Speakers

Dr. Phil Febbo is Chief Medical Officer at Illumina, responsible for developing and executing medical strategy to drive genomic testing into healthcare practice. Before joining Illumina, Dr. Febbo served as CMO of Genomic Health where he was accountable for the development of evidence supporting GHI’s proprietary tests, engaging with the payer community to drive reimbursement. Prior to his years at Genomic Health, Dr. Febbo was a Professor of Medicine and Urology at the University of California, San Francisco, where his laboratory focused on using genomics to understand clinical behavior of prostate cancer, and his clinical practice focused on genitourinary oncology.

Dr. James is the Chief Medical Officer for J&J Innovative Medicine Medical Devices. In the role, he is responsible for overseeing patient monitoring and safety surveillance practices. He also serves on the Board of Directors of the Medical Device Innovation Consortium, a public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle.

Dr. Davide Manissero is Chief Medical Officer at QIAGEN. He joined the industry after training in paediatrics and tropical medicine and working in global public health for WHO and ECDC. His industry experience includes development and introduction of novel antibiotics and ID diagnostics extending to both molecular and immunodiagnostics. His academic interest extends to infectious diseases, antibiotic development and the understanding of antimicrobial resistance. Screen reader support enabled.

Professor Ian T. Meredith AM is executive vice president and global chief medical officer at Boston Scientific. In this role, he is responsible for leading clinical science and medical affairs across Boston Scientific and providing global leadership of the company’s clinical trial strategy. Prior to joining Boston Scientific, Professor Meredith served as professor and director of MonashHeart, and executive director of the Monash Cardiovascular Research Centre at Monash University in Melbourne, Australia. Professor Meredith has over 25 years of experience as a clinical and interventional cardiologist and also served as director of the Cardiac Catheterization Laboratories and Interventional Cardiology. Professor Meredith has been a member of the Board of the National Heart Foundation (Australia) and a member of the Cardiac Society of Australia and New Zealand National Board.

Ms. Allen has more than 15 years’ experience in clinical research, with a historic focus on spine and orthopedic devices. She is responsible for driving growth and performance at MCRA’s CRO, the leading Medical Device CRO. Ms. Allen oversees a team of over 40 skilled clinical professionals to support MCRA’s clients’ needs, while working closely with MCRA’s integrated Regulatory, Reimbursement, and Statistical departments. Prior to joining MCRA, Ms. Allen worked as a Clinical Manager for a privately held medical device company.

Mike Baca is a graduate of the United States Military Academy at West Point. Following his active duty commitment, Mike went into business, working with companies such as J&J Innovative Medicine, Medtronic, and Stryker. Over a 36 year career in Medical Devices, Mike focused on the Quality arena. He retired in 2017 after serving as the Vice President of Quality/Regulatory/Clinical for the Instruments Division of Stryker. He founded White Rook Consulting, LLC in 2018 where he is President and Principal.

Tara Blair is a manager within Medtronic’s Commercial Operations group and has been with the company for 11 years. In her role, she is responsible for leveraging technology to offer innovative solutions that help teams and customers be more successful. Tara went from product to digital marketer when she decided to bring together her creativity and love of technology. Tara holds her Master’s in Business Administration, has 17 years industry experience and resides in RI with her husband and three children.

Lauren Buchholz currently is a Director of Regulatory Operations at Roche Molecular Systems, Inc. Lauren has focused her career on the diagnostics industry, and has had a strong focus on advancing the global processes and technology that support the work. With more than 30 years of experience in the industry, Lauren understands the vital importance of keeping pace with the rapid rate of industry change to maintain a competitive advantage. Lauren believes some of the best ideas for solving problems can come from tapping into knowledge from creative thinkers in analogous fields, and enjoys exploring diverse topics in life science, the arts, and history in her free time.

Quality Leader and Qualified Person with over 15 years’ experience in the Pharmaceutical and Medical Device industry. A background bridging commercial and clinical trial manufacturing for medical devices, sterile injectables, non-sterile tablets, capsules and liquids.

