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
  • Complimentary

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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

Novotech is an Australia based clinical CRO operating across Asia and South Africa. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Our full service offering includes clinical program management, biometrics services and regulatory affairs.

Company Website

To learn more , please visit our website - http://www.novotech-cro.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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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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    Why attend?

    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!

    Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an event not to be missed- take a look at our agenda page & list of keynote speakers.

    The 2023 program boasts 2 streams jam packed with content. The Speaking Faculty includes the likes of AbbVie, Jazz Pharmaceuticals, Pfizer, Cortexyme, PTC Therapeutics, ReShape Lifesciences, Elevar Therapeuticsand many more.

    Don’t miss out; join us in La Jolla on September 26th & 27th. 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

    This is a a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Attendees will hear from industry leading speakers, learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

    300+

    ATTENDEES

    		65+

    EXHIBITORS

    		30+

    SPEAKERS

    		80%

    ATTENDEES AT DIRECTOR + LEVEL

    300+

    ATTENDEES

    		65+

    EXHIBITORS
    30+

    SPEAKERS

    		80%

    ATTENDEES AT DIRECTOR + LEVEL

    Testimonials

    See What It's All About

    2022 Agenda

    • 28 Sep 2022
    • 29 Sep 2022
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    Streams

    Stream one

    Clinical Operations & Outsourcing

    Stream two

    Clinical Technology & Innovation

    11 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;

    11:30 AM

    Decentralized clinical trials and hybrid trials: how to help patients and sites through technology and processes

    • Key learnings from running DCT/hybrid trials so far
    • Points to consider designing your upcoming clinical trials using DCT processes and technologies
    • Make the studies site and patient centric
    • The building blocks in your DCT/hybrid trials

    12 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

    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

    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?

    2 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?

    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

    3 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

    3:30 PM

    Afternoon Refreshments and Networking

    4 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

    5 PM

    Chair’s Summation and Drinks Reception

    7:45 AM

    Registration and Refreshments

    8:20 AM

    Chair’s Opening Remarks

    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?

    9:15 AM

    The Biotech landscape: Market trends, patterns and predictions

    • Trends in clinical development across the globe over the last 5 years
    • Pre and post covid impact on the clinical trial global economy
    • Patterns in investment and clinical trial equity
    • Where do the opportunities lie for further acceleration in clinical development

    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

    10:15 AM

    Morning Refreshments and Networking

    11 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

    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

    12 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

    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

    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: 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?

    2:30 PM

    Fast-Track Your Phase 1 Clinical Trial

    • Understanding the FDA, MHRA and TGA requirements
    • How these requirements translate into different timelines
    • Key benefits and challenges by jurisdiction
    • Choosing what’s right for you

    3 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?

    3:30 PM

    Afternoon Refreshments and Networking

    4 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

    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

    7:50 AM

    Registration and Refreshments

    8:25 AM

    Chair’s Opening Remarks

    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

    9 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

    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

    10 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

    10:30 AM

    Morning Refreshments and Networking

    11 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

    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

    12 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

    12:30 PM

    Lunch and Networking

    1:30 PM

    Technological Advances in Clinical Trials – Exploring the Value of Decentralization

    • Exploring common challenges in the traditional clinical trial model
    • How can decentralized clinical trials offers a more patient-centric experience?
    • How can technology support the evolving clinical trial

    2 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?

    2:30 PM

    Afternoon Refreshments and Networking; Apple Prize Drawer

    3 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

    3:50 PM

    Chair’s summation and close of conference

    2022 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.

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    Christopher Lemasters
    EVP & Chief Operating Officer, Amplyx Pharmaceuticals, Now A Subsidiary Of Pfizer

    Chris LeMasters is the EVP & Chief Operating Officer of Amplyx Pharmaceuticals, now a wholly owned subsidiary of Pfizer, Inc. Amplyx has focused on the development of novel first-in-class therapies for infectious disease affecting immune compromised patients. He led the strategic efforts that resulted in Amplyx’s acquisition by Pfizer in April 2021.

    Mr. LeMasters was previously Executive Vice President and Chief Business Officer of Mirati Therapeutics, a clinical-stage oncology company, where he was responsible for corporate development, strategy and investor relations. During his three years in this role, he oversaw the successful expansion of the company and its market capitalization from $100 million in 2016 to nearly $5 billion in December 2019.

