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10th Annual Outsourcing in Clinical Trials 6th & 7th November, 2018 Boston, Massachusetts

OCT New England is a strategic event targeted at those who have clinical, technological and regulatory responsibility for the outsourcing of clinical trials.

Our three dedicated work streams will focus on clinical trial technology innovation, improving

operational efficiency in clinical trials and our brand new working group clinical operations in early phase development.

The key outcome of this meeting will be to balance outsourcing and in house delivery to overcome

current operational challenges in clinical trials. Take a look at the following agenda to see fresh 2018 content and more interactive sessions.

2018 Advisory Board

Hyun Kim, Head, Clinical Operations, AOBiome Kate Hoffman, PhD, MPH, Director, Clinical & Medical Affairs Allena Pharmaceuticals

Maria Makarovskaya, Director, Clinical & Strategic Sourcing, TESARO Vikas Agarwal PhD., Program and Outsourcing Management, Senior Director, TARIS

Paul Adams, Sales Director-Healthcare, Arena International

2018 Confirmed Faculty CAPT Richardae Araojo, Pharm.D., MS, Associate Commissioner for Minority Health, Director, Office

of Minority Health, U.S. Food and Drug Administration James Sherley, Director, Asymmetrex, LLC

Ken Getz, Associate Professor; Director of Sponsored Programs, Centre for the Study of Drug Development, Tufts University School of Medicine

Eyal S. Ron PhD., Chief Technology Officer, Gelesis Inc Kevin Anderson, Director, Global Clinical Operations, Alexion Pharmaceuticals

Amanda Hayden, Director, Global Clinical Services, Alkermes Giovanni Abbadessa, AVP, Head of Isatuximab Non-Myeloma Development, Sanofi

David Sherris, President & Chief Executive Officer, GenAdam Adrian Orr, Director of Clinical Affairs, Anika Therapeutics

Rinaldo Dorman, Clinical & Medical Category Lead R&D Procurement, Shire Beth Zaharoff, Senior Director, Patient Focused Engagement and Partnerships, TESARO

Matt Weinberg, Director Strategic Sourcing, Agios Pharmaceuticals Heather Shih, Head of Operations & External Services Management, EMD Serono Kimberly Guedes, Executive Director Clinical Operations, Centrexion Therapeutics Christine Tosone, Executive Director, Clinical Operations, Allena Pharmaceuticals

Gina Bellistri, Director, Clinical Outsourcing, CRISPR Therapeutics James White, President and Co-founder, Common Sensing

Paul Kravitz, Director, Regulatory & Clinical Affairs, DEKA Research & Development Corp Kuldeep Neote, Senior Director of New Ventures, Johnson and Johnson Innovation

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Elspeth Carnan, Vice President, Global Head, Service Provider Management Global Clinical Operations, EMD Serono

David Hoey, Chief Executive Officer, Vaxxas Inc Terry Robins, Senior Director Clinical Affairs, Infectious Disease, Alere

Upma Sharma, Vice President, Arsenal Medical Hilary Luderer, Director of Translational and Clinical Research, Pear Therapeutics

Sekou Dilday, Clinical Procurement Lead, Shire Pharmaceuticals Wes DeHaan, PhD, Vice President, Gout Program Lead, Selecta Biosciences

Professor Steve Gould, Scientific Advisory Board, TAVEC Carol Lewis-Cullinan, Vice President, Clinical Operations & Data Management, Seres Therapeutics

Susan Stewart, Senior Vice President Regulatory Affairs and Quality Assurance, Kaleido Biosciences Stephen Palmer, Chief Scientific Officer, TocopheRx

Heather Dibenedetto, Head, Therapeutic Operations, Moderna Therapeutics Querida Anderson, Editor in Chief, GlobalData

Jennifer Goldman, Director, Clinical Business Operations, Deciphera Tony Carita, Strategic Outsourcing, Deciphera

Alyce King, Manager Business Development, Novotech CRO David Ng, Vice President of Biostatistics & Data Operations, ResearchPoint Global

Marcus Stavchansky, Pharm.D., Global Head Pharmacy Services, Covance Travis Caudill, Vice President, Clinical Operations Feasibility & Site Activation, WorldWide Clinical

