Rob Van Maanen Md Mba Ffpm Email and Phone Number
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MBA-qualified Chief Medical Officer with a strong reputation for working in a scientific and rigorous way to solve business problems in the most effective and efficient way possible. Upholding high quality and ethical standards, I avoid medico-legal risks and improve companies’ reputations among customers and regulatory authorities (e.g. FDA, EMA). Thinking and acting on both the strategic level, and small but important details simultaneously, I leverage optimally the diversity of skills and knowledge of my team. A self-starter, I follow through persistently to ensure objectives are met or exceeded. I know my own limits and address these by involving the right experts to secure success. I love learning and am always keen to expand my knowledge and skills and dive into the new and unknown. Working with global experts, I enjoy creatively developing the narrow, twisting path to get new drugs to market and, using Enterprise Risk Management techniques, avoid the many pitfalls! The interconnectedness of science, medicine, regulation and market forces create fascinating projects that drive me.My professional experience stems from both small and large pharmaceutical companies including Khondrion, Astellas, Roche, Organon and Novartis. My notable achievements include obtaining FDA approval for Astellas – without any questions asked – a ‘first’; twice gaining SLT approval of P3 plans along with substantial investment; and achieving RPD designation for Khondrion, within 60 days, despite a moderate probability of success. Specialties:✔️ Business Acumen ✔️ Business Development ✔️ Strategy Formulation and Execution ✔️ Leadership, Management and Decision-Making ✔️ Regulatory Filing Strategy, Writing and Meetings ✔️ Global Drug Development and Clinical Trials ✔️ Medical Affairs ✔️ Pharmacovigilance ✔️ Ethics and Quality Standards ✔️ Global (KOL) Networks Development ✔️ Broad Therapeutic Area / Orphan Experience ✔️ Broad Product Class Experience (including Pediatrics)
Jcr Pharmaceuticals
View- Website:
- jcrpharm.co.jp
- Employees:
- 124
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Chief Medical OfficerJcr PharmaceuticalsSouth Holland, Netherlands
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Chief Medical OfficerBiophytis Sep 2021 - PresentAs a member of the Management Team, I am responsible for all clinical, regulatory, PV, GDPR and medical outsourcing activities. I co-define company and clinical development strategies and safeguard execution. I am responsible for 2 Project Leaders, a regulatory director and medical affairs director and clinical, regulatory, PV and compliance consultants, and I also participate in funding and business development activities.Indications: Duchenne Muscular Dystrophy/orphan disease, age-related sarcopenia, obesity/weight loss, COVID-19.
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Chief Medical OfficerKhondrion Feb 2020 - Sep 2021Nijmegen, NlKhondrion is a clinical-stage pharmaceutical company discovering and developing therapies targeting (orphan) mitochondrial diseases.As a member of the Management Team, I am responsible for all clinical, regulatory, PV, GDPR and clinical outsourcing activities. I co-define company and clinical development strategies and safeguard execution. I am responsible for 1 Study Manager, clinical, regulatory, PV, PK and compliance consultants, and I also participate in funding and business development activities.Indications: primary (hereditary) mitochondrial diseases / orphan-rare disease, pediatric development. Achieved FDA Rare Pediatric Disease designation for MELAS within 2 months of submission. Obtained EMA PIP approval for the KH176 paediatric investigational plan. Designed a study in children and obtained CA and EC approval. Designed, co-authored and submitted protocol for a long-term extension study. Managed and mitigated Covid-19 impact on clinical study and ensured safe continuation of dosing and patient home / hotel assessments during hospital lockdown. Co-authored article on hypothesis that KH176 may ameliorate the inflammation from Covid-19 infection; obtained advice from KOLs and designed an initial Phase 2 study to test the hypothesis. Contracted consultant experts on drug promotion and GDPR compliance. Leveraged personal network to recruit consultants. Co-authored / supervised key regulatory document generation, e.g. pre-IND and scientific advice requests, orphan and RPD designation requests, PIP, protocols, DSUR, IMPD and IB updates. Presented at Scientific Advisory Board to inform company strategy. Gathered a group of experts and supervised strategy and execution of independent safety oversight (DSMB) of the pediatric study. -
Senior Medical Director / Global Medical LeaderAstellas Pharma Jan 2012 - Dec 2018I led a team of 10 globally dispersed functional members and was Deputy Chair of Protocol Approval Committee reviewing all final draft protocols. Contributed to business development activities (due diligence of in-licensing opportunities), reviewed/approved all GCP documents and was responsible for adequate scope and quality of clinical data. I co-authored/approved regulatory documents (CTD/NDA), protocols, study reports, authority response documents, PBRERs, RMPs, DSURs and ASRs for assigned compounds; leveraged KOL networks; and chaired/presented at adboards/medical affairs meetings. Indications: overactive bladder (OAB), nociceptive and neuropathic pain, fixed dose combinations, menopause, prostate hypertrophy/BPH, C. difficile infection, pediatric development. Reviewed and approved NDA submission of EB178 program and obtained FDA approval in tight timeframe: only 1 short set of questions asked at start of procedure and thereafter no questions until approval 9 months later. Label was best possible and commercially attractive text. Wrote/presented comprehensive P3 CDP to corporate governance committee and obtained approval for major investment. Led content preparation of EoP2 and EMA Scientific Advice meeting packages, presented and answered questions at EMA and FDA meetings. Obtained relevant and conclusive authority advice and implemented in the clinical program. Designed/analysed complete program of P2 and P3 studies and supervised completion of study reports. Established and oversaw high performing team managing the studies and led medical monitoring (4 FTEs) and targeted safety analyses. Co-devised and published novel methods for efficacy analyses improving analysis of incontinence, electronic diary optimization and quantitative benefit-risk assessment methodology (MCDA)* (see Publications). Supervised fidaxomicin pediatric P3 study and ensured completion of study report and subsequent publication.
