Daniel Jorgensen, Md, Mph, Mba Email & Phone Number

Philadelphia, Pa, Us

Wayne, Pa, Us

C-Path is a global public-private partnership with expertise in Regulatory Science and Modeling/Analytics. Its goal is to accelerate and advance drug development in areas of unmet medical need, such as Neuroscience, Rare/Orphan Diseases, and Pediatrics. C-Path develops clinical trial tools, such as biomarkers and clinical outcomes assessments (COAs), and leads collaborations with industry, academic experts, and regulators. In my role as CEO: --Provided overall leadership to scientific programs and consortia, lending clinical perspective as needed--Fostered relationships with regulators, clinical experts, consortia members and other partners.--Created Office of Development and strategized on funding sources and metrics

Consultant to biotech/biopharma in adult and pediatric drug development, with focus on infectious diseases, vaccines, diabetes, neuroscience, and microbiome-based therapy, including: clinical development plans; size/cost of clinical trials; biomarkers & endpoints; protocol enhancements; regulatory pathways; disease burden; data analysis; epidemiology and population health; risk/benefit assessments; precision medicine; value metrics and propositions; investor presentations; business strategy; and funding scenarios. Clients include: MM Dillon; CSSi LifeSciences; GLG

Rockville, Md, Us

I-ACT accelerates and advances pediatric drug development by maintaining a large global site network for clinical trials, targeting multiple disease areas, including rare diseases, oncology and gene therapy. I-ACT also provides a network of pediatric experts along with resources and services that facilitate the clinical trial process. The overall goal is to narrow the gap between adult drug approval and pediatric labeling. --Audit & Finance Committee (since June 2023)--Vice Chair (since May 2024)

CEO of neuroscience start-up with small molecule platform licensed from Johns Hopkins University. Initial indication for cancer patients with chemotherapy-induced peripheral neuropathy (CIPN). Worked closely with scientific founder and research team on development plan, including multiple IND-enabling studies for CIPN and other indications, such as DPN. Major focus on financing, pitch deck and investor presentations as part of "road show" to raise funds.

Malvern, Pennsylvania, Us

CMO of ophthalmology start-up, now public, using repurposed drug for ocular graft-vs-host disease (oGVHD) and gene therapy platform for inherited retinal diseases. Worked with R&D team on strategy, Pre-IND meeting, Clinical Development Plan, and creation of SAB. Worked with Executive Team and bankers to hone pitch, raise funds, and eventually go public.

CMO (employee #2) of innovative microbiome start-up that rapidly progressed to clinical trials. Built an exceptional clinical team, a combination of internal FTEs and outsourced personnel. Designed and conducted first successful phase 2 study using microbiota (CP-101) to prevent recurrence of C. difficile infection (CDI). Also wrote the Clinical Development Plan and sections of the IND. Preliminary work in follow-on indications (IBD; Autism Spectrum Disorder). Company merged with Finch Therapeutics.

Beverly, Massachusetts, Us

Cellceutix further developed HDP mimetics based on work at PolyMedix. Conducted a phase 2b safety and efficacy study using brilacidin for skin infections (ABSSSI) and led a successful end-of-phase 2 meeting with FDA, based on key preclinical and clinical data, as well as PK/PD modeling. Further developed brilacidin for two inflammatory conditions: a) phase 2 trial for oral mucositis in head/neck cancer patients post-radiation therapy, which had a Fast Track designation; and b) phase 2 trial for ulcerative proctitis

Us

First C-level position. Responsible for R&D strategy and execution including translational science, clinical development, regulatory, and CMC. Conducted phase 2a proof-of-concept study using brilacidin, the lead compound from a novel antibiotic class: host defense protein mimetics (defensin mimetics) which have antibiotic properties and play a role in innate immunity.

Waltham, Ma, Us

Publicly traded biopharmaceutical company that developed Feraheme (ferumoxytal) for iron deficiency anemia in patients with chronic kidney disease (CKD) and cancer. Responsible for Clinical Research, Global Medical Affairs, Medical Writing, and Health Outcomes & Epidemiology. Multiple late-stage studies (mostly phase 3) to expand the label for at-risk populations. Key role in commercial strategy and business development activities, including licensing and partnerships (Takeda; 3SBio). Member of Institutional Review Board, Harvard School of Public Health

New York, New York, Us

--Business Development: Key role, both technically and strategically, in vaccine-related due diligence activities, including two acquisitions (PowderMed and Coley) and several licensing deals.--Vaccine Development Team Leader. Leader of Pfizer’s first vaccine development group, which included the PowderMed team; functional oversight of approximately 100 employees (matrix structure); single point of accountability for clinical development of Pfizer vaccines before Wyeth deal. --Conducted Pfizer’s first human vaccine trials, using DNA-based influenza vaccines and needleless device targeting dendritic cells.

New York, New York, Us

Azithromycin: Local Clinical Leader; Global Clinical Leader --Assumed roles of increasing responsibility for the Pfizer macrolide (antibiotic) development program, covering all clinical activities (phase I-IV)--Design, conduct, and oversight of eleven (11) phase 3 clinical trials across 5 indications, primarily respiratory tract infections (e.g., pneumonia, AECB, sinusitis, GABHS pharyngitis, acute otitis media) --Key role in 2 NDAs, 2 sNDAs, and several ex-US submissions. Lead author/reviewer of major clinical sections. Speaker at product launch. Worked closely with Medical Affairs.--Key role in FDA meetings, including 2001 FDA Advisory Committee Meeting—Acute otitis media

Formerly Pasteur Merieux ConnaughtClinician/Medical Monitor for vaccines in development (primarily viral vaccines)o Phase 1-3 clinical vaccine trials for Hepatitis A, CMV, Lyme, and rabieso Hepatitis A vaccine clinical leadero Reviewer for key sections of BLAs (ISS, ISE, ISI)

Knoxville, Tennessee, Us

Chief epidemiologist & medical director for Knox County o Designed and implemented one of the country’s first active bacterial surveillance systems for drug-resistant S. pneumoniae. o Supervised Knox County’s TB and STD clinics; created region’s first travel medicine clinic

Chief medical official in Montana state government o Health advisor to Montana state legislature o Interviewed on Montana’s “radon health mines” (ABC World News Tonight)o Medical Officer (Infectious Diseases), “Partnership for Peace” Medical Mission (Lima, Peru),

Atlanta, Ga, Us

Medical epidemiologist ("Disease Detective") in Field Epidemiology --Conducted >30 communicable disease investigations, mostly food-related or respiratory-related.--Refugee Health Lead, Bangladesh (on loan from CDC to UNHCR). Point of contact and coordinator of refugee health activities across 10 refugee camps on the border of Bangladesh and Myanmar (Burma). Investigated outbreak of renal failure caused by post-streptococcal glomerulonephritis (PSGN). Developed metrics to monitor refugee health.

Bachelor Of Science - Bs, Biology

Doctor Of Medicine - Md

Master Of Business Administration - Mba

Public Health And General Preventive Medicine Residency Program

Master Of Public Health - Mph

Pediatric Infectious Diseases Fellowship Program

Epidemic Intelligence Service (Eis)

Pediatrics Residency Program