one nucleus life science leadership series - antibody based therapeutics - 2013 handbook

Life Science Leadership SeriesAntibodyBasedTherapeutics 2013

Handbook

London’s premier Life Science & Healthcare networking conference

12 December 2013

Queen Elizabeth II Conference Centre

Westminster, London, UK

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ContentsWelcome 4

Advisory Board Profiles 6

Advisory Board Articles 10

Agenda 12

Speaker Profiles 14

Gold Member Profiles 20

One Nucleus Limited

Cambridge (Head Office):The PortwayGranta Park Cambridge CB21 6GSUnited Kingdom

+44 (0) 1223 896 450

[email protected]

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London’s premier Life Science & Healthcare networking conference

12 December 2013

Queen Elizabeth II Conference Centre

Westminster, London, UK

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Sponsored by

Harriet Fear | CEO One NucleusWelcome Dear Delegate,

I am delighted to welcome you to the sixth event in our Life Science Leadership Series, focusing on Antibody Based Therapeutics.

Recognising the increasingly complex relationships between medical product developers, regulators and payers, we have launched the Life Science Leadership Series. The aim is to complement the global bio-partnering conferences, facilitating delegates in sharing knowledge and engaging thought-leadership through challenging each other towards best practice in the efficient development of new treatments and technologies.

We are running this series of 1 day events that have a therapeutic and/or technology focus approximately every four months – upcoming events include ‘Personalised Medicine’ in May and ‘Investment Strategies for Life Sciences’ in September.

The programme today includes world-leading experts discussing the challenges they are facing in the discovery, development and commercialisation of antibody-based therapies. Speakers will provide their insights into the topic through showcasing of their own enabling technology platforms, research and alliances against a backdrop of learning and formal One-to-One partnering, alongside the enhanced networking opportunity resulting from delegates aligned to the focus area.

You will have noticed that there is a far lower fee for delegates compared to the traditional life sciences partnering format – we are very mindful of the need to keep costs down, whilst delivering tangible business opportunities for you.

So why this focus on Antibody Based Therapeutics?

Monoclonal antibodies and their analogues have been the fastest growing class of molecule in the pharmaceutical sector since 2006 with global sales reaching over $45Bn, with 32 approved drugs and over 100 drugs in development. As with the development of any new medicines, there are significant challenges along the road to success, both in terms of improved healthcare and commercial return.

This Life Science Leadership Series event will take an ‘Issues & Solutions’ approach to discussing current best practice, trends and challenges in the development of novel antibody based therapeutics. These include issues relating to the R&D, regulatory and business aspects, allowing delegates to fully engage in the debate of how we could be doing this better collectively in order to deliver enhanced treatments and meet the necessary economic and health benefits to attract investors, payers and patients.

The One Nucleus team is on hand today to help you make the right connections and ensure your day goes smoothly.

I wish you a very successful event and look forward to receiving your feedback.

4

BABRAHAM RESEARCH CAMPUS

The Babraham Research Campus,

home to both academic research

and biomedical companies, is

a leading science park and hub

of bioscience innovation in the

United Kingdom.

www.babraham.com

AN ENVIRONMENT PROMOTING A CULTURE OF INNOVATION

The Campus provides lab/offi ce

space on fl exible terms to early-

stage companies, with access to

the Technology Development

Laboratory and world-class facilities

of the Babraham Institute.

Babraham Institute research focuses

on the mechanisms underlying ageing,

development and life-long health,

while also identifying opportunities for

knowledge exchange with industry

and academia.

ACCESS TO STATE-OF-THE-ART RESEARCH AND DEVELOPMENT FACILITIES

For more information contact:

Babraham Bioscience Technologies Ltd

Tel. 01223 496269 [email protected] www.babraham.comBioscienceBabraham

TechnologiesResearchCampus

Babraham

CO-LOCALISED WITH WORLD-LEADING ACADEMIC SCIENCE GROUPS

SITUATED AT THE HEART OF THE CAMBRIDGE BIOSCIENCE CLUSTER

5

BABRAHAM RESEARCH CAMPUS

The Babraham Research Campus,

home to both academic research

and biomedical companies, is

a leading science park and hub

of bioscience innovation in the

United Kingdom.

www.babraham.com

AN ENVIRONMENT PROMOTING A CULTURE OF INNOVATION

The Campus provides lab/offi ce

space on fl exible terms to early-

stage companies, with access to

the Technology Development

Laboratory and world-class facilities

of the Babraham Institute.

Babraham Institute research focuses

on the mechanisms underlying ageing,

development and life-long health,

while also identifying opportunities for

knowledge exchange with industry

and academia.

ACCESS TO STATE-OF-THE-ART RESEARCH AND DEVELOPMENT FACILITIES

For more information contact:

Babraham Bioscience Technologies Ltd

Tel. 01223 496269 [email protected] www.babraham.comBioscienceBabraham

TechnologiesResearchCampus

Babraham

CO-LOCALISED WITH WORLD-LEADING ACADEMIC SCIENCE GROUPS

SITUATED AT THE HEART OF THE CAMBRIDGE BIOSCIENCE CLUSTER

6 Advisory Board Profiles

John Burt Chief Executive Officer, PolyTherics

ProfileJohn joined PolyTherics in November 2010 and became CEO of the company in May 2011. He led the company through a successful financing round in 2011, completed the acquisition of Warwick Effect Polymers in January 2012 and is leading the transformation of the company into a successful technology commercialisation program with a growing presence in the ADC field.

