11th Annual 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, San Diego, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
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Why attend?

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

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

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

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

Veronica Sandoval
Principal, Inclusion & Health Equity
Wendy Pizarro
, Chief Administrative Officer and Chief Legal Officer
Tanja Obradovic
Vice President, Scientific Affairs, ICON

9:15 AM

State of the global biotech landscape: where the opportunities lie

  • Perspective on investment landscape
  • Biotech workforce current trends & the implications for clinical trials
  • M&A activity in the CRO landscape & how that impacts sponsors

Speakers

Aditya Kotta
Regional Director Business Development, Westcoast - USA, Novotech

9:45 AM

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 enroll 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

Wendy Pizarro
, Chief Administrative Officer and Chief Legal Officer

10:15 AM

Morning Refreshments and Networking

10:45 AM

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

Chad Orevillo
Executive Vice President, Head of Operations

11:15 AM

Simplifying Protocols to Enable Home-Base Trial Activities

  • How simplification of a protocol for Parkinson’s disease enabled a home-based trial
  • Lean Design approach to radical simplification: results for Merck protocols
  • Overcoming resistance to simplification: common issues

Speakers

Steven Cummings
Executive Director, San Francisco Coordinating Center at California Pacific Medical Center Research Institute

11:45 AM

Identifying cost drivers in early clinical study planning, recognizing implications of protocol requirements to find greater efficiency for long-term clinical projects and mitigate time-driven costs

  • Highlighting the need for alignment in clinical planning for program/study objectives, understanding vendor-specific requirements and dynamics and how these impact cost in an environment where resources are finite
  • Recognizing the importance of attention to vendor relationship management and governance, featuring:
    ▪ mutual trust in collaborative relationships
    ▪ early, fulsome engagement in full-scope planning, risk identification, and risk mitigation strategies addressing “the known unknowns”
    ▪ shared accountability for budget control and budget optimization strategies
    ▪ effective, timely and sufficient communication around continuous active management of finite resources

Speakers

Barbara Birch
Associate Director, Clinical Procurement & Outsourcing

12:15 PM

FSP Agility & Responsiveness through Employee Trust & Empowerment

  • Flat structure empowers employees
  • Empowerment allows for creative and rapid customized solutions
  • Customized solutions apply to both technology and contracting

Speakers

Dorothy Blythe
Principal Clinical Data Manager, TFS Health Science

12:45 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 2: Finding the right CRO for your study.

TABLE 3: Managing your trial budget during uncertain times.

TABLE 4: Decentralization, for or against?

1:45 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

Brandi Roberts
Chief Financial Officer
Sahar Roshan
Associate Director Clinical Operations

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

Speakers

Nicole Stansbury
Senior Vice President and Head of Global Clinical Operations, Premier Research

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

AJ Bergmann
Chief Financial Officer, Capricor Therapeutics

3:30 PM

Afternoon Refreshments and Networking

4 PM

Boost your trials: expert shares insider tips for streamlining clinical operations and gaining a competitive edge!

  • Navigating risk and vendor management: unveiling strategies to optimize clinical trials
  • Risk reduction made easy: expert insights to safeguard your clinical trials and enhance success
  • Mastering the art of efficient trials: strategies to minimize risks and maximize results

Speakers

Jennifer Lee
Board of Director, Enzyme by Design

4:30 PM

The State of the Biopharmaceutical Industry – Clinical Technology Mid-Year Update and 2024 Outlook

  • Reviewing results from our annual State of the Biopharmaceutical Industry survey - were our 2023 predictions correct?
    • Key themes and technology advancements biopharma industry that are expected to have the largest (positive and negative) impacts on the industry
    • Spotlight on clinical trial technologies - so far through 2023
      • Trends of Cell and Gene Therapies, Virtual Trials and AI used in drug development
    • Leveraging data to predict the outlook for 2024 clinical trial outsourcing
      • Trends, key players, opportunities and threat in biopharma, focusing on AI, DCTs, Cell & Gene Therapy, etc.
      • What the latest investment trends show for small and medium biotechs
      • New technology outlooks for 2024

