Speakers Include

David Larwood, CEO, Valley Fever Solutions Jacquie Mardell, Senior Director, Clinical Operations, Ascendis Pharma

Sameena Sharif, Vice President, Business Operations, Portfolio and Project Management, Astex Pharmaceuticals Gabriel Vargas, Executive Medical Director, Digital Health & Neuroscience Therapeutic Area Head, Amgen

William Goure, COO, Acumen Pharmaceuticals Jennifer Lai, Associate Director Clinical Research, Peregrine Chris Chan, Executive Director, R&D Finance, FibroGen, Inc.

Mark Milberg, Director, Clinical Procurement and Outsourcing, Ultragenyx Pharmaceutical Inc. Donald Kellerman, Vice President Clinical Development, Zosano Pharma

Donna Barragan, Associate Director Clinical Operations, Cytokinetics Lesley Stolz, Head, JLABS California, Johnson & Johnson Innovation, JLABS

Thomas Tremblay, Head of Clinical Operations, Apexigen Dr. Larry Weiss, Chief Medical Officer, AOBiome

Lori Carman, Vice President Clinical Operations, CytomX Therapeutics Gina Morton, Head of Resourcing Excellence, Genentech

Ed Jones, Regional Vendor Manager, North America, Genentech Stephen Smith, Senior Director Program Management, Audentes Therapeutics

Shaily Garg, VP Clinical Development and RA, Vaxart Craig Coffman, Director, Clinical Outsourcing, Nektar Therapeutics

John Kollins, President and CEO, Satsuma Pharmaceuticals Hugo Peris, CEO, Spiral Therapeutics

Scott Currence, Director Clinical Operations, MacroGenics Alec Vardy, Senior Director, Data Management, Jazz Pharmaceuticals

Francis Kendall, Digital Strategy Leader, Roche Genentech Janice Dahms, VP Project Management, Aradigm Vineeta Gulati, Director, Clinical Operations, GSID

Jeff Nelson, VP Program Management, Mateon Therapeutics Richard Shames, CMO, Protagonist Therapeutics

Mary Ann Smith, Director Regulatory Policy, Digital Medicines and Devices, Novartis Sue Naim, Director Clinical Operations, Astex Pharma

Naz Barlow, Previously Associate Director, Global Project Management, ARMO BioSciences Hendrik A Kroon, CMO, Hallux, Inc.

Ken Kengatharan, Managing Partner, Atheneos Capital Lori Carman, Sr. Director, Head of Clinical Operations, CytomX Therapeutics

Javier Szwarcberg, VP of Clinical Research and Business Development, Horizon Pharma Daniella Ajib, Associate Director, Clinical Contracts & Finance, Clinical Outsourcing, Gilead Sciences

Shad Ayoub, Director, Vault Clinical, Veeva Michael Wilkinson, Research Analyst, Tufts Center for the Study of Drug Development

Further Information

For sponsorship opportunities please contact:

Nicholas McCudden | Email: NicholasMcCudden@arena-international.com

For programme enquiries please contact:

Anne-Marie Mongan | Email: Annemarie.Mongan@arena-international.com | Tel: +44 207 9366887

Conference Name: Outsourcing in Clinical Trials West Coast Conference Date: 21st February Programme Day One

07:45 Registration and refreshments

08:20

Chair’s opening remarks Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing – Development Operations, Nektar Therapeutics

08:30

Keynote Panel Discussion Exploring new paradigms in clinical trial operations, partnerships and outsourcing to discern what new challenges need to be addressed

Assessing how outsourcing model preferences are changing among trial sponsors to evaluate how traditional partnerships are changing

Evaluating potential for new partnership models and strategic alliances to improve operational delivery

Determining the impact of new technology on clinical trials to explore what issues need to be overcome before we can see its full benefit

Looking at data-driven approaches for improving efficiency across clinical operations to determine what new capabilities exist for strategic decision-making

Scrutinizing ICHE6 R2 and forthcoming regulations to assess how the industry can proactively align with regulatory updates

Panelists: Alec Vardy, Senior Director Data Management, Jazz Pharmaceuticals Jacquie Mardell, Senior Director, Clinical Operations, Ascendis Pharma Larry Weiss, Chief Medical Officer, AOBiome

09:00

Developing strategies to enable your vendor to become an extension of your in-house team to improve collaboration and engagement

Evaluating how to best gauge chemistry and cultural compatibility during the vendor selection process to ensure you are acquiring a long-term partner

Developing the right management approach to ensure your partner becomes an extension of self

Highlighting the importance of stressing how your vendor’s work plays into your overall clinical objectives to ensure engagement throughout the partnership

Mark Milberg, Director, Clinical Procurement and Outsourcing, Ultragenyx Pharmaceutical Inc.

