Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

The ClinRegs website has been updated and upgraded, according to the National Institute of Allergy and Infectious Diseases.

ClinRegs is an online database of country-specific information on clinical research regulations that was launched in 2014.

Now, the website houses regulatory information for 17 countries and has an interactive map on its homepage to provide a clearer picture of the countries included.

ClinRegs also has a hyperlinked table of contents on each country page that is intended to provide easier navigation.

Drop-down menus allow users to switch between country profiles and make comparisons between countries.

In addition, ClinRegs now provides a Quick Facts table with discrete pieces of information for each country.

And a feedback link has been added to the site to make it easy for users to submit comments or updates to regulations.

Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

The ClinRegs website has been updated and upgraded, according to the National Institute of Allergy and Infectious Diseases.

ClinRegs is an online database of country-specific information on clinical research regulations that was launched in 2014.

Now, the website houses regulatory information for 17 countries and has an interactive map on its homepage to provide a clearer picture of the countries included.

ClinRegs also has a hyperlinked table of contents on each country page that is intended to provide easier navigation.

Drop-down menus allow users to switch between country profiles and make comparisons between countries.

In addition, ClinRegs now provides a Quick Facts table with discrete pieces of information for each country.

And a feedback link has been added to the site to make it easy for users to submit comments or updates to regulations.

Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

The ClinRegs website has been updated and upgraded, according to the National Institute of Allergy and Infectious Diseases.

ClinRegs is an online database of country-specific information on clinical research regulations that was launched in 2014.

Now, the website houses regulatory information for 17 countries and has an interactive map on its homepage to provide a clearer picture of the countries included.

ClinRegs also has a hyperlinked table of contents on each country page that is intended to provide easier navigation.

Drop-down menus allow users to switch between country profiles and make comparisons between countries.

In addition, ClinRegs now provides a Quick Facts table with discrete pieces of information for each country.

And a feedback link has been added to the site to make it easy for users to submit comments or updates to regulations.

Micrograph showing MM

Top-line results from the phase 3 CLARION trial suggest that treatment with carfilzomib, melphalan, and prednisone (KMP) is not superior to treatment with bortezomib, melphalan, and prednisone (VMP).

The trial was designed to compare KMP and VMP in patients with newly diagnosed multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplant.

The results showed that progression-free survival (PFS) rates were similar with the 2 regimens.

And although overall survival data are not yet mature, there seems to be a trend favoring the VMP regimen.

Amgen, the company developing carfilzomib, released these results yesterday.

“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.

“However, the myeloma landscape has changed dramatically since the design of the CLARION study, with very few newly diagnosed patients treated with

melphalan-based regimens, particularly in the US. We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”

Dr Harper said he could not comment on whether the CLARION trial will continue, as Amgen hopes to present data from the trial at the 2016 ASH Annual Meeting.

The CLARION trial is a head-to-head, randomized study in transplant-ineligible patients with newly diagnosed MM. A total of 955 patients were randomized 1:1 to receive KMP or VMP for 54 weeks. The median patient age was 72.

The trial did not meet the primary endpoint of superiority in PFS. The median PFS was 22.3 months in the KMP arm and 22.1 months in the VMP arm. The hazard ratio was 0.91 (95% CI, 0.75-1.10), and the difference between the arms was not statistically significant.

The data for overall survival, a secondary endpoint, are not yet mature. But the observed hazard ratio was 1.21 (95% CI, 0.90-1.64), and there was no significant difference between the treatment arms.

The incidence of grade 3 or higher adverse events was 74.7% in the KMP arm and 76.2% in the VMP arm.

The incidence of grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5% in the KMP arm and 35.1% in the VMP arm.

Fatal treatment-emergent adverse events occurred in 6.5% of patients in the KMP arm and 4.3% of those in the VMP arm.

Micrograph showing MM

Top-line results from the phase 3 CLARION trial suggest that treatment with carfilzomib, melphalan, and prednisone (KMP) is not superior to treatment with bortezomib, melphalan, and prednisone (VMP).

The trial was designed to compare KMP and VMP in patients with newly diagnosed multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplant.

The results showed that progression-free survival (PFS) rates were similar with the 2 regimens.

And although overall survival data are not yet mature, there seems to be a trend favoring the VMP regimen.

Amgen, the company developing carfilzomib, released these results yesterday.

“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.

“However, the myeloma landscape has changed dramatically since the design of the CLARION study, with very few newly diagnosed patients treated with

melphalan-based regimens, particularly in the US. We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”

Dr Harper said he could not comment on whether the CLARION trial will continue, as Amgen hopes to present data from the trial at the 2016 ASH Annual Meeting.

The CLARION trial is a head-to-head, randomized study in transplant-ineligible patients with newly diagnosed MM. A total of 955 patients were randomized 1:1 to receive KMP or VMP for 54 weeks. The median patient age was 72.

The trial did not meet the primary endpoint of superiority in PFS. The median PFS was 22.3 months in the KMP arm and 22.1 months in the VMP arm. The hazard ratio was 0.91 (95% CI, 0.75-1.10), and the difference between the arms was not statistically significant.

The data for overall survival, a secondary endpoint, are not yet mature. But the observed hazard ratio was 1.21 (95% CI, 0.90-1.64), and there was no significant difference between the treatment arms.

