Outsourcing in Clinical Trials Southern California 2022
San Diego Marriott La Jolla, San Diego, CA
28th-29th September, 2022
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Outsourcing in Clinical Trials Southern California 2022
DAY 1|28th September 2022
DAY 2|29th September 2022
Clinical Operations & Outsourcing
Clinical Technology & Innovation
8:20 am Chair’s Opening Remarks

Lei Zhang
Former VP, Global Project Management & Scientific Affairs
Frontage Laboratories, Inc.
8:30 am KEYNOTE DCT & HYBRID PANEL DISCUSSION
With clinical trials picking up globally we are in the position now to share our practical experiences and lessons learned with Decentralized & Hybrid Clinical Trials;
- Strategy/Planning: How do you make the decision to run a DCT; what are the considerations?
- If you could re-do your DCT what would you do differently? What were your biggest hurdles?
- Are Hybrid trials the more realistic and practical approach compared to full DCT – Agree or Disagree?
- Addressing considerations for different therapeutic areas, such as Oncology trial requirements
- Diversity considerations- looking at DCT from tech standpoint and examining language barriers, access to Wi-Fi etc
- Considering how the flexibility in the last 3 years has increased enrolment and patient centricity; how can we continue to do this?
Moderator: Lei Zhang, VP of Clinical Development, Frontage Laboratories
Panellists: Dov Gal, VP Regulatory, Clinical and Quality and Compliance Officer, ReShape Lifesciences;
Joe Shan, Head of Clinical Operations, Mosaic ImmunoEngineering

Lei Zhang
Former VP, Global Project Management & Scientific Affairs
Frontage Laboratories, Inc.

Joe Shan
Head of Clinical Operations
Mosaic ImmunoEngineering

James Wabby
Executive Director, Regulatory Affairs - Device/Combination Products
AbbVie

Dimitri Talantov
Head of Experimental Medicine, Infectious Diseases
The Janssen Pharmaceutical Companies of Johnson & Johnson
9:15 am Session Reserved for Novotech
9:45 am RWE and the outsourcing paradigm – considerations for consensus and innovation
- Evolution of the application of RWE throughout the product development lifecycle
- What information are you really getting with your outsourcing templates
- Leveraging brains, not process to drive effective proposals

Matthew Gordon
VP, RWE
Parexel
10:15 am Morning Refreshments and Networking
11:00 am PANEL DISCUSSION ClinOps team focus: Managing relationships and hiring in the new world
- Strategies for successfully hiring and growing a ClinOps team in this day and age
- Millennials hire differently: Understanding how to hire, and manage, younger people
- Importance of changing expectations in the work place
- WFH vs in an office: Pros and cons of hiring and managing a more remote ClinOps team in the US
- What can small biotech ClinOps teams learn from large Pharma, and vice versa
- Technology works, let’s not put it back on the shelf: exploring tools available for a successful communication framework
Moderator: Dov Gal, VP Regulatory, Clinical and Quality and Compliance Officer, ReShape Lifesciences
Panellists: Jennifer Lee, Senior Vice President of Clinical Operation, Biostats, and Data Management, Elevar Therapeutics;
Tony Yu, Vice President of Clinical Trial Operations, Genelux Corporation

Dov Gal
VP Regulatory, Clinical and Quality and Compliance Officer
ReShape Lifesciences

Jennifer Lee
Senior Vice President of Clinical Operation, Biostats, and Data Management
Elevar Therapeutics

Mary Syto
Director, Clinical Scientists, Early Clinical Development
Bristol Myers Squibb
11:30 am Decentralized clinical research is more than just technology: how concierge services facilitate successful implementations
- Designing fit for purpose workflow around the patient
- Relieving burden of added technical and administrative tasks for site staff
- How customized support increases engagement, compliance and retention

