Shaily Arora, PharmD, is an Executive Regulatory Science Director, Oncology at AstraZeneca, where she orchestrates the regulatory strategy concerning tumor drivers and resistance-related clinical research endeavors. She established and co-leads the AstraZeneca Dose Optimization Working Group to support the dose optimization paradigm across the oncology portfolio. Additionally, she serves as the regulatory lead for several patient-centric initiatives, underscoring her commitment to advancing healthcare outcomes.

Prior to her current role, Dr. Arora served as an Associate Director in the Office of Oncologic Diseases at the U.S. Food and Drug Administration (FDA), where she spearheaded initiatives and projects spanning from pre-IND stages through post-marketing phases. Before assuming this role, Dr. Arora served as a clinical reviewer within the Breast and Gynecologic Malignancies Team at the FDA. Notably, she was instrumental in shaping FDA’s Project Orbis and was a founding member of the Project Optimus initiative. She provided strategic input in the development of various FDA guidances, policy initiatives, and authored impactful publications.

A frequent public speaker at national and international forums, Dr. Arora adeptly represents her organization at external forums, scientific societies, and global conferences. She is the recipient of distinguished accolades, including the 40 under 40 Award from California State University, East Bay (CSUEB) and the Alumni Early-Career Award from the University of California, San Francisco (UCSF), that underscores her dedication, excellence, and multifaceted contributions to the professional, philanthropic, and personal spheres.

Fatima is passionate about elevating the patient voice on a global scale.

She believes that understanding patient experiences and challenges is essential to speeding up the development of life-changing medicines. Further, she advocates in support of patients gaining the skills, courage, and knowledge to navigate through a cancer diagnosis, to make informed decisions, and to ensure they can advocate for and achieve the best care possible.

This fierce passion and commitment to putting the needs of patients first is evident in her decades-long career where she is recognized as an influential global advocate thought leader focused on patient centered research, policy, access, and regulatory impact.

She has held multiple senior management positions in healthcare and is a respected member of the biopharma and cancer communities. Fatima has contributed to numerous publications in partnership with the advocacy community and key academic researchers to advance patient-centered care, as well as being included in the PharmaVOICE 100 in 2014 and receiving the Trailblazer Brand Champion Award from PM3670 in 2015

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.

Emily is a Senior Project Manager for the Research Services Department at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for planning, executing, and moderating patient advisory boards and various other patient engagement activities, which provide insights to support recommendations in the design and/or improvement of clinical trials. She holds a B.S. in Biochemistry and Molecular Biology from University of Massachusetts Amherst and a MSPH in Global Disease Epidemiology and Control from Johns Hopkins University.

With over 25 years of experience in clinical research, Heidi Hoppe brings a wealth of knowledge and leadership to the field. Throughout her career, Heidi has overseen global programs and managed high-performing teams across a broad portfolio of clinical trials, leading departments, streamlining processes, and ensuring the successful execution of complex studies. Having worked in both sponsor and CRO environments, Heidi offers a uniquely comprehensive perspective on the industry. She now leverages her versatile experience with both of these key stakeholders to develop truly collaborative partnership strategies. Known for her commitment to excellence and innovation, she continues to be a driving force in advancing clinical research on a global scale and influencing the Sponsor-CRO relationship for the better.

Beth Chamblin has 25 years of experience in Pharmaceutical/BioPharmaceutical development, including over 15 years in global clinical project management and 4 years in oncology project management. At IQVIA Biotech, she specializes in strategic oversight of late-phase global clinical programs, supporting emerging biotech companies. Beth has managed global Phase I-III studies across multiple regions and has expertise in novel trial designs. She also leads a team of 10 project managers/directors, providing mentoring and support. Her broad experience allows her to align each study with a company's long-term goals, ensuring project success.

Mr Murcar has worked in the CRO industry for 25 years, primarily managing proposal and contract development. He has a particular background in the development of Phase II/III budgeting tools. For the last five years he has worked in biotech helping to facilitate the selection and financial management of CROs related to oncology and infectious disease studies.

: Irisaida Mendez is a seasoned multicultural communications expert with a unique ability to weave compelling narratives that transcend geographic boundaries. She is passionate about raising awareness for global issues through highlighting acculturation and modeling methods that bridge language and cultural divides. Her expertise in multicultural communications and crisis management makes her a leading figure in impactful transmedia projects, seamlessly integrating quantitative and qualitative research. Her contributions span a diverse range of fields, from clinical trial development and end-of-life care to microbusiness empowerment and global training initiatives.

Her storytelling work has taken her impact to Ghana, Ethiopia, Haiti, Colombia, Puerto Rico, Albania, and South Korea, where she has used her skills to amplify the voices of marginalized communities and advocate for social change.