The incidence of grade 3 or higher adverse events was 74.7% in the KMP arm and 76.2% in the VMP arm.

The incidence of grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5% in the KMP arm and 35.1% in the VMP arm.

Fatal treatment-emergent adverse events occurred in 6.5% of patients in the KMP arm and 4.3% of those in the VMP arm.

Micrograph showing MM

Top-line results from the phase 3 CLARION trial suggest that treatment with carfilzomib, melphalan, and prednisone (KMP) is not superior to treatment with bortezomib, melphalan, and prednisone (VMP).

The trial was designed to compare KMP and VMP in patients with newly diagnosed multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplant.

The results showed that progression-free survival (PFS) rates were similar with the 2 regimens.

And although overall survival data are not yet mature, there seems to be a trend favoring the VMP regimen.

Amgen, the company developing carfilzomib, released these results yesterday.

“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.

“However, the myeloma landscape has changed dramatically since the design of the CLARION study, with very few newly diagnosed patients treated with

melphalan-based regimens, particularly in the US. We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”

Dr Harper said he could not comment on whether the CLARION trial will continue, as Amgen hopes to present data from the trial at the 2016 ASH Annual Meeting.

The CLARION trial is a head-to-head, randomized study in transplant-ineligible patients with newly diagnosed MM. A total of 955 patients were randomized 1:1 to receive KMP or VMP for 54 weeks. The median patient age was 72.

The trial did not meet the primary endpoint of superiority in PFS. The median PFS was 22.3 months in the KMP arm and 22.1 months in the VMP arm. The hazard ratio was 0.91 (95% CI, 0.75-1.10), and the difference between the arms was not statistically significant.

The data for overall survival, a secondary endpoint, are not yet mature. But the observed hazard ratio was 1.21 (95% CI, 0.90-1.64), and there was no significant difference between the treatment arms.

The incidence of grade 3 or higher adverse events was 74.7% in the KMP arm and 76.2% in the VMP arm.

The incidence of grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5% in the KMP arm and 35.1% in the VMP arm.

Fatal treatment-emergent adverse events occurred in 6.5% of patients in the KMP arm and 4.3% of those in the VMP arm.

Micrograph showing DLBCL

Interim results of a phase 1/2 trial suggest KTE-C19, a chimeric antigen receptor (CAR) T-cell therapy, can be effective against aggressive non-Hodgkin lymphoma (NHL).

KTE-C19, administered after conditioning chemotherapy, produced an overall response rate (ORR) of

79% and a complete response (CR) rate of 52%.

However, the therapy also caused severe adverse events (AEs), and there were 2 deaths resulting from KTE-C19-related AEs.

Kite Pharma, Inc., the company developing KTE-C19, released these results and said additional data from this trial, known as ZUMA-1, will be submitted for presentation at an upcoming scientific meeting.

ZUMA-1 has enrolled patients with chemo-refractory, aggressive NHL. The phase 1 portion of the trial included 7 patients with diffuse large B-cell lymphoma (DLBCL).

Thus far, the phase 2 portion includes 62 NHL patients—51 with DLBCL and 11 with transformed follicular lymphoma (TFL) or primary mediastinal B-cell lymphoma (PMBCL).

The patients received a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of KTE-C19 (at a target dose of 2 x 10⁶ CAR T cells/kg).

Responses

In the phase 1 portion of the trial (n=7), the initial ORR was 71%, and the CR rate was 57%. At 3 months of follow-up, the ORR and CR rate were both 43%. The response rates remained the same at 6 months and 9 months of follow-up.

In the phase 2 portion of the trial, for all 62 patients, the initial ORR was 79%, and the CR rate was 52%. At 3 months, the ORR was 44%, and the CR rate was 39%.

Among the 51 patients with DLBCL, the initial ORR was 76%, and the CR rate was 47%. At 3 months, the ORR was 39%, and the CR rate was 33%.

Among the 11 patients with TFL or PMBCL, the initial ORR was 91%, and the CR rate was 73%. At 3 months, the ORR and CR rates were 64%.

Longer follow-up data are not yet available for the phase 2 portion of the study.

Safety

For all 62 patients, the most common grade 3 or higher AEs were neutropenia (66%), anemia (40%), febrile neutropenia (29%), thrombocytopenia (29%), and encephalopathy (26%).

Grade 3 or higher cytokine release syndrome occurred in 18% of patients, and neurological toxicity occurred in 34%.

Two patients died from KTE-C19-related AEs—hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of cytokine release syndrome.

Kite Pharma said the primary analysis from this study will include 101 patients with chemo-refractory NHL (DLBCL, TFL, and PMBCL), will have approximately 6 months of follow-up, and is expected in the first quarter of 2017.

ZUMA-1 is supported, in part, by funding from The Leukemia & Lymphoma Society Therapy Acceleration Program.

Micrograph showing DLBCL

Interim results of a phase 1/2 trial suggest KTE-C19, a chimeric antigen receptor (CAR) T-cell therapy, can be effective against aggressive non-Hodgkin lymphoma (NHL).

KTE-C19, administered after conditioning chemotherapy, produced an overall response rate (ORR) of

79% and a complete response (CR) rate of 52%.

However, the therapy also caused severe adverse events (AEs), and there were 2 deaths resulting from KTE-C19-related AEs.

