NBC2 Rhode Island Hub

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					updated 7/26/2012
J. Pino


       Northeast Biomanufacturing Center and Collaborative (NBC2)
                         Rhode Island Hub Report
                                2005-2007
Please note that recent updates are indicated in italics below every section.

Rhode Island Hub Staff

Josephine Pino is the director of the Rhode Island hub and CoPI on NSF-ATE
award #0501953 “The Northeast Biomanufacturing Ceneter and Collaborative:
Building a Sustainable Infrastructure for Biomanufacturing Jobs and Education.
She is currently Assistant Professor of Biology and Coordinator of the
Biotechnology Certificate Program at the Community Collge of Rhode Island
(CCRI). Senior personnel at the RI hub are Professor Richard Cardin, Chair of
the Engineering Department, Professor Thomas Whitfield, Chair of the Chemistry
Department at CCRI, and Dana Hopkins, biotechnology teacher at Davies Career
and Technical High School. Christina Befumo works in a supportive role as a
laboratory technician to support curriculum materials development activities.

October 2006-February 2007 Staff Updates
During Year 2 of the grant, T. Whitfield and R. Cardin will be limiting their
participation to summer. Extra technical assistance from either Christina or
another assistant will help compensate for this change.


Community College of Rhode Island Biotechnology Program
The Community College of Rhode Island (CCRI) is a multi-campus system that
includes 4 large campuses and 4 satellite campuses, serving a total of
approximately 15,000 students. The main campus, the Knight Campus, is
located in Warwick, RI. This campus is home to several technical professional
programs, including those that are relevant to this work: Engineering
Technology, Chemical Technology, and Biotechnology. The latter, launched
during Spring of 2004, exists currently as a 18 credit Biotechnology Certificate
Program. Courses in this program include the following:

1 credit Orientation to Biotechnology (BIOL 1300)
3 credit Introductory Biotechnology Laboratory Skills (BIOL 1310)
4 credit Cell Biology for Technology (BIOL 1000)
3 credit Chemical Technology IA (CHMT 8000)
3 credit Introduction to Instrumentation (Process Control) (INST 1010)
4 credit General Microbiology (BIOL 2480)

This multidisciplinary Biotechnology Certificate Program was initiated with two
goals in mind. First, this 18 credit program was developed primarily to serve
students who already have academic and/or work experience in a related field.
Program prerequisites are completion of a college level composition course and
assessment testing score that shows proficiency in algebra. Second, the 18-



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credit program was developed originally with the idea that it would serve as a
transitional program that could eventually expand into a full degree-granting
program. The intent was to start quickly, taking advantage of preexisiting
coursework and program expertise. In particular, CCRI’s long-lived success in
teach both Process Control and Chemical Technology skills were a solid asset
upon initiation of the certificate program.

The Chemical Technology courses are taught in dedicated laboratory classrooms
that house instrumentation that includes multiple HPLC’s, spectrophotometers,
gas chromatographs, and others pieces of instrumentation that provide many
opportunities for hands-on training of students in a workplace-like environment.
Similarly, CCRI has a dedicated process control laboratory that includes real
instrumentation in student-friendly formats such that students are able to watch
the results of feedback control and other controlled events. At this time, a distinct
teaching laboratory space has not yet been dedicated. However, a small
preparation lab is currently being used for initial NBC2 activities and a tentative
relocation space has been identified in an area that is part of the college’s
“Integrated Manufacturing” facility. Information technology support and facilities
at CCRI’s Knight campus are strong and include computers in most lab
classrooms, several fully-equipped computer classrooms, multiple levels of
information technology support, and videoconferencing capability.

Currently, we are in the process of seeking approval for an Associate of Science
in Biotechnology. This A.S. curriculum has met approval at the college and the
next phase of the process is obtaining approval by the RI Board of Governors of
Higher Education. If approved, the A.S. degree will allow CCRI to expand its
training new students. It will also provide valuable opportunities to teach
biomanufacturing skills in an integrated, project-based sequence that would rely
heavily upon the Global Manufacturing Curriculum.

