Commentaries

19 September 2017

ESMO 2017 Facts and Figures

ESMO 2017TranScrip Senior Partners, Linda Summerton, Paul Branthwaite and Ed Currie report on the ESMO (European Society for Medical Oncology) conference in Madrid, 8-12 September 2017.


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07 September 2017

Medical Affairs in TranScrip

Medical Affairs in TranScripTranScrip’s Medical Affairs team is experienced at conducting and facilitating two-way scientific communications.

TranScrip are unique as an agency in that they provide both strategic and tactical support for medical affairs activities, working closely with clinical development, marketing, sales and market access teams to manage a spectrum of activities from late stage clinical development, through to pre-launch and post marketing periods.


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15 August 2017

Challenges of Programmes for Provision of Unlicensed Medicines Outside Clinical Trials

pic 4.pngTranScrip's Senior Partners, Bob Milsted and Edward Currie, report on 'Challenges of Programmes for Provision of Unlicensed Medicines Outside Clinical Trials'.


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24 July 2017

Mandar Kelkar presents on 'Efficiency Gain in Business Models for Global Pharmacovigilance: - Automation and Burying the Silos'

Mandar PVPresented by Mandar Kelkar at the 9th International Conference and Exhibition on Pharmacovigilance and Drug Safety on 17-18 July in Munich.


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24 July 2017

Flic Gabbay presents on 'Pharmacovigilance in 2020 - Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management'

Flic PV 2020Presented by Flic Gabbay at the 9th International Conference and Exhibition on Pharmacovigilance and Drug Safety on 17-18 July in Munich.


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15 June 2017

Why Pharma should pay attention to Devices & Diagnostics

Ed ArticleTranScrip's Senior Partner, Edward Currie, reports on 'Why Pharma should pay attention to Devices & Diagnostics'.


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30 May 2017

Flic Gabbay presents on 'Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management'

Flic PVPresented by TranScrip's Managing Partner, Flic Gabbay at the 3rd Annual International Conference and Exhibition in Pharmacovigilance, Regulatory Affairs, Risk Management and Clinical Trials in London on 25th May 2017.


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11 May 2017

Meet the CEO fighting Cancer with Mycobacteria

Untitled.pngTranScrip's Senior Partner, Linda Summerton, who serves as CEO for Immodulon Therapeutics Ltd. as part of their virtual team, talks about the excitement and the challenges of steering a promising new cancer treatment through to registration for needy patients.


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01 March 2017

Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management

IntraScience - 12th PV Slides_Final_01 - Copy (640x480) (140x105).jpgPresented by Ennis Lee at the 12th Pharmacovigilance 2017 Conference, 22nd & 23rd February 2017, London.


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28 February 2017

Richard Bax Presents to the Danish Parliament, 25th January 2017

Richard Bax Presents to Danish ParliamentRichard Bax was invited as an honoured guest to a meeting on “Non-Antibiotics as Resistance Breakers to Combat Antibiotic Resistant Microorganisms”.


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07 December 2016

Funding a Biopharma Without Licensing

Untitled.png"Funding a Biopharma Without Licensing" Presented at Genesis 2016, London by Linda Summerton, Senior Partner at TranScrip and CEO of Immodulon.


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02 December 2016

The Case for Small Pharma: A Q&A With Immodulon’s Linda Summerton

Untitled.pngLinda Summerton, Senior Partner at TranScrip and CEO of Immodulon sets out the case for small pharma in this Q&A with Biotech Investing  News. The piece looks at the advantages of investing in small pharma; the challenges being faced by the sector for 2017; and why small pharma is critical to driving growth and innovation in the UK.


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06 October 2016

Benefits and Challenges of Different Drug Safety and PV Business Models: Pilot study to understand Best Practice and innovative methods

Benefits and Challenges of Different Drug Safety and PV Business Models_front page.jpg

Presented by Flic Gabbay at the 3rd Annual Risk Management and Pharmacovigilance Summit, 27th - 29th September 2016, Vienna.


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14 July 2016

Evolving Risk-Management Requirements in Early Development

Evolving Risk-Management Requirements in Early Development - One Nucleus.pngEvolving Risk-Management Requirements in Early Development - presented by TranScrip's Mark Watling, Chris Brearley and Ennis Lee at the One Nucleus Summer Social Event, 13th July 2016.

  • Getting the most out of Early Phase Development - by Mark Watling
  • Issues a company must ensure are addressed before going into man - by Chris Brearley
  • Ensuring compliance with changing strategies and regulations - by Ennis Lee


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13 July 2016

Early Clinical Development - Part 1

Early Clinical Development – Watch TranScrip's Flic Gabbay interview Chris Brearley as the first part of TranScrip's Early Clinical Development webcast series.


