Curriculum Vitae
Personal Details
Name
Address
Telephone
E - mail
Dr. Frank Ottmar Schippers
Geildorfer Bach 8
50321 Bruehl
Germany
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Executive Summary:
More than 15 years in the pharmaceutical industry on Sponsor side have established a good level of
understanding regarding clinical development in all phases of drug development and life-cycle
management / post marketing activities. Furthermore, a detailed knowledge of pharmacovigilance,
incl. risk management, signal detection, periodic reports and single case management provides a
solid background in adjacent fields.
The recent (and ongoing) experience in a mid-size CRO has added valuable insights into the service
provider side of the business and has provided the first chances to use my Six Sigma skills in
projects to improve the monitoring activities on-site, to implement a completely new aspect of
monitoring (remote monitoring), and to establish elements of Risk-based Quality Management into
the overall QM system of the company.
The involvement in various Health Authority interactions, such as Scientific Advise meetings with
the EMA, pre-NDA, mid- and late term review meetings with FDA, PMDA and Health Canada
have taught me to define an overall strategy, deliver the required documents as well as explain and
defend the respective company position successfully versus the regulatory counterparts. The
responsibility for PSURs, DSURs and RMPs as well as contributing the clinical efficacy and safety
modules to successful FDA, EMA and PMDA New Drug Application dossiers completes my
experience re. the most relevant sort of interactions with regulatory agencies.
This sound experience comes on the basis of a structured and well organized educational program
in general anesthesia at university level, which comprised in-depth knowledge of clinical
anesthesia, intensive / acute care and emergency medicine as well as pain therapy. After my board
certification, I focused on Intensive / Acute Care and Emergency Medicine and was in charge of the
entire anesthesia, intensive care and acute pain services during on-call shifts.
Based on this experience I still continue working as a consultant (as much as time allows) in order
to keep my clinical skills and knowledge up-to-date.
Being in charge of teams with or without line management, presenting in front of an auditorium and
writing scientific papers has been part of my entire working history and I feel comfortable and well
equipped to take on new challenges on a national or international level as leading member of a
strong team or as freelance service provider.
October 2024
Present Position:
Freelance Senior Medical Advisor –
Pharmacovigilance and Clinical Development
Current projects:
Biotest AG (intermittently since March 2020)
Dreieich, Germany
Update of RMPs and Addendum Reports to Clinical Overview for
renewal of market authorization for various products
Trial Team member for PV in Phase III trial
Generation of safety sections for the Clinical trial report
Review and update of PV SOP system to satisfy the requirements of
GVP
Generation of Signal validation and assessment documents
Generation of PSUR and DSUR for various products
ClinCompetence Cologne (March 2023 – ongoing)
Cologne, Germany
Project Management for multinational, multicenter, prospective,
randomized, Phase 3b study in Covid-19 patients
Project Management for multinational, multicenter, prospective,
randomized, Phase 3 study in allergic rhinoconjunctivitis
Interim Head of Monitoring
Establishment of Risk-based Quality Management into the QMSystem
Consultant for anaesthesia, intensive care and emergency
medicine
CardioCliniC Cologne
Past projects:
Merz Pharma GmbH & Co KGaA (December 2023 – August 2024)
Frankfurt, Germany
Routine Signal Detection, Validation and Assessments for various
marketed products , incl. Xeomin ®
Health Hazard Evaluations
Creative Clinical Research GmbH (February 2020 – April 2024)
Berlin, Germany
Interaction with EMA during ongoing MAA review
Planning of MAA submission for line extension
Creation of scientific manuscripts for publications, congress material,