Laney Preheim
Vice President, Connected Health Services & Operations
ICON
12:00 pm FIRESIDE CHAT Establishing strong CRO/sponsor/site relationships and building trust
- Oversight with less presence– designing an oversight plan based on KPIs, fewer monitoring visits and more virtual meetings, how to make this work
- Lessons learned on how to effectively build working relationships remotely
- Strategies to deliver training and upskill your clinical trial team
- Handling hard discussions with the site remotely if can’t get there in person
- Guidance on improving CRO communication channels– how to keep CROs in the loop and draw on their extensive experience
- We are all human, we all fail: Ensuring positivity in initial stages and taking responsibility

Jennifer Lee
Senior Vice President of Clinical Operation, Biostats, and Data Management
Elevar Therapeutics

Lei Zhang
Former VP, Global Project Management & Scientific Affairs
Frontage Laboratories, Inc.
12:30 pm How to combine tech and patient perspectives to decrease costs and increase enrollment
- Where is the Research Industry headed and why there is a need for Hybrid/DCT approaches within clinical research?
- When people living with rare diseases decide to participate in a clinical trial, you must keep in mind that…
- They likely have other significant time commitments
- They may have had adverse experiences
- They need clear instructions and guidance to successfully complete testing and processes
- They may not have received effective treatments for their condition to date and may have high hopes in the trial
- Patient perspectives and preferences are the soul of Medable’s Patient Success team

Jena Daniels
VP Patient Success
Medable

Nisha Trivedi
Patient Advocate
1:00 pm Lunch and Networking
JOIN ONE OF OUR NETWORKING TABLES
Eat lunch with a like-minded group of industry colleagues by joining one of our lunchtime discussion groups on the topics below:
TABLE 1: Innovative ways of improving CRO engagement and communication |
TABLE 2: Overcoming common small company pain points |
2:00 pm Delving into the laboratory aspects of clinical trials in the new age
- Exploring best practices for selecting central labs
- Pinpointing strategies for vetting 3rd party vendors and labs
- Discussing in-house vs outsource testing: which should you be doing? How to decide?

Majid Ghoddusi
Senior Director, Clinical Biomarkers
Poseida Therapeutics
2:30 pm Achieving Phase 1 value inflection rapidly and robustly in Australia and the USA
- Insights about setting up an Australian entity
- IP arrangement
- Maximizing R&D rebates
- Further details on executing clinical trials in Australia

Chris Hickey
Executive Vice President — Business Development
Nucleus Network
3:00 pm Data: the new (s)oil in a digitally driven economy
- What does data mean to our patient communities?
- How can we engage and incentivize patients to support decentralized trials?
- How can that data help us to drive solutions in personalized care? While both saving costs and improving quality of life?

Christine Von Raesfeld
Independent Patient Advocate
3:30 pm Afternoon Refreshments and Networking
4:00 pm Innovative solutions for today’s clinical trial needs
- Virtual clinical supply model
- Direct to Patient capabilities
- Medical procedures, services, and product reimbursement
- Global clinical supply offering

Jorge Franceschi
Director, Business Development
TrialCard
4:30 pm AUDIENCE Q+A A playbook for how to handle an undesirable CRO-sponsor partnership & how to turn it around
- Is it worth tweaking the relationship? How do you know when/how to severe ties? This session will consist of a quick 15min presentation followed by audience Q&A
- Utilizing milestone data to identify if the CRO-sponsor partnership is efficient and successful
- Renegotiate – pros and cons of tweaking the CRO relationship compared to cutting ties, particularly in niche areas
- Don’t burn bridges – identifying when to bail and how to go about it with grace
- Exploring exactly why the CRO isn’t hitting those milestones and what can be changed

