<p>Biotech Outsourcing Strategies 2015</p>

Attending Biotech and Pharma

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Speaker Profiles - Discovery/Early Development Track

Dr Garry Pairaudeau, Head of External Sciences,
AstraZeneca
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Garry Pairaudeauis 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.

Read Abstract...

Confirmed presentation title:  "Key components in successful discovery outsourcing"

Externalisation is a well proven strategy for big pharmaceutical companies to create flexibility and support internal research activities in a more dynamic way.  During the last three years AstraZeneca has transformed the way it externalises chemistry and screening activities. This presentation will review these changes focussing on the challenges we overcame and highlighting  key elements that have enabled a sustainable and successful new organisational model.

Dr Stuart McElroy, Head of Biology,
European Screening Centre
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Stuart McElroy took up the position of Head of Biology at the European Screening Centre (ESC) in Newhouse in 2013.  Focussed on hit/lead discovery, the ESC forms part of the European Lead Factory, a novel platform for innovative drug discovery aimed at bridging the gap between large Pharma and Europe’s academics and SMEs.  Stuart gained his degree in Pharmacology at the University of Edinburgh followed by a PhD from the University of Strathclyde before helping to establish the Dundee Drug Discovery Unit (DDU) in 2006, a small biotech style integrated drug discovery group based within Dundee University.  Initially focussed on neglected tropical diseases, Stuart worked on early stage drug discovery projects across a wide variety of target classes before becoming a team leader in 2010.  He went on to help establish the non-tropical disease portfolio within the DDU where he led the DDU discovery biology in partnerships with both large pharma and SMEs prior to taking up his current role.

Read Abstract...

Confirmed presentation title: "European Lead Factory – creating new opportunities for drug discovery". 

The Innovative Medicines Initiative (IMI) European Lead Factory (www.europeanleadfactory.eu) is a major European project established with the aim of generating new lead structures for drug discovery projects in the public and private sectors.  A Joint European Compound Library (JECL) has been established1 by combining selections of approximately 300,000 compounds from participating pharma companies together with new compounds specifically prepared for this project.

Screening of the library and follow-up of resulting hits is carried out at the European Screening Centre based in Scotland and The Netherlands utilising state-of-the-art robotics for compound logistics and uHTS.  Expert triaging and further characterisation of hits including medicinal chemistry is available to public programs (academic and SME based). The output is high quality hits that represent excellent starting points for drug discovery programs or tools for investigating and validating novel pharmacological approaches with the ultimate aim of creating benefit for patients.2

This talk will explain the background and current status of this project as well as presenting some recent results.  In addition, opportunities to participate will be described.

References
1. The Joint European Compound Library: boosting precompetitive research; J. Besnard  et al; Drug Discovery Today; 20, 181, 2015.
2. www.efmc.info/medchemwatch-2014-1/lab.php

Dr Stefan Jaroch, Head ofExternal Innovation,
Bayer Pharma AG
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Stefan Jaroch studied chemistry at the University of Bonn and obtained his PhD from the Ludwig Maximilians-Universität, Munich, in 1993. After a postdoc at the University of California, Irvine, he joined Schering AG and worked as medicinal chemist from 1995-2000 in Berlin and from 2000-2001 at the US subsidiary Berlex Biosciences in Richmond, CA. From 2001-2007, he was director in the medicinal chemistry department in Berlin, and from 2007-2010 in the medicinal chemistry department of Bayer Schering Pharma in Wuppertal. In his 15 years of pharma research experience his main interests were in the areas of anti-inflammation and oncology research. He holds an honorary professorship at the chemistry department of the Philipps-Universität Marburg since 2008.

Since 2010, he focuses on collaborations with partners from academia, research institutes, pharmas, biotechs, and CROs. As Head of External Innovation Technologies he is responsible for partnering activities referring to early drug discovery assets, technologies, and services, also including open innovation approaches. 

Dr Janet Fernihough, Director,
Inspoda Ltd
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Janet is the director and founder of Inspoda, delivering inspired business solutions with passion to companies in the life sciences industry.

Her experience in this sector started with a PhD from Bristol University in arthritis research, followed by working in Switzerland and Germany for a small start-up to determine and patent a novel drug mechanism of action for rheumatoid arthritis. At Oxford University Janet then developed high throughput assays of utrophin upregulation for a muscular dystrophy research programme. This work was also ultimately spun out to form Summit PLC who now have a utrophin upregulating drug in the clinic.