Kite Pharma, Inc., the company developing KTE-C19, released these results and said additional data from this trial, known as ZUMA-1, will be submitted for presentation at an upcoming scientific meeting.

ZUMA-1 has enrolled patients with chemo-refractory, aggressive NHL. The phase 1 portion of the trial included 7 patients with diffuse large B-cell lymphoma (DLBCL).

Thus far, the phase 2 portion includes 62 NHL patients—51 with DLBCL and 11 with transformed follicular lymphoma (TFL) or primary mediastinal B-cell lymphoma (PMBCL).

The patients received a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of KTE-C19 (at a target dose of 2 x 10⁶ CAR T cells/kg).

Responses

In the phase 1 portion of the trial (n=7), the initial ORR was 71%, and the CR rate was 57%. At 3 months of follow-up, the ORR and CR rate were both 43%. The response rates remained the same at 6 months and 9 months of follow-up.

In the phase 2 portion of the trial, for all 62 patients, the initial ORR was 79%, and the CR rate was 52%. At 3 months, the ORR was 44%, and the CR rate was 39%.

Among the 51 patients with DLBCL, the initial ORR was 76%, and the CR rate was 47%. At 3 months, the ORR was 39%, and the CR rate was 33%.

Among the 11 patients with TFL or PMBCL, the initial ORR was 91%, and the CR rate was 73%. At 3 months, the ORR and CR rates were 64%.

Longer follow-up data are not yet available for the phase 2 portion of the study.

Safety

For all 62 patients, the most common grade 3 or higher AEs were neutropenia (66%), anemia (40%), febrile neutropenia (29%), thrombocytopenia (29%), and encephalopathy (26%).

Grade 3 or higher cytokine release syndrome occurred in 18% of patients, and neurological toxicity occurred in 34%.

Two patients died from KTE-C19-related AEs—hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of cytokine release syndrome.

Kite Pharma said the primary analysis from this study will include 101 patients with chemo-refractory NHL (DLBCL, TFL, and PMBCL), will have approximately 6 months of follow-up, and is expected in the first quarter of 2017.

ZUMA-1 is supported, in part, by funding from The Leukemia & Lymphoma Society Therapy Acceleration Program.

Micrograph showing DLBCL

Interim results of a phase 1/2 trial suggest KTE-C19, a chimeric antigen receptor (CAR) T-cell therapy, can be effective against aggressive non-Hodgkin lymphoma (NHL).

KTE-C19, administered after conditioning chemotherapy, produced an overall response rate (ORR) of

79% and a complete response (CR) rate of 52%.

However, the therapy also caused severe adverse events (AEs), and there were 2 deaths resulting from KTE-C19-related AEs.

Kite Pharma, Inc., the company developing KTE-C19, released these results and said additional data from this trial, known as ZUMA-1, will be submitted for presentation at an upcoming scientific meeting.

ZUMA-1 has enrolled patients with chemo-refractory, aggressive NHL. The phase 1 portion of the trial included 7 patients with diffuse large B-cell lymphoma (DLBCL).

Thus far, the phase 2 portion includes 62 NHL patients—51 with DLBCL and 11 with transformed follicular lymphoma (TFL) or primary mediastinal B-cell lymphoma (PMBCL).

The patients received a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of KTE-C19 (at a target dose of 2 x 10⁶ CAR T cells/kg).

Responses

In the phase 1 portion of the trial (n=7), the initial ORR was 71%, and the CR rate was 57%. At 3 months of follow-up, the ORR and CR rate were both 43%. The response rates remained the same at 6 months and 9 months of follow-up.

In the phase 2 portion of the trial, for all 62 patients, the initial ORR was 79%, and the CR rate was 52%. At 3 months, the ORR was 44%, and the CR rate was 39%.

Among the 51 patients with DLBCL, the initial ORR was 76%, and the CR rate was 47%. At 3 months, the ORR was 39%, and the CR rate was 33%.

Among the 11 patients with TFL or PMBCL, the initial ORR was 91%, and the CR rate was 73%. At 3 months, the ORR and CR rates were 64%.

Longer follow-up data are not yet available for the phase 2 portion of the study.

Safety

For all 62 patients, the most common grade 3 or higher AEs were neutropenia (66%), anemia (40%), febrile neutropenia (29%), thrombocytopenia (29%), and encephalopathy (26%).

Grade 3 or higher cytokine release syndrome occurred in 18% of patients, and neurological toxicity occurred in 34%.

Two patients died from KTE-C19-related AEs—hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of cytokine release syndrome.

Kite Pharma said the primary analysis from this study will include 101 patients with chemo-refractory NHL (DLBCL, TFL, and PMBCL), will have approximately 6 months of follow-up, and is expected in the first quarter of 2017.

ZUMA-1 is supported, in part, by funding from The Leukemia & Lymphoma Society Therapy Acceleration Program.

Make the most of your American College of Surgeons (ACS) Clinical Congress 2016 experience by visiting the ACS Resource Center to order the latest educational products; learn about the wide variety of programs, products, and services available to ACS members and meeting attendees; and meet ACS staff. You may update your ACS Member Profile and receive a flash drive with your own professional photo. The ACS Resource Center, located in the Exhibit Hall of the Walter E. Washington Convention Center, Washington, DC, will be open 9:00 am−4:30 pm, Monday through Wednesday. ACS volunteers are invited to visit the Volunteer Wall in the ACS Resource Center lounge where we will recognize and thank all of those members who contribute their time and expertise to the organization. Visit the ACS website at https://www.facs.org/clincon2016/about/resources/resource-center for more information about the ACS Resource Center.