Christopher Lemasters
EVP & Chief Operating Officer
Amplyx Pharmaceuticals, now a subsidiary of Pfizer
5:00 pm Chair’s Summation and Drinks Reception
11:00 am PANEL DISCUSSION Do we need to move away from digital reliance to bring the human touch back? Is there still a big divide? AGREE OR DISAGREE
- Is there too much focus on data and a lack of empathy/compassion in trials?
- Has Covid and the digital age widened the gap between clinical trials and the human touch?
- Panellists give their advice: Building relationships with communities, HCPs, and the patient themselves
- How best to identify and involve touch points in the patient community as well as grass root organizations
- Examining why tech is not always the most effective way to work with patients
- Finding the balance of incorporating tech into trials with the advice of patient groups – getting more from your remote calls/meetings
Moderator: Christopher LeMasters, EVP & COO, XinThera
Panellists: James Wabby, Global Head, Regulatory Affairs – (CoE), Emerging Technologies, Combination Products and Devices, AbbVie;

Christopher Lemasters
EVP & Chief Operating Officer
Amplyx Pharmaceuticals, now a subsidiary of Pfizer

James Wabby
Executive Director, Regulatory Affairs - Device/Combination Products
AbbVie

Kenneth Kleinhenz
COO
Lorem Cytori, USA
11:30 am Decentralized clinical trials and hybrid trials: what you need to understand to run these successfully
- Key learnings from running DCT/hybrid trials so far
- Points to consider designing your coming clinical trials using DCT processes and technologies
- The building blocks in your DCT/hybrid trials

Sverre Bengtsson
Co-Founder
Viedoc Technologies
12:00 pm INTERACTIVE SESSION
All things Combination Products: Strategies for incorporating medical devices into a pharma clinical study
James Wabby will give a 15min intro into the topic, his real-life experiences and best practices; followed by 15min audience interaction and Q&A.
- How can we do a better job of characterising and identifying the product upfront in development process?
- Importance of not assuming is a pharma or drug product, but seeing it as a drug-device system and focussing on safety aspects
- Strategies to partner regulatory affairs and clinical affairs to ensure device delivery system is cleared in all relevant countries
Get data capture right: Developing case report forms to gain data feedback on your device deficiencies during the study

James Wabby
Executive Director, Regulatory Affairs - Device/Combination Products
AbbVie
12:30 pm Train the trainer: How to train patients in an era of decentralized clinical trials
The emergence of DCTs has inspired a new way of thinking about clinical research. As the industry looked to solve the problems created by COVID-19, technologies, protocols, even regulatory standards changed. The needs of patients changed as well.
This panel discussion will highlight:
- Realities of patient-focused training and support in the decentralized trial environment
- Best practices, common errors, and solutions that allow you to consider the support and training of your patients in your trial design
- Considerations for monitoring the success of your training and support to proactively avoid issues resulting from patients misunderstanding proper trial participation

Tim Kulbago
Senior Vice President of Integrated Customer Solutions and Trial Oversight
Clario
1:00 pm Lunch and Networking
JOIN ONE OF OUR NETWORKING TABLES
Eat lunch with a like-minded group of industry colleagues by joining one of our lunchtime discussion groups on the topics below:
TABLE 3: Exploring best practices for conducting international trials in a post-pandemic world |
TABLE 4: What does ‘patient-centricity’ mean to you? |
2:00 pm EDC: Discovering data capture in the age of Decentralized and Hybrid trials
- Using EDC to automate clinical trials – how can we improve information-sharing, by reducing manual processes, improve visibility and oversight?
- Strategies to improve your source data verification processes
- Is eSource DDC which captures data electronically, directly into the eCRF at the moment of data creation, a better option?