Moving out of academia, Janet joined Novartis Pharmaceuticals, where she developed and published a novel model of osteoarthritic joint pain, before taking on a senior role at a not-for-profit independent research organisation (SBL UK c.i.c.). Here, she managed all national and international collaborations, particularly with the Centre for Molecular Immunology in Havana, Cuba and was responsible for establishing a melanoma clinical trial with a leading clinician at a London hospital.

In her most recent post at Vertex Pharmaceuticals, Janet was a senior programme manager for multiple oncology and neurology projects; contributing to a first-in-class oncology drug reaching phase I clinical trial.  

Graduating with an executive MBA in 2014, Janet now combines her exceptional scientific skills with strategic, commercial awareness. As the director of Inspoda, she retains her passion and problem solving skills for the life sciences sector, and employs her considerable tenacity, energy, mentoring and communication skills for a wide variety of clients. In her spare time she mentors for Mass Challenge and is a volunteer consultant for the Grow Movement, helping a Ugandan entrepreneur to grow her business.

Read Abstract...

Confirmed presentation title: "Managing external partnerships to drive internal innovation"


Drug research and development is expensive, exceeding $1 billion on average for each drug that reaches the market. In an attempt to reduce costs and increase the chances of success, companies are increasingly using outsourced partners. Compared to other industries, relationships between buyers and suppliers in the pharmaceutical sector are still relatively immature. However, when managed well, these external relationships can bring many performance benefits. This presentation of a study of relationships between buyers and suppliers in the pre-clinical research phase, describes those features of the relationship that contribute directly to the generation of innovation. When viewed as a process, the relationship shows significant similarity with the process of knowledge creation and can, therefore, contribute to a company's competitive strategic advantage. However, several factors outweigh this advantage: the power imbalance between buyer and supplier; continued focus on the trade off of cost, quality and speed and outsourcing with the goal of managing mundane tasks with little or no sharing of confidential information. Recommendations are suggested to manage external supplier relationships better to drive internal innovation for drug R&D.

Dr Darcey Black, Director,
TherapeutAix
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Formerly, Head, External Innovation in the Innovative Medicines Unit, Grünenthal Innovation, Aachen, DE. He has over 30 years’ experience in pre- and early clinical drug discovery working in all aspects from target ID and validation, LO and translational studies in early clinical development, in several therapeutic areas. Prior to joining Grünenthal, he worked for Merck (formerly Organon/Schering-Plough) in senior project and line management roles, and previously at Pfizer, UK and Glaxo (now GSK) in the UK and Switzerland.

Peter Murray, Consultant and Former Quality Director,
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Peter Murray is consultant and a former Quality Director at GSK, with 45 years’ experience of management of Primary and Secondary Pharmaceutical Manufacture. The experience is primarily in development and consistent routine implementation of effective strategies for Quality Assurance and GMP compliance management.

From 1990 onwards, this experience involved a high proportion of international work as part of GSK’s Corporate Quality Oversight group, with an emphasis on 3rd Party Contract Manufacturer management as the Quality Director attached to a specialist External Supply procurement team.

He is registered as an Eligible Qualified Person and is a member of the MC2 British Pharmacopoeia expert advisory committee.

Read Abstract...

Confirmed presentation title:  "Effective quality management - strategies, organisation and systems required for outsourced pharmaceutical development"

When a sponsor decides to outsource pharmaceutical development or manufacturing activities, only the activity can be outsourced. The regulated nature of the pharmaceutical industry means the Sponsor retains accountability for all aspects of the outsourced activity – particularly accountability for ensuring Quality related systems, data and monitoring necessary to be able to demonstrate the outsourced activity output consistently meet the required standards of patent safety, efficacy and regulatory compliance.

This presentation explores some of the quality related activities which are necessary to ensure the output from an outsourced activity both meets immediate need and will provide the necessary support to enable timely, effective progression of a product through development to a licensed, commercialised product.

Dr Richard Dennett, Director, Regulatory CMC,
Voisin Consulting Life Sciences
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Dr Richard Dennett is responsible for the management of projects involving the development of Chemistry Manufacturing and Control (CMC).

He provides scientific, technical and regulatory expertise for the following activities:

    Quality by Design (QbD), Technology Transfer/Comparability, cGMP compliance/validation, Technical due diligence and gap analysis, identification and project management of outsource cGMP contract manufacture
    Preparation and review of regulatory documentation (CMC sections of IND and IMPD for clinical trials applications and MAA, BLA/IND Module 3 and 2.3 submissions).