posters, abstracts and slide decks
Merck KGaA (August 2020 – Nov 2023)
Darmstadt, Germany
Signal detection and management for fertility, neurology and
immunology portfolio
Generation, review and approval of PBRER, DSUR, RMP and Health
Authority communication
Interaction with worldwide health authorities re. label changes,
answers to objections and changes to safety information
Definition of safety strategy for development compounds and
contribution to safety sections of trial protocol and summary reports,
such Integrated Summary of Safety (ISS) and Summary of Clinical
Safety (SCS)
Eagle Pharmaceuticals, Inc. (February 2020 – Oktober 2022)
Woodcliff Lake, New Jersey, USA
Interaction with Health Authorities (e.g., FDA), planning and
execution of pediatric investigational plan, Lifecycle Management
Medical Registration
Registered in Germany with the German Board of
Anaesthesiologists
Permanent Employment:
March 2015 – March 2020
Medical Director and Vice President Global Clinical
Development
Department of Global Clinical Development
PAION Deutschland GmbH
Aachen, Germany
Leadership and Management: 5 direct reports
• Responsible for all development aspects of all PAION medicinal compounds during the
entire life cycle from PoC until life cycle management
• Define the long-term strategy of each compound to match the development program to the
target product profile (TPP)
• Continuously monitor benefit-risk ratio of PAION compounds and alert all stakeholders of
any relevant changes
• Accountable for Investigators Brochure and medical parts of periodic reports (DSUR, RMP)
• Identify and raise awareness to disruptive new medical thinking and assess the impact for
each development program
• Responsible for budget planning and tracking for the entire department
• Select critical vendors to the department and act as escalation point during conduct of
activity
• Prepare internal and external advisory boards, incl. presentation of material open for
discussion
• Develop, coordinate and implement scientific publication activities
• Establish and maintain connection to external scientific KOLs
• Responsible for the compliance of all parties to ICH-GCP guideline and other applicable
regulations
• Update of existing SOP structure to match requirements of GCP Revision 2
• Establish Sponsor Oversight processes and programs
• Ensure the execution of clinical trials according to time, bugdet and regulatory acceptance
• Responsible for coordination of dossier preparation for the planned NDA / PMDA
submission with our partner companies and for PAION's MAA submission
• Line management for PAION departments of Clinical Development and Medical Affairs,
incl. external vendor management
August 2012 – February 2015:
Senior Risk Management MD
Department of Pharmacovigilance
Boehringer Ingelheim GmbH
Ingelheim, Germany
Responsible for all safety related aspects of assigned compounds for internal and external partners
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Signal detection and implementation of consequences in case of positive signals
Communication and responses to ad-hoc requests by health authorities
Approval of individual case safety reports (ICSR)
Preparation of regulatory documents (e.g., PSUR, PBRER, RMP)
Support in Pradaxa ® US litigation cases
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Leadership and Management: 6-10 functional reports
Chair of Pharmacovigilance Working Group of assigned compounds
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Preparation and presentation of overviews of safety data during ongoing clinical trials for
internal and external decision gates (e.g., Safety Monitoring Boards)
Leading a group of 6-10 Case evaluators and Case processors in the assessment of
listedness, causality and seriousness of ICSR
Approval of requests for unblinding single subjects during clinical trials
Pro-active involvement into the planning of clinical trials to ensure adequate reflection of
safety aspects
Review and approval of safety sections in trial protocols and trial reports
Distribution of relevant safety information to the respective national / regional affiliate and
evaluation of implementation.