Wendy Wu
Sr Director, Clinical Development
Jazz Pharmaceuticals
2:30 pm 15minute Tech Showcase: Data-Driven Operations and Oversight with elluminate
Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources.
- Operational analytics including enrollment, protocol compliance and safety
- Risk-based analyses and insights with elluminate RBQM
- Operational knowledge for data-driven development with elluminate CTMS
- Centralized issue management across roles in operations, data and medical review
- Sample tracking, data forecasting and financial performance indicators

Dan McGann
Solutions Consultant
eClinical Solutions
2:45 pm 15min Tech Showcase Sponsor
3:00 pm A Fireside Chat on…Regenerative Medicine as a future trend
- Hot area for 2022 – what’s the next step for regenerative medicine?
- The fastest growing pipeline for new therapeutic submissions to the FDA – debating the pros and cons
- With the shift away from expensive, personalized treatments, toward more scalable and standardized “off the shelf” treatments… what does this mean for regenerative medicine?
- Reimbursement models will accommodate innovative regenerative medicine products and emphasize value

Bai Xu
CEO
Nanomed
3:30 pm Afternoon Refreshments and Networking
4:00 pm Session Reserved for TrialCard
4:30 pm AUDIENCE Q+A: A playbook for how to handle an undesirable CRO-sponsor partnership & how to turn it around
Is it worth tweaking the relationship? How do you know when/how to severe ties?
This session will consist of a quick 15min presentation followed by audience Q&A
- Utilizing milestone data to identify if the CRO-sponsor partnership is efficient and successful
- Renegotiate – pros and cons of tweaking the CRO relationship compared to cutting ties, particularly in niche areas
- Don’t burn bridges – identifying when to bail and how to go about it with grace
- Exploring exactly why the CRO isn’t hitting those milestones and what can be changed

Christopher Lemasters
EVP & Chief Operating Officer
Amplyx Pharmaceuticals, now a subsidiary of Pfizer
5:00 pm Chair’s Summation and Drinks Reception
7:50 am Registration and Refreshments
8:25 am Chair’s Opening Remarks

Bonnie Bain
Global Head and Executive Vice President of Healthcare Operations and Strategy
GlobalData Healthcare
8:30 am KEYNOTE New patient recruitment challenges in a post-Covid world
- Recognising the risks people are willing to tolerate and risks people accept blindly – how does this impact patient recruitment trends?
- Why do people have irrational behaviours on logical aspects but participate in others that are high risk – how does this impact our work in clinical operations?
- Exploring patients’ behaviours in relation to Covid and clinical trials
- Covid anxiety & patient mentality: How can we combat patients fears with entering into a study?
- Strategies to change people’s views, figure out route cause and utilizing recruitment to reassure and counter that opinion

Kenneth Kleinhenz
COO
Lorem Cytori, USA
9:00 am Remember the patient? Humanizing Decentralized Clinical Trials during their study journey
- Live audience poll and discussion about the strategies and technologies they are thinking of deploying for DCTs
- What patients have to say: Sharing key insights from more than 1,600 patients who responded to a recent global research survey on their experiences and preferences
- Steps to ensure we are more aligned with patients’ needs and preferences during their DCT journey

Kelly Franchetti
Senior Vice President and Global Head, Patient Insights and Strategy
YPrime
9:30 am IN-HOUSE VS OUTSOURCE Developing and nurturing in-house teams in companies with limited resources to streamline ClinOps; when do you ACTUALLY need to outsource?
- Discussing the age-old question of when to outsource and when to keep processes in-house.
- How should a company approach bringing operations in house when they have been reliant on full service CROs?
- At what stage should a company consider in house operations?
- Best practices for developing internal talent
- How can a small company be operationally and cost effective when it comes to outsourcing?
- Identifying when you truly need to outsource and finding a suitable partner

Bonne Adams
Executive Vice President Clinical Operations
TRACON Pharmaceuticals
10:00 am Phase 2 Dose-Finding Trials: Are Adaptive Designs Preferred?
This talk offers a rudimentary overview of some key considerations for deciding whether to implement an adaptive trial design for Phase 2 dose-finding or to pursue alternative efficient modeling approaches for identifying the optimal dose to take forward to a future confirmatory trial.
What You Will Learn;
- Factors to consider when choosing an appropriate design for dose-finding
- When not to use adaptive design constructs in dose-finding
- An alternative approach for identifying an optimal dose in Phase 2 dose-finding

