Generated by All in One SEO v4.9.3, this is an llms.txt file, used by LLMs to index the site. # akta Pharmaceutical Development Our name personifies actions, not words. ## Sitemaps - [XML Sitemap](https://aktapd.com/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [The False Economy of Cheap Labor in Pharma: Why Expertise Is the Highest ROI Variable - Part 1](https://aktapd.com/the-false-economy-of-cheap-labor-in-pharma-why-expertise-is-the-highest-roi-variable-part-1/) - [Science and Pharma: Weathering the Perfect Storm](https://aktapd.com/science-and-pharma-weathering-the-perfect-storm/) - [Sheree Vaickus Cited as Woman to KNOW in 2023 Magazine](https://aktapd.com/sheree-vaickus-cited-as-woman-to-know-in-2023-magazine/) - [aktaPD's Sheree Vaickus Cited as Woman to KNOW in 2023 Magazine](https://aktapd.com/aktapds-sheree-vaickus-cited-as-woman-to-know-in-2023-magazine/) - [IND Business Opportunity](https://aktapd.com/ind-business-opportunity/) - [Filling the Personnel Gap](https://aktapd.com/filling-the-personnel-gap/) - [Happy Holidays 2021](https://aktapd.com/happy-holidays-2021/) - [aktaPD Is Diversifying Its Mix of Consultants by Adding Skyline Biopharma Experts to Its Team](https://aktapd.com/aktapd-is-diversifying-its-mix-of-consultants-by-adding-skyline-biopharma-experts-to-its-team/) - [aktaPD CEO Dr. Lou Vaickus featured on Spectrum News Channel 1](https://aktapd.com/ceo-of-aktapd-dr-lou-vaickus-featured-on-spectrum-news-channel-1/) - [aktaPD’s Dr. Lou Vaickus Appointed To Wilcox Distribution As Head Of Medical Advisory Team](https://aktapd.com/aktapds-dr-lou-vaickus-appointed-to-wilcox-distribution-as-head-of-medical-advisory-team/) - By Chris Lea, WRAL-TV Sports anchor/reporter October15th. 2020 RALEIGH, N.C. — From Enloe High School to Maryland and the NBA. Chris Wilcox was known for his fierce play and protecting the paint. Now, he wants to protect his community, the Triangle, from COVID-19. "Where I'm from, the community invested in me," Wilcox said. "I could go - [Ex-Basketball Star Chris Wilcox Helps Distribute A Potential COVID-19 Game-changer](https://aktapd.com/ex-basketball-star-chris-wilcox-helps-distribute-a-potential-covid-19-game-changer/) - RALEIGH, N.C. (WTVD) -- Having clean air to breathe is critical in confined spaces. Former Enloe High School basketball star Chris Wilcox is distributing a potentially game-changing device that's FDA approved. Houston company Integrated Viral Protection developed this air purification system that claims to kill nearly 100% of airborne SARS-CoV-2, the virus that causes COVID-19. - [Just Because…](https://aktapd.com/just-because/) - [Troubleshoot, Then Take Action and Thrive](https://aktapd.com/troubleshoot-then-take-action-and-thrive/) - [It’s All About The Pitch](https://aktapd.com/its-all-about-the-pitch/) - [aktaPD Clinical Vendor Management](https://aktapd.com/aktapd-clinical-vendor-management/) - [F2F(Lift) Pays Off In Higher Engagement](https://aktapd.com/f2flift-pays-off-in-higher-engagement/) - [Navigating the Waves of Data: Biometrics](https://aktapd.com/navigating-the-waves-of-data-biometrics/) - [akta Pharmaceutical Development Hires Angela M. Esteva to Manage Business Development](https://aktapd.com/akta-pharmaceutical-development-hires-angela-m-esteva-to-manage-business-development/) - [Reflect On This: Do We Change](https://aktapd.com/reflect-on-this-do-we-change/) - [aktaPD and TSEC Team Up on Production Management](https://aktapd.com/aktapd-and-tsec-team-up-on-production-management/) - [Marketability, Not Marketing](https://aktapd.com/marketability-not-marketing/) - [First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury:
A Clinical Pilot Study for Safety and Feasibility](https://aktapd.com/first-human-implantation-of-a-bioresorbable-polymer-scaffold-for-acute-traumatic-spinal-cord-injurya-clinical-pilot-study-for-safety-and-feasibility/) - [Making the Case for an Interim CMO](https://aktapd.com/making-the-case-for-an-interim-cmo/) - [Exemplifying Our Mission in 2015 and Beyond](https://aktapd.com/exemplifying-our-mission-in-2015-and-beyond/) - [aktaPD®ology: 5 Tips for Smart Clinical Operations](https://aktapd.com/aktapdology-5-tips-for-smart-clinical-operations/) - [eNews You Can Use: Advocacy In Action](https://aktapd.com/enews-you-can-use-advocacy-in-action/) - [aktaPD®’s Sheree A. Mann Advocates for Research Spending with Capitol Hill Lawmakers](https://aktapd.com/aktapds-sheree-a-mann-advocates-for-research-spending-with-capitol-hill-lawmakers/) - [A Unique Approach at akta Pharmaceutical Development™](https://aktapd.com/a-unique-approach-at-akta-pharmaceutical-development/) - [aktaPD® In the News…Did You Know?](https://aktapd.com/aktapd-in-the-newsdid-you-know/) - [Our Pharmaceutical Development Philosophy in “action”-aktaPD®ology-Preparation and Partnering](https://aktapd.com/our-pharmaceutical-development-philosophy-in-action-aktapdology-preparation-and-partnering/) - [aktaPD®’s Dr. Lou Vaickus Teams with InVivo Therapeutics in Development of Novel Spinal Cord Injury Clinical Program](https://aktapd.com/aktapds-dr-lou-vaickus-teams-with-invivo-therapeutics-in-development-of-novel-spinal-cord-injury-clinical-program/) - [Success Story aktaPD® ROI (Really Outstanding Impact)](https://aktapd.com/success-story-aktapd-roi-really-outstanding-impact/) - [Dr. Philip G. Janicak Joins aktaPD®](https://aktapd.com/dr-philip-g-janicak-joins-aktapd/) - [The Changing Face of Clinical Research](https://aktapd.com/the-changing-face-of-clinical-research/) - [Venture Capital: aktaPD® Looks at the Risks and Rewards of Pre-Clinical](https://aktapd.com/venture-capital-aktapd-looks-at-the-risks-and-rewards-of-pre-clinical/) - [At aktaPD®, we believe leadership is an action, not a word.](https://aktapd.com/at-aktapd-we-believe-leadership-is-an-action-not-a-word/) - [Why We are Driven to Action](https://aktapd.com/why-we-are-driven-to-action/) - [aktaPD® Expansion – “action our way forward”](https://aktapd.com/aktapd-expansion-action-our-way-forward/) - [InVivo Therapeutics – Interim CMO](https://aktapd.com/invivo-therapeutics-interim-cmo/) - [Happy Holidays From aktaPD!](https://aktapd.com/happy-holidays-from-aktapd/) ## Pages - [Home](https://aktapd.com/) - [et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.16″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_direction=”148deg” background_color_gradient_stops=”#2130b7 19%|#ff915e 100%” background_color_gradient_start=”#2130b7″ background_color_gradient_start_position=”19%” background_color_gradient_end=”#ff915e” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||16vw||false|false” bottom_divider_style=”arrow” bottom_divider_height=”29vw” bottom_divider_repeat=”0.7x” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.16″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” - [NetcaKch®](https://aktapd.com/netcakch/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.27.5″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_direction=”158deg” background_color_gradient_stops=”#2130b7 19%|#8ef1ff 100%” background_color_gradient_start=”#2130b7″ background_color_gradient_start_position=”19%” background_color_gradient_end=”#8ef1ff” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-34-1.png” background_size=”contain” background_position=”center_right” custom_margin=”||||false” custom_padding=”10vw||0||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”arrow” bottom_divider_height=”30vw” bottom_divider_repeat=”0.7x” bottom_divider_repeat_tablet=”1x” bottom_divider_repeat_phone=”1x” bottom_divider_repeat_last_edited=”on|tablet” collapsed=”on” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”off|desktop” _builder_version=”4.16″ max_width=”80%” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” - [Beyond Celiac CRC Focus Group Survey Thank You](https://aktapd.com/beyond-celiac-crc-focus-group-survey-thank-you/) - [et_pb_section fb_built=”1″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” header_font=”|700|||||||” text_orientation=”center” global_colors_info=”{}”]Thank You[/et_pb_text][et_pb_image src=”https://aktapd.com/wp-content/uploads/2025/06/bc-logo-square.png” title_text=”bc-logo-square” align=”center” _builder_version=”4.27.4″ _module_preset=”default” width=”25%” global_colors_info=”{}”][/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font=”|600|||||||” text_font_size=”16px” background_size=”initial” background_position=”top_left” background_repeat=”repeat” text_orientation=”center” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]Thanks for sharing your feedback about the Beyond Celiac CRC Focus Group. We thank you for your time and - [Beyond Celiac CRC Focus Group Survey](https://aktapd.com/beyond-celiac-crc-focus-group-survey/) - [et_pb_section fb_built=”1″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_row _builder_version=”4.27.4″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” width=”60%” width_tablet=”70%” width_phone=”90%” width_last_edited=”on|desktop” custom_padding=”||32vh||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” header_font=”|700|||||||” global_colors_info=”{}”]Beyond Celiac CRC Focus Group Survey[/et_pb_text][et_pb_text _builder_version=”4.27.4″ text_font=”|600|||||||” text_font_size=”16px” background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”]Thanks for sharing your feedback about the Beyond Celiac CRC Live Focus Group, November 19, 2025.[/et_pb_text][et_pb_code _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ custom_css_free_form=”||.qmn_btn {|| - [Beyond Celiac - Internal Test Meeting 11-10-25](https://aktapd.com/beyond-celiac-internal-test-meeting-11-10-25/) - [et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”4.16″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_direction=”148deg” background_color_gradient_stops=”#2130b7 19%|#ff915e 100%” background_color_gradient_start=”#2130b7″ background_color_gradient_start_position=”19%” background_color_gradient_end=”#ff915e” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||0||false|false” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.16″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” hover_enabled=”0″ header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” - [aktaPD Enterprises](https://aktapd.com/aktapd-enterprises/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#FFFFFF” admin_label=”Header” _builder_version=”4.16″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_direction=”158deg” background_color_gradient_stops=”#2130b7 19%|#8ef1ff 100%” background_color_gradient_start=”#2130b7″ background_color_gradient_start_position=”19%” background_color_gradient_end=”#8ef1ff” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-34-2.png” background_size=”contain” background_position=”center_right” custom_margin=”||7vh||false|false” custom_padding=”10vw||||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”arrow” bottom_divider_height=”30vw” bottom_divider_repeat=”0.7x” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”off|desktop” _builder_version=”4.16″ max_width=”80%” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” - [Newsletter](https://aktapd.com/newsletter/) - [Press Releases](https://aktapd.com/press-releases/) - [et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.16″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_direction=”148deg” background_color_gradient_stops=”#2130b7 19%|#ff915e 100%” background_color_gradient_start=”#2130b7″ background_color_gradient_start_position=”19%” background_color_gradient_end=”#ff915e” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||16vw||false|false” bottom_divider_style=”arrow” bottom_divider_height=”29vw” bottom_divider_repeat=”0.8x” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.16″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” - [Internal Support Team](https://aktapd.com/internal-support-team/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.16″ use_background_color_gradient=”on” background_color_gradient_direction=”0deg” background_color_gradient_stops=”rgba(87,104,208,0.18) 0%|#5768d0 100%” background_color_gradient_start=”rgba(87,104,208,0.18)” background_color_gradient_end=”#5768d0″ background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-32-1.png” background_size=”contain” background_position=”bottom_right” custom_margin=”||||false” custom_padding=”10vw||10vw||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”asymmetric” bottom_divider_height=”14vw” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.16″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” - [Our Experts](https://aktapd.com/our-experts/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.16″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_direction=”158deg” background_color_gradient_stops=”#2130b7 19%|#8ef1ff 100%” background_color_gradient_start=”#2130b7″ background_color_gradient_start_position=”19%” background_color_gradient_end=”#8ef1ff” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-34-1.png” background_size=”contain” background_position=”center_right” custom_margin=”||||false” custom_padding=”10vw||0||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”arrow” bottom_divider_height=”30vw” bottom_divider_repeat=”1x” background_last_edited=”on|phone” background_position_tablet=”center_right” background_position_phone=”bottom_center” background_repeat_tablet=”no-repeat” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”off|desktop” _builder_version=”4.16″ max_width=”80%” max_width_tablet=”80%” max_width_phone=”” max_width_last_edited=”on|tablet” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” - [What We Do](https://aktapd.com/what-we-do/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.16″ use_background_color_gradient=”on” background_color_gradient_direction=”0deg” background_color_gradient_stops=”rgba(87,104,208,0.18) 0%|#5768d0 100%” background_color_gradient_start=”rgba(87,104,208,0.18)” background_color_gradient_end=”#5768d0″ background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-32-2.png” background_size=”contain” background_position=”bottom_right” custom_margin=”||||false” custom_padding=”10vw||10vw||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”asymmetric” bottom_divider_height=”14vw” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.16″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”69%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” - 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[Expertise](https://aktapd.com/expertise/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.14.8″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(87,104,208,0.18)” background_color_gradient_end=”#5768d0″ background_color_gradient_direction=”0deg” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-32-2.png” background_size=”contain” background_position=”bottom_right” custom_margin=”||||false” custom_padding=”10vw||10vw||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”asymmetric” bottom_divider_height=”14vw” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.14.8″ max_width=”80%” custom_padding=”0px|0px|70px|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”26px” header_2_font_size_phone=”20px” header_2_font_size_last_edited=”on|phone” - [About](https://aktapd.com/about/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.14.8″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(87,104,208,0.18)” background_color_gradient_end=”#5768d0″ background_color_gradient_direction=”0deg” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-32-1.png” background_size=”contain” background_position=”bottom_right” custom_margin=”||||false” custom_padding=”10vw||10vw||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”asymmetric” bottom_divider_height=”14vw” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”26px” header_2_font_size_phone=”20px” header_2_font_size_last_edited=”on|phone” - [Therapeutic Areas & Indications](https://aktapd.com/therapeutic-areas-indications/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.14.8″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(87,104,208,0.18)” background_color_gradient_end=”#5768d0″ background_color_gradient_direction=”0deg” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-32-2.png” background_size=”contain” background_position=”bottom_right” custom_margin=”||||false” custom_padding=”10vw||10vw||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”asymmetric” bottom_divider_height=”14vw” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”26px” header_2_font_size_phone=”20px” header_2_font_size_last_edited=”on|phone” - [Job Listings](https://aktapd.com/job-listings/) - [et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||16vw||false|false” bottom_divider_style=”arrow” bottom_divider_height=”29vw” bottom_divider_repeat=”0.8x” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” - 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[The Special Events Company](https://aktapd.com/the-special-events-company/) - [et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||0||false|false” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” header_3_font_size__hover=”22px” header_3_font_size__hover_enabled=”22px” header_3_letter_spacing__hover=”0px” header_3_letter_spacing__hover_enabled=”0px” - [Arandi Development Group](https://aktapd.com/arandi-development-group/) - [et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||0||false|false” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” header_3_font_size__hover=”22px” header_3_font_size__hover_enabled=”22px” header_3_letter_spacing__hover=”0px” header_3_letter_spacing__hover_enabled=”0px” - [BioConsulting Partners (BCP)](https://aktapd.com/bioconsulting-partners-bcp/) - [et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||0||false|false” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” header_3_font_size__hover=”22px” header_3_font_size__hover_enabled=”22px” header_3_letter_spacing__hover=”0px” header_3_letter_spacing__hover_enabled=”0px” - [AMRIS](https://aktapd.com/amris/) - [et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||0||false|false” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” header_3_font_size__hover=”22px” header_3_font_size__hover_enabled=”22px” header_3_letter_spacing__hover=”0px” header_3_letter_spacing__hover_enabled=”0px” - [Affiliates](https://aktapd.com/affiliates/) - [et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||0||false|false” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” header_3_font_size__hover=”22px” header_3_font_size__hover_enabled=”22px” header_3_letter_spacing__hover=”0px” header_3_letter_spacing__hover_enabled=”0px” - [History of aktaPD](https://aktapd.com/history-of-aktapd/) - [et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” next_background_color=”#ffffff” admin_label=”Header” _builder_version=”4.14.8″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(87,104,208,0.18)” background_color_gradient_end=”#5768d0″ background_color_gradient_direction=”0deg” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-32-1.png” background_size=”contain” background_position=”bottom_right” custom_margin=”||||false” custom_padding=”10vw||12vw||false|false” custom_padding_tablet=”||44vw” custom_padding_phone=”” bottom_divider_style=”asymmetric” bottom_divider_height=”14vw” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” header_2_font=”Poppins|600|||||||” header_2_font_size=”30px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”26px” - [Testimonials](https://aktapd.com/testimonials/) - [et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||16vw||false|false” bottom_divider_style=”arrow” bottom_divider_height=”29vw” bottom_divider_repeat=”0.8x” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” - [Consulting