Leadership Seminar: Respiratory and Inflammatory Diseases 22 September 2016

Penningtons Manches, 125 Wood Street, London EC2V 7AW

Sponsored by

Hosted by

Programme 10.00 Registration 10.20 Welcome from the Host

10.30 Introduction Adrian Dawkes, PharmaVentures

10.45 Keynote presentations and discussion on unmet clinical needs including:

10.45 Symptoms vs Disease Modification Approach Lars Larson, TranScrip

11.05 Prospects for the prevention and treatment of respiratory virus-induced exacerbations in asthma and COPD Garth Rapeport, Pulmocide

11.25 Eosinophil depletion with benralizumab (anti-IL-5R) for the management of Severe Asthma and Chronic Obstructive Pulmonary Disease (COPD) Suzanne Cohen, MedImmune

11.45 Breath Biopsy - Breath Volatile Organic Compounds (VOCs) as Markers for Respiratory Disease Billy Boyle, Owlstone Medical 12.05 Panel discussion and Q&A

12.30 Lunch and networking

14.00 Data Protection and Liability in Respiratory Connected Devices Oliver Bett, Penningtons Manches

14.20 Adaptive Design in Respiratory Clinical Trials – A Sponsor’s Business Case Alethea Wieland, Scope International

14.40 Development of Immunoassays and Point-of-Care Tests for the Measurement of Active Protease Biomarkers of Chronic Respiratory Disease David Ribeiro, ProAxsis

15.00 Aiming for the Lungs - Formulation Strategies for Delivery of Inhaled Biologics Charlotte Yates, Vectura

15.30 Tea, coffee and networking

16.00 Innovative therapeutic options

16.00 The Development of an IL-17BR therapeutic antibody for the treatment of Asthma and IPF David Matthews, MRC Technology

16.20 Mycobacterium Tuberculosis Derived Peptide as a Disease Modifying Therapy for Asthma Nicky Cooper, Peptinnovate

16.40 Closing Remarks and Drinks Reception

18.00 Event closes

Speaker Profiles

Oliver Bett Associate, Penningtons Manches

Oliver is an associate in our IP, IT and commercial team of Penningtons Manches, based in the London office. He advises on a broad range of non-contentious commercial matters including data protection, focusing primarily on the technology sector.

Oliver’s work is diverse in nature, ranging from advising local authorities on large commercial projects to technology licensing and supply agreements.

Oliver acted as lead adviser on intellectual property, IT and data protection matters regarding investments by two of Europe’s largest technology venture capital firms, including giving advice related to investments into Citymapper, Deliveroo, Worldremit and Nutmeg. Billy Boyle CEO, Owlstone Medical Ltd

Billy Boyle is an engineering graduate from Cambridge University. He is one of the original co-founders of Owlstone Inc, spun out of Cambridge in 2004, which has raised $28M in investment and won >$25M in defence contracts. He initially worked with silicon foundries in the design and fabrication of the core microchip technology and is co-inventor on 19 patents. He then assumed a commercial role with P&L responsibility for the Scientific Instruments and Industrial business units; responsible for sales of FAIMS products and contracts with >150 clients globally, including Agilent, Thermo, Roche Diagnostics, Samsung, GSK, 4D Pharma, Mayo Clinic and the NHS.

Billy started to focus on the medical applications of FAIMS technology after his wife, Kate, was diagnosed and later died of colon cancer as a result of a late diagnosis. He worked closely with clinical partners who integrated FAIMS technology across a broad spectrum of clinical trials in cancer, inflammatory disease & infectious disease. After positive clinical trial results he headed up the newly formed Medical business unit, which won a £1M NHS contract for LuCID to use FAIMS technology in the early detection of lung cancer. With ongoing clinical and commercial success, Billy led the process to spin out Owlstone Medical Ltd and became the founding CEO upon the close of a $7M investment in March 2016. The mission of Owlstone Medical is to save 100,000 lives and $1.5B in healthcare costs.

Suzanne Cohen Senior Scientist, MedImmune

Suzanne joined MedImmune in 2001 after gaining a doctorate in Immunology at the University of Oxford, UK. She has over 15 years experience in preclinical and early clinical development of therapeutic antibodies and currently leads a team focused on lung disease research in the department of Respiratory, Inflammation and Autoimmunity (RIA) in Cambridge, UK.

