clinical trial with second molecule, ABX196, in patients with hepatocellular carcinoma in the US
Dr. Negin Hajizadeh discussing Feinstein Institutes researchers finding an effective COVID-19 ‘cytokine storm’ treatment and more. Dr. Hajizadeh is an ICU pulmonologist and was a part of Northwell Health's, NY largest health system, at the height of the surge. She has experienced and delivered care first hand. She is also a researcher with the Feinstein Institutes.
#Recovery trial #Covid-19
Dr. Pierre Kory Talks Covid-19, Ivermectin and the FLCCC:
Dr. Pierre Kory, Associate Professor of Medicine at St. Luke’s Aurora Medical Center and who TrialSite News would classify as a Pulmonologist and ICU specialist dedicated completely to the COVID-19 patient. He has been a shining light in what can be a dark and murky time in his intense commitment to treat and ensure patients are safe from this pandemic. He was educated at the St. George University Medical School at and has been board certified by the American Board of Internal Medicine in Internal Medicine, Pulmonary Disease and Critical Care Medicine. Now, Recently the topic of a TrialSite News article, Dr. Kory is an active contributor to real world-based COVID-19 protocols based on extensive, unfolding and rich evidence from the clinic during the pandemic. One alliance known as the FLCCC is a topic of discussion today.
Dr. Richard Furie discuss his recent involvement with the Phase 3 BLISS-LN clinical trial that is setting the stage for the first ever FDA approved drug for lupus nephritis.
Dr. Furie is a professor at the Feinstein Institutes for medical research, Northwell Health’s science arm of the health system.
Regarded as one the senior rheumatologists in the New York metropolitan area, he has been on the Boards of Directors of the local chapters of the Arthritis Foundation and the Lupus Alliance of America and has been a member of the Medical-Scientific Advisory Council of the Lupus Foundation of America as well as its Lupus News editorial board. He also is on the Medical and Scientific Advisory Board of the SLE Foundation as well as the Alliance for Lupus Research Scientific Advisory Board.
We sit down with Alan Cannell, who has been a collaborator with TrialSite News down in Brazil and talk about treatments for Covid-19.
An engineer by training he is originally from the Isle Of Man between Scotland and Ireland and moved to Brazil IN THE 1970s and now has a family there. He has been applying his methodical engineering mindset to studying the trends of using Ivermectin at least at the local level in Brazil.
Dr. Peter McCullough sits down to talk with TrialSite News about Pathophysiologic Rationale for Early Ambulatory Treatment for COVID-19 as an Emergency Response to the Pandemic. Dr. McCullough is board certified by the American Board of Internal Medicine in internal medicine and cardiovascular disease. He has a Masters in Public Health in Epidemiology. Dr. McCullough is an internationally recognized authority on the evaluation of medical evidence concerning contemporary issues in medicine and has published widely with more than 1000 publications and 500 citations in the National Library of Medicine. He has been a leader in the medical response to the COVID-19 disaster and has published the first guidance for the medical treatment of ambulatory patients infected with SARS-CoV-2. And, he has published a widely read OPED series on COVID-19 in TheHill.
More on Dr. McCullough below:
TSN Article
YouTube Presentation
Baylor University Medical Center
Dr. Bruce Patterson, a decorated scientist and well-known physician as well as CEO & Co-Founder of IncellDx. Dr. Bruce Patterson talks about COVID-19 and any possible similarities between the HIV/AIDS epidemic and the SARS-COV2 virus.
To learn more go here and here
Mark Erlander, Chief Executive Officer at #CardiffOncology, Inc. talks #KRAS mutations in cancer, and existing products like mCRC, mCRPc and AML, along with three clinical programs including Zytiga-Resistant Metastatic Castration Resistant Prostate cancer (mCRPC); KRAS mutated Metastatic Colorectal #Cancer (mCRC) and Relapsed/Refractory Acute Myeloid Leukemia (AML). You can find out more here
Kathryn Ardizzone of KEI discusses COVID-19 vaccine and treatment contracts obtained by KEI from the USG under the Freedom of Information Act. The government's investment in COVID-19 vaccines and treatments. The Bayh-Dole Act and its implications for COVID-19 technologies, and efforts to get around the Bayh-Dole Act by using Other Transaction Agreements. And, the lack of transparency over federally-funded R&D.
