{"id":4103,"date":"2020-12-11T12:08:36","date_gmt":"2020-12-11T12:08:36","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?page_id=4103"},"modified":"2021-08-11T01:32:59","modified_gmt":"2021-08-11T09:32:59","slug":"case-study","status":"publish","type":"page","link":"https:\/\/www.sfj-pharma.com\/case-study\/","title":{"rendered":"Case Study"},"content":{"rendered":"<p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;grid&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; css=&#8221;.vc_custom_1607690999351{background-color: #ffffff !important;}&#8221; z_index=&#8221;&#8221; padding_top=&#8221;60&#8243; padding_bottom=&#8221;60&#8243;][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; css=&#8221;.vc_custom_1625004860921{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 30px !important;background-image: url(https:\/\/www.sfj-pharma.com\/wp-content\/uploads\/2021\/05\/SFJ-by-the-numbers.jpg?id=8623) !important;}&#8221;][vc_column_inner][vc_column_text]<\/p>\n<h1><strong>SFJ Philosophy<\/strong><\/h1>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;20px&#8221;][vc_column_text]SFJ\u2019s decision-making process aims at enhancing the probability of clinical and regulatory success and maximizing the future value of the asset. Decisions are made in collaboration with the sponsor. A few examples:<\/p>\n<p>&nbsp;<\/p>\n<ul class=\"sjf-solution-list\">\n<li><strong>Study A<\/strong> \u2013 Within the first 9 months of the study, sponsor\u2019s plan was well behind enrollment timelines. SFJ rapidly intervened with additional funding and a plan to increase site numbers. The study ultimately finished 3 months ahead of schedule.<\/li>\n<li><strong>Study B<\/strong> \u2013 SFJ dramatically revised inclusion criteria and resized the sponsor\u2019s trial significantly. These changes ensured focus on the appropriate patients and enhanced likelihood of clinical success. A parallel trial by the sponsor in a different indication failed, while SFJ\u2019s trial led to the drug\u2019s approval.<\/li>\n<li><strong>Study C<\/strong> \u2013 SFJ refined patient inclusion criteria and reclassified endpoint sequence. Trial success was credited in part to these changes.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; css=&#8221;.vc_custom_1607691062886{padding-left: 25px !important;}&#8221;][vc_column_inner][vc_empty_space height=&#8221;40px&#8221;][vc_column_text]<\/p>\n<h2><strong><b>Case Study:<\/b><\/strong><\/h2>\n<p>[\/vc_column_text][vc_column_text]<\/p>\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<h2><strong><b>Vizimpro\u00a0<\/b><\/strong><strong><b>Co-Development\u00a0<\/b><\/strong><strong><b>With Pfizer<\/b><\/strong><\/h2>\n<\/div>\n<\/div>\n<div class=\"vc_empty_space\"><\/div>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;20px&#8221;][vc_column_text]In 2012, SFJ began a partnership with Pfizer for the funding, design, and execution of a 452-patient global Phase 3 trial of dacomitinib (Vizimpro), a first line therapy for EGFR-mutated non small cell lung cancer. Upon the success of the trial, this once-daily oral medication received regulatory approvals globally between December 2018 and May 2019.[\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][vc_column_text]<\/p>\n<h3><strong>Process Highlights For This Global Registration Trial:<\/strong><\/h3>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;20px&#8221;][vc_column_text css=&#8221;.vc_custom_1625212670985{padding-left: 20px !important;}&#8221;]<\/p>\n<ul class=\"sjf-solution-list\">\n<li>SFJ and Pfizer agreed basic study design parameters<\/li>\n<li>SFJ assembled a world-class team of KOL\u2019s as its Scientific Advisory Committee, with representation from Hong Kong, China, Japan, Europe and the US<\/li>\n<li>SFJ\u2019s team led the protocol-drafting effort, with regular alignment meetings with Pfizer peers<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][vc_column_text]<\/p>\n<h3><strong>Results: Several Success-Enhancing Design Changes<\/strong><\/h3>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;10px&#8221;][vc_column_text el_class=&#8221;case&#8221;]<\/p>\n<ul class=\"sjf-solution-list\">\n<li>Inclusion criteria adjustments<\/li>\n<li>Exclusion criteria adjustments<\/li>\n<li>Significant increase in the number of subjects to enhance trial powering<\/li>\n<li>Operational excellence and efficiency:<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][vc_column_text]<\/p>\n<h3><strong>SFJ Value-Add<\/strong><\/h3>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;20px&#8221;][vc_column_text]Within 9 months of the Co-Development Agreement closing, SFJ:[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;20px&#8221;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][qode_elements_holder number_of_columns=&#8221;two_columns&#8221; columns_proportion=&#8221;25_75&#8243; switch_to_one_column=&#8221;never&#8221; alignment_one_column=&#8221;left&#8221;][qode_elements_holder_item vertical_alignment=&#8221;middle&#8221; advanced_animations=&#8221;no&#8221; item_padding=&#8221;0px 20px 0px 0px&#8221;][vc_single_image image=&#8221;11208&#8243; img_size=&#8221;150&#215;68&#8243; alignment=&#8221;center&#8221; qode_css_animation=&#8221;&#8221;][\/qode_elements_holder_item][qode_elements_holder_item vertical_alignment=&#8221;middle&#8221; horizontal_alignment=&#8221;left&#8221; advanced_animations=&#8221;no&#8221; custom_class=&#8221;sfj-bracket-text-right&#8221;][vc_column_text el_class=&#8221;case&#8221; css=&#8221;.vc_custom_1625212707931{padding-left: 20px !important;}&#8221;]<\/p>\n<ul class=\"sjf-solution-list\">\n<li style=\"text-align: left;\">Drafted the protocol and all study documents.<\/li>\n<li style=\"text-align: left;\">Completed all required regulatory meetings.<\/li>\n<li style=\"text-align: left;\">Selected a CRO<\/li>\n<li style=\"text-align: left;\">Secured the comparator drug supply<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/qode_elements_holder_item][\/qode_elements_holder][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_empty_space height=&#8221;80px&#8221;][vc_column_text]<\/p>\n<h2><strong>SFJ Accelerated Recruitment Around The Globe:<\/strong><\/h2>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;10px&#8221;][vc_single_image image=&#8221;8668&#8243; img_size=&#8221;full&#8221; qode_css_animation=&#8221;&#8221;][vc_empty_space height=&#8221;40px&#8221;][vc_column_text]<\/p>\n<h2><strong>Efficiency From Database Lock To NDA<\/strong><\/h2>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;10px&#8221;][vc_single_image image=&#8221;8673&#8243; img_size=&#8221;full&#8221; qode_css_animation=&#8221;&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/6&#8243;][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;grid&#8221; 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