Biotech Outsourcing Strategies 201423rd September, 2014, Royal College of Physicians, London

Discovery/Early Development & Clinical Outsourcing Tracks

23rd September, 2014, Royal College of Physicians, London

Dr Steve LudbrookGroup Leader, R&D Platform Technology & Science, GlaxoSmithKline

Dr Stefan JarochHead of External Innovation Technology, Bayer Pharma AG

Dr Susan Tio-GaillardDirector Clinical Program Management,Astellas Pharma Europe B.V

Dr Amer AlghabbanGlobal Director R&D and Good Vigilance Practice QAAbbott Pharmaceuticals Operations

Dr Frederik Barfoed BeckCMC Outsourcing ManagerZealand Pharma A/S

Andy MerrittAssociate Director, ChemistryMRC Technology

Insight from expert speakers

including;

Key CRO SponsorsGold Sponsors Exhibition Sponsors Silver Sponsors

Events Partners

Go to http://www.bio2bevents.com/bio2b-registration/registration to complete your registration enquiry online

Biotech & Pharma Package

£250 + VAT

Available to biotech and pharma delegates (non service providers only)

PackageCRO Sponsor Package

Silver Sponsor Package

Silver Sponsor Package

Banner Stand Exhibition Sponsor Package

Exhibition Sponsor Package

Exhibition Sponsor Package

Gold Sponsor Package

Key Sponsor

Additional Delegate Pricing for CROs (only in addition to one of the package outlined above)

Sole Trader Consultant Rate (applicable to Sole Trader or Limited Company where proprietor consultant is the sole employee)

Price£1550 + VAT per delegate

£1800 + VAT

£2050 + VAT

£2500 + VAT

£2750+ VAT

£3000 + VAT

£4500 + VAT

Available on Request

£390 + VAT

£390 + VAT

FeaturesSingle delegate access to event and pre-event access to partnering software

Single delegate access to event and pre-event access to partnering software + Branding Package (see media pack for details)

X2 delegate access to event and pre-event access to partnering software + Branding Package (see media pack for details)

X2 delegate access to event and pre-event access to partnering software + Banner Stand + Branding Package (see media pack for full details)

X2 delegate access to event and pre-event access to partnering software + Stand (table top stand solution) + Branding Package (see media pack for details)

X3 delegate access to event and pre-event access to partnering software + Stand (table top stand solution) + Branding (see media pack for full details)

X3 delegate access to event and pre-event access to partnering software + 10 Minute Outsourcing Case Study Presentation + Stand (Table Top Stand Solution) + Branding (see media pack for full details)

Contact Bio2Business for a tailored package

Includes full access to event and full access to pre-event partnering software

Includes full access to event and full access to pre-event partnering software

Book Now By:Registering Online: http://www.bio2bevents.com/bio2b-registration/registration

By Phone: +44 (0)207 691 3568 By Email: info@bio2business.com

What You Can Expect From BOS 2014

Update Technical Operations Skill Sets

Build Specialist Outsourcing Knowledge

Refine Outsourcing

Business Process

Strengthen Existing CMO/CRO Supplier Relationships

Meet New CMO and CRO Partners

Network with Peers from

Biotech, Pharma and CMO/CRO

CommunityA Friendly,

Welcoming Event Which Fosters Networking &

Partnering

Make Efficient Use Of Limited Travel Budgets

By Meeting Your Suppliers All Under 1 Roof

Dr Susan Tio-Gaillard, Director Clinical Program Management, Astellas Pharma Europe B.V

Susan Tio-Gaillard studied bio-medical sciences at the university of Leiden (Netherlands), followed by a nearly 2

years fellowship at the department of neurophysiology. In 1996 she obtained her PhD at the department of Medical Pharmacology at the Leiden Amsterdam Center for Drug Research, in the field of female reproductive neuro-endocrinology. Part of this research work was performed during a 1-year fellowship at the Rockefeller University, The Population Council, Center for Biomedical Research, New York, NY, USA.

After obtaining her PhD, Susan worked for 4.5 years in a CRO setting within Quintiles, followed by 5 years at Yamanouchi Europe as a European study manager.

Susan then joined Centocor BV (Johnson and Johnson) in 2005 where she worked as Clinical Research Manager. Closely working with the US, building and leading clinical teams in the field of oncology and GI, and line and people management were key activities.