Opportunities](https://aktapd.com/consulting-opportunities/) - [et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”Header” _builder_version=”3.22″ background_color=”rgba(239,103,40,0.96)” use_background_color_gradient=”on” background_color_gradient_start=”#2130b7″ background_color_gradient_end=”#ff915e” background_color_gradient_direction=”148deg” background_color_gradient_start_position=”19%” background_image=”https://aktapd.com/wp-content/uploads/2022/03/software-06.png” parallax=”on” custom_margin=”||||false” custom_padding=”10vw||16vw||false|false” bottom_divider_style=”arrow” bottom_divider_height=”29vw” bottom_divider_repeat=”0.8x” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”3.25″ max_width=”80%” custom_padding=”0px|0px|0|0px|false|false” custom_padding_tablet=”40px||40px||true” custom_padding_phone=”” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.8″ text_font=”||||||||” header_font=”Poppins|600|||||||” header_font_size=”5vw” header_line_height=”1.5em” text_orientation=”center” background_layout=”dark” max_width=”80%” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||20px” animation_style=”fade” header_font_size_tablet=”38px” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” header_text_shadow_style=”preset3″ header_text_shadow_vertical_length=”0.3em” header_text_shadow_blur_strength=”1.4em” header_text_shadow_color=”rgba(0,0,0,0.24)” global_colors_info=”{}” ## Experts - [Michael P. Carver, PhD](https://aktapd.com/experts/michael-p-carver-phd/) - TOXICOLOGIST / DRUG DEVELOPER PERSONAL PROFILE 30+ years in global pharmaceutical and biotechnology drug discovery and development EXPERTISE Pharmacology / Safety; Drug Metabolism / Pharmacokinetics (DMPK); Toxicology; Good LaboratoryPractices (GLPs); INDs; Clinical Trial Applications (CTAs); NDAs; MAAs; Internal Reports and InternationalRegulatory Filings and Interactions (IBs, CTAs, PIP); Safety Evaluation Program Operations; QA Audits /Technical Assessments; - [Eva Krusinska , PhD, DSc, MBEE](https://aktapd.com/experts/eva-krusinska-phd-dsc-mbee/) - BIOSTATISTICIAN / CHIEF DATA OFFICER PERSONAL PROFILE 25+ years as a biostatistician and pharmaceutical science executive EXPERTISE Clinical Biostatistics (Phases 1-4), Adaptive Designs, Multivariate Statistics, Data Science, Safety Surveillance Studies, Post-marketing Commitment Studies, Publications, Data Safety and Monitoring Boards, Arbitration Claim Support, Scientific/Regulatory Advising and FDA Interactions, Real-world Evidence, Registries, Quality of Life, and Patient-reported - [Lynn B. Sutton](https://aktapd.com/experts/lynn-b-sutton/) - CLINICAL OPERATIONS PERSONAL PROFILE 40+ years in medical and pharmaceutical arena. EXPERTISE Strategic and Development Vision and Planning, Product Development, Clinical Operations Leadership, Cost/Program Management, Process Improvement (Functional/Operational Efficiency), Third Party and R&D Integration, CRO/Vendor Management/Evaluation, KOL Relationships, Gap Analysis, Clinical QA, Internal Study Audits, Sponsor/ Medical/Clinical Scientific Liaison, Inspection Readiness and Rapid Submissions, Collaboration/Accountability/ - [Ayad Abdulahad, MB, ChB, PhD, MSc, MRCPath, FRCPath](https://aktapd.com/experts/ayad-abdulahad-mb-chb-phd-msc-mrcpath-frcpath/) - MEDICAL DIRECTOR/MEDICAL AFFAIRS – CNS/ONCOLOGY/VIROLOGY PERSONAL PROFILE 40+ years as a medical practitioner, 33 years in medical research, and 23 years in the pharma industry. EXPERTISE CMO/Senior Medical Executive; Clinical/Protocol Development, Life Cycle Management, and Global Strategy of Therapeutic Agents; Global Medical Affairs; Statistics; Regulatory Affairs; Biotechnology; Physician/Researcher (Specialties - Autoimmune Diseases, Urology, Dermatology, Pain, - [Walter Carney, PhD](https://aktapd.com/experts/walter-carney-phd/) - ONCOLOGY & SCIENTIFIC/EXECUTIVE LEADERSHIP & RESEARCH PERSONAL PROFILE 35+ years in diagnostics and pharma scientific clinical research and executive leadership in Oncology, Immunology, and Infectious Diseases; integration of Dx biomarkers into pharma clinical trials; and translational cancer research. EXPERTISE Chief Scientific Officer, C-Suite Executive/Diagnostic and Pharma Management, Biomarkers/Companion Dx, Liquid Biopsy Tests, Clinical Trials, - [Zhihong Huang, MD, MS](https://aktapd.com/experts/huang/) - PHARMACOLOGIST, NEUROSCIENTIST, STROKE EXPERT PERSONAL PROFILE Harvard-trained pharmacologist with stroke, neurotrauma, cardiovascular and metabolic disease background with over 20 years of experience. Also a trained as a clinical scientist. EXPERTISE In vivo pharmacologist with extensive preclinical model development experience and expertise in stroke and neurotrauma therapeutics. Recognized Expert—Received 1996 American Heart/Stroke Association Young Investigator Award - [Sandra Chica, MD](https://aktapd.com/experts/sandra-chica-md/) - ONCOLOGY, CLINICAL DEVELOPMENT, IMAGING PERSONAL PROFILE 15 years of pharmaceutical industry and clinical research experience. EXPERTISE Clinical Development, Imaging, and Research (oncology, small molecules, biologics, medical devices, and diagnostics); Clinical Development Plans; Scientific, Medical, and Operational Leadership of Clinical Trials (all phases); Clinical and Regulatory Strategy; Protocol Development; Site/CRO/Vendor Selection and Oversight; Data Analysis and - [Scott Chase](https://aktapd.com/experts/scott-chase/) - COMPLIANCE, QA, & REGULATORY AFFAIRS PERSONAL PROFILE 13 years in the compliance field. EXPERTISE GXP Auditor, Training, and Document Management; Developing Quality Systems; Part 11 Compliance (back and front end, software and hardware); Validation (process and equipment); Global CMO Oversight and Batch Record Review (France, Italy, Germany); GLP Studies (PK and Tox, rodents/primates); QC of - [Tracy Wild Dachenhausen, MBA, CCDM](https://aktapd.com/experts/tracy-wild-dachenhausen-mba-ccdm/) - DATABASE MANAGER PERSONAL PROFILE 21 years in database management. EXPERTISE Certified Clinical Data Management Professional; Oncology; Project Management; CRO and Vendor Management; Process Improvements; SOP Development; Data/Vendor Management Plans; Standards Creation and Management; Contracts and Financial Analytics; Process Improvement; GCP, ICH, and GMP Compliance; Cross-Departmental Trainer of Multiple Systems and Compliance Topics; Branding and Negotiation; - [Vicki J. Abbas](https://aktapd.com/experts/vicki-j-abbas/) - CLINICAL AND RESEARCH OPERATIONS PERSONAL PROFILE 30 years in medical and pharmaceutical arenas. EXPERTISE Clinical Operations and Research, Operational Planning and Management, Protocol