{"id":8422,"date":"2020-04-06T16:20:16","date_gmt":"2020-04-06T16:20:16","guid":{"rendered":"http:\/\/box5506.temp.domains\/~direxaco\/?page_id=8422"},"modified":"2020-12-22T11:10:09","modified_gmt":"2020-12-22T16:10:09","slug":"8422-2","status":"publish","type":"page","link":"https:\/\/direxaconsulting.com\/","title":{"rendered":"HOME"},"content":{"rendered":"

[et_pb_section fb_built=”1″ admin_label=”Hero Image ” _builder_version=”4.4.5″ background_color=”#331584″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(0,0,0,0.5)” background_color_gradient_end=”rgba(0,0,0,0)” background_color_gradient_direction=”90deg” background_color_gradient_overlays_image=”on” background_image=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/dark-background-1920.jpg” custom_margin=”-60px|-60px|||false|false”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.4.3″ custom_padding=”100px||100px||true|false”][et_pb_column type=”3_5″ _builder_version=”4.4.3″ custom_padding=”|||14px|false|false” animation_style=”slide” animation_direction=”left” animation_duration=”2000ms” animation_intensity_slide=”8%”][et_pb_text admin_label=”Quality by Design Text” _builder_version=”4.4.3″ text_font=”Open Sans|700||on|||||” text_text_color=”#ffffff” text_font_size=”15px” text_letter_spacing=”4px” header_font=”Prata||||||||” header_text_align=”left” background_color=”#a38b49″ background_layout=”dark” width=”70%” custom_margin=”|||-20px|false|false” custom_padding=”6px|21px|6px|21px|false|true” custom_css_main_element=”width: fit-content;” border_radii=”on|0px|0px|0px|0px”]QUALITY BY DESIGN
\n[\/et_pb_text][et_pb_text _builder_version=”4.4.3″ text_font=”Prata||||||||” header_font=”Prata||||||||” header_text_align=”left” header_font_size=”60px” header_line_height=”0.8em” custom_margin=”|||-14px|false|false” custom_padding=”36px||24px||false|false”]<\/p>\n

Direxa<\/span><\/h1>\n

Consulting<\/span><\/h1>\n

[\/et_pb_text][et_pb_text admin_label=”Direxa Text Overview” _builder_version=”4.4.3″ text_font=”Open Sans|600|||||||” text_text_color=”rgba(255,255,255,0.82)” text_font_size=”20px” text_line_height=”1.6em” header_font=”Adamina||||||||” header_2_font=”Adamina||||||||” header_2_text_align=”left” header_2_text_color=”#000000″ header_2_font_size=”32px” header_2_line_height=”1.2em” header_3_font=”Adamina||||||||” header_3_text_align=”left” header_3_font_size=”24px” header_4_font=”Open Sans||||||||” header_4_text_color=”#000000″ header_5_font=”Open Sans||||||||” header_5_text_align=”left” header_6_font=”Open Sans||||||||” header_6_text_color=”#000000″ header_6_font_size=”12px” background_layout=”dark” width=”80%” custom_margin=”-18px||0px|-14px|false|false” custom_padding=”0px||0px||false|false”]Direxa provides statistical strategy and support for biopharmaceuticals from nonclinical development through submission, approval, and the commercial lifecycle.
\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.4.3″ custom_padding=”|||14px|false|false” animation_style=”slide” animation_direction=”left” animation_duration=”2000ms” animation_intensity_slide=”8%”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.4.3″ background_color=”#ffffff” background_last_edited=”on|phone” background_enable_image_phone=”off” parallax_phone=”off”][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” _builder_version=”4.4.4″ custom_margin=”-120px||||false|false” custom_padding=”0px||0px||true|false” animation_style=”slide” animation_direction=”bottom” animation_duration=”2000ms” animation_intensity_slide=”8%”][et_pb_column type=”1_3″ _builder_version=”4.0.5″ background_color=”#896c2e” custom_padding=”25px|25px|25px|25px|true|true” box_shadow_style=”preset1″ box_shadow_horizontal=”-8px” box_shadow_vertical=”0px” box_shadow_color=”rgba(0,0,0,0.1)” box_shadow_position=”inner”][et_pb_text _builder_version=”4.4.4″ header_font=”Prata||||||||” header_2_font=”Prata||||||||” header_2_text_color=”#ffffff” header_2_font_size=”28px” width_tablet=”” width_phone=”” width_last_edited=”on|phone” custom_padding=”|||6px|false|false”]<\/p>\n

