From Discovery to Clinic: Getting Ready for Phase 1 20 April 2016 The Nucleus, Chesterford Research Park, Little Chesterford, Cambridge CB10 1XL
Programme 09.00
Registration and networking
09.15
Introductions Phil Berry, Catalent
09.30
Drug Substance – API development priorities: Positioning for Phase I and beyond John Knight, JKonsult
10.15
Drug Product – Early dose form selection: Selecting and optimizing formulation technologies for clinical success Pascale Clement, Catalent
11.00
Drug Product – Challenges and Solutions for Non-invasive Macromolecule Delivery Julien Meissonnier, Catalent
11.15
Coffee and networking
11:30
Regulatory – Best practices for preparing the IMPD quality section Judith Jones, Catalent
12.00
Clinical – Early clinical studies: What can we achive? Malcolm Boyce, Hammersmith Medicines Research
12.45
Networking lunch
13.15
1:1 Private Consultancy Appointments
14.00
Event closes
Speaker Profiles
Malcolm Boyce I’m the Medical and Managing Director of Hammersmith Medicines Research (HMR), a phase 1 CRO, where I’ve been principal investigator or co-investigator for over 670 phase 1 and early phase 2 trials of all types of molecule, including biologicals.
I qualified in physiology and medicine in Bristol. I’m a Fellow of the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, and the British Pharmacological Society, and an Honorary Senior Lecturer in Clinical Pharmacology at St Bartholomew’s Hospital Medical College, London.
I’ve held various posts in clinical and academic medicine, and I’ve worked for several of the major pharmaceutical companies, during which time I carried out or co-ordinated numerous clinical trials in Europe and the USA across all phases of drug development with a wide variety of new compounds.
I’m chairman of the Faculty of Pharmaceutical Medicine Diploma in Human Pharmacology/ Certificate in Human Pharmacology Advisory Committee, and a member of MHRA GCP Consultative Committee and the National Research Ethics Service Phase 1 Advisory Group, and a former member of the London Research Ethics Committee.
I’ve published over 135 papers in journals and books on drug development and research ethics.
Pascale Clement
Pascale Clement has recently joined Catalent as the Director of Science & Technology ensuring scientific leadership for the Optiform Solution Suite bioavailability enhancement platform and Softgel Development for the European market. Pascale has extensive experience in pharmaceutical development of multiple dosage forms for NCEs and Generics. Over the last 16 years, she has taken progressive leadership roles working at Skyepharma and Pharmascience in Canada and at HWI Analytik (Germany) where she led a Project Management and Pharmaceutical Development team. Pascale graduated with a Ph.D. in Pharmaceutical Sciences from Paris XI University.
Judith Jones
Judith Jones has 20 years of experience in the pharmaceutical industry, including 15 years within Regulatory Affairs, she is currently responsible for the EU arm of the Catalent Global Regulatory Affairs function. Judith is involved in all stages of the product development process from regulatory strategy and advice for early stage development, through pivotal manufacture, dossier preparation and licence application as well as post marketing support and maintenance. She has extensive experience in preparation of CMC dossier sections for a range of dosage forms, with a particular focus on Catalent specific technologies; as well as the collation, management and submission of complete dossiers to EU, US and other international territories. Judith graduated with a BSc. in chemistry from Exeter university. She is a Member of the Royal Society of Chemistry (RSC) and a member of TOPRA (The Organisation for Professionals in Regulatory Affairs).
Speaker Profiles
John Knight Dr John first started his industrial career at the age of 16 as a technician with ICI. Following several years’ laboratory experience he went on to study at the University of Southampton for a degree in chemistry, staying on to complete his PhD with Phil Parsons. John then took up a NATO-funded post-doctoral position with Gilbert Stork before returning to the UK to work for Glaxo, initially in medicinal chemistry before transferring to chemical development. John then moved to work for a small contract research organisation which, after significant growth, is now part of Aptuit. John left Aptuit at the end of 2007, following 14 years in the CRO arena, to join Scientific Update LLP where he provided training and consultancy services. In January 2015 John established his own consultancy business while continuing to work very closely with Scientific Update.
John’s main professional focus is in working with early stage chemical development projects and transfer to plant, often working with small pharma companies where he helps with CMC issues and securing material supplies to toxicological studies and Phase I and II clinical trials.
John can be contacted at: john@jkonsult.co.uk
Julien Meissonnier Julien Meissonnier has recently been appointed Catalent’s Vice President, Science and Technology, and leads a dedicated global team of drug development and technology experts. Mr. Meissonnier had previously led Catalent’s European softgel R&D team, focused on early stage screening activities, developing products including OptiShell™ capsules and OptiGel™ Bio capsules, scale-up and technology transfer, directing clinical supplies, and supporting product launches. He holds an Engineering degree in Physico-Chemistry from the ENSI in Caen, France.
