Outsourcing in Clinical Trials Southern California 2023

Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023!

26 - 27

September

2023
  • Hyatt Regency La Jolla at Aventine, USA
  • Complimentary

2023 Sponsors Included:

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Company Information

Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.

Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.”

About Novotech- The Asia Pacific Centred Global Biotech CRO | Novotech CRO (novotech-cro.com)

Company Website

To learn more , please visit our website - https://novotech-cro.com/

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Company Information

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

Company Website

To learn more , please visit our website - http://www.iconplc.com/

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Company Information

In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients’ lives.

Company Website

To learn more , please visit our website - www.Clario.com

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Company Information

PCM TRIALS screens, hires, trains and manages all of our own Certified Mobile Research Nurses who conduct clinical trial visits in the subject’s homes. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA.  Services are available in U.S., Canada and ROW.

Company Website

To learn more , please visit our website - http://www.pcmtrials.com/

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Company Information

Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

Company Website

To learn more , please visit our website - http://www.premier-research.com/

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Company Information

TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. TFS  demonstrates  scientific  and  medical  competence  across populations and therapeutics, with industry-leading capabilities in:

 

-Dermatology, Immunology and Inflammatory Diseases

-Hematology and Oncology

-Ophthalmology

-Internal Medicine including Neurology & Respiratory

-Pediatrics, Rare Diseases and Orphan Drugs

-Real World Evidence​

Detailed information about TFS, and its business offerings can be obtained through

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Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

Company Website

To learn more , please visit our website - www.viedoc.com

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YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

Company Website

To learn more , please visit our website - http://www.yprime.com/

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Company Information

KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (“FSP”) that offers a clinical outsourcing solution across all phases of clinical drug development. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing.

Operating in 49 countries across the globe, KPS Life is committed to working together with its clients through a hands-on operating model rooted in a partnership approach. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control.

Company Website

To learn more , please visit our website - http://kpslife.com/

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Company Information

eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

Company Website

To learn more , please visit our website - www.eclinicalsol.com

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Company Information

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Learn more at www.iqvia.com.

Company Website

To learn more , please visit our website - www.iqvia.com

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ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

Company Website

To learn more , please visit our website - www.ACMGlobalLab.com

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Company Information

Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience.

Company Website

To learn more , please visit our website - https://www.advancedclinical.com/

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Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance.  Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster.  

Company Website

To learn more , please visit our website - www.advarra.com

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Company Information

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

Company Website

To learn more , please visit our website - www.allucent.com

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Established in 1950, Andwin Scientific specializes in outsourced clinical research supply chain and laboratory supplies management to global life science organizations, providing a single source for study supplies & equipment and custom clinical trial & specimen kitting requirements.

Company Website

To learn more , please visit our website - https://andwinsci.com/

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assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. eCOA is our core focus but not our only service. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades.

Company Website

To learn more , please visit our website - www.assistek.com

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Company Website

To learn more , please visit our website - atreo.io

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Axiom is celebrating 22 years of delivering hundreds of studies in dozens of countries. Since its founding in 2001, Axiom has delivered data-driven, powerful, and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Axiom Fusion eClinical Suite is the most adaptable, Unified Platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Choose from 15+ unified modules on a single platform: EDC, DM, RTSM/IRT, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance.

Company Website

To learn more , please visit our website - https://www.axiommetrics.com

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Barrington James are a Global specialist recruitment consul­tancy working across the Healthcare sector.  Our structure, with separate divisions and dedicated consultants for the markets we serve ensures a thorough, professional and intelligent approach in both permanent and interim solutions.  Our tailored methodologies include Contingency database search and executive search.

Company Website

To learn more , please visit our website - www.barringtonjames.com

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    Why attend?

    Arena International are delighted to announce Outsourcing in Clinical Trials Southern California will be returning to La Jolla on the  26th-27th September 2023!

    For this years event, the conference will be focused on interactive discussions to provide insight into the current major operational issues with running clinical trials in the coming years.

    Don’t miss out on this years two-streamed agenda; join us in sunny San Diego in September 2023. We can’t wait to see you there!

    Southern California Clinical Trials Outsourcing 2023 is pleased to announce an event for all online casino players. Our flagship clinical show will be held in 2023 with the best online casino https://chiefcasinos.com/low-deposits/1-dollar-deposit/ gamblers. This event cannot be missed, and every online casino player can view the agendas on our website.