Mid 2007 Susan took up the position of Associate Director Clinical Development, at Astellas Pharma Europe (merger of Yamanouchi and Fujisawa). Susan fulfilled the role of line / functional manager at Astellas in the Clinical department. Initially Susan managed (associate) study managers as well as clinical program managers, and since 2010, Susan is managing a group of clinical program managers, reporting into the global head in the US. Susan’s current role as Director Clinical Program Management at Astellas, Global Clinical Science, includes line-management , people management and development of a group of global clinical program managers who are accountable for ensuring implementation and execution of the clinical development strategy at the global program level including alignment and oversight of clinical studies (e.g., timelines, resources, budget, etc.) across internal and external stakeholders. This includes phase Ib - IV and post approval commitment and observational studies in the fields of urology, nephrology, pain, and infectious disease. Other key activities include vendor oversight activities, involvement in / leading global process improvement initiatives including business processes as well as processes that positively impact (global) collaboration and organizational cohesion. Furthermore, Susan is the urology / nephrology Clinical representative from a scientific and operational perspective in the Therapeutic Area governance body.

Susan is a member of the Pharmaceutical Contract Management Group (PCMG) committee, and member of the PCMG steering committee organizing the 2014 PCMG annual conference.

Dr Frederik Barfoed Beck, CMC Outsourcing Manager, Zealand Pharma A/S

Dr. Frederik Beck has 20 years of experience from pharmaceutical and biotech companies. He is the CMC outsourcing manager at Zealand Pharma

and has held this position for the past two years. As CMC outsourcing manager Dr. Beck is responsible for the outsourcing of all activities relating to clinical trials, both DS and DP. Prior to joining Zealand Pharma Dr. Beck worked for CMC Biologics as Project Director and as scientist/ project manager at Hexal. Dr. Beck received a Master of Chemical Engineering in 1992 from the Technical University of Denmark and an industrial Ph.D. from the University of Copenhagen in collaboration with DAKO A/S in 1999.

Dr Amer Alghabban, Global Director R&D and Good Vigilance Practice QA, Abbott Pharmaceuticals Operations

Amer completed his M.Sc in Pharmacology at Bradford University, Postgraduate studies in Medical Sciences at University

College Hospital, Diploma in Biological Sciences from Salford University & Postgraduate Certificate in Clinical Research from Surrey University.

Amer is a frequently invited speaker at international congresses and has presented and chaired at over 47 international congresses. He has over 23 years track record in the pharmaceutical industry (Clinical Development, Quality Assurance, Pharmacovigilance, Medical Information, & Medical Communications). For some time, he was the Assistant Editor for 11 Medical & Pharmaceutical journals. He contributed further to these disciplines by writing “The Pharmaceutical Medicine Dictionary” in April 2001 and “The Dictionary of Pharmacovigilance” in May 2004. He is currently writing his 3rd book, Dictionary of Clinical & Pharmaceutical Development.

Amer is currently the Global Head of GCP & GVP Quality Assurance at Acino Pharma AG. Prior to his current role, he was Director, Global Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland. His previous positions include: Global Head of GxP (GCP, GMP, GLP and GPP) Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Auditor at Novartis Pharma Headquarters in Switzerland and he was the first Pharmacovigilance Compliance Coordinator of the Medicines and Healthcare products Regulatory Agency (MHRA).

In these roles, Amer conducted a vast number of audits including a spectrum of GCP, Pharmacovigilance, Clinical Laboratories, GLP, GCLP, GMP, Vendor, Protocol, Clinical Study Reports, Due Diligence, Fraud investigation and Databases audits. He is certified as a Lead Auditor by the International Register of Certified Auditors.

He served as an Executive Committee Member of International Society of Pharmacovigilance (ISoP) and the Good Pharmacovigilance Practice Committee of the British Association of Research Quality Assurance (BARQA), and is a member of the Society of Pharmaceutical Medicine, Associate of the Institute of Quality Assurance (IQA), DIA, Member of the Association of Clinical Research Professional (ACRP), and the Organization for Professions in the Regulatory Affairs (OPRA).

PARTNER ING PRESENTAT ION EXHIB IT ION NETWORKING

Launched in 2006 BOS Events are niche, outsourcing focused partnering events for the biotech, pharma and contract services community. The 1 day event formula includes high quality presentations from thought leaders in the industry, 1 to 1 partnering, exhibition and informal networking. BOS 2014 will feature Discovery/Early Development Clinical Operations tracks creating more opportunities for interaction. As an attendee at BOS 2014 you can expect to develop your skills and build your outsourcing relationships all in a relaxed atmosphere.