Delegate List First name Clare Trevor Karen Phil Susan Malcolm Lesley Aline Pascale Bettina Helen Harriet Hannah Ibrahim Charlotte Sara Flic Ian Chris Takeshi Anna-Marie Simon Stewart Abigail Atholl Judith Tony Sarah Jonathan John G.S. Andrew Andrew Leakey Helen Julien James Tim Jon Farai Gary
Surname Anderton Archbold Bannister Berry Birks Boyce Chaplin Charpentier Clement Cortezi Danagher Dolding Dumbuya El Habbal Ellis Eve Gabbay Hallett Halling Hamada Healy Hodgson Hollington Hope Johnston Jones Jones Karim Kearsey Knight Kohli Lightfoot Maitland Mbaya McKeever Meissonnier Milnes Mitchell Murphy Mutswunguma Newton
Company GlaxoSmithKline Catalent Pharma Solutions Crescendo Biologics Catalent Pharma Solutions Manufacturing Chemist Hammersmith Medicines Research in2phase Ltd One Nucleus Catalent Pharma Solutions Hammersmith Medicines Research Mundipharma International Ltd Diamond Pharma Services Ltd Consultant - Hannah Dumbuya Mastropix PDQ Courier Consultant - Sara Eve TranScrip Partners Imanova Ltd Catalent Pharma Solutions Mitsubishi Tanabe Pharma Europe Ltd Catalent Pharma Solutions KalVista Pharmaceuticals Analytical Services International Mitsubishi Tanabe Pharma Europe Ltd Analytical Services International Catalent Pharma Solutions One Nucleus Mundipharma International Ltd Leads to Development Jkonsult Consultant - G.S. Kohli Peptinnovate Ltd Catalent Pharma Solutions Consultant - Leakey Mbaya Redx Pharma Catalent Pharma Solutions Xention Limited Sareum Limited Astex Pharmaceuticals - UK hVIVO Services Limited Domainex Ltd
Delegate List First name Sarah Myriam Mark
Surname Nicholson Ouberai Pearson
Company QRC Consultants Ltd Spirea Ltd. WuXi AppTec UK Ltd
Vincent Vicky Salman Dave Peter Julia Nadia Ben Manish Hale Matimba Harjit Dee Tomohiro Seav-Ly Stuart John Jeanette Sharon Suzanne Cecil Christina Xiaolin Yexin Christina Xiaolin Yexin
Plassat Price Rahman Roberts Sallabank Saul Shivji Skead Soni Soydan Worthy Swana Tamber Tarday Toida Tran Travers Wahlich Watson Wilson Wilson Wood Woollard Wu Xie Woollard Wu Xie
Catalent Pharma Solutions GlaxoSmithKline Vasgen Ltd Selcia Limited Regulinx iMED Global One Nucleus Cyclacel Ltd Catalent Pharma Solutions Consultant - Hale Soydan Worthy Medical Research Network Ltd Mundipharma International Ltd Consultant - Dee Tarday ONO Pharmaceutical University of Cambridge Sentinel Oncology Ltd John Wahlich Associates Ltd Peptinnovate Ltd GlaxoSmithKline GW Pharmaceuticals iCardiac GW Pharmaceuticals Consultant - Xiaolin Wu Consultant - Yexin Xie GW Pharmaceuticals Consultant - Xiaolin Wu Consultant - Yexin Xie
28 June 2016 Cambridge, UK
Translating UK scientific excellence into global therapeutic strategies
ON Helix is the established translational research conference brought to you by One Nucleus, which brings academia and industry together under one roof; bridging the gap between basic research and launching a product onto the market. Our Keynote Addresses:
• • • • • •
VIP Guest of Honour Dr Susan Windham-Bannister, ex-President of Massachusetts Life Sciences Center Dr David Roblin, COO and Director of Translation, The Francis Crick Institute Professor Nick Lemoine, Medical Director at the NIHR and Director of Barts Cancer Institute Sir John Savill, CEO, Medical Research Council Jane Osbourn, Site Leader and VP Research, MedImmune
What to expect from the conference:
• • • • • •
ON Helix Welcome Reception and BioNewsRound Award | 27 June 2016 Interactive Panel Debates 300 + Delegates 30 Exhibitiors Poster Session 1-2-1 Partnering
Wellcome Genome Campus Conference Centre, Cambridge onhelix.com | join in the conversation #onhelix16