Under Univision Foundation, Irisaida spearheaded a trauma-informed parenting campaign in Spanish, providing crucial support to families navigating the difficult aftermath of disasters like Hurricanes Helene and Milton and the LA Fires. This initiative helped families cope with the emotional challenges of these devastating events. Also, La fuerza STEM, a multi-platform edutainment initiative designed to empower caregivers to cultivate a love for science in children, has earned widespread recognition. This project, which garnered multiple awards including an Emmy Award and a Silver Anthem Award, inspires the next generation of STEM leaders by providing a multigenerational approach to informal science.

Having navigated her own journey as a Stage 4 cancer survivor who is now NED (no evidence of disease), Irisaida is a sought-after Patient Advocate speaker, using her powerful voice to empower others and advocate for their needs at state and national conferences. Her ability to craft and share impactful narratives, born from personal experience, has earned her widespread recognition.

I currently work as Senior Director of Procurement and Vendor Management at Karyopharm Therapeutics Inc. I have been negotiating contracts for little over fifteen years. Working 10 years in the biotech industry I have gained an excellent Understanding of all areas of research and development. In 2019 I helped establish Karyopharm’ s vendor management and procurement department to support vendor oversight, strategic sourcing maximizing financial savings. I am passionate about building partnerships and negotiating business terms of contracts resulting in several million dollar savings annually. I believe that I have perfected my negotiations skills while learning from my very curious 7-year-old son Barton.

Tom has worked in the life sciences industry since 1997, with the first 10 years spent as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis in 2008, created the RxStudy Card offering in 2009 and since then has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency.

Tomasz Adamusiak, MD PhD, serves as the Chief Scientist for Clinical Quality and Data Science at MITRE, where he leads initiatives to improve healthcare outcomes through AI and real-world evidence. Previously, as Head of Data Science at the Pfizer Innovation Research Lab, he led work on digital endpoints and decentralized clinical trials. He has held leadership positions within the American Medical Informatics Association and SNOMED International, and has published extensively in peer-reviewed journals.

Giovanni was born in Naples, Italy. While studying Medicine, he volunteered on projects for the poor, sick and lepers in Italy, Albania, India. He was a subinvestigator on 4 oncology clinical trials during his Clinical Oncology in Milan since 2001; moved to Philadelphia, PA, USA in 2005 where enrolled in a PhD program in Genetic Oncology, performing in vitro and in vivo gene therapy studies in cancer models. In 2007 he moved to Boston to lead cancer drug development programs in small biotech companies; at ArQule he led lab research, clinical development and medical affairs and brought 7 molecules to Ph1-3 clinical development. In 2017 he joined Sanofi, where as VP and Head of Oncology Early Development he oversaw development of over 20 clinical experimental drugs, as many preclinical, through teams of ~300 people, besides helping with Business Development and Investor Relations. In addition, Giovanni consulted for a couple of dozen companies and VC funds, scientific societies, and Governments. In 2008 Giovanni founded the nonprofit Professionisti Italiani a Boston, which has hosted 100+ cultural and networking events; in 2014 he founded Scuola PIB, a nonprofit Italian Saturday school with over 170 pupils in 2025

Leena is a board-certified thoracic oncologist and physician-scientist in immuno-oncology with an academic and industry background in translational research and early and late clinical development. She have developed multiple investigator-initiated trials with associated correlative studies to help define biomarkers of response with a focus on immunotherapeutics in lung cancer. Leena has led phase I-III pivotal trials in lung cancer defining the role of PDL1 in the use of immunotherapy and immunotherapy combinations in NSCLC. Leena has led academic clinical and clinical research programs in immuno-oncology development and oversaw translational and clinical aspects of development of a portfolio that spanned early pre-clinical to late-phase compounds . Leena has also developed the Center for Therapeutic Innovation at DFCI-- an integrated clinical/translational research center focused on early drug development.

Ayat is a leading expert in biospecimen management, solutions, and chain of custody, with over a decade of experience advancing best practices in clinical and research settings. She has a proven track record of developing and implementing innovative strategies for the collection, storage, and utilization of biospecimens while ensuring compliance with the highest regulatory and quality standards.

Passionate about driving progress in the field, Ayat has pioneered solutions that enhance efficiency, integrity, and precision in biospecimen management. Her expertise plays a critical role in supporting scientific discoveries and healthcare advancements. A trusted thought leader, she continues to shape the future of biospecimen management through advocacy and innovative solutions that drive medical breakthroughs and better patient care.

Rebecca is an organized and results-driven Global Clinical Development Operations Project and Team Leader with extensive experience in managing complex clinical trial projects, programs, and portfolios across all phases, from early-stage to late-stage development. Her expertise in clinical trial budget management, Agile project management, and cross-functional leadership, enables successful execution of clinical programs with a focus on operational excellence, quality, and regulatory compliance.

