Khan Maola

About Khan Maola

Over a decade of global regulatory affairs experience from initial application to marketing authorizations across multiple geographies.• Led multiple early and late phase programs and had pivotal impact on the global registration and approval of products including XPOVIO®, and NEXPOVIO®.• Held positions of increasing responsibility at both large pharmaceutical, biotech and small cap companies. Most recently, established the regulatory affairs department at Cyclacel Pharmaceuticals and ArQule (now Merck).• Excellent scientific background in small molecule drug discovery and development with publications in Science, Nature Chem Bio.• Led company in meetings with FDA, regulatory affairs teams in cross-functional meetings and regulatory activities like IND/CTA, protocol, IB, CMC/IMPD, DSUR, annual report, designation request and NDA/MAA submission and approval, in US and ex-US.• As an adjunct assistant professor teaches global regulatory affairs courses in the George Washington University.Areas of Expertise: • Global regulatory strategist of small molecules and biologics for oncology and immunology indications• Authoring and reviewing of IND, IMPD, DSUR, IB, NDA, BLA, protocols, AR, PIP, ICF, and safety reports• Leading regulatory meetings with FDA, EMA, and KOLs • Expertise in CMC, non-clinical and toxicology regulation• Biomarker qualification, Project Optimus for dose selection • Establishing regulatory strategy and operations team

Experience

1. Head of Regulatory Affairs

   Cyclacel Pharmaceuticals, Inc

   Dec 2020 — Present

   Head of Global Regulatory Affairs and leading the regulatory strategy of 4 products for solid tumors, lymphomas and rare hematological disorders. Leading the regulatory strategy for IND/CTA, protocol, IMPD/CMC, DSUR, IB, annual and safety reports submission and approval in US and ex-US. Represented Cyclacel Pharmaceuticals in different regulatory Agency meetings. Collaborated with cross-functional teams i.e, clinical operations, medical, CMC, preclinical and data management.Key Accomplishments:• Planned and successfully executed the global regulatory strategy of four investigational small molecules targeting solid tumors and rare hematological disorders for US and ex-US jurisdictions.• Led the team in obtaining approvals of multiple Phase 1/2 protocols and amendments focusing on solid tumors and leukemias from major global regulatory agencies including the FDA, MHRA, AEMPS, MFDS, and HSA.• Point of contact between our organization and worldwide regulatory agencies, adeptly guiding discussions and negotiations to align strategies and achieve positive outcomes.• Directed cross-functional teams in crafting robust responses to \'Information Requests\' from regulatory agencies, ensuring comprehensive and compliant submissions.• Led the preparation of INDs/CTAs and provided expert oversight to guide CROs in their successful submission to regulatory agencies.• Reviewed, authored, and submitted clinical trial protocols and CMC/IMPDs, DSUR, IB, SUSAR and annual reports.• Led cross-functional team meetings to prepare teams for IND enabling studies, pre-IND meetings, EOP1 meetings.• Held successful meeting with FDA under ‘Project Optimus’ for dose selection and optimization of oncology drugs.• Joined as a sole regulatory strategist and subsequently established an in-house regulatory strategy and operations team.• Selection of and collaboration with CROs (clin-ops, safety, data management, pre-clinical).

Education

• University of Oxford

  PostDoc, Molecular Biology

• Harvard Medical School

  Gene therapy

• RIKEN/Saitama University

  Doctor of Philosophy - PhD