I'm a Healthcare practitioner with 10 years of experience in running my own dental practice. Enabling healthcare is my life’s purpose. I now sit on the cusp of healthcare and technology as part of my new and exciting role at Alexion. I am passionate about novel technologies and in using Innovation to reduce the unmet burden of care amongst the rare disease community.

Regulatory professional with experience managing Phase 1-4 programs across multiple therapeutic areas.

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.

A board-certified radiation oncologist, David Raben, M.D. is currently the CMO at Bicara Therapeutics with more than 25 years of academic translational oncology experience and 4 years in pharma, having most recently served as vice president of global product development and product general manager, oncology, at Amgen. At Amgen, his work centered on driving the anti-DLL3 program in neuroendocrine cancers. Prior to that, Dr. Raben served as vice president and franchise leader, clinical development oncology, at Genentech, focusing on precision medicine and immunotherapy trials in head and neck and thoracic cancer, in both late-stage and locally advanced settings. His career started at the Univ. of Alabama at Birmingham for 1994-1998 followed by over 20 years as a professor and member of the University of Colorado Cancer Center, where his main areas of focus included evaluating and combining novel biologic therapies for patients with locally advanced cancers of the head and neck (HNC) and lung. His expertise also includes translational experience in areas such as EGFR signaling, DNA damage repair, TGFb and checkpoint inhibition. Nationally, Dr. Raben served on the NRG Oncology Head and Neck Cancer (HNC) steering committee for the past 15 years and established and led the Radiation Developmental Therapeutics Committee at the NRG. He remains an active member of the American Head and Neck Society, IASLC, ESMO, AACR and ASTRO and currently serves on the ASCO Research committee. Dr. Raben holds a Batchelor of Arts degree from Duke University and earned his M.D. from Wake Forest University. He completed residency training in Radiation Oncology at the John Hopkins Hospital.

I am a biopharmaceutical executive and board member with more than 25 years of experience working at the intersection of strategy, capital markets, operations, and M&A, spanning early clinical development through global commercialization. I have served as Chief Financial Officer of five public companies and currently serve on multiple boards, including as Audit Chair and Compensation Chair. My experience includes defining corporate strategy for global commercial biopharma organizations as well as early-stage clinical companies, across multiple therapeutic areas and both public and private environments. Over the course of my career, I have led more than $4 billion in public and private financings, including IPOs, follow-on offerings, convertibles, preferred equity, high-yield debt, and structured credit facilities. I have also executed over $1.2 billion in strategic transactions, including M&A, licensing, and platform partnerships, with post-transaction integration efforts generating meaningful and durable cost savings. In operating roles, I have worked closely with CEOs and leadership teams to guide capital allocation, portfolio decisions, investor engagement, and organizational scaling, often during periods of transition or strategic inflection. Earlier in my career, I was CFO of Serono, then the third-largest global biotechnology company, and a member of its executive management board. In addition to board service, I contribute to industry dialogue as a member of the Life Science Leader Editorial Advisory Board and as a frequent guest on the Business of Biotech podcast. I enjoy partnering with boards, CEOs, and leadership teams on strategy, execution, and governance, particularly where clarity, judgment, and disciplined decision-making can unlock long-term value.

Phill Gallacher, Senior Vice President, Clinical Development Operations and Clinical Program Management , Cullinan Oncology

Phill is the SVP, Head of Clinical Operations & Program Mgmt. at Cullinan Therapeutics.

He has over 30  years of experience in Clinical Development across a wide spectrum of environments, organizations and therapeutic areas within Clinical Operations, Program & Portfolio Management, and Functional Line Management / Leadership.

Prior to joining Cullinan, Phill led the Clinical Development Operations at Aprea Therapeutics for over 5 years in various solid tumor and hematological indications, and prior to that he spent over 10 years at Biogen where he had several roles across Clinical Operations, and Program & Alliance Management encompassing both late phase and early phase Neurology development programs.