09:30

Considering quantitative and qualitative factors for outsourcing vs. building internal resources

Defining quantitative vs. qualitative factors to determine what companies should consider when determining the right outsourcing strategy

Appreciating the role that the right outsourcing strategy can play in your company achieving its development goals

Determining how to best analyze gaps in your company’s resources and capabilities to develop a strategy to best acquire them

Defining small and big company perspectives to define the different key factors that should be considered by each in their decision

Chris Chan, Executive Director, R&D Finance, FibroGen, Inc.

10:00 Faster Approvals but Less Innovation: Trend Analysis and Future Considerations

• Analyzing expedited FDA development pathways • Reviewing drug development policies • Exploring future considerations impacting innovation in drug development Nach Davé, Vice President, Global Regulatory Affairs, Premier Research

10:30 Morning refreshments and networking

Outsourcing

Clinical Technology and

Innovation

Early Clinical Development

Chairperson: Craig Coffman,

Executive Director, Clinical Business Operations & Outsourcing –

Development Operations, Nektar Therapeutics

Chairperson: Bruno Gagnon, BPharm, MSc Vice President, Development Operations, Eidos Therapeutics Inc.

Chairperson: Scott Currence, Director Clinical Operations, MacroGenics

11:00

Evaluating how to increase transparency between vendors and your in-house team to ensure trial quality goals are met

Highlighting the need for both parties to agree on definitions of processes and tasks to increase cost transparency

Evaluating the importance of reviewing contracts to test that all provisions are realistic

Jacquie Mardell, Senior Director, Clinical Operations, Ascendis Pharma

Case Study: Driving Innovation in Life Sciences to Deliver Patient Solutions

Appreciating that innovation is just as likely to come from outside the walls of a large healthcare company as it is from within.

Exploring why many innovative ideas fail at the early stage

Discussing a model for early-stage companies to bring their innovations in therapeutics, medical device or consumer health from concept to fruition.

Lesley Stolz, Head, JLABS California, Johnson & Johnson Innovation, JLABS

Exploring different funding sources for your early phase clinical development to determine how best to secure resources

Providing an overview of common funding methods to establish the high-level challenges and benefits of each

Highlighting the pressure that investors can put on biopharma companies to accelerate timelines to determine whether seeking external investment can damage the overall program

David Larwood, Chief Executive Officer, Valley Fever Solutions

11:30

Panel Session Debating whether strategic partnerships have caused your vendor to become complacent to develop innovative strategies for sustaining competitiveness

Determining how to assess if your vendor has become complacent to ensure you are getting the best support possible across your studies

Exploring the challenges and opportunities of machine-learning in drug development

Identifying the current capabilities of machine-learning in drug development

Assessing the key challenges that must be overcome to progress in this field

Exploring what new opportunities currently exist beyond the horizon

On-Stage Interview Critical success factors, challenges and benefits of securing funding from venture capital firms and family offices for life sciences companies. Moderator: Ken Kengatharan, President & CEO, Auxesia Orion and Managing Partner, Atheneos Capital

BRAND NEW FOR 2018!

Agenda Highlight

BRAND NEW FOR 2018!

