Summary
Overview
Work History
Education
Skills
Websites
Socialstatus
Nationalities
Titles
Personal Information
Publications
Languages
References
Timeline
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Mourad Rezk

Huenenberg See

Summary

Senior medical affairs and R&D executive with 30 + years of Biopharmaceutical industry experience and with track record of building and transforming large global medical organizations and leading strategic business development (due diligence, acquisitions and in house developments), with deep experience in strategic planning and developing long term medical and business vision. MD by training with specialty in internal medicine and subspecialty in endocrinology and diabetes management. With broad expertise in immunology, nephrology, hematology, diabetes, and Chronic pain management. With well developed biotech industry career in different senior medical affairs and RnD regional and global roles in world leading Biotech companies (Janssen, NovoNordisk, Biogen and Amgen) Currently working for Biogen as vice president/head of global development and medical affairs for the Biosimilars business Unit (BBU). Substantially contributed to building and leading Biosimilars regional and global medical and development organization (80+ staff members) with highly efficient medical affairs, regulatory , safety , quality and clinical research teams who established Biogen BBU as a scientific partner of choice and helped serving 270,000 patients in 4 different therapeutic areas and more than 20 clinical indications in immunology and ophthalmology while also leading the pipeline expansion with full ownership of developing a pipe line of 3 additional assets with phase I and phase III studies and accountability for regulatory filing.. Highly experienced in clinical development (phase I, II and III) as well as post approval real world evidence data generation and phase IV studies and in setting and executing fit for purpose global medical strategies. Successfully lead Global and EU pre-launches of wide range of novel biological drugs across a large scope of therapeutic areas. Proven business acumen and cross functional collaboration and well established scientific leadership with major contribution to the co-authorship of 50+ publications and speaking in global biotech and medical congresses.

Overview

32
32
years of professional experience

Work History

Vice President, Global Head of Medical & clinical development

Biogen
01.2020 - Current
  • Heading clinical development and medical affairs organization
  • Leading the clinical development and regulatory filing of Biogen’s newly acquired biosimilars pipeline while supporting the due diligence of additional candidate assets for in house end to end development.

Global Head of Clinical development and Medical Affairs

Biogen
01.2015 - 01.2020
  • Leading the clinical development and regulatory filing of Biogen’s newly acquired biosimilars pipeline while supporting the due diligence of additional candidate assets for in house end to end development
  • Heading the global Biosimilars medical affairs organization in charge of a full portfolio of 7 assets in 4 therapeutic areas.

Global Head of Medical

Biogen
01.2012 - 01.2014
  • Charged with building and leading the full medical and regulatory organization global and affiliates based
  • Leading the development, registrational pathways of Biosimilars of the 3 leading anti TNFs and anti VEGFs Biosimilars together with the execution of the post authorisation risk management plans, real world evidence and data generation and medical affairs activities.

Regional Medical Affairs Director

Novo Nordisk
Athens
01.2003 - 01.2006
  • Challenged with developing medical affairs and R&D capacity amongst the Middle East and Africa region, optimizing the medical contribution to the marketing plans, internal and external medical education and communication, advisory boards and key opinion leaders development programs as well as boosting the execution of PMS, CEP and phase 3b and 4 projects, In addition to the regional responsibility for compliance and pharmacovigilance.

Medical affairs and marketing support Lead

Janssen Cilag Egypt
01.1999 - 01.2003
  • Challenged with leading a department that integrated both Clinical research, internal and external medical education together with late business development and marketing planning for new launches
  • Significantly contributed to the outstanding pre-launch of the company new products range in Neurology, GIT, psychiatry and chronic pain management therapy areas.

Hemato-Oncology Marketing champ

Janssen Cilag Middle East and west Asia region
01.1999 - 01.2000
  • Responsible for developing regional marketing strategies and establishing best practice marketing models for the oncology and hematology product range in 20 countries.

Biotech. Business unit head

Janssen Cilag Egypt
01.1996 - 01.1999
  • Responsible for managing the marketing and sales of hemato-oncology and chronic pain management lines
  • Managing a team of 2 product managers, 2 sales managers, and 6 product specialists.

