Speaker Profiles - Clinical Track

Dr 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.

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Confirmed presentation title:  "Implementation of a new outsourcing strategy:  successes and challenges"

Anthony Fuller, Global Head of Sourcing,
Mitsubishi Tanabe
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Anthony Fuller is Global Head of Sourcing at Mitsubishi Tanabe, a Japanese pharmaceutical company.  He is based at their New Jersey office.  Prior to joining Mitsubishi, Anthony worked at Eli Lilly and Bristol-Myers Squibb, following some years spent on the supplier side.

In his tenure with Mitsubishi, Anthony has developed what was a largely administrative vendor management department into a strategic function supporting end to end sourcing activities.  He re-organized the US team on a category basis and focused their work on high-touch, high value projects.  More recently, Anthony was asked to create a global Sourcing function for Mitsubishi, aligning people and processes worldwide.

Anthony is recognized as a strong line manager who invests heavily in coaching as well as supporting more formal training to develop his team.  He himself is a graduate of the Universities of Oxford, Sheffield and Northumbria, with postgraduate studies in business, politics and commercial law.  He holds Six Sigma Greenbelt certification, CPSM from the Institute for Supply Management, and MCIPS.  He lives near Princeton with his wife and two children.

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Confirmed presentation title:  "Evaluating sourcing models: costs, benefits, risks and rewards"

Dr Sandra Hirschberg, Project Leader, Centre for Drug Development,
Cancer Research UK
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Sandra leads cross functional teams to develop cutting edge drugs to contribute to Cancer Research UK’s vision “to bring forward the day when all cancers are cured”. To contribute to this goal Sandra leads science-based decision making and accelerated development of drugs from the early exploratory phase through to phase II clinical trials, with extensive collaboration with commercial and academic partners.

Sandra graduated from the University of Edinburgh and has a PhD in Immunology from Imperial College. She has more than 16 years experience in drug development and prior to her current role spent several years as a project manager within the pharma industry.

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Confirmed presentation title:  New models of collaborative research: a case study of the transfer of a live clinical trial to new sponsors and stakeholders

Abstract:  The ambition of Cancer Research UK is to accelerate progress, so that within the next 20 years three out of four patients will survive cancer. The Centre for Drug Development at Cancer Research UK contributes to this target by developing novel drugs, and its work is underpinned by its effective collaborative relationships with academia and industry.  An example of this collaboration with Sierra Oncology, a clinical stage drug development company advancing next generation DNA Damage Response therapeutics for the treatment of patients with cancer. Cancer Research UK successfully transferred the asset SRA737 to Sierra Oncology while clinical trials were ongoing.  This was done with a view to providing the drug with the highest chance of success and therefore the best opportunity to benefit patients.

Dr Robert Miller, Chief Medical Officer and Managing Partner,
Artemida Pharma Limited
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Robert Miller is the Chief Medical Officer and Managing Partner of Artemida Pharma Limited a drug development consultancy providing medical input into the strategy and design of development programmes in multiple indications and works with a number of companies providing medical advice.

Dr Miller trained as a cardiac surgeon and joined the pharmaceutical industry as a medical adviser with ICI in 1988. He moved into the international division in 1990 taking responsibility for the global development of products in three therapeutic areas including cardiovascular and intensive care. In 1996, he joined Protodigm Limited, the virtual company set up by Roche, as a founder member and was Director of Clinical Development and was a founder and Chief Medical Officer of Fulcrum Pharma PLC an independent product development consultancy.

Dr Miller is a Fellow of the Royal College of Surgeons, The Royal Society of Medicine, and is a Fellow of the Faculty of Pharmaceutical Medicine. He qualified as a physician in 1975 from The London Hospital (England) and has medical degrees from the University of London as well as the Royal Colleges of Surgeons and Physicians of England.

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Confirmed presentation title: Optimal trial design strategies for phase I and proof of principle/concept

 

Abstract:  The key to successful development or licensing of an NCE, especially for smaller biotechs, is a robust Proof of Concept.


While an interesting mode of action may be sufficient, in special circumstances, to out-license a product, the need to demonstrate clinical utility remains the main goal.
It is likely that there will only be one shot at successfully showing that a new compound works. While there is a temptation to go for the indication with the highest medical need or where the primary endpoint can be achieved in the shortest timeframe, very careful consideration as to the actual target and required benefit has to be given. For most small companies, failure of their Proof of Concept study is really not an option.


To make sure that the limited resources available for clinical trials are used effectively, the choice of Proof of Concept model needs to be based on the available preclinical information and other sources where, for example, a class effect or similar mode of action will provide an indication of what patients and trial design represents the most effective path. Ideally, the best target is one where “if it does not work there it will not work anywhere”.


