News

Publications

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 PhUSE  Emerging Trends & Technology How Blockchain Can Transform The Pharmaceutical And Healthcare Industries - Bob Clay is a member of the PhUSE working parting that developed this white paper.


Regulatory challenges in developing new treatments for neglected infectious diseases.
01 September 2016​ Regulatory Rapporteur – Vol 13, No 9, September 2016 Author: Bob Clay


​​Consensus Statement: Clinical development of new drug-radiotherapy combinations.
27 June 2016 Nature Reviews Clinical Oncology 2016 (10.1038/nrclinonc.2016.79 Authors: Ricky A. Sharma, Ruth Plummer. Julie K Stock, Tessa Greenhalgh, Ozlem Ataman, Stephen Kelly, Robert Clay et. al. NCRI CTRad Academia-Pharma Joint Working Group.​


Chapter 6 - Influence of the Regulatory Environment on Attrition:  Robert T. Clay
in ​ Attrition in the Pharmaceutical Industry: Reasons, Implications, and Pathways Forward
Alexander Alex, C. John Harris, Dennis A. Smith  ISBN: 978-1-118-67967-8  November 2015


Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool
30 August 2015​Clinical Infectious Diseases® 2015;61(S1): S5–9 July 30, 2015 Authors: Klaus Romero, Robert Clay, Debra Hanna Article as part of a supplement - An Evidence-Based Drug Development Tool for Tuberculosis Regimens: The Hollow Fiber System Model Volume 61 suppl 1 August 15, 2015 (http://cid.oxfordjournals.org/ content/61/suppl_1.toc​)

Conferences and Presentations

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Bob Clay represented APSGB at the Parliamentary Links Day 2019  organised by the Royal Society of Biology


Bob participated in the TOPRA Summit in London on May 23rd 2019

 

Bob Clay was a presenter and panelist at an event organised by Hyper Recruitment Solutions - HRS on "Quality and Regulatory Considerations  for UK Pharma/Biotech"  

 

Bob Clay chaired the recent TOPRA CRED Navigating European Regulatory Procedures 22-23 March 2018, Utrecht 


Bob Clay presented on  "Novel clinical trial design and technology impact on regulatory advice and shape development of new medicines" at the 10th Adaptive Designs in Clinical Trials meeting presented by SMi in London on April 9-10th 2018


TOPRA delivered training programmes at the Malta Medicines Authority in March for regulatory professionals.  Bob Clay led several sessions on the one-day "Essentials" and two-day "Introductory" courses.


Bob Clay presented at the  6th Medicon Valley Inhalation Symposium: Future Opportunities of Inhalation

in Lund, Sweden on October 11-12th, 2017


As TOPRA Board Member and  President 2017 - Bob Clay  participated in the TOPRA Annual Symposium 2017 in London October 2-4th, 2017


Overview of the EU Framework for Medicines Regulation - May 2017 Bob Clay presented at TOPRA India meeting - Building Regulatory Excellence.  He also chaired the second day of the meeting.


Adaptive Designs in Clinical Trials - April 2016 - Bob Clay presented on Early Dialogue with Regulatory Agencies During Development and Impact on Programme and Study Design at 8th SMi Conference on Adaptive Designs.


Adaptive Designs in Clinical Trials - April 2015 - Bob Clay presented on Adaptive Designs in Clinical Trials - Regulatory Considerations 7th SMi Conference on Adaptive Designs.


CDDF 8TH Alpine Conference -   March 2015 - CURRENT AND FUTURE CHALLENGES OF INNOVATIVE ONCOLOGY DRUG EVELOPMENT - Bob Clay presented on  PFS as a surrogate endpoint and the impact of post-progression treatments.


One Nucleus - Genesis 2014 ​ Bob Clay attended the Genesis 2014 Conference and chaired session on collaborative product development between NHS and Industry - considering the opportunities and challenges.  See the full programme at Genesis 2014​ 


EMA issues draft qualification advice on hollow fiber model of TB 19 November 2014 ​EMA has issued a draft opinion for public comment on the use of the hollow fiber model in the development of drugs for tuberculosis.  The opinion and relatd documents can be found on the EMA website or direct link to the document here.  Bob Clay has worked with Critical Path to TB Regimens on various regulatory activities for more than 5 years - more infromation about CPTR can be found at www.cptriniative.org​.


SENS Rejuvenation Biology Conference http://sens.org/outreach/conferences/rejuvenation-biotechnology-conference-2014​ August 21-23, 2014 Santa Clara, California, USA Bob Clay participated in a panel on Regulating a Damage Repair Approach to Cure the Diseases of Aging   YouTube video of session available​  


Presentation on Regulatory Meetings in EU at DIA Annual Meeting in San Diego ​ Health Authority Meeting Preparation: There Are No Do-Overs  June 18, 2014 - Bob Clay's presentation in this session is entitled: Meetings: Pathways to Success, a European Perspective.  The session is hosted by Mark Ammann, and other presenters are Mark Ammann and Luz Rivera.In the session we will look at approaches to meetings with FDA and compare and contrast with meetings with European Agencies.


PSS- TOPRA- University of Hertfordshire Regulatory Affairs Workshop 20 May 2014 - ​Bob Clay participated in a workshop on European Regulatory Affairs hosted by the Pharmaceutical Society of Singapore.  The meeting explored background to European regulatory procedures and current issues in regulation of medicines.  For more information and photos - see: http://www.pss.org.sg/whats-happening/event-highlights/pss-topra-university-hertfordshire-regulatory-affairs-workshop​  


The Japan – UK Workshop on Health and Medical Innovation, and Regulatory Science 1st April 2014 -  Bob Clay presented on The Regulatory Science of Anti-Cancer Agents at this meeting hosted by the Japanese Embassy in London.


Press and Cuttings

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In his role as TOPRA President in 2017, Bob Clay was interviewed for TOPRA 2020 on the subject of  "What will healthcare regulatory affairs look like in 2020?" - See interview on YouTube


Bob Clay was interviewed for an article published in Pharmafocus "Brain drain: The experts the UK may lose due to Brexit" by Ben Hargreaves.


As TOPRA President, Bob Clay writes an editorial piece for the monthly members magazine - reproduced here: