outsourcing in clinical trials west coast

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HEAR FROM KEY INDUSTRY SPEAKERS: Gavin Choy, Vice President, Clinical Operations, SUPERGEN Nancy Havrilla, Senior Director, Clinical Operations, ACHAOGEN Lorna Dean, Director, SPM-Supplier Performance Management, AMGEN Raymond Starling, Senior Director, Clinical Development and Operations, ATHERSYS Christina DiArcangelo, Associate Director, Clinical Contracts and Outsourcing, FIBROGEN Susan Iovino, Director, Clinical Operations, NOVABAY PHARMACEUTICALS Todd Reul, Associate Director, Clinical Outsourcing, FACET BIOTECH Henry Brandon, Regional Head North America, Global Strategic Outsourcing, BAYER PHARMACEUTICALS KEY REASONS TO ATTEND: Improve your long-term outsourcing strategies to overcome clinical trial challenges in the current economic climate Take away ideas on CRO selection and techniques to maximize the return on your outsourcing investment from proven methods that demonstrate value for money Develop more robust project management processes through case studies highlighting strategies to ensure smooth, cost effective and successful trials Discover ways you can improve your offshoring strategy and make the most of opportunities for conducting trials in emerging countries Supplier selection strategies and vendor management processes to maximize the return on your outsourcing investment REGISTER NOW: Online: www.vibpharma.com/outsourcing/west Tel: +44 (0)20 7753 4268 Email: [email protected] Fax: +44 (0)20 7915 9773 Timothy McNamara, Vice President, Clinical Research and Medical Affairs, ISTA PHARMACEUTICALS Rafael Escandon, Vice President, Clinical Operations, CYTOKINETICS Jacqueline Mardell, Senior Director, Clinical Operations, METABOLEX Francie Kivel, Senior Director, Clinical Trials, AASTROM BIOSCIENCES Elizabeth Shewell, Director, Outsourcing, INCYTE CORPORATION Maria Madison, Director, Clinical Operations, ENANTA PHARMACEUTICALS Wednesday 27 and Thursday 28 January 2010, San Francisco, USA VIB pharma BAYER PHARMACEUTICALS AMGEN FIBROGEN FACET BIOTECH NOVABAY PHARMACEUTICALS METABOLEX CYTOKINETICS ISTA PHARMACEUTICALS ATHERSYS AASTROM BIOSCIENCES ACHAOGEN INCYTE CORPORATION OUTSOURCING IN CLINICAL TRIALS WEST COAST TOP COMPANIES REPRESENTED: Silver sponsors: Gold sponsor: , INC.

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Outsourcing in Clinical Trials West Coast will bring together pharma and biotech manufacturers to share solutions to strategic and operational challenges in outsourcing. Attendees will generate new ideas to save time and cost and increase the return on your outsourcing investment. Located in San Francisco, this event will cover topics including developing an effective selection strategy, measuring agreed outcomes, choosing between tactical and strategic outsourcing, managing multiple vendors, measuring ROI and effectively managing trials run in emerging markets – key components to help you get the most out of your outsourcing investment.

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Page 1: Outsourcing In Clinical Trials West Coast

HEAR FROM KEY INDUSTRY SPEAKERS:Gavin Choy, Vice President, Clinical Operations, SUPERGEN

Nancy Havrilla, Senior Director, Clinical Operations, ACHAOGEN

lorna Dean, Director, SPM-Supplier Performance Management, AMGEN

Raymond Starling, Senior Director, Clinical Development and Operations, ATHERSYS

Christina DiArcangelo, Associate Director, Clinical Contracts and Outsourcing, FIBROGEN

Susan Iovino, Director, Clinical Operations, NOVABAY PHARMACEUTICAlS

Todd Reul, Associate Director, Clinical Outsourcing, FACET BIOTECH

Henry Brandon, Regional Head North America, Global Strategic Outsourcing, BAYER PHARMACEUTICAlS

KEY REASONS TO ATTEND: Improve your long-term outsourcing strategies to overcome clinical trial challenges in the current economic climateTake away ideas on CRO selection and techniques to maximize the return on your outsourcing investment from proven methods that demonstrate value for moneyDevelop more robust project management processes through case studies highlighting strategies to ensure smooth, cost eff ective and successful trialsDiscover ways you can improve your off shoring strategy and make the most of opportunities for conducting trials in emerging countries

Supplier selection strategies and vendor management processes to maximize the return on your outsourcing investment

REGISTER NOW: Online: www.vibpharma.com/outsourcing/west Tel: +44 (0)20 7753 4268Email: [email protected] Fax: +44 (0)20 7915 9773

Timothy McNamara, Vice President, Clinical Research and Medical Aff airs, ISTA PHARMACEUTICAlS

Rafael Escandon, Vice President, Clinical Operations, CYTOKINETICS

Jacqueline Mardell, Senior Director, Clinical Operations, METABOlEx

Francie Kivel, Senior Director, Clinical Trials, AASTROM BIOSCIENCES

Elizabeth Shewell,Director, Outsourcing,INCYTE CORPORATION

Maria Madison, Director, Clinical Operations, ENANTA PHARMACEUTICAlS

Wednesday 27 and Thursday 28 January 2010, San Francisco, USA

VIBpharma

BAYER ●

PHARMACEUTICALSAMGEN ●

FIBROGEN ●

FACET ● BIOTECHNOVABAY ●

PHARMACEUTICALS METABOLEX ●

CYTOKINETICS ●

ISTA ●

PHARMACEUTICALSATHERSYS ●

AASTROM ●

BIOSCIENCESACHAOGEN ●

INCYTE ●

CORPORATION

OUTSOURCING IN CLINICAL TRIALS

WEST COAST

TOP COMPANIES REPRESENTED:

Silver sponsors:Gold sponsor:

, INC.

Page 2: Outsourcing In Clinical Trials West Coast

Program Day One Wednesday 27 January 2010

11:40 Risk management for small pharma and biotechs: making the right decision on how much to outsourceAvoiding costly and critical mistakes that can cripple small biotechs ●

Compare full service versus functional outsourcing models and the ●

implications for small scale trialsFinding CROs with the right level of expertise and experience in ●

similar sized trialsEnsuring that your trial is given the resources and time it needs ●

when competing with large scale trialsChristina DiArcangelo, Associate Director, Clinical Contracts and Outsourcing, FIBROGEN

12:10 The CRO selection process: how it can hinder or help identifying the best possible partnerOperating a preferred provider list versus a competitive tender ●

process: over-reliance versus a lengthy inefficient selection process?Avoiding path dependency on the selection processes without ●

reinventing the wheelAssessing strengths and weaknesses of potential partners using ●

case study data and like for like comparison toolsSaving time through developing your own bid grid for CROs to ●

submit proposalsEnsuring consistent understanding and interpretation amongst ●

vendors of sponsor expectations, timelines and budgetsMaria Madison, Director, Clinical Operations, ENANTA PHARMACEUTICAlS

12:40 Lunch

2:00 Implementing optimal outsourcing strategies to safeguard the future of the virtual pharma modelOutlining the present trends for virtual pharma companies and ●

implications for the outsourcing modelSolutions for cutting costs without compromising drug ●

development activities in the current funding crisisIdentifying expertise and guidance on cost effective alternatives to ●

outsourced functionsFinding the right trial partner to fit your business model and size, is ●

bigger always better?Managing delays due to unexpected factors controlled by suppliers ●

to ensure timelines are kept on trackAvoiding common time and cost overruns and ensuring the best ●

service from your CROA panel of speakers from the two days will discuss and take questions on this important issue

2:30 Offshoring to emerging countries: reducing costs and achieving consistency in uncertain trial environmentsUnderstanding the nuances of the changing regulatory ●

environments in offshore clinical trials to better manage trial risksKnow your environment: an up-to-date picture of standards in the ●

EU, India and ChinaMatching trials to the right country: evaluating trial requirements ●

with different regulatory and environmental factorsChoosing CROs that have credible and substantiated experience in ●

trials with key groupsJacqueline Mardell, Senior Director, Clinical Operations, METABOlEx

3:00 Panel Discussion: Metrics and KPIs for improving trial processesStandardization of trial functions and use of metrics to measure ●

desired outcomesIdentifying CROs that can operate within the framework of your KPIs ●

Ensuring compliance with in-house processes and protocols ●

Improving the sponsor’s ability to control and monitor studies ●

in order to significantly reduce trial timesA panel of speakers from the two days will discuss and take questions on this important issue

8:30 Registration

9:00 Opening remarks from the ChairMaria Madison, Director, Clinical Operations, ENANTA PHARMACEUTICAlS

Sustainable strategies to safeguard the return on your outsourcing investment9:10 Keynote presentation:

Outsourcing in uncertain times: asset management strategies for long term survivalGetting the balance right between retaining in-house capacity and ●

relying on CROsMaking the most of the opportunities for cost savings and cheaper ●

trials in the current economic climateStrategies for leveraging CROs on cost in a competitive market ●

Identifying solutions to project management resource obstacles to ●

ensure a smooth trial processGavin Choy, Vice President, Clinical Operations, SUPERGEN

9:40 Making the right outsourcing decision first time: avoiding a chop and change approach to reduce costly errors Understanding and setting manageable expectations of your ●

trial partnerTaking the time to get the contract right to save time during trials ●

Making decisions on the basis of evidence and sustained ●

trial outputManaging the pressure to get results quickly without compromising ●

your trialKnowing when to end a relationship and preventing rushed ●

decisions on the effectiveness of a CRONancy Havrilla, Senior Director, Clinical Operations, ACHAOGEN

10:10 Managing costs and expenditure in outsourced clinical trialsUnderstanding how trial costs are calculated to enable better ●

decision makingAddressing the cost implications of outsourcing different functions ●

Getting value for money from CRO partners ●

Evaluating inconsistencies between CRO pricing models and how to ●

interpret themMeasuring ROI on outsourced trials ●

Quantifying the value of a partnership for quicker decision making ●

on future trialslorna Dean, Director, SPM-Supplier Performance Management, AMGEN

10:40 Morning Refreshments

Improving selection processes to minimize risk and maximize time and cost savings11:10 Ensuring trial partners are fit for purpose by

implementing an efficient and thorough selection processDetermining your selection criteria for seeking out the right ●

quality partnerGathering information on potential partners to ascertain capabilities ●

and strengthsMeasuring track records and expertise: using case studies to gauge ●

competenciesMitigating inherent risks in outsourcing: ensuring your contract ●

covers all areas of the timeline, service and budget during the negotiation stageEstablishing a relationship prior to selection to get the trial off to the ●

best startRaymond Starling, Senior Director, Clinical Development and Operations, ATHERSYS

Page 3: Outsourcing In Clinical Trials West Coast

8:30 Registration

9:00 Opening remarks from the ChairRafael Escandon, Vice President, Clinical Operations, CYTOKINETICS

Offshore clinical trials: keeping complex projects on time and within budget9:10 Keynote presentation:

Ethical responsibilities of developed world sponsors conducting clinical trials in developing countriesKey decision drivers supporting the conduct of your trial abroad ●

Appreciating cultural differences and minimizing risks of errors ●

Assessment of partner’s ability to meet trial expectations ●

Analyzing history of ethical and GCP compliance and regulatory ●

track record Appropriate site selection and other resource allocation, planning ●

and logistics Patient recruitment considerations in new trial localities ●

Site and vendor contract strategies ●

Sustaining local access to treatments ●

Rafael Escandon, Vice President, Clinical Operations, CYTOKINETICS

9:40 Keynote presentation: Conducting strategic clinical trials in China: 2010The current status of the Chinese regulatory environment for ●

conducting clinical trialsClinical facilities accredited by China SFDA to conduct trials ●

Advantages and disadvantages of conducting trials in China ●

Recent outcomes regarding US FDA site inspections in China ●

Strategic practices to conduct successful trials: planning, ●

training and partnershipDr xiaxiong Wei, Director, Clinical Pharmacology, MEDPACE

10:10 Panel discussion: Developing effective supply chain planning for shipping to offshore trial sitesPlanning how much supply is needed and coordinating with ●

trial partnersBlinding techniques for various phases and purposes in clinical trials ●

Pharmaceutical and biotech aspects of blinding comparators ●

Understanding the role and responsibilities of clinical supply ●

chain planners and managersClinical supply management team structure and effectiveness ●

Collaborating and working with clinical groups: challenges ●

and opportunitiesA panel of speakers will discuss these issues and take questions on project management processes.

Overcoming patient recruitment challenges and building flexibility into your clinical trials10:40 Boosting patient participation and compliance using

an in-home clinical service modelIncreasing patient comfort and convenience to maximize patient ●

recruitment, compliance and retentionIncreasing efficiency by understanding what a centrally managed in- ●

home clinical service model is and what services can be provided to study patients at their home or other convenient locationsEffectively implementing these services and addressing the ●

regulatory issues to optimize patient recruitment strategiesPractical case studies: trials that effectively utilized homecare ●

services to speed recruitment, enhance compliance and increase patient satisfaction Gail Adinamis, President and CEO, ClINICAl RESOURCE NETWORK

11:10 Morning refreshments

3:30 Afternoon refreshments

A step-by-step approach to selecting trial partners to avoid costly errors4:00 Identifying and selecting your short-list and

preferred CRO partnersLooking at your organization and the specific areas that you are ●

trying to enhance when selecting providersBreaking down functional areas during selection: therapeutic ●

expertise, geographic reach, clinical service areas, lab, imaging from one provider or multiple providersManaging the process of canvassing the marketplace of all the ●

providers that offer required services and submitting Request for Information (RFI)Evaluation of RFI responses and face-to-face meetings with a ●

subset of suppliersIdentifying the right number of partners - how many is reasonable ●

and the advantages and disadvantages of more or lessMSA process and terms and conditions to consider while going ●

through this processHenry Brandon, Regional Head, North America Global Strategic Outsourcing, BAYER PHARMACEUTICAlS

4:30 An outcome-based approach to outsourcing: balancing cost and quality considerations for optimal resultsFocusing clinical trial processes and outsourcing decisions on ●

desired outcomesConducting a study-specific analysis using key factors such as the ●

ideal patient profile, technological and expertise needs for the trial when determining whether to outsourceIdentifying the best opportunities for strategic partnerships ●

Knowing your partner’s capabilities to determine agreed ●

outcomes prior to a trialDetermining the right level of support and monitoring for ●

optimal resultsTimothy McNamara, Vice President, Clinical Research and Medical Affairs, ISTA PHARMACEUTICAlS

5:00 Closing remarks from the Chair and end of day one

Day One Wednesday 27 January 2010

REGISTER ONLINE NOW! www.vibpharma.com/outsourcing/west

Program Day Two Day Two Thursday 28 January 2010

Page 4: Outsourcing In Clinical Trials West Coast

11:40 Investigational medicinal products for the EU: rules, regulations, solutions and supportFramework and context of EU legislation including the CTD Directive ●

2001/20/EC and annex 13 to the EU GMPs under 2003/94/ECPractical requirements and preferences in operational GMPs ●

Product specification files ●

Investigational medicinal product dossiers ●

What do Qualified Persons do? ●

Conducting QP audits of non EU facilities and QP declarations ●

for importProvision of comparators and ‘NIMPs’ ●

Answering the ten key questions for outsourcing IMP supply to the EU ●

Paul Thomas, Chief Scientific Officer, PENN PHARMA

Building flexibility into your processes for smoother clinical trials12:10 Panel discussion:

The impact of internal processes and diverse project teams on CRO managementHow to overcome internal differences in communication and ●

monitoring of CROsDeveloping a preferred list of providers to speed up the trial set ●

up processUsing hybrid project teams to improve the relationship ●

management processLearning from success and failure to improve project management ●

of outsourced trialsDealing with the challenge of maintaining control and decision ●

making speed while managing internal growthA panel of speakers from the two days will discuss and take questions on this important issue. Panel will also include Susan Iovino, Director, Clinical operations, NOVABAY PHARMACEUTICAlS

12:40 Lunch

Innovation in project management to better trial monitoring2:00 Precontract audits of CROs to reduce outsourcing risks

Assessing the capabilities and free capacity of CROs to achieve ●

project goalsIdentifying CRO standard operating procedures to ensure ideal fit ●

with sponsor processesQuantifying impact on resource availability of subcontracted ●

functions to third partiesContinuous development and training of staff to keep up to date ●

with technologies and standardsMatching hardware and software capabilities to trial needs to ●

ensure quick and cost efficient data analysisFrancie Kivel, Senior Director, Clinical Trials, AASTROM BIOSCIENCES

2:30 Agreeing the parameters of communication and reporting by CROs during the trial processEnsuring that everyone knows their responsibility at the outset ●

of a trialKeeping track of progress to address issues early without ●

jeopardising outcomesDeveloping a strategic process to achieve agreed outcomes on time ●

and on budgetReducing the amount of necessary oversight to increase trial ●

efficiency and ease the burden on sponsorsIdentifying vendors with good reporting tools and transparent ●

communication processesTodd Reul, Associate Director, Clinical Outsourcing, FACET BIOTECH

Successful trial management: reducing change orders and keeping to budget3:00 Building flexibility into processes to incorporate

changes to the scope of your trialNegotiating budgets and agreements to ensure visibility on all sides ●

Understanding internal budgetary implications of change orders ●

How to determine the limits of your budgets and agreeing these ●

with your CRO Strategies to reduce the likelihood of change orders ●

Elizabeth Shewell, Director, Outsourcing, INCYTE CORPORATION

3:30 Afternoon refreshments

Successful vendor management frameworks for clinical trials4:00 Establishing a sustainable governance relationship

What is governance and why is it important? ●

Getting internal buy-in and commitment for governance ●

Navigating levels of governance (executive, operational and ●

business management)Establishing metrics and identifying CROs that can operate within ●

an agreed performance frameworkDeciding on the content to be covered by each level of governance ●

Keeping momentum going during a trial to ensure desired ●

outcomesHenry Brandon, Regional head North America, Global Strategic Outsourcing, BAYER PHARMACEUTICAlS

4:30 Relationship management and partnership working across multi-site trialsGiving CROs flexibility while ensuring best use of resources and ●

minimal delaysMaintaining ongoing communication to ensure key deliverables ●

and timelines are metRelationship management across multiple trial sites: balancing ●

cost decisions with the practicalities of monitoring and communicationMaking the right decision: keeping project management in-house ●

or outsourcing to a service provider?Jason lindow, Associate Director, Clinical Operations, OxIGENE

5:00 Closing remarks from the Chair and end of conference

Program Day Two Day Two Thursday 28 January 2010

Page 5: Outsourcing In Clinical Trials West Coast

Do you wish to exhibit your products and services at this exclusive event? Contact details: Nick McCudden, Sponsorship Manager +44(0) 207 753 [email protected]

Testimonials from our past event“This has been a very informative conference. All the speakers were interesting and provided a lot of information. I enjoyed the roundtable discussions. It was really nice to talk to all the vendors. There weren’t too many and there wasn’t too little. Really enjoyed the two days. The setup with the breaks and lunch with the vendors was good for interactivity.” Director, Clinical Ops. NOVOBAY

“I am impressed by the quality and experience of the speakers. Learning the approaches of other sponsor speakers provides valuable information that I can use when dealing with vendors. The conference has been excellent and I hope to attend again next year.”Outsourcing and Contracts Manager, SCHWARTZ BIOSCIENCE/UCB