Evaluating whether performance-

based incentives or penalties are the best way to reintroduce competition into the partnership

Donna Barragan, Associate Director Clinical Operations, Cytokinetics & Ed Jones , Regional Vendor Manager, North America, Genentech

Francis Kendall, Digital Strategy Leader, Roche Genentech

John Kollins, President, CEO & Cofounder, Satsuma Pharmaceuticals, Inc. Hugo Peris, Chief Executive Officer, Spiral Therapeutics Inc

12:00

Examining CROs’ progress in unifying clinical operations: Results from the Veeva 2017 Clinical Operations Survey: Annual CRO Report

Determining the drivers and barriers to unifying clinical systems and processes from the CRO perspective

Gaining insight into the current state of collaboration among CROs and sponsors

Understanding the approach CROs are taking to enable end-to-end processes, visibility, and collaboration in clinical trial execution

Shad Ayoub, Director, Vault Clinical, Veeva Systems

Overcoming Imaging Challenges: Strategies to Minimize Risk and Generate Higher-Quality Data

Enabling more objective

assessments unencumbered by

reader bias

Streamlining regulatory

compliance and speeding

approval timelines

Achieving greater data

consistency and complete data

transparency

Reducing rework and driving

operational efficiencies

Tim Kulbago, Vice President, Imaging ERT

Highlighting the top 3 benefits of Phase I manufacturing in a clinical research unit

Describing some challenges and

pitfalls in current common Phase I

manufacturing processes

Considering how you can

transition from preclinical to FIH

studies without a full CMC

process

Highlighting how Covance’s

unique Phase I GMP

manufacturing capabilities can

help you save time and money

while ensuring cGMP quality for

patient safety

Marcus Stavchansky, Pharm.D. Director, Pharmacy Services NA GCP, Covance CRU - Dallas

1:00 Lunch and networking

2:00

Whiteboard Session Developing best practices for RFP to ensure you can effectively compare vendors to select the best match for your study In this session, the host will share current practices and compile creative ideas from the audience to create an ideal RFP template and other best practices

Determining what selection criteria should be included to write a comprehensive proposal template

Evaluating how to account for non-numerical values such as

Exploring the current regulatory perspective on new clinical trial technologies to identify how the industry can move towards greater innovation in clinical research

Identifying key regulations past and present which have opened the way for innovation in clinical trials

Developing strategies for effective communication with regulatory agencies if you are considering implementing new technology into a trial to minimize future roadblocks

Workshop Exploring lessons learned from previous early phase studies to develop best practices moving forward During this session, delegates will be split into small working groups and tasked to identify best practices for each of the issues covered in the bullet points below

Investigating what is needed to properly resource an early phase study to ensure you have set aside sufficient time and budget

Assessing various study designs for early phase trials to decipher

WHITEBOARD SESSION

expertise to come to an informed decision

William F. Goure, Chief Operating Officer, Acumen Pharmaceuticals

Mary Ann Smith, Regulatory Policy Head of Digital Medicines and Devices, Novartis

which is best for balancing patient safety with quick progression to Phase II

Tasi Nelson, MSHS Sr. Clinical Program Leader, Clinical Operations & Rajesh Menon, MBA Associate Director, Clinical Operations Genentech, Inc.

2:30

Adopting new clinical trial innovations through outsourcing: strategies for implementation

Maximizing partnerships with vendors and SMEs to more effectively manage increasing study complexity

Offering new strategies for systems integration and change management at this time of explosive innovation in clinical research technology

Julie Ross, President, Advanced Clinical

Investigating Electronic Health Records (EHR) as eSource in clinical trials – from concept to reality

Describing changes in regulatory guidance for eSource that are paving the way to EHR integration

Exploring the challenges of integrating EHR to EDC

Defining the Value Proposition

Questioning whether EHR integration is a viable option for your studies

Discussing what approaches are available for EHR integration and detailing common objections

Exploring some Case Studies on EHR to EDC eSource Projects

Neil Vivian, Senior Director of Business Solutions, Omnicomm Systems

Transitioning to clinical trials: key insights for life science companies

Developing a strategy for your

clinical trials

Managing risk

What to avoid when creating your

plan

Marc Hoffman MD, Chief Medical Officer, Celerion

3:00

Identifying how to best develop and negotiate vendor contracts to ensure a solid foundation for your partnership

Underlining the importance of fully understanding how and what you will be charged for by the vendor to ensure accurate budget allocation

Considering the benefits of fixed fee site contracts to get quality data in a cost-efficient manner

Fireside Chat Exploring strategies for advancing clinical trial design to improve outcomes An informal discussion on-stage between the moderator and speaker. Delegates will have the opportunity to submit questions beforehand Richard Shames, Chief Medical

Developing strategies for finding the right partner to conduct your early clinical development study