Prior to joining PolyTherics he co-founded Thiakis which he led through to a successful sale to Wyeth in 2008 and previously worked across a range of finance, strategy, business and corporate development roles with Vernalis, GlaxoSmithKline and Imperial Innovations.

John Elvin Senior R&D Manager and Scientific External Liaison, MedImmune

ProfileJohn works for MedImmune Ltd based at Granta Park near Cambridge. MedImmune is the worldwide biologics business arm for AstraZeneca and was formed in 2007 from the integration of the AstraZeneca acquisitions of Cambridge Antibody Technology (CAT) and MedImmune.

Having completed his BSc in Microbiology at the University of Bristol in 1987 he worked in a technical role in the Nuffield Department of Medicine for two years and then gained a D.Phil. from University of Oxford in T cell immunology in 1992 while working with Alain Townsend and Andrew McMichael in the (Weatherall) Institute of Molecular Medicine. He then held an MRC Junior Research Fellowship at the Laboratory of Molecular Biology with Michael Neuberger in Cambridge before joining Cambridge Antibody Technology (CAT) in 1995.

During his 17 years at CAT and MedImmune he has held various positions in the Research Department. John’s experience has included: use of proprietary phage display antibody libraries to isolate therapeutic antibodies to a range of targets; project management; biological assay development in the oncology therapeutic area and set up and management of the Hybridoma Technology Group on the Cambridge Site.

John’s current role working in MedImmune R&D involves interaction with external scientific contacts within universities and government funded institutions with a view to exploring potential collaborations and mutually beneficial interactions.

Maureen Graham Founder and Managing Director, Diamond BioPharm

ProfileDr. Maureen Graham has over 25 years’ experience within the pharmaceutical industry and has worked for several different companies including Glaxo, Merck & Co, IVAX and Amgen. Dr. Graham has held a number of Directorships including European Director of Regulatory Affairs at Amgen.

Dr. Graham founded Diamond BioPharm Limited in 2005, which is a leading technical and scientific consulting group of companies serving the biotechnology and pharmaceutical industry. Dr. Graham has direct experience with many types of products including biotechnology, gene-therapy, new chemical entities and generics. Dr. Graham also has a wealth of experience and expertise when it comes to the regulatory and product development issues associated with medicinal product for rare indications. Dr. Graham’s experience covers products at all stages of development ranging from preclinical to registration.

Advisory Board Profiles 7

Matthew Roe Chief Business Officer, Crescendo Biologics

ProfileMatthew Roe joined Crescendo in 2011 to build business and corporate capability through deal-making, collaboration and partnerships. He has over 25 years’ industry experience at Genzyme, Wyeth and Glaxo encompassing business development and licensing, alliance management, business strategy, market and competitor analysis, sales and marketing, and regulatory affairs.

Most recently Matthew negotiated and managed multiple agreements for Genzyme platform technologies in the USA, Europe and Japan, and was a core team member for the divestment of Genzyme’s Pharmaceuticals business. Matthew has a BSc in Biochemistry from Brunel University, London, and an MBA from the University of Warwick Business School.

Tom Shepherd Chief Business Officer, Kymab

ProfileDr. Shepherd is Chief Business Officer of Kymab, based in Cambridge and has over 30 years’ experience in the pharmaceutical industry including CEO and executive business development roles in the USA, France, UK and Australia. He has led multiple pharmaceutical asset and technology licensing transactions and has been responsible for strategic company-building acquisitions. He has also raised significant amounts of equity capital to grow early stage companies into sustainable commercial operations.

Dr. Shepherd was previously CEO of CXR Biosciences in Scotland and Neurotech S.A. in Paris and Vice President Business Development at Valeant Pharmaceuticals and Intrabiotics Pharmaceuticals in California. He was awarded a Ph.D. in biochemistry from the University of Strathclyde in 1981.

John Haurum Chief Executive Officer, F-star

ProfileJohn Haurum joined F-star in May 2012. Previously he was VP Research, Biologics Products at ImClone Systems, NY, and the Chief Scientific Officer and a co-founder of Symphogen A/S, Denmark.

After graduating in 1992, Dr. Haurum received a D.Phil. in immunology from the Institute of Molecular Medicine, University of Oxford, England. Subsequently, he took up a position at the Danish Cancer Society and completed his medical training. He has extensive research experience in molecular immunology and biochemistry and served as a consultant for several biotech companies. He is a “Pathfinder” and holds a Scandinavian International Management Institute diploma in “Managing Medical Product Innovation”.