Value Delivered<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.4″ text_font=”Open Sans||||||||” text_text_color=”#FFFFFF” custom_padding=”|||8px|false|false”]Build investor and health authority confidence to accelerate submissions. Design robust processes and assays.\u00a0Conserve materials and analytical resources.
\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.5″ background_color=”#a38b49″ custom_padding=”25px|25px|25px|25px|true|true” box_shadow_style=”preset1″ box_shadow_horizontal=”-8px” box_shadow_vertical=”0px” box_shadow_color=”rgba(0,0,0,0.1)” box_shadow_position=”inner”][et_pb_text _builder_version=”4.4.4″ header_2_font=”Prata||||||||” header_2_text_color=”#ffffff” header_2_font_size=”28px” custom_padding=”|||6px|false|false” custom_padding__hover_enabled=”off|desktop”]<\/p>\n

CMC Statistics<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.4″ text_font=”Open Sans||||||||” text_text_color=”#ffffff” custom_margin=”|||8px|false|false” custom_padding=”||||false|false”]Statistical applications in the context of nonclinical biopharmaceutical development and Chemistry, Manufacturing & Controls (CMC).\u00a0Work spans the continuum from policy and strategy development to implementation.
\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.5″ background_color=”#bca754″ custom_padding=”25px|25px|25px|25px|true|true” box_shadow_style=”preset1″ box_shadow_horizontal=”-8px” box_shadow_vertical=”0px” box_shadow_color=”rgba(0,0,0,0.1)” box_shadow_position=”inner”][et_pb_text _builder_version=”4.4.4″ header_2_font=”Prata||||||||” header_2_text_color=”#ffffff” header_2_font_size=”28px” custom_padding=”|||6px|false|false”]<\/p>\n

Strategy + Execution<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.7.7″ text_font=”Open Sans||||||||” text_text_color=”#ffffff” background_layout=”dark” custom_margin=”||15px|8px|false|false” hover_enabled=”0″ sticky_enabled=”0″]<\/p>\n

Breadth and depth of knowledge in applied statistics coupled with a knack for translating to the language of regulatory science. Track record supporting accelerated approvals.<\/p>\n

Elected Fellow of the American Society for Quality, November 2020.<\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Section Background” _builder_version=”4.4.5″ background_color=”#00208a” use_background_color_gradient=”on” background_color_gradient_start=”rgba(255,255,255,0.79)” background_color_gradient_end=”rgba(255,255,255,0.81)” background_color_gradient_overlays_image=”on” background_image=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/1348521470-huge.jpg” module_alignment=”center”][et_pb_row _builder_version=”4.4.3″][et_pb_column type=”4_4″ _builder_version=”4.4.3″][et_pb_text _builder_version=”4.4.3″ text_font=”Open Sans|700||on|||||” text_text_color=”#ffffff” text_font_size=”18px” text_letter_spacing=”3px” background_color=”#0b1f8f” custom_padding=”12px||12px||false|false”]<\/p>\n

TRACK RECORD<\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.4.3″ custom_margin=”-36px||||false|false”][et_pb_column type=”4_4″ _builder_version=”4.4.3″][et_pb_text _builder_version=”4.4.3″ header_font=”Prata||||||||” header_text_align=”center” header_2_font=”Prata||||||||” header_2_text_align=”center” header_2_font_size=”44px” header_3_font=”Prata||||||||” text_orientation=”center” custom_padding=”14px||||false|false” header_font_tablet=”” header_font_phone=”” header_font_last_edited=”on|tablet” header_font_size_tablet=”48px” header_font_size_phone=”36px” header_font_size_last_edited=”on|phone”]<\/p>\n

Where Direxa Has Delivered<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.4.4″ animation_direction=”bottom”][et_pb_column type=”1_4″ _builder_version=”4.4.3″ background_color=”#FFFFFF” animation_style=”zoom” box_shadow_style=”preset2″ box_shadow_color=”#6b6b6b”][et_pb_image src=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Hepatitis-virus.jpg” title_text=”Hepatitis virus” show_bottom_space=”off” align=”center” force_fullwidth=”on” src_tablet=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Hepatitis-virus.jpg” src_phone=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Hepatitis-virus.jpg” src_last_edited=”on|phone” _builder_version=”4.7.7″ height_tablet=”” height_phone=”” height_last_edited=”on|desktop” custom_padding=”||||false|false”][\/et_pb_image][et_pb_text content_tablet=”<\/p>\n

FDA training & seminars<\/h2>\n

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FDA training & seminars<\/h2>\n

