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DTSTART;TZID=America/Vancouver:20191202T080000
DTEND;TZID=America/Vancouver:20191202T170000
DTSTAMP:20191118T152137Z
CREATED:20191118T152137Z
LAST-MODIFIED:20191118T152137Z
UID:7238-1575273600-1575306000@scienceinboston.com
SUMMARY:Cambridge Biomedical December 2nd - Lunch Event\, Enrollment and Retention in IO studies: Patient and Site Centricity
DESCRIPTION:Overview\n\nEnrollment and Retention in IO studies: Patient and Site Centricity \nAbstract \nEnrollment and patient retention remain the most significant barriers to executing successful randomized clinical trials for sponsor companies today\, impacting timeline\, quality\, and budget.  More than 80% of clinical studies fail to complete enrollment on time\, and approximately half of the sites selected for clinical trials enroll between zero and one patient. \nOvercoming the recruitment challenge requires a sponsor’s delicate coordination of multiple stakeholders\, all of whom have different goals and motivations:  CROs\, vendors\, regulators\, and the two most important partners\, investigators and the patients they are treating. \n  \nRapid developments in the immuno-oncology (IO) field in recent years offer both a challenge and an opportunity for drug developers to design and execute trials with patients and sites in mind (“patient and site centricity”).  The FDA has also evolved in its own patient engagement approach with programs like the Patient-Focused Drug Development (PFDD) initiative. \nKelly Brady\, Vice President\, Clinical Operations Seres Therapeutics \nKelly holds a BS degree in Neuroscience from Lafayette College\, and an MS in Biotechnology from Johns Hopkins where she began her career as a research associate in the Orthopaedic Oncology department.   Kelly  has held positions  of increasing responsibility in Clinical Operations and Clinical Program management over the past 12 years. \n  \nAs a clinical associate at Osiris Therapeutics\, Kelly managed global  pediatric and hematology projects (GVHD\, COPD)\, and was a member of the operational and submission team who worked on Prochymal\, an allogeneic stem cell therapy  which received approval for treatment of GVHD in children in Canada in 2012.  Following Osiris\,  Kelly moved to Millenium/Takeda where she was global phase 3 clinical leader for the Adcetris trials in Hodgkins Lymphoma\,  in conjunction with Seattle Genetics\, run in 29 countries.  Kelly then held positions in Operations and Program management at Acetylon\, and was a member of the team involved in the acquisition of the company by Celgene.  Prior to joining Seres\,  Kelly was  Senior Director\, Global Clinical Program Lead at Akebia\, overseeing the pivotal program including 4 Phase 3  cardiovascular outcomes studies in 27 countries\, and initiated a Clinical Trial Educator program in North America. \n  \nKelly continues to be active with the Leukemia and Lymphoma Society\, and lives in Cambridge with her husband.
URL:https://scienceinboston.com/event/cambridge-biomedical-december-2nd-lunch-event-enrollment-and-retention-in-io-studies-patient-and-site-centricity/
LOCATION:MassBio\, 300 Technology Square 8th Fl\, Cambridge\, MA\, 02139\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Vancouver:20191202T080000
DTEND;TZID=America/Vancouver:20191202T170000
DTSTAMP:20191118T152137Z
CREATED:20191118T152137Z
LAST-MODIFIED:20191118T152137Z
UID:27391-1575273600-1575306000@scienceinboston.com
SUMMARY:Cambridge Biomedical December 2nd - Lunch Event\, Enrollment and Retention in IO studies: Patient and Site Centricity
DESCRIPTION:Overview\n\nEnrollment and Retention in IO studies: Patient and Site Centricity \nAbstract \nEnrollment and patient retention remain the most significant barriers to executing successful randomized clinical trials for sponsor companies today\, impacting timeline\, quality\, and budget.  More than 80% of clinical studies fail to complete enrollment on time\, and approximately half of the sites selected for clinical trials enroll between zero and one patient. \nOvercoming the recruitment challenge requires a sponsor’s delicate coordination of multiple stakeholders\, all of whom have different goals and motivations:  CROs\, vendors\, regulators\, and the two most important partners\, investigators and the patients they are treating. \n  \nRapid developments in the immuno-oncology (IO) field in recent years offer both a challenge and an opportunity for drug developers to design and execute trials with patients and sites in mind (“patient and site centricity”).  The FDA has also evolved in its own patient engagement approach with programs like the Patient-Focused Drug Development (PFDD) initiative. \nKelly Brady\, Vice President\, Clinical Operations Seres Therapeutics \nKelly holds a BS degree in Neuroscience from Lafayette College\, and an MS in Biotechnology from Johns Hopkins where she began her career as a research associate in the Orthopaedic Oncology department.   Kelly  has held positions  of increasing responsibility in Clinical Operations and Clinical Program management over the past 12 years. \n  \nAs a clinical associate at Osiris Therapeutics\, Kelly managed global  pediatric and hematology projects (GVHD\, COPD)\, and was a member of the operational and submission team who worked on Prochymal\, an allogeneic stem cell therapy  which received approval for treatment of GVHD in children in Canada in 2012.  Following Osiris\,  Kelly moved to Millenium/Takeda where she was global phase 3 clinical leader for the Adcetris trials in Hodgkins Lymphoma\,  in conjunction with Seattle Genetics\, run in 29 countries.  Kelly then held positions in Operations and Program management at Acetylon\, and was a member of the team involved in the acquisition of the company by Celgene.  Prior to joining Seres\,  Kelly was  Senior Director\, Global Clinical Program Lead at Akebia\, overseeing the pivotal program including 4 Phase 3  cardiovascular outcomes studies in 27 countries\, and initiated a Clinical Trial Educator program in North America. \n  \nKelly continues to be active with the Leukemia and Lymphoma Society\, and lives in Cambridge with her husband.