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Safety Science Leader OncologyRoche Jun 2010 - Dec 2011Switzerland 🇨🇭 , ChMy role was to ensure full safety surveillance of MabThera®, a monoclonal AB / immune therapy in haemato-oncology. I line-managed the Safety Scientist and had dotted-line management responsibility for 2 contract Safety Scientists.Indications: immuno-oncology (CLL, lymphoma, DLBCL), rheumatoid arthritis. Performed regular signal detection, including reporting to and obtaining endorsement from senior leadership and approvals of 50+ global authorities for proposed revisions of the oncology sections of package insert texts regarding safety and benefit-risk. Closely collaborated with counterpart responsible for rheumatoid arthritis part of MabThera® strategy Represented Roche in multi-company PML consortium and ensured strategy and proposals from consortium were endorsed by Roche leadership and implemented accurately. Led annual safety reporting and timely submission in 50+ countries; ensured local regulatory authority acceptances of safety data dossiers, PBRERs / PSURs, Risk Management Plans (RMPs), package insert amendments and responses to questions. Kept abreast of scientific developments in the immuno-oncology area and pharmacovigilance legislation including conference and workshop attendance, self-initiated learning and literature review. Medical leadership ensuring safety input in all MabThera® development activities (oncology and rheumatology) and membership as Safety Lead in the oncology Life Cycle Management team with responsibility for the strategy and implementation of all life cycle management activities. Presented Failure Mode Effect Analysis (FMEA) in the pharmacovigilance department. Conducted medical monitoring of all oncology studies with MabThera® and assessed real-world-data for relevant ADRs. -
Director CnsEisai Aug 2005 - Jun 2010Nutley, Nj, UsLeading the Zonegran® project shortly after it was in-licensed by Eisai and ensuring medical content for 4 NDAs in EU, Switzerland, Russia and Australia as well as supervising succesful launch in Europe. Contributing as Clinical Expert to numerous EU / US variations and several HTA submissions, I also presented Zonegran® at a commercial (French) launch event and at international scientific conferences. In addition, I reviewed and signed-off UK promotional materials against the ABPI code of practice.Indications: epilepsy / seizure disorders, neuropathic pain, dementia and migraine prophylaxis. Created prioritized development plan (including choice of indications) for post-launch indication expansion, creating CDP of 11 studies (including a PASS and paediatric studies). Obtained SLT approval for large investment and created / submitted 11 protocols for execution throughout the world. Monotherapy (in adults) and adjunctive pediatric indications are now EMA approved. Led high-performing global teams to ensure rapid start-up of large package of globally-conducted clinical studies (including in India, Brazil and China) and successfully delivered an orally dispersible formulation for patients with swallowing difficulties. Obtained endorsement for LCM plan and maintained good relationship with licensor Dainippon Sumitomo. Set up DSMB and KOL network to develop protocols and (safety) endpoints for design of pivotal studies in new indications and pediatric development. Obtained authorities’ acceptance of PIP / PDP and ensured successful submissions to ethics committees and local authorities and speedy study start-ups. Contributed to FIM transitions of several CNS compounds including preparing ‘go’ decisions by senior management and participated in SAD / MAD / BA study designs. Contributed as medical expert to 2 in-licensing / due diligence assessments. -
Clinical Research PhysicianOrganon May 2000 - Aug 2005Jersey City, Nj, UsIn this role, I led the Global Clinical Development Team (GCDT) and was responsible for budgets and timelines. I designed 2 PoC Clinical Development Plans and several more study protocols and study reports (phase I-IIIb) (drugs and medical device), medical monitoring and MAA maintenance (the oncology immune therapy OncoTICE®), DSMB (DMC) set-up and oversight.Indications: major depressive disorder, psychotic disorders / schizophrenia, sleep apnea / OSA, anaesthetics, neuromuscular blocking and reversal agents, post-operative pain, oncology (OncoTICE® for bladder cancer), medical devices. Established a global Advisory Board and designed a POC study for novel compound in OSA