Richard brings over 20 years' applied industrial and commercial biopharmaceutical experience to his role, with a previous 8 years in cGMP Biopharmaceutical Contract Development and Manufacture; acquiring in depth knowledge across a broad range of biopharmaceutical technologies and product types including recombinant vaccines, gene therapies, (stem) cell-based therapies, monoclonal antibodies and biosimilars.

Richard has worked on a number international projects involving successful ‘start to finish’ recombinant drug product development, cGMP manufacture and market approval. Richard has significant experience with cGMP facility design and realization; including interfacing project management for the construction and validation of a €30M, UK Government funded ‘National Biomanufacturing Centre’, Liverpool, UK (now a biologics subsidiary of Actavis Plc.).  He has additional expertise in technology transfer of intellectual property and the commercialization of new start-up companies and therefore readily understands the challenges for emerging biotech and early stage biopharmaceutical development.

Richard has held key role positions at companies which include Eden Biodesign, Celltech Medeva, Automation Partnership, Sheffield University, AstraZeneca.

With a PhD research grounding in applied biochemistry, obtained at Liverpool John Moores University (UK), matched with his industrial technical background, Richard is able to provide cross matched technical and regulatory expertise; being able to readily understand and translate the needs of the client to deliver focused and successful projects.

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Presentation title:  "Building a CMC package to meet regulatory requirements at IMPD - key learnings when interacting with regulatory agencies"

Christian Jones, Commercial Director,
Johnson Matthey
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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.

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Confirmed presentation title:  "Aligning custom research and development organisations to the needs of biotech and pharma"

Doreen Coull, Regional Sales Director,
Albany Molecular Research Inc
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Doreen Coull MBA has worked within CMOs and CROs for over 20 years.
 
Prior to working at Albany Molecular Research Inc (AMRI), Doreen had operational and business development roles at SCM Pharma, and worked over 10 years in an operational role at Covance Clinical Research Unit, focussing on Phase 1 & 2 Clinical Trials.
 
Doreen joined Aptuit Glasgow in June 2014, and AMRI acquired Aptuit Glasgow in January 2015.  
AMRI Global offer Drug Discovery & Development Services;  API manufacturing and Drug Product manufacturing.  

Doreen has a business development role offering the Glasgow site services.  The site specialise in Formulation Development & scale-up; Lyophilisation and Drug Product GMP Manufacturing for large and small molecules.


 

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Confirmed presentation title:  "Planning ahead……  -  formulation development and scale-up"

 

Speaker Profiles - Clinical Track

Lidia Cappellina, Head of Outsourcing Management,
Chiesi Corporate R&D
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Lidia is the Head of Outsourcing Management for Chiesi Corporate R&D. She has 23 years’ experience in the pharmaceutical industry, started in 1992 in GSK Italy where she covered the role of Head of Licensing and License Management Department  and subsequently she become the Head of Procurement. She moved in Astra Zeneca Italy in 2003 with the role of Strategic Business Development & Planning Director, and joined Chiesi with the current role in 2009. Lidia has an extensive business development, commercial and procurement / outsourcing areas experience, with in-depth knowledge of large and medium pharma commercial and R&D processes and needs, and consolidated skills in outsourcing and business development strategies, asset evaluation & prioritisation, deal making, alliance management, P&L optimisation processes, at affiliate and corporate level.

Roger Joby, Managing Director,
1to1to1 Ltd
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An international project management consultant and educator in Project Management, with over 40 years experience in the pharmaceutical sector. Roger has worked for both Pharmaceutical companies in project management and outsourcing, and in CROs as head of clinical operations and in a number of senior positions in contracts and proposal departments.

Roger has also taken an active role in project management research collaborating with Professor David Bryde Liverpool JM University as well as being an active member of the planning and project control special interest group of the Association for Project Management(APM).

Over the last decade Roger has worked with a number of sponsor and supplier companies including MedImmune, AstraZenica, Boehringer Ingelheim, NovoNordisk, Solvay, Misubushi, Ono Pharma, Quintiles, Harrisons, CroMedica, and Bio Products Laboratory.

Read Abstract...