Highly motivated, results driven Clin Ops leader with medical background and over 20 years of experience in clinical research (biotech, CROs), from IND/FIH to global ph3. Combines deep industry knowledge with a proven track record of clinical trial execution across multiple functions. Extensive experience in early phase oncology, as well as other therapeutic areas (rare disease, autoimmune etc). Broad skillset (CRO/vendor management, clinical operations, safety and DM oversight, medical monitoring) with ability to be an individual contributor as well as building and leading my team. Speaker at the industry conferences (SCOPE, OCT etc) My passion is planning and executing clinical trials in the most efficient and creative way while staying on budget. I enjoy building high functioning and stable clinical teams and department infrastructure. Operational oversight, cross-functional coordination and leadership. Training programs, process development and improvement, SOP writing.

Global biopharmaceutical executive with 25+ years of enterprise leadership across the US, Europe, Japan, China, and APAC. Proven record in securing diversified biotech financing, leading corporate transformation initiatives, portfolio strategy prioritization, governance, organizational leadership, and health system stakeholder engagement. Experienced in leading both early and late‑stage development companies through pivotal inflection points—including structured financings, mergers & acquisitions, delivered 15+ FDA, EMA, and PMDA approvals/launches across therapeutic areas, built high‑performing fit for future global organizations. Enthusiastic for impactful patient centric solutions, health system sustainability initiatives and refining development efficiencies to accelerate speed-to-market.

Karen Peterson is a nationally recognized patient advocate, community scientist, and Stage IV triple-negative breast cancer (TNBC) survivor whose lived experience has reshaped how clinical research teams engage with patients — particularly those historically underrepresented in trials. Her journey began with a life-altering diagnosis that forced her to navigate a complex healthcare system, confront uncertainty, and make critical treatment decisions often without clear guidance. What emerged from that experience was not only survival, but a calling: to ensure other patients would not face research, treatment, and decision-making alone.

Her work quickly expanded beyond peer support into systems change. Karen became a trusted collaborator to researchers, pharmaceutical companies, and clinical trial teams seeking authentic patient insight, including her successful partnership with the Tisch Cancer Institute’s Phase I Clinical Research Team in NYC.

In addition to direct patient navigation, Karen has become a sought-after speaker, consultant, and thought leader. She advises organizations on patient experience strategy, recruitment materials, and community engagement, helping teams design research processes that reflect real patient needs. Her voice has been featured across media, conferences, including The Today's Show , Health.com and Black Doctors.org.

Today, Karen Peterson stands at the intersection of advocacy, research, and health equity. Through Karen's Club and her broader role as a community scientist, she continues to champion a future where every patient — regardless of background — has the knowledge, confidence, and support needed to participate in research and access innovative care.

Soo is a senior biotech executive with 25+ years of experience creating value through strategy, partnerships, and disciplined execution. She has a proven track record advancing innovative therapies and aligning scientific, clinical, and commercial priorities to drive enterprise outcomes. Soo has led business development, alliance management, operations, and technical commercialization across global organizations, delivering actionable results through partnerships, transactions, and portfolio execution. She is known for converting complex opportunities into clear strategic narratives that support investment, governance, and long-term value creation. A trusted board-level operator and global connector, Soo brings deep cross-border relationships spanning investors, biopharma partners, and scientific leaders. She builds high-performing teams, instills a culture of accountability and quality, and consistently delivers against ambitious, first-in-class objectives.

Experienced Data Manager having worked in the following therapeutic areas:
* Oncology
* CNS
* Diabetes
* Infectious Diseases
* Respiratory

Also, experience in Phase I, II, III and IIIb studies in both the EDC environment (primarily in OC RDC and Medidata) and the paper CRF environment.

Provides process development and evaluation.
Develops training for data manager in areas from GCP and the CDM role to query writing and CRF development.
Provides mentoring and general consulting to the DM group.