Exploring different approaches to finding niche CROs to ensure your partner can meet your specific study needs

Identifying the best outsourcing model for working with service providers during early clinical development to discover whether functional or full outsourcing will provide you with the best quality resources

WORKSHOP

Gina Morton, Head of Resourcing Excellence, Genentech

Officer, Protagonist Therapeutics Moderator: Javier Szwarcberg, VP of Clinical Research and Business Development, Horizon Pharma

Lori Carman, Vice President Clinical Operations, CytomX Therapeutics

3:30 Afternoon refreshments and networking

4:00

Using heat maps, PBM data, predictive modeling and medical expertise in understanding, targeting and conducting effective patient recruitment

Discussing the use of geo-targeting to help understand where the highest volumes of patients and prescribers can be found

Illustrating how medical expertise for protocol analysis is essential for query design and targeting the right patients

Using real world evidence (RWE) for various medical conditions and diseases across the U.S. to improve site selection and patient enrollment

Detailing real-life examples that demonstrate the importance of data in increasing efficiencies across studies

Nancy Mulligan, Executive Director, Patient & Physician Services, United Biosource Corporation

Exploring the promise of technology outsourcing with cloud solutions, delivering simplicity and enhanced sponsor/provider relationships

Illustrating how cloud-based technologies simplify the transition as pharma and biotech companies increasingly move to outsource their technology solutions

Exploring how innovative providers can take away the burden of outsourcing by providing scalable solutions

Highlighting how the higher level of security and data transparency delivered by cloud solutions can enhance sponsor/ provider relationships

Paul Bidez, Ph.D, VP Regulatory & Clinical Solutions, PAREXEL

Session Reserved for Sponsor

4:30 Exploring best practices for conducting the bid defence meeting to ensure you select the best partner for your study

Examining what key personnel

should be in attendance to

ensure a thorough examination of

the service providers’ credentials

Detailing common mistakes made

by service providers to determine

how both sides can be best

prepared for the meeting

Donald Kellerman, Vice President, Clinical Development, Zosano Pharma

Case Study Exploring Amgen’s mHealth migraine study to determine the drivers and challenges of siteless trials

Describing the objectives of the study to determine the roadmap to success

Identifying initial pitfalls to develop strategies for overcoming common challenges

Gabriel Vargas, Executive Medical Director, Digital Health & Neuroscience Therapeutic Area Head, Early Development, Amgen

Evaluating Australia as a location for your early phase clinical trials to establish key benefits and challenges of this region

Establishing projected study start-up time in Australia to evaluate whether limited hurdles in this area outweigh other challenges

Reviewing the government’s R&D Tax Incentive to establish how cost-competitive this benefit makes Australia compared to other popular locations

Janice Dahms, VP Project Management, Aradigm

5:00

Attend Track B or C

Case Study Investigating the drivers and challenges of conducting mobile-enabled clinical trials to determine tangible benefits to patient engagement

Highlighting how mobile-enable clinical trials can widen your recruitment pool to ensure a more representative patient population for your study

Assessing to what extent retention rates are improved by reducing time and transportation issues for patients

Larry Weiss, Chief Medical Officer, AOBiome

Whiteboard Session Developing a holistic-approach to protocol development to avoid costly changes during your Phase 1 trial An interactive session; the host will work with the audience to compile a comprehensive list of best practices for protocol development

Highlighting the importance of performing a gap analysis to check that all necessary work has been carried out before you begin early clinical development

Determining how to accurately assess the time needed for procedures and assessments to evaluate the impact on patient enrollment timelines

Scott Currence, Director Clinical Operations, MacroGenics

5:30

Chair’s summary and close of conference Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing – Development Operations, Nektar Therapeutics

Conference Name: Outsourcing in Clinical Trials West Coast Programme Day Two Conference Date: 22nd February

Agenda Highlight

08:15 Registration and refreshments

08:50 Chair’s opening remarks

Clinical Operations and Outsourcing Clinical Software and Data-Driven Approaches

Chairperson: Anca Maria Copaescu, Chief Executive Officer, Strategikon Pharma

09.00

Developing an internal management strategy for multiple vendors to ensure effective use of time and resources

Highlighting the importance of determining what internal expertise is needed for effective vendor oversight to ensure you are meeting your requirements as a trial sponsor