    A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

    As this event returns you can expect high level discussion and presentations with industry thought leaders focusing on novel and innovative solutions to some of this years key challenges. Additionally with our technology and innovation stream, learn what is in store for the future of clinical trials.

    450+

    ATTENDEES

    		65+

    EXHIBITORS

    		30+

    SPEAKERS

    		50%

    ATTENDEES AT DIRECTOR + LEVEL

    450+

    ATTENDEES

    		65+

    EXHIBITORS
    30+

    SPEAKERS

    		50%

    ATTENDEES AT DIRECTOR + LEVEL

    Testimonials

    See What It's All About

    Agenda

    • 26 Sep 2023
    • 27 Sep 2023
    Expand All

    Streams

    Stream one

    Outsourcing & Clinical Operations

    Stream two

    Clinical Trial Technology & Innovation

    7:45 AM

    Registration and Refreshments

    8:20 AM

    Chair’s Opening Remarks

    8:30 AM

    KEYNOTE PANEL Patient engagement – What we as an industry need to do to promote trust

    • How other experts are boosting engagement across therapeutic indications
    • Talking the good, the bad and the ugly of recruitment
    • Discussing innovative patient recruitment tools being used in the industry

    Speakers

    9 AM

    Session Reserved for Novotech

    9:30 AM

    Oversight of clinical studies in India & Eastern Europe

    • What are the main hurdles to overcome to run a trial here
    • Balancing the cost efficiency of running trials here with the extra work needed to ensure good clinical quality data
    • Managing compliance in the region

    10 AM

    Morning Refreshments and Networking

    10:45 AM

    What is your competitive secret sauce – a talk from an expert sharing tips to speed up trials

    • Competitive clinical operations, being the best you can be
    • Risk mitigation and vendor management?
    • How quickly can you activate your sites?
    • How do you reduce your risks

    Speakers

    11:30 AM

    Session Reserved for PCM Trials

    12 PM

    Finding CROs and partners as a small to medium sized company: challenges and considerations

    • Finding the right match for your specific indication
    • The do’s and don’ts of who to work with as a small biotech
    • Discussing how to enter contract negotiation on the right footing

    Speakers

    12:30 PM

    Session Reserved for TFS Health Science

    1 PM

    Lunch and Networking

    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: Patient enrollment, what are we doing to improve uptake in new trials. TABLE 3: Managing your trial budget during uncertain times.
    TABLE 2: Finding the right CRO for your study. TABLE 4: Decentralization, for or against?

    2 PM

    PANEL DISCUSSION – Top tips and tricks for managing your trial budget during unstable times

    • Understanding what the reality of the costs of clinical trials are and what could happen to increase costs
    • Planning out the entire trial with a budget focus, what steps are truly needed
    • Everyone is undergoing cost savings, what are key areas to cut down in

    Speakers

    2:30 PM

    Feeling Pressure to Curb Costs? How Central Monitoring Can Stretch Your Budget Without Compromising Quality

    • Considerations for implementing a successful central monitoring strategy
    • The value proposition: Where central monitoring can have the greatest impact for reducing clinical trial costs
    • How central monitoring may impact the future role of the CRA

    3 PM

    Working alongside your finance team from the clinical side to make your budget go further

    • Handling the funding issues of newer trials in an unpredictable economy
    • Tips and tricks for small and medium pharma to work alongside your financial team
    • Discussing alternative financing methods rather than compromise the quality of your trials
    • Design changes to incorporate early in your study cycle to reduce costs

    Speakers

    3:30 PM

    Afternoon Refreshments and Networking

    4 PM

    Navigating the perfect storm as a small biotech company: what you need to know to succeed

    • How macro-political and economic issues affect clinical trials and mitigating risk surrounding this
    • Cutting costs and maximizing resources: the financial consequences of the storm on small biotech organizations
    • Understanding the changing regulatory environment for trials in 2023
    • Keeping the patient at the center of changes to clinical trials: navigating the storm while minimizing patient impact

    Speakers

    4:30 PM

    Is Outsourcing Clinical Trials with Multiple Consultants Right for My Company? Balancing the Tradeoffs vs a Full Service CRO

    • Fostering co-operation between different vendors on one clinical study
    • How to manage the tradeoffs of multiple consultants against the use of a full service strategy

    Speakers

    5 PM

    Chair’s Summation and Drinks Reception

    10:45 AM

    PANEL DISCUSSION – Evaluating the use of modern technology in clinical trials in a post-COVID landscape

    • Are we better off now with technology or were we better off before
    • What useful changes have we received since the pandemic
    • What is here to stay and what should be left behind?

