About
I have more than 20 years of professional editorial and writing experience. As the writer…
Activity
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So you could not attend DIA 2024!! Now read an exclusive report by our regulatory experts available in Cortellis Regulatory Intelligence by…
So you could not attend DIA 2024!! Now read an exclusive report by our regulatory experts available in Cortellis Regulatory Intelligence by…
Liked by Jaime Gavazzi
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Check out a new report from a series of regulatory reports on drugs to watch from Clarivate! A colleague and I contributed research, some writing…
Check out a new report from a series of regulatory reports on drugs to watch from Clarivate! A colleague and I contributed research, some writing…
Shared by Jaime Gavazzi
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Report alert! Fresh off the press!! Drugs to Watch 2024: Regulatory Focus: Zolbetuximab(IMAB362) I am happy to share that following the success of…
Report alert! Fresh off the press!! Drugs to Watch 2024: Regulatory Focus: Zolbetuximab(IMAB362) I am happy to share that following the success of…
Liked by Jaime Gavazzi
Experience
Education
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Stevenson University
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Activities and Societies: Choir, Spectrum literary magazine
Completion of Spanish language and literature courses
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Activities and Societies: Choir, yearbook, literary magazine, newspaper
Volunteer Experience
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Habitat for Humanity - house demolition
Baltimore City, Maryland
- 1 month
Performed demolition of an inner-city rowhome in preparation for remodeling.
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Holiday Events Volunteer
Rippon Lodge Historic Site
- 1 year
Arts and Culture
Participated in family volunteering for various holiday events at the historic Rippon Lodge.
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Yearbook Staff
Monocacy Valley Montessori Public Charter School
- 1 year 10 months
Education
Assisted in the creation of the school yearbook for 2 school years, including gathering and taking photos, writing content for pages, designing and formatting pages, and attending meetings with students and the club leader.
Publications
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Drugs to Watch: Regulatory Focus – Zolbetuximab
Clarivate
Investigational drug takes advantage of an accelerated review process for oncology treatments
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FDA’s New Draft Guidance for Psychedelic Drugs Opens Doors for Drug Developers in the US
Journal for Clinical Studies
In July 2023, Australia became the first country to permit psychiatrists to prescribe 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin for use in psychedelic-assisted psychotherapy to treat certain mental health conditions (MDMA for post-traumatic stress disorder [PTSD] and psilocybin for treatment-resistant depression [TRD]). This change in regulation directly followed an action taken by the US Food and Drug Administration (FDA) that could accelerate similar changes in the US. It also…
In July 2023, Australia became the first country to permit psychiatrists to prescribe 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin for use in psychedelic-assisted psychotherapy to treat certain mental health conditions (MDMA for post-traumatic stress disorder [PTSD] and psilocybin for treatment-resistant depression [TRD]). This change in regulation directly followed an action taken by the US Food and Drug Administration (FDA) that could accelerate similar changes in the US. It also came on the heels of positive published results from a clinical program evaluating MDMA as a treatment for PTSD that is close to seeking regulatory action.
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The Liver Meeting 2022 - American Association for the Study of Liver Diseases (AASLD) 73rd Annual Meeting
Drugs of the Future/Clarivate
The Liver Meeting—the American Association for the Study of Liver Diseases (AASLD) 2022 annual meeting—returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began and included a virtual option. Comprised of scientists and healthcare professionals, AASLD is the leading organization committed to preventing and curing liver disease. The “hottest meeting in hepatology,” according to the AASLD, included plenary sessions, presentations and over…
The Liver Meeting—the American Association for the Study of Liver Diseases (AASLD) 2022 annual meeting—returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began and included a virtual option. Comprised of scientists and healthcare professionals, AASLD is the leading organization committed to preventing and curing liver disease. The “hottest meeting in hepatology,” according to the AASLD, included plenary sessions, presentations and over 4,800 scientific abstracts highlighting the latest scientific advancements in the field of hepatology. Research and clinical trial updates were provided in many specific liver disease areas, including hepatitis, fibrosis, nonalcoholic fatty liver disease, cirrhosis, nonalcoholic steatohepatitis, transplantation, and so on. Along with groundbreaking research in hepatology, many presentations included the impact of COVID-19 on patients with these diseases. This report highlights a selection of presentations about treatment updates provided during the conference.
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The Importance of Conducting Diverse US Trials for US Cancer Patients
Journal for Clinical Studies
Page 10
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American Academy of Neurology (AAN) – 74th Annual Meeting: The Great Neuro Reunion
Drugs of the Future
The 2022 American Academy of Neurology (AAN) annual meeting returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began. AAN is the largest association of neurologists and neuroscience professionals with over 38,000 members. This meeting included plenary sessions and over 2,400 scientific abstracts highlighting the latest scientific advancements in brain disease. Research and clinical trial updates were provided in many specific disease areas,…
The 2022 American Academy of Neurology (AAN) annual meeting returned to in-person attendance for the first time in 2 years since the COVID-19 public health emergency began. AAN is the largest association of neurologists and neuroscience professionals with over 38,000 members. This meeting included plenary sessions and over 2,400 scientific abstracts highlighting the latest scientific advancements in brain disease. Research and clinical trial updates were provided in many specific disease areas, including Parkinson's, Huntington's, amyotrophic lateral sclerosis, migraine, multiple sclerosis, epilepsy, narcolepsy, Alzheimer's, and so on. Along with groundbreaking research in neurology, many presentations included the impact of COVID-19 on patients with these diseases and ongoing neurology clinical trials. This report highlights a selection of presentations about treatment updates provided during the conference.