Jason Baumgartner, a graduate from Duke University, both undergrad and MBA, has established a successful career in the world of clinical trials and drug development. In 2017 Jason founded BEKHealth Corporation. BEKHealth Corporation has advanced solutions working with health systems and their electronic medical records to support and facilitate clinical research.
Jason talks with us today about the current state of research operations in a COVID world. How COVID has impacted researcher capacity. How technology is improving patient pre-screening and enrollment . How sites can implement new technologies to alleviate manual processes and see more patients.
You can see more about Jason Baumgartner here
Today we have Dr. Hebbar from CalciMedica joining us today. Dr. Hebbar has 10+ years of clinical development and product development experience in both the pharmaceutical and diagnostics industries. Now, Privately held CalciMedica is dedicated to the discovery and development of novel small molecule drugs for the treatment of autoimmune disorders, organ transplant rejection, and other immune diseases. Founded in 2007 the San Diego-based company focuses on the discovery and development of CRAC channel inhibitor drugs. With the onset of the pandemic the company registered studies targeting severe COVID-19 pneumonia, a dangerous condition.
Today we welcome Roseanne Onyia Founder of a Clinical Research Organization in Nigeria called Clinique Research Development Limited.
TrialSite suggested in previous writings that perhaps clinical research could represent a framework to bring together healthcare assets nationwide in a way that encourages innovation helping it to potentially leapfrog existing constraints. Ms. Onyia is the convener of the nation’s Clinical Investigators Summit bringing together key stakeholders representing clinical research to discuss the state of clinical trials in Nigeria.
Bree Burks talks about how Clinical trials have gone through a transformation since the onset of COVID-19. Where and when possible research sponsors are moving to remote, decentralized or so-called virtual trials. She also discusses the ongoing challenges with the study start-up process and how her companies SiteVault Free eRegulatory solution for Clinical Research Sites can help.
https://www.linkedin.com/in/bree-burks-78a26040/
https://www.veeva.com/
Discussion with Dr. Jordan Dubow, about addressing the unmet need in the narcolepsy treatment landscape. Dr. Dubow has an impressive track record working in research, in the clinic, in health systems, in biotech companies, an impressive array of medical and research experience with an emphasis on neurology and vascular neurology.
Check out Avadel Pharmaceuticals here
We talk with Dr. Michael Brant-Zawadzki and Dr. Burton Eisenberg Hoag is First in Nation to Test Innovative Antibody Brain Cancer Drug; clinical trial for a novel immunotherapy treatment that holds considerable promise for glioblastoma (GBM), the deadliest form of brain cancer; Hoag's research and clinical trials.
To learn more https://www.hoag.org/specialties-services/cancer/
To learn more about Dr. Michael Brant-Zawadzki, M.D. https://www.hoag.org/about-hoag/leadership/michael-brant-zawadzki-m-d-f-a-c-r-/
To learn more about
Burton L. Eisenberg, M.D. https://www.hoag.org/specialties-services/cancer/physicians/burton-eisenberg-m-d-/
Listen as we talk to Dr. Taglietti about SCYNEXIS and their drug Ibrexafungerp
The press release below talks about their successful meeting with the NDA- https://ir.scynexis.com/press-releases/detail/216/scynexis-reports-successful-completion-of-pre-nda-meetings recently for Ibrexafungerp for the treatment of VVC, the common fungal infection affecting millions of women each year in the U.S.
To view a presentation go here
In this episode of TrialSite News Podcast we speak with Dr. Theresa Deisher about supercharging the body's own natural immune response; a potential solution to global pandemics, no-option cancers, and auto-immunity.
AVM Biotechnology's lead product, AVM0703, is based on a repurposed active ingredient (Dexamethasone) approved and in use for over 60 years. Originally being researched as a precursor conditioning agent to alleviate the side effects of chemotherapy, we discovered that significantly increasing the dose of AVM’s purified version induced novel natural killer T-cells (NKT), supercharged cytotoxic T-cells, and supercharged dendritic cells.
The combination of these three amplified immune cells mobilized by AVM0703 show promise in aggressive cancer models. NKT cells and cytotoxic T lymphocytes are by nature programmed to kill viruses and bacteria as well as cancer. The combination of these three mobilized supercharged immune cells should kill the COVID-19-causing virus (SARS CoV2) and induce long-term. These are cells which are not normally present in circulation and are uniquely induced by AVM0703. AVM received FDA IND permission to test our lead product AVM0703 for treatment of lymphoid malignancies. The mechanism of action that makes AVM0703 work against aggressive cancers may also prove effective against COVID-19.
