ENAS I. HASAN

ENASHASAN75@GMAIL.COM

079-5779944

LINKEDIN.COM/ENAS-HASAN- 978AB418

SKILLS

Management, Strategic Planning, Communication, Leadership, Generic Product Development, Formulation Development and Dosage Form Design, Quality by Design,                 Bioequivalence, Intellectual Property, New Product Selection, Regulatory Affairs, Variations,

Enas I. Hasan

Al-Thuhair-Jordan | 0795779944 | enashasan75@gmail.com

EXPERIENCE

R&D SENIOR MANAGER| HIKMA PHARMACEUTICALS | NOVEMBER 2016 – APRIL 2019

• Led the Formulation development team for Hikma Branded Business for Oral Products (Non- Oncology) in Central R&D Function; more than 20 projects at various stages of development at any time.
• Technology Transfer for centrally developed and outsourced products from Central R&D function to Hikma MENA
• Major participant in the pipeline selection process from the wish list stage, to screening to technical do-ability to pipeline addition.
• Identifying the fastest way for the selected products to be present in the market; with the objective of being first to market more often in Jordan and MENA sites; being well aware of the local requirements in Jordan, KSA, GCC, Algeria, Sudan, Tunis and Morocco
• Due Diligence for outsourced dossiers.
• Prepared R&D budget annually and updated the forecast quarterly.
• Tracked the amount spent per project, and created a system to track the cost of product
• Created a system for responding diligently to any received Deficiency letter from the regulatory authorities.
• Reviewed BE studies quotations and study designs; managed to get approval for all BE studies and Biowaiver requests from JFDA; even in cases of
• Led the Launch team to smoothen the transfer from R&D to operations and to be ready for launch at the time of approval.
• Tracked progress of R&D activities in all Hikma sites.
• R&D Owner for the 5 year Business Plan for Hikma Branded Business in MENA
• Provided summaries on the R&D progress for Upper Management; CEO, CSO and Technical VP

Achievements:

• Reformed the department upon restructuring; and placed a remediation plan for all pipeline
• Managed to close all pending variations and DLs from R&D side in record
• Responsible for the formulation development of the more than 10 products as in house for Hikma, that have either been approved or have been submitted to regulatory review at
• Let the R&D part for Technology Transfer of several originator products into Hikma
• Created a system for transferring the projects to HIKMA sites simultaneously rather than

R&D AND REGULATORY AFFAIRS MANAGER | HAYAT PHARMACEUTICALS | JUNE – OCTOBER 2016

• Led the R&D (AR and PR) and the Regulatory Affairs Departments, in addition to the Technical Manager role for JFDA communication purposes

R&D DEPARTMENT MANAGER | JPM | MARCH 2014 – MAY 2016

• Created a systemized approach to product development, by identifying the development phases and creating a reporting system for each.
• Created the system for product Technology Transfer to the Manufacturing
• Incorporated the concept of Quality by Design (QbD) to product
• Led the team to submit a JPM product to WHO, complying with all requirements, and responded to all received deficiency letters; dossier was
• Created new template for JPM CTD to assure its compatibility with eCTD requirements, introducing as well numerous updates to enrich the technical information presented in the dossier to comply with the evolving regulatory

Other duties:

• Active member of JPM New Products Selection Committee; a committee that is specializing in selecting JPM pipeline products, duties included;
  • Targeting possible candidates for development
  • Research information related to; manufacturing capabilities, regulatory status, stability, bioequivalence, API and finished product specifications, and primary
  • Perform a full IP exercise on candidate products, including patents and data
  • Perform patent intelligence investigation to determine patent challenges, possible time of submission/launch in target markets, API form or PSD, formulation technique, potential API suppliers, design around necessities
  • Patent searches on Espacenet, WIPO, KACST, GCC and Indian

DEPUTY TECHNICAL DIRECTOR | JPM | APRIL 2012-MAY 2016

• Provided the R&D Department with technical support to assure developed products were in compliance to regulatory, technical and Bioequivalence Starting from dosage form design, small scale experiments, stability and dissolution, review scale up batches, stability results, specifications and other regulatory requirements.
• Handling all JFDA communications in lieu of Technical
• Assisting the Technical Director in a variety of GMP follow
• Following up with the Technical Director the GMP inspections from KSA, JFDA, South Africa and