Development, Pharmaceutical Drug Development (Phases 1 - 3), Regulatory Compliance, Quality Assurance, Program Management, Strategic Planning/Development/Implementation, CRO Oversight, Cost/Resources/Budget Maximization, Vendor/Clinical Supplies Management, e-CTD Submissions and Documentation, Biotech Startups, Presentation and Report - [Susie Szembek, BS](https://aktapd.com/experts/susie-szembex-bs/) - PHARMACOVIGILANCE, SAE REPORTING, MEDICAL CODING, MONITORING PERSONAL PROFILE *20 years of global pharmacovigilance, safety protocols, medical coding, and database management. EXPERTISE Pharmacovigilance; Safety Protocols in Phase 1, 2, and 3 Clinical Trials; Database Management; AE/SAE Reporting and Narration Development; Coding Reviews; Reconciliation; Program Management; Physician Interaction; Marketing. Study Therapeutic Areas of Expertise: Oncology, Allergy, Pain, - [Serge Guzy, PhD](https://aktapd.com/experts/serge-guzy-phd/) - STATISTICAL EPIDEMIOLOGY, PHARMACOMETRICS, PHARMACOKINETICS, & PHARMACODYNAMICS PERSONAL PROFILE 27 years in pharmacometrics, global modeling, and simulation for private companies and in academic settings. EXPERTISE Pharmacometrics; Statistical Epidemiology; Mathematical and Statistical Modeling; Clinical Trial Simulation; Pharmacokinetics; Pharmacodynamics; Compartment Analysis; Experiment Design; Algorithm Optimization; Non-continuous Likelihood-based Response Analysis (continuous/discrete Markov processes, generalized time/event analysis [single/multiple, and right-/left-/interval-centered - [Susan M. Smith](https://aktapd.com/experts/anders-tamsen-md-phd-2/) - QUALITY ASSURANCE, BUSINESS PLANNING & ANALYSIS, AND PROJECT MANAGEMENT PERSONAL PROFILE 18 years in pharmaceutical quality systems, technical writing, metrics, and project management. EXPERTISE ICH/GCP and GMP, Quality Systems (Document Management/Training), Project Coordination and Management, Costs and Operational Efficiencies, Organizational Data Analysis, Strategic Mapping, Training, eTMF Inspection Preparedness, Budgeting and Headcount Analysis, Metrics and Goals - [Stephen Villano, MD](https://aktapd.com/experts/villano/) - CLINICAL TRIAL DESIGN & OVERSIGHT, MEDICAL MONITORING PERSONAL PROFILE 19 years of experience in pharmaceutical industry; 10 years in medicine and laboratories. EXPERTISE CMO; Protocol Design and Writing; Medical Monitoring; Clinical Trials Phases 1-4; Clinical R&D/Operations Oversight; Data Analysis; Safety/Pharmacovigilance Assessments; Medical Affairs; Medical Writing - Clinical Study Reports, Regulatory Documents (NDA), IND Updates, Safety - [Tim Freeman](https://aktapd.com/experts/tim-freeman/) - CLINICAL PROJECT MANAGEMENT, TRIAL LOGISTICS, OPERATIONS PERSONAL PROFILE 30+ years in clinical drug development, with strong history in trial logistical and operational knowledge 15+ years as a functional manager 19+ years in project management 20+ years in sound operational strategies, functional areas, and project resources EXPERTISE Clinical Project Management, Operational Strategies, Project Resourcing, Trial Logistics/Measures/Metrics, - [Steven Bloom](https://aktapd.com/experts/steven-bloom/) - CHIEF STRATEGY OFFICER / BUSINESS AND CORPORATE DEVELOPMENT LEADER PERSONAL PROFILE Senior Executive with 35 years of experience in the life sciences industry leading teams in corporate development, commercial planning, corporate affairs, and strategic consulting. EXPERTISE Corporate Development; Commercial Strategy and Planning; Corporate Affairs; Corporate / Department / Project Strategic Consulting, Planning, and Support; Business - [Philip Gregory Janicak, MD](https://aktapd.com/experts/philip-gregory-janicak-md/) - PSYCHIATRIC CLINICAL TRIALS PERSONAL PROFILE 40 years in the psychiatric medicine field EXPERTISE Mood and Psychotic Disorders; Research Psychiatry; Therapeutic Neuromodulation ECT (electroconvulsive therapy), and TMS (transcranial magnetic stimulation); Psychiatric Drug Development (psychosis and depression); Clinical Trials; Management and Treatment of Schizophrenia, Depression, and Bipolar Disorder; Psychopharmacology; Scientific Writing; Education/Teaching; Lecturing/Public Speaking. BS and MD - [Ross A. Reife, MD, MBA](https://aktapd.com/experts/ross-a-reife-md-mba/) - MEDICAL EXECUTIVE PERSONAL PROFILE > 25 years in pharma industry, building top-tier global teams that consistently achieved strategic and financial objectives. Strong leader with the ability to create a global vision, effectively allocate resources, and customize/operationalize regional medical strategies that support business growth. > 10 years (prior to industry) in clinical/academic neurology practice. EXPERTISE Medical - [Philippe Chahinian, MD](https://aktapd.com/experts/philippe-chahinian/) - CMO, INTERNAL MEDICINE, ONCOLOGY PERSONAL PROFILE 30 years in academic oncology. 9 years in pharma industry as a medical executive. US Board-Certified in Internal Medicine and Oncology. EXPERTISE CMO; Medical Monitoring; Phase 1-3 Clinical Trials; Medical Expertise for Study Feasibility, Design, Site, Conduct, Analysis, Reporting, Databases, and Efficacy/Safety; Regulatory Submissions; RFPs and RFIs; Business Development; - [Ray Colburn, PhD](https://aktapd.com/experts/colburn-2/) - PHARMACOLOGY, DRUG DISCOVERY, DRUG INFUSION DEVICES & NONCLINICAL DRUG DEVELOPMENT PERSONAL PROFILE Pharmacologist / implantable device scientist / consultant with 25+ years in pharma drug discovery / development and medical devices. EXPERTISE Pharmacology, Nonclinical Drug Discovery / Development, Management / Leadership, Regulatory Filings (IND / NDA), Grant Applications, and Collaborations. Therapeutic and Technical Specialties: Neuroimmunology, - [Ronald Zolty, MD, PhD](https://aktapd.com/experts/zolty-2/) - TRANSLATIONAL MEDICINE, CLINICAL TRIALS, CARDIOLOGY PERSONAL PROFILE Experienced cardiologist/internist and clinical trialist with more than 15 years of clinical research experience, as well as industry experience as a medical director in pharmaceutical R&D. EXPERTISE Clinical Trials, Trial Design, Protocol Development, Medical Monitoring, Safety Review and Reporting, Trial Execution/PI (Phases 1-3), Cardiology Leadership, R&D Medical Director, - [Ric Stanulis, PhD, DABT](https://aktapd.com/experts/stanulis-2/) - TOXICOLOGY, SAFETY PHARMACOLOGY, & DRUG DEVELOPMENT PERSONAL PROFILE Board-certified toxicologist with more than 20 years of experience in pharma drug development, including small and large molecule programs at all stages of development in a wide variety of therapeutic areas. EXPERTISE Nonclinical Safety – Toxicology, Pharmacology, PK / ADME, Small / Large Molecule Programs, Nonclinical Program - [Peter Johnson, MD, FACS](https://aktapd.com/experts/peter-johnson/) - MEDICAL EXECUTIVE/CMO PERSONAL PROFILE 30+ years as successful C-suite executive, Chief Medical Officer, and board member, expert in drug and biotech Medical/Scientific/Clinical strategy and management, development/commercialization, funding, and entrepreneurism. EXPERTISE CMO/CEO/Executive Management; Vision and Strategic Planning; Drug Development/Commercialization; Program Creation; Clinical Trials Research, Development, and Management; Medical/Scientific Affairs; SAEs/AEs; New Product R&D and Strategic Planning; - [Pirkko Tamsen](https://aktapd.com/experts/pirkko-tamsen/) - CLINICAL OPERATIONS/PROGRAM MANAGEMENT PERSONAL PROFILE Performance and results-driven executive in Europe with 30 years of extensive experience impacting corporate performance in the life science sector: from start-ups to big pharma companies to CROs. EXPERTISE Clinical Operations, Program Management, CRO Contracting / Governance, Clinical Trials Management (mainly in Europe), Executive Leadership, Business Development, Entrepreneurship, Collaborations / - [Lou Vaickus, MD, FACP](https://aktapd.com/experts/lou-vaickus-md-facp/) - CHIEF EXECUTIVE OFFICER & FOUNDER PERSONAL PROFILE 35+ years in medicine and the pharmaceutical industry 20+ years of executive pharma leadership EXPERTISE Physician Executive, Executive Leadership, Clinical Development and Medical Affairs, Preclinical Development, Regulatory Affairs/Quality Assurance, Business Development/Fundraising, Commercial Marketing, Medical Writing/Communications, and C-suite Activities. Extensive experience at start-up, small-, medium-, and large-sized companies in - [Marc S. Rudoltz, MD](https://aktapd.com/experts/marc-s-rudoltz-md/) - ONCOLOGY CLINICAL DEVELOPMENT PERSONAL PROFILE More than 26 years in radiation oncology. 13 years in pharma industry oncology clinical development. EXPERTISE Practicing Radiation Oncologist, Oncology Clinical Trials (Phases 1-4), Chief Medical Officer, Global Clinical Development, Research (academic and pharma), Regulatory Filings, Commercialization, Strategic Decision-Making and Operational Processes, Scientific Writing, Communications, Education/Teaching, Lecturing/Public Speaking. BS from - [Mary-Anne McKenna, M.Ed.](https://aktapd.com/experts/mary-anne-mckenna-m-ed/) - CLINICAL OPERATIONS PERSONAL PROFILE 16 years, mostly in clinical operations. EXPERTISE Clinical Trials Management; Compliance; Protocol Synopsis/Development; Project Budgets and Timelines; Management of Field CRAs and Internal Project Coordinators; Vendor Selection, Oversight, and Audit (CROs, labs, imaging, drug distribution); Patient Recruitment and Retention; SAEs and Regulatory Reporting; Site Feasibility, Selection, and Management; Monitor Training and - [Melanie Raskin](https://aktapd.com/experts/melanie-raskin/) - STAFF WRITER PERSONAL PROFILE 33 years in the communications field, specializing in medical/pharmaceutical, health/wellness, and state government/public interest. EXPERTISE Writing - Video, Audio, Print, Web/e-, and PR/Marketing; Communications Project Management; Video and Audio Producing/Directing; Client Relations/Sales and Expectations Management; KOL/Patient/Clinician Interviewing; Copy Editing; Creative Brainstorming; Storytelling and Audience Engagement; Public Speaking/Workshops; Voiceover Narration; Customer Service. - [Oscar Laskin, MD](https://aktapd.com/experts/oscar-laskin-md/) - RESPIRATORY & ONCOLOGY PERSONAL PROFILE 27 years of drug development experience in large and small pharma companies. 36 years in medical/research field. EXPERTISE Physician Scientist, Medical Executive, Translational Medicine, Academic Clinical Investigator, Clinical Pharmacology, Drug Development, Clinical Trials, Oncologics, Biologics, Chief Medical Officer, Global Management, Regulatory, Advisory Boards, Emerging Markets. World authority on translational medicine - [Parker Ress](https://aktapd.com/experts/parker-ress/) - GRAPHIC DESIGNER PERSONAL PROFILE 15 years as a data-driven graphic design expert in a broad range of industries including pharma, manufacturing, military, and higher education. EXPERTISE Presentation Design, Poster Design, Branding, Marketing Materials, Visualizing and Simplifying Complex Concepts. PROFESSIONAL EXPERIENCE Virtual Apiary, Inc. – Owner/Graphic Designer Specializes in fast turnaround, budget conscious, and user-friendly design - [Michael Fafunso, MD](https://aktapd.com/experts/fanfunso/) - ONCOLOGY CLINICAL TRIALS, SITE MANAGEMENT, MONITORING PERSONAL PROFILE 9 years of pharma clinical trials management experience; 14 years as a physician. EXPERTISE Oncology Clinical Trials Phases 1-3 (breast, hepatic, renal, prostate, GI, melanoma); Study Protocols; Site Selection, Management, and Monitoring; Sponsor / KOL Relationships; Study Forms and Documents; Vendor Management; Budgets and Contracts; Study Best - [Patrick Sarmiere, PhD](https://aktapd.com/experts/sarmiere/) - TRANSLATIONAL RESEARCH, CLINICAL DEVELOPMENT, & BIOMARKERS PERSONAL PROFILE 40 years as a physician.20+ years of translational research and bioanalytics experience in biotech and pharma. EXPERTISE Preclinical Development; Translational, Molecular, and Cellular Research; Nonclinical Development Study Design; Pharmacology; Biotherapeutic Manufacturing; SBIR / STTR Grant-writing; Pre-IND / IND​ Writing; Biomarker​ ​Identification; Bioanalytics,​ Informatics,​ ​and​ Data​ Analysis, In - [Inder Kaul, MD, MBBS, MPH](https://aktapd.com/experts/inder-kaul-md-mbbs-mph/) - MEDICAL EXECUTIVE, CLINICAL DEVELOPMENT PERSONAL PROFILE 20+ years as a pharma executive, 27+ years in clinical development, and 30+ years as a physician. EXPERTISE CMO; Clinical Development (drugs, biologics, and medical devices); Global Clinical Trials (Phases 1 – 4); Product Registration and Post-Marketing Activities; Project Management of INDs, IDEs, NDAs, BLAs, CTDs, PIPs, PSPs, sNDAs, - [Jamie Blackburn](https://aktapd.com/experts/jamie-blackburn/) - eLEARNING / KNOWLEDGE TRANSFER PERSONAL PROFILE 25 years in F100 and Life Sciences Information Technology EXPERTISE Project Management, Six Sigma, Systems Integration, Technical Architecture and Custom Software Development. Senior leader with proven ability to drive projects successfully and to collaborate with a wide variety of people in a fast-paced environment. PROFESSIONAL EXPERIENCE Director, Virtual Platforms - [Jeana Burt](https://aktapd.com/experts/jeana-burt/) - CLINICAL OPERATIONS SUPPORT / TRIAL ASSISTANT PERSONAL PROFILE 11 years in clinical operations support. EXPERTISE Operations Management, Information Systems Management, Regulatory Affairs Management, Fiscal Management, Clinical Trial Assistant (cardiology, dermatology, device, gynecology, gastroenterology, oncology/hematology, urology), Process Analyst, Data Flow Analysis and Documentation of US Clinical Trial Process, In-house CRA, and Project Management. PROFESSIONAL EXPERIENCE CEO, - [Larry Yarmaloff, CCRA, RQAP-GCP](https://aktapd.com/experts/larry-yarmaloff-ccra-rqap-gcp/) - PROJECT MANAGEMENT / CLINICAL OPERATIONS & DEVELOPMENT PERSONAL PROFILE 24 years in clinical development of investigational therapeutic and diagnostic products. EXPERTISE Clinical Operations; Monitoring; Clinical Research Line Management; Domestic and International Phase 1-4 Pharmaceutical Studies and Pilot, Pivotal, and Post-market Medical Device Studies; Investigational Site Feasibility and Management; Training of Investigators, Study Coordinators, and Study - [Jeana Burt](https://aktapd.com/experts/jeana-burt-internal-team/) - CLINICAL OPERATIONS SUPPORT / TRIAL ASSISTANT Jeana Burt specializes in getting things done. The consummate manager of, well, everything, she puts her analytical expertise to work in the key pharma areas of operations, regulatory affairs, and document management, and in information systems for fiscal oversight, project management, and document management. She supports organizations as an - [Lee Schacter, PhD, MD](https://aktapd.com/experts/bob-clay-2/) - REGULATORY AFFAIRS PERSONAL PROFILE Seasoned, versatile physician executive and academic, board-certified in internal medicine and medical oncology, with 35+ years of medical, clinical, and pharma research and development experience. EXPERTISE Pharma Research / Development, Clinical Strategy / Plans, Trials Design / Writing / Management / Conduct (Phases 1-3), Protocols, Regulatory Interactions (NDAs, INDs, special protocol - [James Wachholz, BS, MBA](https://aktapd.com/experts/wachholz/) - REGULATORY AFFAIRS & DRUG DEVELOPMENT PERSONAL PROFILE 26 years of experience in new drug development in pharma and biotechnology; 19 years as senior Regulatory Affairs management. EXPERTISE Design / Conduct / Oversight / Monitoring of Clinical Trials Phases 1-3 and GLP Nonclinical Safety Studies; Defining Clinical Indication, Sample Population / Size, Primary and Secondary Endpoints; - [Judi Sills, PharmD](https://aktapd.com/experts/judi-sills/) - PHARMACOVIGILANCE/SAFETY COMPLIANCE PERSONAL PROFILE 30 years of experience in pharmacovigilance, specializing in establishment and optimization of inspection-ready global pre- and post-marketing PV function. Expertise in large and small pharma companies, including PV operations, cross-functional integration, compliance, safety data exchange agreements, outsourcing (vendor selection and management), signal detection and management, benefit-risk assessment/management, and safety governance. EXPERTISE Pharmacovigilance; - [John McKinney, BS MA](https://aktapd.com/experts/john-mckinney/) - CLINICAL OPERATIONS PERSONAL PROFILE Clinical Operations Manager with a strong background in psychology, specializing in neuroscience-focused operations in clinical trials. EXPERTISE Clinical Trials Oversight / Operations; Protocols; Clinical Development Plans; Budgets; Operations Documents; Site Monitoring / Auditing; Consultant / Vendor Selection, Contracts, and Oversight; Risk Assessment; Project Management; Medical / Scientific Article Writing; Programming Statistics; - [Jessica Lee](https://aktapd.com/experts/jessica-lee/) - WRITER / COPY EDITOR / PROPOSALS PERSONAL PROFILE 15 years in the writing and copy editing field; and 20+ years in personal and team training and proposalwriting EXPERTISE Creative Copywriting; Editing; Communications Consulting; Website and Promotional Copy; CVs and Cover Letters; Storytelling; Education and Curriculum Creation; Brand Alignment; Program/Model Design and Implementation; Proposals; Employee Recruitment, - [Cornelia Reininger, MD, PhD](https://aktapd.com/experts/cornelia-reininger-md-phd/) - ONCOLOGY, NEUROLOGY, CARDIOVASCULAR PERSONAL PROFILE 14 years experience in pharmaceutical industry; 20+ years as a surgeon and intensive/emergency care physician. EXPERTISE CMO; Design, Implementation, and Execution of Global Clinical Trials and Key Documents (Phases 1 to 3); Clinical/Regulatory Strategic Planning; Global Regulatory and IND/NDA Submissions (US, EU, China, Japan, and Canada); Pharmacovigilance; Quality Assurance and - [Gary Maier, PhD](https://aktapd.com/experts/gary-maier-phd/) - PHARMACOLOGY/CLINICAL DEVELOPMENT PERSONAL PROFILE Over 30 years in clinical research field and pharmaceutical industry. EXPERTISE Scientist/Researcher, Senior Pharma Executive, Drug Development, Clinical Trials (IND - Phase 4), Early Clinical Research, PK/PD Analysis, Globalization of Clinical Pharmacology, FDA Interactions (INDs, NDAs, sNDAs), Contracts/Budget Management PhD in Pharmaceutical Sciences from State University of New York at Buffalo. - [Dr. Philip G. Janicak Joins aktaPD®](https://aktapd.com/experts/dr-philip-g-janicak-joins-aktapd/) - [gview file="http://aktapd.com/wp-content/uploads/2016/02/Dr-Janicak-Press-Release-November-5.pdf" width="100%" save="1"] - [David William Brewster, PhD, DABT](https://aktapd.com/experts/david-william-brewster-phd-dabt/) - TOXICOLOGY PERSONAL PROFILE Board-certified toxicologist with 30+ years of research experience in toxicology. 20+ years experience in pharmaceutical drug development. EXPERTISE Regulatory/Biochemical Toxicology; Preclinical Toxicology Program Development; Lab Management/ Leadership; Global Submissions for Small Molecules and Biotherapeutics (INDs, NDAs, BLAs, CTDs ); Early/Late State Drug Development Oversight (new molecular entities, medical devices, reformulations of marketed - [Gregory Rainey](https://aktapd.com/experts/gregory-rainey/) - EXECUTIVE BUSINESS CONSULTANT PERSONAL PROFILE 41 years in healthcare and medical biologics products industries, delivering expert business consulting strategies to organizations ranging from Fortune 500 companies to start-up medical device and healthcare firms. EXPERTISE Business Development, Strategic Business Planning, Revenue Growth Strategies, Process Improvement, Program Development, Contract Negotiation, COS Reduction, Organic/Acquisition Growth, Budget Administration, Product - [Ed Dow, MD](https://aktapd.com/experts/ed-dow/) - MEDICAL EXECUTIVE PERSONAL PROFILE 24 years as a Hematologist/Medical Oncologist 20 years in clinical