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FDA training & seminars<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.3″ custom_padding=”|20px|20px|20px|false|true”]Developed and delivered sessions on CMC statistics for FDA Staff College; specification setting for Office of Tissues and Advanced Therapies; process capability for CBER vaccines division; by invitation.
\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.4.3″ background_color=”#FFFFFF” animation_style=”zoom” box_shadow_style=”preset2″ box_shadow_color=”#6b6b6b”][et_pb_image src=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Adenovirus-1.jpg” title_text=”Adenovirus Disease” show_bottom_space=”off” align=”center” force_fullwidth=”on” src_tablet=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Adenovirus-1.jpg” src_phone=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Adenovirus-1.jpg” src_last_edited=”on|desktop” admin_label=”Hepatitus” _builder_version=”4.7.7″ custom_padding=”||||false|false”][\/et_pb_image][et_pb_text content_tablet=”<\/p>\n

Seasoned industry leader<\/h2>\n

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Seasoned industry leader<\/h2>\n

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Seasoned industry leader<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.5″ custom_padding=”|20px|20px|20px|false|true”]<\/p>\n

Ten years in Merck Regulatory & Analytical Sciences and Technical Operations. Led the team to design and implement global Continued Process Verification monitoring for Keytruda and all vaccine manufacturing.<\/p>\n

Read more<\/a><\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.4.3″ background_color=”#FFFFFF” animation_style=”zoom” box_shadow_style=”preset2″ box_shadow_color=”#6b6b6b”][et_pb_image src=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Varicella-zoster-virus.jpg” title_text=”Varicella zoster virus” show_bottom_space=”off” align=”center” force_fullwidth=”on” src_tablet=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Varicella-zoster-virus.jpg” src_phone=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Varicella-zoster-virus.jpg” src_last_edited=”on|phone” _builder_version=”4.7.7″ custom_padding=”||||false|false”][\/et_pb_image][et_pb_text content_tablet=”<\/p>\n

Accelerated approvals<\/h2>\n

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Accelerated approvals<\/h2>\n

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Accelerated approvals<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.3″ custom_padding=”|20px|20px|20px|false|true”]Direct support for first-in-class gene therapies, vaccines,\u00a0 and other novel biological products. Authored Control Strategy, Justification of Specifications, Quality Summary, et al. Represent sponsors in regulatory review discussions and responses to questions.
\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.4.3″ background_color=”#FFFFFF” animation_style=”zoom” box_shadow_style=”preset2″ box_shadow_color=”#6b6b6b”][et_pb_image src=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Coronavirus-2.jpg” title_text=”Coronavirus Outbreak” show_bottom_space=”off” align=”center” force_fullwidth=”on” src_tablet=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Coronavirus-2.jpg” src_phone=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/Coronavirus-2.jpg” src_last_edited=”on|phone” _builder_version=”4.7.7″ custom_padding=”||||false|false”][\/et_pb_image][et_pb_text content_tablet=”<\/p>\n

Professional network<\/h2>\n

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Professional network<\/h2>\n

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Professional network<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.5″ custom_padding=”|20px|20px|20px|false|true”]<\/p>\n

CASSS Associate Director and Scientific Organizing Committee for WCBP (Well Characterized BioPharmaceuticals). Editorial Boards of Quality Engineering and Life Science Leader. BioPhorum Operations Group Continued Process Verification team.<\/p>\n

Read more<\/a><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.4.3″ background_color=”#ffffff”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.4.4″][et_pb_column type=”1_2″ _builder_version=”4.0.5″][et_pb_divider color=” #0b1f8f” _builder_version=”4.4.3″ background_color=” #0b1f8f” min_height=”6px” custom_padding=”2px||2px||true|false”][\/et_pb_divider][et_pb_text _builder_version=”4.4.3″ header_font=”Prata||||||||” header_2_font=”Prata||||||||” header_2_font_size=”44px” custom_margin=”-12px||||false|false” custom_padding=”||12px||false|false”]<\/p>\n