Trials Vicki Anastasi, Vice President and Global Head, Medical Device and Diagnostics Research, ICON plc

Charles Raymond, Director, Business Operations & Strategic Alliances Medical Device and Diagnostics Research, ICON plc

Christine McLennan, Director Clinical Operations, EveloBio Kathleen Findlen, Head of Clinical Operations and US Project Management, Life Molecular Imaging,

Inc

Colin Hayward, Chief Medical Officer, Premier Research

Lynn DiFinizio, Director of Clinical Programming and Technical Solutions, Alkermes

Matthew Kratz, Senior Manager, Patient & Physician Services, United BioSource Corporation

Chris Heckman, Executive Director, Global Clinical Development, Celerion

Brion Regan, Product Manager, ERT

Harry Barnett, Executive Chairman, Lubris BioPharma

Further Information For sponsorship opportunities please contact:

Nicholas McCudden | Email: NicholasMcCudden@arena-international.com |Tel +61(0) 468 609 047 For program enquires please contact:

Charlie Abrines | charlie.abrines@arena-international.com|Tel +44 207 832 439

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Day One 6

th November 2018 I Boston, Massachusetts

8:15

Registration and Refreshments

8:50

Opening Remarks – James Sherley, Director, Asymmetrex, LLC

9:00

Mid-term election special US isolationism vs global outlooks; how does the current political climate affect biopharma?

Considering what has changed since November 2016 until today, is the industry better off?

Unpacking how new appointments at the FDA have affected the industry’s competitiveness

Discussing current trends surrounding biopharma regarding healthcare legislation

Predicting future scenarios 2018-2020 Moderator: Querida Anderson, Editor in Chief, GlobalData Vikas Agarwal PhD., Program and Outsourcing Management, Senior Director, TARIS Harry Barnett, Executive Chairman, Lubris BioPharma David Sherris, President & Chief Executive Officer, GenAdam Susan Stewart, Senior Vice President Regulatory Affairs and Quality Assurance, Kaleido Biosciences

9:30

The Engagement Gap: Bridging From Pre-Clinical to First Patient In

You’ve received funding, now what?

Early regulatory engagement and creating a sound development strategy

Assessment and hiring of key staff members: Which positions to fill immediately and which can wait

Ingredients for a cost-effective infrastructure and strategic trial oversight

Making the best use of a biotech startup’s limited resources

Colin Hayward, Chief Medical Officer, Premier Research

10:00

Making clinical trial participation diverse; why recruiting minority group patients is good for America

Exploring ways clinical trial participation can be diversified

Addressing the need for inclusion of racial and ethnic minority participants in clinical trials to ensure products are safe and effective for the populations that will use them

Showcasing how community engagement can improve minority enrollment in clinical trials

Policy strategies to support diverse participation in clinical trials

CAPT Richardae Araojo, Pharm.D., MS, Associate Commissioner for Minority Health, Director, Office of Minority Health, U.S. Food and Drug Administration

10:30

Australia's R&D Refund and Simplified Regulatory Environment as a Gateway to Asia

Presenting how Australia’s scientific talent, excellent medical infrastructure and lucrative R&D cash refund

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scheme makes it a preferred destination for early phase clinical trials.

Recognizing that patient availability makes Asia a key region to accelerate later phase development, at lower costs.

Highlighting the partnership between regional specialists, an alternative to large global CRO to manage complex global trial while keeping the flexibility required for Mid-size Biopharma companies.