To further that research, AVM Biotechnology has filed with the FDA for approval to proceed with clinical trials against this virus as well as Influenza virus which also causes deadly ARDS. With a global advisory team including experts in oncology, respiratory disease, and vaccines.
Fine out more about Dr. Deisher and AVM
To read more from AVM News go here
We talk with Robert Ietswaart about drug side effects, known as adverse drug events and how AI machine learning can possible help predict these reactions. According to some reports adverse drug reactions are responsible for about 2 million U.S. hospitalizations per year reports the Department of Health and Human Services.
To learn more or to reach out to Robert Ietswaart you can use the links below:
Harvard Medical School press release on our work
Link to publication and data
link to tweetorial: the whole paper explained 12 tweets
Today we have the pleasure of introducing Dr. Jean-Jacques Rajter a Broward Health Medical Center physician and his wife Dr. Juliana Cepelowicz Rajter, in Florida. We covered a story about Dr. Rajter back in April, where they were “pioneering” the use of the anti-parasitic drug ivermectin on COVID-19 patients. Today, we talk to with them both about the results from the Sunshine state, and what the future holds.
Visit Dr. Rajter at http://pscflorida.com/
In this episode we speak with Dr. Raphael Stricker about PrEP, Hydroxychloroquine, and Malaria treatments for COVID-19. Dr. Raphael Stricker also does great work with Lymes Disease. Below you will find several articles on Dr. Stricker's work and more information about him overall.
Lyme Disease
Lyme Disease Information
USMAMED
Lyme Disease Mexico
TrialSite News Article
In this podcast we were lucky enough to have #Dr.RogerSeheult from medcram join us here to go over a variety of topics, with a focus on #Ivermectin. Make sure yo go over and check his YouTube out as he's been following COVID-19 closely, and studies in relation to it. https://www.youtube.com/user/MEDCRAMvideos Or visit him at www.medcram.com #medcram
Below are the questions we asked Dr. Paraic Kenny about genomic sequencing and COVID-19
- First before we get into COVID-19 Dr. Kenney could you tell us about yourself. It certainly is impressive that you have your own lab. Kenny Lab, What got you interested in health and medicine not to mention research?
- On to COVID-19 when did you first start thinking this virus was going to be a big problem? · What was the genesis of the study to better under stand COVID-19 strains?
- How did you get involved with the local health department (La Cross Public Health Department)?
- We know that you have international partners in this endeavor? How did this come about?
- What have you learned thus far about the novel coronavirus (SARS-CoV-2)?
- Dr. Kenney we have heard that there are a number of SARS-CoV-2 strains—can you update the TrialSite Network audience—how many strains of SARS-CoV-2 are there? Are some more potent or dangerous than others?
- Do all the strains originate from Wuhan China? Is that conclusive?
- Based on your tests and investigation has any material strategies changed there at Gunderson in relation to COVID-19 treatments?
- How far along is this type of testing and analysis coming along across the United States?
- What are the implications for what you have accomplished thus far?
- Gunderson Health System has a great reputation—could you name three things that make it stand apart for other researchers to hear?
- Any parting words of wisdom for other researchers interested in similar pursuits? Any collaborations for them to consider
In this episode Carlos Chaccour will talk about potential Ivermectin use for COVID-19, the safety of Ivermectin, potential Ivermectin use for malaria, Ivermectin use for other communicable diseases and other potential uses of ivermectin. You can view more about Carlos Chaccour below: Carlos Chaccour -ISGlobal The Epidemiology and Economics of Coronavirus 1 The Epidemiology and Economics of Coronavirus 2
As director of neurology at Hudson Medical in New York Dr. Pitts heroically saved a women’s life back in April during the apex of the pandemic. Dr. Pitts connected with a mother of three and respiratory therapist who at one point was intubated for 16 days—sick with a severe to approaching critical form of COVID-19. Thankfully through Amy de Vos doctor heard about a study involving Dr. Pitts—who included Ms. de Vos in the small emergency approved study and the rest is history. The patient is alive today thanks to this study and clinical investigator. Listen to hear more about this situation and Dr. Pitts interested in clinical research and trials. To find out more about Dr. Tom Pitts please see the links below: Hudson Medical
400 million worldwide are impacted with rare diseases and approximately 30 million in America. With organizations like Global Genes we have come quite a ways to evangelize what amounts to very vulnerable groups. In this episode Christian Rubio talks about Global Genes and how they started, their goals, and what the future looks like, especially while dealing with COVID-19.