Haematology/Nephrology product manager

Janssen Cilag Egypt
01.1994 - 01.1996
  • Responsible for developing and executing the launch plans and campaigns and KOL development.

Clinical research associate

Janssen Cilag Gulf region
01.1993 - 01.1994
  • Responsible for monitoring phase 4 trials programs in 7 Gulf countries intended to develop a hemato-oncology premium product.

European Medical Director

Amgen
Zug
  • In charge of setting and executing the European headquarters ‘medical affairs strategies for supporting the current innovators’ biotech lines as well as to support the development of the upcoming Biosimilar GIT, RA and Oncology products.

International Clinical Research Medical Director

Amgen
  • Leading a wide range of international CKD-MBD (mineral and bone disease) clinical studies and PHPT (primary hyperparathyroidism) as well as offering nephrology specific support to the European biosimilars’ task force and EU affiliates.

International Development Medical director

Amgen
  • Responsible for strategic planning and leading the execution of the European and international R&D and medical affairs programs supporting the nephrology franchise with focus on data generation (International phase IIIb, Phase 4 and epidemiological studies) and data dissemination plans (publications plans, International congresses and company sponsored symposia) as well as KOL management programs (International advisory boards etc.) and supporting medical liaison teams.

Medical Communications lead

Amgen
  • Challenged with providing medical input in analyzing, reporting the competitive medical data as well as preparing the appropriate medical strategies and tools, (publications plans, trainings and educational slide decks, opinion leaders management) for ensuring the company’s medical readiness to deal with competitive challenges.

Education

Master of Business Administration (MBA) -

Alexandria Arab Academy of Science And Technology
01.2000

Marketing and sales diploma -

American University of Cairo
01.1998

Master degree in internal medicine (Diabetes) -

Cairo University
01.1995

Bachelor of medicine and surgery (M.B, Bch) -

Ain Shams University of Cairo
01.1989

Master degree in Chronic Pain Management -

National Cancer Institute Cairo University
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Skills

  • Strategic planning
  • Business development
  • Clinical development
  • Medical affairs
  • Regulatory filing
  • Real-world evidence data generation
  • Phase I, II, and III studies
  • Global medical strategies
  • Cross-functional collaboration
  • Scientific leadership
  • Publication writing
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
  • Microsoft Outlook
  • Fluent in English
  • Good in French
  • Mother tongue Arabic
  • Business Development
  • Strategic Planning
  • Public Speaking