    Speakers

    11:30 AM

    Optimizing early development to maximize success probability in the late stage development

    • Dose escalation: Critical elements to support informative drug safety profile and initial efficacy
    • Selection of the dose for the late-stage development: decisions around monotherapy, combination regimens
    • Incorporation of the patient voice, alignment with medical quality measures, considerations around existing treatment options landscape

    Speakers

    12 PM

    Dealing with Phase 3 data challenges; how to get data collection back on track

    • Handling adversity when challenges arise in your study
    • Highlighting the value of hands-on experience when managing a complex study
    • How to negotiate with a partner after issues have arisen, getting your money’s worth
    • Lessons learned when managing large data sets
    • Advice for future trials, how to ensure data collection and quality is on point

    Speakers

    12:30 PM

    15 Minute Tech Spotlight by eClinical Solutions

    • 15 Minute Tech Spotlight by IQVIA

    1 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: Patient enrollment, what are we doing to improve uptake in new trials. TABLE 3: Managing your trial budget during uncertain times.
      TABLE 2: Finding the right CRO for your study. TABLE 4: Decentralization, for or against?

    Speakers

    2 PM

    The upcoming importance of diversity in clinical trials And how it can promote patient recruitment

    • A look into the new requirements made by the FDA and what you need to be aware of
    • How to most efficiently enrol the right patients needed for your trial to be approved
    • Looking at all aspects of diversity and why they are important for clinical trials

    Speakers

    2:30 PM

    Session Reserved for YPrime

    3 PM

    Interactive Workshop – Exploring the use of innovative technologies in clinical studies

    • Understanding the benefits and challenges of using newer technologies such as AI in clinical studies.
    • Discussing the factors to consider when deciding whether to implement emerging technologies in clinical studies.
    • Identifying the potential use cases of innovative technologies in clinical trials, and how they can improve study outcomes.

    Speakers

    12:30 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 3: Exploring best practices for conducting international trials in a post-pandemic world
    • TABLE 2: Overcoming common small company pain points TABLE 4: What does ‘patient-centricity’ mean to you?

    3:30 PM

    Afternoon Refreshments and Networking

    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

    5 PM

    Chair’s Summation and Drinks Reception

    Streams

    Stream one

    Outsourcing & Clinical Operations

    Stream two

    Clinical Trial Technology & Innovation

    7:50 AM

    Registration and Refreshments

    8:25 AM

    Chair’s Opening Remarks

    8:30 AM

    Mining for Gold: Looking at trends and budget analysis to find cost savings

    • How to monitor and record cost savings in a clinical stage business
    • Proving your net worth through your negotiations
    • Finding savings in hidden places

    Speakers

    9 AM

    Session Reserved for Event Sponsor

    9:30 AM

    PANEL DISCUSSION Talking through vendor management tips and tricks

    • Tips to manage your relationship with your CRO
    • Working with new staff turnover and how to maintain high data quality
    • A refresher on metrics and KPIs, how we analyze our partnerships with CROs
    • How to maintain a positive relationship with your CRO.

    Speakers

    10 AM

    Session Reserved for Event Sponsor

    10:30 AM

    Morning Refreshments and Networking

    11 AM

    PANEL DISCUSSION – Working closely with your site to achieve a mutually beneficial relationship

    • How to curate a positive relationship with your site
    • Data collection in sites –what can you do as a sponsor to bring it back up to speed?
    • What lessons have we learnt when moving in and out the clinic, a reflection from the past few years
    • How to make your IMP stand out amongst the crowd

    Speakers

    11:45 AM

    Session Reserved for Event Sponsor

    12:15 PM

    How do you build your clinical team – people leadership development

    • How to train your team as future leaders from the beginning
    • How we as an industry can work together to develop the next generation of leaders

    Speakers

    12:45 PM

    Lunch and Networking

    1:45 PM

    PANEL DISCUSSION – What are the lessons learned from decentralizing – what takeaways do we have as an industry from the last few years

    • Weighing the advantages and disadvantages of having decentralized
    • What do both the sponsor and vendor want to gain from decentralizing trials and how can we balance that
    • Look at the real costs of DCT, does it impact your data quality