Alyce King, Manager Business Development, Novotech CRO

11:00

Networking and Refreshments sponsored by

Stream A

Clinical Operations in Early Phase Development

Stream A will address those challenges specific to early phase trials and present case-studies to guarantee your newest drug makes it to patients who need it Chair: David Sherris, President & Chief

Executive Officer, GenAdam

Stream B

Clinical Trial Technology & Innovation

This track will unpack new and tested technologies which will help you reduce timelines and bring drugs to market faster

Chair: James Sherley, Director,

Asymmetrex, LLC

Stream C

Improving Operational Efficiency in Clinical Trials

This stream aims to address those key aspects of clinical operations which need addressing to ensure your business remains competitive

11:30

Regulation of the outsourcing of manufactured therapeutic tissue stem cells in early phase trials

Considering updates to FDA regulations regarding study oversight and execution by sponsors to remain compliant

Establishing global regulatory divergence in safety and efficacy standards requirements for sponsors trialing stem cell based treatments

Determining how relationships between sponsors and vendors will change as a result of more complex clinical trials

Strategically adopting novel approaches to your patient recruitment; harnessing the power of social media and e-technology to keep patients engaged

Assessing cost and benefits associated with the adoption of a social media strategy to determine whether this is right for your company

Exploring social media as a viable alternative to traditional sources of patient recruitment asses its validity for your trial

Highlighting draw backs to using social media as it could lead to patients becoming de-anonymized and sharing

GDPR and implications for

sponsors of clinical research in

the EU

Unpacking what is the General Data Protection Regulations (GDPR)

Highlighting what GDPR does; standardizing and strengthening privacy rights of EU citizens by changing how companies acquire, store and use personal data

Uncovering GDPR’s application; processing of personal data of EU citizens by any company that processes the data of

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Exploring ways to ship stem cell treatments from manufacturing sites to patients while retaining product integrity

James Sherley, Director, Asymmetrex, LLC

information without sponsor knowledge

Harnessing social media as a tool to build relationships between sponsors, site physicians and patients as a mechanism to improve retention

Considering ways through which you can build these capabilities internally to avoid increasing costs

Adrian Orr, Director of Clinical Affairs, Anika Therapeutics

EU citizens regardless of where a company is located

Recognizing when it applies; full compliance expected now: in full effect since May, 2018 after 2 year implementation period

Ensuring compliance; impact to sponsors reaches beyond EU subject clinical data

Susan Stewart, Senior Vice President Regulatory Affairs and Quality Assurance, Kaleido Biosciences

12:00 Reducing or minimizing “white space”:

the importance of provider selection

Defining “white space” in advancing from POC; causes and mitigations

Considering ways provider selection can mitigate: data integrity, system compatibility, site and KOL

Providing essential input into pivotal trial design

Offering potential for seamless handover to next phase providers

Experience in moving through asset transfer

Chris Heckman, Executive Director, Global Clinical Development, Celerion

Beyond risk-based monitoring: employing risk-based banagement

Exploring process, resource, and technology challenges in implementing risk-based management (RBM)

Overcoming challenges in data source variability, data latency and data aggregation

Moving beyond RBM: Incorporating study start-up metrics, milestone tracking and other KPIs

Complying with ICH E6 guidance: Sponsor / CRO roles in risk-based management and oversight

Finding the best model and solution for your organization: The value of pilots and proofs of concept (POCs)

Brion Regan, Product Manager, ERT

Incorporating China in global studies - what are the key considerations for conducting studies in China

Clarifying the regulatory

approval process allow

for sufficient enrollment

period relative to ROW

Showcasing how patient

recruitment strategies

different

Managing site operations

– physicians have very

limited time to see

patients, so how do they

add on research

responsibilities

Presenting the necessary

considerations for data

entry, and the move

toward EHR

David Ng, Vice President of Biostatistics & Data Operations,

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ResearchPoint Global

12:30

Live debate Journeying together; can you stay with the same solution provider from early phase until product commercialization?

Determining ways to select partners who can progress with you from a biotech perspective

Debating difficulties in changing provider throughout a clinical programs development

Exploring flexible contract arrangements to cope with study changes

Discussing partnership expectations early on in a clinical program’s trials conception to ensure all parties are committed to success

Considering ways through which solution provider team members can be brought into the sponsor company to create a cohesive unit which will further the success of your trial

Upma Sharma, Vice President, Arsenal Medical For: Maria Makarovskaya, Director, Clinical & Strategic Sourcing, TESARO

Panel Discussion Discussing ways industry and academia can work together to harness the power of new technologies for clinical development

Tapping into the talent available in Boston’s star-up hub and make this commercially viable

Uncovering challenges faced by biotech’s when adopting new, untested technologies