Speakers

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

5 PM

Chair’s Summation and Drinks Reception

10:45 AM

How to implement and control your social media campaign to maximize study exposure and reach more patients

  • Sharing a case study of a phase 3 study outline
  • Improving your digital presence by focusing on study branding (POLARIS-AD), study website & digital campaigns
  • Discussing the importance of;
    • Performance Marketing
    • Strategy & Implementation
    • Management and analysis

Speakers

James Rock
President and Chief Clinical Officer, AriBio

11:15 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

Tanja Obradovic
Vice President, Scientific Affairs, ICON

11:45 AM

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

Brandi Roberts
Chief Financial Officer

12:15 PM

Running up that hill: accelerate cycle times & reach patients faster with elluminate

Learn how the elluminate Clinical Data Cloud and Biometrics Services deliver

  • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
  • Improved study oversight with a holistic view of risk across all data sources
  • 50 out-of-the-box visualizations to support supports cross-study analysis for deeper insights with self-service access to clinical and operational analytics
  • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

Speakers

Dan McGann
Solutions Consultant, eClinical Solutions

12:30 PM

eCOA: A necessity or a nice to have?

  • What are COAs and why do they matter in clinical research
  • How has the evolution of the use of COAs in clinical trials paved the way for adoption of eCOA
  • Choosing the right eCOA partner

Speakers

Melissa Mooney
Director, eCOA Sales Engineering, IQVIA eCOA Technologies

12:45 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 2: Finding the right CRO for your study.

TABLE 3: Managing your trial budget during uncertain times.

TABLE 4: Decentralization, for or against?

1:45 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

Mirta Grifman
Vice President, Clinical Development and External Innovation
Emily Solomon
Vice President, Clinical Operations, Biosplice Therapeutics

2:30 PM

Successfully navigating the regulatory complexities of EU CTR

  • Provide in-depth knowledge and share practical experiences to help guide industry partners through the regulatory processes for clinical trial applications under EU CTR.
  • Deep dive into key aspects such as new requirements, timelines, submission strategies, transparency requirements, naming conventions, managing RFIs, working in CTIS and CTD transitions
  • Highlight the latest challenges and discuss solutions for managing the regulatory processes under EU CTR

Speakers

Zachary Bynum
B.A. Biological Sciences Sr. Manager, Regulatory Affairs, Regulatory Science, PPD

5 PM

Chair’s Summation and Drinks Reception

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Clinical Trial Technology & Innovation

8:15 AM

Registration and Refreshments

8:55 AM

Chair’s Opening Remarks

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

9 AM

Fear reduction as the core of the patient experience strategy in clinical trials

  • Understanding where patient concerns lie when participating in clinical trials and what pharma companies can do to mitigate against these
  • Aiming to reduce the burden of trial participation on patients as much as possible: where are pharma companies falling short?
  • What more needs to be done when it comes to patient accessibility for clinical trials?

Speakers

Roel van der Heijde
Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

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

Sormeh Mahjouri, MPH, PMP
Program Director
Nonna Snider
VP, Clinical and Operations, JeniVision Inc
Grace Indyk
Director Clinical Operations, Aptose Biosciences
Aditya Kotta
Regional Director Business Development, Westcoast - USA, Novotech

10 AM

Cutting-Edge Solutions and Innovations in Early Clinical Development Operations for Emerging Professionals within Sponsor’s Product Development Teams

  • Early Career ClinOps Rep role on Sponsor Product Development Teams (PDTs)
  • Clinical Trial Technology: Streamlining operations through innovative tools and solutions
  • Strategic Outsourcing in Early Development PDTs: Maximizing efficiency and effectiveness
  • Fostering Cross-Functional Collaboration: Communication tools for PDT awareness and decision-making

Speakers

Krishna P. Allamneni
Chief Development Officer, Concarlo Therapeutics, Inc.