    Speakers

    2:15 PM

    The journey of Drug Product from Manufacturing to Clinical Administration

    • Challenges of Supply chain logistics across the globe with different biologics
    • Selecting Storage and Supply Depot across the globe
    • Robustness around Clinical in-use study design and Clinical administration

    Speakers

    2:45 PM

    Afternoon Refreshments and Networking; Apple Prize Draw

    3:15 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 30 minutes, and delegates may attend up to 2 roundtables
      RT 1 Talking all things study design, how to have a clear end point when designing your study

      Joseph Shan, Executive Director, Clinical Development Operations, MEI Pharma
      RT 2 Managing CRO relationships, what we are doing to work with our future partners.

      Kerry Clancy, Director of Outsourcing, AnaptysBio
      RT 3 The state of current biotech financing: navigating uncertain times

      Peter B. Heifetz, President and CEO, OrPro Therapeutics

    4:15 PM

    Close of conference

    8:30 AM

    MDR – a deep dive into the complexity of the problem

    • How Did We Get Here and is it Really Fixing the Problem?
    • What Happens to Innovation
    • Unintended Consequences: Long Term and Short Term Downstream Effects
    • Who are the Winners and Losers?
    • Where are we Now and What to Expect Next

    Speakers

    9 AM

    Hybrid trials using DCT technology and processes; focus on patients and the sites

    • Highlighting the complexity that Hybrid/DCT brings whilst moving away from the common brick-and-mortar sites.
    • Discussing the rise in regulator concerns in areas such as investigator oversight, and participant’s safety when face to face contact is limited.
    • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more.
    • Major points to consider in designing hybrid/DCT trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind.Sverre Bengtsson

    Speakers

    9:30 AM

    IVD, Combining the regulatory & clinical strategy to improve clinical trial outcome

    • General regulatory strategy to consider when planning your clinical trials
    • Cross functional work between the regulatory and clinical teams to achieve a strong regulatory submission package
    • Key global IVD clinical regulatory changes to take note of in the coming years

    Speakers

    10 AM

    Session Reserved for Event Sponsor

    10:30 AM

    Morning Refreshments and Networking

    11 AM

    Modern issues with sample and data reconciliation and how to get around them

    • Relationship with site and your central lab
    • Between labs, working with central and focused analytical labs
    • Managing your data post analytics

    Speakers

    11:45 AM

    Session Reserved for Event Sponsor

    12:15 PM

    Precision clinical trials in the era of big data, artificial intelligence, and precision medicine

    • Exploring the innovations in modern clinical trials that have made a difference in precision medicine.
    • In the modernising world of AI how much impact can we expect that to have on clinical trials.
    • Identifying the future of Precision trials and highlighting the big players in the fie

    Speakers

    12:45 PM

    Lunch and Networking

    Speakers

    Select a speaker to learn more

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    Jennifer Lee
    Senior Vice President Of Clinical Operation, Biostats, And Data Management , Elevar Therapeutics

    Jennifer Lee is Senior Vice President of Clinical Operation, Biostats, and Data Management at Elevar Therapeutics. Jennifer brings over 25 years of industry expertise in clinical strategies, asset evaluation, and advancing novel and innovative clinical programs spanning phases I-IV across therapeutic areas, including oncology, infectious disease, inflammation, urology, CNS, cardiovascular, rare disease, and stem and cell therapies.

    She is an invited speaker at international conferences and has successfully submitted market applications leading to seven NDA approvals. Previously, Jennifer worked at G.D. Searle, Pharmacia, Pfizer, Astellas Gilead Sciences, and other mid- and micro-cap companies.

    Jennifer holds a BS in Biochemistry from the University of Illinois and an MS in Clinical Research and Regulatory Administrations from Northwestern University. She is an active mentor, Women in Bio supporter, and board member.

    Session Details:

    What is your competitive secret sauce – a talk from an expert sharing tips to speed up trials

    2023-09-26, 10:45 AM

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    Roger Davies
    Vice President Operations

    Session Details:

    PANEL DISCUSSION – Working closely with your site to achieve a mutually beneficial relationship

    2023-09-27, 11:00 AM

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    Betsey Zbyszynski
    Director, Clinical Contracts & Outsourcing

    Betsey has been in clinical research industry for 25 years with a focus of responsibility in clinical operations, outsourcing and strategic planning.  Betsey has extensive experience managing vendors, client relationships, identifying and mitigating risks as well as negotiating contracts and budgets.  She has worked in both the pharma and CRO sectors.