She has proven success in:
• Leading global clinical trial operations and developing operational strategies to support clinical program objectives.
• Oversight of CROs, vendors, and clinical sites, ensuring compliance with ICH/GCP, local regulations, and organizational SOPs
• Developing and delivering operational strategies, ensuring budget, timelines, and resource management for large-scale clinical trials
• Driving innovation and adopting AI to optimize clinical operations and accelerate drug development.
• Providing mentorship and fostering team development, creating high-performing teams aligned with corporate strategy.

Kelly is a communications leader with more than 15 years of experience across all facets of pharmaceutical communications. In her current role as Head of Communications & Public Affairs for Servier Pharmaceuticals - she devises, manages and implements communications strategies across a range of internal and external channels and vehicles in support of corporate initiatives, pipeline and marketed products. She strives daily to meet patient needs and ensure their voice is heard.

Elaina has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry through positions at large pharma, small biotech, and CROs. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

After Reyna completed a Master's in Nutrition in 1998, and  a short stint at a Endocrinology clinic and Research center she was recruited by Ilex Oncology, and got a crash course in clinical research. During her career she had run the gambit of clinical research, working as a CRA, Project Manager, and later Independent Consultant. After a 4 year hiatus from corporate and contractor life that included staying home with young kids, pursuit of some food/nutrition related entrepreneurial interests and a position on the Wheatsville Food Coop Board of Directors, she answered the siren call of research and again joined the ranks of pharmaceutical professionals.

Ms. Ferrari is Vice President of Clinical Operations at Curis. Ms. Ferrari is an end-to-end drug development professional with twenty years of biotech industry experience. Previously, she led program management and clinical operations at Aileron Therapeutics as Vice President, Clinical Development and Program Management. Earlier, Ms. Ferrari had a lengthy tenure at ArQule, working in positions of increasing responsibilities within clinical operations and clinical development in both oncology and rare disease. While at ArQule, Ms. Ferrari was responsible for leading programs from pre-IND through all stages of clinical development. Of note, Ms. Ferrari led the development team responsible for ArQule’s BTK program from IND enabling through early-stage clinical operations leading to the acquisition of ArQule by Merck. Prior to ArQule, Ms. Ferrari worked at Ziopharm Oncology and Epix Pharmaceuticals where she was part of the team leading to the FDA approval of Vasovist. She earned her Bachelor of Science degree from the University of Massachusetts, Amherst.

Nipun is a passionate advocate for patient centric healthcare & Clinical Trial solutions. He leads the implementation of Smurfit Westrock’s innovative, digital, and traditional pharma packaging solutions.  

With a collaborative, science-driven approach, Nipun works closely with stakeholders across clinical, medical, and commercial functions in the pharmaceutical, biotech, and clinical trial sectors. He is recognized as a trusted knowledge exchange partner, bringing deep expertise and insight into the integration of advanced healthcare packaging and digital health solutions.

Nipun brings over 30 years of diverse international experience through Smurfit Westrock and its legacy companies. His career spans R&D, product and business strategy development, supply chain optimization, and digital health innovation.

He holds a PhD in Organic Chemistry from the Council of Scientific & Industrial Research in India and completed post-doctoral research at North Carolina State University. Nipun currently resides in Connecticut, USA.

Thiago Favano serves as Senior Director, Program Operations, leading MiNK’s clinical operations and portfolio strategy. Over 17 years of extensive experience across clinical development and operations, clinical research, market access, project management and strategic business projects on a global scale. with a remarkable ability to navigate complex regulatory landscapes and drive operational efficiency. He previously served as Senior Director of Clinical Development and Operations, and Senior Strategic Advisor for Orphan DC. He also served various positions in the Pharmaceutical industry, including Clinical Operations Consultant at Atea Pharmaceuticals, and roles at Alexion Pharmaceuticals. He is fluent in English, Spanish, French, and Portuguese, and received a PharmD and MBA from Universities in Brazil.

• With over 30 years of experience in the contract research organization (CRO) industry, Ximena Valenzuela is a seasoned leader responsible for defining and executing account strategies in close partnership with Commercial teams. She excels in building and leading high-performing cross-functional teams, fostering a culture of accountability and operational excellence. Valenzuela is known for cultivating strong client relationships, ensuring delivery excellence across the portfolio, and driving strategic project execution. Her performance metrics include account revenue growth, new business generation, delivery timeliness and quality, financial forecasting accuracy, project margin optimization, and overall client satisfaction. The Therapeutic Area Expertise includes
  Oncology, Infectious Diseases, Cardiovascular, Neurology (Stroke), Gastroenterology, Rheumatology, Rare Diseases, Gene Therapy, and Ophthalmology. Valenzuela holds a Master of Science in Biochemistry and is based in Miami, Florida.