<p>Biotech Outsourcing Strategies 2016</p>

Dr Emma Blaney currently works as a Senior Programme Manager at C4X Discovery, running multiple drug discovery projects. 

Emma received her BSc in Chemistry and Pharmacology from the University of Liverpool and a PhD in Organic Chemistry from the University of Leeds. She subsequently spent 6 years working in Lead Optimisation for GSK, gaining experience managing in-house teams, as well as coordinating synthetic chemistry outsourcing. Emma then added 5 years experience working as a Section Head for Peakdale Molecular, a medicinal and synthetic chemistry CRO.

Since joining C4X nearly 3 years ago, Emma has been responsible for coordinating outsourcing activities to enable project delivery. This has included primary and cellular assay validation, tool compound synthesis, medicinal and synthetic chemistry, ADME, biomarker studies, disease models, PR&D and toxicology.

Ian Leader has twenty years’ experience in R&D and commercial product/process development, quality, clinical/analytical/bioanalytical sciences with GSK, P&G, Wyeth, Pfizer, Shire and Britannia Pharmaceuticals.  Currently engaged as Head of Research & Development for Britannia Pharmaceuticals with a remit to lead the development programs for all assets for the company.  This role entails full responsibility for all preclinical, development, CMC and clinical related activities using a fully virtual (outsourced) development and manufacturing model for both parenteral and non-parenteral applications. 

Prior to this Ian was Product Development Director at Shire Specialty Pharmaceuticals responsible for leading the pharmaceutical development programs for both early and late phase assets within a virtual model, as well as being responsible for establishing and leading Shire’s Quality Risk Management (QRM) and Quality by Design (QbD) process within the product development cycle.  Ian has worked extensively with CDMO/CMO/CRO’s at all stages of the product development cycle in the US, EU and Asia.  He has a PhD in Chemistry, is Lean6-Sigma certified and a member of the RSC.

Daniel has over 13 years drug discovery and development experience working in biotech, contract research and consultancy organisations on programmes ranging from lead optimisation, through full clinical development and right though to registration – so has experience spanning most of the drug development process.

Daniel spent the early part of his career at Evotec in the UK specialising in in vitro ADME/DMPK.  He then moved to Fulcrum Pharma Developments Ltd. (latterly Aptiv Solutions) in 2006, broadening his experience as a Preclinical Project Manager working across the Preclinical, Project Management and Clinical Development teams for multiple clients across a variety of therapeutic areas.  Daniel moved to e-Therapeutics Plc. in 2012 where he took up the position of Preclinical Manager taking responsibility for the identification, commissioning and project management of key preclinical studies for discovery and development.

Since 2006 Daniel has contributed towards nine successful first time in man enabling preclinical development programmes of work and has also contributed towards the development of three novel successfully registered products.

Dr Lilian Alcaraz is currently Senior Director – Medicinal Chemistry Leader at Johnson & Johnson Innovation London where is responsible for assessing emerging opportunities, running external collaborations across multiple therapy areas, developing  novel collaborative drug discovery models and contributing to J&J external incubator strategy. Lilian has over 17 years’ experience in Drug Discovery gained through working in both large pharma and CRO environments. Before joining JJI in 2015, Lilian was Senior Director of Chemistry at Charles River (Argenta) where he co-headed the chemistry department and led a large multidisciplinary tri-party partnership, overseeing the delivery of multiple drug discovery projects. Prior to that, Lilian spent 13 years (1998-2011) at AstraZeneca Charnwood advancing in various leadership roles spanning lead optimisation, lead identification and library design and synthesis whilst working in the field of respiratory and inflammation. He obtained his PhD in Organic Chemistry from the Strasbourg University in 1995 followed by post-doctoral studies at York University.

Wim-Jan joined Lygature as Director Business Development in 2014. He brings with him over 20 years of experience in the health research environment. Wim-Jan started his career in Drug Discovery Research at Organon (now Merck) following which he moved to Strategy & Portfolio Management as Senior Director Global Research Alliances. He then took a position as Vice-President IP & IP Commercialization at a genomic research biotech company (KeyGene). Subsequently, he joined the Radboud University Medical Centre to become Team Leader Business Development after which he took up his current position at Lygature. He has been instrumental in over 45 deals, several of which were multi-million euro in value. His motto: Collaboration is sharing your expertise to reach a commonly shared goal

Dr Rob Harris has over 30 years experience in the pharmaceutical industry. He started his career in production support roles with Warner Lambert and GSK before spending time in academia as a Research Fellow at the University of Manchester, developing novel drug delivery systems. For the last 15 years Rob has worked in the contract pharmaceutical development sector, holding senior technical roles with Quay Pharma, Capsugel and Penn Pharma.