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    CHRISTINE VON RAESFELD
    Independent Patient Advocate

    Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences dedicated to the rare disease community and disease awareness initiatives. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and stimulates dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program, All of Us Research, and the 23andMe Lupus initiative. For her many contributions to her field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future 50, and one of Medika Life's medikal life 50 most influential voices in healthcare 2022 among other distinctions. With her guidance and support, we will continue to optimize the patient journey for people worldwide.

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

    Dr. Gal has over 30 years of medical device experience as a practicing veterinarian, academician at Tufts University School of Medicine and subsequently in industry. Dov held R&D, clinical marketing and clinical affairs positions with increasing responsibilities in private start-up, and medium to large public medical device companies.

    Most recently, Dov led the clinical organization for the Heart Valve Therapy business at Edwards Lifesciences, overseeing clinical trials of Class III implantable devices. Prior to Edwards Lifesciences, he led the clinical organization at Broncus Technologies, a start-up with an investigational, minimally invasive device-drug combination product for the treatment of patients with severe COPD. The system was evaluated in an international clinical trial under an IDE. Prior to Broncus, Dov was a director of clinical research at Medtronic Vascular responsible for the AAA stent graft product line

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    Bonnie Bain, PhD
    Global Head And Executive Vice President Of Healthcare Operations And Strategy, GlobalData Healthcare

    Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

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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.

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

    Over 19 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. In addition, an adjunct assistant professor at USC – School of Pharmacy – Regulatory and Quality Sciences.

    Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

    • CMC Global Dossiers and Global Device Regulatory Strategy Registrations
    • EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
    • 21 CFR Part 3 and Part 4 - Combination Products
    • CE Marking
    • ISO 13485:2016/MDSAP
    • Product Development – Design Controls
    • Risk Management
    • Human Factors Engineering
    • Acquisitions/Divestitures
    • Import/Export – U.S. Agent
    • Production Controls
    • Regulatory Inspection Management
    • Materiovigilance
    • Health-Care Related Laws and International Regulations
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    Stefan Lukianov
    CEO , Salve Therapeutics

    Stefan N. Lukianov, AM MS is the first-time JHU grad student founder of Salve Therapeutics, Inc. of Los Angeles, CA.  He has undergraduate degrees from the University of Maine and masters from the University of Pittsburgh and Harvard University in the biomedical sciences.  He has worked in reputable labs at Boston Children’s Hospital, Brigham and Women’s Hospital, McLean Hospital and the UPMC Hillman Cancer Center. He also has extensive experience in science journalism and education that contribute to his company leadership and vision.

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    Steven Chen
    Chief Medical Officer , Avelas Biosciences

    Steven Chen, MD, MBA is the Chief Medical Officer of Avelas Biosciences in La Jolla, CA, a company with a drug/device combination focused on intraoperative margin detection.  He is also a surgical oncologist in San Diego, CA.  Dr. Chen received his medical degree and completed general surgery and critical care residencies at the University of Michigan, followed by a surgical oncology fellowship at the John Wayne Cancer Institute.  Subsequently, he was  the Chief of Breast Surgery at UC Davis Medical Center, and an Associate Professor of Surgery at City of Hope National Medical Center.  He serves as the Director of Surgical Oncology at OasisMD.  Dr. Chen is a past President of the American Society of Breast Surgeons and serves on committees for a number of professional societies including the American Medical Association and the American College of Surgeons

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

    Dr. Lei Zhang has over25 years of experience spanning across the biotech/biopharma, medical device, diagnostic, and CRO industries. Her unique drug development lifecycle expertise includes global clinical development & operations, scientific innovation, and regulatory interactions with the FDA (CDER, CBER, CDRH). Dr. Zhang engaged various therapeutic indications in oncology, cardiology, endocrinology, dermatology, OB/GYN, gastroenterology, urology, and infectious diseases. Her track record includes contributions to development strategy, corporate partnership, clinical trial design and execution (Phase I-III, 510(k), PMA) as well as regulatory submissions. Lei provides leadership overseeing functional teams in clinical/regulatory affairs, program management, Biostat, data management, medical writing, CRO/vender selection.

    Dr. Zhang received her M.S. from Beijing Medical Univ. and Ph.D from Germany; performed postdoc research at MIT. Lei is an active speaker at biotech & biopharma forums on clinical/regulatory topics.

     

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    Bai Xu
    CEO, Nanomed

    Nanomed, with the headquarter at Cupertino, CA, applies innovative microfabrication technology to make a delivery tool for skincare actives. This is a new way of overcoming skin barrier and delivering actives without needle injection.

    The product successfully went through two clinical trials and got into the finals of Asian Innovation Award together with IBM Healthsolution Lab's product sponsored by the Wall Street Journal and won Silver Prize in 2010.