To find out more about Global Genes and Christian Rubio please see the links below:
Continuity of Care RARE Patient Impact Grant programRARE Drug Development Symposium RARE List Global Genes
In this podcast Dr. Robert Jeanfreau talks about a range of specifics, from how he got involved in medicine and founded MedPharmics to MedPharmics collaboration with East Jefferson General Hospital to collect blood samples to support clinical trials addressing COVID-19 extreme cases. You can see more information about Dr. Jeanfreau and MedPharmics here
Ed Seguine, CEO of Clinical Ink, talks about how hybrid trials, BYOD ePRO, and DDC can provide a valuable solution during a healthcare crisis like COVID-19
You can learn more about Ed Seguine and Clinical Ink below: https://www.clinicalink.com/virtual-trials/
Irfan Khan, M.D. talks about COVID-19 and the effect it will have on clinical trials, CROs, IROs, and research.
Dr. Khan goes over new capabilities that sites need to develop, be it virtual, home healthcare, or flexibility, and more, in order to stay competitive and keep high patient participation.
Below is a summary of the questions he answers in this podcast:
- What is an Integrated Research Organization (IRO) and how is Circuit Clinical positioned in this space?
- What did Circuit do to accommodate for Trial Continuity during COVID19?
- Can you describe what virtual engagement means to Circuit?
- What can Sponsors and CRO's do to help prevent participants from dropping out of studies and improve engagement?
- Do research sites need a stimulus for business to continue after COVID-19?
- Where do you see the future in clinical research going post-COVID-19 and what changes can the industry expect?
- What's the best outcome that can happen post-COVID-19? What can industry stakeholders do to rescue their studies and get back on track?
You can learn more about Dr. Khan and Circuit Clinical here and here
In this podcast Craig Lipset will discuss the following:
Telehealth
What technologies he thinks will come out on top after COVID-19
What process changes that might be organized in the future
How do you think rural healthcare will change How studies will evolve post COVID-19
And so much more
You can see more about Craig Lipset below: https://www.linkedin.com/in/lipset/ https://www.youtube.com/channel/UCOixPCH4cDmCVgRP2nDLLsQ/videos https://www.youtube.com/watch?v=Ezpamq6vO_c&feature=youtu.be
Gidon Akler, MD talks about collecting samples and sequence genomes from COVID-19 patients. They hope this will help identify protective and risk bearing genetic factors, there would help in diagnostic and treatment methods.
Below is a summary:
The Israel Ministry of Health and the Israel Innovation Authority, along with Sourasky (Ichilov) Medical Center and Rambam Health Care Campus in addition to a startup venture called Geneyx have formed a public-private consortium that will collect samples and sequence genomes from thousands of COVID-19 patients in an effort to identify protective and risk-bearing genetic factors with the aim of identifying new diagnostic and treatment methods. The startup offers next-generation sequencing data analysis, interpretation, reporting and storage products and services.
You can see more here and here
Rich Horgan has quite a personal and unique story about how he started "Cure Rare Disease" you will want to give this podcast a listen.
Cure Rare Disease has a focus on CRISPR gene-editing therapy, and how they can improve drug development for those with rare diseases. Listen below to hear about their goal to bring various groups together to find treatments for millions of people suffering with a rare disease.
You can learn more about Rich Horgan and "Cure Rare Disease" below:
- Facebook: https://www.facebook.com/CureRareDisease/
- Instagram: https://www.instagram.com/cureraredisease/
- Twitter https://twitter.com/cureraredisease
- LinkedIn: https://www.linkedin.com/company/cureraredisease/
Dr. Tiwari's lab focuses on developing AI and image-analysis techniques for personalized diagnostics and therapeutic applications in Glioblastoma. In this Podcast she will discuss the implications of this work in regards to clinical trials and how it may have an impact not just as "virtual biopsies" but also for targeting radiation therapy treatments.
You can find out more about Dr. Tiwari here and here
And watch more here
In this podcast we talk with Clark Swanson of Flavocure Biotech about their flavonoid derivative of Cannabis and its demonstrations in therapeutic potential in preclinical models of metastatic pancreatic cancer.