From Biotech & Pharma: Executives involved in the following disciplines: Discovery biology, discovery chemistry, pharmacology, DMPK, lead validation, lead optimisation, in vitro ADME, early scale up, scale up, pre-formulation, formulation, CMC, regulatory affairs, clinical development, clinical operations, project managers, programme managers, clinical research, outsourcing managers, contracts managers

From CROs and CMO – business development, sales, marketing and corporate management functions

Who should attend BOS 2014

BOS 2014, 23rd September, 2014 Discovery/Early Development Track

BOS 2014, 23rd September, 2014 Clinical Operations Track

“The meeting allows you to connect to

people in an efficient and open manner”

Prof Hans-Jurgen Federsel, Senior Principal Scientist, AstraZeneca (BOS cmc, 16th June, 2011)

Here are some comments from past attendees...

Introduction to BOS London and to the BOS Events Formula

Featured speaker profiles Dr Andy Merritt, Associate Director, Chemistry, MRCT

Dr Andy Merritt has held the post of Associate Director, Chemistry at the MRCT Centre for Therapeutics Discovery (CTD), the drug discovery arm of MRC Technology

since the summer of 2009. In close collaboration with academic scientists, the CTD develops and subsequently prosecutes innovative drug discovery programmes emerging from academic research.

Prior to his current position Andy was a Director of Discovery Medicinal Chemistry at GlaxoSmithKline, a role which encompassed early lead discovery from screening campaigns plus global responsibility for outsource support for lead discovery chemistry and for the provision of molecular tools for target validation. He was at the forefront of the development and application of combinatorial chemistry and technologies to drug discovery, high throughput screening and hit to lead development from the initiation of the approach in the early 1990s. The use of outsourced resources to support early stage drug discovery in GSK was developed within his teams, building an operation spanning the globe and encompassing all aspects of chemistry services for early drug discovery.

Andy sits on the RSC Chemical Biology interface Forum Executive and the Chemistry World editorial board, and was for a number of years the European regional editor for the journal Combinatorial Chemistry and High Throughput Screening.

Dr Penny Ward, CMO, Topivert Pharma Ltd

Dr Penelope (Penny) Ward is Chief Medical Officer at Topivert Pharma Ltd. She qualified in medicine from University Hospital London entering the pharmaceutical industry as a clinical

research physician in 1991, after a clinical career in academic medicine and obstetrics and gynaecology. She has enjoyed an extensive industry career, including senior roles in both large pharma and small biotech companies. Her experience encompasses translational medicine, early and late stage clinical development, medical affairs, OTC switch and pharmacovigilance. Her work has resulted in the launch of several innovative medicines, small molecule and biologics, now used for the treatment of infection, inflammatory disorders, osteoporosis, neurological conditions, cancer and sexual and reproductive disorders.

Roger Joby, Managing Director, 1to1to1 Ltd

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.

“BOS cmc is a rare example of an event focused

on partnering in outsourcing and thereby

attracts those function in Pharma & Biotech

companies that we as a CMO need to meet:

a focused partnering event with excellent

participation”

Dr Marcel Hogerheide,Senior Business Development Manager, Hovione (BOS cmc, 16th June, 2011)

“Good Opportunity to meet people and get an update,

nice and relaxed format”

Dr Hans Lindner,Head of Global Pharma Development, Bayer Schering Pharma AG (BOS cmc 16th June 2011)

Correct at date of print 22nd August 2014

08.00 Registration and Partnering

16.00 Exploring the secret to sustainable, productive outsourcing partnerships. Perspectives on what makes a partnership work.

