Archives: Speakers

Amanda Hayden is a Senior Vice President of Clinical Operations at Amylyx Pharmaceuticals, and has worked for over 25 years in the Clinical Operations space. Amanda started her career as a CRA with a small CRO, progressing to Project and Program Management roles at Antigenics (now Agenus) and Millennium Pharmaceuticals (now Takeda). She then transitioned into Clinical Leadership positions at Lantheus Medical Imaging, and at Alkermes, where Amanda spent 8 years overseeing Study Start Up, Clinical Compliance, Clinical Systems and Disclosure and Technical Solutions. She has extensive prior monitoring and project management experience, with significant focus in Oncology, Neurology and Endocrinology trials. Amanda has continued to build upon her leadership, and enjoys finding additional ways to contribute to organizational health including through efforts such as spearheading the launch of internal mentoring and employee engagement programs.

Mike Herman is resiliency personified—a 13-year multiple myeloma survivor, two-time stem cell transplant recipient, participant in two groundbreaking clinical trials, global patient advocate, and Founder and Chief Visionary Officer of Cancer CAREs International.

Mike does not speak about the patient experience from the outside. He brings the lived experience of the patient directly into the rooms where clinical trials are designed, sponsored, managed, explained, and evaluated.

He understands what participation requires beyond the protocol: the uncertainty of an incurable diagnosis, complex consent documents, fear of an unknown treatment, extended hospital stays, severe side effects, travel and financial burdens, caregiver dependence, and the daily decision to remain in a trial when leaving may feel easier.

After exhausting numerous established treatments, Mike participated in two bispecific-antibody clinical trials at Penn Medicine. During his first trial, teclistamab reduced his cancer markers by more than 99% within 48 hours. The investigational therapy was later approved as Tecvayli, giving Mike the extraordinary knowledge that his participation helped advance a treatment now available to other patients.

When his cancer returned, Mike entered a second clinical trial involving cevostamab. The treatment made his cancer undetectable within two weeks. He completed 17 cycles and has remained in complete remission and off active cancer treatment for approximately three years.

Those experiences taught Mike that enrolling a patient is not the same as preparing, understanding, or supporting one. His lived experience allows him to illuminate the often-unseen reasons patients struggle with—or leave—clinical trials, including inadequate preparation, communication gaps, treatment burden, fear, loss of trust, caregiver pressures, and the difference between signing an informed-consent document and genuinely understanding what lies ahead.

Mike’s journey was featured in the American Association for Cancer Research’s Cancer Today magazine in the survivor profile “From Fear to Action.” He has served on multiple pharmaceutical patient advisory boards and has spoken and moderated for pharmaceutical organizations, contract research organizations, and numerous cancer, healthcare, and clinical-research conferences.

Through Cancer CAREs International, Mike is also leading groundbreaking global work on durability—examining how patient understanding, trust, ownership, participation, behavior change, and program impact can be intentionally designed to endure beyond an initial intervention, funding period, or clinical trial.

Mike brings candor, humor, urgency, gratitude, and an unmistakably human perspective to every stage. He welcomes opportunities to speak, moderate, and contribute lived experience wherever patients, clinical research, healthcare innovation, and lasting change come together.

Dori Sarkis is Sr. Director of Strategic Partnerships at Alcanza Clinical Research, a wholly owned, multi-therapeutic site network. Dori’s focus is building and managing strategic partnerships with sponsors and CROs to optimize research collaboration across Alcanza’s 30 research sites. With over nine years clinical research, Dori has worked in site network operations, business development, and strategy across a multiple study delivery models. Trust is the foundation of Dori’s approach. Trust is earned through transparency, surfacing risks early, and follow-through, ensuring commitments made during feasibility hold true once a study is running.

Kevin Anderson is a clinical operations executive with more than 30 years of experience across biotech and pharma, including roles at Amgen, Biogen, Shire, Alexion, and Moderna. His work has spanned pre-IND through post-approval, with involvement in five BLA programs and multiple regulatory inspections.

Most recently, Kevin led AI enablement within Development Operations at Moderna. Earlier this year, he founded Avery & Riley, an AI advisory and consulting firm helping biotech companies and AI solution providers apply emerging technologies to clinical development, operations strategy, and pharma go-to-market efforts.

Akash Patel is Sr. Director, Design Assurance and Global Process Owner for Human Biological Sample Management (HBSM) at GSK. He leads global teams to build strategies that integrate quality, compliance, and governance across clinical development, with a focus on biospecimen management, GCP laboratory compliance, and outsourced clinical research. Akash is passionate about building practical, risk-based compliance frameworks that enable innovation while protecting patients and advancing high-quality clinical research.

Sonal Kalra is the founder of Lokashi, based in Boston, Massachusetts, a certified meditation teacher. Known for her warm and approachable style, she blends the research-backed & time-tested practices of eastern wisdom with modern science to create accessible & transformative mindfulness programs. Sonal holds degrees in Psychology, Human Resource Development, Labor Laws & Labor Welfare, and Training & Development, along with advanced training in Somatic EMDR. She hosts a mindfulness podcast, has been featured on numerous podcasts, and leads workshops for corporations, conferences, schools, community groups, yoga festivals and nonprofits, helping people cultivate resilience, emotional intelligence, connection, and inner peace.

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.

Hana is a Research Analyst at Tufts CSDD where she conducts grant-funded research including global online surveys, interviews, quantitative and qualitative data analysis, and literature reviews. Her most recent work examines the impact of artificial intelligence on drug development, as well as the impact of real-world data and real-world evidence, and risk-based and centralized monitoring on clinical trials.