    Session Details:

    PANEL DISCUSSION – Top tips and tricks for managing your trial budget during unstable times

    2023-09-26, 2:00 PM

    Session Details:

    PANEL DISCUSSION Talking through vendor management tips and tricks

    2023-09-27, 9:30 AM

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    Maribelle Guloy
    Director, Clinical Development, HBT LABS - A Wholly Owned Subsidiary of American Regent

    Maribelle Guloy is the Director of Clinical Development at American Regent, A Daiichi Sankyo company, where she is responsible for the development of clinical trial protocol design and strategic direction and execution of a clinical program.

    Maribelle is a member of the Advisory Board in Clinical Trials: Medical Device & Drug Development at University of California, Irvine. Maribelle was previously a member of the Board of Directors at the Society of Clinical Research Associates (SoCRA) and continues to serve as its Chairperson in Orange County, California

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    Kenneth Kleinhenz
    COO, Lorem Cytori, USA

    Kenneth Kleinhenzhas held numerous executive-level quality assurance and regulatory affairs position at public and private biotechnology companies to include 15 years of service as the Vice President and Chief Operating Officer at Cytori Therapeutics, a device-based, adipose-focused stem cell company. Previously, Mr. Kleinhenz was the Vice President of Quality and Regulatory at Avelas Biosciences, Director of Regulatory Affairs at MacroPoreBiosurgery, Chief Microbiologist for Becton Dickinson, and theManager of Quality Assurance and Regulatory Affairs at Pacific Pharmaceuticals. Mr. Kleinhenz is a veteran of the United States Navy where he served as a Clinical Microbiologist for 6 years at the NavalHospital, San Diego. Mr. Kleinhenzreceived his BS in Microbiology at the University of California, San Diego (UCSD) and his MBA in Technology Management at the University of Phoenix.

    Session Details:

    MDR – a deep dive into the complexity of the problem

    2023-09-27, 8:30 AM

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    Saeid Yazdani
    Vice President Portfolio Management - Therapeutics Product Development

    Saeid Yazdani serves as the Vice President of Program Management for Caribou Biosciences. He brings over 30 years of Program & Portfolio leadership experience from therapeutic discovery to commercialization, working with cross-functional leaders in research, development, operations, CMC, clinical, regulatory, quality, commercial, and executive team. Previously, he was Vice President of Therapeutics Program Management at Huyabio International, during which time he led two IND approval and oversaw six therapeutics development programs. He is an entrepreneur and inventor with U.S. patents. Saeid has held a variety of leadership, business, and program & portfolio positions of increasing responsibility at Thermo Fisher, Nestle Health Science, Merck (EMD), Genentech, Gilead, and Synergic Analytics, and adjunct professor at the University of California, San Diego extended studies. Saeid holds a B.S. in Chemistry from Western Michigan University & MBA from the University of Southern California.

    Session Details:

    How do you build your clinical team – people leadership development

    2023-09-27, 12:15 PM

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    Amish Patel
    VP of Technical Operations

    Dr. Amish Patel has over 18 years of leadership experience in global biopharma and biotech industry, providing strategic guidance throughout the entire biologic product life-cycle.  Dr. Patel is responsible for critical oversight of Global Manufacturing, Quality Control, Quality Assurance and Supply Chain to produce Clinical and Commercial cancer therapies utilizing Calidi’s innovative oncolytic viral therapies with stem cell-based delivery platforms to treat a wide range of cancers with significant unmet needs.

    Over the course of his career, he has led the development of over fifteen INDs, two commercial product approvals, and numerous PAS submissions. He was most recently, the Senior Director of Product Development at Emergent BioSolutions (formerly PaxVax, Inc., prior to acquisition), where he successfully built and directed cross-functional teams working on numerous biologic Clinical products.

    Session Details:

    The journey of Drug Product from Manufacturing to Clinical Administration

    2023-09-27, 2:15 PM

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    Peter B. Heifetz
    President And CEO, OrPro Therapeutics
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    Sormeh Mahjouri, MPH, PMP
    Program Director

    Sormeh is currently Program Director at local biotech start-up in cancer imaging, Imagion Biosystems. She has previous experience in Program Management, Clinical Operations, and Regulatory Affairs and has worked in the biopharma/medical device industries for over 12 years (Arena Pharmaceuticals – recently acquired by Pfizer, Gilead, Medtronic).