Abie Ekangaki, PhD,
Vice President, Statistical Consulting, Premier Research
10:30 am Morning Refreshments and Networking
11:00 am PANEL REUNION DEBATE POST COVID: How long will we feel ripples of the pandemic?
Debating how COVID-19 has impacted the way we outsource and conduct clinical trials in the future; a follow up from our 2021 session, what has changed?
- No going back – what’s the ‘New Normal’ in clinical trial operations?
- How can we develop a clinical trial model that can withstand global disruption?
- Addressing clinical staffing issues due to vaccine mandates – explore the impacts on current and future trials
- Highlighting technologies accelerated during the pandemic – are these a flash in the pan or what technologies should we continue to invest in?
- Tips and tricks for keeping studies flexible and on track
- Future trials – summarizing lessons learned from COVID-19, what we carry forward and how to reduce the burden on patients

Steven Chen
Chief Medical Officer
Avelas Biosciences

Kenneth Wilson
Outsourcing Lead
Pfizer

Melody Anderson
Sr Director, Clinical Operations
Avelas Biosciences
11:30 am How to leverage IRT to match the increasing need for flexibility in the clinical supply chain
- Case studies: how variable is the clinical supply chain between protocols?
- What flexibility can IRT provide to adapt to protocol-specific requirements?
- Key learnings from turning supply chain complexity into simplicity in IRT

Alexis Garelli
Technical Solutions Director
Calyx
12:00 pm Facing up to increased trial costs: Top tips for staying in budget
- Exploring what costs are rising in 2022 and what you need to be keeping an eye on
- Offering advice on budgeting for large and small clinical trials
- Top tips on how to get the best deals and keep costs down without compromising on quality

AJ Bergmann
Chief Financial Officer
Capricor Therapeutics
12:30 pm Lunch and Networking
1:30 pm Managing clinical studies at medical device startups
- Inhouse vs Outsource: Do you outsource to cover processes that can no longer be dealt with in house?
- Exploring protocol design strategies for medical device studies
- Surprises and challenges that arose when running your device trial – and how these were overcome
- Forecasting potential challenges for the future and what we can do now to prepare

Terry Arnold
Senior Director of Medical Affairs
DermTech
2:00 pm GLOBALDATA SPOTLIGHT Embracing Disruption in Pharma - Is COVID-19 a Catalyst for Lasting Change?
- Themes that are shaping the biopharmaceutical industry – both today and into the future
- Key emerging technologies & disrupters for 2022
- Industry, regulatory and macro-economic factors affecting pharma in 2022?

Bonnie Bain
Global Head and Executive Vice President of Healthcare Operations and Strategy
GlobalData Healthcare
2:30 pm Afternoon Refreshments and Networking; Apple Prize Drawer
3:00 pm Speaker Hosted Roundtables
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 a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
Each roundtable session lasts for 20 minutes, and delegates may attend up to 2 roundtables |
CRO partner selection: With such a crowded CRO landscape on the West Coast, how can we differentiate and make a choice?
Stefan Lukianov, CEO, Salve Technologies |
Mining for Gold: Looking at trends and budget analysis to find cost savings
Kenneth Wilson, Outsourcing Lead, Pfizer |
Equity raise vs. non-dilutive funding for early stage companies: navigating uncertain times
Peter B. Heifetz, President and CEO, OrPro Therapeutics |

Stefan Lukianov
CEO
Salve Therapeutics

Kenneth Wilson
Outsourcing Lead
Pfizer

Peter B. Heifetz
President and CEO
OrPro Therapeutics
3:50 pm Chair’s summation and close of conference
SPONSORSHIP OPPORTUNITIES
Nick McCudden
T: +61 280 978 126
E: NicholasMcCudden@arena-international.com
SPEAKING OPPORTUNITIES
Chloe Roberts
T: +44 (0) 207 936 6822
E: chloe.roberts@arena-international.com