𝐌𝐚𝐫𝐤 𝐇𝐚𝐲𝐝𝐨𝐜𝐤 - 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐚𝐥 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐧𝐭 I started Agile Biologics Consulting with a mission to help biologics companies navigate the CMC challenges of bringing therapies to patients. Before becoming a consultant, I served as Vice President of CMC at Cue Biopharma and bring over 30 years of experience in biopharmaceutical CMC operations at Chiron, Aventis, Medarex, Morphotek, Mersana Therapeutics, and Eisai. During my biotech industry career, I created the CMC departments, manufacturing processes, and initial CMC data packages for three successful companies. I also led all aspects of the CMC development and manufacturing of Farletuzumab from pre-IND through fast-track authorization and BLA writing. I’ve managed CMC relationships with strategic partners, the FDA, and other global regulatory agencies and wrote the CMC sections of regulatory filings to over 30 countries. 𝐈 𝐮𝐬𝐞 𝐚 𝐡𝐚𝐧𝐝𝐬-𝐨𝐧 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥 𝐚𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐡𝐞𝐥𝐩 𝐛𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐬 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬….. ✓ Create and implement CMC development and manufacturing strategies. ✓ Remediate analytical, drug substance, drug product, and clinical distribution issues. ✓ Select and manage contract development and manufacturing organizations (CDMOs). ✓ Create and manage CMC program management systems. ✓ Author the CMC sections of regulatory filings. My approach allows clients to advance their product while anticipating a variety of potential issues months in advance, significantly de-risking their CMC program. Contact me for an initial consultation or visit www.agilebiologics.com to learn how I can help your company succeed.