10:30 AM

Morning Refreshments and Networking

11 AM

Clinical Studies & Clinical Professionals in the Medical Device Industry

  • Background of Medical Device Industry with a focus on Musculoskeletal
  • Regulatory Environment Effect on Clinical:
    o US: 510k vs IDE/PMA
    o EU: MDD to MDR
  • State of Clinical Research in US & EU
  • Industry Sponsored Research
    o Stats
    o CME rules

Speakers

Dr. Bryan Cornwall
Chief Scientist / FEED-Research

11:30 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

Ken Kobayashi
Senior Vice President
Roberta Vezza Alexander
Senior Director of Clinical Research
Sanjay Shrivastava
CEO

12:15 PM

Lunch and Networking

1:15 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

Jiao Song
Director, Early Clinical Science
Ken Kobayashi
Senior Vice President

2 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

Yuchen Wang
Associate Director, Biologics Product Development, Calidi Biotherapeutics

2:30 PM

Afternoon Refreshments and Networking; Apple Prize Draw

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 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

Patient enrollment: what are we doing to improve uptake in new trials

Gina Fulgar, Executive Director, Development Operations, eFFECTOR Therapeutics, Inc.

RT4

Considerations when choosing your site: pros, cons and pitfalls to avoid

Nonna Snider, VP Clinical and Operations, JeniVision Inc

Speakers

Joseph Shan
Executive Director, Clinical Development Operations, MEI Pharma
Kerry Clancy
Director of Outsourcing,
Gina Fulgar
Executive Director, Development Operations, eFFECTOR Therapeutics, Inc.
Nonna Snider
VP, Clinical and Operations, JeniVision Inc

4 PM

Close of conference

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

Speakers

Sverre Bengtsson
Co-Founder, Viedoc

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

Patty Law
Sr. Director, Clinical Affairs

10 AM

How to leverage data standards and machine learning for more efficient Imaging oncology clinical trials

  • Discuss how unstandardized data poses challenges within oncology clinical trials in Imaging
  • How to utilize Clario Data Standards and automated data mapping of studies to optimize the workflow
  • Demonstrate how an automated workflow and data cleaning offers a unified interface for review and resolution
  • Present a machine learning project that utilizes AI models and standardized data for late phase clinical trials

Speakers

Shyam Banuprakash
Senior Vice President, Data Science, Clario

10:30 AM

Morning Refreshments and Networking

Speakers

Select a speaker to learn more

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Jennifer Lee
Board of Director, Enzyme by Design

Jennifer is a senior life sciences executive with over two decades of experience turning breakthroughs into life-saving treatments. Jennifer has successfully contributed to the global approvals of seven novel treatments, generating $20B value creation.

Jennifer has business expertise in R&D leadership, strategic planning, business revitalization, global operations, and regulatory compliance.

Jennifer received a B.S. in biochemistry and an M.S. in clinical research and regulatory administration.

Session Details:

Boost your trials: expert shares insider tips for streamlining clinical operations and gaining a competitive edge!

2023-09-26, 4:00 PM

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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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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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Jiao Song
Director, Early Clinical Science

Jiao is a clinical development leader with proven track record in leading trials from Phase 0 to III. She has over 12 years of working experience in pharmaceutical industry across discovery and development. Currently, she is a director in early clinical science and operations, responsible for the development and execution of multiple infectious disease and vaccines trials, with various roles as global program lead and/or study responsible scientist. Previously, she was an innovation leader with Janssen Clinical Innovation (JCI), a team whose mission is to develop and deliver innovative solutions to trials to enhance operational efficiencies of clinical research. In this role, Jiao led the development of novel trial models and platforms/processes leveraging real world data and digital technologies to address the pressing needs of patients, as well as to improve patient engagement and recruitment. Prior to joining JCI, Jiao worked as an research scientist in Immunology Discovery Research at Janssen and later transitioned to the Discovery Sciences team, where she focused on personalized medicine programs in various therapeutic areas using proteomic and metabolic profiling approaches. Jiao obtained her PhD in Molecular Pharmacology and MS in Statistics from Purdue University, Indiana.