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The 40th Annual J.P. Morgan Healthcare Conference
Drugs of the Future
The 40th Annual J.P. Morgan Healthcare Conference was conducted as a virtual conference for the second consecutive year due to the COVID-19 pandemic. Being the largest investment symposium in the healthcare industry, the conference brought together thousands of investors around the globe and hundreds of companies from the whole global healthcare landscape, that includes pharmaceutical companies, medical device firms, healthcare service providers, and profit and not-for-profit organizations…
The 40th Annual J.P. Morgan Healthcare Conference was conducted as a virtual conference for the second consecutive year due to the COVID-19 pandemic. Being the largest investment symposium in the healthcare industry, the conference brought together thousands of investors around the globe and hundreds of companies from the whole global healthcare landscape, that includes pharmaceutical companies, medical device firms, healthcare service providers, and profit and not-for-profit organizations. This report covers a selection of company presentations given over the duration of the conference.
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Deep Brain Stimulation Could Address Suicide Risk in Individuals Resistant to Treatment
Journal for Clinical Studies
Pages 12–13
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World Vaccine Congress USA. Virtual - May 4-6, 2021
Drugs of the Future
The 21st World Vaccine Congress, held on May 4-6, 2021, virtually, was organized by Terrapinn and engaged academia, researchers, technology companies, pharmaceutical executives, scientists and military personnel in a 3-day discussion about the current state of global vaccine development. COVID-19 largely dominated panel discussions and presentations, comprising the majority of sessions. The meeting opened with the conference chair, Gregory Poland (Mayo Clinic), and subsequent presentations…
The 21st World Vaccine Congress, held on May 4-6, 2021, virtually, was organized by Terrapinn and engaged academia, researchers, technology companies, pharmaceutical executives, scientists and military personnel in a 3-day discussion about the current state of global vaccine development. COVID-19 largely dominated panel discussions and presentations, comprising the majority of sessions. The meeting opened with the conference chair, Gregory Poland (Mayo Clinic), and subsequent presentations outlined ongoing clinical studies for vaccines to prevent COVID-19, including emerging technologies that could change the landscape of vaccine administration and the efficacy of vaccines against variants of concern. In addition to COVID-19, presenters offered results from studies of cancer vaccines for melanoma, human papillomavirus and glioblastoma and an update on a Food and Drug Administration-approved cholera vaccine under evaluation for use in pediatric patients. The entirety of day 3 consisted of panel discussions about COVID-19 vaccines for pediatric patients, tackling future pandemics, the threat of misinformation in a public health emergency, and the use of databases to streamline COVID-19 efforts. Dr. Poland provided take-home remarks that emphasized the need for preparedness and said, "While COVID-19 was a surprise, it should not have been a shock. We have been warned many times in many ways." He concluded that, moving forward, 2 significant cultural problems remain: "scientific illiteracy and the false notion of the democratization of expertise."
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Regulatory Response to the COVID-19 Pandemic: Fast Tracking Therapeutics
Clarivate (Cortellis)
The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment. In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new guidance to fast track and conditional approvals.
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Psychedelics Make a Comeback to Treat Mental Health Conditions
The Journal for Clinical Studies, Volume 12, Issue 6
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The Trials Must Go On: Conducting Clinical Studies During the COVID-19 Pandemic
Clarivate (Cortellis)
While it may seem like the whole world is on pause due to COVID-19, clinical trials in the U.S. can continue with adjustments to conditions or protocols while still adhering to regulations and ensuring patient safety.
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COVID-19 Testing: FDA Guidance Update
Clarivate (Cortellis)
As SARS-CoV2 continues to spread, resulting in Coronavirus Disease 2019 (COVID-19) in patients, we examine FDA guidance on in vitro diagnostic testing and respirator use in healthcare settings and highlight current trials for treatment and vaccines.
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The Need to Finally Get It Right With Universal Influenza Vaccines
Journal for Clinical Studies, Volume 11, Issue 6
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Closing the Gap: A Hopeful Outlook for Paediatric Medical Devices
Journal for Clinical Studies
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Gene Therapy Products for Life-Threatening Diseases Are Getting the Green Light
Journal for Clinical Studies
Honors & Awards
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Elizabeth McWethy Award
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Awarded to one graduating student who "demonstrated exceptional creativity, manifested genuine concern for society, and has actively influenced the lives of others."
Languages
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English
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Spanish
Elementary proficiency
Organizations
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National Scleroderma Foundation
Member
- Present -
Regulatory Affairs Professionals Society
Member
- Presenthttps://bcert.me/sqqeybbph
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Drug Information Association (DIA)
Member
- Present
More activity by Jaime
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Check out my latest article, "FDA’s New Draft Guidance for Psychedelic Drugs Opens Doors for Drug Developers in the US," published in the Journal for…
Check out my latest article, "FDA’s New Draft Guidance for Psychedelic Drugs Opens Doors for Drug Developers in the US," published in the Journal for…
Posted by Jaime Gavazzi
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My latest article is out! Check out vitiligo treatments in development.
My latest article is out! Check out vitiligo treatments in development.
Shared by Jaime Gavazzi
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The latest issue of the Journal for Clinical Studies is out now! Click the link below:
The latest issue of the Journal for Clinical Studies is out now! Click the link below:
Liked by Jaime Gavazzi
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Our team is seeking 2 medical writers to report on FDA advisory committee meetings. Must be local to the MD/DV/VA area or willing to relocate. Apply…
Our team is seeking 2 medical writers to report on FDA advisory committee meetings. Must be local to the MD/DV/VA area or willing to relocate. Apply…
Shared by Jaime Gavazzi
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I have so enjoyed freelancing with Flyeye Design since 2003 and will keep Flyeye Design for my creative ventures and face painting, but I was ready…
I have so enjoyed freelancing with Flyeye Design since 2003 and will keep Flyeye Design for my creative ventures and face painting, but I was ready…
Liked by Jaime Gavazzi
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