Archives: Speakers

Extensive clinical operations experience, with expertise in contracts and forecasting.

With over 25 years’ experience in the pharmaceutical industry, Ms. Hart has a wide range of experience from working with manufacturing, toxicology and clinical CROs in various roles. An analytical chemist by training, Ms. Hart got her start in the industry performing bench chemistry for analytical CROs such as AAI Pharma (Alcami), and Alpharma (acquired by Pfizer), then migrated into Quality Assurance, responsible for investigations and cGMP compliance. After that, Ms. Hart spent several years at RTI (Research Triangle Institute) in RTP, NC in Quality Assurance overseeing GLP and GMP Quality programs before migrating into commercial business development, where she established short- and long-term partnerships with biotech and pharma companies in support of their programs.  Ms. Hart then became Sr. Director of Business Development at RTI, overseeing a $5M portfolio and 3 Business Development reps.  After spending 6 years at RTI, Ms. Hart became analytical lab director of the new Patheon facility in RTP, NC.  In that role, she managed projects, trained employees, and help set up the lab.  Around 2010, Ms. Hart migrated into the clinical world with a role in business development at Jubilant Clinsys, a boutique CRO based in Raleigh, NC. After her tenure at Jubliant Clinsys, Ms. Hart moved to Duke Clinical Research Institute where she started in business development, but also worked in marketing, project management, cross-functional liaison between Neurology and Psychiatry groups.  During her tenure at DCRI, Ms. Hart created the EEG coordinating center for CNS clinical trials to offer to companies needing EEG central adjudication for clinical endpoints. After leaving DCRI, Ms. Hart became Vice President of Cohortias Intl, a clinical CRO in Monterrey, MX.  During her tenure there, she oversaw the business development groups, creation of the entire QMS (Quality Management System), training, project management, and clinical development groups.  Finally, the last 5 years of experience has been working on the sponsor side at Evecxia Therapeutics as the Executive Director of Operations. In this role, she is responsible for all outsourcing, project management, finance, and quality for nonclinical, clinical, and manufacturing operations of Evecxia’s two main products EVX-101 and EVX-301.

Create, implement and grow an action oriented portfolio strategy organization ensuring we are accelerating health outcomes for people living with diseases through the delivery of the right human experience driven digital solutions

Senior quality leader with a proven track record bridging the gaps transitioning from R&D through commercialization and globalization. History of creating efficiencies and agility, minimizing risks, and optimizing competitive edge by developing right sized risk based global quality management systems and building effectiveness through collaborative internal and external partnerships.

Technical expertise includes GCP, GLP, GMP and Drug Safety / Pharmacovigilance quality system, process, program support as well as global and local quality system design, development and implementation on various scales and complexities.

Specialties: Over 35 years in the global pharmaceutical research environment participating in over 30 NDA/BLA/MAA submissions across all therapeutic areas with emphasis in Cardiovascular, Oncology, Anti-Infective/Immunology, Pulmonary/Respiratory, Gene Therapy/Gene Transfer, Nuclear Medicine/Diagnostic Imaging, CNS and Rare Disease. Experience spans complex small molecules, biologics, medical device and drug device combo products as well as transdermal and scheduled products.

Corinne Scripps is the Account Manager at CISCRP (Center for Information and Study on Clinical Research Participation). Corinne primarily collaborates with industry partners to support patient engagement, clinical research education, and clinical trial participation. She holds a Masters of Public Health from Boston University School of Public Health, and Bachelor’s degrees in both Health and Human Services focusing on Gerontology, and Global Gender Studies from The University of Buffalo. Her graduate work primarily focused on the effects of race and quality of maternal healthcare experiences on maternal and infant health outcomes. She is passionate about expanding the availability of healthcare education and creating transparency amongst diverse and underrepresented populations.

Kevyn Matijevich, RQAP-GCP, is Associate Director, Research and Development (R&D), Clinical Quality Assurance at Menarini Stemline. In this role, Ms. Matijevich is responsible for supporting oncology research trials.  Ms. Matijevich is registered with the Society of Quality Assurance in Good Clinical Practices (RQAP-GCP) and holds a Master’s certificate in regulatory affairs from the University of Georgia. She has more than 20 years of quality experience within the pharmaceutical/life sciences industry. She has extensive experience in quality systems, computer systems validation, risk based quality management, process improvement, change management, auditing, vendor management, and electronic records/signature regulations. Additionally, Ms. Matijevich is the SQA CVIC AVA subcommittee chair and is the past president of the North Carolina Chapter of the Society of Quality Assurance board.

Willy Burkhardt, former Finwave CEO is now in charge of the international development of Fibonacci Group.

Finwave is now part of Fibonacci Group, an international software company that operates in the financial sector offering vertical solutions for factoring, leasing and consumer credit.

Experienced Enterpreneur and Managing Director with a demonstrated history of working in the IT and services industry.

Skilled in Management of Listed Companies and Start-ups, Integration, and Business Strategy.

Debra Caballero is an accomplished consultative sales and business development leader with over 25 years dedicated to the life sciences/clinical trial logistics space.

Her passion for new and innovative products and processes in the logistics world enables cutting edge therapies and streamlines the journey of medicines from clinical to commercial.

As VP of Revenue at Life Couriers, Debra’s responsibilities are to bring customizable solutions and forward-thinking processes to the pharmaceutical and life science world, to support the challenges new therapies and medicines carry with them.

Areas of Expertise

• Clinical trials
• Healthcare logistics
• Team leadership
• Sales strategy
• New technology in healthcare logistics

Career

2024 – today:               VP Revenue, Life Couriers

2023 – 2024:               Business Development Director, Clinigen Clinical Supplies Management

2020 – 2023:               Sr Manager Sales Support & Quote Teams North America, World Courier

2006 – 2020:             Director of Business Development, MidWest, World Courier