He is a dynamic biotech leader and executive manager with broad biopharmaceutical business, research, and drug development experience, including experience in integration of innovation, drug discovery, and preclinical product development. He has a proven track record in leading biologics drug product candidates through all phases of discovery and preclinical development, manufacturing and regulatory filing. Through his career he has obtained significant experience with business development and VC financing activities, and he has lead the establishment of several collaborative project Joint Steering Committees in both Japan, US, EU, as well as had overall responsibility for Intellectual Property Rights.

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KnowledgeTransferNetwork

HealthTechand Medicines

www.healthtechktn.com

Innovation depends on an intimate knowledge of a technology and close relationships with subject experts on one hand, and a breadth of contacts and an overview of the supply chain on the other.

The HealthTech and Medicines Knowledge Transfer Network is a single front door through which members can find all the expertise and support they need across the innovation chain, from first idea, to patenting and packaging intellectual property, finding academic and industrial partners for product development and manufacturing scale-up, meeting regulatory standards, and getting access to market.

The HealthTech and Medicines KTN also help members to access funding from the Technology Strategy Board for prototype development and proof of concept work.

Membership of the KTN provides access to a dynamic, UK-wide knowledge transfer network covering all aspects of medical devices, diagnostics, and medicines. In addition, the KTN works with these communities, actively promoting sharing of knowledge, building value chains and suggesting possible collaborations and partnerships. It is also involved in developing international networks, supporting business engagement in the US, China, Japan and Europe.

The KTN has set up specialist groups in areas including Advanced Wound Management, Assisted Living, Clinical Trials, Regenerative Medicines, Healthcare-Associated Infections and Stratified Medicines to help companies home in on the particular resources they need to address any of these areas.

Members of HealthTech and Medicines KTN get an Innovation BoostThe HealthTech and Medicines KTN supports business innovation through partnerships, funding and knowledge transfer:

l Connecting partners: Bringing together and facilitating collaborations with a common goal

l Access to funding: Identify and influence new and existing sources of funding

l Knowledge transfer: Opening doors to wider networks of people, organisations

l Technology Strategy Board, National and EU funding competitions

l Impartial advice and access to the full KTN network

l Key individuals within the community – putting you in touch with the right partners for forming collaborations

l Networking opportunities and events

Membership of the KTN provides access to:

Led by key opinion leaders, these specialist groups bring researchers, entrepreneurs, companies, clinical and regulatory experts together to identify opportunities, flag up potential roadblocks and foster new partnerships. Backing up these meetings, the KTN’s innovation platform features online tools that enable partners to explore projects and issues they are working on together.

For more information and how to engage with the HealthTech and Medicines KTN community visit:

www.innovateuk.org/healthktn

KnowledgeTransferNetwork

HealthTechand Medicines

www.healthtechktn.com

www.innovateuk.org/healthktn

l Practitioner network into industry, industry friendly academia and clinical groups

10 Advisory Board Articles

Therapeutic Monoclonal AntibodiesJohn Elvin Senior R&D Manager and Scientific External Liaison, MedImmune

Ever since Kohler and Milstein discovered how to generate and culture “fused cells secreting antibody of pre-defined specificity” in 1975, monoclonal antibodies have become routine laboratory reagents. Their exquisite specificity is used to interrogate our biological world in assays and experimental work, and we can often obtain those we want from our national or international colleagues or can consult large catalogues from commercial vendors.

The potential for these useful molecules to make effective medicines was clear at the beginning, and indeed the first therapeutic monoclonal, muromonab-CD3 (Orthoclone OKT3) directed against T cells for treatment of transplantation rejection, was approved for use in1986, just eleven years after the technique was made public.

Naturally we therefore would expect that over the last quarter century of advances in the discovery, generation, production and manufacture of monoclonal antibodies that we would now have a cornucopia of monoclonal based therapies.

However it has not been that simple.

As of October 2012 there are 31 branded (i.e. excluding biosimilars) marketed therapeutic monoclonal antibodies worldwide. Of these 25 are approved for use in the EU and the US; three are approved in the US only; one is approved for use in the EU only and two approved for use outside these regions.

If we look at the pattern of approvals over time, there is a large gap between 1986 and the next approval, abciximab (ReoPro®), in 1994. Thereafter the number of marketed antibody based therapeutics available for use accumulates steadily at around one to two a year, with a few years where there are more, such as 2009 (6 approvals in EU and 4 in US).

While there have been some monoclonal antibody therapeutics which have been approved for use (EU or US) at one point and then later withdrawn or discontinued (for a number of reasons), these number only six 1.

So, this leads to a modest total of 37 new monoclonal antibody based therapeutics which have been approved for use since 1986. For comparison the FDA approved 35 new drugs (all classes) for use in 2011 alone 2.

Given that the rewards for a successful antibody therapy can be so significant, for example adalimumab (Humira® ) worldwide sales in 2011 were $7.9 billion (Abbott 2011 annual report) why do we not see more?

Part of the answer does lie in the complex nature of biologic therapies as medicines. These concerns are well known in the industry and we address them with a diverse array of technologies to generate, engineer and produce antibodies and antibody fragments which are fit for purpose.

But perhaps a more significant part of the answer is the need for a deep biological knowledge and understanding of the disease we aim to treat and evidence to show that a specific intervention will be effective.