    Nanomed's antiblemish product was successfully launched at AAD, the largest dermatology annual meeting in US. Together with Sephora's product, Nanomed's delivery product got into the top three for the International Package Design Award (tool category) at 2012 HBA Global in New York City.

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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.

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    Wendy Wu
    Sr Director, Clinical Development , Jazz Pharmaceuticals

    Certificated professional for clinical research and regulatory affairs, with over 15 years of experience in designing, conducting, and reporting clinical & medical trials for investigational therapeutic products and companion diagnostic/prognostic products.

    Broad clinical and scientific knowledge and industrial experience across multiple therapeutic areas including diabetes, GI, oncology, and rheumatology. Experience in working with both small molecules and biologic agents.

    Track record in executing and overseeing clinical studies from early phase to large-scale global registrational trials (phase I to IV), including clinical reporting and regulatory submissions that have led to successful market approvals in multiple products.

    Accomplished in mid-sized to large pharmaceutical corporations, with ability to balance corporate obligations with day-to-day responsibilities of developing effective and safe new therapies and clinical tools.

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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.

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    Joanna Bolger
    VP Of Clinical Operations , Cortexyme

    Clinical Operations Leader with over 18 years of drug development and clinical project management experience.

    I am very passionate about drug development process and bringing new therapies to patients in need. My expertise benefits small and large biotech and pharmaceutical companies with all stages of drug and medical device development programs. I have worked in the following therapeutic areas: Alzheimer’s disease, oncology (hematologic malignancy T- cell therapy, and solid tumors), cardiology (stem cell therapy), infectious diseases, endocrinology and rare diseases.

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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.

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    Majid Ghoddusi
    Senior Director, Clinical Biomarkers, Poseida Therapeutics

    Dr Ghoddusi has over 15 years of experience in some of the most challenging areas of oncology with focus on drug discovery and clinical development. Dr Ghoddusi has broad and overarching insights into unmet therapeutic areas with expertise in translational sciences and clinical biomarker development which allows him to provide unique perspective on how to propel therapeutic projects from discovery to approval. Trained as a translational pathologist he has held numerous positions at large pharmaceutical and small biotech companies including Novartis, Celgene, and Juno Therapeutics. His current focus is Immuno-oncology, Gene and Cellular Therapy.

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    Melody Anderson
    Sr Director, Clinical Operations, Avelas Biosciences

    Melody began her clinical career over 35 years ago at Abbott HPD in Illinois; she moved to California to work for Syntex (now Roche).  She has worked for several small biotech companies with experience in medical devices, pharmaceuticals, biologicals, drug/device combinations, and drug delivery systems.  In 2001 she relocated to AUSTRALIA to establish a subsidiary of Clinimetrics; she subsequently worked for St. Jude Medical--Australia.  Upon returning to San Diego in mid-2009 she was a clinical consultant for a few years before returning to industry in 2015. She is currently employed by Avelas Biosciences, a COI Pharmaceuticals company.

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    Sverre Bengtsson
    Co-Founder, Viedoc Technologies

    Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.

     

    Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

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    Peter B. Heifetz
    President And CEO, OrPro Therapeutics
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    Gary Urban
    VP Quality, Nucleus Network

    Based in Los Angeles, Gary has 26 years of drug development experience, holding global leadership positions in Information Technology, Clinical Operations, and Quality Assurance.

    Passionate about innovation and business transformation, Gary has spent the last 4 years working to advance industry adoption and regulatory acceptance of the virtual, decentralized and hybrid clinical trial models, and is currently exploring how elements of these may serve to streamline early phase clinical trials.

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    Jena Daniels
    VP Patient Success, Medable

    Jena is an experienced research manager with 10 years of experience in enabling digital solutions within academic and industry sponsored clinical trials. As a 2021 PharmaVoice100 recipient and Best Decentralized Clinical Trial Businesswoman of 2022, Jena is most known for establishing Medable's Patient Success department and Patient Caregiver Network. These teams engage and empower expert patient and caregiver advocates to assist product development, refine study workflows, and tailor the overall trial experience. This results in meaningful, actionable, and patient-focused solutions. She is incredibly passionate about enabling effective therapies to get to patients faster by disrupting legacy standards with scalable and personalized digital solutions. Prior to Medable, she worked as a Clinical Research Manager at Harvard Medical School and Stanford University School of Medicine. She has co-authored over 30 peer-reviewed publications focusing on how to leverage machine-learning, artificial intelligence, and remote patient monitoring to triage, diagnose, and provide early intervention for children with autism spectrum disorder

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    ABIE EKANGAKI
    Vice President, Statistical Consulting, Premier Research

    Abie Ekangaki is responsible for bringing expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development, and operational experience across different therapeutic areas. With more than 25 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has over 19 years in the pharmaceutical industry in both large pharma and CROs, where he has held several lead technical and senior leadership positions.