Socialstatus

Married and a father of 2

Nationalities

  • Canada
  • Egypt
  • Swiss C permit

Titles

  • MD
  • M.Sc
  • MBA

Personal Information

Title: Vice President, Global Head of Medical & Development at Biogen

Publications

  • Unlocking the Value of Anti-TNF Biosimilars: Reducing Disease Burden and Improving Outcomes in Chronic Immune-Mediated Inflammatory Diseases: A Narrative Review., Rezk MF, Pieper B., Adv Ther, 2020 Sep, https://pubmed.ncbi.nlm.nih.gov/32740789/
  • The road from development to approval: evaluating the body of evidence to confirm biosimilarity, Paul Declerck, Mourad Farouk Rezk, Rheumatology, Volume 56, Issue suppl_4, 1 August 2017, javascript:;
  • An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review., Hariprasad SM, Gale RP, Weng CY, Ebbers HC, Rezk MF, Tadayoni R., Ophthalmol Ther, 2022 Jun, https://pubmed.ncbi.nlm.nih.gov/35278204/
  • Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect., Rezk MF, Pieper B., Rheumatol Ther, 2017 Dec, https://www.ncbi.nlm.nih.gov/pubmed/29032452
  • Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review., Ebbers HC, Pieper B, Issa A, Addison J, Freudensprung U, Rezk MF., Rheumatol Ther, 2019 Sep, https://pubmed.ncbi.nlm.nih.gov/31385263/
  • To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars., Rezk MF, Pieper B., Adv Ther, 2018 Jun, https://pubmed.ncbi.nlm.nih.gov/29873005/
  • Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali) Versus Etanercept (Enbrel) - Findings from a Nurse Survey in Europe., Rheumatology and Therapy, Rheumatology and Therapy, June 2016, Volume 3, Issue 1, http://link.springer.com/article/10.1007/s40744-016-0035-1
  • Budget Impact Analysis of An Etanercept Biosimilar for The Treatment of All Licensed Etanercept Indications for Adults In Europe., Value Health, Value Health, 2015 Nov, http://www.ncbi.nlm.nih.gov/pubmed/26533586
  • Budget Impact Analysis of An Etanercept Biosimilar for The Treatment of Rheumatoid Arthritis In Europe., Value Health, Value Health, 2015 Nov, http://www.ncbi.nlm.nih.gov/pubmed/26533585
  • Biosimilarity Versus Manufacturing Change: Two Distinct Concepts., Pharm Res, Pharm Res, 2016 Feb, http://www.ncbi.nlm.nih.gov/pubmed/26381277
  • Outcomes in patients with chronic kidney disease not on dialysis receiving extended dosing regimens of darbepoetin alfa: long-term results of the EXTEND observational cohort study, Nephrol Dial Transplant, Nephrol Dial Transplant, 2016 Apr 15, http://www.ncbi.nlm.nih.gov/pubmed/27190334
  • Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study., Pediatr Nephrol, Pediatr Nephrol, 2016 Mar, http://www.ncbi.nlm.nih.gov/pubmed/26482252
  • Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study., Adv Ther, Adv Ther, 2014 Nov, http://www.ncbi.nlm.nih.gov/pubmed/24173670
  • Dose conversion ratio in hemodialysis patients switched from darbepoetin alfa to PEG-epoetin beta: AFFIRM study., Adv Ther, Adv Ther, 2013 Nov, http://www.ncbi.nlm.nih.gov/pubmed/23328710
  • Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism., Nephrol Dial Transplant, Nephrol Dial Transplant, 2013 May, http://www.ncbi.nlm.nih.gov/pubmed/21329635
  • Epoetin biosimilars in europe: five years on., Adv Ther, Adv Ther, 2013 Jan, http://www.ncbi.nlm.nih.gov/pubmed/21435267
  • Extended dosing of darbepoetin alfa in peritoneal dialysis patients., BMC Nephrol, BMC Nephrol, 2011 Mar 24, http://www.ncbi.nlm.nih.gov/pubmed/21435267
  • An observational study of the effectiveness of darbepoetin alpha administered in dialysis patients once every 2 weeks for 12 months., Clin Nephrol, Clin Nephrol, 2011 Mar, http://www.ncbi.nlm.nih.gov/pubmed/22140136
  • Extended dosing of darbepoetin alfa in peritoneal dialysis patients., Feriani BMC Nephrol, BMC Nephrol, 2011 Mar 24, http://www.ncbi.nlm.nih.gov/pubmed/21435267

Languages

English
First Language
French
Intermediate (B1)
B1
German
Beginner (A1)
A1
Arabic
Proficient (C2)
C2

References

References available upon request.

Timeline

Vice President, Global Head of Medical & clinical development

Biogen
01.2020 - Current

Global Head of Clinical development and Medical Affairs

Biogen
01.2015 - 01.2020

Global Head of Medical

Biogen
01.2012 - 01.2014

Regional Medical Affairs Director

Novo Nordisk
01.2003 - 01.2006

Medical affairs and marketing support Lead

Janssen Cilag Egypt
01.1999 - 01.2003

Hemato-Oncology Marketing champ

Janssen Cilag Middle East and west Asia region
01.1999 - 01.2000

Biotech. Business unit head

Janssen Cilag Egypt
01.1996 - 01.1999

Haematology/Nephrology product manager

Janssen Cilag Egypt
01.1994 - 01.1996

Clinical research associate

Janssen Cilag Gulf region
01.1993 - 01.1994

European Medical Director

Amgen

International Clinical Research Medical Director

Amgen

International Development Medical director

Amgen

Medical Communications lead

Amgen

Master of Business Administration (MBA) -

Alexandria Arab Academy of Science And Technology

Marketing and sales diploma -

American University of Cairo

Master degree in internal medicine (Diabetes) -

Cairo University

Bachelor of medicine and surgery (M.B, Bch) -

Ain Shams University of Cairo

Master degree in Chronic Pain Management -

National Cancer Institute Cairo University
Mourad Rezk