This, of course, is a need common to any attempt to make medicines but is particularly important for such precisely specific drugs such as monoclonal antibodies.

In support of this, once a disease and associated molecular target has been validated it becomes very popular: the current marketed antibodies and those in late stage clinical development show a conservative approach to both the indications to be treated and in which molecules they target 3.

This understanding is not something we can acquire in isolation but requires partnership with disease experts in academia, physicians, and patients, and is why that the forming of effective collaborations and in particular around translational medicine is currently a major focus for the industry.

The next leaders in antibody therapeutics will be those who can use these collaborations to discern the disease targets within appropriate patient populations and then tailor their molecule with the right properties to treat them.

1. Reichert, J. M. “Marketed therapeutic antibodies compendium.” MAbs 4(3): 413-5.

2. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278383.htm

(accessed October 2012)

3. Elvin, J.G., et al., Therapeutic antibodies: Market considerations, disease targets and bioprocessing. Int J Pharmaceut (2012), doi:10.1016/j.ijpharm.2011.12.039


Transgenic in vivo Fully Human Monoclonal Antibody PlatformsTom Shepherd Chief Business Officer, Kymab

Since the 1980s, several in vitro and in vivo monoclonal antibody generation platforms have been developed, with the objective of improving the selectivity and potency of monoclonal antibody drugs. However, despite significant advances, demand for new and improved mAbs remains in order to meet the challenges posed by new and often complex drug targets.

In vitro systems, such as phage display, allow rapid screening of human mAb libraries, providing leads that can be further engineered to generate potent antibodies. Although in vitro platforms are widely used, immunisation of animals has remained a key means to discover highly specific, potent antibodies.

Today, there are two principal approaches to discovering therapeutic antibodies via immunisation. The first is to generate antibodies in wild-type mice or other species using traditional immunisation techniques. Selected mouse antibodies with the desired properties can then be “humanised”; this involves replacing murine antibody sequences, other than the complementarity determining regions (CDRs), with human sequences that have similar functionality. Humanisation results in antibodies the do not induce the human anti-mouse antibody response that would otherwise occur following repeated administration to man.

The second approach is to construct genetically modified mice which contain elements of the human antibody gene repertoire in their genome and which are capable of directly generating human antibodies following immunisation. Fully human antibodies are increasingly preferred as they are unlikely to be antigenic in man.

While in vitro platforms such as phage display libraries can generate human antibodies, of the 9 fully human antibodies approved by the FDA to date, 7 were generated in transgenic mice and 2 originated from in vitro platforms as shown in the table above.

Early transgenic human antibody platforms, such as transgenic mouse strains developed by Medarex and Abgenix, have resulted in some successful drugs reaching the market. These mouse strains however, have deficiencies in performance due to the limited chromosomal engineering tools available at the time.

Two particular limitations of early transgenic mouse platforms were their sub-optimal B-cell mediated immune response compared to wild type mice and their limited human immunoglobin gene repertoire compared to humans. Although some excellent antibodies were generated in these mice, the smaller B-cell compartment, restricted human immunoglobin gene repertoire and poor somatic hypermutation rates limited the diversity of the available antibody pool. The practical consequence of this is that immunisation campaigns require more mice, more intense immunisation schedules, more hybridoma screening and resulting antibodies often required in vitro affinity maturation to improve potency.

As chromosomal engineering and embryonic stem cell technologies have advanced, the construction of mouse strains that overcome these limitations has become possible. Regeneron and Kymab have developed mouse strains that exhibit a normal immune response in conjunction with an extensive

human antibody gene repertoire. Antibodies generated in these newer platforms have not yet reached the market, but there are several human antibodies in clinical trials that were generated in the Regeneron platform and Kymab is now generating novel antibodies to a wide range of drug targets implicated in oncology, inflammatory and infectious diseases in Kymouse strains.

There is no definitive published data demonstrating that the antibody pools from the new generation platforms are superior to those from the prior generation, but this seems a reasonable assumption based on the design of the genetic modifications and the characteristics of the animals. Anecdotal evidence from the characterisation of antibodies from the Kymouse platform indicates that high affinity (<10pm), neutralising antibodies are readily generated using small numbers of mice without the need for in vitro affinity maturation. Of particular interest is that these antibodies have undergone extensive somatic hypermutation in vivo and have CDR3 regions that are longer than mouse CDR3 regions, being similar to those found in humans.

Antibody NameCompany Platform Approval Year

Generic ProprietaryAdalimumab Humira® Abbott Phage display 2002Panitumab Vectibix® Amgen Transgenic mice 2006Golimumab Simpioni® J&J Transgenic mice 2009Camakinumab Ilaris® Novartis Transgenic mice 2009Ustekinumab Stelara® J&J Transgenic mice 2009Ofatumumab Arzera® Genmab Transgenic mice 2009Denosumab Prolia® Amgen Transgenic mice 2010Ipilimumab Yervoy® BMS Transgenic mice 2011Belimumab Benlysta® HGS / GSK Phage display 2011

12 Agenda

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9 July 2013 Cambridge, UK


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9 July 2013 Cambridge, UK

Jan A. Alfheim is CEO of Nordic Nanovector

AS, a privately held company based in Oslo,

Norway. The company is developing innovative

radioimmunotherapeutics that target difficult to

treat cancers.