Chair: Roger Joby, Managing Director, 1to1to1 Ltd

Panel Member: Frederik Barfoed Beck, CMC Outsourcing Manager, Zealand Pharma A/S Life Science Consulting Director, Quintiles

Panel Member: Sarah Athey, Life Science Consulting Director, Quintiles

Panel Member: Dr Susan Coote, Head, Non-Clinical Global Outsourcing Management, Scinovo UK17.00 Conference Close – Drinks Reception

Outsourcing & Discovery Module Chair: Dr Duncan Judd, Discovery Science Consultants, Awridian Ltd

10.00 The resurgence of Phenotypic screening in drug discovery - Factors driving renewed interest and the opportunity for external technology providers Dr Steve Ludbrook, Group Leader, R&D Platform Technology & Science, GlaxoSmithKline

10.30 Translating academic drug discovery – balancing in house and CRO, Dr Andy Merritt, Associate Director Chemistry, MRC Technology

11.00 Selecting the right partnership model to fit your lead discovery & medicinal chemistry objectives, Dr Stefan Jaroch, Head of External Innovation Technology, Bayer Pharma AG

11.30 Making the most from out-sourcing (partnering) discovery and development: a novel immunotherapy (HF1020) for chronic inflammatory disease as a case study Professor Neil Williams, CSO, KWS Biotest

11.45 Early safety screening as a part of drug discovery, Dr Minna Komu, Business Development Manager, Admescope

12.00 Lunch and partnering

Outsourcing Early Development Module Chair: Dr Paul Madeley, Managing Director, Synth-Isis Ltd

13.30 Accelerating early development through smart repositioning strategies Dr Andy Baxter, Discovery & Development Consultant, ProPharma Partners Ltd, Dr Elena Lasterra, Independent IP Consultant, Lasterra IP, Dr Julie Warneck, Director, Protogenia Consulting Ltd

14.00 API sourcing strategy for early stage development Dr Paul Deutsch, Head of Chemical Process Development, UCB Pharma SA

14.30 Phase I formulation strategies – selecting the appropriate oral dosage form in early stage development Dr Rudolf Hausmann, VP Technical Development & Operations, Santhera Pharmaceuticals Ltd.

15.00 Particle engineering: bridging between drug substance and formulation development Dr Marcel Hogerheide, Senior Business Development Manager, Hovione

15.15 Hazard evaluation in drug substance development at Shasun Pharma Solutions Mike Smallwood, Business Development Director Shasun Pharma Solutions

15.30 Refreshments and partnering

Clinical Outsourcing Business Process Module Chair: Sandra Johnson, Independent Outsourcing Specialist, Freelance

10.00 Trials of the future: - adopting disruptive technologies by working with external partners to drive innovation in clinical development Tilo Hache, Development Strategic Sourcing, Global Category Manager, Novartis Pharma AG

10.30 Procuring niche technologies - adapting outsourcing process to accommodate breakthrough technologies and niche suppliers Dr Tamzin Blagbrough, Sourcing Consultant, Clinical Pharmacology Study Delivery Solutions, Eli Lilly

11.00 Tools and strategies to enhance communication & outsourcing process –RFI/RFP process and templates, Defining scope of work, Communication plan in outsourcing Roger Joby, Managing Director, 1to1to1 Ltd Dr Susan Tio-Gaillard, Director Clinical Program Management, Astellas Pharma Europe B.V

11.30 Biotech and CROs – forging strategic clinical development relationships Dr Peter MacLennan, Group Director of Business Development, SIMBEC–ORION

11.45 Xcellerate®: the power of data in optimising country and site selectionrelationships Martin Knight, Director, Operational Strategy and Planning, Covance

12.00 Lunch and partnering

Relationship Management in Outsourcing Module Relationship Management in Outsourcing Module

Dr Stephen Greentree, Director of Clinical Science, Takeda Pharma Europe,

13.30 Oversight and due diligence of clinical suppliers: perspectives from large pharma and small biotech Richard Scaife, General Manager, Vendor Management, Mitsubishi Tanabe Pharma

14.00 Working in partnership to manage regulatory inspections: Strategies for sponsors and vendors to effectively manage regulatory oversight and inspections Dr Amer Alghabban, Global Director Research & Development and Good Vigilance Practice Quality Assurance, Abbott Pharmaceuticals Operations

14.30 Clinical Development Strategies for SME Biotech: - Evaluating the different clinical development models to achieve POC within the unique parameters of the SME biotech Penny Ward, Chief Medical Officer, TopiVert Pharma Ltd

15.00 The bread and butter of early engagement: when more is better, Dr Jean-Marie Houle, Vice President Phase I, and Managing Director, Quintiles Drug Research Unit at Guy’s Hospital

15.15 Translational Pharmaceutics: How industry is benefitting from an integrated delivery platform Kieron Hall, Vice President, Business Development, Quotient Clinical

15.30 Refreshments and partnering