GROUP I (Analytical and Formulation Development)
- QBD & Product Performance
- Process development & process modeling & simulation
- Modified Release: Drug layering, Pellets/ Beads Coating
- Formulation of Insoluble Drugs:
- Hot-melt Extrusion
- Inhalation & Nasal Technology
- Ocular Drug Delivery/ Transmucosal Drug Delivery
- Transdermal Patch
- Process Analytical Technology
- In-vitro Release & Dissolution Testing
- Bio-indicative dissolution method
- Bio-relevant dissolution method
- Impurities in Drug Products
- API related
- Excipient related
- Process related
- Technical Documentation/Review
Thirteen (13) scientists from diverse fields attended this focus group. The disciplines included quality control, quality assurance, USP analysis, FDA reviewer, R&D formulation, analytical R&D, technical writing and graduate/Ph.D studies. The moderator requested each member to introduce themselves while focusing on two points: 1) purpose of attending the convention, and 2) suggestion for fulfilling the purpose.
Following members participated in the discussion:
- Ehtesham Reza /LIU Student
- Abu Hasan Islam /CV Fleet
- Naziba Islam /Teva QC Virginia
- Nahid Kamal / LIU & Howard University student
- Abdullah Mahmud /NCL?
- Sushanta Sarkar, Student
- Mohammed Khair / Teva NY Technical writing
- Mokarrem Chowdhury /Formerly Sandoz AR&D – job seeking
- Shamim Hasan / Formerly Sandoz R&D – job seeking
- Mohiuddin / Sun Pharma QA
- Ashraf Khan / USP scientist
- Ashequr Rahman /FDA OGD
- Abul Azad (moderator) /Teva NY R&D
Finding opportunities through networking and helping the fellow member in the same way were the prime objectives of all the focus group members. It was observed that there were some job opportunities with the federal agencies like FDA and the independent organization like USP. Applying to these job openings require tweaking of the resume and appropriate answering of the questionnaire. Assistance from the existing employee could be critical in getting through the HR screening stage. Another better option was to go through the employee referral program. Compatriot scientist Ashraf Khan from USP mentioned opportunities under Promoting Quality Medicines (PQM) in USP. It was also noted that FDA was hiring for OGD.
Group II (Biologics)
Biologic drugs are top 6 revenue earners out of the top10 drugs sold in USA in 2012. Humira (a monoclonal antibody) is the top selling drug used for the treatment of rheumatoid arthritis. While biologic drug development is expanding, some of these top selling drugs are also going off-patent in the US and EU. This has created opportunities for countries like Bangladesh, India and China to develop and manufacture these drugs and sell at a cheaper price. In this Focus Group, participants are welcome to discuss the following questions with an objective to share knowledge about a topic or issue:
- Who are we and what is our expertise in Biologics: discovery, development and manufacturing
- What are the career and networking opportunities: strategies for success
- What are the current challenges and opportunities to develop Biosimilars
- What is ahead of us: Antibody Drug Conjugate (ADC), bi-specific antibodies and other new entities
- How can we contribute to develop Biologics in Bangladesh: role of AABPS
Create a permanent Biologics Focus Group within AABPS. The current members are the attendees of the 1st focus group meet: Eva Sultana Khan Alam (Astra Zeneca), Masrur Alam (Imad) (Grad Student), M. Delwar Hussain (Texas A&M Univ.), Rajib K. Paul (NIH), Muhammad Shameem (Merck) and Musaddeq Hussain (Merck). The focus group discussion was moderated by M. Shameem and M. Hussain. The Biologics Focus group will be open for collaboration and share and post job/career opportunities.
- Create a permanent Biologics Focus Group within AABPS. The Biologics Focus group will be open for collaboration and share and post job/career opportunities.
