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Insights into vaccine regulatory protocols outside of a pandemic from Susan F. Langlois.
  • Susan Langlois started her career in 1972 as a lab technologist at Cana Laboratories. 2:50

  • Langlois’ expertise spans from biologicals to medical devices in the pharmaceutical industry. 3:10

  • She transitioned to regulatory affairs in 1976, overseeing compliance with new regulations. 3:42

  • Langlois retired as the Director of Regulatory Affairs at Cana Laboratories after 20 years. 4:16

  • She continued her regulatory work with startup biologic companies post-retirement. 4:58

  • Her vast experience includes working with biologic companies on regulatory affairs, clinical trials, and quality control. 5:33

  • Langlois’ highlight was her involvement in the approval process of BCG vaccine for therapeutic use. 6:23

  • Langlois worked on getting the BCG vaccine approved for therapeutic use in bladder cancer. 6:33

  • She was instrumental in the approval of BCG vaccine for bladder cancer treatment in Canada and the U.S. 7:06

Overview of vaccine development process and regulatory protocols explained by Susan F. Langlois.
  • Regulations for biologics and vaccines were established in the 1970s to ensure safety for healthy recipients. 9:26

  • Vaccines are given to healthy individuals to prevent diseases, unlike drugs for treating the sick. 10:04

  • Research is required to determine the need for a vaccine and understand the disease before production. 13:09

  • Testing in animals for safety and efficacy is a crucial step in vaccine development. 13:48

Overview of vaccine regulatory protocols and timeline for development outside emergencies.
  • Vaccine development process involves preclinical studies, safety studies, effectiveness studies, and manufacturing consistency checks. 13:55

  • Regulatory process includes submitting data to regulators, conducting safety and effectiveness studies, and obtaining establishment licenses. 14:02

  • Phase one focuses on safety, phase two on effectiveness, and phase three on efficacy through placebo-controlled studies. 14:10

  • Scaling up production requires demonstrating consistency in manufacturing and passing regulatory inspections. 16:22

  • Postmarketing strategies, labeling, and advertising also need regulatory approval before vaccine launch. 17:06

  • Standard vaccine development process takes around 10 years due to rigorous regulatory requirements and testing. 17:23

  • Regulations allow for streamlining processes for unique products targeting unmet medical needs. 18:09

  • Staggering phases can be done in emergencies to accelerate vaccine development while meeting regulatory standards. 18:54

  • All steps in the regulatory process are essential for ensuring the safety and efficacy of vaccines before approval. 19:06

Overview of emergency vaccine approval regulations during a pandemic
  • Emergency use approval process in the US and Canad. 19:33

  • US FDA process for emergency use release. 20:30

  • Regulators prioritize safety and data availabilit. 20:30

  • Companies must meet safety criteria for approva. 21:11

  • Interim order in Canada with one-year expir. 21:57

  • Expedited submission process for emergency approval. 22:38

  • Priority reviews for COVID-related products worldwid. 24:49

  • No preferential treatment for companies in approval proces. 25:08

  • Regulations amended for fast-track submission. 25:59

Explanation of why vaccine data is not released immediately under emergency approval.
  • mRNA technology allowed quicker vaccine productio. 26:48

  • Regulators evaluate data for safety profile and risk-benefi. 27:14

  • FDA protects interim data as intellectual propert. 30:09

  • Companies redact proprietary information before data releas. 31:04

  • Requests for data under Freedom of Information Act are processed chronologicall. 31:41

  • Approval process for full data release may take up to a year or mor. 32:07

Regulatory protocols for vaccine approval during emergencies require expedited processes.
  • Regulators struggle to explain complex processes to the general public. 32:16

  • External contractors often manage clinical trials for pharmaceutical companies. 34:09

  • Pharmaceutical companies follow regulatory guidelines to expedite vaccine production. 36:23

  • Regulators request minimum data for initial approval with a commitment to gather more over time. 38:07

Overview of vaccine regulatory protocols and safety monitoring systems for emergency drug releases.
  • Safety monitoring systems rely on physician-reported adverse events related to vaccinations. 38:30

  • Public health agencies play a role in monitoring signals of adverse events beyond initial surveillance. 40:05

  • Long-term effects beyond 28 days post-vaccination may not be captured by current surveillance systems. 41:25

  • Government and medical authorities should ensure transparency in communicating known and unknown risks of vaccines. 43:00

  • Concerns exist about the lack of long-term safety data for emergency-released vaccines. 43:14

  • Individuals have the right to accept or reject vaccines under emergency use authorization. 43:36

