For the last several decades, there has been little innovation in the way pharmaceuticals are produced commercially, i.e., by a multistep batch process involving large-scale equipment. In addition to being lengthy and cumbersome, the batch process also introduces several possible degradation and contamination stop points.
To prevent against loss of time and raw material in this lengthy batch manufacturing process, regulatory agencies including the US Food and Drug Administration (FDA) are pushing for the development of processes capable of producing pharmaceuticals in a single facility, from raw material to finalized dosage forms. This initiative is backed by years of research in both academia and the pharmaceutical industry. Continuous manufacturing will not only eliminate loss of material and products, but will also be able to respond to variations in requirements due to an ever-changing market of pharmaceutical dosage forms.
While many chemical and petrochemical industries have successfully transitioned to continuous manufacturing of products, the transition is still in its nascent stages. There is a significant strive to develop and implement continuous processes combining multiple pharmaceutical unit operations, and a noteworthy body of scientists and regulatory administrators are working to address the challenges associated with developing not only the processes for different dosage and API forms, but also the guidelines for approval of these products.
“Challenges in Continuous Manufacturing of Pharmaceuticals” is the theme of the 11th Annual Jarowski Symposium on Industrial Pharmacy. In this symposium, we invite key opinion leaders from industry, academia, and the FDA to discuss innovative tactics to maximize the potential and also to bridge the information gap among different segments of the pharmaceutical development process. We strive to bring together the cutting-edge advances in basic, translational, and regulatory research to foster understanding of various tools and mechanisms available for a seamless transition from batch to continuous processing of pharmaceuticals.
When: Monday, May 6, 2019
Where: D’Angelo Center Ballroom
St. John's University, Queens, NY
In 2006, three distinguished Pharmacy professionals proposed that they create an alumni group to build support for St. John’s College of Pharmacy and Health Sciences and its Industrial Pharmacy Program. With the goal of inspiring and training the next generation of research scientists, Salah Ahmed ’85GP, ’91Ph.D., Navnit Shah ’73GP, ’81Ph.D. and Abu Serajuddin ’82Ph.D. formed the Industrial Pharmacy Committee.
Together they conceptualized the Dr. Charles I. Jarowski Industrial Pharmacy Symposium, which would act as a dynamic forum for the exchange of information among distinguished research scientists. The Symposium would be an annual event designed to offer our world class alumni the opportunity to explore topics relevant to the changing dynamics within the pharmaceutical industry. It would also act as an opportunity for networking and professional development between students, alumni and industry representatives.
Mansoor Khan, R.Ph. ’92Ph.D. was the first of many distinguished alumni to present at the Jarowski Symposium. He would subsequently become a key member of the Industrial Pharmacy Planning Committee.
Today, the Symposium has evolved into a major event for both the University and distinguished scientists in Pharmacy and the related professions, attracting over 100 participants annually. The theme for the Symposium is chosen by the Industrial Pharmacy Planning Committee each year to reflect the current trends in the pharmaceutical industry.
Each year, selected graduate students in the Industrial Pharmacy Program have the honor of presenting their research findings to attendees, affording them the opportunity to develop their presentation skills, seek career guidance and engage in networking with their peers and world class scientists.
Pharmaceutical industry suppliers and manufacturers also have the opportunity to sponsor the Symposium. In recognition of their support, they are given the chance to set up tables to demonstrate their products and showcase their technology to their key customers, our alumni.
Since its inception, the Dr. Charles I. Jarowski Symposium has become one of the largest academic forums for Industrial Pharmacy in the Northeast.
Dr. Ajaz S. Hussain is currently President of the National Institute for Pharmaceutical Technology and Education (NIPTE), a collaboration among pharmaceutical science and engineering programs at 17 major universities in the US. He has held this position for the last two years. Before being elected NIPTE President, he was appointed Executive Director. Dr. Hussain also spearheads his consulting firm, Insight Advice and Solutions LLC, launched in July 2013. In addition, he also serves as Adjunct Professor at The Arnold & Marie Schwartz College of Pharmacy and Health Sciences at Long Island University (2017).
Dr. Hussain trained at Bombay College of Pharmacy (’81B.Pharm.) and received an interdisciplinary doctoral degree from the University of Cincinnati (1986). He has worked for more than 30 years in biopharmaceuticals in different capacities at academic institutions, at the US Food and Drug Administration (FDA), and in pharmaceutical industry. Major positions include Deputy Director, Office of Pharmaceutical Science (2000); Vice President and Global Head for Biopharmaceutical Development at Sandoz (a division of Novartis Corp.); Chief Scientific Officer, Philip Morris International Switzerland; and Chief Scientific Officer and President Biotechnology at Wockhardt Ltd. He also served under the Senior Biomedical Research Service, a track under the Public Health Service Act.