Also located in the Exhibit Hall will be the ACS Theatre, which will be open to all attendees and will highlight select ACS programs during the lunch hour on Monday through Wednesday. Several short 30-minute programs will be featured each day, including the following:

Monday

Resources for International Members

Advanced Trauma Life Support (ATLS) 10th Edition: Demonstrating Innovation through Multimodal Education

ACS NSQIP: Tools for Improvement in Geriatric Surgery

Tuesday

The New AJCC [American Joint Committee on Cancer TNM Staging System [extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M)]: Vision, What’s New, and Preparing for Implementation January 1, 2017

A Rising Tide Lifts All Boats: Developing Geriatric Surgical Standards [https://www.facs.org/quality-programs/geriatric-coalition] to Improve all Older Adult Care

Member Engagement through Operation Giving Back

Wednesday

The National Stop the Bleed [http://www.bleedingcontrol.org] Campaign: The Bleeding Control (B-Con) Course

Strong for Surgery

Look for the ACS Theatre schedule which will be posted in the ACS Resource Center and near the Theatre in the Exhibit Hall of the Walter E. Washington Convention Center. Find more information about the ACS Theatre Sessions on the ACS website at https://www.facs.org/clincon2016/about/resources/theatre.

Make the most of your American College of Surgeons (ACS) Clinical Congress 2016 experience by visiting the ACS Resource Center to order the latest educational products; learn about the wide variety of programs, products, and services available to ACS members and meeting attendees; and meet ACS staff. You may update your ACS Member Profile and receive a flash drive with your own professional photo. The ACS Resource Center, located in the Exhibit Hall of the Walter E. Washington Convention Center, Washington, DC, will be open 9:00 am−4:30 pm, Monday through Wednesday. ACS volunteers are invited to visit the Volunteer Wall in the ACS Resource Center lounge where we will recognize and thank all of those members who contribute their time and expertise to the organization. Visit the ACS website at https://www.facs.org/clincon2016/about/resources/resource-center for more information about the ACS Resource Center.

Also located in the Exhibit Hall will be the ACS Theatre, which will be open to all attendees and will highlight select ACS programs during the lunch hour on Monday through Wednesday. Several short 30-minute programs will be featured each day, including the following:

Monday

Resources for International Members

Advanced Trauma Life Support (ATLS) 10th Edition: Demonstrating Innovation through Multimodal Education

ACS NSQIP: Tools for Improvement in Geriatric Surgery

Tuesday

The New AJCC [American Joint Committee on Cancer TNM Staging System [extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M)]: Vision, What’s New, and Preparing for Implementation January 1, 2017

A Rising Tide Lifts All Boats: Developing Geriatric Surgical Standards [https://www.facs.org/quality-programs/geriatric-coalition] to Improve all Older Adult Care

Member Engagement through Operation Giving Back

Wednesday

The National Stop the Bleed [http://www.bleedingcontrol.org] Campaign: The Bleeding Control (B-Con) Course

Strong for Surgery

Look for the ACS Theatre schedule which will be posted in the ACS Resource Center and near the Theatre in the Exhibit Hall of the Walter E. Washington Convention Center. Find more information about the ACS Theatre Sessions on the ACS website at https://www.facs.org/clincon2016/about/resources/theatre.

Make the most of your American College of Surgeons (ACS) Clinical Congress 2016 experience by visiting the ACS Resource Center to order the latest educational products; learn about the wide variety of programs, products, and services available to ACS members and meeting attendees; and meet ACS staff. You may update your ACS Member Profile and receive a flash drive with your own professional photo. The ACS Resource Center, located in the Exhibit Hall of the Walter E. Washington Convention Center, Washington, DC, will be open 9:00 am−4:30 pm, Monday through Wednesday. ACS volunteers are invited to visit the Volunteer Wall in the ACS Resource Center lounge where we will recognize and thank all of those members who contribute their time and expertise to the organization. Visit the ACS website at https://www.facs.org/clincon2016/about/resources/resource-center for more information about the ACS Resource Center.

Also located in the Exhibit Hall will be the ACS Theatre, which will be open to all attendees and will highlight select ACS programs during the lunch hour on Monday through Wednesday. Several short 30-minute programs will be featured each day, including the following:

Monday

Resources for International Members

Advanced Trauma Life Support (ATLS) 10th Edition: Demonstrating Innovation through Multimodal Education

ACS NSQIP: Tools for Improvement in Geriatric Surgery

Tuesday

The New AJCC [American Joint Committee on Cancer TNM Staging System [extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M)]: Vision, What’s New, and Preparing for Implementation January 1, 2017

A Rising Tide Lifts All Boats: Developing Geriatric Surgical Standards [https://www.facs.org/quality-programs/geriatric-coalition] to Improve all Older Adult Care

Member Engagement through Operation Giving Back

Wednesday

The National Stop the Bleed [http://www.bleedingcontrol.org] Campaign: The Bleeding Control (B-Con) Course

Strong for Surgery

Look for the ACS Theatre schedule which will be posted in the ACS Resource Center and near the Theatre in the Exhibit Hall of the Walter E. Washington Convention Center. Find more information about the ACS Theatre Sessions on the ACS website at https://www.facs.org/clincon2016/about/resources/theatre.

