I am a seasoned regulatory affairs expert with nearly ten years of industry experience in medical devices, combination products and in vitro diagnostic devices. My latest experience includes regulatory registration for digital health technologies (DHTs) being utilized in decentralized clinical trials and DHTs being part of the combination product. I have master’s degrees in Biochemistry and Regulatory Affairs and a bachelor’s degree in biotechnology. I have extensive experience in global registrations including FDA, Health Canada, EMA, JMHW, NMPA, and other foreign agencies for various types of medical devices.

With over 30 years of experience in healthcare technology, I currently serve as a patient advocate and board member for organizations committed to driving positive change in healthcare and supporting those impacted by cancer. Previously, I held the position of marketing leader at Vocera Communications, a public company based in Silicon Valley. Following Vocera's acquisition by Stryker in February 2022, I provided advisory support during the transition throughout 2023.

I dedicate my time and energy to enhancing the lives of cancer patients and the front-line caregivers who support them.

'An experienced and passionate patient and caregiver advocate, helping improve the lives of those that have followed in her path on a cancer journey.  Motivational leader with record of success creating, executing, and managing programs that lead to immediate and long-term results. Experience building marketing divisions from the ground up, leading turnarounds for under-performing areas, and building consensus to advance adoption of services and technologies.'

Abhijit Ramachandran, Director of Clinical Operations at Corcept Therapeutics Inc. is an established versatile leader with deep experience in clinical trial operations management. Expertise in conducting and coordinating multi-center international clinical trials and managing cross-functional project teams. Highly skilled in liaising with Contract Research Organizations (CROs) and other suppliers to achieve program and company goals. Adept at managing the progress of clinical studies and ensuring adherence to study protocols, regulatory/internal SOPs, intended timelines, and budget. Solid experience with early and late-phase clinical studies, including orphan disease indications.

Clinical research professional with a pharmacy and nursing background experienced in managing clinical development studies in multiple therapeutic areas specializing in oncology in a fast-paced, cross-functional environment.

Physician life sciences and drug development strategist providing clinical insight and direct oversight of multi country clinical trials, expanded access protocols, diagnostics, and therapeutic collaborations in the oncology sector.

Notable Therapeutics:
SD-101,  Toll-like receptor 9 agonist, inducing inflammatory antitumor immune responses and has demonstrated clinical synergy with anti-PD-1 antibodies in PD-1 Ab-naïve and PD-1 Ab-refractory melanoma and in patients with anti-PD-1/PD-L1 naïve, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

LUMAKRAS (soratasib), first in class KRAS G12C inhibitor indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Notable Diagnostics:
Therascreen Qiagen RGQ PCR (an FDA-approved companion diagnostic (CDx) test to identify NSCLC patients harboring specific KRAS mutations in tumor DNA isolated from formalin-fixed paraffin-embedded (FFPE) NSCLC tumor tissue and that may be eligible for treatment with LUMAKRAS (soratasib).

A two-time cancer survivor, Crawford, a media professional amd a member of the Rotary Club of San Jose,  is most noted for “changing the landscape” of cancer care in Silicon Valley and California.  She served on the American Cancer Society’s National Extramural Grants programs a Stakeholder, helping to award some $100 million research dollars.  She is a founder of the second non-profit hospice in California; she found  an annual program serving 400 kids with cancer every year; she is the founder and firs president of  the Cancer Registry for the State of California, and an Emeritus member of Stanford Cancer Center South Bay’s Patient and Family Advisory Council.   Inn 2009,  she co-founded Cancer CAREpoint, which provides free non-medical services for cancer patients and families in the Bay Area and currently serves on their Advisory Sustaining Board.

Crawford has many awards to her credit, including the National Ellen Stovall Award for Innovation in Cancer Care, (a national award for cancer patient advocacy). She was selected by KRON TV for their 2024  Remarkable Woman program; The Jefferson Award from KPIX TV CBS, in 2014 she was selected for the Citizen’s Award from Santa Clara County Medical Association; the Silicon Valley Business Journal named her a Woman of Influence in 2015 and she has received numerous honors from the American Cancer Society, where she is an honorary life member.

Basic research on the role of viruses in the development of cancer. Studying how ancient endogenous retroviruses, which are present in all humans, become overexpressed in breast, ovarian, pancreatic and other cancers. Evaluating the efficacy of therapeutic antibodies and other therapies aimed at blocking human endogenous retrovirus expression in cancer cells.

Keya brings 25 years of experience in building and leading high-functioning teams in drug development inclusive of clinical operations, data sciences and trial support services. An executive in operational and commercial roles, she has extensive experience in implementing strategies and delivering excellence for complex, global Oncology trials.

Julie Martin, MSc, Lean Certified, CEO is a 17-year industry veteran who has led Scimega as CEO for 5 years. Her passion for Scimega’s business and team stems from knowing its expert oncology clinical development services add distinct value to industry stakeholders at a time when it’s needed most. As CEO, Julie’s vision is to secure the company’s long-term success by leveraging her in-depth industry expertise and business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership, and collaboration with the managing Board of Directors, combined ensure the business excellence upon which Scimega has built its reputation. Julie plays a vital role in promoting Scimega’s expertise and showcasing Canada’s attributes as a formidable partner in global oncology drug development with an evolving Lean methodology.

