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For Cell Therapies Apr2020 https://www.scendea.com/making-the-most-of-opportunities-to-interact-with-european-regulators-june2020 daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604069942671-MFOD8JVBA1HS6AYWTN01/Interact+with+European+Regulators+tab1 Making The Most of Opportunities to Interact With European Regulators June2020 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604070511030-YVF8YG8NW8GLZ53NRPXE/Screenshot+2020-10-30+at+15.03.27.png Making The Most of Opportunities to Interact With European Regulators June2020 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604070232090-1SN4130CCQRBMMNKQZ7W/Interact+with+European+Regulators+fig1 Making The Most of Opportunities to Interact With European Regulators June2020 https://www.scendea.com/engaging-with-regulators-on-novel-statistical-approaches-to-clinical-development-june2020 daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604328585994-UAW0QQUG05EJ0XEVLH95/Exploristics+Paper+img1 Engaging With Regulators on Novel Statistical Approaches to Clinical Development June2020 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604328867545-VMQWS42MLUDU9821MIKD/Exploristics+Paper+table1 Engaging With Regulators on Novel Statistical Approaches to Clinical Development June2020 https://www.scendea.com/novel-methodologies-for-modern-drug-development-jul2020 daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604661075855-RJ2GCB2H2PO7PSH730VS/Novel+methods+Fig1 Novel Methodologies for Modern Drug Development Jul2020 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604661366119-SDZYRT1YG3OUYSJC3OIW/Novel+Methods+Tab1 Novel Methodologies for Modern Drug Development Jul2020 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604664224818-6UEK48EBBG8ICEGE3S11/Novel+Methods+Tab2 Novel Methodologies for Modern Drug Development Jul2020 https://www.scendea.com/drug-development-in-the-european-union-attaining-accelerated-assessment-aug2020 daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1604666799825-C428BIBIYAJ6X7PPSU8X/Screenshot+2020-11-06+at+12.46.08.png Drug Development in the European Union: Attaining Accelerated Assessment Aug2020 https://www.scendea.com/postbrexit-transition-period-changesuks-new-regulatory-landscape daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606481159966-EKFF1D7KIAX2O608JSZR/jaron-nix-7wWRXewYCH4-unsplash%2Bcopy.jpg Post-Brexit Transition Period Changes.UK’s New Regulatory Landscape https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606481274762-ZIY2KXOGZOED46FVUK6O/Screenshot+2020-11-27+at+10.55.16.png Post-Brexit Transition Period Changes.UK’s New Regulatory Landscape https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606481453376-OHKQBB7YI23JR5K32A7Z/Screenshot+2020-11-27+at+11.03.55.png Post-Brexit Transition Period Changes.UK’s New Regulatory Landscape https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606481582477-GBJ2MGJR6XGOWA0KX7YJ/Screenshot+2020-11-27+at+11.10.13.png Post-Brexit Transition Period Changes.UK’s New Regulatory Landscape https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606481736430-6LRVC1GKYX2AFCZ4VB4K/Screenshot+2020-11-27+at+11.50.10.png Post-Brexit Transition Period Changes.UK’s New Regulatory Landscape https://www.scendea.com/novel-tools-for-modern-drug-development-a-us-perspective-part-1 daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606479173894-2JD9ACZDDIVR6OPULILW/Screenshot+2020-11-26+at+11.15.35.png Novel Tools for Modern Drug Development: a US perspective Part 1 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606479337684-U0ZZEDQNC8S6W5Y64P38/Screenshot+2020-11-26+at+11.22.13.png Novel Tools for Modern Drug Development: a US perspective Part 1 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606479550712-1YQT5JUYGG894MT655SI/Screenshot+2020-11-26+at+11.29.26.png Novel Tools for Modern Drug Development: a US perspective Part 1 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1606479714418-OTSUG1I0Y73SH9JJ9XXP/AC+US+DDT+QualificationTABLE2.jpg Novel Tools for Modern Drug Development: a US perspective Part 1 https://www.scendea.com/making-the-most-of-opportunities-to-interact-with-the-us-fda daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1612270170438-5DGOLEQY9TC1P8UX09BF/Screenshot+2021-02-02+at+12.14.33.png