The American College of Surgeons (ACS) Transition to Practice (TTP) Program in General Surgery will host an informal Meet and Greet at the ACS Clinical Congress 2016, 12:00 noon–1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. The ACS TTP Program supports the transition from residency to independent practice in general surgery. Program participants will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program. Successfully incorporating the TTP Program, Dennis W. Ashley, MD, FACS, FCCM, TTP chief , Mercer University School of Medicine (MUSM), Cordele, GA, and William P. Pannell, MD, FACS, Senior Associate, MUSM, will share their experiences with participants. Learn more about the TTP Program on the ACS website at https://www.facs.org/education/program/ttp. Contact [email protected] for more information or stop by the Division of Education booth at Clinical Congress and learn more about this growing program.

The American College of Surgeons (ACS) Transition to Practice (TTP) Program in General Surgery will host an informal Meet and Greet at the ACS Clinical Congress 2016, 12:00 noon–1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. The ACS TTP Program supports the transition from residency to independent practice in general surgery. Program participants will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program. Successfully incorporating the TTP Program, Dennis W. Ashley, MD, FACS, FCCM, TTP chief , Mercer University School of Medicine (MUSM), Cordele, GA, and William P. Pannell, MD, FACS, Senior Associate, MUSM, will share their experiences with participants. Learn more about the TTP Program on the ACS website at https://www.facs.org/education/program/ttp. Contact [email protected] for more information or stop by the Division of Education booth at Clinical Congress and learn more about this growing program.

The American College of Surgeons (ACS) Transition to Practice (TTP) Program in General Surgery will host an informal Meet and Greet at the ACS Clinical Congress 2016, 12:00 noon–1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. The ACS TTP Program supports the transition from residency to independent practice in general surgery. Program participants will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program. Successfully incorporating the TTP Program, Dennis W. Ashley, MD, FACS, FCCM, TTP chief , Mercer University School of Medicine (MUSM), Cordele, GA, and William P. Pannell, MD, FACS, Senior Associate, MUSM, will share their experiences with participants. Learn more about the TTP Program on the ACS website at https://www.facs.org/education/program/ttp. Contact [email protected] for more information or stop by the Division of Education booth at Clinical Congress and learn more about this growing program.

The American College of Surgeons (ACS) Division of Education has released a new video, Surgeons as Leaders: From Boardroom to Operating Room, which highlights the Surgeons as Leaders course, a three-day program for surgeons of all backgrounds and specialties who aspire to enhance their skills in leading individuals and organizations across the surgical landscape. The video is available at https://www.facs.org/education/division-of-education/courses/surgeons-as-leaders/video.

The two-minute video demonstrates how the course provides surgeons with the skills that are essential to effective leadership and with an understanding of the leadership required at all levels of practice and in the surgical community. ACS Fellows in the video describe how the course’s interactive forums, small group discussions, and presentations by national leaders have helped participants recognize and develop leadership attributes they already possess, as well as translate the principles of leadership into action.

Share the Surgeons as Leaders video with other surgeons in your network, and stay tuned for additional videos highlighting of ACS Division of Education programs. Visit the College’s website at https://www.facs.org/education to learn more about ACS Education and Training opportunities.

The American College of Surgeons (ACS) Division of Education has released a new video, Surgeons as Leaders: From Boardroom to Operating Room, which highlights the Surgeons as Leaders course, a three-day program for surgeons of all backgrounds and specialties who aspire to enhance their skills in leading individuals and organizations across the surgical landscape. The video is available at https://www.facs.org/education/division-of-education/courses/surgeons-as-leaders/video.

The two-minute video demonstrates how the course provides surgeons with the skills that are essential to effective leadership and with an understanding of the leadership required at all levels of practice and in the surgical community. ACS Fellows in the video describe how the course’s interactive forums, small group discussions, and presentations by national leaders have helped participants recognize and develop leadership attributes they already possess, as well as translate the principles of leadership into action.

Share the Surgeons as Leaders video with other surgeons in your network, and stay tuned for additional videos highlighting of ACS Division of Education programs. Visit the College’s website at https://www.facs.org/education to learn more about ACS Education and Training opportunities.

The American College of Surgeons (ACS) Division of Education has released a new video, Surgeons as Leaders: From Boardroom to Operating Room, which highlights the Surgeons as Leaders course, a three-day program for surgeons of all backgrounds and specialties who aspire to enhance their skills in leading individuals and organizations across the surgical landscape. The video is available at https://www.facs.org/education/division-of-education/courses/surgeons-as-leaders/video.

The two-minute video demonstrates how the course provides surgeons with the skills that are essential to effective leadership and with an understanding of the leadership required at all levels of practice and in the surgical community. ACS Fellows in the video describe how the course’s interactive forums, small group discussions, and presentations by national leaders have helped participants recognize and develop leadership attributes they already possess, as well as translate the principles of leadership into action.

Share the Surgeons as Leaders video with other surgeons in your network, and stay tuned for additional videos highlighting of ACS Division of Education programs. Visit the College’s website at https://www.facs.org/education to learn more about ACS Education and Training opportunities.