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, 1:15 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, 1:15 PM

Session Details:

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

2023-09-27, 11:30 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, 1:45 PM

Session Details:

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

2023-09-26, 11:45 AM

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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, 9:45 AM

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Kerry Clancy
Director of Outsourcing,

Session Details:

Speaker Hosted Roundtables

2023-09-27, 3:00 PM

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Chad Orevillo
Executive Vice President, Head of Operations

Chad Orevillo, MPH is co-founder and Executive Vice President and Head of Operations of Longboard Pharmaceuticals, Inc. Mr. Orevillo has 30 years of industry experience in pharmaceutical clinical development and operations and leading project teams from early to late phase development. He has a wide breadth of experience spanning from start-up biotech to large global pharma companies including Merck, Pharmacia, Pfizer, Novartis, Pearl Therapeutics, Astrazeneca and Arena Pharmaceuticals. Mr. Orevillo has an M.P.H. from Tulane University and B.S. in Biology from William Paterson University and is a veteran of the US Marine Corps.

Session Details:

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

2023-09-26, 10:45 AM

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Barbara Birch
Associate Director, Clinical Procurement & Outsourcing

Session Details:

Identifying cost drivers in early clinical study planning, recognizing implications of protocol requirements to find greater efficiency for long-term clinical projects and mitigate time-driven costs

2023-09-26, 11:45 AM

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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, 1:45 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, 1:45 PM

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Tanja Obradovic
Vice President, Scientific Affairs, ICON

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, 11:15 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.

Session Details:

Speaker Hosted Roundtables

2023-09-27, 3:00 PM

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Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Session Details:

Chair’s Opening Remarks

2023-09-26, 8:20 AM

Session Details:

Chair’s Opening Remarks

2023-09-27, 8:55 AM

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Roel van der Heijde
Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

Roels inspiration: “Be the change you wish to see in the world” - Ghandi

Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor.

He is a driven and experienced trainer and facilitator in:

  • - Patient Fear Reduction (for all caregivers);
  • - Team Collaboration;
  • - Vulnerability & Leadership;
  • - Discrimination & Inclusion.

Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”.

“Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

Session Details:

Fear reduction as the core of the patient experience strategy in clinical trials

2023-09-27, 9:00 AM

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Steven Cummings
Executive Director, San Francisco Coordinating Center at California Pacific Medical Center Research Institute

Dr. Cummings is the Executive Director of the San Francisco Coordinating Center (SFCC) that he founded in 1979. He is also a professor of medicine, epidemiology, and biostatistics emeritus at the University of California, San Francisco (UCSF).  He is an internationally renowned expert in research on aging and osteoporosis.

Session Details:

Simplifying Protocols to Enable Home-Base Trial Activities

2023-09-26, 11:15 AM

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Zachary Bynum
B.A. Biological Sciences Sr. Manager, Regulatory Affairs, Regulatory Science, PPD

With over nine years of regulatory experience in clinical research and pharmaceutical development, Zachary provides expert regulatory advice and technical expertise to industry partners. He has expertise in oversight and project delivery for global clinical trial applications and client portfolio management globally and across all phases and a variety of therapeutic areas.

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Successfully navigating the regulatory complexities of EU CTR

2023-09-26, 2:30 PM

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Dorothy Blythe
Principal Clinical Data Manager, TFS Health Science

From TFS HealthScience, Dottie is a principal clinical data manager with more than 39 years of project management experience spanning the pharma and CRO industries in various therapeutic areas. Her clinical trial experience includes Data Management responsibility for a portfolio of vaccine trials, hands-on management of phase 1 adaptive designs for oncology candidates, and large cardiovascular endpoint trials.