October 2006-February 2007 Curriculum Updates
The proposed facilities plan does not seem feasible at this point due to financial
constraints. Preliminary estimates of the cost of transforming the proposed
space into an appropriate Biomanufacturing/Biotechnology training facility were
over $200,000.00.

The Biomanufacturing/Biotechnology A.S. degree proposal plan has been
postponed indefinitely due to the aforementioned lack of dedicated space and the
absence of an operating budget to sustain such a training program. Program
approval in RI must be accompanied by a “break-even” budget unless an
external, sustainable source of funding is available.


Baseline Information
At the beginning of the grant period, approximately 20 students were enrolled in
one or more biotechnology program courses; however, only 3 had officially



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applied and met the requirements to gain designation as Biotechnology
Certificate students. (Requirements include an application fee, assessment
testing, and transcript evaluation.) As the grant period begins, it is also worth
noting that we had recently formed our local industry advisory board, with 8
participating members, representing 6 companies. We were initiating
partnerships with the University of Rhode Island and Davies Career and
Technical High School. As has been noted above, we began this grant period
with good equipment and facilities for the teaching of chemical technology
(including many QC skills) and process control skills, but had identified several
gaps in necessary equipment and space for the teaching of skills such as
mammalian cell culture, upstream processing, and low pressure
chromatography. At the beginning of this grant period, only 4 students had
completed the requirements for the certificate of Biotechnology at CCRI and of
these, one was continuing work as a chemical technician, one was working in an
environmental testing laboratory, one was seeking employment in the
biotechnology industry, and the other had ceased contact, perhaps due to
relocation.

October 2006-February 2007 Student Updates
Recruitment and retention efforts are showing rewards. Although our official tally
of program students stands at 6, surveys indicate that 20 students are actively
pursuing the certificate. (The reason for the discrepancy is that many students
have double majors, but only one can be indicated on the official documentation).
Enrollment records indicate that almost 60 have at some point indicated
Biotechnology as their desired major. Of these, some have gone on to find
employment, 7 have received their certificates, others are still working on their
admissions requirements, and some are unaccounted for. We are now working
with a new admissions officer who has helped improve the overall process of
admission and related communications.

Anecdotal observations indicate a growing interest in Biotechnology among
younger students. In addition, awareness of the field seems to be growing in the
region as indicated by the broader demographics of current biotechnology
students. Many of our certificate students are enrolled in majors from diverse
fields including Engineering, Health Occupations, Pharmacy, and Chemistry.



The following is a summary of the goals of the NBC2 and the deliverables
that have been achieved at the time of this report.

1) Establish Sustainable Learning Communities around Community
College Hubs

     Several students have either joined or attempted to join ISPE. New
      England ISPE leaders have addressed the problems we’ve had


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         regarding the full vs part-time student status as it relates to ISPE
         eligibility. At this time, students are allowed to join as long as they
         show commitment to pursuit of the Biotechnology certificate. During
         the Spring of 2006, 5 students and J. Pino toured Pfizer with ISPE.
        The RI hub director has posted one web log at
         www.biomanufacturing.org.
        Josephine Pino is a member of the steering committee for the Rhode
         Island high school biotechnology initiative. She also communicates
         with area high school teachers via the RI biotech listserve and the
         Bio-Link listserve. The relationship with the major high school
         partner, Davies, is strong. The RI hub activities during Summer and
         Fall of 2006 have supported Dana Hopkins in the development of
         curricula for upstream and downstream processing for use at the
         secondary school level.
        Several Industry partnerships have been established. However,
         active communication has been somewhat difficult to maintain with
         the local biomanufacturing industry. (Please see the “challenges”
         section at end of this report.)
        Josephine Pino has built relationships with the RI Department of
         Labor and Training via meetings and sharing of information.
         Students currently have access to HIB VISA Biotechnology Training
         funds.
        Partnerships with higher education in the RI hub area are in
         development. Progress has been made, particularly via the RI
         EPSCoR project. (EPSCoR = NSF “Experimental Program to
         Stimulate Competetive Research”). As a result of participation in the
         EPSCoR pre-project meetings, CCRI has become a more active
         participant in the state’s Life Science Initiatives. However, several
         challenges remain. (Please see the “challenges” section at end of
         the report.)