LICENSING-IN MANAGER, LICENSING DEPARTMENT | JPM | APRIL 2009-MARCH 2014

• Sourcing finished products of interest from partners, and evaluating dossiers and
• Aligning the received dossiers with the JFDA
• Following up of the registration in Jordan Food and Drug Administration (of JPM in- house and licensed products). Assuring their timely registration and response to requirements and deficiency
• Following up and joining the JFDA inspection team to 2 manufacturing plants in
• Following up registration requirements of the licensed products in JPM export
• Preparing Technical agreements with the licensing

Other duties:

• Proceeding as an Active member of JPM New Products Selection Committee; a committee that is specializing in selecting JPM pipeline
• Following up all of JPM’s Bioequivalence studies; initiation, conduct and
• Handling all deficiency letters received by JPM from the regulatory authorities concerning BE

Achievements:

• Compiled and followed the registration of the first Biosimilar Insulin in JFDA, approved as per EMA
• Led the team to the submission and regulatory approval of the JPM licensed products (around 30 products).

GROUP LEADER AND CLINICAL SPECIALIST– R&D | JPM | 2000-2008

• Pre-formulation Studies of active drug substances, including analytical methods development, physicochemical properties, compatibility studies…etc.
• Formulation Development of various pharmaceutical dosage forms, tablets, capsules,
• Pharmaceutical Analyzing of drug substances and pharmaceutical dosage forms using HPLC,

UV/Visible, Automatic and Manual Titration methods. Performing an analysis using and troubleshooting of HPLC, UV/Visible Spectrophotometer, Automatic titrator and Karl Fisher titrator.

• Preparation of Common Technical Document (CTD) Module 3, submitted to the Regulatory Authorities in Jordan and
• Preparation of SOP’s, Working Guidelines and Official documents according to internal

documentation system.

• Analytical method validation
• Evaluating the IP status of different products under Conducting searches, analyzing, categorizing and interpretation of the IP search results.
• Monitoring of Bioequivalence studies conducted for JPM with various Contract Research
• Communicating with various CRO’S, protocol approval, monitoring of clinical and Bio- analytical conduct of BE Studies, Final protocol reviewing and Statistical analyses

RESEARCHER– R&D | JPM | 1997-2000

SPECIALISED COURSES

Patents of Inventions and Data Protection of Pharmaceuticals” a specialized course part of the Arab Certified Intellectual Property Practitioner (ACIPP) Program which was held in cooperation with Talal Abu-Ghazaleh College of Business – German Jordanian University from January 8, 2007 to March 22, 2007.

CONFERENCES “LECTURER”

• Leading lecture in QbD Training for JFDA personnel, organized by JPM, entitled “New Quality Paradigm:

Quality by Design: ICH Q8-Q9-Q10”, Amman, November 2014. n

• Leading lecture in IP and Pharmaceuticals Workshop, organized by JAPM, entitled “Patents”, Amman, July

2011.

• The Third Middle East JAPM Bioequivalence Conference, Regulations and Debates, Amman, April 2010. Title of lecture: Overview of the Comments on the Draft EMA Bioequivalence
• The Forth Middle East JAPM Bioequivalence Conference, Amman, April 2011, Title of lecture: International Guidelines on
• 8th Annual Bioavailability/Bioequivalence and Dissolution Testing Conference, Organized by: Informa life sciences, Continental Zara Hotel, Budapest, Hungary, May 2012. Title of Lecture: Achieving Regulatory Compliance for Biowaivers. And the evening Seminar: Case study: Success strategies for obtaining a

PUBLICATIONS

• Assessment of controlled release hydrophilic matrix formulation for Metoclopramide European Journal of Pharmaceutics and Biopharmaceutics 55 (2003) 339-344.
• Effect of light and Heat in the stability of Montelukast in solution and in its solid state, Journal of Pharmaceutical and Biomedical Analysis, 2007 Nov 5; 45(3):465-71.

OTHER ACTIVITIES

• Member of the JAPM Working Group for
• Member of the JAPM Working Group for
• Participated as an expert in placing the JFDA Bioequivalence and Biowaiver Guidelines in 2009, and in their discussion later on in the JFDA Higher Committee