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FSP Agility & Responsiveness through Employee Trust & Empowerment

2023-09-26, 12:15 PM

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Sanjay Shrivastava
CEO

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

2023-09-27, 11:30 AM

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Shyam Banuprakash
Senior Vice President, Data Science, Clario

Shyam has 15+ years of experience in data management and life sciences industry and has a strong expertise in data science and analysis. Shyam heads up the data science department for the Medical Imaging business segment of Clario. The department oversees design, collection, cleaning and standardization of medical imaging data; and creating analysis and AI models on clinical, operational, and financial data. His experience includes working for Janssen Alzheimer’s Immunotherapy and Medtronic. Shyam has a master’s in data science and engineering from UCSD. 

Session Details:

How to leverage data standards and machine learning for more efficient Imaging oncology clinical trials

2023-09-27, 10:00 AM

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James Rock
President and Chief Clinical Officer, AriBio

James Rock is the President and Chief Clinical Officer for AriBio Co., Ltd. out of San Diego, CA.  AriBio is a Korean based biotechnology company developing novel treatments for neurodegenerative diseases including Alzheimer’s disease and other forms of dementia. Previously, Mr. Rock was the Vice President of Clinical Operations and Research Collaboration for DermTech (DMTK) developing assays for the non-invasive detection of skin cancers and the Vice President of Clinical Affairs for Trinity Biotech working on cardiac markers.  He has over 25 years of drug, device and diagnostic development experience having successful completed multiple registration studies bringing both therapeutics and diagnostics through regulatory approval and the commercialization process.  Mr. Rock holds a BS from the University of Vermont, received his MSc from Springfield College and MBA from Pepperdine University.

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How to implement and control your social media campaign to maximize study exposure and reach more patients

2023-09-26, 10:45 AM

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Yuchen Wang
Associate Director, Biologics Product Development, Calidi Biotherapeutics

Dr. Wang is an experienced leader in CMC product development within the global biotech space. She has been responsible for analytical development, process development, formulation, and fill and finish of clinical drug products for late-stage biologic programs. With a track record of success, she has effectively managed multiple Contract Drug Manufacturing Organizations worldwide and the supply chain for clinical studies involving 30+ sites. Dr. Wang is currently the Associate Director of Biologics Product Development at Calidi Biotherapeutics, a clinical stage biopharma utilizing stem cell-based platforms to revolutionize oncolytic virotherapies for cancer applications. Dr. Wang is responsible for establishing the CMC strategies and leading the tech transfer, clinical manufacturing, and supply chain with Calidi's global CDMO network and clinical sites.

Before joining Calidi, Dr. Wang worked as a Senior Manager of product development at Emergent BioSolutions, where she led the technical development of virus-like particles vaccine programs from early to late phases. She has 10+ scientific articles published on her research work on developing various biologic modalities, nanotechnologies, and drug delivery systems. Additionally, she serves as the Vice Chair of the Women in Bio for the SoCal chapter.

Session Details:

The journey of Drug Product from Manufacturing to Clinical Administration

2023-09-27, 2:00 PM

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Sverre Bengtsson
Co-Founder, Viedoc

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.

Session Details:

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

2023-09-27, 9:00 AM

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Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

Session Details:

The State of the Biopharmaceutical Industry – Clinical Technology Mid-Year Update and 2024 Outlook

2023-09-26, 4:30 PM

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Nonna Snider
VP, Clinical and Operations, JeniVision Inc

Nonna Snider serves as VP, Clinical and Operations at JeniVision Inc. and has over 20 years in pre-clinical and clinical drug development in both Pharmaceutical Industry and Academia in dermatology, oncology, and ophthalmology.  Her career began at Allergan, focusing on drug discovery research, later transitioning to project management in a startup environment, gaining hands-on experience in conducting pre-clinical and clinical research in US, India and Latin America, interfacing with FDA, investigational sites and managing global CROs. Mrs. Snider was also a part of the Clinical Investigations Support Office (CISO) leadership team at the USC Norris Comprehensive Cancer Center working within a multidisciplinary team enhancing QA and DSMC programs and was responsible for ensuring safe and compliant implementation of Phase I-III oncology clinical trials conducted at USC.