March 2012 – July 2012:
Deputy Head
Department of Medical Sciences
FARCO – Pharma GmbH
Cologne, Germany
Responsible for clinical development and life-cycle management of all Farco products, and
for medical supervision of pharmacovigilance as well as regulatory activities
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Responsible for the generation of development activities of new medical devices
Creation and update of clinical development plans
Responsible for the compliance of all parties to ICH-GCP guideline and other applicable
regulations
Generation and / or approval of all response documents / briefing packages for regulatory
authorities / notified bodies
Preparation of internal and external advisory boards, incl. presentation of material open for
discussion
Development and approval of information material for marketing and advertisement of
Farco products (together with Dep. of Marketing)
Assessment of product ideas and product proposals (Due Diligence)
Management and Leadership: 4 direct reports
Coordination of all necessary steps in the preparation, conduct and finalization of clinical
trials
Leading and coordinating external vendors, such as statistical and clinical CROs
KOL management during meetings and congresses
Leading internal and external development boards
Representative of the company for medical or scientific aspects during regulatory audits and
inspections, incl. development and implementation of necessary process changes
Initiating, contributing and/or authoring publications (e.g. for journals, abstracts,
presentations at conferences etc)
Supervision and approval of pharmacovigilance assessments and aggregated reports
4 direct reports from area of pharmacovigilance and regulatory affairs
July 2011 – March 2012:
Global Safety Leader
Global Pharmacovigilance and Risk Management
Bayer Healthcare AG
Wuppertal, Germany
Experience in the safety relevant aspects and strategic positioning of Bayer
cardiovascular medicinal products during development and post market approval
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Responsible for the timely generation of aggregated safety reports, such as PSUR, SBR,
Development and Core RMP
Generation of the safety sections for IMPD and other regulatory documents
Responsible for regular review and update of CCSI of assigned products and communication
of necessary changes of SmPC / PIL to Dep. of Reg. Affairs
Responsible for preparation of response documents to queries from Regulatory authorities
regarding safety aspects
Conduct of quantitative and qualitative signal detection for assigned products
Contribution to Due Diligence teams evaluating new molecular entities
Leadership and Management: 3-5 functional reports
Preparation and presentation of overviews of safety data during ongoing clinical trials for
internal and external decision gates (e.g., Safety Monitoring Boards)
Leading a group of 3-5 Case evaluators and Case processors in the assessment of listedness,
causality and seriousness of ICSR
Approval of requests for unblinding single subjects during clinical trials
Leading the Safety Management Team during clinical trials
Pro-active involvement into the planning of clinical trials to ensure adequate reflection of
safety aspects
Review and approval of safety sections in trial protocols and trial reports
Generation of post-approval safety studies (in collaboration with Dep. of Med. Affairs)
Distribution of relevant safety information to the respective national / regional affiliate and
evaluation of implementation.
April 2009 – June 2011
Senior Clinical Scientist
Global Early Clinical Development; Grünenthal GmbH, Aachen,
Germany
Experience in the development and strategic positioning of a wide range of pain
medication at stage of consensus meeting as well as phase 1 and 2 clinical trials
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Responsible for the preparation of the Advanced protocol synopsis (APS), Trial protocol
including amendments to the trial protocol, Informed consent form, Integrated clinical trial
report
Medical supervision of ongoing trials
Contribution to Clinical submission documents or any documents that need to be
submitted/discussed with health authorities, Information required to complete submission to
public databases, Topline results report
Development/discussion of trial designs for trial protocols (including evaluation of
endpoints, assessments, trial designs, models, indications etc.)
Final data review (together with statistician)
Filing of function specific clinical trial related documentation
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Leadership and Management:
Evaluation/discussion of results in ICTR (together with Biostatistician, ICL, DSMA and
Medical Writer)
Provide input into clinical development plan and suggest development opportunities to the
Clinical Core Team / Clinical Project Team
Presenting the protocol and any medical / scientific aspects involved in the conduct of
studies during investigator meetings
Presenting the compound, protocols, results etc. at expert meetings, advisory boards,
scientific congresses
Medical monitoring / review and contribution to signal detection during a trial.
