ABOUT THIS EPISODE
Getting pharma, medical device, and drug-device combination products into clinical trials takes a clear strategy for INDs, IDEs, FDA meetings, and first-in-human studies.
Dr. Robert Bilkovski joins Subhi Saadeh to discuss clinical development, pre-IND meetings, Q-Submissions, clinical trial design, site selection, and sponsor oversight.
What should you have figured out before meeting with FDA? How does the clinical strategy change when you pair an existing drug with a new delivery device? And what happens between preparing a submission and enrolling the first patient?
IN THIS EPISODE
- The chief medical officer’s role in clinical development, safety, and medical affairs• Clinical strategy for drugs, medical devices, and combination products• Bridging an existing drug to a new delivery device• INDs, IDEs, and preparing for first-in-human studies• Bringing focused questions and a proposed strategy to FDA meetings• Using early studies to inform endpoints, sample sizes, and labeling• Selecting, qualifying, and activating clinical trial sites• Sponsor oversight and considerations for studies outside the United States
ABOUT DR. ROBERT BILKOVSKI
Contact Robert: http://www.RNBVenturesConsulting.com/podcast
Dr. Robert Bilkovski is an emergency physician whose industry experience includes Hospira, GE Healthcare, and Abbott Molecular. He advises companies on clinical development as a fractional chief medical officer and is the author of Make Your Story Believable: Diagnosing the Pitfalls of Healthcare Innovation.
ABOUT SUBHI SAADEH
Subhi Saadeh is the founder of Combinate and host of Let’s Combinate, helping pharmaceutical and medical device companies solve the quality challenges where drugs and devices meet. His career spans engineering and quality roles at Baxter, Pfizer, and Gilead, supporting drug delivery systems and combination products from development and clinical use through launch and commercial manufacturing.
His experience includes prefilled syringes, autoinjectors, infusion devices, and a frozen prefilled syringe platform supplying more than 100 million units annually. He has chaired industry working groups through the Combination Products Coalition and Rx-360, contributed to AAMI’s combination product work, and co-created the CQA Master Class. Subhi is an ASQ Certified Quality Auditor and Certified Quality Engineer, an ISO 13485 Lead Auditor, and a bioengineering graduate of the University of Illinois Chicago.
WORK WITH SUBHI
Consulting, audits, and training:https://letscombinate.com/services/
Discuss your project:https://calendly.com/letscombinate/quick-chat
LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21/
Email: subhi@letscombinate.com
RESOURCES
Free guide: Drug vs. Device Qualityhttps://letscombinate.kit.com/216fbfc6c2
CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-course
FOLLOW LET’S COMBINATE
YouTube:https://www.youtube.com/@LetsCombinate
Spotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2
Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792
#ClinicalTrials #CombinationProducts #FDA