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    Bonne Adams
    Executive Vice President Clinical Operations, TRACON Pharmaceuticals

    Ms. Adams joined us as our Vice President of Clinical Operations in August 2006, was promoted to Senior Vice President of Clinical Operations in July 2014, and was promoted to Executive Vice President of Clinical Operations in January 2019. Prior to joining us, Ms. Adams was a Manager of Clinical Operations at Pfizer, Inc., a pharmaceutical corporation, from 2004 to 2006 and at Biogen Idec, Inc., a biotechnology company, from 2002 to 2004. Ms. Adams managed clinical trials at Pfizer that contributed to the 2006 approval of Sutent® in renal cell carcinoma and gastrointestinal stromal tumors, and she managed clinical trials at Biogen Idec that fulfilled post-approval commitments for Zevalin® and Rituxan®. Ms. Adams has managed both early and late-stage oncology studies of small molecules as well as biologics in the areas of lymphoma, lung, colorectal, ovarian, kidney, sarcoma and breast cancers. From 2000 to 2002, she managed non-oncology programs at Quintiles Inc., a service provider for biopharmaceutical and health sciences companies, including studies in the areas of allergy and pulmonary disease. Ms. Adams received a B.A. in Kinesiology and Biology from the University of Colorado and an M.B.A. in Technology Management from The University of Phoenix.

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    Kim Hedges
    Sr. Director, Concierge Services, ICON

    Kim Hedges has 25 years of experience in managing patients by utilizing digital health solutions to expand access virtually to healthcare and clinical research.  She has expertise in executing solutions to implement, oversee and ensure best practices are integrated into the end-user experience for providers, sites, and patients.  She helped pioneer the application of mobile-first strategies for use across a variety of healthcare settings for providers, payers, academic institutions, and patients to expand access to care virtually.  Ms. Hedges has focused on the use of real-world experiences and insights gained to drive the successful implementation of mobile and virtual clinical trials.  Her current focus involves collaboration in digital health strategy & solutions from protocol assessment through solution deployment.

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    Kelly Franchetti
    Senior Vice President And Global Head, Patient Insights And Strategy, YPrime

    Kelly Franchetti is a Sr. Vice President and Global Head of Patient Insights and Strategy at YPrime. A highly experienced registered nurse who continues to spend time with patients directly, her diverse background comprises patient advocacy and clinical research. Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

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    Jorge Franceschi
    Director, Business Development, TrialCard

    Since 2002 Jorge has been involved in pharmaceutical, biotech, and biologics research in a variety of roles including clinical, operations, finance, market Intelligence and business development at the site level, SMO, CRO, and now for clinical supply solutions and access at TrialCard.  Past employment includes Sarkis Clinical Trials, Radiant Research, Covance, Interventional Concepts,  MedPrimo Research as an independent consultant, FutureLife LLC advisory board member, and the University of Florida/VAMC Department of Neurology.  Cumulatively he has been involved in over 350 clinical trials including Phase I-IV, PK/PD, vaccine, 510k submission, vaccine research, and has conducted both pediatric and adult trials. Mr. Franceschi completed his undergraduate work at the University of Florida in Food Science & Human Nutrition and completed his Masters of Science in Health with emphasis in nutrition at the University of North Florida in Jacksonville.  A majority of his clinical trial work has been within the CNS realm supporting major depressive disorder, anxiety, bipolar, ADHD, and PTSD research but most recently he is learning about and supporting clinical teams needing oncolytic co-therapy medications.