    Session Details:

    PANEL DISCUSSION Talking through vendor management tips and tricks

    2023-09-27, 9:30 AM

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    Rupesh Kanchi Ravi
    Head, Pfizer Oncology Clinical Research Lab

    Rupesh Kanchi Ravi is the Lab Head in the Pfizer Oncology Clinical Research Laboratory (POCRL), a clinical genomics GCLP lab overseeing Pfizer Oncology custom genomics clinical sample testing and new platform evaluations for genomics biomarker strategy and clinical utility working with CROs. Previously, Rupesh held the role of Biomarker Assay Specialist as clinical genomics and NGS expertise managing clinical NGS testing for Translational Oncology Phase 1 study programs and working with cross-functional teams that included GPD Oncology, ECD, and Computational Biology.

    Prior to joining Pfizer Oncology, Rupesh held senior scientist positions at Genoptix, UCSD’s Genomics Center, TGen in which he developed, validated, and launched novel NGS assays (cfDNA, targeted DNA, targeted RNA, exosomal RNA, miRNA) for GCLP and CAP/CLIA lab environments, and developed novel NGS library generation techniques for numerous nucleic acid sample types. Rupesh earned his PhD in Biotechnology at Pondicherry University where he studied the anti-inflammatory and anti-cancer properties of marine natural products. He received his first postdoctoral training at the French National Center for Scientific Research (CNRS) in the Extreme Environments Microbiology Lab where he characterized the DNA replication/repair machinery of hyperthermophiles. He received his second postdoctoral training at University of Arizona where he identified novel alternate DNA repair pathway Base Excision Repair pathway inHSV-1 and developed a High Thorough put assay for identifying single strand DNA-protein inhibitors.

    Session Details:

    Modern issues with sample and data reconciliation and how to get around them

    2023-09-27, 11:00 AM

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    Majid Ghoddusi
    Senior Director, Clinical Biomarkers, Poseida Therapeutics

    Majid joined Janux in June 2022 as executive director and head of clinical biomarkers responsible to devise strategy, source best technology and platforms and execute comprehensive laboratory testing plans in support of Janux clinical studies.  Majid has over 15 years of experience in some of the most challenging areas of oncology therapeutics with a primary focus on predictive oncology clinical development. Trained as a translational pathologist he has held impactful positions with increasing responsibilities at large pharmaceutical and small to medium biotech companies including Novartis, Celgene, Juno Therapeutics, Five Prime, and Poseida Therapeutics.

     

    Majid has a Doctor of Veterinary Medicine degree, a postgraduate diploma and a PhD from the University of Queensland in Australia.

    Session Details:

    PANEL DISCUSSION – Evaluating the use of modern technology in clinical trials in a post-COVID landscape

    2023-09-26, 10:45 AM

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    Anusha Perera
    Senior Director, IT

    Experienced IT leader specializing in clinical technology, adept at launching programs that safeguard data, streamline operations, drive innovation, and advance business strategy within the healthcare industry. Well-versed in clinical systems, electronic health records, medical device integration, data analytics, and regulatory compliance, ensuring efficient and effective patient care delivery.

    Session Details:

    PANEL DISCUSSION – Evaluating the use of modern technology in clinical trials in a post-COVID landscape

    2023-09-26, 10:45 AM

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    AJ Bergmann
    Chief Financial Officer, Capricor Therapeutics

    AJ Bergmann is currently the Chief Financial Officer of Capricor Therapeutics, Inc. (NASDAQ: CAPR). Mr. Bergmann joined Capricor in 2011 and he also serves as the Company’s corporate treasurer. During his time at Capricor, Mr. Bergmann directly coordinated the Company’s reverse merger and subsequent uplisting to the NASDAQ and financings yielding over $100.0 million, to date. He has experience in developing corporate and financial strategy alternatives and executing strategic plans. Mr. Bergmann manages the Company’s finance, accounting, business development, and human resource functions. Prior to joining Capricor, Mr. Bergmann had experience in accounting, finance, and operations management of companies ranging in size from start-ups to mid-size companies. Most recently he was with the business management firm, Gettleson, Witzer, and O’Connor, in Beverly Hills, California, where he focused on accounting and finance for several production studios generating motion picture releases and worldwide revenue that exceeded $1 billion. The firm’s clients included foundations, trusts, and independent actors, writers, producers and directors across the entertainment industry. While at the firm, he focused on budgeting, tax forecasting, and asset management. Earlier in his career, Mr. Bergmann served in financial positions in various industries. Mr. Bergmann graduated from Providence College with a Bachelor of Science degree in Management and a minor in Finance. He has an M.B.A. from the University of Southern California’s Marshall School of Business.