Analytically Speaking<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.4.3″ text_font=”Open Sans||||||||” text_text_color=”#000000″ custom_margin=”-12px||20px||false|false” custom_padding=”||12px||false|false”]Principal Consultant Julia O’Neill’s approach to bridging statistics and science developed from early training with George Box, Bill Hunter and Stu Hunter, highlighted in this interview with JMP’s Anne Milley.
\n[\/et_pb_text][et_pb_button button_url=”https:\/\/www.jmp.com\/en_us\/events\/ondemand\/analytically-speaking\/bridging-statistics-and-chemical-engineering-for-biotech-and-pharma.html” button_text=”Watch the Video” _builder_version=”4.4.3″ custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”#a38b49″ button_border_width=”0px” button_border_radius=”50px” button_font=”|||on|||||” button_use_icon=”off” custom_padding=”5px|15px|4px|15px|false|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(0,0,0,0.1)” button_text_color__hover_enabled=”off|desktop” button_bg_color__hover_enabled=”on|hover” button_bg_color__hover=”#23232d” button_bg_enable_color__hover=”on”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.4.4″ background_image=”https:\/\/direxaconsulting.com~direxaco\/wp-content\/uploads\/2020\/05\/Great-Headshot-Retouch.jpg” link_option_url=”https:\/\/www.jmp.com\/en_us\/events\/ondemand\/analytically-speaking\/bridging-statistics-and-chemical-engineering-for-biotech-and-pharma.html”][et_pb_divider show_divider=”off” _builder_version=”4.4.5″ background_image=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/05\/Great-Headshot-Retouch.jpg” custom_padding=”125px||125px||true|false”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.4.4″ background_color=”#f7e0a5″ custom_padding=”0px||||false|false”][et_pb_row _builder_version=”4.4.4″ background_color=”rgba(0,0,0,0)” custom_padding=”|35px||35px|false|true” animation_direction=”bottom” border_color_all=”rgba(0,0,0,0)” border_style_top=”double” border_color_bottom=”#a38b49″ border_style_bottom=”double”][et_pb_column type=”4_4″ _builder_version=”4.4.4″ custom_padding=”||||false|false” border_color_all=”rgba(0,0,0,0)”][et_pb_divider color=”#0b1f8f” divider_weight=”12px” _builder_version=”4.4.4″ background_color=” #0b1f8f” width=”100%” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”100%” min_height=”6px” custom_padding=”2px||2px||true|false” border_color_all=”rgba(0,0,0,0)”][\/et_pb_divider][et_pb_text content_tablet=”<\/p>\n

Benefits You Gain Working with Direxa<\/h2>\n

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Benefits You Gain Working with Direxa<\/h1>\n

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Working with Direxa<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ make_equal=”on” _builder_version=”4.4.4″ custom_margin=”-24px||||false|false”][et_pb_column type=”1_3″ _builder_version=”4.4.4″ background_color=”#a38b49″ custom_padding=”24px|24px|24px|24px|true|true” animation_style=”zoom” box_shadow_style=”preset2″ background__hover_enabled=”on|hover” background_color__hover=”#8d7732″ background_enable_color__hover=”on” box_shadow_color__hover_enabled=”on|hover” box_shadow_color__hover=”#6b6b6b”][et_pb_blurb title=”Partnership” admin_label=”How it Works Blurb” _builder_version=”4.4.4″ header_level=”h2″ header_font=”Prata||||||||” header_text_align=”center” header_text_color=”#ffffff” header_font_size=”28px” body_font=”Open Sans||||||||” body_text_color=”#ffffff” body_font_size=”18px” background_color=”rgba(0,0,0,0)” text_orientation=”center” background_layout=”dark” custom_padding=”|12px||12px|false|true” animation_style=”zoom” background__hover_enabled=”on|desktop”]<\/p>\n

Long-term collaboration<\/p>\n

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Coaching to build your team’s skills<\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.4.4″ background_color=”#a38b49″ animation_style=”zoom” box_shadow_style=”preset2″ background__hover_enabled=”on|desktop” background_color__hover=”#8d7732″ background_enable_color__hover=”on” box_shadow_color__hover_enabled=”on|hover” box_shadow_color__hover=”#6b6b6b”][et_pb_blurb title=”Responsive” admin_label=”Economical” _builder_version=”4.4.4″ header_level=”h2″ header_font=”Prata||||||||” header_text_align=”center” header_text_color=”#ffffff” header_font_size=”28px” body_font=”Open Sans||||||||” background_color=”rgba(0,0,0,0)” custom_padding=”24px|12px|24px|12px|true|true” animation_style=”zoom”]<\/p>\n

Statistics resource available on demand<\/span>
\n<\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

QUALITY BY DESIGN Direxa Consulting Direxa provides statistical strategy and support for biopharmaceuticals from nonclinical development through submission, approval, and the commercial lifecycle. Value Delivered Build investor and health authority confidence to accelerate submissions. Design robust processes and assays.\u00a0Conserve materials and analytical resources. CMC Statistics Statistical applications in the context of nonclinical biopharmaceutical development and […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-8422","page","type-page","status-publish","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t