Establishing partnerships between academia and industry to trial new technologies and speed up their adoption

Improving communication between academia and business to make new technologies commercially viable

Kimberly Guedes, Executive Director Clinical Operations, Centrexion Therapeutics Kate Hoffman, PhD, MPH, Director, Clinical & Medical Affairs Allena Pharmaceuticals

Case Study Designing and Implementing a Quality Management System

Selecting and implementing the right Quality Management System for your organization

Providing the appropriate training and messaging to ensure consistency across and within teams

Considering key stakeholders and affected systems and processes

Amanda Hayden, Director, Global Clinical Services, Alkermes

1:00

Lunch and Networking sponsored by

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2:15 Panel Discussion

Sourcing strategies for early phase development – planning for the unforeseen?

Outlining challenges in finding a partner when developing an early phase trail from a small and mid-size biotech perspective

Determining which trial components to outsource given vendor rigidity in early phase trials

Considering adaptive partnership models between sponsors and vendors to cope with the unexpected nature of phase 1 trials

Considering hybrid models towards contract writing to take into account changes in protocol requirements

Matt Weinberg, Director, Strategic Sourcing, Agios Pharmaceuticals

Heather Shih, Head of Operations & External Services Management, EMD Serono Alyce King, Manager Business Development, Novotech CRO

Balancing practical and innovative approaches to making clinical trial personalization a reality

Why the emphasis on patient centricity NOW

Understanding the value and promise of patient centricity in clinical trials

Exploring ways to involve patients from study-start to guarantee their needs are met while delivering the results you need

Beth Zaharoff, Senior Director, Patient Focused Engagement and Partnerships, TESARO

Game Changer: proven ways to reduce your phase I timeline by 6-8 months

Mitigating risk and cost associated with drug product manufacture without sacrificing quality or patient safety while maintaining cGMP compliance

Saving at least 6 months in time to start FIH studies

Reducing financial risk associated with any last minute regulatory required changes

Gaining flexibility to adjust dosage quickly with efficient modifications made to local batch process

Marcus Stavchansky, Pharm.D., Global Head Pharmacy Services, Covance

2:45

Case Study The Emerging Potential of Exosome-Based Diagnostics and Therapeutics

Highlighting how exosome production and uptake are universal features of animal biology

Showcasing ways exosomes contain molecular hallmarks of health and disease

Demonstrating how exosome-based diagnostics allow remote sensing for liquid biopsy

Demonstrating ways

Panel Demonstrating a ROI; why adapting current technologies for pharma’s needs can improve trial efficiency and lower costs

Harnessing mobile phone infrastructure to enable 24/7 management of your trial and patients

Developing portable software systems which can enable patients to enroll on trials and report in real time

Exploring increasing growth in wearable devices and what

Plan like a Pro: an uncommon approach to using predictive models to optimize your country site strategy

Driving decision-making by building your model with downstream inputs in mind and ensuring you understand the limitations of your tools. The complexity of the clinical trial model you are using should increase over time

Learning how simulation

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exosomes offer the potential for targeted drug delivery

Professor Steve Gould, Scientific Advisory Board, TAVEC

this means for your trial management

Determining which trials will benefit from technological customization

Recognizing how adopting new technologies can reduce overall trial costs and minimize growing financial pressures on industry

Rinaldo Dorman, Clinical & Medical Category Lead R&D Procurement, Shire Christine McLennan, Director Clinical

Operations, EveloBio

tools can help you test your strategy and manage risk proactively

Leveraging the enrollment model as a site management tool by embracing transparency and focusing on site commitments.