Brenda is currently senior manager clinical systems operations at Edwards Lifesciences. During her career, she has worked on both the employee and consultant side in a variety of industries and utilized a variety of programming platforms and tools. Since moving into the Medical Device industry in 2003, Brenda also held positions at Boston Scientific and American Medical Systems in which she was responsible for data management, performing study builds, and clinical systems operations. She graduated from DeVry Chicago with a BS in Computer Information Systems.

Patti Griese, Principal Clinical Trial Administrator at NAMSA. Patti has experience working at a CRO, at the site as a study coordinator, and at the Sponsor as a Monitor. Patti has worked on pharmaceutical and medical device research and provides leadership to the clinical trial administrator team at NAMSA.

James is Head of Regulatory Operations at GE Healthcare. He has 19 years experience in the industry, including 9 years at a major innovator, as well as stints in outsourcing, consulting, Generic Pharma and now Nuclear Medicine. Recent extensive experience of system and process design, migration, training and system ownership for a full Veeva RIM implementation (Registrations, Submissions and Submissions Archive)

Lori Holder is the Director of Global Regulatory Operations at Alcon Laboratories, Inc., a leading manufacturer of ophthalmic medical devices located in Fort Worth Texas. She has over 25 years of experience in the medical device industry through positions at Guidant Corporation, Sulzer Orthopedics, Sulzer Intermedics, and Cyberonics, Inc. She has held positions of increasing responsibility in clinical research, quality assurance, and regulatory affairs, and currently is the head of Alcon’s Regulatory Operations group. Lori has earned her Regulatory Affairs Certification (RAC) and has a B.S. in Biomedical Engineering from Texas A&M University.

Jennifer Kerr is the President of Cook Research Incorporated (a Cook Medical Company), in the Purdue Research Park, West Lafayette, Indiana. Jennifer’s role includes executive oversight of product development, testing, clinical studies, medical/scientific writing, and regulatory submissions for medical devices. She is Cook’s Global Leader for Clinical Affairs which is responsible for the design, oversight, and management of pre-market and post-market clinical projects. She also collaborates with experts on Good Clinical Practice (GCP) including the international standard ISO 14155 (Clinical standard for conducting medical device studies).

Larry leads Baxter Healthcare’s Global Regulatory Affairs (GRA) Global Strategy and Delivery (GSD) organization, designed to create an aligned and unified approach to regulatory support across the GRA organization. His primary focus is on simplifying regulatory processes and providing strategic support to business partners to further enable efficiency and effectiveness on a global scale, while delivering with excellence through speed, courage, collaboration and simplicity across the Baxter portfolio. Prior to Baxter, Larry served in senior leader roles within Johnson and Johnson and Sanofi-Aventis spanning local, regional, and global functional areas, within and linked to Regulatory Affairs.

Ayaz Malik has spent the majority of his career in building, transforming and enabling marketing and communications teams with a focus on healthcare/medical devices. His passion in the last decade has increasingly turned to marketing in the digital era and the evolving roles within a highly matrixed organization – especially those of the marketer and communicator, as they work to remain relevant and capable in the face of rapidly evolving technologies that enable a company’s content creation, curation, management, delivery and measurement today. Ayaz’s peers describe him as a polymath and seek him out for his ability to connect-the-dots across multiple and complex business challenge, and to lead collaboration efforts that result in relevant, compelling and actionable solutions.

Brianna Phillips is the head of Quality and Regulatory at Biodesix, Inc. She has extensive experience in Quality Compliance and Regulatory Affairs. She leads multi-disciplinary teams in the implementation and maintenance of the Biodesix QMS. She continues to focus her efforts on bringing Biodesix to the highest level of compliance and establishing a “Best in Class” globally certified medical laboratory.

Matthew Purner leads the Clinical Affairs team at Illumina, Inc. He aspires to build a center of excellence around compliant clinical trial conduct to deliver meaningful genetic testing results to physicians and patients and improve human health globally. Creative growth opportunities are one of his top priorities and he loves surrounding himself with people who inspire him to be the best that he can be. His husband, Steven, is at the top of the list.

