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What is our Strategic Advisory Panel?

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Our Advisory Panel is a team of experienced professionals with expertise across all areas of drug development. We can offer an in-depth review of programmes and development plans to help streamline and improve speed to approval by identifying opportunities or risks early in the process and providing risk minimisation strategies.

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Our team are

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Highly skilled accomplished professionals passionate about drug development with hands on experience
and in depth knowledge of the regulatory environment.

They will:

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circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”Support KOL Development and Engagement: seeking expert community input either on a one to one basis or through more formal Advisory Boards” backgroundcolor=”” icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][/fusion_content_boxes][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” 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border_radius_bottom_left=”” border_radius_bottom_right=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”10″ box_shadow_spread=”-8″ box_shadow_color=”#cecece” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”false” first=”false”][fusion_title hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”center” size=”2″ font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”50px” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” style_type=”default” sep_color=””]

Our team includes

[/fusion_title][fusion_content_boxes layout=”clean-vertical” columns=”2″ heading_size=”2″ title_color=”#ffffff” body_color=”#ffffff” backgroundcolor=”#ed6063″ iconspin=”no” circlecolor=”#ffffff” icon_size=”0″ hover_accent_color=”#ffffff” icon_align=”left” animation_type=”fade” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility”][fusion_content_box title=”Regulatory, CMC, Non Clinical, Clinical, Statistical, Development experts” backgroundcolor=”” icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”Network of SMEs ” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

ex-Regulators/Inspectors/Specialists

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Our team will

[/fusion_title][fusion_content_boxes layout=”icon-on-top” columns=”3″ heading_size=”2″ title_color=”#214d72″ body_color=”#214d72″ iconspin=”no” hover_accent_color=”#50bfc3″ icon_align=”left” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility”][fusion_content_box title=”Analyse the situation” backgroundcolor=”” icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”https://rapportss.com/wp-content/uploads/2019/09/AdvizON-Icon-2-1.png” image_id=”4785|full” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”AdvizON™ the path forward” backgroundcolor=”” icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”https://rapportss.com/wp-content/uploads/2019/09/AdvizON-Icon-2-1.png” image_id=”4785|full” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”Apply the advice to the development programme” backgroundcolor=”” icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”https://rapportss.com/wp-content/uploads/2019/09/AdvizON-Icon-2-1.png” image_id=”4785|full” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][/fusion_content_boxes][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” border_style=”solid” margin_bottom=”20″ padding_bottom=”40″][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ center_content=”no” target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ animation_direction=”left” animation_speed=”0.3″ last=”true” first=”true” min_height=”” link=””][fusion_imageframe image_id=”4467|medium” max_width=”” style_type=”” blur=”” 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border_style=”solid” border_position=”all” border_radius=”” box_shadow=”no” dimension_box_shadow=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Our team offers a flexible approach and can AdvizON whole programmes, specific issues or provide ad hoc support:

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Stage one

[/fusion_title][fusion_checklist circlecolor=”#2e7795″ size=”16px” hide_on_mobile=”small-visibility,medium-visibility,large-visibility”][fusion_li_item icon=””]

Review development plans before implementation

  • Identify risks and opportunities
  • Offer Clinical and Regulatory Development Proposals with supporting rationale

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Challenge plans 

  • Identify potential issues/risks e.g.
    • Clinical study designs
    • Outcome measures
    • Develop risk log 
    • Focus on the issues that can make the difference between success and failure
  • Develop risk mitigation plans
  • Challenge normal pathways – are there alternatives?
  • Evaluate risks of alternatives
  • Support Go-No-Go decisions
  • Organise a brainstorming panel to work through issues with company experts to ensure robust argumentation is developed through rigorous challenge and debate

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Check before you invest

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Stage two

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Review data available preparing

  • Gap analysis
    • What is missing 
    • How do we fix? 
    • What are the time/budget implications? 
    • What are the alternatives?
  • Identify and evaluate precedents
  • Zone into details as required

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Stage three

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Support Agency meetings

  • Prepare Questions for Agencies
  • Develop Briefing Packages
  • Agency meeting preparation planning – questions, positioning, and planning, rehearsals

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AdvizON global Regulatory pathways

  • Accelerated routes to approval
  • Orphan
  • Paediatric
  • Timelines to market
  • Multiple regions – EU, US, Canada, Japan, Australia, MENA

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Support the ‘Red Thread’ messaging in your dossier

  • Build a clear viable story
  • Distil the messages
  • Ensure a clear flow of information – this is critical to ensure assessors come to one conclusion.
  • Fill the assumption gaps

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Stage four

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Manage the review period

  • Prepare for the dossier review
  • Prepare key arguments, rationales in advance of questions.

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AdvizON™ maximising regulatory opportunities

  • Early Access Schemes or
  • Regulatory Incentives, eg ‘US voucher’, Accelerated Approval, conditional/exceptional, SME, ODD

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Ad hoc follow up throughout the development programme

  • Sounding board
  • Trusted challenge

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