Read more here
You can see more at Flavocure.com
New York-based #ProofPilot was launched in 2014 to make #clinicaltrials easier to set up and run not to mention elicit #participation by making them fun. With ProofPilot anyone can design a research study (you don’t have to be a PhD)! Now with more rigorous studies, we get more and better answers that improve our healthcare—based on evidence. ProofPoint is privately held and has raised at least $1.85 million in venture funding from CueBall Capital and Brooklyn Bridge Ventures.
TrialSite talks to ProofPilot's Matthew Amsden about all of that and much more. You can learn more about ProofPilot and Matthew Amsden below:
ProofPilot
Matthew Amsden
We ask Dr. Alptunaer about his experience dealing with COVID-19 in Washington at this time.
- Although TrialSite News focuses on clinical research we are surely interested in improving, progressing the entire healthcare system.
- We have noticed many doctors must work for big health care systems now and that that there is less engagement and connection with the patient—has this been your experience? What about COVID-19? What are your thoughts on this pandemic? Should our federal government been more prepared? What about state governments? Public health agencies? Your thoughts are appreciated.
- We have seen some researchers warn about a "Bat Corona Virus" that could be more dangerous. It is scary how this virus has evolved to be far more contagious. Do you think there is more of this coming.
- We know you have emergency disaster preparedness background. Can you share how relevant that is to the novel coronavirus pandemic today?
- What lessons learned did you pick up on that are relevant too today?
- The government appears to have been caught flatfooted in our response. In fact we did the local New Orleans podcast and found that few actually were there to help in an orchestrated way at first Is this your general observation? We know you were in disaster readiness at some point…Do you have ideas of how we are doing with COVID-19? How can we improve? What could have been done earlier? Testing? More containment, etc.?
- We did an article that it appears China censored a good deal of the information in at least Dec. 2019- and perhaps even in Nov. If so, they indirectly causes the lives of many more people. If this is true, do you think that the censure of COVID there made it worse in some ways?
- Have you ever been involved with any clinical research? If yes could you share your high-level experience and what importance you place on real world evidence studies (e.g. use of large troves of electronic health data).
- Do you think the experiences from COVID-19 will help contribute to a new and more accessible health care model? E.g. insurance companies make coverage easier, etc.
You can learn more about Dr. Alptunaer below:
https://smhs.gwu.edu/emed/education-training/fellowships/ems-disaster/disaster-and-operational-medicine-fellows
PACE conference in Mexico on hospital evacuation. https://paceforum.org/ ASTRO (Radiation Oncology) telepresentation (zoom) on my experience with COVID and current practice trends/perspectives from an Emergency Medicine Physician.
Laurence Heifetz, MD founded the Gene Upshaw Memorial Tahoe Forest Cancer Center in the rural town of Truckee, located in the Sierra Nevada mountain range in California. Based in a rural part of California with previously no cancer center, with the use of telehealth technology, commitment, local participation and a partnership with University of California, Davis, the residents of this part of the beautiful and relatively isolated part of California now have access to not only high-quality cancer care but also direct opportunity to participate in global clinical trials with cutting-edge experimental therapies—literally these studies can save lives that a decade ago couldn’t be saved.
You can read more below:
https://tahoecancercenter.com/multimedia/video-addressing-cancer-care-disparities-via-virtual-tumor-boards
https://www.vumedi.com/video/addressing-disparities-in-cancer-care/
https://tahoecancercenter.com/multimedia/podcast-a-model-for-rural-oncology
https://www.targetedonc.com/search?keywordTerm=Heifetz&x=0&y=0
Dr. Bella Madan discusses Hemophilia with TrialSite News. Dr. Madan has been focusing on new, gene-therapy based treatments for hemophilia. She joined Guy’s and St. Thomas’ hospital in the UK as a consultant hematologist in 2002. With extensive expertise in the management of inherited and acquired bleeding and thrombotic disorders such as hemophilia, she has been serving as a principal investigator on a number of important clinical trials involving gene therapy and other novel treatments. She has been an influential force including co-authoring of joint RCOG/UKHCDO guidelines on obstetric management of women inherited bleeding disorders and has a special interest in hemophilia. She leads a Phase I /2 gene therapy trial as well focusing on hemophilia.
You can reach her here
A special edition Podcast episode where we had a chance to sit down with Chris Guccione, a musician and resident of New Orleans who has been under self quarantine for sometime now because of the Virus Covid-19 TrialSite News focuses on clinical research with an emphasis on actual clinical trials. The COVID-19 crisis has obviously got us focusing and learning about this emerging pandemic.