    Session Details:

    Working alongside your finance team from the clinical side to make your budget go further

    2023-09-26, 3:00 PM

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    Ken Wilson
    Outsourcing Lead, Pfizer

    Ken has been in the industry for over 30 years, with just over 20 in the CRO world, at Quintiles, Statprobe, and Clinimetrics/Omnicare. Ken joined Pfizer in 2010 in an outsourcing role, and has been leading outsourcing efforts for multiple development programs. Experience prior to Pfizer includes hands-on and line management roles in Statistical Programming, Biostatistics, Data Management, and Project Management, as well as overall responsibility for a local CRO office in San Diego that employed more than 70 local employees.

    Session Details:

    Mining for Gold: Looking at trends and budget analysis to find cost savings

    2023-09-27, 8:30 AM

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    Jiao Song
    Director, Early Clinical Science

    Session Details:

    PANEL DISCUSSION – What are the lessons learned from decentralizing – what takeaways do we have as an industry from the last few years

    2023-09-27, 1:45 PM

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    Tracy Lawhon
    Chief Development Officer

    Session Details:

    Is Outsourcing Clinical Trials with Multiple Consultants Right for My Company? Balancing the Tradeoffs vs a Full Service CRO

    2023-09-26, 4:30 PM

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    Ken Kobayashi
    Senior Vice President

    Experienced drug developer and executive with deep expertise across early and late development, multiple indications (including solid tumors and hematological malignancies), and drugs with many different mechanisms of action. Led highly successful global teams in US and AP regional teams while based in Japan. Moves easily between tactical/executional work at study team level and overall portfolio-level strategy and prioritization work at senior leadership level.”

    Session Details:

    PANEL DISCUSSION – What are the lessons learned from decentralizing – what takeaways do we have as an industry from the last few years

    2023-09-27, 1:45 PM

    Session Details:

    PANEL DISCUSSION – Working closely with your site to achieve a mutually beneficial relationship

    2023-09-27, 11:00 AM

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    Brandi Roberts
    Chief Financial Officer

    Brandi Roberts is the Executive Vice President and Chief Financial Officer at Longboard Pharmaceuticals (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Ms. Roberts has more than 25 years of public accounting and finance experience, including 22 years at publicly traded pharmaceutical, medical technology, and life science companies. Ms. Roberts is a certified public accountant with the State of California and received her B.S. degree in business administration from the University of Arizona and her M.B.A. from the University of San Diego.

    Session Details:

    PANEL DISCUSSION – Top tips and tricks for managing your trial budget during unstable times

    2023-09-26, 2:00 PM

    Session Details:

    Dealing with Phase 3 data challenges; how to get data collection back on track

    2023-09-26, 12:00 PM

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    Patty Law
    Sr. Director, Clinical Affairs

    Patty is currently the Head of Clinical Affairs for the Diagnostic Solutions Division at Hologic. Previous work experience includes serving as a Program Director for multiple CROs and as a Research Physiologist for the Naval Health Research Center.

    Session Details:

    IVD, Combining the regulatory & clinical strategy to improve clinical trial outcome

    2023-09-27, 9:30 AM

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    Veronica Sandoval
    Principal, Inclusion & Health Equity

    Veronica Sandoval is a Principal in the Patient Inclusion and Health Equity team in the Chief Diversity Office (CDO) at Genentech. Veronica's policy and medical background, along with the personal and professional intersection of her Latino roots and health equity efforts, bring a rich perspective to Genentech’s ongoing work in health equity and inclusive research.

    Veronica joined Roche-Genentech in 2018 as a Global Medical Collaboration Lead supporting the early clinical development program for autism. Prior to her role as Principal in the CDO, she supported the respiratory portfolio as a Medical Science Liaison. She has experience in health equity, medical affairs, thought leader development, patient engagement, and external partnerships. Therapeutic areas of expertise include ophthalmology, oncology, multiple sclerosis, immunology, asthma, inflammatory bowel disease, women’s health, autism spectrum disorder, idiopathic pulmonary fibrosis, and influenza. Veronica also practiced as an intellectual property litigation attorney focusing on complex patent litigation in the life sciences and pharmaceutical fields.

