Patrick Hardesty Email & Phone Number

San Francisco, Ca, Us

Waltham, Ma, Us

Waltham, Ma, Us

· Lead clinical scientist for SNDX-5613 (revumenib) Compassionate Use in R/R AML and front-line development in AML with KMT2A, NPM1, or NUP98 mutations. Lead clinical oversight of multiple NDA submissions. · Provide clinical oversight of the study execution in collaboration with all members of the clinical study team. Participates in site visits.· Lead the review and monitoring of emerging safety and efficacy clinical data and develop sound, strategic solutions for study and program issues and success.· With the MD leader, develop program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.· In collaboration with biostatistics, clinical pharmacology, clinical operations and data management, contributes to the development of the plan to execute on trial design.· Develop presentations and communicate study data results to colleagues internally and to external audiences, including investigators at sponsor meetings or general audiences at scientific conferences.· Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.

North Chicago, Illinois, Us

· Led the ongoing Phase 1b/2 development of giloralimab (anti-CD40) in combination with modified FOLFIRINOX + anti-PD1 in front-line metastatic pancreatic cancer.· Led the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attended congresses and reviewed literature to develop and augment clinical expertise.· Contributed to the development of program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviewed competitive landscapes and helped identify and evaluate business development opportunities.· Was responsible for providing focused scientific and clinical study support from start-up clinical study report.· Led scientific education of internal and external stakeholders on the pre-clinical and clinical data relevant to program. Engaged opinion leader interactions to build pipeline awareness and foster research collaborations.· Contributed to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.· Contributed to the creation of electronic database, IRT, CRFs, and associated training documents and review data completeness and fidelity throughout study conduct.· Collaborated cross-functionally to help create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage assets.

North Chicago, Illinois, Us

· People leader and direct supervisor of one headcount from May 2020 – August 2021. Additionally managed of 10-week summer interns who had visibility across all of Medical Affairs.· Led strategy for and creation of standard response letters and FAQs (created new letters, wrote updates, collaborated with medical writers, created review calendar, coordinated collaboration partner approvals).· Led the renovation of the medical information (MI) website to include searchable MI content and countless other integrations to enhance the user experience.· Led medical communications launch readiness planning.· Led strategy for compendia and pathway submissions.· Medical reviewer of promotional and non-promotional materials.· Managed internal education and training of vendor call center.· Researched and provided custom responses for escalated MI inquiries.· Created non-promotional field medical tools.· Created state of the art external medical education materials.· Led the creation and review of literature surveillance summaries.· Created congress booth content and staffed Medical Information booth at major medical congresses.

North Chicago, Illinois, Us

High Point, Nc, Us

· People leader and direct supervisor of multiple pharmacy personnel.· Oversaw and managed all aspects of protocol-related investigational product (IP) procedures and pharmacy operations. Contributed to development of study protocols, IBs and pharmacy manuals.· Collaborated with Medical Director and Principal Investigators on all aspects of study conduct. Active member of study team providing expertise and support, such as evaluating study feasibility, study set up and conduct, participating in internal and external client meetings.· Responsible for receipt, storage, preparation, disposition and retention of study investigational products in compliance with standard operating procedures and FDA/DEA regulations concerning investigational product handling, accountability and security. Reviewed and understood study protocol requirements regarding investigational product handling.· Provided training for and monitored for preparation and administration of investigational products. Trained all staff in pharmacy-related matters.· Manager/preceptor to Foreign Pharmacist Graduate obtaining licensure.

Wilmington, Nc, Us

Provided unsolicited medical and drug information through verbal and written responses, ensuring the highest quality of documentation and communication. Created and updated medical information content that could be shared with HCPs and third parties. Collaborated with internal business partners to review promotional materials and manage clinical trial content. Ensured adequate resources were available to meet current needs of client. Presented new content to internal partners as needed & at yearly conferences. Initiated and maintained pharmacovigilance cases and product complaints.

Buies Creek, Nc, Us

Woonsocket, Ri, Us

Doctor Of Pharmacy (Pharmd)

Ms, Clinical Research

Bs, Chemistry

Certified Professional (Cp) Certification