Making the Most of Opportunities to Interact with The US FDA 1 Not applicable to written response only. Adapted from “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, Guidance for Industry” https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1612270408533-R0FMZPVLV6U7U4AZPRQ7/Screenshot+2021-02-02+at+12.53.14.png Making the Most of Opportunities to Interact with The US FDA https://www.scendea.com/orphan-drug-designation-in-the-us-eu-gb daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1614331431169-3SR01G3CHVDKSNLRR8SU/Screenshot+2021-02-09+at+12.15.52.png Orphan Drug Designation in the US, EU & GB a) Protocol assistance is the term given to scientific advice for orphan medicinal products. b) Paediatric-related protocol assistance is restricted to the development of an orphan medicinal product for the paediatric population, where the advice requested does not include the adult population. https://www.scendea.com/realworld-data-possible-applications-challenges-emerging-role-within-regulatory-affairs daily 0.75 2021-03-09 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1614332818738-9D9UQBACY4A87CK0FR4Y/Screenshot+2021-02-15+at+15.29.11.png Real-World Data: Possible Applications, Challenges & Emerging Role within Regulatory Affairs Source: (FDA, 2020) https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1614332887634-DG7WGDA3SRKZCAE5KE1X/Screenshot+2021-02-15+at+15.43.24.png Real-World Data: Possible Applications, Challenges & Emerging Role within Regulatory Affairs Source: (McKinsey & Company, 2018) https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1614332967005-IYBHBKWME493BIKP2NJC/Screenshot+2021-02-15+at+15.51.26.png Real-World Data: Possible Applications, Challenges & Emerging Role within Regulatory Affairs Source: (Xu, 2019; FDA, 2020; Pharmaphorum, 2020) https://www.scendea.com/fast-track-designation-and-breakthrough-therapy-designation daily 0.75 2021-06-11 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1623404108895-WNGYQVK2Y96YIEKII07J/Screenshot+2021-06-10+at+17.08.09.png Fast Track Designation and Breakthrough Therapy Designation - Make it stand out Adapted from (Chary, 2016) https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1623404386858-PCQ5QV92MQ4C9A777X8A/Screenshot+2021-06-10+at+17.30.05.png Fast Track Designation and Breakthrough Therapy Designation - Make it stand out Adapted from (CBER, 2020; CDER, 2020) https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1623404574629-82ZMJCFKNG06M2PG12SH/Screenshot+2021-06-10+at+17.42.44.png Fast Track Designation and Breakthrough Therapy Designation - Make it stand out a. Title VIII of FDASIA, Generating Antibiotic Incentives Now (GAIN), provides incentives for the development of antibacterial and antifungal drugs for human use intended to treat serious and life-threatening infections. Under GAIN, a drug may be designated as a qualified infectious disease product (QIDP) if it meets the criteria outlined in the statute. A drug that receives QIDP designation is eligible under the statute for fast track designation and priority review. Adapted from (FDA, 2014) https://www.scendea.com/early-interaction-with-regulators-on-innovative-technologies daily 0.75 2022-07-29 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1626796526173-GNBR8JLGC9J4ANH48K1Z/Screenshot+2021-07-01+at+13.29.17.png Early Interaction With Regulators on Innovative Technologies https://www.scendea.com/novel-tools-for-modern-drug-development-a-us-perspective-part-ii-sept2021 daily 0.75 2021-09-07 https://www.scendea.com/biosimilar-development-qa daily 0.75 2021-10-15 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1633348660630-KTY16GQSLML7IX64Z5L0/zeb-headshot.png Biosimilar Development - Q&A - Make it stand out Zeb Younes, Principal Consultant at Scendea https://www.scendea.com/approaches-and-regulatory-considerations-for-the-development-of-potency-tests daily 0.75 2021-11-02 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/243b082f-353a-464d-9fe2-12528461aad2/Collab+Logos.png Approaches and Regulatory Considerations for the Development of Potency Tests - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.scendea.com/regulatory-aspects-of-paediatric-drug-development daily 0.75 2021-12-07 