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07 July 2016

Brexit and Regulatory Approval for Drugs in Europe - What Happens Now?

Q and A -Brexit and Regulatory Approval for Drugs in Europe - What Happens Now_07Jul2016_FRONT PAGE.jpg7th July 2016: Following the UK's European Union (EU) referendum, TranScrip has received many questions on what the impact is likely to be for pharmaceutical and biotech companies on the development and approval of future drugs. The following summarises TranScrip’s responses to these questions.


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29 June 2016

Indegene and TranScrip Alliance

On Helix 28Jun2016.pngIndegene and TranScrip Alliance- presented by Flic Gabbay at the One Nucleus On Helix Event, 28th June 2016.


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20 June 2016

Antimicrobial Discovery and Development Approaches

ASM Microbe presentation.pngAntimicrobial Discovery and Development Approaches - presented by Flic Gabbay at ASM Microbe, 18th June 2016.


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16 June 2016

Implementing Changes in Pharmacovigilance Regulations

2nd Pharmacovigilance.pngImplementing Changes in Pharmacovigilance Regulations - presented by Dr. Ennis Lee at the 2nd Pharmacovigilance 2016 Conference, 14th June 2016.


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14 June 2016

TranScrip's Tim Joslin reflects on the recent American Thoracic Society 2016 (ATS) conference

ATS 2016 Overview Commentary_14Jun2015.jpgThe American Thoracic Society 2016 (ATS)  in San Francisco was better attended than previous years (over 17,000 registered delegates from 90 countries, with nearly 7,000 scientific abstracts, case reports, and late-breaking abstracts were presented).  It saw the resurgence/return of the major players in Respiratory (GSK, AZ, Sanofi) due to on-going interest in idiopathic pulmonary fibrosis (IPF), the advent of biological therapies for asthma (anti IL-4, anti-IL-5, anti-IL-13) plus the surge in phenotyping and endotyping for asthma and chronic obstructive pulmonary disease (COPD).


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09 June 2016

TranScrip's Sarah Daniels and Flic Gabbay reflect on the recent DIA Euromeeting 2016

DIA Euromeeting post conferencer report_ Final_09Jun2016_Page_1.jpgAs we run up to the DIA 2016 in Philadelphia it is worth reflecting on what happened at the 28th Annual Euromeeting held by DIA in Hamburg in April this year. The overall theme was ‘Do you win by being Innovative?’ As usual there was a packed agenda including 14 themes with almost 1400 registered participants, the majority of whom were from Europe, however there were also attendees from the US and Japan, Brazil and Korea.


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10 May 2016

A Marketing Authorisation Application (MAA) can be the same document as a New Drug Application (NDA) except for Module 1, correct? Close, but not entirely true!

MAA NDA Commentary front page 10May2016.pngTranScrip are often asked by pharmaceutical companies whether the Marketing Authorisation Application (MAA) dossier for the EU and the New Drug Application (NDA) dossier for the USA differ and, if so, in which sections and why. This appears to be a topic of some confusion, particularly when the submission dossier is for an anti-infective product.


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10 March 2016

Idiopathic Pulmonary Fibrosis – Implications of 2015 guideline updates

Idiopathic Pulmonary Fibrosis Implication of 2015 guideline updates_Final 10 Mar 2016_FRONT PAGE.jpgJust over a decade ago research into Idiopathic Pulmonary Fibrosis (IPF) and dedicated drug development was very limited. However recent improvements in the understanding of the underlying biology, and the success of developmental agents to show a measurable positive effect on lung function, have spurred pharmaceutical companies to take a serious interest in the disease.


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26 February 2016

TranScrip's Maureen Rankine reports on the MHRA GPvP Symposium

transcrips-maureen-rankine-reports-on-the-mhra-gpvp-symposium1.pngOn 6 November 2015, TranScrip attended the annual MHRA Symposium on GPvP (Good Pharmacovigilance Practice) inspections presented by a speaker panel of MHRA Inspectors. The symposium tackled different aspects of the EU pharmacovigilance (PV) legislation, common PV inspection findings and advice on improving internal practices. This symposium is a valuable source of information, and has been particularly important since 2012 with the ongoing implementation of the changes in the EU PV legislation, which continue to present many challenges for marketing authorisation holders (MAHs) and for competent authorities (CAs).


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19 February 2016

The age of virtual pharma: Challenges and solutions for investor directors and successful boards

Biotech2016

Watch TranScrip's workshop recording from the Biotech Showcase 2016 conference.
(Video source: © PharmaTelevision)


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