Based on our research we have uncovered that the U.S. coronavirus testing infrastructure, unfortunately has not been as ready as any of us would of liked. Unfortunately this is impacting people all over the country that don’t have access to tests. This is in contrast to countries such as China, South Korea and Germany where testing seems to be more pervasive and methodical.
Dr. Michael Weiner discusses the challenges in patient recruiting in clinical trials for Alzheimer's Disease, and more.
Michael Weiner, MD, is a Professor in Residence in Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology at the University of California, San Francisco.
Below are some clinical trials Dr. Weiner is currently working on- source UCSF
- Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol Start Date: Oct 2016 Estimated Completion Date: Oct 2021 Recruitment Status: Recruiting Condition(s): Mild Cognitive Impairment,Alzheimer's Disease
- Online Neuropsychological Test Validation Project With Imaging Pilot Start Date: Jan 2015 Estimated Completion Date: Dec 2020 Recruitment Status: Active, not recruiting Condition(s): Validation of Online Cognitive Testing
- Brain Health Registry Start Date: Sep 2013 Estimated Completion Date: Sep 2028 Recruitment Status: Recruiting Condition(s): Neurodegenerative Disease
The small, Chicago-based biotech venture Errant Gene Therapeutics, which was engaged in a court battle against a well-funded biotech called Bluebird Bio and a venture capital firm known as Third Rock Ventures. With allegations of breach of contract, tortious business interference, and fraud, TrialSite News initiated a project to review publicly available information, including court records, to derive a more thorough understanding of the case at hand.
First podcast is located here
Published in the Medical Journal of Australia, the authors included Lee-Fay Low, Associate Professor in Ageing and Health at the University of Sydney conclude what is definitely a factor in America and undoubtedly elsewhere. Those that have less means, that may be different than the majority, that may face a past of discrimination face residual bias in the research and health establishments.
You can read more here
You can find Dr. Lee-Fay Low here and here
"The only way we will cure cancer is if we work together to collect and share scientific rigorous data on thousands of patients in a transparent way that also protects patient privacy." Dr. Dane Dickson
Taproot Health has signed memorandums of understanding with several National Cancer Institute-designated cancer centers and community oncology clinics to conduct a master observational trial with the aim of collecting and sharing data that will help advance precision oncology. Read more here
We talk to Taproot Health, a data-as-a-service enterprise uniting oncology stakeholders, which is powered by a patient and clinic-centric model of shared data and revenue mediated through proprietary methods and technology. The guests we spoke with were Dane Dickson, Ceo and Founder, and Rebecca Owens, Chief Commercial Officer and Co-Founder of Taproot Health.
You can reach Dr. Dane Dickson here
You can reach Taproot here
Christine Chio, PhD, assistant professor of genetics and development at Columbia University Medical Center, recently was the recipient of the Pancreatic Cancer Action Network (PanCAN) Catalyst Grant. She has been recognized for among other things, innovative use of “organoids” or a way to grow clusters of cells three-dimensionally in a dish in an effort to investigate the behavior of pancreatic cancer cells. This process led to the identification of a potential new drug target.
You can reach Christine Chio, PhD here and you can read more here
Teresa Quattrin, MD and University of Buffalo (UB) distinguished professor of pediatrics and senior associate dean of research integration spreads the word about clinical trials worldwide in a novel and brilliant way—through a children’s story book. By co-authoring this coloring book she sought to introduce the world of clinical trials to children and their parents creatively in away that gets more to open their eyes to the potential of clinical research. The book was supported by UB’s Clinical and Translational Science Institute and the International Institute of Buffalo. The book is titled “Sofia Learns about Research” and TrialSite News has been a proud sponsor of the book on our website.
Sofia learns about research
The Association of Black Cardiologists (ABC) recently held an event with Black community leaders in downtown Atlanta. They were joined by a panel of medical professionals and community leaders and the discussion centered on the disparities in health care for African Americas including the lack of access when it comes to cardiovascular-related issues. African American participation in cardiovascular-based clinicals was identified as a critical factor toward improved health.
The group at this workshop—both medical professionals and community leaders—agreed that access to healthcare information and clinical trials is key moving forward. Why? Well, for starters, Dr. Jayne Morgan, a cardiologist with Piedmont Healthcare, declared that their profession is not doing enough to secure approval for Blacks.