Session Details:

Speaker Hosted Roundtables

2023-09-27, 3:00 PM

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PANEL DISCUSSION Talking through vendor management tips and tricks

2023-09-27, 9:30 AM

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Krishna P. Allamneni
Chief Development Officer, Concarlo Therapeutics, Inc.

Krishna is a seasoned biopharmaceutical executive with a 20+ year track record in translating benefit-risk for regulatory authorities across diverse therapeutic areas. She led the early development of six successful marketed products and managed 25+ IND/IMPD submissions.

Currently, Krishna serves as the Chief Development Officer at Concarlo Therapeutics, Inc., focusing on a p27 inhibitor and overseeing preclinical R&D, CMC, pipeline strategy and portfolio management, clinical strategy, and regulatory affairs. Previously, she was Vice President and Head of Development Sciences at Turning Point Therapeutics, Inc. (now BMS) and served in various leadership roles at Jazz Pharmaceuticals, NGM Biopharmaceuticals, and Genentech. She has also contributed to the American College of Toxicology as a board member. Krishna's leadership ensures expedited and cost-effective global early development regulatory strategies, making her a trusted figure in the clinical and investment communities.

Krishna is a board-certified toxicologist, with a Postdoctoral Training in Pathology and Developmental Lung Biology from Harvard Medical School, an MS/PhD in Pharmacology/Toxicology from University of California, Davis, and a Bachelor of Veterinary Science and Animal Husbandry (Doctor of Veterinary Medicine equivalent).

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Cutting-Edge Solutions and Innovations in Early Clinical Development Operations for Emerging Professionals within Sponsor’s Product Development Teams

2023-09-27, 10:00 AM

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Dr. Bryan Cornwall
Chief Scientist / FEED-Research

Bryan Cornwall, PhD, MBA, PEng is an Academic Scientist with 25+ years experience in the Medical Device Industry. Dr. Cornwall is adjunct faculty at the Surgical Orthopedic Research Laboratory (SORL) at the University of New South Wales (UNSW) and the Shiley-Marcos School of Engineering (SMSE) at the University of San Diego (USD); he is also principle of FEED-Research, a medical device consulting firm.

Bryan Cornwall’s most recent industry role was as Executive Vice President, Research and Clinical Affairs at Surgalign. The company had a global spine implant business and had the first US 510k cleared spine navigation system combining Augmented Reality for enhanced visualization and Artificial Intelligence (AI) for intraoperative spine anatomy recognition and autonomous pedicle screw planning. Dr. Cornwall has numerous publications including 25 peer-reviewed journal articles, 26 U.S. patents and eight book chapters.

Session Details:

Clinical Studies & Clinical Professionals in the Medical Device Industry

2023-09-27, 11:00 AM

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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.

Session Details:

Running up that hill: accelerate cycle times & reach patients faster with elluminate

2023-09-26, 12:15 PM

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Melissa Mooney
Director, eCOA Sales Engineering, IQVIA eCOA Technologies

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eCOA: A necessity or a nice to have?

2023-09-26, 12:30 PM

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Nicole Stansbury
Senior Vice President and Head of Global Clinical Operations, Premier Research

Nicole Stansbury joined Premier Research in May 2023 as the Senior Vice President and Head of Global Clinical Operations. Prior to joining Premier, Nicole spent 25 years in the CRO industry where she served in leadership roles including Global Head of Clinical Trial Management, Global Head of Central Monitoring, and Head of Global Clinical Performance, a team responsible for SOPs, metrics, training, clinical systems, and clinical quality. Nicole’s 30 years of industry experience has included positions at the site level and other CRO roles such as CRA and Project Manager.