Mr. Alfheim has more than 25 years of experience

in the healthcare and chemical industries. Before

joining Nordic Nanovector, he worked for the

Norwegian cancer drug development company,

Clavis Pharma ASA, as Chief Business Officer and

a member of the senior management team. Prior

to joining Clavis, Mr Alfheim spent seven years in

Canada, first as Director of Business Development at

Neurochem Inc and as President of Stempath Inc. He

holds a M.Sc. in chemistry from Concordia University

and a MBA from McGill University in Montreal.

Jan Alfheim Chief Executive Officer, Nordic Nanovector

Dr. Anderson joined ICON as part of the acquisition

of Prevalere Life Sciences, having started there

in 2006. Mike previously managed ICON’s

immunogenicity group in Syracuse for 5 years

before taking on the management of all support

aspects for US Bioanalytical Operations, as well as

business ownership for the development of iBio

-- ICON’s Laboratory Infor¬mation Management

System (LIMS).

Dr. Anderson currently serves as Director of Global

Bioanalytical Operations, where he manages the

laboratory functions for the US and UK labs, as

well as op¬erational and scientific oversight of the

immunoassay services in the UK. Dr. Anderson is also

a member of the AAPS committee on biosimilar

assay validations.

He holds a Ph.D. in Immunology from Upstate

Medical University and spent three years completing

a Cancer Research Training Fellowship at the

National Cancer Institute. Dr. Anderson has extensive

experience with plate-based ligand binding

immunoas¬says, in vivo and in vitro cellular based

immunoassays and flow cytometry.

Michael Anderson Director of Global Bioanalytical Operations, ICON Development Solutions

John Chappell has spent 20 years in the Contract

Research industry supporting both preclinical and

clinical drug development. John has specialised

in the bioanalytical support of macromolecule/

biological compounds including Pharmacokinetic,

Immunogenicity and Biomarker analysis. He has

spoken at many international conferences on

various areas including Oligonucleotide analysis,

Biomarker Assays, Immunogenicity and the

analytical support of Biosimilar programs.

John now leads the Applied Immunology

department at Aptuit Verona where he provides

technical support for immunological assays,

immunotoxicology and immunogenicity testing.

He is a Member of the Royal Society of Chemistry

and the American Association of Pharmaceutical

Scientists. He is also involved with the AAPS

Biosimilar Committee which aims to provide

guidance to the industry on the bioanalytical

requirements for Biosimilar compounds.

John Chappell Head of Applied Immunology, Aptuit Verona

14 Speaker Profiles

Dr Michael Dalrymple is Director of Business

Development at MRC Technology. Mike completed

his PhD at the MRC Virology Unit, Glasgow, followed

by postdoctoral research at Yale and Edinburgh

Universities.

He moved into industry with the CRO Inveresk

Research then PPL Therapeutics where he worked

from spin-out to IPO and was involved in the

creation of the lesser known, but far more significant,

cloned sheep ‘Polly’. He completed an MBA at the

University of Edinburgh in 1997 before joining MRC

in 1998 as Director of the MRC Collaborative Centre

Scotland and later MRC Technology as part of the re-

organisation of MRC’s technology transfer activities.

Mike has held various positions at MRCT including

Director of Applied Research and served on the

boards of several spin out companies.

Mike Dalrymple Director of Business Development, MRC Technology

Speaker Profiles 15

Dr. Yajun Guo graduated from the Third Military

Medical University in China in 1978 and received

his Ph.D. from the Shanghai Second Military

Medical University. He did his post-doctoral training

in Shanghai Institute of Biochemistry, Academy

of Sciences of China. He went to Harvard School

of Medicine in 1989 as a visiting professor and

then, joined the faculty of Case Western Reserve

University as an assistant professor in 1993.

In 1996, Dr. Yajun Guo became a professor in

Sidney Kimmel Cancer Center in San Diego and

relocated his laboratory to Eppley Cancer Research

Institute of Nebraska University Medical Center at

Omaha in 2000. Starting from 1994, Dr. Yajun Guo

established the Shanghai Tumor Immunology

and Gene Therapy Center as an international

research program and in 1999, he enlarged the

center into the present International Joint Cancer

Institute. From 2009, he has been working as a

director of PLA general hospital cancer center. Dr.

Yajun Guo’s Lab focuses on experimental cancer

immunotherapy and immunogenetherapy. The

ultimate goal of their research will be further

developing the novel strategy for generation

effective cellular cancer vaccines and monoclonal

antibody-based immunotherapy protocols such

as it can be translated into clinical treatment

for human cancers. Dr. Yajun Guo has received

many honor and awards and was invited to give

lectures at many international conferences. He is a

distinguished professor and director at Shanghai

International Joint Cancer Institute, PLA General

Hospital Cancer Center and Chinese National

Engineering Research Center for Antibody

Medicine. He is also a PI of the National key Basic

Research program Project “Structure and function

of antibody” and is conducting Seven clinical trials

of therapeutic antibodies in China. Currently, Dr.