Managing expectations and improve future models by benchmarking against a baseline

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

3:15

Afternoon Refreshments and Networking

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4:00

On-stage Interview Pursuing the money trail; approaching funding opportunities strategically when bringing a new product to market

Exploring funding opportunities available for biotech’s and what VC’s require to invest in your product

Assessing which alternative funding models to VC’s are available to offer new avenues for growth and investment in your company

o Alternative sources of seed funding: corporate venture groups, angel investors, SBIR

Examples of J&J Innovation investments

o Vendanta Therapeutics

Kuldeep Neote, Senior Director of New Ventures, Johnson and Johnson Innovation

Panel Considering technological shortfalls throughout a trial’s’ development; why one-size-fits all doesn’t work

Highlighting different technologies available for phases I-IV to ensure you have the right tech for each trial

Ensuring you’re contracting technology which is relevant to each phases of your clinical study regardless of therapeutic area

Guaranteeing technology is compliant across regions to prevent regulatory rejection

Highlighting ways small companies can bring this technology on board when budgets are limited

Determining ways to integrate various vendors’ platforms to avoid task duplication

Lynn DiFinizio, Director of Clinical Programming and Technical Solutions, Alkermes Terry Robins, Senior Director Clinical Affairs, Infectious Disease, Alere Kathleen Findlen, Head of Clinical Operations and US Project Management, Life Molecular Imaging

Vendor Alliance: Cultivating the Most Beneficial Vendor Relationships

Proposal and protocol: how to procure the perfect partnerships

Early engagement: exploring vendor engagement timeframes to ensure adherence to established schedules

Case Study: exploring model relationships in clinical trial supply outsourcing

Outsourcing overload: identifying methods to find your ideal vendor number to improve results

Eyal S. Ron PhD., Chief Technology Officer, Gelesis Inc

4:30 Case Study

PD-1/PD-L1, CTLA-4 Checkpoint

Inhibitors – What is Next? – “Super-

Checkpoint Inhibitors”

Low efficacy rates for current checkpoint inhibitors – problems and answers?

Why so many PD-1/PD-L1 checkpoint inhibitors – does one size fit all?

Next generation checkpoint inhibitors – targeting outside

Case Study Predicting IO efficacy?

Considering whether preclinical models can predict IO efficacy?

Discussing if biopharma as an industry has been spoiled by precision medicine?

Should the clinical development paradigm change?

Panel Uncovering ways through which you can manage your vendors without duplicating tasks, affecting trial integrity or increasing in-house responsibilities

Highlighting key challenges faced by small-pharma and biotech when managing vendors to design strategies for best

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of the B7/CD28 pathway

David Sherris, President & Chief Executive Officer, GenAdam

Giovanni Abbadessa, AVP, Head of Isatuximab Non-Myeloma Development, Sanofi

practice

Reviewing vendor management strategies to avoid task duplication whilst ensuring your vendor is delivering as promised

Exploring ways through which communication between partners can be improved to ensure that deliverables are presented on time and delays are avoided

Debating whether full or functional outsourcing is the best model to reduce unnecessary oversight and remain within budget

Comparing niche vendors vs one-stop-shop CRO’s and which are easiest to manage for your trial type and company size

Kimberly Guedes, Executive Director Clinical Operations, Centrexion Therapeutics Heather Dibenedetto, Head, Therapeutic Operations, Moderna Therapeutics

5:00

Summation and close of day one – James Sherley, Director, Asymmetrex, LLC

5:05

Drinks reception sponsored by

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Day Two

7th

November 2018 I Boston, Massachusetts

8:15

Registration and Refreshments

8:50

Chairperson’s Opening Remarks

Biopharmaceutical Stream

Chair: Sekou Dilday, Clinical Procurement Lead, Shire Pharmaceuticals

Medical Device Stream

Chair: Hilary Luderer, Director of Translational and Clinical Research, Pear Therapeutics

9:00

Panel How to select the best vendor, keep them engaged to successfully run your trial

Reviewing current partnership models; which one works best for you company’s size and budget

Discussing ways alliances can be best managed to ensure you get the best service for what you pay for

Evaluating ways you can keep your partner engaged throughout a trial

Determining whether contract incentives work to keep partners committed to your success

Presenting practical actions that have delivered positive results

Gina Bellistri, Director, Clinical Outsourcing, CRISPR Therapeutics Elspeth Carnan, Vice President, Global Head, Service Provider Management Global Clinical Operations, EMD Serono Carol Lewis-Cullinan, Vice President, Clinical Operations & Data Management, Seres Therapeutics

Case Study Creating digital therapeutics for the treatment of patients with substance use disorder

