Drug Development Project Management

HANAN F. KAKISH

Marietta, GA, USA - 470-***-**** - *************@*****.***

Professional Summary

A pharmaceutical professional of more than 27 years’ experience with advanced skills in drug development, GMP requirements and regulatory guidelines in MENA, US and Europe. Expert in enhancing drug development, process improvement and ensuring regulatory compliance in addition to advanced training skills. Known for being initiative and strong collaboration with high adaptability in dynamic environments, excelling in analytical thinking and project management, including technology transfer and contract manufacturing.

Accomplishment

• Have one patent "WO 2023/037394 A1, Pharmaceutical of Sildenafil and a formulation thereof"

• I was a member in several regulatory-industry committees for updating drug regulations and guidance

• Speaker in more than 30 international and domestic conferences and training workshops

• Have several publications including two papers and five analytical papers on different drug regulations and pharmaceutical industry in select MENA countries. Work Experience

Pharmaceutical Consultant - Self Employed, July 2024- Current

• Training pharmaceutical industry and regulators on:

- Post Approval Changes & Pharmaceutical Product Line Extension Requirements of U.S. FDA, EMA, Jordan FDA (JFDA), & Saudi FDA (SFDA).

- Bioequivalence (BE) requirements & BE Bioanalysis & Biowaiver Requirements of U.S. FDA, EMA, JFDA, & SFDA.

- GMP requirements

- Data integrity updated requirements and DIRA

- Customized regulatory and technical pharmaceutical topics

• Consultation in pharmaceutical industry, product developments, troubleshooting, regulatory affairs & submissions to health authorities.

Technical Director at Amman Pharmaceutical Industries, Amman, Jordan, Mar 2018 – July 2024

• Provided leadership and oversight of a manufacturing organization consisting of 8 production lines, three of which are aseptic lines.

• Provided overall management to the technical and laboratory departments including QA, QC, RA and R&D. I guided & significantly built the team’s knowledge in the four departments.

• Enriched R&D pipeline through strategic planning & enhanced collaboration with business & marketing in addition to

• Provided overall management and leadership necessary to ensure commercial and pharmaceutical products are produced to meet annual objectives concerning product quantities and forecasts, timelines, and cost of goods while ensuring highest quality standards are implemented.

• Provided guidance and develop individuals within the organization to maintain a strong manufacturing culture, process improvement, and validation capability recognized for its quality, creative accomplishments, speed of action, and technical expertise.

• Developed and maintained good working relationships with all functional areas in the company in order to facilitate a team-based approach to meeting the company's objectives.

• Managed multi-projects of CMOs & technology transfer between different facilities/companies. R&D Manager and Clinical Monitor at Jordan River Pharmaceutical Industry, Amman, Jordan, Feb 2015 – Mar 2018 & June 2007 - Nov 2009

• Developed more than 20 new generic products and submitted their registration files.

• Managed multi-projects of technology transfer & new products registration/importation in several MENA countries.

• Reviewed protocols/study designs and monitoring several BE studies for the developed generics.

• Scaling up, process validation & solving several production problems for different dosage forms. Regional Technical and Innovation Director at Apex Pharmaceutical Services, Jan 2014 – Feb 2015 Focused on consultancy and building pharma capacity for pharmaceutical industry in the region. Medical Research Scientist, USFDA, Office of International Programs, MENA Post, The American Embassy in Amman, July 2012 – Dec 31, 2013

• Building strong and trusting network of relationships with FDA regulatory counterparts and industry in most countries of the region through meetings, conferences, and personal visits to the countries.

• Strengthening communication between FDA and its stakeholders, including foreign governments by notifying them of updated and new regulations, rules, requirements, standards, and other initiatives that aim to keep their knowledge of FDA up-to-date.

• Developing a robust understanding of the regulatory system governing production of medical products manufactured in the region through authoring analytical papers about drugs regulations and drugs regulatory systems in select MENA countries, and writing regulatory profiles of MENA countries.

• Increasing collaboration with the MENA medical products industries to help assure their understanding of and compliance with FDA standards, regulations, & requirements through delivering talks mainly about generic drug premarket applications & updated BE data submission requirements.

• Providing support and capacity building efforts to FDA’s counterparts and industry by responding to their regulatory and technical questions.

• Supporting the Senior Regional Advisor of the MENA Post in developing budget, strategic plans, and databases for MENA contacts.

• Analyzing USFDA-generated data about medical products imported from the region for a better understanding of the compliance problems these products face at the U.S. borders.

• Conducting USFDA inspection for a Contract Research Organization (CRO), which included both the clinical and analytical parts of the study.

Pharmaceutical Consultant (CCRA) Self Employed, Amman, Jordan, Jan 2011 – July 2012

• Trained pharmaceutical industry and regulators from different MENA countries in Post Approval Changes & Pharmaceutical Product Line Extension Requirements, & BE Bioanalysis & Biowaiver Requirements of U.S. FDA, EMEA, JFDA, & SFDA.

• Monitored the clinical and analytical parts of BE studies for local manufacturing companies; this included reviewing study protocol/design, CRO’s SOPs, analytical validation procedures, clinical conduction, analysis of authentic samples, and final report. Clinical & Analytical Manager Pharmaceutical Research Unit, Amman, Jordan, Nov 2009 - Nov 2010

• Responsible for analytical department staff developing & validating new analytical methods & analyzing plasma samples for volunteers recruited in BE studies.

• Reviewing BE protocols/study designs.

• Responsible for clinical team conducting the clinical part of BE study. Products Development Section Head, CRA & Solid Products Section Head, Arab Pharmaceutical Manufacturing Company (APM), Salt, Jordan, June 2006 - June 2007

• Developing new generic product & preparing registration files

• Reviewing protocols/study designs & monitoring BE studies

• Scaling up, validation & solving production problems for different dosage forms

• Solving production problems for solid dosage forms

• Responsible for granulation, compression & coating sections in solid products department Reformulation & Trouble Shooting Section Head, APM, October 2005 - June 2006

• Reviewing protocols/study designs and monitoring BE studies

• Solving production problems for solid, semi solids, & liquids dosage forms

• Reformulating solid, semi solids, & liquids dosage forms

• Scaling up, validation & solving production problems R&D research scientist-Products Development Department, APM, May 1998 - October 2005

• Developing new generic drug products,

• Reviewing protocols/study designs and monitoring BE studies

• Scaling up, validation & solving production problems for solid, liquids, semi solids & sterile products Education

• Continued Education-Certified Clinical Research Associate (CCRA), March 2011.

• M.Sc. Pharmaceutical Technology with Honor, Jordan University of Science and Technology, Irbid, Jordan, Sept,1996- Jan, 1999

• B.Sc. Pharmacy, University of Jordan, Amman, Jordan, Sept, 1991-June, 1996

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