Morgan and others firmly believe that clinical research as a care option—access to clinical trials in community settings within African American districts in cities such as Atlanta, for example, can better ensure that Blacks receive the best medical care—that is, “maximal care.” She went on to declare, “Clinical trials, especially cardiology and oncology, that can potentially add precious years to your life go unaccessed by members of our community.”
You can find Dr. Jayne Morgan here and here
What does it take to start doing virtual trials? Listen as Kim Kundert, RN, BSN VP of Operations of VirTrial goes over how to start getting your organization ready and certified to offer these.
Pratia, purported to be the largest network of clinical research sites in Europe, has inked a partnership with VirTrial to complete their Virtual Trial Capable training and establishing them as the first site network in Europe trained and certified as “Virtual Trial Capable” and ready to conduct decentralized clinical trials (DCT).
Read more here
Visit VirTrial Here
You can also follow Kim Kundert here
Elizabeth “Betsy” Nugent, MSPH, CCRP, becomes the inaugural Director of Clinical Trials Development and Accreditation/Chief Clinical Research Officer, effective September 3, 2019. Ms. Nugent will lead to the establishment of the School of Medicine and Public Health and UW Health as a premier research organization.
Nugent, internationally recognized for leveraging clinical trials to transform research into therapies that help treat diseases and advance human health, brings a wealth of practice experience to UW.
To read more about Betsy Nugent, MSPH,CCRP click the links below
https://www.uwhealth.org/onlineservices/cancertrials/
https://ictr.wisc.edu/groups/office-of-clinical-trials-oct/
http://www.acresglobal.net/
https://acrpnet.org/
https://www.socra.org/
https://www.magiworld.org/
Georgia Institute of Technology (Georgia Tech) researchers have produced a striking study revealing the lengths patients need to go to secure funding for advanced personalized medicines, such as CAR T. The study’s authors investigate the use of crowd funding for two types of blood cancer and associated expenses to access investigational clinical trials.
Read more
UCLA Geneticist Steve Horvath has led a small clinical study that effectively reversed the participant’s epigenetic clock for what appears to be about 2.5 years as reported in Nature. The study involved a combination of drugs and growth hormones. Patients were treated with a combination of growth hormone and two diabetes medications which appeared to have worked—also rejuvenating the participant’s immune systems. The participating scientists found themselves surprised by the results.
The Study
The study actually started back in 2015 when Gregory Fahy, the chief scientific officer and co-founder of Intervene Immune in Los Angeles, the study sponsor. An immunologist by profession, Fahy requested that Horvath analyze the results to assess the impact on the patients’ epigenetic clock or biological age reported Newsweek. The study went on for a year and involved nine healthy participants. They were administered a cocktail of three common drugs—growth hormone and two diabetes medications. Called the Thymus Regeneration, Immunorestoration and Insulin Mitigation (TRIIM) trial, 9 white men participated—between the ages of 51 and 65 years of age. The study was approved by the FDA in May 2015. It was conducted at Stanford Medical Center in Palo Alto, CA.
To reach out to Dr. Fahy at Intervene Immune go here
For more information about Dr. Fahy and his work go here and here
Linda Lopez-George discusses why it is important to improve access and participation in clinical trials among minority and undeserved populations.
To view Linda Lopez-George Linkedin go here https://www.linkedin.com/in/linda-lopez-george/
To view UT Health San Antonio please go here
https://www.uthscsa.edu/?utm_source=uthealthsaorg&utm_medium=pageredirect&utm_campaign=uthealthsa
Linda Lopez-George discusses why it is important to improve access and participation in clinical trials among minority and undeserved populations.
To view Linda Lopez-George Linkedin go here https://www.linkedin.com/in/linda-lopez-george/
To view UT Health San Antonio please go here
https://www.uthscsa.edu/?utm_source=uthealthsaorg&utm_medium=pageredirect&utm_campaign=uthealthsa
June Round, a microbiome researcher at the University of Utah School of Medicine in Salt Lake City says “It’s possible that things that are happening in our mice are also happening in individual [humans],”
For video-Dr. Alejandro Soto-Gutierrez talks about UPMC McGowan Institute for Regenerative Medicine spearheading the growth of genetically modified miniature human livers to emulate human liver disease progression and support ongoing therapeutics testing.
Join us as we talk to Ron Bercume about his experience with hidradenitis suppurativa.
Hidradenitis Suppurativa is one of the most painful autoimmune and/or autoinflammatory conditions. It leaves patients with open wounds, scars, and in some cases depression, anxiety, and much more.
