Without strategy, execution is aimless. Without execution, strategy is useless. Morris Chang
Boston's Board & Development Committee Member
Manages the teams and provides leadership for the assets' development in alignment with the organization’s business goals and overall strategic vision. Supervises and gives direction to CMC, Regulatory, Clinical, QA, ClinOps, partners, and vendors. Drives company results from both an operational and a financial perspective, working closely with the CEO, COO, and other key leadership team members. Participates in the strategic planning process of the organization and works with leadership to direct the preparation of short-term and long-range plans based on defined corporate goals and growth objectives. Discusses the company's roadmap with potential investors. In conjunction with the CFO, develops budgets, metrics (KPIs) to meet the organization’s sustainability needs. Implement programs that meet company goals and objectives. In conjunction with the CFO, negotiate strategic contracts and supervises the delivery of service-level contract commitments. Develops and implements the structure and processes necessary to manage the organization's current activities and its projected growth. Work with the CEO to define and execute ongoing organization communication plans. Informs the board of directors of all program issues and accomplishments.
Played a key leadership role in developing and executing Adial’s Pharmaceuticals drug and business strategies and expanding growth/opportunities. Led development activities for Adial’s clinical program(s) and provided subject matter expertise and direction to the development and operations of clinical projects.
Managed a portfolio of complex projects as the clinical development contact and spokesperson for potential licensing, acquisition, collaborations, co-development agreements and strategic alliances. Worked closely with VC, transaction leads, legal, commercial and financial analysis team to ensure deals of highest priority are advanced and executed. Responsible for leading the development of technology pipeline and roadmap for injection devices.
Author of "Can the Use of Novel Digital Devices Improve the Productivity of Drug Development?", Clinical Pharmacology & Therapeutics
Served as "CEO” for the clinical development, regulatory submissions and lifecycle management of the asset. Advanced development of Avelumab (anti-PD-L1) through a streamlined, integrated development plan and in collaboration with Pfizer. Focused on compound differentiation and incorporating appropriate investment, risks/opportunities, and mitigation aimed at delivering maximum asset value for the pipeline. Liaised between EMD Serono (Merck KGaA) and Joined Development Governance bodies and the Program Team involved in the development of the product. Avelumab [anti-programmed death-ligand-1] JAVELIN program in co-development with Pfizer as of May 2016, included 30 ongoing clinical programs and nine pivotal studies and approximately 2,200 patients, being treated across more than 15 tumor types including breast cancer, gastric/gastro-esophageal (GEJ) cancers, head and neck cancer, Merkel cell carcinoma, melanoma, NSCLC, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer. Following the first FDA approvals (Merkel Cell Carcinoma in March and urothelial carcinoma in May 2017) and commercial launch of Bavencio® in Q1 2017, Merck KGAa expects at least one additional potential launch per year through 2022.
To see the program highlights, please see the below section.
Merck KGaA, Darmstadt, Germany, and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products on 25th November 2015.
Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma on 18th November 2015.
Served as "CEO” for the clinical development, regulatory submissions and lifecycle management of the asset. Advanced development of assets through streamlined integrated development plan. Focuses on compound differentiation and incorporating appropriate investment, risks/opportunities and mitigation aimed at delivering maximum asset value for the pipeline.
Clinical Development Programs: anti-IL-17 A/F nanobody, Atacicept (anti-Blys/anti-APRIL fusion protein), Avelumab (anti-PD-L1). Plus 2 NCEs/NBEs in lead optimization to pre-clinical phase.
Oversaw project design, planning, initiation, conduct, completion and reporting. Managed complex clinical program according to developed project plans, including Clinical Trial Budgets (>$100M/year). Led the cross-functional integration of all components of a study by working with study team members to ensure project and program delivery to agreed goals. Drove product delivery on study and program level; achieving product score card measures aligned with Oncology Business Unit requirements.
Clinical Development Programs: REFACTO®, TORISEL®, Inotuzumab ozogamicin.
Managed 4 high quality clinical research programs and 17 clinical studies. Established effective and efficient intra-departmental processes, including department SOP development and maintenance. Prepared operating project plans in alignment with company and department strategies. Managed proper collection, analysis and presentation / publication of clinical data. Performed direct and indirect management of clinical research personnel, including PMs and vendors / partners. Prepared trial-related documents. Managed departmental budget and resourcing.
Clinical Development Programs: DuraSeal™, VascuSeal™ and SprayShield™