Suleyman Eralp

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. Email and Phone Number

Global Clinical Pharmacology Medical Lead | Sr. Translational Medicine Expert @ Novartis
East Hanover, NJ, US
Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s Location
East Hanover, New Jersey, United States, United States
Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s Contact Details

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. work email

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. personal email

About Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.

- Physician-Scientist/Pharmaceutical/Biotech R&D Executive/Translational Medicine/Clinical Pharmacology Subject Matter Expert/Drug Developer with an exceptional track record in Early Development for Adult and Pediatric Indications-20+ years of innovation experience in the US pharmaceutical/biotech industry (Roche, Johnson & Johnson, Novartis, The Medicines Company, Former VP at Parexel)- Postdoc training at UCSF as MSD International Fellow in Clinical Pharmacology- Fellow of the American Heart Association- Scientific Advisor for INDdose, a smartphone app to calculate estimated maximum safe starting dose in First in Human clinical trials- Early Phase Drug Development/Translational Medicine/Clinical Pharmacology Expertise for Small Molecules and Biologics- Contributed development activities of 100+ NMEs at various phases of development ranging from IND/Phase 1 to NDA and Global Registration trials- Co-developer 5 successfully filed and approved first in class NDAs:- Fuzeon®: First in class HIV fusion inhibitor drug. Approved for Adult and Pediatric indications in less than two years of clinical development time.-Exelon Patch®: First transdermal therapeutics for Alzheimer’s Dementia-Orbactiv®: First single-dose antibiotic for Skin and Skin structure infections-Kengreal®: First and only intravenous P2Y12 antiplatelet agent approved as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events.-Leqvio®: First in class siRNA PCSK9 inhibitor to lower cholesterol.

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s Current Company Details
Novartis

Novartis

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Global Clinical Pharmacology Medical Lead | Sr. Translational Medicine Expert
East Hanover, NJ, US
Website:
novartis.com
Employees:
79781
Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. Work Experience Details
  • Novartis
    Global Clinical Pharmacology Medical Lead | Sr. Translational Medicine Expert
    Novartis
    East Hanover, Nj, Us
  • Iq Consortium
    Advisory Board Member
    Iq Consortium Oct 2024 - Present
    Novartis representative for Clinical Pharmacology Leadership Group in IQ Consortium
  • Novartis
    Sr. Clinical Pharmacology Consultant Medical Lead
    Novartis Jan 2021 - Present
    Basel, Baselstadt, Ch
    Medical Leadership role within NIBR Translational Medicine supporting clinical pharmacology projects across therapeutic areas including immunology, neuroscience, cardiovascular, musculoskeletal, infectious diseases and oncology early development.
  • Pharmahelpline International
    Owner And Senior Principal Consultant
    Pharmahelpline International Oct 2019 - Present
    Drug development consulting services to multiple clients in a range of startups to clinical-stage public pharmaceutical/biotech companies. Services include IND-enabling studies, IND filing, Clinical Pharmacology gap analysis, First in Human Dose calculation, study design, protocol writing, Phase 1, Phase 2 POC study design and Phase 3 program management, NDA, sNDA regulatory advice, BA/BE, PK/PD, DDI and TQT studies, safety review, Medical, and Scientific affairs support, due diligence expertise. Clinical research experience over 20 years in the areas of Clinical Pharmacology, Translational Medicine, Cardiovascular, CNS and Infectious Disease therapeutic areas.
  • Wuxi Clinical
    Chief Scientific Advisor
    Wuxi Clinical Dec 2020 - May 2023
    Austin, Texas, Us
    Chief Scientific Advisor role at global scale focused on Clinical Pharmacology and early phases of drug development including Pre-IND/ IND filing activities, medical monitoring and regulatory interactions.
  • Cyclerion
    Sr. Clinical Pharmacology Consultant
    Cyclerion Mar 2020 - Feb 2022
    Cambridge, Ma, Us
    Lead Clinical Pharmacology role to support development programs focused on the sGC-NO pathway targeting CNS, Hematology, and Vascular indications including rare/orphan diseases.
  • Valo
    Interim Head Of Clinical Pharmacology | Sr. Consultant
    Valo Apr 2021 - Oct 2021
    Lexington, Ma, Us
    A contract role to conduct Clinical Pharmacology gap analysis and contribute IND filing and clinical study design related activities for an asset in cardiovascular indication.
  • Parexel
    Vice President, Worldwide Medical Sciences & Clinical Pharmacology
    Parexel Apr 2018 - Oct 2019
    Durham, North Carolina, Us
    As an industry thought leader, Clinical Pharmacology and Therapeutic Area Consulting including supporting the Business Development, and Scientific Services functions of the PAREXEL Worldwide Early Phase Group and US and European operations including London, Berlin, Baltimore, and Los Angeles Early Phase clinical units. Also, responsible for providing therapeutic expertise in CVS, CNS, and infectious disease drug development and methodology as required.
  • The Medicines Company
    Vice President, Clinical Pharmacology
    The Medicines Company Jan 2014 - Mar 2018
    East Hanover, Nj, Us
    Clinical Pharmacology Head and Member for the DLT (Development Leadership Team), supporting entire clinical development portfolio. Contributing one IND, one Phase I, one Phase II, 2 Phase III and 1 Phase IV potential game changer projects in Cardiovascular and Infectious Disease Therapeutic areas:*ApoAI-Milano*Oritavancin*Oritavancin Pediatric*Cangrelor*Angiomax*Inclisiran (acquired by Novartis)
  • The Medicines Company
    Sr Director, Head Of Clinical Pharmacology Center Of Excellence
    The Medicines Company Oct 2010 - Dec 2013
    East Hanover, Nj, Us
    Clinical Pharmacology Head and Members for the DLT (Development Leadership Team) and Safety Management Team (SMT), supporting entire clinical development portfolio.
  • Pfizer
    Clinical Pharmacology Consultant
    Pfizer Feb 2009 - Sep 2010
    New York, New York, Us
    Global Clinical Pharmacology support for Established Products Business Unit (review and update product core data sheets/labels, local registration support, product differentiation strategies, bioequivalence study design and analysis).
  • Novartis
    Senior Translational Medicine Expert
    Novartis Nov 2006 - Jan 2009
    Basel, Baselstadt, Ch
    Translational Medicine leadership role for entire neuroscience pipeline and CNS products in the market. Worked in Exelon Patch team to get NDA approval and provided clinical pharmacology support for regulatory meetings with FDA and international health authorities (EMEA, Canada, RoW). Prepared IND safety updates for CNS portfolio (Clozaril/Leponex, Comtan/Stalevo and Exelon/Exelon Patch). Regularly attended Novartis Scientific Review Committee (SRC) meetings as reviewer/co-chair to provide advice on Novartis study protocols across therapeutic areas. Represented Novartis in due diligence meetings for in-licensing activities.
  • Scios (Johnson & Johnson Company)
    Director, Head Of Clinical Pharmacology
    Scios (Johnson & Johnson Company) Apr 2005 - Oct 2006
    New Brunswick, Nj, Us
    Reporting to VP of Clinical Research, built and managed clinical pharmacology department. Responsible for early pipeline development and new transdermal formulation for Natrecor, congestive heart failure treatment. Supervised population PK activities aiming to reduce variability in response and improve safety with optimum individual dosing. Served in Drug Safety Monitoring Board to provide ongoing safety review on clinical trials. Successfully presented Phase I study design to JnJ First in Human Drug Safety Board. Unfortunately JnJ decided to shut down Scios 1.5 year after I joined them.
  • Hoffmann-La Roche
    Associate Director, Clinical Pharmacologist
    Hoffmann-La Roche Oct 1999 - Apr 2005
    Switzerland 🇨🇭 , Ch
    Clinical Pharmacologist role for assigned projects. Study design, PK/PD analysis, report writing and safety review on compounds under development for dose escalation or go/no-go decisions. Contributed development of first in-class HIV fusion inhibitor drug Fuzeon. NDA approval was obtained for adult and pediatric indication in less than 2 years of development time. Lead clinical pharmacologist for pediatric indication. This was my first job in industry and I learned a lot at Roche working with great professionals for about 6 years.
  • Merck
    Postdoctoral Fellow
    Merck Sep 1997 - Aug 1999
    Rahway, New Jersey, Us
    MSD Clinical Pharmacology International Fellowship at UCSF
  • Adnan Menderes University
    Assistant Professor Of Pharmacology
    Adnan Menderes University Apr 1994 - Jul 1997
    Aydın, Tr
    Teaching pharmacology to medical and health sciences students, served in ADU hospital formulary board, PK studies and clinical trials.