Rob is currently Chief Technical Officer at Juniper Pharma Services.

Richard is the founder and managing director of XenoGesis Ltd, a rapidly growing contract research organisation based in BioCity Nottingham in the UK.

Having joined Astra Charnwood in 1997 within Discovery DMPK, Richard progressed to Group and Project Leader at AstraZeneca. During that time Richard gained and developed an in-depth knowledge of all aspects of in vitro and in vivo Drug Metabolism and Pharmacokinetics from Hit Identification to Candidate Drug nomination and beyond.

Richard gained a first class honours degree in chemistry with awards for the best performance in every year, followed by a medicinal chemistry PhD with a Wellcome Trust scholarship at the University of Leicester and two subsequent postdoctoral positions at the Welsh School of Pharmacy. He has authored and co-authored twenty one publications to date and in 2014, Richard was invited to become a Fellow of the Royal Society of Chemistry.

Adrijana Vinter obtained her PhD in Chemistry at the University of Zagreb in the field of new macrolide antibiotics and an MBA at Cotrugli Business School, Croatia. Adrijana has been working in the pharmaceutical and biotech companies (PLIVA, GlaxoSmithKline and Galapagos) for the last 10 years. During this period she worked in the areas of anti-infectives, anti-fungals, inflammation and CNS, holding different scientific positions. She has broad experience in collaborations on internationally driven scientific projects. Adrijana commenced her new role in Business Development department at Fidelta in January 2013.

Dr Sree Vadlamudi joined eTherapeutics in 2013 as Programme Manager where he is responsible for overseeing outsourcing and programme management activities to enable delivery of multiple projects in timely and cost effective manner. Sree is a Medicinal Chemist by training with over 14 years’ experience in the Biotechnology industry. Sree has significant experience in leading projects from inception to lead generation and optimisation, and is a named author on multiple patents and publications. Sree has also gained commercial experience in managing alliances, collaborations, technology commercialisation and business development activities in biotech and CRO environments.

Christian Jones is Commercial Director for Custom Development and Manufacturing – Europe at Johnson Matthey Fine Chemicals where he is focussed on enabling innovative pharmaceutical companies in their R&D and manufacture of novel therapies. He has many years’ experience in providing services and solutions to the Pharmaceutical Industry having worked with clients across Europe, US and Asia-Pacific from pre-clinical candidates to commercial drugs in both Drug Substance and Drug Product supply. Prior to joining Johnson Matthey, Christian worked for Dr Reddy’s Laboratories where he held multiple roles in Europe and his last post was leading their Asia Pacific Business. Christian’s other commercial experience includes Prosonix, a company specialising in particle engineering where he was the first employee and led their Sales and Marketing and Tripos Discovery Research where he worked as a Process Chemist and Marketing Associate.

Mr. Wolfgang Schiek, Director, Sales and Business Development is based in Düsseldorf and has responsibility for expanding the company’s custom development sales growth, developing customer relationships and managing the interface for new projects in Germany, Austria, Switzerland and the UK.

Wolfgang has a Ph.D. in Chemistry and has worked in the pharmaceutical industry for over 15 years. He brings with him a wealth of CMO experience, particularly within chemical process development and manufacturing. During Wolfgang’s time at Novasep, he had responsibility for business development for global Fine Chemistry and Agrochemicals and business development in addition to increasing expansion of the Pharma division in Europe and the US.

I joined MMV in 2009 when I saw a unique opportunity to apply novel and exciting science to solve some real problems which will not only stop people from dying or becoming sick but can also turn their lives around and enable them to escape from poverty. I have almost nineteen years of experience in drug discovery and development gained in the  biotechnology and contract research sectors and  including six years at MMV.    Prior to joining MMV, I held positions in business development with  Paragon Biomedical, Synarc Inc., and PPD in Cambridge, UK and before that I  worked as a research and senior scientist at Cambridge Antibody Technology.   I have a Ph.D. in Immunology from the University of London and a B.Sc. in Biochemistry from the University of Glasgow. In 2014, I enrolled for a master’s degree in biomedical ethics and healthcare with the University of Leeds.

Dr Stephen Nabarro, Head of Clinical Operations and Data Management, CRUK Centre for Drug Development

My scientific career to date has been underpinned by Cancer Research UK’s vision ‘to bring forward the day when all cancers are cured’: my PhD in paediatric oncology at University College London; eight years and counting working at CRUK; culminating in my current role as Head of Clinical Operations and Data Management in the CRUK Centre for Drug Development.