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    NISHA TRIVEDI
    Patient Advocate

    For the last few years, Nisha has been a patient advocate for the rare disease community, raising public awareness of the genetic skin disorder Epidermolysis Bullosa. Through the EveryLife Foundation’s Rare Disease Week on Capitol Hill and Rare Across America events, along with other organizations' advocacy events, she has shared her story with members of Congress to encourage them to support policies that benefit rare disease patients. She currently represents EB Research Partnership on EveryLife Foundation's Community Congress. Previously, she spent six years on the board of directors of The Shanti Project, a San Francisco–based nonprofit that enhances the health, quality of life, and well-being of people with serious illnesses. Nisha lives in South San Francisco, CA and works at mbaMission, a leading MBA admissions consulting firm, guiding applicants to top business schools in the U.S. and abroad in building their personal brands by identifying and showcasing the strongest aspects of their candidacy in their applications. She is also a certified business etiquette trainer, and coaches organizations on positive professional behaviors. Her BA in Communication from the University of Pennsylvania and deep interest in understanding the consumer inspired her to initially pursue a career in marketing research, which led her to positions at Time Inc., Rosetta, and KPMG LLP in New York City. After getting her MBA from the University of Michigan Ross School of Business, Nisha worked in brand management in San Francisco at Big Heart Pet Brands (now part of The J.M. Smucker Company).

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    Tim Kulbago
    Senior Vice President Of Integrated Customer Solutions And Trial Oversight, Clario

    Senior Vice President of Integrated Customer Solutions and Trial Oversight

    As Senior Vice President of Integrated Platforms and Trial Oversight at Clario, Tim is responsible for delivering solutions that bring together the Clario portfolio of products to provide exceptional experiences for patients, sites, and sponsors.  His team focuses on minimizing the burden for patients and sites through the delivery of intuitive streamlined applications by uniquely combining traditional eCOA, Respiratory, Cardiac Safety and Imaging interactions in a harmonized ecosystem. Tim has 25 years’ experience of working in healthcare, with a focus on the medical imaging industry. He has held many executive positions, including Product Line Executive, CTO, CSO, and also as President and CEO at ImageIQ, where he led the company’s deployment of software engineering, high-resolution imaging and custom-tailored image analysis, to support the delivery of high-quality imaging data for clinical research

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    Dimitri Talantov
    Head Of Experimental Medicine, Infectious Diseases, The Janssen Pharmaceutical Companies Of Johnson & Johnson
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    Aditya Kotta
    Regional Director, Business Development, Novotech

    Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

     

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    Matthew Gordon
    VP, RWE, Parexel

    Matthew has over 20 years’ experience designing global real-world evidence solutions to support the development and commercialization of pharmaceutical / biotechnology products and devices.  His experience covers a wide-range of therapeutic areas, as well as strategic objectives from natural history programs, external control arm studies for regulatory approval, and global safety-surveillance mandate. His technical expertise includes program strategy and operational structure in disease and product registries, prospective pharmacoeconomic studies, and systematic reviews of scientific literature.

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    Dan McGann
    Solutions Consultant, EClinical Solutions

    As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs.

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    Elisa Lanni
    Senior Project Manager, DermTech Stratum

    Highly experienced project manager with specialization in clinical operations and logistics. Over 10 years of experience managing industry-sponsored clinical trials in Biotech, CRO, and academic settings.

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    Dr. Ahmar Zaidi
    Medical Director, Clinical Development, Agios Pharmaceuticals

    Dr. Ahmar U. Zaidi is a pediatric hematologist who spent the last several years at the Children’s Hospital of Michigan, where he helped care for over 800 patients with sickle cell disease. He currently serves as Medical Director, Clinical Development for Agios Pharmaceuticals. Along with numerous publications and clinical trial experience, he has worked tirelessly as an advocate for sickle cell disease patients, fueled by a belief that medical misinformation and disinformation steadily contribute to poor outcomes in sickle cell disease patients.  He co-founded and hosts the sickle cell educational podcast, Cheat Codes; and has been an advocate for social media as a tool for patient and physician education.  He currently serves as the Chair of the Hematology Anti-Racism Task Force for the American Society of Hematology and the Chair of the Board for The Sickle Cell Reproductive Health Directive.

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    Alexis Garelli
    Technical Solutions Director, Calyx

    Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services.

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    HILLARY TRENT
    Clinical Consultant

    Proficient clinical research/medical affairs professional with demonstrated success in a multitude of roles across numerous therapeutic areas and study phase in the US, Canada, APAC and EMEA. Provider of high quality independent consulting services to Medical Device, Biotechnology, and Pharmaceutical clients in support of study start-up, ongoing, rescue, and close out activities of clinical trials in all phases.

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    Brittany Maley
    Manager, Research Delivery, Patient Experience Team, CorEvitas, LLC

    Brittany Maley has more than 16 years of experience in customer service, instructional design, and research, working in the pharmaceutical industry for the last seven years. Along with her experience in gathering insights to enhance recruitment and retention, she uses her degrees in education and educational technology, and instructional design to bring the patient voice to clinical trials using creative and innovative methods.

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    Kenneth Wilson
    Outsourcing Lead
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