From Discovery to Clinic: Getting Ready for Phase 1

20 April 2016

The Nucleus, Chesterford Research Park, Little Chesterford, Cambridge CB10 1XL

09.15

09.30

10.15

11.00

11.15

11:30

12.00

12.45

13.15

09.00 Registration and networking

Programme

14.00 Event closes

IntroductionsPhil Berry, Catalent

Drug Substance – API development priorities: Positioning for Phase I and beyondJohn Knight, JKonsult

Drug Product – Early dose form selection: Selecting and optimizing formulation technologies for clinical successPascale Clement, Catalent

Drug Product – Challenges and Solutions for Non-invasive Macromolecule DeliveryJulien Meissonnier, Catalent

Coffee and networking

Regulatory – Best practices for preparing the IMPD quality sectionJudith Jones, Catalent

Clinical – Early clinical studies: What can we achive?Malcolm Boyce, Hammersmith Medicines Research

Networking lunch

1:1 Private Consultancy Appointments

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.

Speaker Profiles

Delegate List

First name Surname CompanyClare Anderton GlaxoSmithKlineTrevor Archbold Catalent Pharma SolutionsKaren Bannister Crescendo BiologicsPhil Berry Catalent Pharma SolutionsSusan Birks Manufacturing ChemistMalcolm Boyce Hammersmith Medicines ResearchLesley Chaplin in2phase LtdAline Charpentier One NucleusPascale Clement Catalent Pharma SolutionsBettina Cortezi Hammersmith Medicines ResearchHelen Danagher Mundipharma International LtdHarriet Dolding Diamond Pharma Services LtdHannah Dumbuya Consultant - Hannah DumbuyaIbrahim El Habbal MastropixCharlotte Ellis PDQ CourierSara Eve Consultant - Sara EveFlic Gabbay TranScrip PartnersIan Hallett Imanova LtdChris Halling Catalent Pharma SolutionsTakeshi Hamada Mitsubishi Tanabe Pharma Europe LtdAnna-Marie Healy Catalent Pharma SolutionsSimon Hodgson KalVista PharmaceuticalsStewart Hollington Analytical Services InternationalAbigail Hope Mitsubishi Tanabe Pharma Europe LtdAtholl Johnston Analytical Services InternationalJudith Jones Catalent Pharma SolutionsTony Jones One NucleusSarah Karim Mundipharma International LtdJonathan Kearsey Leads to DevelopmentJohn Knight JkonsultG.S. Kohli Consultant - G.S. KohliAndrew Lightfoot Peptinnovate LtdAndrew Maitland Catalent Pharma SolutionsLeakey Mbaya Consultant - Leakey MbayaHelen McKeever Redx PharmaJulien Meissonnier Catalent Pharma SolutionsJames Milnes Xention LimitedTim Mitchell Sareum LimitedJon Murphy Astex Pharmaceuticals - UKFarai Mutswunguma hVIVO Services LimitedGary Newton Domainex Ltd

Delegate List

First name Surname CompanySarah Nicholson QRC Consultants LtdMyriam Ouberai Spirea Ltd.Mark Pearson WuXi AppTec UK Ltd

Vincent Plassat Catalent Pharma SolutionsVicky Price GlaxoSmithKlineSalman Rahman Vasgen LtdDave Roberts Selcia LimitedPeter Sallabank RegulinxJulia Saul iMED GlobalNadia Shivji One NucleusBen Skead Cyclacel LtdManish Soni Catalent Pharma SolutionsHale Soydan Worthy Consultant - Hale Soydan WorthyMatimba Swana Medical Research Network LtdHarjit Tamber Mundipharma International LtdDee Tarday Consultant - Dee TardayTomohiro Toida ONO PharmaceuticalSeav-Ly Tran University of CambridgeStuart Travers Sentinel Oncology LtdJohn Wahlich John Wahlich Associates LtdJeanette Watson Peptinnovate LtdSharon Wilson GlaxoSmithKlineSuzanne Wilson GW PharmaceuticalsCecil Wood iCardiacChristina Woollard GW PharmaceuticalsXiaolin Wu Consultant - Xiaolin WuYexin Xie Consultant - Yexin XieChristina Woollard GW PharmaceuticalsXiaolin Wu Consultant - Xiaolin WuYexin Xie Consultant - Yexin Xie

Translating UK scientific excellence into global therapeutic strategies

28 June 2016 Cambridge, UK

onhelix.com | join in the conversation #onhelix16

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

Wellcome Genome Campus Conference Centre, Cambridge

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