Gold SponsorMedpace is a full-service, global contract research organization (CRO) that partners with biopharmaceutical companies to

bring innovative drugs to market. Medpace, based in Cincinnati, Ohio, manages global studies and regulatory submissions, providing clinical trial support in all phases of development up to and including submissions to regulatory agencies. In addition to full-service CRO functionality, Medpace has international operations that include bioanalytical and pharmacology capabilities, central laboratory, and core imaging services. Medpace physicians have extensive experience conducting clinical trials and understand the issues from the perspective of the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. Medpace brings these perspectives to each clinical trial that we conduct. www.medpace.com

Silver SponsorPenn Pharma is a leading provider of integrated product development and custom manufacturing services to the international healthcare industry including formulation and analytical

development, clinical trial supply, custom manufacture, high containment processing, CMC consultancy and QP release services. Penn manufactures to GMP and is MHRA licensed and FDA inspected. www.pennpharm.co.uk

Clinical Resource Network, LLC is a leading provider of specialized in-home and alternate-site nursing, pharmacy and phlebotomy services for phase I-IV studies conducted in the US, Canada, UK,

Europe and Israel. These services decrease development time by accelerating patient recruitment and improving compliance and retention. CRN supports trials in all therapeutic categories and age groups. CRN centrally manages an extensive network of clinicians from over 3,000 agencies with services available 24/7. Services for taking selected protocol visits to the patient include:

Study drug dispensing and administration (IV, injection, oral) •Blood draws (safety labs, serial pK) •Patient training, education and assessments •

www.clinicalresource.net/

M2S offers a full range of image management services, utilizing cutting-edge technologies to provide high-quality data at the lowest total delivered cost. Our “end-to-end” clinical trial services

include protocol development, electronic image collection, independent radiological review, archiving and web-based data reporting as well as clinical data registries and post-surveillance data management. www.m2s.com

We offer worldwide comparator drug sourcing and distribution for clinical trials. With GDP licensed facilities in Switzerland, Germany and New Jersey we fulfill needs of single lot, long expiration date, Certificate of Analysis, Material

Safety Data Sheet, GMP Certificate, samples, etc. We have the capacity and experience to supply large amounts fast directly from the manufacturer. www.multipharmaus.com

Sponsors and Media Partners

Media partnersPharmaceutical Technology is used daily as a means of creating partnerships and as a point of reference by professionals

within the pharmaceutical industry. This comprehensive resource supplies the latest news releases, detailed information on industry projects, white papers, event information and a thorough breakdown of products and services. www.pharmaceutical-technology.com

World Pharmaceutical Frontiers: The pharmaceutical industry is changing fast. There are more regulations, technologies,

faster product launches and shorter product life cycles than ever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront of these changes, so visit us at www.worldpharmaceuticals.net and stay up to date with all latest developments.

Drugdevelopment-technology.com: is a procurement and reference resource providing a one-stop-shop for professionals

and decision makers within the drug development and medicines industry. They provide a comprehensive breakdown of drug development contractors and suppliers, up-to-date news and press releases, white papers and detailed information on current industry projects and trends. Their recruitment area provides career information and the latest job vacancies in the field. www.drugdevelopment-technology.com

Pharmaceutical Business Review: The Business Review websites are your number one stop for all the latest news, comment and industry information. Each Business Review website offers content that is produced by a

dedicated team of journalists and global industry experts.In addition to the free content made available on the sites an intelligence store will provide you with premium market analysis reports from the leading global suppliers of market research and industry analysis.Pharmaceutical Business Review is the world's leading pharma website, being used by over 100,000 visitors every month. For further information contact [email protected]

World Pharmaceutical Frontiers www.worldpharmaceuticals.net

a division of

Exhibitors

, INC.

Page 6: Outsourcing In Clinical Trials West Coast

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Oursourcing in Clinical Trials West Coast, Wednesday 27 and Thursday 28 January 2010, San Francisco, USA

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