Paul Quinn has 20 years Clinical Development experience with a recent focus on Clinical Operations, currently Director – Clinical Operations, at Vectura an SME pharmaceutical company specialising in inhaled therapies.  Paul has worked in the Pharma industry previously at Pfizer and Shire where he lead new initiatives in electronic capture of patient data and more recently novel approaches in patient recruitment in and engagement with clinical trials, these included eConsents and trial websites.  Paul has also lead effective changes in clinical outsourcing strategy at Shire and Vectura.

Liz Eagling-Vose has 12 years’ pharmaceutical industry experience, with a strong background in Clinical Operations, currently Associate Director - clinical studies, at Vectura an SME pharmaceutical company specialising in inhaled therapies. Liz worked within both CRO and Pharma industry, including AstraZeneca, and Parexel.  She has clinical experience includes study management, site monitoring/management, medical writing, data management, ethics and regulatory applications.   Liz holds a BSc (Hons) in biology with analytical science, and is presently studying for an MBA.

Oliver Timmis (Email: [email protected] / Twitter: @OliverTimmis)

Oliver Timmis is the CEO for the AKU Society, an entrepreneurial patient organisation supporting those diagnosed with a rare disease, alkaptonuria (AKU). Oliver leads on funding applications for new projects, allowing for the creation of a National AKU Centre for UK patients, and international phase III clinical trials called DevelopAKUre. He graduated with a BA(hons) in Natural Science (Physiology, Development and Neuroscience) from Cambridge University. Oliver volunteers at Eurordis (Rare Diseases Europe) on their DITA (Drug Information, Transparency and Access) taskforce, sits on the Patient Advisory Council at the RD Connect registries project, and is a member of the Patient-centered Special Interest Group at ISPOR. He also volunteers for Findacure, the Fundamental Diseases Partnership.

Professor Neil Williams is Founder and Chief Scientific Officer of KWS BioTest Ltd.  He was also Founder of Trident Pharmaceuticals Inc, and inventor of their novel T regulatory cell inducing therapy for inflammatory disease. His positions have included Professor of Immunology and Research Director at the University of Bristol and Chairman of the British Society for Immunology. He brings a huge depth of expertise in immunology, inflammation and infection, and has led a range of programs where novel PD biomarkers have played a key role in mapping and confirming mechanism of action in pre-clinical and clinical settings. Professor Williams' expertise in drug discovery enables KWS BioTest to act as true partners for their many clients across Europe and the rest of the world.

Pete Chan is Chief Innovation Advocate at Raremark, a new online service for families affected by rare disease. Pete is an expert on rare diseases, particularly in the development of new online strategies. He is responsible for programme development, data sourcing and quality control. Previously, he served as an editor for the pharmaceutical industry’s news and analysis service Scrip Intelligence and the annual Scrip 100 analysis.

Christa van Kan has more than 20 years experience in managing clinical trials in a broad range of diseases, including many orphan and paediatric indications. In addition to her MSc in biomedical sciences, Christa has a PhD in clinical epidemiology. Christa is co-owner and Director Clinical Operations of PSR Group, a services company specialising in clinical development of medicines for rare diseases. During her career, Christa has successfully led a department of dedicated clinical research professionals who are responsible for the set-up, management and monitoring of complex clinical trials across Europe and the US. She is currently involved in several EU-funded projects which aim to bring to market a drug for a rare disease with no current treatment. Christa has found that close collaboration with patient advocacy groups is very valuable for successfully running an orphan drug trial and adds a very interesting new dimension to her work. Christa is often asked to give presentations about the practical aspects of performing orphan drug trials.

Kausik Kumar Ray is currently Professor of Public Heath, Department of Public Health and Primary Care, School of Public Health, Imperial College London. Professor Ray received his medical education (MB ChB, 1991) at the University of Birmingham Medical School, his MD (2004) at the University of Sheffield, a postdoctoral fellowship at Harvard Medical School and finally an MPhil in epidemiology (2007) from the University of Cambridge.
A Fellow of the American College of Cardiology, the European Society of Cardiology, the American Heart Association and the Royal College of Physicians, Kausik Ray is also a member of the British Cardiovascular Society and European Atherosclerosis Society. Professor Ray has been the national lead investigator, served on the committees for several major medical trials, including T-EMERGE 8, SOLID TIMI 52, SAVOR TIMI 54, DAL OUTCOMES II, DAL-ACUTE, ODYSSEYOUTCOMES, DECLARE TIMI 58, CAMELIA TIMI 61, CARAT, PROMINENT and THEMIS and is currently involved in 8 ongoing trials including PI of ORION 1 and BETONMACE.