The American College of Surgeons (ACS) Foundation Board of Directors will present the 2016 Distinguished Philanthropist Award to Mary H. McGrath, MD, MPH, FACS, professor of surgery, University of California, San Francisco (UCSF), at its annual Donor Recognition Luncheon Monday, October 17, at Clinical Congress 2016 in Washington, DC. Dr. McGrath will be recognized for her generous contributions to the College, her service to the larger philanthropic community, her long-standing record of ACS volunteerism, and a career-long dedication to the quality of surgical patient care.

A graduate of St. Louis University School of Medicine, MO (1970), she completed her general surgery residency at the University of Colorado Medical Center, Denver (1976), trained in plastic surgery at the Yale University School of Medicine (1976–1978), New Haven, CT, and completed a fellowship in hand surgery at the University of Connecticut, Storrs, and Yale University (1978).

Contributions to the profession

Since then, Dr. McGrath has made outstanding clinical and academic contributions to the field of plastic surgery, especially in the areas of breast and hand surgery, wound healing, introduction of new technology, and workforce issues. Her career as an academic surgeon started at Yale in 1978 with a position as assistant professor of surgery in the school of medicine’s division of plastic and reconstructive surgery.

In 1980, she became assistant professor of surgery, division of plastic and reconstructive surgery, Columbia University College of Physicians and Surgeons, New York, NY. In 1984, she moved to the George Washington University Medical Center, Washington, DC, where she began as chief, division of plastic and reconstructive surgery, and director, residency training program, and ultimately, ascended to professor of surgery. She has held her current position at UCSF since 2003.

A Fellow of the College since 1983, Dr. McGrath has provided exceptional service to the ACS and has served for 25 years in leadership roles, including First Vice-President (2007–2008); Vice-Chair, Board of Regents (2005–2006); member, Executive Committee, Board of Regents (2002–2006); Regent (1997–2006); and Chair, Committee on Ethics (2003–2006).

She served on the Board of Governors Executive Committee and as a Governor-at-Large representing the District of Columbia and is a member of the ACS Foundation Board. In 2009, the ACS appointed her to serve on the Board of Commissioners of The Joint Commission; she is currently serving her third term in this capacity. For this remarkable service, Dr. McGrath received the College’s higher honor, the Distinguished Service Award, in 2011.

Generous philanthropist

As an ACS donor since 1994, Dr. McGrath’s generous philanthropy has elevated her to the Fellows Leadership Society Legacy Circle, one of the top giving tiers that ACS Foundation donors may achieve. Remarking on her reasons for supporting the ACS, she said, “The surgical profession and other surgeons have enabled me to be personally and financially successful, for which I am tremendously grateful. I encourage other Fellows to consider making their own contributions and join the community of colleagues planning to see surgery survive successfully in the future.”

The American College of Surgeons (ACS) Foundation Board of Directors will present the 2016 Distinguished Philanthropist Award to Mary H. McGrath, MD, MPH, FACS, professor of surgery, University of California, San Francisco (UCSF), at its annual Donor Recognition Luncheon Monday, October 17, at Clinical Congress 2016 in Washington, DC. Dr. McGrath will be recognized for her generous contributions to the College, her service to the larger philanthropic community, her long-standing record of ACS volunteerism, and a career-long dedication to the quality of surgical patient care.

A graduate of St. Louis University School of Medicine, MO (1970), she completed her general surgery residency at the University of Colorado Medical Center, Denver (1976), trained in plastic surgery at the Yale University School of Medicine (1976–1978), New Haven, CT, and completed a fellowship in hand surgery at the University of Connecticut, Storrs, and Yale University (1978).

Contributions to the profession

Since then, Dr. McGrath has made outstanding clinical and academic contributions to the field of plastic surgery, especially in the areas of breast and hand surgery, wound healing, introduction of new technology, and workforce issues. Her career as an academic surgeon started at Yale in 1978 with a position as assistant professor of surgery in the school of medicine’s division of plastic and reconstructive surgery.

In 1980, she became assistant professor of surgery, division of plastic and reconstructive surgery, Columbia University College of Physicians and Surgeons, New York, NY. In 1984, she moved to the George Washington University Medical Center, Washington, DC, where she began as chief, division of plastic and reconstructive surgery, and director, residency training program, and ultimately, ascended to professor of surgery. She has held her current position at UCSF since 2003.

A Fellow of the College since 1983, Dr. McGrath has provided exceptional service to the ACS and has served for 25 years in leadership roles, including First Vice-President (2007–2008); Vice-Chair, Board of Regents (2005–2006); member, Executive Committee, Board of Regents (2002–2006); Regent (1997–2006); and Chair, Committee on Ethics (2003–2006).

She served on the Board of Governors Executive Committee and as a Governor-at-Large representing the District of Columbia and is a member of the ACS Foundation Board. In 2009, the ACS appointed her to serve on the Board of Commissioners of The Joint Commission; she is currently serving her third term in this capacity. For this remarkable service, Dr. McGrath received the College’s higher honor, the Distinguished Service Award, in 2011.

Generous philanthropist

As an ACS donor since 1994, Dr. McGrath’s generous philanthropy has elevated her to the Fellows Leadership Society Legacy Circle, one of the top giving tiers that ACS Foundation donors may achieve. Remarking on her reasons for supporting the ACS, she said, “The surgical profession and other surgeons have enabled me to be personally and financially successful, for which I am tremendously grateful. I encourage other Fellows to consider making their own contributions and join the community of colleagues planning to see surgery survive successfully in the future.”

