DB-1303/BNT323, anti-HER2 antibody drug conjugate

VB10.NEO, individualized cancer neoantigen vaccine

siRNA in cancer

• Involvement from late preclinical phase to translation into the clinic in Phase 1/2a FIH study leading the PK/PD simulation to establish the starting dose
• Designed and executed the study with a bifurcated design to combine with CPI
• Led multiple scientific advices in Europe and pre-IND meeting with FDA
• Authored study documents (e.g., study protocol, ICF, pharmacy manual, DSMB charter), developed eCRF with data managers, identified and engaged trial sites, performed SIVs on-site, regular medical review on Spotfire including biomarker data, and SAE assessment
• Conducted safety calls and dose decision meetings
• Developed CDP, TPP and identification of multiple indications with new patient segmentation for combination with other IO drugs

• Performed medical review, final data analysis and authored the CSR for Phase 1/2a trial
• Designed the POC and pivotal Phase 3 studies with KOL engagement as well as through conduct of advisory board
• Authored the briefing book for Type B FDA meeting, presented trial data and proposed study designs in such meetings with FDA and EMA
• Execution and implementation of global Phase 2 trial

• Designed a Phase 1/2a FIH study that seeks to develop 2 compounds together with a potential for combination with CPI and other BioNTech assets
• Led the program and study teams from translation to clinical phase
• Safety assessment, risk management and patient protection for ongoing studies, including leadership of DRC meetings
• Responsible for protocol development and day-to-day running of trials, maintenance of clinical data quality, including data review
• Managed patient screening and enrollment
• SAE review, medical lead for SAE processing and reporting, periodic SAE reconciliation and preparation of SAE patient narratives for CSR write-up

• Led the program team to reach a historic achievement for the company by being the first BioNTech-sponsored study to be approved by FDA
• Strategic input into development and Phase 1/2a study design for a compound with a known challenging safety profile
• Engagement of lung cancer KOLs as asset primarily developed for combination with CPI in ES-SCLC
• Strong involvement as medical monitor in the day-to-day running of the study from start-up phase, site activation, patient enrollment, dosing, data review, study arm closure and interim analysis.

• Responsible for development of asset with known proof of efficacy by the same founders of Zolbetuximab
• Close interaction and consultation with PEI for successful Phase 1/2a study approval in the US, Canada, Europe and Asia
• Identification of ADA assay development and its implementation in clinical trials
• Identification of unique indications beyond Zolbetuximab and responsible for CDP, TPP and IDP as well as helping commercial plan for a business case in potential registration

• Involvement with translation of the compound with prolonged exposure vs classical bispecific antibody
• Successful approval of Phase 1/2a study in US and Europe for a first-in-class molecule
• Authored the study protocol, study documents, DSMB charter and eCRF
• Development of successful pre-screening methodology that saves cost and speeds up enrollment which has then been adopted company-wide for biomarker-driven trials

• Responsible for the design of Phase 1/2a study design that employs adaptive elements with bifurcated trial design for early combination
• Authored a highly complex study protocol with challenging logistical requirements based on previous experience working with autologous cell therapy including establishment of leukapheresis centers
• Authored the applications for multiple regulatory designations including PRIME, orphan drug status and BTD in testicular cancer

• Responsible for restarting the Phase 1/2a study after acquisition from another company including renewed engagement with sites through on-site visits in the USA
• Successfully resumed dose escalation after trial has been stopped due to improper DLT definitions
• Authored a complete CDP across multiple CA19-9 high-expressing tumors in monotherapy and in combination with chemotherapy
• Further work with MSKCC running IITs where the molecule was initially developed
• Investigator management and clinical interaction with site staff, managing relationship between sponsor and investigators, briefing KOLs and driving recruitment, review of feedback with sponsor

• Developed and wrote clinical study protocols phase 1 and 2
• Day-to-day management of clinical study execution including screening/ enrollment package review and sign-offs, SAE review and reporting, clinical data review with eCRF, listings and data queries

• Developed and wrote clinical study protocols phase 1 and 2
• Responsible for identifying and resolving gaps in clinical development as company’s main focus at that time was in oncology
• Spearheaded the development plan and path to approval
• Engagement of KOLs and potential PIs through regular virtual and onsite meetings

• Took over two phase 2 studies in separate lines of therapy nearing study closure
• Re-enrollment in one study by adding 30 more patients to further generate supporting data
• Performed medical review and authored the CSRs
• Authored and submitted 2 abstracts to ASCO Annual Meeting 2018 with one accepted for plenary oral presentation which was a huge success for a relatively unknown biotech company in Prague
• Formulated responses and defended the data in-person in front of the COMP committee at EMA HQ in London for orphan drug designation with a positive outcome

• Wrote the study protocol and designed an adaptive trial design alongside the statistician with multiple primary endpoints with endorsement by EMA, HTAb and FDA
• Engagement with several KOLs in European and North American network where typically ovarian cancer trials are run within collaborative groups like ENGOT and GOG
• Represented the sponsor in the steering committee between the sponsor and collaborative groups

• Performed data analysis and medical review of phase 3 study leading to database lock
• Authored the CSR, internal study reporting and publications
• Designed a potential new study in combination with oncolytic virus
• Developed clinical strategy for development in combination with CPI

• Authored the translational substudy including performance of skin biopsy to assess immunological responses
• Involvement in day-to-day study activities from start-up phase, enrollment, dosing and study expansion

• Authored FIH phase 1/2a study protocol and the whole CDP in new therapeutic area
• Responsible for program leadership within multifunctional team including preclinical scientists and clinical operations
• Engagement with experts in the TA to receive inputs and advice on sound development plan

• Authored and developed together with company’s medical monitors a new patient reported outcome that integrates quality of life and improvement in CT/MR imaging
• Authored a subsection of study protocol contributing to the surgical aspect of the trial seeking label expansion with regional team
• Advised on the use of contrast-enhanced MRI in assessing treatment outcome

• Authored the study protocol assessing treatment outcome after regular application in patients with spinal and brain surgeries
• Reviewed and approved medical information and regulatory documents

• Advised on the procedural aspects of treatment application after brain tumor resection and on how to assess effectiveness

• Subinvestigator in phase 2 study of new TKI in RCC
• Subinvestigator in phase 3 study of CPI in combination with chemotherapy in HNSCC
• Subinvestigator in phase 3 study of CPI in combination with BRAF inhibitors in melanoma
• Performed epidemiological data entry for national database
• Involvement in direct patient care, multidisciplinary boards, supportive care treatment and radiotherapy
• Interest to further work in clinical research and making an impact at a larger scale led to full-time employment in the industry

• Conducted academic study in the use of functional MRI in correlation with responses elicited during awake brain surgeries
• Contributed and authored sections of study protocol on the use of intraoperative neuromonitoring during brain tumor surgeries
• Performed numerous surgical procedures of the brain, spine and peripheral nerves; involvement in direct patient care including active participation in neuro-oncology tumor board
• Interest in the use of different modalities to treat cancers led to a switch into oncology

• Educated medical students in surgical education; worked closely with academic professors to promote patient-centric and evidence-based medical education.

• Conducted research in the field of multiple sclerosis and immunological techniques under the guidance of Dr. Rodriguez in a basic science laboratory setting
• Acquired proficiency in essential laboratory techniques such as PCR, ELISA, Western Blot, Cell culture, and FISH
• Demonstrated a strong aptitude for mastering and executing experimental protocols accurately and efficiently
• Collaborated with a team of researchers to collect, analyze, and interpret scientific data.