The trial programme should select the most appropriate dose and dosing regimen, determine whether monotherapy or combination therapy is required for the selected indication and be able to demonstrate satisfactorily that the product does what its mode of action suggests (Proof of Principle) and then to effectively show that it should have clinical utility (Proof of Concept) and be representative of the wider population that would constitute a Phase III pivotal trial.


In considering the most appropriate “roadmap” to achieve a successful Proof of Concept a reverse clinical development strategy starting at the Proof of Concept and working backwards to Phase I, incorporating the Proof of Principle, should provide the optimal route to this important development milestone.

Anthony Hall, Therapeutic Area Head, Orphan Drugs,
Mereo Biopharma
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Anthony is an experienced pharmaceutical physician with knowledge spanning a broad range of disciplines and therapy areas. Having founded and built his own successful company, he demonstrated an ability to lead, inspire and motivate, together with keen strategic vision and commercial acumen.

From 2010 – 2014, Anthony worked as a consultant exclusively on orphan drugs and became heavily involved with all facets of the rare diseases community, regularly speaking at conferences. He has built trusted relationships with stakeholders at many different levels, including patient groups, key opinion leaders and academics. Anthony has gained significant experience in drug development for orphan drugs, from understanding the special regulatory requirements applicable for orphan drugs to designing the clinical programs to meet them.

Anthony is very interested in clinical endpoint development, including surrogate endpoints and in innovative drug development pathways, such as adaptive licensing with the involvement of all stakeholders, including payers at an early stage.

He graduated from King’s College London with a first class honours in Physiology and Pharmacology before going on to study medicine at the Royal Free Hospital, London.
[extracted from entry on LinkedIn]

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Provisional presentation title:  "Working in alliance with the patient and external partners to transform clinical development in an SME"

Dr Ian Hodgson, Head of Clinical Operations,
Mereo BioPharma
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Confirmed presentation title:  Vendor governance strategies from an SME perspective

Dr Peter MacLennan, Chief Operating Officer,
Tailored Clinical Research Solutions (TCRS)
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Peter MacLennan has worked on early phase clinical trials throughout a 30-year career spanning academia, biotech and CROs.

With Dr Davy Yeung, he is co-founder of Tailored Clinical Research Solutions (TCRS). Their objective was to build a new kind of CRO that places patients, and the hospital sites that treat them, at the very heart of the clinical trial process.

TCRS’ approach is proving highly effective in early stage clinical studies with Biotech/SME sponsors.

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Confirmed presentation title:  Working in partnership with hospital sites to achieve rapid, efficient and cost effective delivery of early phase clinical trials

Abstract:  Peter’s presentation will discuss how close partnerships with hospital sites ensure that clinical studies are delivered rapidly, cost-effectively and to the highest standards of quality.

Helen Springford, Vice President of Strategic Development,
Illingworth Research Group
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Having worked as a nurse in cardiac transplantation in the UK and Australia, Helen moved into clinical research 26 years ago. She started her clinical trials career as a research nurse in London. Since then, she has managed an SMO and held various positions in both CROs and big pharma within several functional areas including Clinical Operations, Project Management, Business Development and Proposals. Within Illingworth Research Group Helen is responsible for Business Development, Strategic Partnerships, and Executive Oversight and is a keen exponent of trial strategies to improve the patient experience.

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Confirmed presentation title:  "The politics of utilising a mobile research nursing in clinical trials"

Speaker Profiles - Session Chair

Duncan Judd, CEO,
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.

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Chair of the Interactive Plenary session

Dr Stephen Greentree, Senior Director Development Team Leader,
Kyowa Kirin
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Steve has had a long and varied career in drug development. Currently he is a Senior Director and Development Team lead for Kyowa Kirin working primarily in the area of immuno oncology drug development. Previously he held the position of Director of Clinical Science at Takeda in the Centre for External Innovation where he was responsible for pulling together development plans for products covering a diverse range of orphan indications with a view to externalising the asset. 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.

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Chair of the Clinical Operations Outsourcing session of the Clinical Operations track

Keith M Borkett, Consultant,
Independent Consultant
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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 in 2016 and currently works as a Freelance Consultant.

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Chair of the Clinical Operations Outsourcing session of the Clinical Operations track

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).

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Chair of the Outsourcing and Discovery session of the Discovery / Early Development track

Dr Paul Madeley, Managing Director,
Synth-Isis Ltd
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Paul Madeley, Ph.D., is an organic chemist with over thirty years’ experience of chemical synthesis. He has worked for three large companies (Boots, Courtaulds and Abbott Laboratories) and two biotech companies (British Biotech and OSI Pharmaceuticals) before setting up his consultancy company, Synth-Isis Ltd. Dr. Madeley has worked on over one hundred projects, comprising more than six hundred individual reaction steps; at scales ranging from a few grams to several metric tonnes.