The American College of Surgeons (ACS) Foundation Board of Directors will present the 2016 Distinguished Philanthropist Award to Mary H. McGrath, MD, MPH, FACS, professor of surgery, University of California, San Francisco (UCSF), at its annual Donor Recognition Luncheon Monday, October 17, at Clinical Congress 2016 in Washington, DC. Dr. McGrath will be recognized for her generous contributions to the College, her service to the larger philanthropic community, her long-standing record of ACS volunteerism, and a career-long dedication to the quality of surgical patient care.

A graduate of St. Louis University School of Medicine, MO (1970), she completed her general surgery residency at the University of Colorado Medical Center, Denver (1976), trained in plastic surgery at the Yale University School of Medicine (1976–1978), New Haven, CT, and completed a fellowship in hand surgery at the University of Connecticut, Storrs, and Yale University (1978).

Contributions to the profession

Since then, Dr. McGrath has made outstanding clinical and academic contributions to the field of plastic surgery, especially in the areas of breast and hand surgery, wound healing, introduction of new technology, and workforce issues. Her career as an academic surgeon started at Yale in 1978 with a position as assistant professor of surgery in the school of medicine’s division of plastic and reconstructive surgery.

In 1980, she became assistant professor of surgery, division of plastic and reconstructive surgery, Columbia University College of Physicians and Surgeons, New York, NY. In 1984, she moved to the George Washington University Medical Center, Washington, DC, where she began as chief, division of plastic and reconstructive surgery, and director, residency training program, and ultimately, ascended to professor of surgery. She has held her current position at UCSF since 2003.

A Fellow of the College since 1983, Dr. McGrath has provided exceptional service to the ACS and has served for 25 years in leadership roles, including First Vice-President (2007–2008); Vice-Chair, Board of Regents (2005–2006); member, Executive Committee, Board of Regents (2002–2006); Regent (1997–2006); and Chair, Committee on Ethics (2003–2006).

She served on the Board of Governors Executive Committee and as a Governor-at-Large representing the District of Columbia and is a member of the ACS Foundation Board. In 2009, the ACS appointed her to serve on the Board of Commissioners of The Joint Commission; she is currently serving her third term in this capacity. For this remarkable service, Dr. McGrath received the College’s higher honor, the Distinguished Service Award, in 2011.

Generous philanthropist

As an ACS donor since 1994, Dr. McGrath’s generous philanthropy has elevated her to the Fellows Leadership Society Legacy Circle, one of the top giving tiers that ACS Foundation donors may achieve. Remarking on her reasons for supporting the ACS, she said, “The surgical profession and other surgeons have enabled me to be personally and financially successful, for which I am tremendously grateful. I encourage other Fellows to consider making their own contributions and join the community of colleagues planning to see surgery survive successfully in the future.”

The Convocation Ceremony on Sunday, October 16, which officially will open the American College of Surgeons (ACS) Clinical Congress 2016, confers Fellowship upon surgeons who meet ACS requirements and provide optimal care to their patients. ACS Officers will be installed at the ceremony, and 2016−2017 ACS President Courtney M. Townsend, Jr., MD, FACS, will deliver the Presidential Address. The ceremony also will include recognition of the Honorary Fellows as well as presentation of the Distinguished Service Award, the Mary Edwards Walker Inspiring Women in Surgery Award, and the Scientific Forum Award. In addition, this year’s Convocation Ceremony will recognize the 25- and 50-year Initiate classes from 1966 and 1991. The first Convocation Ceremony took place on November 13, 1913, at the Congress Hotel in Chicago, IL. The inaugural class of 1,059 surgeons represented the U.S. and Canada and included 6 female surgeons. Clinical Congress participants are encouraged to attend this year’s ceremony to welcome the 2016 class of 1,823 Initiates. Visit the ACS website at https://www.facs.org/member-services/initiates for more information on the ceremony and additional benefits that new initiates will receive.

The Convocation Ceremony on Sunday, October 16, which officially will open the American College of Surgeons (ACS) Clinical Congress 2016, confers Fellowship upon surgeons who meet ACS requirements and provide optimal care to their patients. ACS Officers will be installed at the ceremony, and 2016−2017 ACS President Courtney M. Townsend, Jr., MD, FACS, will deliver the Presidential Address. The ceremony also will include recognition of the Honorary Fellows as well as presentation of the Distinguished Service Award, the Mary Edwards Walker Inspiring Women in Surgery Award, and the Scientific Forum Award. In addition, this year’s Convocation Ceremony will recognize the 25- and 50-year Initiate classes from 1966 and 1991. The first Convocation Ceremony took place on November 13, 1913, at the Congress Hotel in Chicago, IL. The inaugural class of 1,059 surgeons represented the U.S. and Canada and included 6 female surgeons. Clinical Congress participants are encouraged to attend this year’s ceremony to welcome the 2016 class of 1,823 Initiates. Visit the ACS website at https://www.facs.org/member-services/initiates for more information on the ceremony and additional benefits that new initiates will receive.