practical experience 4 years experience physician executive. EXPERTISE Medical Affairs Strategy and Oversight; Management Oversight and Development of Clinical Phases 1-4 Clinical Trials; Post-FDA Approval Investigator Initiated Research (IIR); Investigator-Initiated Sponsored Research (IISR); Strategy and Content Creation for Global Key Opinion - [Gregory K. Pennock, MD](https://aktapd.com/experts/pennock/) - ONCOLOGY MEDICAL MONITORING AND CLINICAL TRIAL LEAD PERSONAL PROFILE 21 years of clinical trial leadership and medical monitoring specializing in oncology and internal medicine. EXPERTISE Clinical Trial Leadership and Management, Medical Monitoring, Medicine (attending physician), and Academia. Specialty: Medical Oncology and Internal Medicine. Has 23 publications, two grants, and nine invited presentations, internationally. MD, University - [Dawn Edgerton](https://aktapd.com/experts/edgerton/) - CRO GOVERNANCE, OPERATIONS, BIOSTATISTICS/DATA PERSONAL PROFILE Expert clinical data sciences professional leveraging 20+ years of experience in research computing and 10 years proven leadership in operational aspects of drug development at CROs. EXPERTISE Drug Development Operations; Vendor Selection and Quality Oversight; Development and Evaluation of Project Scope and Specifications; Analytical Review and Coordination of Project - [Gerald Klein, MD](https://aktapd.com/experts/gerald-klein/) - MEDICAL EXECUTIVE/CMO PERSONAL PROFILE 40+ years as successful C-suite pharma executive, Chief Medical Officer, and board member of large and small companies, with global experience ranging from preclinical development of biologics, devices, diagnostics, and drugs, to post-marketing studies. 2017-Present: BOD to Plakous Therapeutics 2016-Present: CMO to ArunA Biomedical 2015-Present: Principal, MedSurgPI, LLC 2011-2015: President and - [Deyaa Adib, MD](https://aktapd.com/experts/deyaa-adib-md/) - MEDICAL EXECUTIVE / ONCOLOGY PERSONAL PROFILE Clinical oncology expert with 20 years of extensive pharmaceutical experience, strong analytical capabilities in multidisciplinary areas of oncology research and development, and deep expertise in pharma and biotech: academic medicine and research (from clinic to bedside), pharmaceutical drug development (from preclinical to post-marketing), and medical/regulatory oversight review (from IND - [Bob Clay](https://aktapd.com/experts/bob-clay/) - REGULATORY AFFAIRS PERSONAL PROFILE 30 years of experience in drug development across a diverse range of therapeutic areas and product types. EXPERTISE Global Regulatory Affairs, Oncology and Infection, Neuroscience, Drug Development, Seasoned Executive, Strategic Thinking, Internal Change Management. PROFESSIONAL EXPERIENCE Vice President, Regulatory Affairs, Oncology and Infection, AstraZeneca Led the global regulatory function supporting oncology - [Cathy O’Connor, BS](https://aktapd.com/experts/cathy-oconnell-bs/) - CLINICAL OPERATIONS & STUDY MANAGEMENT PERSONAL PROFILE 10 years of global study management experience. EXPERTISE Global Study Management; Vendor Selection and Oversight; Project, Budget, and Time Line Management; Issue Management; Team Leadership and Training; Site Identification and Selection; Enrollment Models; Clinical Supply Planning; Investigator/Vendor Meetings; Monitoring Plans; Study Forms (Consent Forms, Trial Master File, EDC/Case - [Catherine O’Brien](https://aktapd.com/experts/catherine-obrien/) - PHARMACOVIGILANCE & MANAGEMENT PERSONAL PROFILE 20 years of global clinical trial management in oncology, neuroscience, anti-infective, and ophthalmology. EXPERTISE Protocol Writing/Feasibility, Clinical Supply Chain, CTA Application, Statistical Analysis Plan, Strategic Vision and Planning, Data Management (OC-RDC), Patient Recruitment Plan, Clinical Monitoring, Consensus-building, Clinical Study Reports, Global Team Management, Contract and Vendor Negotiation, Large-Scale Budgets/Finance Plans, - [Barbara Geiger, BSN, RN](https://aktapd.com/experts/geiger/) - CLINICAL OPERATIONS PERSONAL PROFILE Seasoned, global clinical operations executive with 30+ years of pharma experience. EXPERTISE Clinical Operations; Study/Project Management; Investigator Meetings, Site Selection and Qualification; Vendor/CRO RFP Development, Selection, and Oversight; Protocol/ICF/CRF/Study Report Development; Clinical Plans and Monitoring; Budgeting; Strategy; Leadership; Business Development; Global Acquisitions; Due Diligence; Vendor/Academic Relationships; Pharmacovigilance; Regulatory Document Collection and - [Bob Mittleman, MD, MS, FACC](https://aktapd.com/experts/mittleman/) - CLINICAL TRIALS/MEDICAL MONITORING / CARDIOLOGY PERSONAL PROFILE Board-certified cardiologist with 17 years of experience in clinical development, and more than 10 years on the faculty of a major medical school with clinical, clinical research, teaching, and administrative duties. EXPERTISE Clinical Development, Clinical Trials Design / Plan (Phases 1-4), Medical Monitoring, Investigator Meetings and Site Interactions, - [Andrew Mallon, PhD, GPharmC, MRPharmS, BSc (Hons) PharmD](https://aktapd.com/experts/andrew-mallon/) - ONCOLOGY, NEUROLOGY, CARDIOVASCULAR PERSONAL PROFILE 19 years in pharmacology, biotechnology, clinical/medical, pharmaceutical, and healthcare investment arenas. EXPERTISE Pharmacology; Biotechnology; Pharma Research, Development, and Commercialization; Strategy; Medicine; Business Development/Fundraising/VC Partnerships; Due Diligence; Study Design, and Safety/Efficacy. Therapeutic Areas of Expertise: Oncology, Neuroscience (psychiatric and neurology), CNS, Autism, Neuropathic Pain, Intracellular Neurotrophic Signaling, Ophthalmology, Corneal Healing, Glaucoma, - [Andrew Eisen, MD, PhD](https://aktapd.com/experts/eisen/) - TRANSLATIONAL MEDICINE / CLINICAL DEVELOPMENT PERSONAL PROFILE 18 years of in biotech/pharma ranging from drug target discovery through clinical drug development. 10 years in academic medicine and research. EXPERTISE Translational Medicine and Strategy; Drug Research and Development; Clinical Development Planning; Trial Design; Medical Management of Phase 1-2 Clinical Trials; Development of Biomarker Strategies; PK/PD Assessments; - [Anders Tamsen, MD, PhD](https://aktapd.com/experts/anders-tamsen-md-phd/) - MEDICAL & SAFETY MONITORING PERSONAL PROFILE 40 years as a physician. 30 years in clinical trials for drug development. 20 years as medical/clinical entrepreneur. EXPERTISE Anesthesiology, Clinical Pharmacology, Surgery, Internal Medicine, Regulatory Affairs. 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