Specialties: Vendor Management
Risk Analysis & Management
Problem Solving
Team Building and Communication
Training
Mentoring
GCDMP
SQL and SAS Programming
Tableau

I am an attorney specializing in Food & Drug and Healthcare law, with a particular expertise in drug development, government drug pricing and reimbursement issues. I also do compliance, M&A and advocacy in this area. My clients include start-ups and Fortune 500 companies that manufacture and market drugs and medical devices. My public health background and research and international experience inform my practice.

Seasoned, forward-thinking, business savvy, highly skilled biomarker, CDx and clinical development business operations biopharmaceutical program management professional. Enjoy building sustainable infrastructure and delivering high-value real-time technology solutions, hiring, managing and leading teams to get there faster and smarter. Focused on creating agile turnkey, robust operations, proven to decrease study start-up lead times, delivering on corporate goals and R&D pipeline milestones. Demonstrated success to Sr. Mgmt. as high value, high performing employee, leader and people manager. Extensive experience in defining and driving operational strategy, commercializing oncology products, spinning off- biotech companies, third-party vendor and alliance management. Significant Sponsor, CRO and vendor facing experience.

Health and life sciences leader with extensive experience in patient advocacy and public policy.

I am a physician-scientist at the intersection of pathology diagnostics, AI, and drug development. Currently a Global Medical Affairs Lead in Pathology at Roche Diagnostics, my mission is to architect the next generation of precision diagnostics through the AI-enabled multimodal integration of digital pathology, spatial biology, and multianalyte tissue detection. With a career spanning elite research institutions and biopharma / diagnostics / biotech, I have a strong track record of bridging the gap between foundational biological discovery and the delivery of transformative clinical tools. Core Areas of Expertise: • Precision Diagnostics: Diagnostic and companion diagnostic (CDx) development, biomarker strategy, and technology assessment. • Digital & Spatial Innovation: AI-enabled integration of traditional morphology, molecular pathology, and spatial biology. • Clinical & Translational Leadership: USA board-certified anatomic pathologist with deep experience in drug safety (toxicology), translational medicine, molecular and investigative pathology, and medical affairs. • Strategic Diligence: Expert in biotech/biopharma life sciences and diagnostics diligence. My Journey: From Foundational Discoveries to Global Leadership From the beginning, my work has been rooted in a deep commitment to revealing and modeling human biology, which was first inspired by studying chemical engineering, cardiology, and immunology. During my MD-PhD at UCLA, I discovered the molecular basis of DNA-protein recognition by bHLH-PAS transcription factors—a finding that helped unify fields as diverse as cell fate determination, toxicology, circadian rhythms, and oxygen sensing. I further honed this expertise through a pathology residency and fellowships at Stanford University, where I later served as faculty. For nearly a decade, I balanced teaching and clinical practice with leading a research laboratory focused on genetics, developmental biology, and cancer biology at UT Southwestern. Since entering industry in 2009, I have applied this rigorous scientific lens to every stage of the drug and diagnostic lifecycle. My goal has been to evolve how we see and treat disease by merging traditional pathology with the power of modern digital and molecular tools.

Early Development Clinical Project and Team Leader, leading pre-clinical operational strategy and First In Human clinical trails globally.

George Tetz, MD, PhD, and CEO/Cofounder of Second Life Group, has dedicated his life’s work to addressing some of medicine’s most unmet needs.

Second Life Group includes three different clinical-stage entities, including Second Life Therapeutics, Second Life Diagnostics, and Second Life Vaccines. Together, these companies address some of the most critical, unmet needs in medicine, including advanced solid tumors, antibiotic resistance and longevity with first-in-class personalized medicines and medical devices.

Throughout his career as both a medical practitioner and researcher, Dr. Tetz has focused on applying cutting-edge multifactorial approaches to a variety of medical problems. One of his most groundbreaking findings is the existence of the previously unknown Universal Receptive System and Teazeled receptors. With this discovery, Dr. Tetz is modulating cellular memory for the first time, bringing cell control to a new and unprecedented level.