The Convocation Ceremony on Sunday, October 16, which officially will open the American College of Surgeons (ACS) Clinical Congress 2016, confers Fellowship upon surgeons who meet ACS requirements and provide optimal care to their patients. ACS Officers will be installed at the ceremony, and 2016−2017 ACS President Courtney M. Townsend, Jr., MD, FACS, will deliver the Presidential Address. The ceremony also will include recognition of the Honorary Fellows as well as presentation of the Distinguished Service Award, the Mary Edwards Walker Inspiring Women in Surgery Award, and the Scientific Forum Award. In addition, this year’s Convocation Ceremony will recognize the 25- and 50-year Initiate classes from 1966 and 1991. The first Convocation Ceremony took place on November 13, 1913, at the Congress Hotel in Chicago, IL. The inaugural class of 1,059 surgeons represented the U.S. and Canada and included 6 female surgeons. Clinical Congress participants are encouraged to attend this year’s ceremony to welcome the 2016 class of 1,823 Initiates. Visit the ACS website at https://www.facs.org/member-services/initiates for more information on the ceremony and additional benefits that new initiates will receive.

American College of Surgeons (ACS) Clinical Congress 2016 attendees should plan to stay in Washington, DC, through the evening of Wednesday, October 19, to participate in the ACS Taste of the City. Join this fun event, 5:00–7:00 pm in Hall D of the Walter E. Washington Convention Center and enjoy Washington, DC’s diverse dining and cultural scene. Enjoy live music and networking with ACS leaders, staff, friends, and colleagues. The event is free to all attendees and their families. Plan to move seamlessly from Wednesday’s educational sessions to the ACS Taste of the City. The hotel shuttle bus schedule will be extended to accommodate attendees and their family members. Casual dress is encouraged. Visit the ACS website at https://www.facs.org/clincon2016/about/events/engagement for more information on this event.

American College of Surgeons (ACS) Clinical Congress 2016 attendees should plan to stay in Washington, DC, through the evening of Wednesday, October 19, to participate in the ACS Taste of the City. Join this fun event, 5:00–7:00 pm in Hall D of the Walter E. Washington Convention Center and enjoy Washington, DC’s diverse dining and cultural scene. Enjoy live music and networking with ACS leaders, staff, friends, and colleagues. The event is free to all attendees and their families. Plan to move seamlessly from Wednesday’s educational sessions to the ACS Taste of the City. The hotel shuttle bus schedule will be extended to accommodate attendees and their family members. Casual dress is encouraged. Visit the ACS website at https://www.facs.org/clincon2016/about/events/engagement for more information on this event.

American College of Surgeons (ACS) Clinical Congress 2016 attendees should plan to stay in Washington, DC, through the evening of Wednesday, October 19, to participate in the ACS Taste of the City. Join this fun event, 5:00–7:00 pm in Hall D of the Walter E. Washington Convention Center and enjoy Washington, DC’s diverse dining and cultural scene. Enjoy live music and networking with ACS leaders, staff, friends, and colleagues. The event is free to all attendees and their families. Plan to move seamlessly from Wednesday’s educational sessions to the ACS Taste of the City. The hotel shuttle bus schedule will be extended to accommodate attendees and their family members. Casual dress is encouraged. Visit the ACS website at https://www.facs.org/clincon2016/about/events/engagement for more information on this event.

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) will sponsor several activities at Clinical Congress 2016. The WiSC will present the inaugural Mary Edwards Walker Inspiring Women in Surgery Award to Mary Maniscalco-Theberge, MD, FACS, department of surgery, National Naval Medical Center, Bethesda, MD, during Convocation 6:00−8:00 pm October 16 at the Walter E. Washington Convention Center, Hall D. Alexa I. Canady, MD, FACS, will present the Olga M. Jonasson Lecture, The Journey: Becoming a Neurosurgeon and Back Again, 2:30–3:00 pm, October 18 in the convention center, Room 145. Check the Program Book or meeting app for details. View a complete list of Women in Surgery Committee–sponsored events at Clinical Congress on the ACS website at https://www.facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/activities.

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) will sponsor several activities at Clinical Congress 2016. The WiSC will present the inaugural Mary Edwards Walker Inspiring Women in Surgery Award to Mary Maniscalco-Theberge, MD, FACS, department of surgery, National Naval Medical Center, Bethesda, MD, during Convocation 6:00−8:00 pm October 16 at the Walter E. Washington Convention Center, Hall D. Alexa I. Canady, MD, FACS, will present the Olga M. Jonasson Lecture, The Journey: Becoming a Neurosurgeon and Back Again, 2:30–3:00 pm, October 18 in the convention center, Room 145. Check the Program Book or meeting app for details. View a complete list of Women in Surgery Committee–sponsored events at Clinical Congress on the ACS website at https://www.facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/activities.

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) will sponsor several activities at Clinical Congress 2016. The WiSC will present the inaugural Mary Edwards Walker Inspiring Women in Surgery Award to Mary Maniscalco-Theberge, MD, FACS, department of surgery, National Naval Medical Center, Bethesda, MD, during Convocation 6:00−8:00 pm October 16 at the Walter E. Washington Convention Center, Hall D. Alexa I. Canady, MD, FACS, will present the Olga M. Jonasson Lecture, The Journey: Becoming a Neurosurgeon and Back Again, 2:30–3:00 pm, October 18 in the convention center, Room 145. Check the Program Book or meeting app for details. View a complete list of Women in Surgery Committee–sponsored events at Clinical Congress on the ACS website at https://www.facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/activities.