Yajun Guo has several visiting professorships in

University of West Australia (2008 Rain Professor),

Imperial College of London (2008-2010) and

several Universities in China.

Professor Yajun Guo President, Chinese Engineering Research Centre for Antibody Medicine

16 Speaker Profiles

Kevin is CEO of Isogenica Ltd a private

biotechnology business based near Cambridge, UK,

which partners with multinational pharmaceutical

companies and smaller biotechs to identify

peptides, scaffolds and antibody drug candidates.

Prior to the current role, Kevin was CEO of Oxonica

plc, a nanomaterials company, which he took

public in 2005. Kevin is a non-executive director

and Chairman of the remuneration committee

of Elementis plc, a FTSE 250 speciality chemicals

company. He is also a non-executive director of

Cellectricon AB, a Swedish biotechnology business.

He holds a D.Phil in chemistry from Oxford

University.

Kevin Matthews Chief Executive Officer, Isogenica

John Hartley has a B.Sc. in Biochemistry and a Ph.D.

in Medicine (Experimental Chemotherapy) from

Manchester University. He was a Visiting Fellow

at the National Cancer Institute, NIH, USA and an

Alberta Heritage Research Fellow at the University

of Alberta, Canada. He joined the Oncology

department at UCL in 1988 and has been Professor

of Cancer Studies at UCL since 1996. He has also

been Director of the Cancer Research UK Drug-

DNA Interactions Research Group since 1995 and

Co-Lead of the UCL Experimental Cancer Medicine

Centre since 2008.

John has over 250 publications in the field of

cancer therapeutics and is a Fellow of the Society

of Biology. He was a founding scientist of Spirogen

Ltd where he is currently Director of Pre-clinical

Development.

Professor John Hartley Director of Research, Spirogen

David Lowe is a Fellow in the Department of

Antibody Discovery and Protein Engineering at

MedImmune Ltd.

David joined Cambridge Antibody Technology,

(later MedImmune), in 1997. He has over 15

years of experience in the field of therapeutic

antibody discovery and engineering. His research

interests include structural analyses of antibody

/ antigen interactions, early assessment of

protein developability and the development of

high-throughput methodologies for antibody

characterization. Prior to joining CAT, he obtained

his PhD from Cambridge University.

David Lowe Principal Scientist, MedImmune

After completing his post-doctoral research in

Germany, Edwin Moses began a commercial

career with successful periods spent at Amersham

International, Enzymatix and Raggio-Italgene. From

1993-2001, first as CEO and later as Chairman,

he was responsible for the growth of Oxford

Asymmetry (OAI) through a series of venture

rounds cumulating in a flotation (LSE) in 1998 at a

value of £120 million. This was followed by a sale

of the company to Evotec Biosystems in 2000 for

£316 million. During this period, OAI grew from

four people to over 250. Over the past eight years,

Edwin has played an important role at Board level

(primarily as Chairman) in over 15 European life

science companies. During this time he has been

involved in a number of financing rounds, a series

of M&A transactions and four IPOs. He has been

Chairman of Ablynx since 2004, and in 2006 he

accepted the offer by Ablynx’s Board of Directors to

extend his role as Chairman to include that of Chief

Executive Officer.

Edwin Moses Chief Executive Officer and Chairman, Ablynx

Mike Romanos is CEO of Crescendo Biologics,

an innovative transgenic antibody fragment

company based in Cambridge, UK. He has 25 years’

biotech and pharmaceutical industry experience

in NCE and biologic drug discovery across several

therapeutic areas, starting with Wellcome Biotech

in the 1980s. Previously, Mike held international

positions in GSK R&D, leading Discovery

organisations that made a major impact in targets,

technology and pipeline projects. He established

GSK’s antibody lead discovery capability which

generated several clinical monoclonal antibodies.

Mike holds a degree from Cambridge University, a

PhD in Molecular Virology from Imperial College,

and undertook postdoctoral research in Virology

at NIMR and in Yeast Biotechnology at Leicester

Biocentre. He is currently a panel member of the

MRC’s Developmental Pathway Funding Scheme

and a Fellow of the Society of Biology.

Mike Romanos Chief Executive Officer, Crescendo Biologics

Speaker Profiles 17

Tom Saylor is an experienced CEO with a track

record of building and managing entrepreneurial

organizations. Tom was CEO of Sirus Limited, a drug

targeting and delivery company, and Chairman

and founder of Lotus Healthcare Corporation,

an Asian-based fully integrated pharmaceutical

company producing and marketing analgesics,

cardiovascular and GI products in 35 cities of

China. He was also CEO of Cell Systems Limited,

a company focusing on medical applications of

cryo-preservation and algal biotechnology, and

Executive Vice President of a multibillion dollar

trade and finance company based in New York.

Tom was a principal trade negotiator for the US

Government during the Tokyo Round and is

Chairman of the SME Platform, a member of the

board of EuropaBio and the Executive Committee

of the British North American Committee. He

holds an MBA from Harvard University, undertook

doctoral studies in molecular biology and a degree

in molecular biology from the Georgia Institute of

Technology.