Exploring the benefits of having one point-of-contact in-house for all vendors to ensure successful integration

Determining how to balance under-performing and over-achieving vendors to meet deadlines

Investigating what current systems and tools exist to aid management of vendors in a cost and time-effective way

Sameena Sharif, Vice President, Business Operations, Portfolio and Project Management, Astex Pharmaceuticals

Exploring the benefits of implementing analytics software to optimize your clinical trials

Highlighting how aggregating trial data into one platform facilitates efficient and effective trial management

Examining different types of risk and how they might be measured

Exploring ways of reducing the amount of information into meaningful measures

Understanding the limitations of analytics software and models – the human element in trial management

Alec Vardy, Senior Director Data Management, Jazz Pharmaceuticals

09:30

Increasing Enrollment While Reducing Sites

Using patient enrollment feasibility to inform patient accrual costs and timelines

Learning how sponsors’ reliance on in-practice patients is the ultimate driver of slow enrollment and misguided planning

Introducing global site networks to dramatically reduce study start-up times and costs, while increasing data quality

Using operational efficiencies to enhance your clinical trials

Daniel Brunwasser, Associate Director, Marketing Operations, Acurian

Easing The Burden Of Providing Clinical Study Subjects Unblinded Medication And Supplies

Exploring existing challenges with traditional processes for providing subjects with unblinded study medication and supplies

Presenting a paradigm change: an alternative process for providing subjects with unblinded study medication and supplies

Defining where the new process can be applied

Defining the benefits the new process delivers

Explaining how the new process works

Detailing case studies on applications of the new process and how study teams benefited

Jorge Franceschi MSH; Director Business Development, RxSolutions

BRAND NEW FOR 2018!

10:00 Developing strategies for small companies to ensure you always work with the A-Team for your study

Detailing why you should always meet your potential project manager during the bid-defense to assess whether they are a good fit with your in-house team

Highlighting the importance of stipulating in the vendor contract the individuals that you have agreed to work with to avoid having a subpar team manage your trial

Jennifer Lai, Associate Director Clinical Research, Peregrine

Exploring the rise of specialist payment providers to determine how site payments can be made more efficient

Evaluating the challenges of the common method of outsourcing site payments to your CRO to see where efficiency could be gained

Identifying how specialist payment platforms can streamline the payment process to reduce workload and related costs

Exploring the intricacies of properly managing site payments on a global scale to show how the process can be automated

Describing how specialist payment platforms can further support the aggregation of financial data to better enable CROs and trial sponsors to manage trial costs

Jeff Nelson, VP Program Management, Mateon Therapeutics, Inc.

10.30 Morning refreshments and networking

11:00

Developing risk assessment and mitigation strategies to ensure your clinical trial runs smoothly

Providing an overview of keys steps that should be taken in risk assessment to ensure the process is robust

Highlighting the importance of identifying root cause risks to effectively plan actions and trigger points to implement these actions

Defining how to decide risk responses based on perceived severity of risk to ensure appropriate mitigating action is taken

Assessing how to proactively weave risk evaluation and mitigation into your trial design to ensure the correct procedures are in place from the beginning

Thomas Tremblay, Senior Director Clinical Development, Apexigen

Determining the advantages of eTMF to evaluate whether adoption of this software will result tangible cost-time benefits Exploring what traditional burdens of sponsor-vendor partnerships eTMF is removing to determine how the solution benefit your vendor relationships

Detailing what internal resources and expertise are needed to properly manage eTMF and what can be outsourced

Evaluating how to make the most of eTMF capabilities for real-time tracking and documentation to analyze existing data and quickly determine what is missing

Assessing how eTMF can quicken study start-up and study close-out to shorten clinical trial timelines

Hendrik A Kroon, CMO, Hallux, Inc.