Presentation title:  "Utilising agile project management theory in outsourced clinical research"

Dr Matt Cooper, Business Development and Marketing Director,
NIHR Clinical Research Network
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The National Institute for Health Research Clinical Research Network is the research delivery arm of the NHS.  It invests some £300m each year into an infrastructure of specially-trained clinical research nurses and other clinical professionals across England, to support rapid study set-up and patient identification/recruitment into clinical research studies.  In recent years, the Network has placed a particular focus on its support for the commercial life-sciences industry, which has resulted in year-on-year improvements in patient recruitment numbers for industry studies.

Dr Matt Cooper was recently appointed as the organisation's Business Development & Marketing Director.  He brings a wealth of experience to the post, having been part of the Network structure for many years.  In his previous role he was a member of the leadership team for the Network’s Cancer Specialty, (previously known as the NIHR Cancer Research Network), where he helped to improve patient recruitment to the extent that one in five patients diagnosed with cancer now participate in clinical research – a figure without compare in any other country.  He was also influential in developing alliances between industry and academic researchers to explore innovative uses for new compounds – an initiative he hopes to extend into new therapy areas in his new role.

Further background:
Matt gained a PhD in molecular virology (1997) and conducted post doctoral research with the Molecular Medicine Unit at St James’s Hospital, Leeds. He joined AstraZeneca UK as a Clinical Research Scientist and then Study Manager in their Clinical Studies Group and over the next 5 years conducted phase II and III studies in a variety of therapy areas.

In 2003 he came back to academia first in a Clinical Trials Unit at Bradford Teaching Hospitals NHS Foundation Trust, and later a Musculoskeletal Disease trials group at the Leeds Institute of Molecular Medicine. He joined the NIHR Cancer Research Network (now known as the Cancer Specialty within the NIHR Clinical Research Network) in December 2006 as Principal Fellow for Clinical Trials and was responsible for the programme of work liaising with the Pharmaceutical Industry to adopt commercial research into the national portfolio of trials. Matt was appointed Assistant Director in 2009. Matt was appointed as NIHR Clinical Research Network Life-Sciences Development Director at the NIHR CRN Coordinating Centre in June 2014. Following the networks successful retender and restructure in April 2015 Matt was appointed to his current role -  Business Development and Marketing Director.

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Confirmed presentation title: "Expediting clinical research in the UK - case studies from the NIHR clinical research network"

Ronald Openshaw, CEO,
Simbec-Orion
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Ronald was appointed CEO of Simbec-Orion upon completion of the merger of Simbec Research and Orion Clinical Services in 2014.

Ronald is a partner in Lucia Capital LLP a strategic advisory firm which he founded in 2008.  Previously he was CEO of Plethora Solutions Holdings PLC, a urology and sexual health specialty pharmaceutical company, which he led during its successful reacquisition of its lead drug PSD502 and its approval by the EMA. Ronald was CEO of Pharmagene plc / Asterand plc where he lead it through a successful merger and refocusing of the business.

Ronald spent a significant period of his career as a senior investment banker in the healthcare and life sciences sector with each of Jefferies and earlier Panmure Gordon.

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Confirmed presentation title:  "Clinical case studies: “The good, the bad, and the ugly""

Dr Kirsty Wydenbach, Medical Assessor - Clinical Trials Unit,
MHRA
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Having qualified in medicine from Imperial College (University of London) I went on to complete 7 years in Anaesthesia and Intensive Care, working at hospitals across London and the South East of England. On leaving the NHS I joined BOC (a member of the Linde Group) in 2007 as part of their UK based clinical team, working specifically within the medical gases and healthcare sector. The role included experience in multiple areas, from medical education and stakeholder advice, to clinical trials and internal European regulatory affairs.

I joined the MHRA in February 2009 as a Medical Assessor in the Clinical Trials Unit, and have been specifically involved in the UK regulation of clinical trials across all therapy areas and all phases of development. This has included trials for both chemical and biological products, Advanced Therapy Products, many first-in-man studies, and in a diverse arena of therapy areas. I have also been involved in European discussions aiming to establish an EU harmonised approach to decisions regarding clinical trials, particularly for Developmental Safety Update Reports (DSURs) and also including Voluntary Harmonised Procedure (VHP) applications. More recent EU priorities have included the new Clinical Trial Regulation and I currently sit on the safety subgroup of the Clinical Trials Facilitation Group (CTFG) that is working on how this will be implemented in 2016.