Among his most memorable peer recognitions are FDA Scientific Achievement Awards; Fellow status in the American Association of Pharmaceutical Scientists (AAPS) and in the Swiss Society of Pharmaceutical Sciences; the Industrial Pharmacy Medal (International Pharmaceutical Federation); Scientific Achievement–Regulatory Science Award (AAPS); the Dr. M. Venkateswarlu Memorial Lecture Award (Indian Pharmaceutical Association); and the Distinguished Alumni (2004) and Outstanding Alumni (2017) Awards from his alma mater, the University of Cincinnati.
Jim Bonner, Ph.D., is a Senior Principal Engineer at Takeda, leading the transformation of the batch Vyvanse process to continuous manufacturing. He serves in the drug product group, ensuring quality production of Takeda’s small molecule products, efficient technical transfers, and collaborative CMO efforts. Dr. Bonner was formerly a Director of Technical Operations at Merck and Company, managing drug product and packaging external manufacturing from a technical perspective. He also consulted for five years with The One When, a problem solving and technology transfer company. Dr. Bonner holds an M.S. from the Massachusetts Institute of Technology and B.S. and P.hD. degrees from the Georgia Institute of Technology, all in Chemical Engineering.
Diane J. Burgess, Ph.D., Distinguished Professor, Pfizer Distinguished Chair in Pharmaceutical Technology, University of Connecticut. B.Sc. Pharmacy, University of Strathclyde (1979) and Ph.D. Pharmaceutics, University of London (1984). Fellow of AAPS, CRS, APSTJ, and AIMBE. 2010 CRS President; 2002 AAPS President. Editor of International Journal of Pharmaceutics (2009–18). Editorial board member of 13 international journals. Recipient of 2018 AAPS Wurster Award in Pharmaceutics; 2014 AAPS Research Achievement Award; 2014 AAPS Outstanding Educator Award; 2014 CRS Distinguished Service Award; 2013 AAPS IPEC Ralph Shangraw Memorial Award; 2011 APSTJ Nagai International Woman Scientist Award; and 2010 CRSI Fellowship. More than 220 refereed publications, more than 585 research presentations, more than 290 invited presentations, and 22 keynote and plenary addresses.
Atul Dubey, Ph.D., is Director of Pharmaceutical Continuous Manufacturing at US Pharmacopeia. Dr. Dubey holds a PhAD in Mechanical Engineering from Rutgers University, followed by multiple years of experience in process engineering. He is interested in all aspects of the continuous manufacturing of pharmaceuticals, the adoption and development of the technology domain, and standards development.
Andrew Farrington graduated from the University of Notre Dame in Notre Dame, IN, earning a B.S. degree in Chemical Engineering in 2003. He earned his M.S. degree in Pharmaceutical Sciences from Temple University in Philadelphia, PA, in 2006.
Prior to joining Merck & Co, Inc., Mr. Farrington worked as an Excipients Technologist in the Global Technical Services group at Colorcon in West Point, PA. Mr. Farrington joined the Formulation Development group at Merck Research Laboratories in 2004. His experience spans from preclinical formulation development through drug product commercial site scale up and new drug application authoring for solid oral dosage forms. He has made major contributions to the development of new drug candidates for infectious diseases including HIV and HCV, as well as ongoing contributions to drug product development for the treatment of type 2 diabetes. Mr. Farrington has also contributed to publications in the areas of hot melt extrusion, liquid filled capsule, and pediatric minitablet formulation development.
He is currently a colead of Merck’s Continuous Manufacturing Technology Development Team, and serves as working group leader for one of Merck’s continuous manufacture product development teams.
Zoltan K. Nagy, Ph.D., is a professor of chemical engineering at Purdue University, and heads Crystallization and Particle Technology Systems Engineering research group there. Professor Nagy’s research is characterized by the development and application of process systems, engineering approaches, and tools for engineered product design and optimal process operation, with applications in pharmaceutical, fine chemical, biotechnology, food, and agrochemical industries. Our research combines modeling, optimization, and advanced control approaches with experimental investigations using modern measurement techniques, with the generic aim to develop theoretically founded, practical methodologies for complex processes with quantifiable system performance improvements that can be supported in an industrial environment.