URL:https://scienceinboston.com/event/cambridge-biomedical-december-2nd-lunch-event-enrollment-and-retention-in-io-studies-patient-and-site-centricity-2/
LOCATION:MassBio\, 300 Technology Square 8th Fl\, Cambridge\, MA\, 02139\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20191202T180000
DTEND;TZID=America/New_York:20191202T210000
DTSTAMP:20191118T152259Z
CREATED:20191118T152259Z
LAST-MODIFIED:20191118T152259Z
UID:7241-1575309600-1575320400@scienceinboston.com
SUMMARY:Private Screening: In Their Shoes\, Unheard Stories of Reentry and Recovery
DESCRIPTION:Overview\n\nMassBio will be holding a private screening of In Their Shoes\, Unheard Stories of Reentry and Recovery\, a moving documentary which is set in Boston and explores the connection between mental health\, addiction\, and incarceration. The film will be followed by a panel featuring Dr Bertha Madras of Harvard Medical School and Former US Representative Patrick Kennedy\, both members of President Trump’s Commission on the Opioid Crisis. \nThe documentary recounts the journey of four men from addiction to prison and the complexity of their lives on the outside and is interspersed with interviews and commentary by Mayor Marty Walsh\, Congressman Joe Kennedy III\, Sheriff Michael Bellotti\, Professor Randall Horton\, and more. \nThe screening will be held at the MassBio office\, 300 Technology Square\, Cambridge on December 2nd. Registration and networking with refreshments and hors d’oeuvres will start at 6:00 pm and the documentary will begin at 6:30 pm. \nPlease join us on December 2nd and participate in this critical conversation. Your RSVP response is requested by November 18th\, via email to John Hallinan. \nMore info on the documentary can be found  at https://www.intheirshoesfilm.com/ and additional information on the sobering metrics of opioid abuse at Facts – In Their Shoes Film.
URL:https://scienceinboston.com/event/private-screening-in-their-shoes-unheard-stories-of-reentry-and-recovery/
LOCATION:MassBio\, 300 Technology Square 8th Fl\, Cambridge\, MA\, 02139\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20191202T180000
DTEND;TZID=America/New_York:20191202T210000
DTSTAMP:20191118T152259Z
CREATED:20191118T152259Z
LAST-MODIFIED:20191118T152259Z
UID:27392-1575309600-1575320400@scienceinboston.com
SUMMARY:Private Screening: In Their Shoes\, Unheard Stories of Reentry and Recovery
DESCRIPTION:Overview\n\nMassBio will be holding a private screening of In Their Shoes\, Unheard Stories of Reentry and Recovery\, a moving documentary which is set in Boston and explores the connection between mental health\, addiction\, and incarceration. The film will be followed by a panel featuring Dr Bertha Madras of Harvard Medical School and Former US Representative Patrick Kennedy\, both members of President Trump’s Commission on the Opioid Crisis. \nThe documentary recounts the journey of four men from addiction to prison and the complexity of their lives on the outside and is interspersed with interviews and commentary by Mayor Marty Walsh\, Congressman Joe Kennedy III\, Sheriff Michael Bellotti\, Professor Randall Horton\, and more. \nThe screening will be held at the MassBio office\, 300 Technology Square\, Cambridge on December 2nd. Registration and networking with refreshments and hors d’oeuvres will start at 6:00 pm and the documentary will begin at 6:30 pm. \nPlease join us on December 2nd and participate in this critical conversation. Your RSVP response is requested by November 18th\, via email to John Hallinan. \nMore info on the documentary can be found  at https://www.intheirshoesfilm.com/ and additional information on the sobering metrics of opioid abuse at Facts – In Their Shoes Film.
URL:https://scienceinboston.com/event/private-screening-in-their-shoes-unheard-stories-of-reentry-and-recovery-2/
LOCATION:MassBio\, 300 Technology Square 8th Fl\, Cambridge\, MA\, 02139\, United States
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