- Big Pharma has biologics in focus now:
- There are 6 Biologics out of top 10 revenue earners among all class of pharmaceuticals in USA
- There is a patent cliff by 2014 opening up opportunities for Biosimilars and participation by pharmaceutical companies in Bangladesh
- There is a safety advantage inherent in biologics
- New biologic drug classes like Antibody Drug Conjugates are very promising
- Make Bangladesh academic institutions aware of biologic drugs as drugs of future and they should:
- Create curriculum fit for biologic drug development
- Train future and current workers
- We should use whatever leverage AABPS has in bringing these changes in Bangladesh
- We are ready to collaborate with pharmaceutical companies in Bangladesh to create curriculum and train workers for biologic drug development and manufacture.
Group III (Clinical Research)
- Introduction of participants with their background, areas of work and research
- Screening the areas of interest of the participants in AABPS and assessing the need in the group with focus on the areas for clinical research in the field of Inpatient and Ambulatory Care Pharmacy along with pure clinical research
- Brain storming for ideas to find out some solution or guidance: How members or teams in AABPS can help each other
- Take home points from the group
- We need a clinical research focus group committee who will be responsible to work on our dedicated page for clinical research focus group under AABPS website.
- Our home page will serve as an educational and networking site for all who are interested and related to the field of clinical research.
- We agreed that the field has a tremendous opportunity which needs to be explored, invented & re-invented. Our website can serve as a tool for all who are interested to learn or get connected.
- AABPS clinical research focus group member information can be provided in the website for networking purpose.
- We will post updates, publications and honors of the members along with relevant job postings in the homepage for clinical research.
Group IV (Information Sciences)
- Purpose of this focus group
- Introduction and areas of research of attending members
- Our goal (s)
- AABPS and our expectations
- How to enhance participation of Information Scientists (Data Management, Programming, Statistics and IT) in AABPS activities
- Next steps
- Formation of a Task Team of Information Scientists for AABPS activities
This breakout session was planned for Information Scientists, which conceptually includes, but not limited to, Statistician, Programmer, Database Setup and Design Specialist, Data Manager, and Information Technology Specialists. The session was unable to attract enough audience who were professionals in the above mentioned areas. Thus, discussions around the agenda topics were not targeted for above mentioned disciplines, rather addressed for general audience.
The attending members thought that the following should be a part of AABPS’s strategic goals:
- Advisory and guidance for students based on their need for future.
Tactical plan for AABPS should include the following:
- Arrange mechanism for guidance for new immigrants with education in pharmaceutical sciences and those who would like to pursue career in North America in pharmaceutical industry, academia, research institutes or a government regulatory agencies.
- Offer or make arrangement for short courses on statistics for non-statisticians.
- Offer relevant continuing education courses for its members at the convention.
- Create networking tool in the AABPS site to facilitate networking among the members for collaboration, job prospects, guidance and advice.
- Post member profiles in the AAPBS web site with their contact information.
- Post job opportunities in the AABPS website.
- Attract students at all levels, starting from high school and increase their awareness for pharmaceutical professions.
- Encourage research collaboration among its members.
- Engage families (i.e., spouses and children) by continuing on the social and cultural aspects of the convention.
- Engage current members to:
- Increase their participation and get their help to expand membership
- Build and expand the role of this organization
- Develop a sense of giving, i.e., what can we do for the organization?
Group V (Regulatory Affairs)
- There are three ways of applying for FDA approval of drug product. One is under 505(b) (1), another one is 505(b)(2) and the third one is 505(j) .
- What information we have regarding 505(b)(2) applications
- How can we help Bangladeshi Manufacturer in filing this type of applications
- CMC consideration for this type of applications
- Major and minor amendment or post approval supplements
Group VI (Generic Product)
- Challenges of selecting a generic drug
- Understanding formulation, process, patent, technology
- Developing generic using QbD – things to prepare
- Manufacturing of submission/bio batch
- BE study/Stability of the drug product
- Submission of ANDA in e-CTD
- Example of Major FDA Deficiencies and How to respond to the deficiencies
- FDA Approval
- Validation Exercise
- Product Launch for commercial distribution