Tom Saylor Chief Executive Officer, Arecor

2.35pm

Laboratory technician Jenny determines the immunogenicity of a monoclonal antibody at our laboratory in Manchester.

24 hours in the life of ICONWhen it’s 9.35am at our New York lab it’s 2.35pm at our lab in Manchester where a custom method is being developed to determine the immunogenicity of a monoclonal antibody. This is just one example of how ICON Development Solutions provides global expertise for early drug development. No matter the hour of the day there’s an ICON expert somewhere around the world working to deliver results for informed, timely decision-making.

ICON Development Solutions:www.iconplc.com/bioanalytical

ICON Development Solutions

Manchester, UK.

As head of EIP Life, Andrew focuses on the life

sciences, with clients ranging from start-ups to

top-ten pharmaceutical and biotech companies.

His background is in molecular biology, and he

has experience in the fields of biotechnology,

pharmaceuticals, and medical devices.

Andrew’s expertise includes patent drafting and

prosecution, oppositions, freedom to operate and

patent entitlement disputes. As a solicitor as well as

a Chartered and European patent attorney, Andrew

has advised on litigious proceedings from the

Patents County Court to the House of Lords, and

on transactions including VC investment and multi-

million pound acquisitions. He has advised several

clients on the structuring and prosecution of their

patent portfolios for antibody-based technologies,

as well as on contentious matters in relation to

antibody products.

Andrew Sharples Partner, EIP

Tony is an establish biotechnology Serial

Entrepreneur. He was initially an Academic, moving

to Roche for 16 years working in various parts of

the Pharmaceutical business.

Following this tony has been CEO of four

Biotechnology companies, a mixture of public

and private and has been chairman of UK and

European companies. He is currently executive

chairman of Thiologics ltd.

Tony Sedgwick Executive Chairman, Thiologics

18 Speaker Profiles

2.35pm

Laboratory technician Jenny determines the immunogenicity of a monoclonal antibody at our laboratory in Manchester.

24 hours in the life of ICONWhen it’s 9.35am at our New York lab it’s 2.35pm at our lab in Manchester where a custom method is being developed to determine the immunogenicity of a monoclonal antibody. This is just one example of how ICON Development Solutions provides global expertise for early drug development. No matter the hour of the day there’s an ICON expert somewhere around the world working to deliver results for informed, timely decision-making.

ICON Development Solutions:www.iconplc.com/bioanalytical

ICON Development Solutions

Manchester, UK.

Abcam is a producer and distributor of high quality

research-grade antibodies and associated protein

research tools. Headquartered in Cambridge

(UK), Abcam has subsidiary offices in Bristol

(UK), Cambridge, MA (USA), Eugene, OR (USA),

SanFrancisco, CA (USA), Tokyo (Japan), Hangzhou

and Hong Kong (both in China), allowing it

to serve a global customer base in over 130

countries. Abcam employs over 600 staff across

its eight operating companies. Abcam now has

an online catalogue of over 100,000 products

sourced from over 400 suppliers. The catalogue

includes a growing range of non-primary antibody

products such as secondaries, proteins, peptides,

lysates, immunoassays and other kits. Products are

available for life science research and distributed

to academic and commercial users. A highly

developed eCommerce platform, which includes

regional websites for the Chinese and Japanese

markets, allows customers to access up-to-date

and detailed technical product data sheets at the

Company’s website www.abcam.com.

Applied Exomics Ltd provides support for drug and

diagnostic target discovery, delivering consultancy,

advice and technical project support in the

computational aspects of bioscience across -omics

disciplines. With a translational view based on

functional genomics, my approach is to facilitate

discovery of exploitable targets, realising their

potential by supporting the development of robust

biologics. Working together offers a cost-effective

route to increase understanding of the biological

significance, context and potential of your leads and

targets. I can add value to your technology base to

support investment or funding opportunities, and

offer routes to engineer optimal function and de-risk

future development.

Lonza is a leading supplier to the pharmaceutics,

healthcare and life-science industry. Our products

and services span customers’ needs from research to

final product manufacture. Lonza is headquartered

in Basel, Switzerland, and has sites worldwide.

Based in Cambridge, Lonza’s Applied Protein Services

(APS) platform is effective at improving the quality,

safety, efficacy and manufacturability of antibodies,

proteins, peptides and vaccines. By supporting

the successful selection, optimization and early

development of drug candidates, APS can help

improve your chances of success and risk mitigation.

We offer a complete line of in silico and in vitro

services for immunogenicity, stability, humanization,

and protein engineering. These technologies

include our Epibase® T-cell epitope screening

platform for Immunogenicity prediction. In addition

to our full range of protein analysis services, we offer

custom supply of mg to g quantities of non-GMP

material. This streamlined service, called Light Path™,

is available for both mammalian and microbial

applications.