11:30

Using the Right Predictive Model at the Right Time to Conduct Clinical Site Feasibility

Managing the burden of high level program

planning, complexity, and specificity as individual

studies are designed and launched

Understanding how various predictive modelling

approaches can be applied at various stages of

feasibility to drive optimal decision-making and

program and study planning

Exploring Three Key Ways ICH E6 (R2) Impacts Study Oversight

Determining how alignment and stronger relationships can be built between Sponsors and CROs

Investigating how to share trial data to improve transparency and trial outcomes

Exploring the best ways to measure performance and conduct between the Sponsor and CRO with a risk-based approach

Adapting predictive models in response to new

information as protocol and site feasibility

activities progress

Evaluating trial strategy and anticipating

enrollment outcomes to produce more clear and

accurate risk profiles

Travis Caudill, Vice President, Clinical Operations Feasibility & Site Activation, Worldwide Clinical Trials

Julie Peacock, VP Marketing Comprehend Systems, Inc & Christopher M. McSpiritt, Director Consulting Services, Life Sciences Sector

12:00

Exploring New Tufts Research on Sponsor / CRO eClinical Trends

Highlighting how sponsor and CRO cycle times compare for database build, data entry, and database lock

Understanding how seemingly minor decisions can significantly impact overall clinical trial timelines

Overcoming key clinical data management challenges including protocol changes, source data verification, and more

Michael Wilkinson, Research Analyst, Tufts Center for the Study of Drug Development

Exploring ways to negotiate and manage study budgets to ensure resources are allocated efficiently

Assessing best practices for negotiating budgets with new vendors to decide on a reasonable amount and align timelines for the study

Pinpointing methods for forecasting protocol design costs to improve efficiency

Highlighting the importance of regular communication with stakeholders to determine the resources required for the trial

Promoting strategies for monitoring sites and vendors to ensure the study stays within a strict budget

Considering alternative methods for appealing to new investors to achieve as much funding as possible for your trial

Kunal Sampat, Senior Manager, Clinical Affairs, Abbott

12:30 Lunch and networking

1:30

Assessing the benefits and pitfalls of functional outsourcing to determine whether it is the optimum model for increasing efficiency of clinical trials

Evaluating whether outsourcing across functions results in better quality data to determine which model is best for meeting your objectives

Debating whether the functional model works for international trials to determine whether you should instead outsource to a CRO with local expertise in this scenario

Highlighting the flexibility functional outsourcing provides by being a scalable model which will allow your company to increase or decrease support requirements as needed

Determining whether the functional model guarantees your company best-in-class resources to avoid working with the B-team for your study

Exploring when and how to diversify your asset – some opportunities and limitations

Setting the stage: what are triggers of a go/no go decision to asset diversification in clinical development?

Exploring different pathways: Common vs emerging paths to asset diversification to consider

Setting context: How does targeted or personalized medicine impact asset diversification – or does it yet?

Ben Cadieux, Head Medical Affairs, Rigel Pharmaceuticals, Inc

Agenda

Highlight

Daniella Ajib, Associate Director, Clinical Contracts & Finance, Clinical Outsourcing, Gilead Sciences

2:00

Developing strategies for better site engagement to minimize site drop-out from your trials

Highlighting the need to avoid overly complex protocol which is difficult to translate into practice

Underlining the importance of providing ongoing training for site staff to ensure adherence to protocol and data quality

Determining how to improve direct communication and involvement with sites to ensure continued engagement in your study

Debating the extent to which sponsors and CROs should be involved in the site engagement process to determine the most efficient balance

Naz Barlow, Previously Associate Director, Global Project Management, ARMO Biosciences

Assessing the unique challenges that gene therapy companies face in clinical operations and outsourcing

Navigating the complex site approval process for gene therapy studies

Scaling up manufacturing to produce sufficient vector for systemic administration

Finding subjects for gene therapy studies in rare / ultra-rare diseases

Stephen Smith, Senior Director, Program Management, Audentes Therapeutics

2:30 Afternoon refreshments and networking

3:00

Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on running trials successfully in a specific region, this session will enable you to discover 10 best practices for working in your region of choice. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables. A list of best practices for each roundtable will be distributed after the conference

Topic: Establishing best practices for running international trials to overcome cultural, operational and regulatory barriers

Roundtable 1

Europe Host: Shaily J. Garg, Executive Director Clinical Development, Bioverativ Therapeutics

Roundtable 2

China Host: Sulan Yao, Director, Program Management, Ambrx, Inc

Roundtable 3

South Africa Host: Vineeta Gulati, Director, Clinical Operations, GSID

4:30 Chair’s summary and close of conference