Medical co-monitoring on site
Reporting any suspected fraud / misconduct
Setting up a DSMB / IDMC if required
Initiating, contributing and/or authoring publications (e.g. for journals, abstracts,
presentations at conferences etc)
Acting as deputy International Clinical Leader in sub-projects
Scientific head of “Drug Induced Liver Injury Working Group”
January 2006 - March 2009
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Drug Safety Scientist
Drug Safety; Bayer Vital GmbH; Leverkusen; Germany
Experience across a wide range of products from early development to post approval from
the perspective of a local affiliate
Management of AE/ADR collection, documentation, reporting and archiving
Monitoring of progress in case documentation and follow-up process
Provision of medical expertise in evaluation, analysis and report of data generated from
literature, spontaneous reports and clinical trials
Expert statement for Legal Department in reimbursement cases
Improving the services by innovative solutions to support Drug Safety Unit and Medical
Information Department
Set up and implementation of Pregnancy Report Forms
Close interaction with Bayer Vital departments including regulatory affairs, clinical
operations and legal
Cooperation with CROs in all aspects of data management in terms of clincal trials
Cultivating an active professional network inside and outside the organisation
Contribution to the integration of the national Schering Drug Safety Unit into the Bayer
Vital Unit
Leadership and Management: 2–5 functional reports
• Leading a team of Drug Safety Technicians (between 2 and 5) by providing clear
operational directives and convincing others to follow
March 2004 - March 2009
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Consultant of Anesthesiology
University Hospital of Cologne; Cologne
Experience across the entire range of anesthesiological procedures
Providing general anesthesia in the operation-theatre for various surgical operations
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Pre-operative assessment of patients and development of plan to diagnose and optimize
concomitant diseases
Medical care for trauma or vitally instable patients in the emergency room in close cooperation with trauma surgeons, radiologists and neurosurgeons
Sedation of children (premature infants up to teenagers) for diagnostic and therapeutic
procedures
Management and Leadership: 5-10 functional reports
Development, and implementation of SOPs in area of peripheral regional anesthesia
Management of Intensive Care capacity in co-operation with the assistant medical directors
in surgery and internal medicine
Set up of therapeutic guidelines for up to 24 Intensive Care patients
Development of a new anesthesiological comprehension for the use of anesthesic agents in
stereotactic operations
Teaching house officers in all fields of anesthesia
Teaching and examining students and nurses in major fields of anesthesia
Being in charge and supervision for up to 5 house officers and 3 to 5 nurses during daily
work in the operation theatre
Leadership of Trauma team for medical care in the emergency room
August 2001 – ongoing
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Executive Emergency Physician
Emergency Physician sites in Murnau (Bavaria) and
Wesseling / Brühl (Northrhine - Westfalia)
Experience in the entire field of pre-hospital medical care
Rapid diagnosis focussing on medical history and clinical symptoms
Development of hyposthesis and working according to specific therapeutic guidelines
Selection of an appropiate hospital and quick securing of transportability
Management and Leadership:
Analysis and structuring of complex scenarios after major accidents
Establishment of close interaction with executive fireman and policeman to coordinate
rescue troops efficiently
Prevention of panic reaction patterns by defining fields of activity
Estimation of personel and material support to deliver best medical care for the individual
patient
Collaboration with firemen in rescuing and saving patients
Directing other Emergency physicians and paramedics to their field of activity
Medical Expertise
Intensive Care Medicine
Diploma "Intensive Care Medicine"
December 2009
Leitender Notarzt (LNA)
Executive Emergency Physician
November 2007
Emergency Medicine
Certificate „Emergency Medicine“ (replaces diploma from 2001)
October 2007
Dissertation
“Comparison of wake-up time after anesthesia with remifentanil plus
isofluran vs. sevofluran for arthroscopic surgery of the knee”
May 2004
Board Certification
German Board of Anesthesiologists
March 2004
Ultrasound
Diploma „Abdominal Ultrasound Diagnostics“
November 2001
Emergency Medicine
Diploma „Emergency Physician“
April 2001
Intensive Care Medicine
Diploma „Intensive Care Transport“ according to recommendation of
DIVI
September 2000
Transfusion Medicine
Diploma „Authorized Person for Transfusion of Blood Products
April 1999
Medical Education
Anesthesiology &
Intensive Care
University of Cologne, Germany
July 2003 - March 2009
Anesthesiology &
Intensive Care
Traumacenter Murnau (Berufsgenossenschaftliche Unfallklinik)
Germany
January 2001 - June 2003
Anesthesiology
University of Cologne, Germany
January 1999 - December 2000
Anesthesiology
Royal North Shore Hospital Sydney, Australia
July 1998 - September 1998
General Surgery
Long Island Jewish Hospital New York, USA
October 1997 - February 1998
Publications:
Articles:
Gopalakrishnan S, Krebs-Brown A, Nogueira Filho M, Kuroki Y, Bachmann A, Becker A,
Schippers F, Fluck M, Yalkinoglu Ö, Klopp-Schulze L. Safety, tolerability, pharmacokinetics and
pharmacodynamics of a single orally administered dose of enpatoran in a Phase 1 study of healthy
Japanese and Caucasian participants. Ann Rheum Dis 2022; 81(Suppl 1):- DOI:
10.1136/annrheumdis-2022-eular.2860
Dao VA, Schippers F, Stoehr T. Efficacy of remimazolam versus midazolam for procedural
sedation: post hoc integrated analyses of three phase 3 clinical trials. Endoscopy Int Open 2022;
10(4):E378-85. DOI: 10.1055/a-
Linke J, Schippers F, Stoewe F. Wertschöpfungskette “Medizinische Daten” - Folge III.