Mark is currently the Senior Director, Global Quality at Epredia. Epredia was formerly the Anatomical and Pathology Division of Thermo Fisher Scientific. Epredia is now part of the PHC Group and is focused on cancer diagnostics. He has global responsibility for all quality related activities. Mark was previously the Senior Global Director of Quality Assurance for the Industrial and Healthcare Materials Group at Avery Dennison. While there, he focused on harmonizing quality management systems globally to be compliant with: ISO 13485, Title 21 CFR Part 820, ANVISA (Brazil), KGMP (Korea), Medical Device Single Audit Program (MDSAP), and the Medical Device Regulations (MDR).

Mary Ryan is Director of Innovation, Technology and Regulatory Affairs at Penlon Ltd, responsible for delivering the strategic, quality, and technical requirements in the development of medical devices for global markets. With almost 30 years in quality assurance, Mary champions efforts to bring a more modern technology outlook to Penlon’s product vision and is driving initiatives in the area of creating and levering new technology solutions and clinical partnerships. More recently, she was a leader in the UK NHS Ventilator Challenge.

Flora Sandra Siami, MPH, brings 25 years of corporate management, clinical and RWE research, and strategy and business development experience to her position as Senior Vice President of NESTcc at the Medical Device Innovation Consortium.

Ms. Siami previously served as staff vice president of Clinical Research, Regulatory Affairs, and Quality Assurance at HealthCore, Inc., as well as in leadership roles at New England Research Institutes, Inc. She has given over 45 scientific presentations and has over 50 publications in major medical journals and book chapters.

Ms. Siami received her BS from Vanderbilt University and MPH from George Washington University.

Nicole Stansbury, Vice President, Central Monitoring Services, joined Syneos Health in February 2019. Nicole has 29 years of experience in the industry beginning as a study coordinator in a multi-therapeutic site followed by 21 years at a large, global CRO where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into leadership roles. Nicole’s leadership roles included Head of Clinical Management in the Central US where she oversaw Clinical Team Managers (CTMs), CRAs and administrative staff and Head of Global Clinical Performance, a group responsible for clinical metrics, systems, process and quality where Nicole led the development of the risk-based monitoring (RBM) strategy, process and tools. Nicole has consulted with biotech companies on ICH E6 R2 compliance, conducted risk management training, performed a detailed assessments of EDC, CTMS, RBM and eTMF technologies for a small CRO and completed a risk management and centralized monitoring process assessment for a large pharmaceutical company.

Nearly 30 years’ experience in clinical trials and statistical sciences across all phases of product development in industry, academia, and NIH settings. Currently leads Alcon’s Clinical R&D team responsible for the strategic and operational design, execution, and reporting of all Alcon clinical development activities and all global medical affairs brand plans for Alcon’s pipeline and existing marketed portfolio of products.

Coming soon …

As the current Associate Director of Clinical Data Management at Illumnia, Phil Tayco holds 10+ years of experience in IT Business Systems Analysis. Phil entered the Clinical Data Management space in 2006 where he managed all areas of Clinical Database development and project management. Additionally, Phil has served as a part-time software engineering college instructor for the last 20 years.

Tristin Wolff Cope is the Regulatory Compliance Officer at Biodesix, Inc. As the Regulatory Compliance Officer, she has ownership of the Biodesix Internal Auditing System for all site Quality Management Systems and conducing all audits per governing regulatory requirements and ensuring compliance to those governing requirements.

Lee Young has worked in the quality and regulatory life sciences environment for 26 years. He has worked at companies including Intel Corporation, Abbott Diagnostics, Carefusion, Life Technologies/Thermo Fisher Scientific, and Hologic. He now serves as the Vice President of Quality and Regulatory Affairs at Caris Life Sciences. Lee currently teaches at the University of San Diego (USD) and sits on USD’s scientific advisory board.