Professor Ray’s research interests have focused on the prevention of cardiovascular disease with a special interest in lipids and diabetes. He has investigated the early benefits of statin therapy, the advantages of more/less intensive glycaemic control, and the risks/benefits of aspirin therapy. These have influenced AHA/ACC and ESC guidelines. His work on statins and diabetes risk led to a global label change for statins by the FDA and EMEA.  He continues to investigate the role of lipids, lipoproteins, diabetes, inflammation and thrombosis and coronary events. He has received numerous research grants including from the British Heart Foundation and the Wellcome Trust Project. Currently Professor Ray leads the EAS FH Studies collaboration and is the Senior PI for the TOGETHER study looking at cardiometabolic risk in the vascular health checks in 250 000 people in London. Whilst Professor of CVD Prevention at St George’s, University of London he developed and led the Integrated Care Pathway for patients with acute coronary syndromes, the first electronic pathway for such patients in the world.

Jane as Director of the Translational Research office is responsible for a team of 24 highly experienced industrial translational scientists tasked with establishing the organisational culture, capability and processes necessary to deliver the UCL and BRC’s mission of "Accelerating translation for health and wealth".  The TRO supports the development of early stage research from across UCL and its partner hospitals, into projects attractive for translational funding or further development with partners and nurture access to complementary capacity, expertise and skills in translational science. The TRO achieves this through the integrated activities of three specialist groups a Drug Discovery Group (DDG) provides expert advice and practical support for small molecule drug discovery projects across UCL; a Translational Research Group who provide experienced project leaders to guide projects (gene, cell and regenerative medicine therapies, devices, diagnostics, small molecules) through their development; and an Industrial Partnerships Group who initiate and manage relationships with industry.

Duncan is an enthusiastic and accomplished medicinal chemist with extensive outsourcing experience, a 40-year proven track record with a Blue-Chip Pharmaceutical Company, and is the founder of Awridian Ltd.

Duncan has made significant contributions to numerous drug discovery projects, and is cited on many patents and publications including research areas such as prostaglandin agonists, histamine H2, opioids, angiotensin II and CCR3 receptor antagonists. He has been pivotal numerous lead generation projects gaining a unique insight into project and compound tractability. He has extensive outsourcing experience including projects to enhance screening collections, where he engaged with external partners to design, and synthesise appropriate compounds in a cost effective and timely manner. Duncan has recently published and presented on Open Innovation in Drug Discovery for which he is a strong advocate. He was a founder member of the DiscoverAssist™ Panel at the Stevenage Bioscience Catalyst.

Duncan formed his consultancy company (Awridian Ltd) in 2012, and is currently working with a range of international companies and UK academics.

With over 30 years of clinical development experience within the pharmaceutical industry, Keith started his clinical research career working in the Clinical Pharmacology Unit of G D Searle in 1983, before moving on to manage European Phase II and III studies with G D Searle in gastroenterology.  In the late 1980’s Keith moved to Schering Plough as a Medical Research Associate in oncology and respiratory diseases.  Following a brief period at Amersham International, he joined Amgen in 1990 with responsibility for European Clinical Development in haematology/oncology from Phase I through to licensing.  Keith joined Roche in 2003 as Operations Project Leader where he planned, staffed and directed global clinical operations in haematology/oncology and rheumatoid arthritis, and then joined CeNeS, a small virtual pharma company, in 2005 to work in the CNS area.  PAION UK Ltd took over CeNeS in 2008, where he remained as Director of Clinical Operations, based in Cambridge, UK.  Keith left PAION earlier this year and currently works as a Freelance Consultant.

Steve joined Takeda in the UK as a Director of Clinical Science in the general medicine group. In this role he is responsible for pulling together development plans for products covering a diverse range of indications and leading the clinical development teams that execute these plans. Prior to joining Takeda, Steve spent a number of years working on challenging drug development projects in Zurich Switzerland and Amsterdam in the Netherlands. Whilst in Zurich, Steve was the Director for Global Project Management for the biosimilars development group at Mylan responsible for project and program management of a portfolio of eight biosimilar products.   In Amsterdam,  Steve was head of clinical operations at Amsterdam Molecular Therapeutics (now UniQure) designing and managing the execution of the pivotal study that led to the approval of Glybera, the Western Worlds first gene therapy product.