  • Regulations mandate informing individuals of known risks and benefits of emergency vaccines. 43:50

  • Data gaps exist in certain populations like pregnant or immune-compromised individuals. 44:04

  • Pharmaceutical companies publish monographs detailing available data on vaccines. 44:11

Challenges in ensuring informed decisions and responsibilities in COVID-19 vaccine mandates.
  • Concerns about lack of informed consent for vaccine recipient. 44:50

  • Regulators and companies provide information, but politicians make mandate decision. 45:15

  • Responsibility for vaccine mandate decisions unclea. 46:45

  • Regulators ensure safety but may not challenge government mandate. 49:00

  • Definition of ‘safe’ varies and may not imply zero risk. 49:25

  • Government repeats safety claims without ensuring informed consen. 50:04

  • Lack of monitoring for informed consent in vaccine administratio. 50:31

  • Government push for vaccination without complete data may harm public healt. 50:36

Discussion on vaccine risk-benefit assessment, regulatory responsibilities, and response to vaccine efficacy.
  • Risk-benefit assessment varies based on health profiles and comorbidities. 50:55

  • Individuals need to make decisions on vaccine risk-benefit based on their health status. 52:01

  • Mass vaccination aims for herd immunity but may not always be effective. 53:14

  • Regulatory responsibility includes ongoing safety and efficacy reviews of vaccines. 54:38

  • Companies may need to adjust vaccines based on efficacy and safety signals. 55:10

  • Changes to vaccines require additional approval processes and clinical trials. 55:54

  • Vaccine efficacy is not just about antibody response but also about disease spread prevention. 56:13

  • Clinical trials need to consider easy-to-demonstrate endpoints for positive outcomes. 56:43

Vaccine efficacy in reducing severe disease and deaths, but not focused on stopping spread. Ethical concerns on booster distribution.
  • Vaccines aimed at reducing hospitalizations and deaths, not infection spread. 56:55

  • Lack of evidence demonstrating vaccines reduce infection spread. 57:01

  • Shift from lockdowns for vulnerable to herd immunity strategy questioned. 57:52

  • Vaccines initially targeted high-risk individuals, then expanded to younger age groups. 58:06

  • Monitoring based on positive PCR tests, not disease symptoms. 1:00:25

  • Ethical dilemma in distributing boosters to children while vulnerable populations lack vaccines. 1:02:09

  • Importance of boosting for individuals with compromised immune systems. 1:02:51

  • Limited long-term studies on vaccine efficacy and duration of antibodies. 1:03:26

Responsibilities for monitoring all-cause mortality and adverse effects post-vaccine administration.
  • Public health is responsible for monitoring all-cause mortality and adverse effects post-vaccine administration. 1:03:37

  • Long-term studies are necessary to track antibody levels and vaccine efficacy over time. 1:03:43

  • Ethical considerations may lead to offering vaccines to placebo groups post-trial. 1:04:21

  • All-cause mortality is typically monitored during clinical trials, with government oversight post-trial. 1:06:00

  • Public health agencies are responsible for monitoring trends in all-cause mortality and adverse effects post-vaccine introduction. 1:09:24

Insights on vaccine development, regulatory challenges, and public health messaging during pandemics.
  • Vaccine adverse events are reported to companies and governments for monitoring. 1:09:43

  • Public health monitors signals of adverse events post-vaccination over time. 1:10:01

  • COVID-19 may trigger autoimmune responses, impacting severe disease outcomes. 1:10:27

  • Vaccines aim to prevent severe disease in high-risk individuals with comorbidities. 1:12:54

  • Challenges exist in rebuilding trust in pharmaceutical industry and public health. 1:13:32

  • Pharmaceutical companies faced criticism for vaccine efficacy amidst evolving virus strains. 1:14:07

  • Clear messaging from governments is crucial to address public confusion on vaccine purpose. 1:15:05

Insights into upcoming events and gratitude expressed at the end of the interview.
  • Mention of the upcoming interview and wishing a great evenin. 1:15:39

  • Expressing gratitud. 1:15:51

  • Music playing in the backgroun. 1:16:24

  • Music continue. 1:17:17

Understanding the impact of liver diseases and potential mechanisms in managing them
  • Presentation on liver diseases and potential mechanisms • 0:08
  • Fatty liver prevalence and its link to insulin resistance • 1:29
  • Focus on alcohol liver disease, fatty liver, and liver injury • 2:05
  • Importance of recognizing liver health for overall well-being • 2:36
  • Risk of harm from multiple factors affecting liver function • 2:54