Datenströme und ihre Visualisierung – KI führt Nutzer durch relevante Analysen. PM QM 2022;
24(3):52-61
Linke J, Schippers F. Wertschöpfungskette “Medizinische Daten” - Folge II. Der medizinische
Datenstrom – Hintergrund, praktische Beispiele und Kommentare. PM QM 2022; 24(2):50-60
Linke J, Schippers F. Wertschöpfungskette “Medizinische Daten” - Folge I. Der medizinische
Datenstrom kann zahllose werthaltige Informationen enthalten. PM QM 2022; 24(1):14-18
Pastis NJ, Hill NT, Yarmus LB, Schippers F, Imre M, Soehngen W, Ostroff R, Callahan SP, Silvestri
GA. Correlation of Vital Signs and Depth of Sedation by Modified Observer’s Assessment of
Alertness and Sedation (MOAA/S) Scale in Bronchoscopy. J Bronchol Intervent Pulmonol 2021.
DOI: 10.1097/LBR-
Stoehr T; Colin P, Ossig J, Pesic M, Borkett K, Winkle P, Struys MMRF, Schippers F.
Pharmacokinetic properties of remimazolam in subjects with hepatic or renal impairment. Br J
Anaesthesia 2021; 127(3). DOI: 10.1016/j.bja-
Zhou J, Curd L, Lohmer LRL, Delpratt N, Ossig J, Schippers F, Stoehr T, Schmith AD. A
Population Pharmacodynamic Markov Mixed‐Effects Model for Determining Remimazolam‐
Induced Sedation when Co‐administered with Fentanyl in Procedural Sedation. Clin Translat Sci
2021; 14(4). DOI: 10.1111/cts.13023
Zhou J, Curd L, Lohmer LL, Ossig J, Schippers F, Stoehr T, Schmith V. Population
Pharmacokinetics of Remimazolam in Procedural Sedation With Nonhomogeneously Mixed Arterial
and Venous Concentrations. Clin Transl Sci 2021; 14: 326–334; doi:10.1111/cts.12875
Rex DK, Bhandari R, Lorch DG, Meyers M, Schippers F, Bernstein D. Safety and efficacy of
remimazolam in high risk colonoscopy: A randomized trial. Digestive and Liver Disease 2020,
53(1); DOI: 10.1016/j.dld-
Pesic M, Stoehr T, Ossig J, Borkett K, Donsbach M, Dao VA, Webster L, Schippers F.
Remimazolam Has Low Oral Bioavailability and No Potential for Misuse in Drug-Facilitated
Sexual Assaults, with or Without Alcohol: Results from Two Randomised Clinical Trials. Drugs in
R&D 2020; 20(3): 267-77; DOI: 10.1007/s-
Pesic M, Schippers F, Saunders R, Webster L, Donsbach M, Stoehr T. Pharmacokinetics and
pharmacodynamics of intranasal remimazolam-a randomized controlled clinical trial. Eur J Clin
Pharmacol 2020; DOI: 10.1007/s--z
Zhou J, Leonowens C, Ivaturi VD, Lohmer LL, Curd L, Ossig J, Schippers F, Petersen KU,
Stoehr T, Schmith V. Population pharmacokinetic/pharmacodynamic modeling for remimazolam in
the induction and maintenance of general anesthesia in healthy subjects and in surgical subjects.