Michael Rooney is a pharmaceutical engineer and thought leader with more than 30 years of experience in the design and construction of cGMP facilities in the US, Europe, and Asia. He specializes in secondary pharmaceutical operations including oral solid dosage and fill/finish.
Half of Mr. Rooney’s career has been within operating companies, including 12 years as Senior Director of Operations at Elan Technology, directing the commercialization of nanotechnology products. The balance of his career has been focused on the design of efficient and compliant processes and facilities. He has been active in the International Society for Pharmaceutical Enginnering Oral Solid Dosage (OSD) continuous manufacturing group and led an OSD continuous manufacturing program at ISPE’s 2016 annual show. He has helped numerous clients plot the course from batch to continuous manufacturing and is currently working with a client to implement continuous manufacturing their entire 12 billion units/year network.
Bayan Takizawa, M.D., M.B.A., is a cofounder and Chief Business Officer at CONTINUUS Pharmaceuticals, a spin off from the Novartis-MIT Center for Continuous Manufacturing that is leveraging a novel continuous manufacturing platform to develop and produce drugs faster, cheaper, and of better quality. Dr. Takizawa has helped the CONTINUUS team raise more than $18 million in financing and establish industry partnerships with multiple companies. Before joining CONTINUUS, he was a consultant with The Chartis Group, an advisory firm that provides strategic and operational consulting services for hospitals and healthcare systems. Prior to Chartis, Dr. Takizawa was a Senior Analyst at Actin Biomed, a New York-based healthcare investment firm. Dr. Takizawa has an M.D. from Yale, an M.S. in Engineering Systems and M.B.A. from MIT, and a B.S. in Chemical Engineering from Cornell. He has multiple publications in peer-reviewed journals, and is an active member of the Massachusetts life sciences community.
Registration and breakfast
Russell J. DiGate, Ph.D.
Dean, College of Pharmacy and Health Sciences
St. John’s University
Ajaz S. Hussain, Ph.D.President
National Institute for Pharmaceutical Technology & Education
Coffee break and exposition
Moderator – TBD
SpeakersDiane J. Burgess, Ph.D.
Board of Trustees Distinguished Professor of Pharmaceutics
University of Connecticut
Zoltan K. Nagy, Ph.D.
Professor, Davidson School of Chemical Engineering
Atul Dubey, Ph.D.
Director, Pharmaceutical Continuous Manufacturing
11:45 a.m.–1 p.m.
Industry sponsor presentations
Moderator – TBD
SpeakersBayan Takizawa, M.D., M.B.A.Cofounder and Chief Business Officer
Michael RooneyDirector, Process Engineering, Genesis Engineers
Coffee break, posters, exposition
Moderator – TBD
Jim Bonner, Ph.D.Senior Principal Engineer
Andrew FarringtonPrincipal Scientist
Merck & Co., Inc.
Poster viewing, exposition, and open reception
Awards and closing remarks
St. John’s University College of Pharmacy and Health Sciences calls for presentations at the 11th Annual Dr. Charles I. Jarowski Symposium on May 6, 2019, in Queens, NY. The theme of the symposium is “Challenges in Continuous Manufacturing of Pharmaceuticals.” Authors are encouraged to submit their presentation abstracts in line with the symposium theme as early as possible, no later than 5 p.m. EDT, on Thursday, April 4, via the Poster and Submission Form.
Abstract Submission Deadline: 5 p.m. EDT, April 4
Abstracts should have the following format:
**The author responsible for correspondence must include his/her e-mail address and phone number for communication in the body of e-mail.
Presentation of a poster provides an opportunity for effective one-to-one communication. The longer presentation time of the poster session enables the author(s) to present a more in-depth description and discussion of their work.
To make a success poster presentation:
All posters will be allotted a number. On the day of the presentation, the poster should be mounted on the numbered posterboard provided by the symposium. Presenting authors must be present at their posters during the entire session. Presenting authors will be responsible for setup and removal of their posters.
Questions? [email protected]
10th Annual Dr. Charles I. Jarowski Industrial Pharmacy Symposium
As the scientific community discovers novel groundbreaking therapies for a variety of medical conditions, new challenges unfold in translation of basic science discoveries into clinically effective therapies. These challenges exist in a variety of forms and shapes, especially in the areas of determining the correct dose, dosage form, and regulatory status for the new product.
The 10th annual Charles Jarowski Symposium focused on a theme of “Bench 2 Bedside: Advances in Delivery Technologies and Regulatory Strategies for New Drug Approval,” encompassing a carefully selected panel of speakers discussing innovative tactics to bridge basic and translational scientists in biomedical research. The theme stands at the crossroads of many relevant disciplines in not only therapeutic but diagnostic applications as well.
