Dr. Kamal A. Rashid has over forty years of academic experience in both research and biotechnology program development. During his career he has developed, directed and implemented biotechnology and biomanufacturing training courses at Worcester Polytechnic Institute (WPI), Utah State University, Penn State University and internationally. He has delivered bioprocessing training programs on-site in numerous countries, including, China, Dominican Republic, Egypt, Indonesia, Iraq, Korea, Malaysia, Philippines, Puerto Rico, Vietnam, Thailand, Taiwan, and Singapore. He has collaborated with numerous biotechnology companies, delivering joint training programs both in US and abroad.
Dr. Rashid is very well recognized for his continuing education, teaching and international programs. He received a Faculty Service Award in 1997 from the University Continuing Education Association for his meritorious service to Penn State University. He was also honored in 2012 as the international professor of the year in College of Agriculture and Applied Sciences at Utah State University. His present research emphasis is on bioprocessing utilizing mammalian cell systems. He received his Ph.D. from Penn State University with emphasis on toxicology and genotoxic effects of environmental pollutants on human health. Presently he is a Professor Emeritus from WPI and President of International Biotechnology Associates (IBA), a consulting firm he started in 1997 to provide the growing biotechnology with technical expertise in biotechnology and biomanufacturing.
WHAT IS CBET?
The Center for Biopharmaceutical Education and Training will educate undergraduate and graduate students and provide workforce training in the manufacturing of biopharmaceuticals. It will include:
- Laboratory experience in upstream processing in a simulated cGMP environment.
- Laboratory experience in downstream processing in a simulated cGMP environment.
- A quality control lab for both upstream and downstream.
- An aseptic finish fill demonstration module.
Who will CBET educate?
CBET will educate traditional students in the following tracks:
- BSc in Microbiology with a concentration in Industrial Microbiology.
- BSc and MSc in Pharmaceutical Sciences with a concentration in Bioanalytics.
- A one-year Professional Science Masters (PSM) program in Pharmaceutical Science of Bioprocess primarily for students without a background in biological sciences.
- Professional Elective Courses for PharmD students.
CBET will also train individuals currently in the workforces through:
- Open Enrollment Short Courses on topics of current interest in biopharmaceutical manufacturing.
- Customized Short Courses tailored to the needs of a specific company.
ACPHS faculty will teach courses involving traditional students and adjunct faculty from industry will teach in the short courses. Short courses are typically four-day workshops featuring hands on experience that enroll approximately 20 students per workshop.
Biopharmaceuticals or biologics are transforming the pharmaceutical industry.
- The global biopharmaceutical industry had $237B in products last year and this is expected to grow at the rate of 8.6% per year for the next 5 years.
- Biopharmaceuticals are estimated to contribute 50% of the top 100 products sales by 2022.
- Biopharmaceuticals or biologics now constitute roughly 40% of the newly approved drugs coming out of the FDA.
CBET is a response to the high and growing need for talent in the biopharmaceutical industry. The production of biologics is much more complicated than traditional small molecule therapeutics that have been the historic strength of the pharmaceutical industry. The need for an educated workforce is becoming more acute and staffing and technical skills has been recently cited as the single largest constraint to growth in this sector. Workforce needs are driven by:
- Increased demand for manufacturing capacity.
- Demand for the manufacturing of new therapeutic modalities such as cell and gene therapy.
- Diversification of manufacturing technologies- from batch to single use to continuous flow.
Innovation does not stop with product development but encompasses manufacturing practices as well. Current genetically engineered systems are so productive that bioreactors can be operated at much smaller volumes than in the past. This allows biologics to be manufactured for small patient population and pave the way for personalized medicine. The tag line is “the process is the product”.
How is CBET going to be implemented?
CBET will be implemented in two stages whose timing will be dependent in large part on the ability to identify resources for the project.
Stage 1. Stage 1 will begin in January 2020 with the occupancy of 2200 sq. ft of laboratory space on the UAlbany East Campus in Rensselaer, an office park housing Regeneron, AMRI and a number of small biotech companies. Stage 1 will be funded by a $9M fundraising effort from ACPHS donors and corporate partners. Stage 1 will see the development of the laboratory courses associated with the traditional degree program and a limited number of open enrollment courses. Stage 1 will be overseen by a newly appointed founding Director of CBET, two ACPHS faculty members and the Program Director for Microbiology and the Department Chair for Pharmaceutical Sciences.
Stage 2. Stage 2 will see CBET move to a 20,000 sq. ft building that we currently anticipate will be newly constructed. Construction and equipment fit out of the new site is priced at $21M. We also anticipate $7M in operating expenses in the newly fitted and fully staffed facility. A site is available on the ACPHS campus for this facility. During this stage, a full complement of 20 open enrollment workshops and 20 customized workshops will be developed. We anticipate beginning site work on Stage 2 in January 2021, but that will be dependent on successfully identifying external sources of funding.
The housing of a biopharmaceutical center in a college with a strong pharmacy program offers a distinct value proposition that differentiates it from other settings. ACPHS grounding in pharmacy practice is well aligned with the domain knowledge and skill sets required by industry. The pharmacist’s sensitivity toward the end user and knowledge of the critical importance of formulation is well aligned with today’s approach to biopharmaceutical development and manufacturing. Additionally, ACPHS strong alumni base in the pharmaceutical industry has allowed it to form an industry advisory board for CBET that features established national experts in biopharmaceutical manufacturing.
ACPHS is uniquely positioned to develop the programming around CBET. CBET will be:
- The first in its kind supporting the NYS biopharmaceutical industry and providing infrastructural support for early stage companies.
- The first bioprocess center in a pharmacy college.
- The first to target health scientists and pharmacists for education in biopharmaceutical manufacturing.
- A uniquely strong focus on quality control and assurance issues for both upstream and downstream bioprocess.
- The first center to have a fill-finish unit.
What are Biopharmaceuticals?
Biopharmaceuticals are created by genetically engineering mammalian cell lines or a variety of microorganisms to produce a large therapeutic agent, usually a protein, that is often processed by the cell in a number of distinctive ways. The first recombinant protein was insulin brought to the market in the 1980s by Genentech. Before this, insulin was obtained from cadavers or from pigs. Current biomanufacturing of human insulin yields the equivalent of the insulin from 15 billion pigs. Currently, only 440 million pigs are farmed worldwide. This is a scientific and technological success story. In the 30 years following the creation of recombinant insulin, biopharmaceuticals have demonstrated therapeutic value in a range of chronic illnesses and cancers. They are now a mainstay of the pharmaceutical industry.