Nicky Cooper CSO, Peptinnovate

Nicky has 25 years’ experience within the biotech industry (Amersham International, Almirall, Chiroscience, , Arakis, Sosei, Acacia Pharma). Working in therapeutic areas including respiratory disease, inflammation, pain and cancer, Nicky has progressed molecules from discovery into PhII clinical trials and been the lead biologist on a number of key out-licensing deals (Chiroscience PDE4 programme to Schering Plough, Arakis muscarinic antagonist to Novartis (Ultibro®)). Before working with Peptinnovate Nicky was Head of Discovery at the drug re-positioning, cancer supportive care company Acacia Pharma where she progressed 2 molecules into development now in Phase II/III clinical trials

Speaker Profiles

Adrian Dawkes Managing Director, PharmaVentures

Since joining PharmaVentures in 2007, Adrian has led a number of consultancy and licensing mandates and is increasingly involved in M&A. Among his successful projects at PharmaVentures are the recent agreement between MedGenesis and Pfizer for a unique therapeutic approach which will be used in the clinical development of treatments for Parkinson’s disease and the acquisition of NanoSight Ltd. by Spectris plc where it will become part of the highly successful group company Malvern Instruments.

During his professional career, Adrian has significant multi-discipline expertise spanning research and development through to sales, marketing and business development. He has held senior positions with Johnson & Johnson, drug discovery platform company Acumen Bioscience and the Healthcare Consultancy company Execute Technologies. Adrian has over 30 years in the pharmaceutical, biotechnology and in vitro diagnostics sectors. Adrian holds a BSc in Biochemistry and a PhD in Immunochemistry.

Lars Larsson Senior Partner, TranScrip

Lars Larsson has more than 30 years’ experience from academia and pharma/biotech industry in the field of respiratory and allergic diseases. He became MD at the University of Umeå Sweden, 1977 and holds board certificates in Internal Medicine, Pulmonary Medicine and Allergy. He is Associated Professor in pulmonary medicine at the University of Umeå. Lars has been active in the since 1995, including positions as head Medical Department, Astra Draco, VP Medical and Regulatory Affairs, Pharmacia Diagnostics AB, VP and CMO Biolipox AB, Clinical Research Head Cough, Cold and Allergy at Novartis Consumer health and Executive Medical Director Licensing for Respiratory and Inflammation therapeutic area in Astra . Since 2013 he is a Senior Partner of Transcrip, Reading UK.

During his years in industry Lars has worked in small startup biotech companies as well as large pharma companies and he has been involved in all stages of drug development and in a large number of licensing deals in several therapeutic areas.

David Matthews Associate Director BioTherapeutics, MRC Technology

After completing is PhD in immunology at University College London studying the functional relationship of IL-4 and IL-13, he subsequently did post docs at UCL, Wurzburg University and at the LMB in Cambridge UK again studying the functional roles of IL-4 and IL-13. In 2001 he joined AERES Biomedical Ltd, a biotech specialising in antibody humanisation. In 2006 he joined the MRC Technology’s antibody engineering group and in 2012 he became the head of the BioTherapeutics Group. David and his team have been developing therapeutic antibodies to wide range of targets in collaboration with academic and industrial partners. Speaker Profiles

Garth Rapeport CEO, Pulmocide

Garth Rapeport is visiting Professor at the National Heart & Lung Institute, Imperial College School of Medicine in London and CEO of Pulmocide Ltd, a drug discovery company working on new treatments for Invasive Aspergillosis and RSV http://pulmocide.com/

Garth is a medical graduate who undertook post-graduate training in General Medicine and Clinical Pharmacology at the Universities of Glasgow and Oxford. He joined Pfizer Central Research in 1988 and was involved in the early development of range of new compounds. After moving to GSK he was appointed directed of the Respiratory Centre of Excellence for drug discovery (CEDD) leading to the development of new treatments for allergy, COPD and asthma including Relvar/Breo, Avamys and Anoro. In 2006 he founded Respivert based at Imperial College in London. Respivert was responsible for the discovery and development of inhaled NMEs for steroid refractory asthma and COPD delivery. Respivert was acquired by Johnson and Johnson in June 2010.

David Ribeiro CEO, ProAxsis Limited

Dr David Ribeiro is CEO of ProAxsis Limited, a Northern-Ireland based company developing in vitro diagnostics for the measurement of active protease biomarkers of disease, with a particular emphasis on respiratory diseases. David has previously held senior commercial management roles at Solvay Healthcare, Encysive, Pfizer and Pharmaxis Pharmaceuticals Limited, a Sydney-based company with two launched products – a diagnostic test for assessing bronchial hyper-¬responsiveness in asthma, and a therapeutic for patients with Cystic Fibrosis.