Presenting prescription digital therapeutics as a new class of software as a medical device

Reviewing prescription digital therapeutics are FDA regulated medical devices with labeled claims to treat disease

Showcasing Pear Therapeutics pipeline of digital therapeutics, designed to treat diseases with high unmet medical needs

Hilary Luderer, Director of Translational and Clinical Research, Pear Therapeutics

9:30

An innovative approach to simplify the Clinical Supply Process for unblended medication and supplies A review of current clinical supply trends and issues and a case study based presentation of an innovative approach that provides a more efficient alternative to traditional processes

Case-study Adopting novel technologies in medical device trials

Demonstrating how a new class of medication and diagnostic monitors are changing the game with regards to studying home-use injectable medicines

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Unpacking current clinical supply issues and trends

Case Studies: Practical applications of an Innovative Approach

Presenting cost comparisons for the clinical supply process utilizing real world data

Explaining the pharmacy adjudication process and how you can benefit

Michelle Novak, Director of Business Development, RxSolutions

Presenting the results of the Gocap insulin dose in collaboration with the Joslin Diabetes Center and University of Massachusetts Worcester Memorial Medical Center

Combining new diagnostic tools and home treatment reports to generate insights participants and clinicians

Highlighting how these tools and reports resulted in high participant and investigators satisfaction, clinical outcomes, and novel data sets

James White, President and Co-founder, Common Sensing

10:00 Two-way discussion

Reviewing the riddles of recruitment and retention

Evaluating the errors in enrolment estimates to better anticipate final retention

Analyzing the flexibility of vendors to better respond to fluctuating enrolment figures and avoid wastage in supplies

Exploring new methods of recruiting the right patients and trial sites to increase efficiency in enrolment and trial supplies

Examining best practice techniques for enrolment to maximize patient retention ensuring patients receive trial drugs on time

Christine Tosone, Executive Director, Clinical Operations, Allena Pharmaceuticals Kate Hoffman, PhD, MPH, Director, Clinical & Medical Affairs Allena Pharmaceuticals

EU vs US; presenting a business case for trialing in EU when carrying out medical device studies

The impact of the shifting regulatory landscape under the new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR)

Determining what steps need to be taken for medical device companies to acquire a CE mark for their products

Showcasing whether trials in Europe are more cost effective given greater patient availability

Appreciating EU and US regulatory compliance of foreign clinical trial data when bringing a product to market

Exploring sponsor requirements when using data from outside of the USA (OUS) in FDA submissions

Vicki Anastasi, Vice President and Global Head, Medical Device and Diagnostics Research, ICON plc Charles Raymond, Director, Business Operations & Strategic Alliances Medical Device and Diagnostics Research, ICON plc

10:30 Virtual Interactions: Effective Patient Recruitment Strategies in the Digital Era

Looking at the current environment of digital

use in patient recruitment, including

Morning Refreshments and Networking

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regulatory and legal considerations

Employing best global and US-centric

practices to when implementing digital

initiatives around patient recruitment

Harnessing Facebook and other tools to target

potential patients, implementing successful

response mechanisms, and the flexibility of

digital tactics vs. traditional

Applying digital outreach in a specific disease

area: how digital outreach has expanded the

reach of rare disease trials

Moving forward with digital initiatives to

harness patient communities for recruitment,

retention and virtual trials

Matthew Kratz, Senior Manager, Patient & Physician

Services, United BioSource Corporation

11:00

Morning Refreshments and Networking

Incorporating FDA’s Patient Preference Initiative (PPI) in your trial design to drive patient-centric innovation

Considering steps device companies can take to on-board patient preferences when developing products

Outlining how by taking PPI onboard medical device companies can improve patient adherence

Establishing industry best practice to ensure feedback use is maximized

Reviewing current risk tolerated by patients to ensure device design is agreeable to regulators and patients alike

Paul Kravitz Director, Regulatory & Clinical Affairs, DEKA Research & Development Corp

11:30 Lessons Learned and Best Practices in GCP Inspection

Readiness

Exploring the differences between FDA, EMA and MHRA guidelines for inspection readiness

Building inspection readiness into your internal and outsourced operational processes