Emily McInturf, Director of Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives. As a director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Accomplished leader with 20+ yrs. of clinical trial experience in oncology, respiratory, and metabolic diseases. Industry expert, consistently delivering programs with high integrity. Adept at influencing stakeholders. Spearheads innovation. Passionate about transforming patient and caregiver experience in clinical trials.A Diversity, Equity and Belonging champion- founder of inclusive research group in Phase I oncology trials at AbbVie and creator of affinity groups within the community.
A suitcase-loathing adventurer. A Tiny Human’s Personal Assistant.

• Chair, Life Science Committee, Keiretsu Forum
• Mentor, Investor, and Board Member of Companies that create value and make the world a better place.

Sandra Shpilberg is the CEO & Co-founder of Adnexi, a software platform that helps biopharma identify the best trial sites (Site Intelligence), Key Opinion Leaders (KOL) and Digital Opinion Leaders (DOL) who can accelerate treatment development. Adnexi provides rapid, accurate, tech-enabled, customized, complete and continuously updating identification of trial sites, searching for prior experience that's relevant to your trials. Prior to Adnexi, Sandra was the CEO & Founder of Seeker Health, a successful patient finding platform that was acquired by Eversana. Prior to being an entrepreneur, Sandra held executive roles at biopharma companies including BioMarin and Johnson & Johnson.

John is a results-driven leader with a genuine passion for turning business strategies into reality through financial planning and analysis across various industries. He has a knack for financial modeling, budgeting, strategic planning, and variance analysis, which helps me tackle complex challenges and support data-driven decision-making.

Throughout his career, he's crafted and executed innovative financial strategies, streamlined processes, and led cost-saving initiatives that have significantly boosted operational efficiency and performance. He's managed multi-million-dollar budgets and steered investment strategies for complex project portfolios, making sure resources are used wisely to meet strategic goals.

He's also committed to building and empowering high-performing teams. He's spearheaded organizational transformations, enhanced the scalability of financial operations, and created talent acquisition strategies and leadership programs to support diversity and inclusion.

Jim Eamma’s experience in scientific and clinical research spans more than two decades and includes work in academic, clinical and CRO settings. Although oncology is his primary area of focus, he has also worked on clinical trials in other therapeutic areas. His intimate knowledge of studies at the level of the investigative site gives him the logistical and practical perspective needed for effective leadership and oversight. Today Jim will share more about Worldwide Clinical Trials and how the Worldwide team can help with your  oncology trials.

John McAdory, MHA has a strong background in clinical operations and project management in the healthcare industry. John is currently serving as the Vice President of Clinical Operations at CG Oncology (Cold Genesys).

John has spent the last 20 years global clinical research specializing in the development novel oncolytic therapies. He has lead global clinical operation from clinical study design to submission of final study report including BLA filing. John has expertise in strategy development, risk management, project planning and execution and consistently achieving program goals. With a Six Sigma Green Belt, John specializes in identifying key area to find efficiency in clinical study conduct to save time and reduce cost. John previously held leadership and management positions at SillaJen, Inc, Janssen, Inc, and Amgen. John is a graduate of Hampton University with an BS in biology and has a Masters in Health Administration from the University of North Carolina, Chapel Hill.

Ph.D. in biomedical engineering with 15+ years leading research and clinical trials. Extensive experience with international business operations and establishing collaborations. Excellent communication with scientific and lay audiences. Sound leadership skills in managing interdisciplinary teams across institutions with and without authority. Focus on problem-solving, conflict management, and creative solutions.

Experienced Clinical Development and Drug Safety physician. Served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities.

Karen Benson has over 20 years of experience in the pharmaceutical industry, serving in various roles including medical affairs and regulatory affairs.

Throughout her career in regulatory affairs, Karen has worked across the various phases of development (PreIND, Phase 1 through Phase 4) and has experience in Oncology, Investigational New Drug Applications (INDs) and IND submissions, clinical trial applications (CTAs) and submissions, New Drug Applications (NDAs) and post market submissions.

With over 25 years of comprehensive clinical development expertise spanning biotech companies, CROs, and academic research sites, I have contributed to advance novel therapies across diverse therapeutic areas such as oncology, immunology, virology, etc. in global Phase 1-4 programs, driving regulatory submissions, and achieving approvals for significant HIV therapies at Gilead Sciences.  I’ve held various Clinical Operations leadership roles at Amgen, Gilead, and currently at Profound Bio as Executive Director heading Clinical Operations department.

Steve Warner, PhD, is the Senior Vice President, Head of Translational Research & Medicine - Oncology at Sumitomo Pharma America. He specializes in small molecule drug discovery, new screening platforms in drug discovery, and translational research focusing on cancer therapeutics. He is an expert in the discovery of novel cancer agents, with experience spanning organizations including the University of Arizona, the Translational Genomics Research Institute, SuperGen Inc, the Huntsman Cancer Institute. Dr. Warner co-founded Tolero Pharmaceuticals in 2011, which was acquired by Sumitomo Pharma in 2017. Throughout these experiences, Dr. Warner has led drug discovery projects that have produced ten first-in-human clinical compounds and has published dozens of peer-reviewed publications and patents from multiple drug discovery projects.