Christopher Hill retired last year from Merck, where he was VP and Head of Discovery Chemistry.  Earlier previous  responsibilities  included  Global  Chemistry  Head  and  Site  Head  of  Rahway  in  October  2011.  He  was  site  head  for  Merck  Research  Laboratories,  Kenilworth  in  March  2011.  Previous  responsibilities  include  site  head  at  Boston  (2010  -2011)  and  site  head  at  Schering-Plough's  Newhouse,  Scotland,  facility  (2007-2010).  Prior  to  joining  Schering-Plough,  Chris  was  senior  vice  president  and  site  director  for  Organon  Research  where  he  was  responsible  for  shaping  and  transforming  research  operations  there  toward  a  therapeutic  focus  on  neuroscience,  improving  lead  finding  operations  and  implementing  a  translational,  proof-of-concept approach to ensure better informed decisions in research and development.

Earlier  roles  included  executive  director  of  Medicinal  Chemistry  at  Organon  and  director  of Chemistry at Roche. Chris received his BSc in chemistry from the University of Manchester and his PhD from the University of Manchester Institute of Science and Technology. He undertook postdoctoral  research  in  synthetic  methodology  at  the  CNRS,  Gif-sur-Yvette,  France  before  joining the medicinal chemistry department at Roche in 1985.

Martin  has twenty eight years’ experience in CMC development spanning early phase product and process development through to commercial manufacturing having worked for RPP, Aventis, Innovata Biomed, Shire and currently as Director of Product and Deceive development at Mundiphatma Research based in Cambridge.

He leads the development of the Germany based internal CMC development group along with externally partnered programs covering all aspects of product and process development for APIs, drug products and medical devices.

Prior to joining Mundipharma Martin was Senior Director of Product Development at Shire Pharmaceuticals responsible for the ADHD portfolio for a number of years, spending 4 years working out of the USA office and leading the initial development program into ophthalmology, prior to his time at Shire he spent 15 years working on inhalation products within Innovata Biomed and Aventis.

Garry Pairaudeau is currently Head of External Sciences at AstraZeneca with responsibility for Open Innovation, external collaborations in the chemistry and hit identification areas and discovery chemistry outsourcing.  He obtained his PhD in chemistry from the University of Southampton in 1991, followed by post-doctoral work at UC Irvine California.  He joined AstraZeneca in 1994 as a medicinal chemist and was part of the medicinal chemistry team that discovered Brilinta . He has experience leading projects through all phases of Drug Discovery contributing to multiple clinical candidates in the respiratory inflammation and CV areas. He has a long standing interest in lead generation, hit identification and diversity screening.  Prior to taking up his current position in 2012 he was Director of Chemistry for the cardiovascular group at Alderley Park.

Vicky joined Selcia in 2008 as a senior scientist and was promoted less than a year later to group leader where she managed and led key client discovery projects. She was promoted to Associate Director Discovery in 2013 and to Director, Discovery in 2015.

 Vicky brings to Selcia significant big pharma experience having previously worked in senior scientific roles at GlaxoSmithKline (2005 – 2008) and Merck Sharp and Dohme (2002 – 2005). This was preceded by a two year placement in the USA as a Royal Society Fulbright Postdoctoral Fellow.

Her main areas of therapeutic interest and experience include anti-viral macrolides (Hepatitis C), anti-bacterials (MRSA), anti-inflammatory macrocyclic natural products, and kinase inhibitors and gamma-secretase modulators (both for Alzheimer’s disease). She is named on over 20 peer reviewed papers and patents.

Vicky has a BSc in chemistry from Imperial College and a PhD in organic chemistry from the University of Cambridge. She is a member of the Royal Society of Chemistry and has served on the SCI’s Fine Chemicals Group Committee.

David gained his PhD in synthetic organic chemistry under the guidance of Dr Stuart Warren (Cambridge). This was followed by postdoctoral fellowships with Prof. Peter Kündig (Geneva) and Prof. Tim Donohoe (Manchester/Oxford) before joining GSK’s Medicines Research Centre in Stevenage as a medicinal chemist in 2003. Within GSK, David has worked in the Respiratory and Inflammation therapy areas and during this time he has led integrated teams of scientists working on discovery programs spanning target identification through to clinical candidate selection. His areas of expertise include nuclear receptors, ion channels, kinases and phenotypic screening. 

Recently David has taken on the role of Chemistry Scientific Officer within the Crick/GSK Biomedical LinkLabs; this is a innovative new partnership which draws upon the complementary skills and capabilities of researchers in the Francis Crick Institute and GSK to address compelling biological problems of relevance to human disease.