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COVID and the FDA: New Product Approvals and Studies
Thursday, November 11, 2021
Join us on Thursday, November 11th at 8:30 am to experience the same great BioBreakfast event in a virtual setting.
At the November BioBreakfast attendees will learn about new Covid-19 product approvals and soon-to-be-launched studies. Our Delaware researchers will share their recent experience successfully managing clinical trials for a new diagnostic and planning for a broad study of an important Delaware population, and we’ll be joined by a national expert on working with the FDA.
ANP Technologies CEO Ray Yin will provide an update on their newly-approved rapid antigen test for Covid-19, and Dr. Judith Ross, Director, Center for Clinical Pediatric Research (CCPR) at Nemours will share plans for an important Covid-related study. Dr. Heather Hatcher, Regulatory Scientist with the law firm Womble Bond Dickinson will provide an overview of the FDA clinical trial process and key learnings on successfully working with the agency. Presentations will be followed by a panel discussion including Kim Englert, Quality Assurance and Clinical Research Education manager for Nemours Biomedical Research.
Event Speakers
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| Ray Yin
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Dr. Judith Ross
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Dr. Heather Hatcher
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| CEO |
Director, Center for Clinical
Pediatric Research |
Regulatory Scientist |
| ANP Technologies |
Nemours |
Womble Bond Dickinson
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My research goals have been to dissect the clinical, genetic, and neurobiological pathways related to X and Y chromosome disorders including Klinefelter syndrome (47,XXY), XYY syndrome, and Turner syndrome. For the male X-chromosome disorder, Klinefelter syndrome, I successfully initiated and completed a recent NINDS-funded clinical trial investigating the effects of early androgen replacement on motor function, cognition, and brain imaging. The results of this study will provide significant evidence-based recommendations about childhood androgen replacement in boys with testicular failure and prevention of obesity and cardiovascular morbidities in this at risk population. In boys with XYY, we hypothesized that the increased autism risk is related to increased Y chromosome gene copy number and over-expression of Y-linked genes related to brain development and function. |
Heather joined the firm as a Regulatory Scientist. She has extensive experience in Regulatory Affairs and as a basic and clinical research scientist. She effectively guides clients through the complex regulatory landscape governed by the US Food and Drug Administration (FDA) toward market authorization. In addition to advising clients on early regulatory strategy and product development issues, Heather prepares regulatory submissions to the FDA for drugs, biologics, and medical devices. Her experience includes the preparation of pre-submissions, initial Investigational New Drug (IND) and Investigation Device Exemptions (IDE) applications, annual progress reports, and FDA meeting requests.
Heather also helps clients prepare responses to the FDA and provides regulatory advice on best practices for Phase I/Phase II clinical trials, standard operating procedures and protocols for Good Manufacturing Practices (GMP), and quality control testing for stem cell therapy and biomaterials. She has experience researching predicate devices for 510(k) submissions, and preparing requests for Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE).
Before joining Womble Bond Dickinson, Heather worked in academic research and research administration at Wake Forest Baptist Medical Center for 12 years.
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• Hear from and meet with executives at the top life science companies making a difference here in Delaware
• Connect with new business opportunities
• Get the pulse on the latest life sciences trends
• Network with peers and potential partners
Registration Policy
The “In Transition” rate is available for first-time attendees seeking employment. If you are still searching for employment after the first BioBreakfast and wish to continue attending, we offer you a discounted rate of $25 to attend. The “Non-Member” rate is for those who very occasionally attend our events ( no more than two events) or for those who are evaluating whether they wish to join Delaware Bio. This is not intended for individuals who attend every event in a series. If you fall into this category, we ask that you join the organization. Information about membership can be found by contacting us at info@delawarebio.org.
Please note that Delaware Bio is a member-supported organization, preference is given to our members. If an event becomes sold out and you are registered as a non-member, we reserve the right to cancel your registration and refund your payment. If you are retired and wish to attend BioBreakfast, we ask that you join the organization as a member, at our new, discounted retired membership level.
When registering please use your company email address, so we can verify membership (if applicable). Registration for our virtual events will end 24-hours before the event is set to begin to ensure you receive the proper communication to join the event. Please register in advance, as it may fill up quickly. Thank you!
Refund Policy
Cancellations must be made in writing, via email to Yvette Murray more than one (1) week prior to the event to receive a refund minus 25% for registration/administrative costs. If the cancellation is made within one week of the event or the attendee is a no-show, Delaware Bio will not issue a refund. If you have any questions or concerns, please contact Yvette Murray.
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