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Confirmed presentation title:  "Regulatory developments to support clinical innovation in Europe"

Clinical trials in the UK are currently conducted under the remit of Directive 2001/20/EC, put in place to protect the health and safety of clinical trial participants, to ensure reliability and robustness of data generated in clinical trials and to simplify and harmonise the administrative provisions governing clinical trials in order to allow for cost-efficient clinical research.

But has it met these objectives? Applications for clinical trials fell by 25% from 2007 to 2011, costs increased, the average delay for initiating a CTA has increased and there has been a failure to harmonise requirements across the EU. The Voluntary Harmonisation Procedure (VHP) has in part addressed the latter point but the Directive is arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals.

So what is next? In December 2008 the Commission announced that an assessment would be made of the application of the Clinical Trials Directive. Almost 6 years later new legislation has come into force, Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

This talk will provide a review of the new legislation and how this may impact future clinical trials and innovation in clinical research.

 

Dr Mohammad Charki, Partnerships Director, Open Innovation Strategy, Scouting & Partnerships,
Sanofi
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Mohammed Charki has an Emergency Care MD background. He has practiced in various settings comprising private and public sectors with a particular focus on transversal project management, which led him to work in the field of coordinated healthcare circuits.

Following a first sales experience in the Pharma industry, Mohammed has decided to integrate ESCP Europe where he obtained the degree of Specialized Master in Medical Management acquiring skills in Marketing, Business Development and Finance. In parallel, he has enriched his experience by chairing the Caduceus of Medical Communication, a French association focused on the pharmaceutical industry, and he has also co-founded a start-up in the field of Innovative Communication.

Finally Mohammed Charki has joined Sanofi as a project manager on a telemonitoring and decision support program in Diabetes and then as cardiovascular Portfolio Medical Manager for Europe and Canada with a focus on patients’ centred services based on new technologies. His passion for innovation has led him to join Sanofi R&D as Partnerships Director since he’s always been convinced that healthcare industries needed to establish strategic alliances and partnerships with industries from different horizons (Bioconvergence) to answer patients and growing populations needs; therefore he’s been a strong advocate of Open Innovation within the group and beyond in the life science industry.

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Confirmed presentation title:  "The rise of a resurgent industry"

Paul Quinn, Director, Clinical Operations,
Vectura
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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.

Read Abstract...

Confirmed presentation title:  "Exploring the benefits of outsourcing to niche, specialist, clinical CROs versus the full service approach"

During our presentation we present an analysis of the Outsourcing Process, drivers for change and CRO Outsourcing Strategy challenges at Vectura.

We will then look at the new outsourcing strategy options and objectives, the standardised Bid and Assessment Process and scoring matrix pilot and implementation.

To finish we will look at considerations for future enhancements, and summarise the takeaway points.

Liz Eagling-Vose, Associate Director, Clinical Studies,
Vectura
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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. Worked within both CRO and Pharma industry, including AstraZeneca, and Parexel.  Clinical  experience includes study management, site monitoring/management, medical writing, data management, ethics and regulatory applications.   BSc (Hons) biology with analytical science, presently studying for MBA.

Read Abstract...

Confirmed presentation title:  "Exploring the benefits of outsourcing to niche, specialist, clinical CROs versus the full service approach"

During our presentation we present an analysis of the Outsourcing Process, drivers for change and CRO Outsourcing Strategy challenges at Vectura.

We will then look at the new outsourcing strategy options and objectives, the standardised Bid and Assessment Process and scoring matrix pilot and implementation.

To finish we will look at considerations for future enhancements, and summarise the takeaway points.

John Faulkes, Consultant,
PPMLD
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John has worked fo 20 years as a consultant focusing on leadership, team effectiveness, change management and partnership working. He began his career as a scientist in a diagnostics company, and still works for  many lifescience clients, big pharma, small biotech and public sector.

In the last 5 years John has focused particularly on relationship building and relationship skills development, developing clients' alliance management and CRO outsourcing capabilities. He has published articles, particularly around overcoming problems in CRO outsourcing, in the Journal of Clinical Studies and other publications. He has spoken and led workshops at Partnerships in Clinical Trials, the DIA annual meetings and One Nucleus forums.

John is on the Exec committee of the Pharmaceutical Industry Project Management Group (PIPMG), and helps to organise regular networking meetings in the UK and mainland Europe. He is also a founder member of a new association, The Collaboration Project, which seeks to build an open network for alliance managers, outsourcing managers, project managers and others involved in partnership working.

