William Hahne, Md Email & Phone Number

Newark, California, Us

Responsible for day-to-day operations for all areas of the Company's clinical programs including management of clinical staff, reporting, budget performance as well as other key responsibilities. Additionally, you will work with the executive leadership team in developing and executing the Company's clinical strategic plan.

Satellite Beach, Florida, Us

Paris, Paris, Fr

Assist with BLA review for USA

Gaithersburg, Maryland, Us

Assist with Medical review for durvalumab BLA components.

My responsibilities include helping the CMO start and execute clinical studies

Bothell, Washington, Us

● Contract Medical Director for a novel Antibody Drug Conjugate for the treatment of Lymphoblastic Leukemia.● Provided medical oversight for large Phase I study, including data review, efficacy and adverse event assessment and presentation preparation.

Us

● Provided pre IND consultation and strategy for a unique combination product for oncology patients.

● Assisted VP Clinical Research with expanding US-approved Drug Device for CTCL to other countries (Israel)

Summit, New Jersey, Us

● Led an internal team to get a key IND (corporate priority) to FDA on time through 14 days of blackout following Hurricane Sandy. Phase I successful. Phase II started in late 2014. ● Performed due diligence for a potential in-licensed product.

Waltham, Ma, Us

● Collaborated with CMO in the clinical execution of study reports on ferumoxytol for iron deficiency anemia (IDA). ● Worked with clinical research, pharmacovigilance, clinical operations, project management, and regulatory areas during this contract which was completed in April.

● As VP of clinical research, provided medical oversight for CPX-351.● Succeeded with three successful FDA meetings and acquired EMA experience in scientific advice and orphan designation.

Us

● Corporate officer who reported to the CEO of this 40-person firm.● Medical responsibility (post clinical trial execution) for NDA (eCTD) submissions, safety summaries, report writing, clinical pharmacology.● Medical aspects of ODAC preparation.● Established a separate pharmacovigilance department and designated a professional to handle safety full-time

Us

● Managed all aspects of clinical development conducted in U.S. for liposomal drug-device combination (ThermoDox®) to be used in liver and breast cancer as head of Clinical and then as Head of R&D.

Us

● Advanced clinical portfolio development in biologics, based on Curagen work on the human genome.● Collaborated and published with the preclinical team to establish core program for targeted monoclonal therapies. ● Grew clinical department from one to eight associates, building collaborative, matrix-managed study teams committed to increasing productivity and improving quality.

Us

● Supervised all clinical research conducted in U.S. (as Executive Director, then VP Clinical Research and Development) with budget of $70 Million and 70 clinical employees. ● Chaired joint development committees for Aricept® with Pfizer and Aciphex® with Johnson & Johnson as global team leader driving co-promotion initiatives. that led to approval of Pariet/Aciphex®,● Created and oversaw four therapeutic areas: GI/Oncology, CNS, Anti-Infectives, and Medical Affairs.● Supervised Multiple INDs.

● Led the Global clinical team to success with submitted INDs, and approved NDAs and MAAs for Anzemet® IV and oral.● Played a pivotal transition committee role between Merrill Dow to MMD integrating MMD, Anzemet® and Allegra® teams.

● Constructed IB, clinical protocols and submitted the original IND in 1986 for the breakthrough product, Zofran®.● Wrote Phase II summaries for EMEA submission of Zofran® MAA.● Wrote and submitted and important supplemental approved FDA submission for Zantac Injection® (Contiguous Infusion Ranitidine)

M.D., Surgery, Medicine

Ba, Chemistry