J Clin Anesth 2020; 66: 109899; DOI: 10.1016/j.jclinane-
Schippers F, Pesic M, Saunders R, Borkett K, Searle S, Webster L, Stoehr T. Randomized Crossover
Trial to Compare Abuse Liability of Intravenous Remimazolam Versus Intravenous Midazolam and
Placebo in Recreational Central Nervous System Depressant Users. J Clin Pharmacol 2020; DOI:
10.1002/jcph.1614
Kleiman RB, Darpo B, Thorn M, Stoehr T, Schippers F. Potential strategy for assessing QT/QTc
interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the
effects of intravenous remimazolam on cardiac repolarization. Br J Clin Pharmacol 2020;
DOI: 10.1111/bcp.14270
Lohmer LL, Schippers F, Petersen KU, Stoehr T, Schmith VD. Time‐to‐Event Modeling for
Remimazolam for the Indication of Induction and Maintenance of General Anesthesia. J Clin
Pharmacol 2020; 60(3); DOI: 10.1002/jcph.1552
Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi MM, Shojaee S, Tanner
NT, Callahan SP, Feldman G, Lorch DG, Ndukwu I, Pritchett M, Silvestri GA. Safety and Efficacy
of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During
Bronchoscopy. Chest 2018; 155(1); DOI: 10.1016/j.chest-
Silvestri GA, Pastis NJ, Chen A, Feldman G, Shojaee S, Ndukwu M, Lorch D, Akulian J,
Wahidi M, Boscia J, Schippers F, Blatter J, Yarmus L. Results of a Phase 3, Multicenter,
Randomized, Placebo-Controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine
for Bronchoscopy. Chest 2017; 152(4): A739; DOI: 10.1016/j.chest-
Conference Papers:
Hill N, Pastis NJ, Schippers F, Imre M, Silvestri GA. Correlating Depth of Sedation with Vital
Signs and Adverse Events in Bronchoscopy.
Conference: American Thoracic Society 2020 International Conference, May 15-20, 2020 Philadelphia, PA
DOI: 10.1164/ajrccm-conference-_MeetingAbstracts.A6854
Hill N, Pastis NJ, Schippers F, Silvestri GA. Comparing the Efficacy and Safety of Remimazolam
Versus Midazolam Based on Age and ASA Class in Sedation for Bronchoscopy.
Conference: American Thoracic Society 2019 International Conference, May 17-22, 2019 –
Dallas, TX
DOI: 10.1164/ajrccm-conference-_MeetingAbstracts.A1399
Poster Presentations:
Schippers F, Pesic M, Stoehr T. A Phase 1 pilot trial to explore safety, pharmacokinetics, and
bioavailability of intranasal remimazolam in healthy subjects.
Conference: DIA Europe; April 17-19, 2018; Basel; Switzerland
DOI:-/RG-
Bevilacqua C, Probst S, Eibel S, Hasheminejad E, Herzig S, Schippers F, Hoech R, Ender J.
Anästhesie für kardiochirurgische Eingriffe mit dem kurzwirksamen Benzodiazepin Remimazolam
überwacht durch Neuromonitoring mit dem Narcotrend -System.
Conference: Deutscher Anästhesie Congress (DAC); April 14-16, 2016; Leipzig; Germany
DOI:-/RG-
Peer-Reviewer
International Journal of Medical Sciences (http://www.medsci.org)
Memberships
BDA
Bund deutscher Anästhesisten
( Professional Association of German Anaesthesiologists )
AGNNW
Arbeitsgemeinschaft Notärzte in NRW
( Consortium Emergency Physicians in Northrhine - Westfalia )
DGSS
Deutsche Gesellschaft zum Studium des Schmerzes
( German Society for the study of pain )
EFIC
European Federation of IASP chapters
ESAIC
European Society of Anaesthesiology and Intensive Care
ASA
American Society of Anesthesiologists
Languages
German
native speaker
English
fluent in writing and talking
French, Dutch
basic
Additional Qualifications
Six-Sigma Green Belt