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Confirmed joint presentation title:  "Why most CRO partnerships don't deliver - and what you can do to make sure yours does"

David Davies, Managing Director,
David Davies Pharma Consulting
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David has twenty seven years’ experience within global contract clinical research organisations (Pharmaco, PPD,Clintrials) and pharma companies (Glaxo Group, David has twenty seven years’ experience within global contract clinical research organisations (Pharmaco, PPD,Clintrials) and pharma companies (Glaxo Group, Wellcome Foundation, Zambon, Futura Medical). Previously CDO and Board Director of a virtual pharmaceutical development company, where he was responsible for all product development activities. An expert in building and maintaining high performance development teams, project management, implementation of quality management systems and governance (corporate and regulatory), he now runs his own consultancy in pharmaceutical and medical device product development.

David has presented/chaired many events, notably speaking on performance metrics and outsourcing in a virtual company.  He is constantly inspired by the ongoing challenge of delivering outsourced clinical trials on time, on budget and to quality standards.  What could possibly go wrong?

David is also a Director of the not-for-profit Pharmaceutical Contract Management Group Ltd. (www.pcmg.org.uk) and a Director of the charity O2e Ltd. (www.O2e.org).  

Read Abstract...

Confirmed joint presentation title:  "Why most CRO partnerships don't deliver - and what you can do to make sure yours does"

Speaker Profiles - Session Chair

Dr Brian Cox, Professor of Pharmaceutical Chemistry,
University of Sussex
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Brian has had a highly successful career in drug discovery in industry with GSK and Novartis.  Brian has a BSc in Pharmacy and PhD from the University of Manchester where he worked on novel antifungal agents. This was followed by Post Doctoral study at the University looking at novel opioid-like analgesics, then a two-year industrial Post Doctoral position at Schering Plough in New Jersey focussed on the total synthesis of the marine natural products Pseudopterosins.

Brian then spent 12 years at Glaxo/GlaxoWellcome/GSK working in many different disease areas (CNS, respiratory, cardiovascular, GI and antibacterials). Moving to Novartis (Horsham) in 2002 he became Head of Chemistry with the site specialising in respiratory and GI research, as well as acting as an expertise hub for automated synthesis for the Novartis chemistry organisation (Global Discovery Chemistry). He developed a keen interest in the modulation of ion channels as a target class and the design of inhaled medicines, which he is now a recognised expert in.

Brian moved to the University of Sussex (November 2014), where he is now Professor of Pharmaceutical Chemistry growing a medicinal chemistry platform underpinned by extensive automated synthesis capability. His group’s focus is the application of high throughput automated synthesis in hit and lead optimisation and the synthesis of novel archive diversity enhancement libraries.

He is a Fellow of the Royal Pharmaceutical Society of Great Britain and registered pharmacist, Fellow of the Royal Society of Chemistry, chartered Chemist and chartered scientist. He is an elected member of the Royal Society of Chemistry’s Chemistry Biology interface division Board and the organic and Medicinal Chemistry Sector committee. He is associated with a number of marketed compounds and multiple late stage clinical candidates and is a champion of diversity and inclusion (D&I).

Miriam McCloskey, Pharma External Sourcing Specialist,
Perceptive Partnering
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An experienced pharmaceutical external manufacturing leader who believes that perceptive partnering is a critical skill and has developed partnering methodologies to aid success of virtual and CMO organizations. With over 20+ years of proven success at Eli Lilly & Co in the manufacturing, supply and distribution of medicines and drug devices, Miriam has used her knowledge and experience to improve the overall business of partnering. Miriam recently led the External manufacturing drug product business at Lilly, responsible for identifying and implementing the manufacturing of new and existing products at more than 20 CMOs in Europe, Africa and Asia.

Dr Stephen Greentree, Director, Clinical Sciences,
Takeda Pharma Europe Ltd
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Steve recently 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.

Duncan Judd, Discovery Science Consultant,
Awridian Ltd
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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.

Dr Joan Herbert, Director Business Development,
Medicinces for Malaria Venture
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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 PhD in Immunology from the University of London and a BSc 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.