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/0a6fe48b-f55d-420c-ba93-9e6f1118d97f/Table1.png Regulatory Aspects of Paediatric Drug Development. Table 1: Paediatric Drug Development Regulations and Guidelines https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/181f5290-68fb-4bbb-a0cd-3792b6f50731/fig1.png Regulatory Aspects of Paediatric Drug Development. Figure 1: PIP Assessment Procedure https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/a8bfc81c-dd83-4aac-99ad-9cfd71070845/FIG2.png Regulatory Aspects of Paediatric Drug Development. Figure 2: Assessment Pathways for UK-PIPs from 1 January 2021 Source: Guidance on procedures for UK-PIPs, Annex I https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/b3d53bd9-fc92-45ef-8638-0938e45f45e9/FIG3.png Regulatory Aspects of Paediatric Drug Development. - Make it stand out Figure 3: iPSP assessment procedure https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/27584cef-9666-444e-88d6-47ab311ae829/TABLE2.png Regulatory Aspects of Paediatric Drug Development. - Make it stand out *Regulatory aspects of the EU apply to the UK [Human Medicines Regulations 2012, as amended by the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 (HMRs)]. Abbreviations: BPCA: Best Pharmaceuticals for Children Act, CHMP: Committee for Medicinal Products for Human Use, EoP: end-of-phase, FDASIA: FDA Safety and Innovation Act, MAA: marketing authorisation application, PDCO: paediatric committee, PeRC: paediatric review committee, PIP: paediatric investigation plan, PREA: Paediatric Research Equity Act, PSP: paediatric study plan, SPC: supplementary protection certificate, WR: written request. https://www.scendea.com/bia-mhra-conference-blog daily 0.75 2021-12-15 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/6347f7d9-e692-48b3-9580-aacef95c7f86/hannah-headshot.png BIA MHRA Conference Blog - Make it stand out Hannah Lewis, Consultant at Scendea https://www.scendea.com/clinical-trial-regulation daily 0.75 2022-01-31 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/fa8d366d-461d-495a-ba14-75a6b05cecbe/Figure+1.png Clinical Trial Regulation Adapted from https://www.ema.europa.eu https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/3e77efb8-22e7-4f25-a33d-a3d5ab14325b/Figure+2.png Clinical Trial Regulation Adapted from https://www.ema.europa.eu https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/eba7cd2b-25de-4778-a0b8-68a2e5f8b056/Publication+timing5.png Clinical Trial Regulation https://www.scendea.com/scendea-team-getaway daily 0.75 2022-07-22 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/f794169f-fc9e-459e-b6dc-b8a64ea679df/Bristol_Team.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/90d84079-7cbd-4ea4-b503-e4aed6a14431/asset-0792-F1FF-4962-5DA6-E603.jpeg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/8ea7bcc3-05ed-4da9-8c3f-9a633d6f9772/Quotes2.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/7c8f5605-0aa4-471c-8a2a-b904bb124b85/IMG_7275.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/d9d923fa-8424-451d-b971-487136d3921e/DSC05099.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/01972a50-f452-464d-958b-6b89efb0889a/Quotes3.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/4ea9dd42-0eef-40a4-95d7-d8879ae0f0f7/IMG_7298.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1651248429094-7ONB6QEXH7I8JOUXLPUR/DSC05106.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/e4b5c958-9fb4-4550-88e0-8b97bf56a8f3/Quotes.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/e53996d5-9839-4e9c-8d1b-335bb08885c1/Quotes5.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/487bb2b4-5ecd-49e2-a4d6-5f02cc0b8b9e/asset-53D4-918A-2A1B-5C13-E82C.jpeg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/1830b9ac-2682-4f6b-b2d2-55dce164eeb0/IMG_2601.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/7dbbd64c-6b9e-43a2-ace2-76546a4070c8/IMG_7284.jpg Scendea Team Getaway https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/52fed0c2-303e-4544-aeb8-142c6e6a9c4d/Quotes4.jpg Scendea Team Getaway https://www.scendea.com/lumanity-the-importance-of-regulatory-strategy daily 0.75 2022-06-13 https://images.squarespace-cdn.com/content/v1/5e146e2d43bfbc53ec197100/d831bfc4-a02f-438f-9df9-fbf3c1625f57/logo+lumanity-01.png Lumanity - 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