The eminent speakers focused on providing an overview of their respective areas of expertise in (i) regulatory landscape for new products, (ii) quantitative PK/PD modeling, and (iii) novel drug delivery approaches. The symposium brought together the cutting-edge advances in basic, translational, and regulatory research to foster understanding of various tools and mechanisms available for a seamless transition from discovery to drug development.
Wyndham Garden Fresh Meadows Flushing
6127 186th Street, Fresh Meadows, NY, 11365
Wyndham Garden is located 1.5 miles from St. John's University, easily accessible to restaurants, shopping, medical providers and pharmacies.
The park-like Queens campus is readily accessible by car, bus, subway, or air. Located between JFK and LaGuardia Airports, the campus is just off the Grand Central Parkway, which connects Nassau and Suffolk Counties to Queens, Manhattan, and upstate New York.
St. John's University
8000 Utopia Parkway
Queens, NY 11439
GPS: 40.721378, -73.790375
Take the Queens Midtown Tunnel to the Long Island Expressway, exit at Utopia Parkway. Stay on the service road to Utopia Parkway and turn right. Follow Utopia Parkway to Union turnpike; the campus is on the right.
From Brooklyn Option One
Take the Belt Parkway (East) to the Van Wyck Expressway (678 N.), exit at Main Street/Union Turnpike. Proceed to the third traffic light and make a right onto the Grand Central Parkway service road. Go left on Utopia Parkway (at fourth traffic light) and proceed to the campus.
Take the Jackie Robinson Parkway (East) to the Grand Central Parkway (East); exit at Utopia Parkway, and make a left on to the campus.
From the Bronx Option One
Take the Throgs Neck Bridge to the Clearview Expressway. Take exit 2 and make a right onto Union Turnpike. Make a left onto Utopia Parkway; proceed to main gate (1) and make a right onto the campus.
Take the Triboro Bridge to the Grand Central Parkway. Exit at Utopia Parkway. Turn left at the light and left onto the campus.
From Long Island (North) Option One
Take the Northern State Parkway to the Grand Central Parkway, exit at 188th Street. Turn left at the light, and make an immediate right onto the service road. Follow the service road to Utopia Parkway; bear right to campus.
Take the Long Island Expressway and exit at Utopia Parkway. Make a left on Utopia Parkway and proceed to Union Turnpike. The campus is on the right.
From Long Island (South)
Take the Southern State Parkway to the Cross Island Parkway. Proceed to the Grand Central Parkway (west), and exit at 188th Street. Turn left at the light, and make an immediate right onto the service road. Follow the service road to Utopia Parkway and bear right to campus.
From Connecticut (North)
Follow I-95 South to the Bruckner Expressway toward the Throgs Neck Bridge. Cross the bridge to the Clearview Expressway. Take exit 2 from the Clearview and make a right onto Union Turnpike. Make a left onto Utopia Parkway; proceed to main gate (1) and make a right onto campus.
From New Jersey
Take I-95 North or I-80 East to the George Washington Bridge. Cross the bridge and take the Cross Bronx Expressway to I-295 to the Throgs Neck Bridge. Follow directions above from Bronx (Option One).
Parking Rules and Regulations
View the parking program page for more information on:
La Guardia Airport
Take the Grand Central Parkway east (toward Long Island). Exit at Utopia Parkway, turn left at the light and left onto the campus (a 15 minute drive).
Take the Van Wyck Expressway to the Main Street/Union Turnpike, exit. Proceed to the third traffic light and make a right onto the Grand Central Parkway service road. Make a left on Utopia Parkway (at the fourth traffic light) and enter the campus (a 15-20 minute drive).
I.N.D. Subways E Train
Take train to Kew Gardens/Union Turnpike station. Take Q-46 bus to Union Turnpike and Utopia Parkway.
Take train to 169th Street station. Take Q-30 or Q-31 bus to St. John's University main gate on Utopia Parkway and 82nd Avenue.
I.R.T. Subway, 7 Train
Take train to Main Street, Flushing.
Take Q-17 bus to Utopia Parkway and the Long Island Expressway. Transfer to the Q-30 or Q-31 bus to St. John's University main gate on Utopia Parkway and 82nd Avenue.
Long Island Railroad (L.I.R.R.)
Take L.I.R.R. to Jamaica Station. Take the Q-30 bus to St. John's University main gate on Utopia Parkway and 82nd Avenue.