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. Skills

Clinical Development Clinical Trials Drug Development Pharmaceutical Industry Pharmacology Biotechnology Infectious Diseases Clinical Pharmacology Translational Medicine Fda Clinical Research Life Sciences Therapeutic Areas Ind Biologics Nda Cro Medicine Oncology Neuroscience Gcp Pharmacovigilance Regulatory Submissions Medical Writing Pharmacokinetics Pharmacodynamics Biomarkers Drug Safety Protocol Regulatory Affairs Pharmaceutical Research R&d Due Diligence Translational Research Drug Metabolism Disease Lifesciences Immunology Product Life Cycle Management Pharmaceuticals Cardiovascular Medicine Cholesterol Atherosclerosis Heart Disease Anti Infectives Virology Alzheimer's Disease Neuropharmacology Pk Pd

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. Education Details

  • University Of California, San Francisco
    University Of California, San Francisco
    Clinical Pharmacology
  • Università Degli Studi Di Milano
    Università Degli Studi Di Milano
    Medical Pharmacology
  • Ege University
    Ege University
    Medical Pharmacology
  • Nato Asi Erice International School Of Pharmacology
    Nato Asi Erice International School Of Pharmacology
    New Trends In Pharmacokinetics; Pharmacovigilance
  • Ankara University
    Ankara University
    Medicine

Frequently Asked Questions about Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.

What company does Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. work for?

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. works for Novartis

What is Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s role at the current company?

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s current role is Global Clinical Pharmacology Medical Lead | Sr. Translational Medicine Expert.

What is Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s email address?

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s email address is er****@****xel.com

What schools did Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. attend?

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. attended University Of California, San Francisco, Università Degli Studi Di Milano, Ege University, Nato Asi Erice International School Of Pharmacology, Ankara University.

What skills is Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. known for?

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha. has skills like Clinical Development, Clinical Trials, Drug Development, Pharmaceutical Industry, Pharmacology, Biotechnology, Infectious Diseases, Clinical Pharmacology, Translational Medicine, Fda, Clinical Research, Life Sciences.

Who are Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s colleagues?

Suleyman Eralp "Al" Bellibas, Md, Phd, Faha.'s colleagues are Patrick Bush, Vepuri Mary Swarnalatha, Sina Gugel, Angel Herrera R., Michael Kasis, Melissa Pulley, Stephanie Aslan.

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