Archives: Speakers

Colleen has worked in Clinical Data Management since 1989 working at biotech, pharma and CROs.  She has held roles ranging from data processing to data programming to data management.  She has been responsible for the implementation and maintenance of global Data Management strategy for both clinical trials and programs. Provided day to day leadership support for Data project management, medical coding, data systems and quality, and is accountable for overall project delivery.  Participated in clinical and corporate project team interactions on the development of internal data management processes, cross-departmental procedures. Defined, maintained, and updated metrics and other performance measurements, as well as review of external vendor procedures to ensure compliance with corporate expectations.

Clinical research professional with over 25 years in the biotech/pharma industry. Educated in organizational development and change management and enjoys using both work experience and education to help individuals, teams, and organizations become better versions of themselves. Skilled in cross functional training, process improvement and management, communication, and collaboration.

: 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.

Dr. Markus Vallaster currently serves as the Vice President and Head of Clinical Development at Affini-T Therapeutics, Inc. an immune-oncology company focused on TCR T cell therapies that target oncogenic driver mutations such as KRAS and TP53 in patients with solid cancers.  Prior to joining Affini-T, he held clinical development positions of increasing responsibility at major pharmaceutical companies.  Dr. Vallaster’s expertise lies in stem cell transplant, cell therapies, and hemato-oncology.

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

Juliet is a biopharma leader with experience in clinical development, business development, portfolio strategy, finance, marketing, and sales.  She has worked in venture backed start-ups and global pharmaceutical companies.  At AstraZeneca, she led the launch of Imfinzi in lung cancer, which achieved blockbuster status the fastest of any AZ product.  Prior to AZ she worked at Bristol-Myers Squibb, where she led the marketing team for Erbitux in head & neck cancer, and was the global commercial lead for lung portfolio strategy, providing commercial input for early oncology clinical development programs.  Prior to BMS, Juliet worked at EMD Serono, where she was a member of global product teams overseeing development of early and late-stage oncology molecules.  She began her oncology work at Genentech, where she worked on the Avastin clinical development team.  Juliet started her biopharma career at Eyetech Pharmaceuticals, a venture backed start-up which went public and was acquired by OSI.  There she focused on finance and business development, working on the Pfizer Macugen deal, the 3^rd largest biotech licensing agreement at the time, and in-licensing ophthalmology candidates.  Juliet has an MBA from Columbia Business School and a BA from Bryn Mawr College.

Steve has 20 years of clinical research experience and has spent the majority of that time working within oncology.  He is driven to help patients by developing new therapies that improve outcomes.  He started his career as a Study Coordinator in the Neuroimaging Center at a McLean Hospital before moving to his first industry position at Genzyme where he worked in various roles within clinical operations and has worked in small biotechs, as well as big pharma.  Steve has spent the last 7 years at GSK working as a Clinical Operations Program lead, and helped the team move an asset from a first-in-human trial through numerous phase II and III trials which have resulted in multiple marketing authorizations around the globe within endometrial cancer and dMMR solid tumors.  He takes a pragmatic approach while focusing on quality, timely delivery, and efficiency.

Sergio Santillana is a medical oncologist with more than 25 years of oncology drug development and clinical practice experience. Prior to providing strategic consultancy services to a variety of life science companies, including Ikena Oncology, he was Chief Medical Officer for Merrimack Pharmaceuticals, focused on developing biologics and nanotherapeutics for solid tumors. Before joining Merrimack, he was Chief Medical Officer for ARIAD Pharmaceuticals, a commercial-stage biotechnology company that was acquired by Takeda. Under Sergio’s leadership, ARIAD obtained US regulatory approval of Brigatinib for the treatment of ALK+ NSCLC, and had continued growth of its portfolio of targeted agents in solid tumors. Preceding his executive role at ARIAD, he served in various oncology clinical development leadership roles at Takeda, GlaxoSmithKline and Eli Lilly. Before entering the biopharma industry, he was a practicing board-certified medical oncologist for 15 years, including tenure at the National Cancer Institute of Peru (INEN) where his research focus was in clinical studies of novel agents. He holds an M.D. and B.S. from the Universidad Nacional Federico Villarreal School of Medicine in Lima, Peru and a M.Sc. in Experimental Therapeutics from Kellogg College at the University of Oxford. He also holds an MBA from the MIT Sloan School of Management.

For more than 20 years, Mick Ribeiro, MSc., PMP, has been a leader in clinical research, managing and overseeing the development of various compounds and vaccines from Phase 1 to Phase 4 studies. He has worked with biotechs and Fortune 500 companies, bringing perspective and balance to an industry that thrives on discovery.

As the Vice President Clinical Operations at Ribon Therapeutics, he is responsible for the strategic planning, execution, and oversight of the company’s clinical programs, ensuring quality, compliance, and efficiency. He also runs his own consulting business, Biotech Clinical Consulting LLC, providing services to start-ups and early stage biotech companies in clinical operations, business operations, vendor selection and management, and inspection support. Multi-lingual and globally minded, he coordinates operations across diverse regions and cultures, applying his expertise in Good Clinical Practice (GCP) and Project Management.