Speaker Profiles - Plenary

Dr David Andrews, Associate Director, Oncology Chemistry,
AstraZeneca
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Dr David Andrews, (BPharm, PhD, GPhC, MRPharmS, FRSC) trained as a pharmacist at Nottingham University and then undertook PhD research in organic synthesis at Liverpool University. From 1990-2003, he held positions of increasing seniority in medicinal chemistry at GlaxoSmithKline. Since 2003, he has worked as an Associate Director in the Oncology iMed Chemistry Department of AstraZeneca where he led projects delivering the development candidates AZD4547 and AZD9496. He currently heads AstraZeneca's Oncology early-stage chemistry collaboration and Open Innovation efforts alongside a secondment as an Industry Associate at the RSC, leading the National Compound Collection Open Innovation initiative.

Read Abstract...

Confirmed presentation title:  "Compound passport"

Abstract: 
More early discovery collaborative agreements are being put in place between large pharma companies and partners in which the rights for assets may reside with a partner, exclusively or jointly.  Our corporate screening collection, like many others was built on the premise that compounds generated in-house and not the subject of paper or patent disclosure were proprietary to the company.  Collaborative screening arrangements and medicinal chemistry now make the origin, ownership rights and usage of compounds difficult to determine and manage.  The Compound Passport Service is a dynamic database, managed and accessed through a set of reusable services that borrows from social media concepts to allow sample owners to take control of their samples in a much more active way.

Dr David Clark, Director of Computer-aided Drug Design,
Discovery Services, Charles River
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Dr David E. Clark is Director of Computer-aided Drug Design (CADD) and Information Services at Argenta Discovery, of which he was a founding scientific team member in August 2000. David began his career working for Proteus Molecular Design for three years where he was involved in developing software for de novo ligand design and protein-ligand docking. He then spent four years working in the CADD group of Aventis/Rhone-Poulenc Rorer before joining Argenta. David is a graduate of the University of Oxford where he studied chemistry. His post-graduate studies (MSc, PhD) were carried out at the Department of Information Studies at University of Sheffield under the supervision of Professor Peter Willett.

In 2003, David was the recipient of the Corwin Hansch award, which is presented annually by the QSAR and Modelling Society.

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Confirmed presentation title:  "Drug discovery grant applications: success through collaboration"

This brief presentation will provide an overview of the main grants available for funding for drug discovery research, focusing on the UK and Europe in particular. The benefits of working with a CRO on such grant applications will be summarised together with the collaboration model employed at Charles River. Finally, a case study will be presented highlighting an academic-CRO collaboration that ran successfully from grant application to pre-clinical candidate nomination.

Dr Peter Atkinson, Senior Manager - Open Innovation,
Eisai Ltd
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Peter contributes to the strategic direction and management of external collaborations and consortia to enable target validation and lead generation within the Neuroscience and General Medicine Product Creation Unit, Eisai  This builds upon over 15 years working as a pharmacologist in neuroscience drug discovery for Wyeth (USA) and GlaxoSmithKline (UK).  During this time Peter led preclinical neuroscience programs working extensively with global, multidisciplinary project teams.

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Confirmed presentation title:  "An open innovation approach to neuroscience target validation"

Dr Chris Watkins, Head of Knowledge Exchange ,
The Francis Crick Institute
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Chris Watkins, Director Translational Research and Industry at the Medical Research Council, with 16 years of research strategy and management experience at MRC Head Office. He has led the development and implementation of MRC’s translational research strategy from its inception. Chris has been responsible for numerous MRC translational funding initiatives including the Developmental Pathway Funding Scheme, Confidence in Concept, the MRC/Innovate UK Biomedical Catalyst, and the Industry Engagement Fund. In addition, he has led a number of innovative industry partnership initiatives including: the MRC/Industry compound access initiative with seven major biopharmaceutical companies; the MRC/AstraZeneca Centre for Lead Discovery; and the MRC/UCB antibody discovery platform. In addition, Chris leads on Knowledge Transfer and Exchange for MRC, including assessing the plans and outputs of MRC’s Institutes and Units. He is a member of the EPSRC Healthcare Advisory Team, the STFC Healthcare Focus Group and Grand Challenges Panel, and the cross-Research Council group on impact.

After undergraduate and postgraduate studies in Biochemistry at Imperial College, Chris undertook post-doctoral research at the Royal Free Hospital and then at the MRC’s National Institute for Medical Research. He has been engaged in research management at MRC Head Office since 1999, with previous roles including responsibility for the MRC’s clinical trials portfolio, the MRC’s Health Services and Public Health Research Board, before leading its Translational Research and Industry activities since 2008.

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Confirmed presentation title:  "The Francis Crick Institute – discovery without boundaries"

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