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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 Kathryn Hoffman, Director, Clinical Development, GE Healthcare

Maria Makarovskaya, Director, Clinical & Strategic Sourcing, TESARO Vikas Agarwal, Senior Director, TARIS Biomedical

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 Clinical Development, Sanofi David Sherris, President & Chief Executive Officer, GenAdam

Ramon Mohanlal, Chief Medical Officer, BeyondSpring Pharmaceuticals Adrian Orr, Director of Clinical Affairs, Anika Therapeutics

Brian Meltzer, Executive Director, Clinical Development, Adare Pharmaceutical Rinaldo Dorman, Clinical & Medical Category Lead R&D Procurement, Shire

Beth Zaharoff, Director, Patient Focused Drug Development, TESARO Matt Weinberg, Director Strategic Sourcing, Agios Pharmaceuticals

Heather Shih, Head of Operations & External Services Management, EMD Serono Kimberly Guedes, Senior Director Clinical Operations, Centrexion Therapeutics

Christine Tosone, Executive Director, Clinical Operations, Allena Pharmaceuticals Gina Bellistri, Director, Vendor Management, Agenus Inc.

Hilary Ginsburg, Director of Clinical Research, Common Sensing Paul Kravitz, Director Clinical Research, NeoSync (2017-2018)

Kuldeep Neote, Senior Director of New Ventures, Johnson and Johnson Innovation Elspeth Carnan, VP, Global Head, Service Provider Management Global Clinical Operations, EMD

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Serono David Hoey, Chief Executive Officer, Vaxxas Inc

Lisa Corey, Director, Clinical Program Management, Alkermes 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, SVP Regulatory Affairs and Quality Assurance, Kaleido Biosciences Stephen Palmer, Chief Scientific Officer, TocopheRx

Heather Dibenedetto, Head, Therapeutic Operations, Moderna Therapeutics Kristin Stephens, Vice President Clinical Operations, Syros Pharmaceuticals

Querida Anderson, Editor in Chief, GlobalData

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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Program Day One 6

th November 2018 I Boston, Massachusetts

8:15

Registration and Refreshments

8:50

Chairperson’s Opening Remarks

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

9:30

Session reserved for Premier research

10:00

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

Showcasing how grassroots movement and key community leaders can improve minority enrolment in clinical trials

Addressing the need for more minority partisans in clinical studies to ensure your products can be used by more patients

Ensuring underrepresented populations, genders and age groups are recruited within your trial to showcase your data is applicable to country population as a whole

Appreciating how more personalized medicines will require greater diversity within patient pools to increase product accuracy and usefulness

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 43.5% R&D Refund and Simplified Regulatory Environment as a Gateway to Asia

Presenting how Australia’s scientific talent, excellent medical infrastructure and lucrative 43.5% R&D cash refund 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.

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Alyce King, Manager Business Development, Novotech CRO

11:00

Networking and Refreshments

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 Chairman: 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

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

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

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 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

Unpacking EU’s GDPR directive and its impact for patient data

Content TBC

q

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James Sherley, Director, Asymmetrex, LLC

capabilities internally to avoid increasing costs

Adrian Orr, Director of Clinical Affairs, Anika Therapeutics

Susan Stewart, SVP Regulatory Affairs and Quality Assurance, Kaleido Biosciences

12:00

Session reserved for Celerion

Session reserved for ERT

Session reserved for 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

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, Senior Director Clinical Operations, Centrexion Therapeutics

Case Study Designing and Implementing a Quality Management System

Content TBC

Amanda Hayden, Director, Global Clinical Services, Alkermes

1:00

Lunch and Networking

q

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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, Director, Patient Focused Drug Development, TESARO

Session reserved for Covance

2:45

Case Study Liquid Biopsy approaches to early Diagnosis and Novel Therapeutics

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

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:

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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

identifying methods to find your ideal vendor number to improve results

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

3:15

Afternoon refreshments and networking

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3:45

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

Sharing business strategies to showcase your trial’s’ feasibility and improve your ability at acquiring external investment

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

Investigating funding opportunities to increase your current resources and stretch your budget

Showcasing which funding opportunities are available in Massachusetts to maximize your budget and increase your revenue stream options

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

Panel Discussion 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

Lisa Corey, Director, Clinical Program Management, Alkermes Terry Robins, Senior Director Clinical Affairs, Infectious Disease, Alere

Session reserved for WorldWide

Clinical Trials

4:15 Case Study

Competing for patients; China, where can you recruit for early phase immuno-oncology and launch your trail successfully

Reviewing current struggles to recruit patients given increasing competition in early phase trials