    Veronica holds a Ph.D. in neuropharmacology from the University of Utah, a J.D. from Seattle University School of Law, and a B.A. in molecular and cell biology from the University of California, Berkeley.

    Session Details:

    KEYNOTE PANEL Patient engagement – What we as an industry need to do to promote trust

    2023-09-26, 8:30 AM

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    Wendy Pizarro
    , Chief Administrative Officer and Chief Legal Officer

    Session Details:

    KEYNOTE PANEL Patient engagement – What we as an industry need to do to promote trust

    2023-09-26, 8:30 AM

    Session Details:

    The upcoming importance of diversity in clinical trials And how it can promote patient recruitment

    2023-09-26, 2:00 PM

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    Kerry Clancy
    Director of Outsourcing,
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    Chad Orevillo
    Vice President, Head of Operations

    Session Details:

    Finding CROs and partners as a small to medium sized company: challenges and considerations

    2023-09-26, 12:00 PM

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    Prasun Mishra
    Founding Partner, World Investors and Entrepreneurs Society

    Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American
    Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He
    is leading research efforts focused on preventing curing chronic diseases not only treating
    the sick but also providing knowledge/tools to individuals to live longer, healthier lives

    He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company
    committed to revolutionizing drug discovery development through technology, big data,
    robotics, and artificial intelligence He is a serial entrepreneur who founded his first company
    after graduating high school, and his second company during his Ph D Since then, he has
    accumulated a wealth of experience by building, investing, and advising numerous other
    companies He is an investor, co founder/ board member of a few corporations, focused on
    accelerating drug discovery/ development, data analytics, robotics, mental health, and digital
    health He is also the founder of AAPM Angels and Investors AAi an investment group focused
    on investing in drug discovery, diagnostics, precision medicine, technology healthcare
    companies He is also the founding investor and advisor to Barcelona Ventures and serves as an
    advisor to a 100 M private equity fund

    Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has
    keynoted, chaired, curated, and organized numerous successful international conferences He
    served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where
    he participated in several drug discovery project teams Moreover, his passion for drug
    development and precision medicine has led to the identification of new drug targets,
    biomarkers, companion diagnostics, and several drugs/ combinations in the clinic

    His research work has been recognized globally by over 40 prestigious awards and honors Due
    to his unique perspective selfless service, he is a highly respected sought after mentor to
    many The companies that he has advised have raised multimillion dollars Notably, he serves
    as a mentor and advisor to several VC funds and startup accelerators, including IndieBio
    HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture,
    UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life
    sciences innovation ecosystem

    Session Details:

    Precision clinical trials in the era of big data, artificial intelligence, and precision medicine

    2023-09-27, 12:15 PM

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    Barbara Birch
    Associate Director, Clinical Procurement & Outsourcing

    Session Details:

    Navigating the perfect storm as a small biotech company: what you need to know to succeed

    2023-09-26, 4:00 PM

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    Mirta Grifman
    Vice President, Clinical Development and External Innovation

    Session Details:

    Interactive Workshop – Exploring the use of innovative technologies in clinical studies

    2023-09-26, 3:00 PM

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    Emily Solomon
    Vice President, Clinical Operations, Biosplice Therapeutics

    Session Details:

    Interactive Workshop – Exploring the use of innovative technologies in clinical studies

    2023-09-26, 3:00 PM

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    Tanja Obradovic
    Vice President, Scientific Affairs

    Session Details:

    KEYNOTE PANEL Patient engagement – What we as an industry need to do to promote trust

    2023-09-26, 8:30 AM

    Session Details:

    Optimizing early development to maximize success probability in the late stage development

    2023-09-26, 11:30 AM

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    Joseph Shan
    Executive Director, Clinical Development Operations, MEI Pharma

    Collaborative and outcome-based biopharmaceutical servant-leader providing 20+ years of clinical operations experience. Passionately advancing the mission of improving patients’ lives through timely and efficient execution of clinical trials. Adept at building and managing cross-functional teams comprising internal and/or external partners and CROs to meet the dynamic business needs of virtual start-ups to leading life science companies.

    Next speaker

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