Dr. Tetz began his career as a medical practitioner, then earned his PhD in molecular microbiology. He serves as Director of the Department of Systems Biology at the Human Microbiology Institute, where he played an integral role in groundbreaking studies. Dr. Tetz is also a member of the American Society for Microbiology, Society for Neurosciences, and New York Academy of Sciences.

Digital health product lead with expertise in SaMD, AI/ML-enabled screening, and clinical decision-support tools, with a track record of delivering multiple diagnostic devices that have achieved global regulatory clearance and market launch. My work spans diagnostics and digital health products across neurology, gastroenterology, oncology, and rare diseases.My role centers on building digital diagnostics platform capability—a reusable diagnostic foundation that supports therapeutic programs across the enterprise. This includes defining diagnostic value propositions, evidence requirements, technology development pathways, algorithm deployment frameworks, clinical workflow integration, and digital productization models that scale across the US, EU, Japan, and China.Backed by a strong foundation in regulated diagnostic development, I bring execution-focused leadership across the full product lifecycle—from requirements definition and validation planning to cross-functional alignment with clinical, translational science, regulatory, commercial, and global development partners.Previously a co-founder of a connected-health startup, I combine an innovation mindset with enterprise-level product leadership to shape Takeda’s approach to digital diagnostics, diagnostic algorithms, and clinical decision-support solutions.

A highly accomplished physician, oncologist, pathologist, scientist, and senior medical leader with over 30 years of expertise in medicine and biopharmaceutical research and development, particularly in oncology. Renowned for proficiency in immuno-oncology, vaccine development, and fostering strategic collaborations across government, academia, hospitals, and industry. Demonstrates comprehensive expertise in clinical development, medical affairs, and navigating regulatory submissions (IND, BLA/NDA), with a proven record in leading and mentoring multidisciplinary teams. Skilled in building and guiding global oncology portfolios for diverse organizations, showcasing outstanding business acumen as a co-founder, board member, and a pivotal contributor to business development and alliance management. An extensive academic career includes mentoring, leading major clinical and research initiatives, and securing substantial research funding. Held key leadership roles such as Division Director, Department Head, and US Head of Global Oncology Development Unit. Committed to nurturing talent, team integration, and delivering impactful results, with exceptional communication skills that make complex scientific concepts accessible to diverse audiences. In addition to extensive scientific and medical accomplishments, am also a passionate advocate for human rights and social equity, recognizing socioeconomic inequalities as a profound threat to human well-being and a key driver of disease, necessitating decisive political action. Ran twice for President of the Democratic Republic of Congo, championing a platform focused on political and socioeconomic reforms, and advancing pro-poor policies.

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to industry drug development performance, including clinical research associate (CRA) performance, impact of decentralized clinical trials (DCT), and investigative site burden. She recently received her Master’s in Health Informatics and Analytics from Tufts University and has a BS in Data Science and Mathematics from St. Michael’s College. She also has experience in web development for North Shore Nurse Practitioner Associates, a psychopharmacology practice.

Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Biotech executive with 20+ years of experience driving innovation at the intersection of science, medicine, and technology. Currently VP, Head of Translational Medicine at Verge Genomics, where I built the function from the ground up and advanced neurology programs through Phase 2/3 readiness using FDA-validated biomarkers. Previously at Pfizer, I led cross-functional teams delivering novel digital endpoints, secured FDA/EMA alignment, and helped advance Ponsegromab from Phase 1 to Phase 2/3. At Biogen, I drove digital diagnostics initiatives, advanced technologies in Alzheimer’s and stroke, and helped spin out a new venture. I also founded a digital diagnostics startup, Usin’Life, which exited with a few assets. Passionate about advancing therapies for patients with high unmet medical needs, I bring expertise in translational medicine, biomarker strategy (digital & fluid), regulatory engagement, using technology ( including AI/ML !) and partnerships across biotech, pharma, and academia.