Considering alternative geographies to make up for

Weighing up the cost of innovation; outlining which new features will offer a returns and which is worth allocating resources to while giving you a competitive advantage

Outlining key technologies such as Artificial Intelligence, Blockchain and wearables being promoted as game changes in clinical trials

Considering the investment

Panel Discussion 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 practice

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patient shortage and execute your trial within study timelines

Uncovering regulatory differences between US and Chinese authorities to ensure compliance and data integrity

Determining differences in recruitment strategies for US and Chinese patients and appreciating that a one-size-fits all is not feasible

Ramon Mohanlal, Chief Medical Officer, BeyondSpring Pharmaceuticals

needed to onboard these technologies

Exploring which outsourcing model is both most affordable and practical for your current trials

Determining whether this technology will make you more competitive and add an edge to your business

Showcasing what new tech needs to offer to make senior management buy into its acquisition

Giovanni Abbadessa, aVP Clinical Development, Sanofi

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, Senior Director Clinical Operations, Centrexion Therapeutics Heather Dibenedetto, Head, Therapeutic Operations, Moderna Therapeutics

4:45

Chairperson’s summation and close of day one

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Program Day Two 7

th November 2018 I Boston, Massachusetts

8:30

Registration and Refreshments

8:50

Chairperson’s Opening Remarks

Biopharmaceutical Stream

Medical Device Stream

9:00

Panel Discussion 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, Vendor Management, Agenus Inc. Elspeth Carnan, VP, 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

Content TBC

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

Unpacking current clinical supply issues and

Session reserved for Sponsor

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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

10:00

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 Brian Meltzer, Executive Director, Clinical Development, Adare Pharmaceutical

Case-study: adopting novel technologies in medical device trials

Content TBC Hilary Ginsburg, Director of Clinical Research, Common Sensing

10:30

Session reserved for UBC

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

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

Considering EU General Data Protection

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Regulation (GDPR) changes and potential impact on your trial set-up

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

11:00

Morning Refreshments and Networking

11:30 Evaluating your inspection readiness strategy to

guarantee you are on top of the changing regulatory requirements

Reviewing current FDA, EMA & MHRA guidelines to ensure your team is up to date on guideline changes and can comply with agency inspections

Presenting tactics to ensure you are inspection ready from trial start to wrap-up

Designing cross departmental reporting systems that ensure operations and supply teams are working collaboratively and avoid task duplication

Establishing internal tracking and reporting structures to ensure your global trials are adequately amended and seamlessness is ensured

Determining whether internal rearrangements are best achieved through in-house restructuring or outsourcing to guarantee you are prepared for your next inspection

Kevin Anderson, Director, Global Clinical Operations, Alexion Pharmaceuticals

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 Clinical Research, NeoSync (2017-2018)

12:00 Ensuring audit preparedness to guarantee your data

integrity when building partnerships with external teams

Discussing stakeholder expectations prior to audit planning to reduce unforeseen surprises and ensure adequate vendor oversight

Reviewing current internal audit structures to evaluate their usefulness in guaranteeing compliance given increasing complexity of clinical trials and protocol design

Case Study How to carry out a trial in Australia and make your combination product a clinical success

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Designing systems which enable sponsors to monitor their outsourced functions in real time and minimizing downstream regulatory concerns

Evaluating sites electronic health care records to ensure clinical compliance with FDA and MHRA expectations

Examining ways through which sponsors can ensure CRO’s management of third party vendors is improved to reduce risk

Kristin Stephens, Vice President Clinical Operations, Syros Pharmaceuticals

David Hoey, Chief Executive Officer, Vaxxas Inc

12:30

Lunch and Networking

1:30

Panel Discussion Maximizing data from electronic patient reported outcomes (ePRO) to improve study design and comply with regulatory expectations

Outlining current technologies available to aggregate PRO’s and allow sponsors to improve product knowledge

Appreciating the technological complexities that arise from using ePRO’s and what support management you will need to adopt this within your trials

Exploring ways ePRO data can influence trial designs and make these more appealing to patients

Analyzing how ePRO’s allow sponsors to gain faster regulatory approvals and establish a more competitive market price

Sekou Dilday, Clinical Procurement Lead, Shire Pharmaceuticals

2:00 Outsourcing model adoption and new approaches to CRO oversight

Content TBC

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

2018

Highlight

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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

Reviewing how uncertainty over Brexit could affect your timelines and outlining potential next steps to take

James Shirley, Director, Asymmetrex, LLC

RT2

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

RT3

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

RT4

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

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

RT5

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