Ron who owns and manages hsawareness.org wants to make sure the world knows about his conditions and all those who are suffering. He wants to make sure the medical community knows HS patients are growing in numbers and hope for a cure.
You can follow Ron and his work with HS below
Facebook-https://www.facebook.com/groups/HSGlobal/
You can also read an article that CNN did on his condition here
The nation has been in the grip of a national crisis involving opioid addiction. One of the major manufacturers of opioids was Purdue Pharma—the makers of Oxycotin.
Thanks to the efforts by Dr. Jason Beaman and team Oklahoma State University (OSU) secured a windfall from a settlement with opioid maker Purdue Pharma earlier this year. OSUs quest to
become a major hub for addiction research just got more serious as the company also handed over thousands of proprietary molecules, patient samples and other data.
Listen as Dr. Beaman discusses this and some initiatives they are looking into.
You can follow Dr. Beaman on twitter here
OSU Medicine Opens Addiction Medicine Clinic
Listen as Dr. Brumley discusses the possible ramifications of bill H.R. 1959, a bill titled "Preserving Patients Access to Compound Medications Act of 2019", if they don't allow access to the compound medications needed.
Dr. Brumley also touches on using some vitamins and other natural routes to help support cancer care.
You can visit Dr. Brumley on her website here
You can look at the bill here
In this Podcast we speak with Sharee Page who has battled Breast Cancer. She tells us about her journey and and gives us a positive outlook on her journey. You can keep up with her amazing journey at her YouTube channel, Breast Cancer Babe: https://www.youtube.com/channel/UCKnE...
The small, Chicago-based biotech venture Errant Gene Therapeutics, LLC was engaged in a court battle against a well-funded biotech called Bluebird Bio (which has raised over $400 million) and a venture capital firm known as Third Rock Ventures. With allegations of breach of contract, tortious business interference, and fraud, TrialSite News initiated a project to review publicly available information, including court records, to derive a more thorough understanding of the case at hand.
In this podcast we ask Mr. Girondi about how this all started.
In this podcast we discuss hidradenitis suppurativa and it's possible link with gut bacteria. The Doctors from Attune Functional Medicine go over how these two can be linked and how to start healing your gut. They go over more than just food and the gut as well, as they know that it isn't ALWAYS the link, some HS patients require different treatments.
The Doctors have created an autoimmune cookbook to help make eating easy.
For more information on them and their work with HS you can follow their social media pages:
Youtube
The Cookbook and more
We had several requests from our Hidradenitis Suppurativa readers to do a follow up on the article "Is XBiotech on the Cusp of a Superior Hidradenitis Suppurativa Treatment?"
So we asked XBiotech if they would be willing to sit down and talk with us about their upcoming pipeline for HS.
"Our Antibodies are 100% derived from human immune system, and so the safety profile is unprecedented"
XBiotech is working towards helping those who have Hidradenitis Suppurativa, Psoriasis, Atopic Dermatitis, and even oncology.
You can email clinicaltrials@xbiotech.com to speak with someone about applying to participate in a clinical trial.
In this Podcast we speak with someone who has lived with #AS for over 10 years. She offers some suggestions that have worked for her on putting AS into #remission, some suggestions for the medical community, and a view of what someone living with AS goes through.
No matter how important the scientific value of a study, the amount of money a Sponsor has or how lucrative the contract, the cornerstone of a successful study starts and ends with recruitment and retention of the study participant. In any walk of life, people have the fundamental need to feel valued and safe in the hands of the people who care for them. Clinical trial volunteers are no exception. If we want study participants to stay the course, we as research nurses and study coordinators, must make them feel safe and valued.
A confident, well informed, friendly research nurse or coordinator, is usually the participant’s greatest support within the clinical trial setting. Forming a good rapport from the outset is imperative. Instilling confidence and trust begins at the first meeting.
Listen to Patricia discuss her methods.
In this episode we talk with Dr. Lucero about Bio-Identical Hormones and if they are safe or not, how they interact with our systems, and so much more.
In this episode we talk to Dr. West from Tanner Clinic in Roy Utah about the Obesity Crisis. We discuss why he thinks this is happening, what benign obesity is, and several ways to try to fix this crisis.
https://tannerclinic.com/specialty/weight-loss/
Adam Hatten was diagnosed with stage 3 Hidradenitis Suppurativa, an autoimmune disease. He was able to put his HS into remission through food. In this episode he goes over some of the key items that helped him, and how he sticks to his diet.