which received endorsement from FDA and several European authorities (NL, DK, Sweden). Wrote the protocol and ensured smooth start-up of study and start of enrolment. Study found conclusive absence of efficacy. Designed a POC study for drug/device combination in which the device measured the drug’s effect and adjusted the dose (a Closed Loop Infusion System); wrote study protocol that successfully combined drug and device regulatory systems while collaborating with the company that out-licensed the device IP. Submitted the safety section of NDA submission for gepirone (in-licensed anti-depressant). Outcome: FDA response indicated no deficiencies in a complex pooled package of 70+ studies from 4 prior companies. -
Medical Adviser Cns (Nl)Novartis Feb 1998 - May 2000Basel, Baselstadt, ChRecruited to this Medical Affairs role to introduce 2 new CNS drugs (Exelon®, Comtan®) to the Dutch market, I designed strategy and executed the marketing plan in collaboration with the Product Manager and supported marketing activities for other post-launch assets (Leponex®, Ritalin®, Trileptal®). Indications: Alzheimer’s Disease, Parkinson’s Disease, epilepsy, mild cognitive impairment, schizophrenia, stroke, ADHD, ALS. Generated materials and delivered training (TA knowledge and product information) to internal staff. Presented Exelon®, and Comtan® to medical (KOLs /adboards, specialists, GPs) and pharmacist audiences. Designed, implemented and reported phase IV trials with Exelon®, and Comtan® and ensured HQ-initiated phase II-IV trials were executed within budget and on time. Contributed to HTA / market access applications for Exelon®, and Comtan® including CEA. Supported medical information activities, including writing, updating and reviewing Q&As. -
PhysicianElisabeth Hospital Amersfoort Feb 1997 - Feb 1998Treating physician not in training at the psychiatry ward of this general hospital, treating in- and outpatients and providing liaison services to other departments.
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PhysicianUniversity Hospital Utrecht Feb 1996 - Feb 1997Treating physician not in training in the neurology ward and outpatient clinic of this university hospital; also liaison consultancy services.
Rob Van Maanen Md Mba Ffpm Skills
Rob Van Maanen Md Mba Ffpm Education Details
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University Of Amsterdam - Amsterdam Business SchoolMaster Of Business Administration - Mba -
Faculty Of Pharmaceutical MedicinePharmaceutical Medicine
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Hult Ashridge Executive EducationFinance For Non-Financial Managers
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Hult Ashridge Executive EducationLeadership Process
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Management Centre EuropeLeadership)
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Vrije Universiteit BrusselPharmaceutical Medicine
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Utrecht UniversityMedicine
Frequently Asked Questions about Rob Van Maanen Md Mba Ffpm
What company does Rob Van Maanen Md Mba Ffpm work for?
Rob Van Maanen Md Mba Ffpm works for Jcr Pharmaceuticals
What is Rob Van Maanen Md Mba Ffpm's role at the current company?
Rob Van Maanen Md Mba Ffpm's current role is Chief Medical Officer.
What is Rob Van Maanen Md Mba Ffpm's email address?
Rob Van Maanen Md Mba Ffpm's email address is ro****@****tis.com
What schools did Rob Van Maanen Md Mba Ffpm attend?
Rob Van Maanen Md Mba Ffpm attended University Of Amsterdam - Amsterdam Business School, Faculty Of Pharmaceutical Medicine, Hult Ashridge Executive Education, Hult Ashridge Executive Education, Management Centre Europe, Vrije Universiteit Brussel, Utrecht University.
What are some of Rob Van Maanen Md Mba Ffpm's interests?
Rob Van Maanen Md Mba Ffpm has interest in Founder Of Artbynature, Geology And Mineralogy, Statistics And Trial Design, Private Interests, Popular, Natural Art, Art, Fusion Jazz, Com, Med Marketing.
What skills is Rob Van Maanen Md Mba Ffpm known for?
Rob Van Maanen Md Mba Ffpm has skills like Clinical Development, Clinical Trials, Oncology, Pharmacovigilance, Clinical Research, Drug Development, Neurology, Protocol, Medical Writing, Gcp, Medicine, Urology.
Who are Rob Van Maanen Md Mba Ffpm's colleagues?
Rob Van Maanen Md Mba Ffpm's colleagues are Shunichi Nakamura,mba, Hiroyuki Sonoda, Denise Lee, Yuri Koyama, Franco Romero, Hanneke Van Den Akker, Jun Tsushima.
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