David has a PhD in Clinical Biochemistry from the University of Surrey, where he investigated the impact of shift work on risk factors for cardiovascular disease.

Charlotte Yates Team Leader, Vectura

Charlotte Yates is a Team Leader for focussing on the development of biopharmaceutical formulations for inhalation.

Charlotte studied Chemistry at Bristol University graduating in 2001 and has spent the last 15 years working in the pharmaceutical industry. Charlotte began her career in the industry initially working for Patheon before moving to work for Vectura Group in 2003. During her 13 years at Vectura, Charlotte has worked on and led numerous development projects primarily focused on the formulation of dry powders for delivery to the lung. In 2014 Charlotte moved to specialising in the delivery of biologics for inhalation where she now leads a technology project that focuses on developing dry powder formulations containing biologics for pulmonary delivery. Alethea Wieland Managing Director, SCOPE International

Alethea Wieland serves as the Managing Director of the US affiliate of a global, full-service contract research organization (CRO) headquartered in Mannheim, Germany with 17 offices throughout Europe, UK, and Russia. Previously, she served in clinical research and regulatory affairs leadership roles at ALung Technologies, Inc., Precision Therapeutics (now Helomics), and the National Surgical Adjuvant Breast and Bowel Project (NSABP) over a 15-year period. In her clinical research and regulatory affairs capacities, Alethea has participated in numerous negotiations, meetings, and communications with the US FDA, Health Canada’s HPFB, the UK’s MHRA and NICE, the Australian TGA, the German BfArM, the Korean MFDS, and independent Notified Bodies. She also has 10 years of grants management experience with the National Institutes of Health and Department of Defense. As a passionate promotor of work in quality management, clinical research, regulatory affairs, and of the regulations and ethical standards that govern life science companies, Alethea provides strategic consulting services for executives, academicians, investors, and entrepreneurs alike who seek assistance in navigating the complexities of these disciplines in a real-world setting.

Outside of research, Alethea has held a business development management role at CECity.com, a Pittsburgh-based IT continuing medical education and healthcare quality performance solutions company, and communications directorship roles in both a large academic institution and a national thoracic surgery medical society.

Delegate List

Firstname Surname Organisation Tuc Ahmad Fisher Scientific UK Aidan Ancill Scope International Ltd Katya Ascher Penningtons Manches LLP Oliver Bett Penningtons Manches LLP Billy Boyle Owlstone Medical Ltd Rachel Bradley Penningtons Manches LLP Richard Broadhead Precision NanoSystems UK Limited Andrew Carnegie Clinical Network Services (CNS) Pty Ltd Aline Charpentier One Nucleus Suzanne Cohen MedImmune Limited Chris Collins Q Scientific Consulting Ltd Nicky Cooper Peptinnovate Ltd Sarah Crouch MedImmune Limited Adrian Dawkes PharmaVentures Ltd Mehrnaz Elmi Pneumolabs (UK) Ltd Ciaran Flanagan Quotient Clinical Ltd Kazuhiro Ito Pulmocide Ltd John Kelly MRC Technology Jennifer Kernan Scope International Ltd Jim Kinnier Wilson Penningtons Manches LLP Ian Knowles Pneumolabs (UK) Ltd Matthew Konneh Biotrial International Claire Lachlan UKTI - Trade Services (East of England) Lars Larsson TranScrip Peter MacLennan TCRS David Matthews MRC Technology Ross McNaughton Penningtons Manches LLP Joanne Miller Envigo Jonathan Moore Horizon Discovery Group plc Alexander Munro Vectura Group plc Gary Newton Domainex Ltd Clare Nott MedImmune Limited Kathryn Owen Imperial Innovations Barry Porter King’s College London Business Ltd Garth Rapeport Pulmocide Ltd Oliver Rausch NIHR Office for Clinical Research Infrastructure (NOCRI) David Ribeiro Proaxsis Dave Roberts Selcia Limited Pat Saini Penningtons Manches LLP Clare Sansom Dr Clare Sansom (freelance) Chris Shelley Penningtons Manches LLP Nadia Shivji One Nucleus James Stephen Penningtons Manches LLP Will Stimpson Envigo Richard Ward Envigo Allan Watkinson Envigo Paul Whittaker hVIVO Services Limited Alethea Wieland Scope International Ltd Tim Wright Vectura Group plc Charlotte Yates Vectura Group plc Amy Yip GlobalData