In 1995, having worked as a pilot plant manager for five years with Abbott Laboratories, Dr. Madeley moved to virtual pharma and has been responsible for outsourcing more than two hundred manufacturing contracts. This involved development of template agreements and site visits for technical appraisal of potential manufacturers. He has visited more than fifty manufacturing sites in Europe and the US. He has acted as the CMC technical lead for a number of due diligence meetings on behalf of clients on more than twenty occasions; in which he presented the technical package for the API to potential investors. He has also undertaken due diligence examinations of potential in-licensing opportunities. Since setting up Synth-Isis Ltd in 2004, Dr. Madeley has worked with over twenty small biotech and emerging pharma companies, together with a number of service companies, and has prepared the chemistry sections of seventeen IMPDs and three INDs. This has included technical oversight of manufacture of the APIs.

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Session chair of the Outsourcing and Early Development Module of the Discovery / Early Development Track

Speaker Profiles - Plenary

Dr Brian Dickie, Director Research and Development,
Motor Neurone Disease Association
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Brian Dickie graduated in 1991 with a Ph.D in Neuropharmacology from the University of Wales College of Medicine. He then took up a research fellowship in the Department of Pharmacology, University of Oxford, where his research on the mechanisms of cell death in Parkinson’s disease was combined with medical teaching at Lincoln College, Oxford.

He has worked for the UK Motor Neurone Disease Association as Director of Research Development for 20 years. His role includes providing strategic guidance to the Association’s research activities, raising the Association’s profile within the biomedical and clinical research communities, increasing the quantity and quality of Association-sponsored and collaborative research, organising the annual International Symposium on Amyotrophic Lateral Sclerosis/Motor Neuron Disease and communicating advances in MND research to lay and specialist audiences.

Dr Rick Thompson, CEO,
Findacure
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Dr Rick Thompson joined Findacure in 2015, after completing his PhD in Evolutionary Biology at the University of Cambridge. He has recently moved to the position of CEO, after working as Head of Research. He is responsible for the running and development of the charity, as well as their scientific projects. These aim to develop a socially financed drug repurposing programme – Findacure’s rare disease drug repurposing social impact bond (RDDR SIB). Rick has designed and completed a proof of concept study to demonstrate the feasibility of the RDDR SIB to the NHS, investors, industry, and patient groups. Rick works to encourage industry engagement with rare disease patient groups, promoting an open and collaborative approach to rare disease research.

Dr Madhu Madhusudhan, Senior Business Manager,
LifeArc
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Dr Madhu Madhusudhan has over 15 years’ experience in research and business development earned in companies which include multinationals, start-ups and IP consulting firms in the UK, New Zealand and India.  His current role as the Senior Business Manager (Charity Sector) at LifeArc is to focus entirely on facilitating translation and impact of charity-funded research, thus enabling medical research charities to maximise benefits to patients. LifeArc (the new name for MRC Technology)  is a medical research charity with a 25 year legacy of helping scientists and organisations turn their research into treatments and diagnostics for patients.

Email:  madhu.madhusudhan@lifearc.org
Web: www.lifearc.org/

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Confirmed presentation title:  "Partnering for impact – charities helping charities"

Abstract:  LifeArc (the new name for MRC Technology) is a medical research charity with a 25 year legacy of helping scientists and organisations turn their research into treatments and diagnostics for patients.  We have helped develop treatments for advanced melanoma, non-small-cell lung cancer, rheumatoid arthritis, multiple sclerosis and Crohn’s disease.  Partnering with others to achieve greater and tangible patient impact is at the centre of our new strategy.   Through the creation of collaborative communities we act as a catalyst to promote and develop innovative models to develop and progress life changing diagnostics and medicines.    To achieve this we proactively share our resources to facilitate and aid seamless translation of exciting and innovative science in academia worldwide.  

Since 2012 we have been engaging and working with over 65 medical research charities worldwide offering our skills in drug discovery and development as well as expertise in technology transfer and translation to enable these charities to achieve greater patient impact.  Being an independent, self-funded charity, allows us the freedom to reinvest our earnings (at least £30 million) from our phenomenal success over the past two decades in two funds specifically established to help progress early stage research.  This short presentation will provide few successful examples of collaborative LifeArc initiatives.

Dr Roger Legtenberg, Chief Executive Officer,
PSR Orphan Experts
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After obtaining his PhD in physiology at the University Medical Center Nijmegen, Roger has worked over 15 years in various positions in the CRO industry. During the last six years, as CEO of PSR, he succesfully lead PSR’s specialisation & expansion into the orphan drug niche. Besides his role at PSR, he is also actively involved as member of the advice group orphan drugs and rare diseases of HollandBio (Dutch Biotech Association) and member of the board of the Association of Contract Research Organisations in the Netherlands (ACRON).

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Panel member in the interactive plenary session

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