Nicole’s therapeutic experience has primarily been in Dermatology, Gastroenterology, Urology and Women’s Health; however, Nicole has leadership experience overseeing trials in Oncology, Neuroscience and General Medicine.

Nicole has a Bachelor’s in Animal Science from Texas A&M University and has a Lean Six Sigma Yellow Belt. Nicole has served as Co-Lead for the Association of Clinical Research Organization’s (ACRO) Risk-Based Monitoring (RBM) Working Group since 2014 where she works with TransCelerate and global regulatory authorities on driving RBM adoption in the industry.

Nicole is a member of PhUSE, collaborates regularly in industry publications, and is a frequent presenter and panelist at SCOPE, DIA, and other industry conferences.

Session Details:

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

2023-09-26, 2:30 PM

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Roberta Vezza Alexander
Senior Director of Clinical Research

Dr. Roberta Alexander is the Director of Clinical Research at Biological Dynamics, a diagnostics company in San Diego that focuses on early cancer detection. She has been at Biological Dynamics for approximately 7 months. Before then, she was leading the clinical research activities in a rheumatology-focused diagnostic company. Overall, she has worked in clinical research in the diagnostic space for approximately 9 years. Previously, Dr. Alexander was a scientist and worked in preclinical research and drug discovery in the pharma industry. She has a PharmD and a PhD and did her postdoctoral fellowship at the University of Pennsylvania in Philadelphia.

Tanja Obradovic

Dr. Obradovic has over 25 years of experience in clinical pharmaceutical development in Oncology. After holding academic appointment of Research Assistant Professor at Temple University of Pharmacology leading Immunooncology laboratory she joined pharmaceutical industry. She was holding senior positions at Merck within Oncology Clinical Research, Regulatory and Medical Affairs where during her 13 year tenure she was leading over 30 novel drug entities across tumor indications including acting as Strategy lead for Keytruda clinical development and life cycle management across tumor types including melanoma, lung, women’s cancers and many other indications across lines of therapy including neoadjuvant/adjuvant strategies. Her background includes Keytruda development, regulatory approvals and launches in more than 20 solid malignancies and lines of therapy in over 50 countries in the US, EU,  Asia (Japan, China, other East Asia regions) and Latin America. Dr Obradovic held numerous leadership positions on Pharma Collaboration Programs, partnerships with major Oncology Guidance and Consortia Organizations.  Most recently she was leading development of cell-based and novel drug therapies in hemes and solid tumors at Takeda Oncology Clinical Sciences as a Senior Director of Cell Therapy and Redirected Immunity prior to joining ICON in January 2022 as VP of Scientific Affairs leading Oncology medical development strategy.

Session Details:

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

2023-09-27, 11:30 AM

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Gina Fulgar
Executive Director, Development Operations, eFFECTOR Therapeutics, Inc.

Georgina Fulgar is a seasoned Clinical Development professional with over 25 years of early-phase to post-approval experience.  GCP Clinical Consulting, Inc. was created by Georgina more than 12 years ago.  Her work with small to large sized organizations has contributed to various key approvals.  Her global development operations experience includes: Oncology, Immunology, Rare Disease, Dermatology, Cardiology, Neurology, Obesity, and Mental Health.  In her current role as Executive Director, Development Operations at eFFECTOR Therapeutics, Inc., Georgina and her mighty team are working effectively to advance the organizations pipeline of Selective Translation Regulator Inhibitors (STRIs) to support patients in need.

Session Details:

Speaker Hosted Roundtables

2023-09-27, 3:00 PM

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Aditya Kotta
Regional Director Business Development, Westcoast - USA, 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.

Session Details:

State of the global biotech landscape: where the opportunities lie

2023-09-26, 9:15 AM

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PANEL DISCUSSION Talking through vendor management tips and tricks

2023-09-27, 9:30 AM

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Grace Indyk
Director Clinical Operations, Aptose Biosciences

Session Details:

PANEL DISCUSSION Talking through vendor management tips and tricks

2023-09-27, 9:30 AM

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