Ensuring your TMF is MHRA inspection ready

Case Study Conducting a successful vaccination trial in Australia with a combination product

Reviewing the Australian regulatory agency’s(TGA) two approval pathways for clinical trials (CTX and CTN)

Unpacking how CTN offers an accelerated path to human data, key focus on safety

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through preparation and remediation

Best practices for running successful Mock Inspections

Lessons learned from on-site sponsor inspections

Kevin Anderson, Director, Global Clinical Operations, Alexion Pharmaceuticals

and ethics

Showcasing the simple documentation requirements and submission process

Highlighting similarities and differences to IND

Approval process and timing

ICH GCP compliant - acceptable for US IND and international regulatory submissions

David Hoey, Chief Executive Officer, Vaxxas Inc

12:00 Marriage pitfalls & how to avoid them: Clinical

Finance & Strategic Outsourcing

Projecting study costs: initial budgets and scenario planning

Sourcing strategy; what is the impact of unit or performance based milestone payments on forecasted spend?

Death, taxes and change orders; best practices and change process

Providing a costed portfolio of clinical trial costs in a dynamic environment; being BOD budget ready;

Contract Closeout – Don’t leave money on the table

Jennifer Goldman, Director, Clinical Business Operations, Deciphera Tony Carita, Strategic Outsourcing, Deciphera

Lunch and Networking

12:30

Lunch and Networking

1:30

Panel Which outsourcing model is most beneficial for your company; pros and cons of a dual CRO strategic partnership

Considering the benefits and drawbacks of dual partnerships versus traditional one-stop-shop CRO’s

Reviewing what is driving industry towards a dual outsourcing model and what advantages this offers sponsors budgets

Determining which model is must suitable to your current business culture and processes

Sekou Dilday, Clinical Procurement Lead, Shire Pharmaceuticals Vikas Agarwal PhD., Program and Outsourcing Management, Senior Director, TARIS

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2:00

Assessing Outsourcing Model Adoption and CRO Oversight Practices

Reviewing new benchmarks on the most prevalent outsourcing models used by biopharmaceutical companies

Presenting new research results on sponsor approaches to structuring and implementing CRO oversight mechanisms

Discussing oversight objectives, effectiveness and opportunities for improvement

Ken Getz, Associate Professor; Director of Sponsored Programs, Centre for the Study of Drug Development,

Tufts University School of Medicine

2:30

Encouraging teambuilding between in-house and partners’ teams to improve trust, create a transparent environment and maximize resources

Reviewing current communication arrangements between vendors and sponsors to ensure both parties are aligned and improve information exchanges

Exploring opportunities for vendors and sponsors to exchange roles and understand one another business priorities

Considering if partner team members can be brought in-house during to improve working relationships and reduce miscommunication

Uncovering best practice techniques to guarantee commitment from partners for a trials success to ensure quality is maintained throughout study duration

Considering which outsourcing model is most suited to establishing a partnership between vendors and sponsors

Wes DeHaan, PhD, Vice President, Gout Program Lead, Selecta Biosciences

3:00

Afternoon Refreshments and Networking

3:30

Roundtables

Each roundtable session lasts for 30 minutes, and delegates may attend 2 roundtables. The roundtables will be allocated on a “first come first serve” basis.

RT1

Ensuring ethnic diversity is represented within patient groups participating in your clinical trial to ensure they accurately represent the US population as a whole

Stephen Palmer, Chief Scientific Officer, TocopheRx

RT2

Considering funding opportunities available for small and medium size pharma and device companies to bring your product to market

Eyal S. Ron PhD., Chief Technology Officer, Gelesis Inc

RT3

Examining your current site management arrangement to maximize engagement and results delivery

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Wes DeHaan, PhD, Vice President, Gout Program Lead, Selecta Biosciences

RT4

Assessing future technologies which could further your budget and improve your clinical trails

Rinaldo Dorman, Clinical & Medical Category Lead R&D Procurement, Shire

4:30

Chair’s Closing Remarks and End of Conference

Chair: Sekou Dilday, Clinical Procurement Lead, Shire Pharmaceuticals