Abcam

Applied Exomics

Lonza

www.abcam.com

www.appliedexomics.com

www.lonza.com

20 Featured Gold Member Profiles

F-star is a biopharmaceutical company dedicated to

developing novel bispecific antibody products that

provide a significant improvement over the current

standard of care. It is the only biopharmaceutical

company creating bispecific antibodies by modifying

the constant region of an antibody. Using Modular

Antibody Technology, F-star generates full-sized

antibodies with bispecificity (mAb2™) and antibody

fragments that have full antibody functionality and

long half-life but are much smaller in size (Fcab™).

Since its founding in 2006, the company has secured

funding and support from leading VC investors:

Aescap Venture, Atlas Venture, Novo Ventures and

TVM Capital; as well as from renowned global

strategic corporate investors: Merck Serono Ventures,

MP Healthcare Venture Management and SR One.

The company has major alliances with Boehringer

Ingelheim and Merck Serono, each covering multiple

targets. F-star currently employs 30 people at its

research site in Cambridge, UK.

F-star

www.f-star.com

Oxford Labs is the European online marketplace

that connects buyers and sellers of used laboratory

equipment.

Using the latest web technologies, we give you the

ability to search for, request and advertise used lab

equipment.

Our service helps organisations to source lab

equipment at significantly lower costs and re-

coup some of the costs incurred by redundant lab

equipment, whilst reducing environmental impact.

Use the Discount Code 1NUCLEUS2013 to run your

first For Sale Advert for free.

PolyTherics is a UK biotech company providing

technology solutions enabling development of

better biopharmaceuticals. PolyTherics has offers

proprietary site-specific conjugation technologies

for half-life extension of protein therapeutics, the

creation of bispecific products and the efficient

production of stable, homogeneous antibody-drug

conjugates, including antibody fragment-drug

conjugates. PolyTherics partners include Nuron

Biotech (TheraPEG™ interferon), Celtic Pharma

Holdings/Pro Bono Bio (TheraPEG™ variants of

Factor VIIA and Factor IX) and Spirogen (for the

development of novel ADC reagents).

Quotient Bioresearch is a leading provider of early

stage and specialist drug development services to

life science clients worldwide. We provide tailored

solutions for pharmaceutical, biotechnology

and agrochemical clients, using state-of-the-

art technologies underpinned by unparalleled

medical, chemical and biological expertise. Our

consultative, science-driven approach ensures the

highest quality service to support and accelerate

new product development. Our extensive range

of capabilities spans Chemistry and Metabolism,

Bioanalytical Sciences, and Clinical. These can

be provided independently or integrated into

bespoke work programmes. For additional

information or to discuss your specific needs,

contact us on [email protected] or

visit www.quotientbioresearch.com

Oxford Labs

PolyTherics

Quotient Bioresearch

www.oxfordlabs.co.uk

www.polytherics.com

www.quotientbioresearch.com

Featured Gold Member Profiles 21

Vasgen Ltd is a recently formed UK biotech

company based in London. The company’s

primary objective is to develop commercially

viable therapeutic solutions for unmet clinical

needs in the ophthalmology and cancer space

applying AbIMP™ technology that utilises targeted

antibodies as inhibitors of metalloproteinase

activity. With a particular focus on the ADAMs

family of cellular sheddases, Vasgen’s lead

therapeutic programme seeks to develop and

evaluate a novel, therapeutic AbIMP as a first-in-

class anti-angiogenic drug to target unmet needs

in the treatment of neovascular ocular diseases and

particular aggressive cancers.

Vasgen

www.vasgen.co.uk

ONE SOURCE. INFINITE SOLUTIONS.

Whether it’s laboratory or fine chemicals, consumables or equipment, Fisher Scientific has over 200,000 product lines to provide you with consistent, reproducible results.

Fisher Scientific is your No 1 choice not only because of ourcomprehensive product range but also because it is supported by:

• First class customer service

• Efficient delivery

• Online ordering

• Competitive pricing

The complete solutionfor N-Glycan preparation and profiling

GlykoPrep™ - manual using centrifugation for low throughput applications

GlykoPrep-Plus™ - automated using Agilent AssayMAP™ technology for high throughput applications

GlykoPrep™ is: • quantitative, robust, reproducible • able to integrate into any workflow • able to give results in a working day • modular with optional affinity purification and choice of labelling procedures • compatible with HPAEC-PD, HPLC, UPLC,CE and MSGlykoPrep™ is a trademark of ProZyme, Inc., Hayward, CA USAAgilent AssayMAP™ Bravo™ Liquid Handling Workstation is a trademark of Agilent Technologies, Inc., Santa Clara, CA USA

For further details of this technology, or the complete

GLYKO range of products,

In Europe please contact:

Europa Bioproducts Ltd15-17 North Street, Wicken

Ely, Cambridgeshire CB7 5XW www.europa-bioproducts.com

+44 (0)1353 721118In ROW please contact:

3832 Bay Center PlaceHayward, California,

9454-3619, USA. www.prozyme.com

+1 510 6386900

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Life Science Leadership Series

Cambridge, UKonenucleus.com/events

Personalised Medicine23 May 2013

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one nucleus life science leadership series - antibody based therapeutics - 2013 handbook

Documents

traditional life sciences

development of novel

commercialisation of

based therapies

advisory board profiles

engaging thoughtleadership

speaker profiles

queen elizabeth