October 2006-February 2007 Learning Community Updates
  o CCRI is launching a new Student Chapter of the New England ISPE
     (International Society of Pharmaceutical Engineers). We held an
     informational meeting, hosted by Mark Sitcoske (NE chapter pres) and
     Peter Fox (Board member) in December. Our first official chapter meeting
     is on Feb 19. We currently have 8 student members.
  o Several faculty, staff and student representatives from CCRI attended the
     ISPE-sponsored BioPharma Conference in Warwick on January 18.
  o The RI hub director, J. Pino has posted one web log at
     www.biomanufacturing.org
  o J. Pino continues participation as a member of the steering committee for
     the RI high school “Bioscience Academy” initiative, whose goal is to
     introduce a new 3-year biotechnology curriculum in several RI high


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         schools. The plan is to include a biomanufacturing module in the senior
         year. Mary Jane Kurtz of Minuteman Technical High School in Mass. will
         be an extremely valuable resource as the high shcool initiative in RI
         develops to include biomanufacturing.
    o    J. Pino and C. Befumo continue to work with Dana Hopkins of Davies High
         School to bring more biomanufacturing into their curriculum. The initial
         focus has been on upstream methods of yeast growth, with a S.
         cerevisiae-GFP system. Currently, we are helping Dana identify methods
         and materials for development of downstream curricula to purify GFP.
         Much of the work has been based on information and some materials
         shared by Tom Burkett.
    o    Efforts to network with the local biomanufacturing community continue.
         Alexion Pharmaceuticals is currently hiring and setting up a new facility in
         Smithfield, RI where they’ll be producing Soliris™(eculizumab), is a whole
         antibody, complement inhibitor that we have developed to treat a blood
         disorder, PNH. We have begun a good working relationship with them.
         Alexion’s HR representative has indicted a desire to recruit interns and
         employees from CCRI’s program.
    o    J. Pino and Dean Woodberry have met with Diane Ritter, the new Life
         Science director at the RI Economic Development Corporation. Dr. Ritter
         has expressed a strong interest in continuing to work with us as members
         of the state’s workforce development team. We have been invited to
         participate in the RI-display at the upcoming BiO conference. We also
         had a positive meeting with leaders of the RI Department of Labor and
         Training where we were able to describe not only CCRI’s program, but the
         goals and activities of the NBC2.
    o    Students in our program are currently receiving tuition benefits from an
         H1B Visa Biotechnology grant. CCRI students were not included during
         the first 2 years of the grant period, so this marks a significant
         improvement.
    o    J. Pino continues to participate as a proxy-member of the RI EPSCoR
         Advisory Board and Co-PI on the RI EPSCoR grant. An outreach
         coordinator will soon be hired. His/her role will be to help promote careers
         and opportunities for training in biotechnology and biomanufacturing.



2) Develop Biomanufacturing Curricula and Instructional Materials

  An action plan was generated for the RI Hub for the development of
      curricula and instructional materials to support Upstream and
      Downstream Processing. However, several factors, including
      purchasing delays and financial constraints have presented
      numerous challenges to the creation of curricular materials to
      support upstream and downstream processing training. (See
      “challenges”)

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  Resource materials (textbooks and other) to support biomanufacturing
     and training and the workforce for upstream and downstream
     manufacturing jobs have been posted to www.biomanufacturing.org.

October 2006-February 2007 Curricular Materials Updates
Financial challenges have persisted. Also, administrative inexperience with
federal science grants at CCRI has resulted in delays during the billing and
budget adjustments that accompanied the transition between year 1 and year 2
of the NBC2 grant. As a result, our ability to purchase educational supplies was
frozen until just recently. We are currently in the process of purchasing supplies
to pursue our most immediate goals of developing SOPs for Protein-A affinity
chromatography and process controlled bioreactor growth of Pichia pastoris.
We will be presenting the former as a workshop at Bioman 2007.

We realize that to bring the Global Biomanufacturing Curriculum into our existing
training program, we will have to be creative and innovative. Our current plan is
to integrate the GBC in a “modular” format. To do this, we’ve begun an analysis
of our current courses and resources with the goal of mapping out the most
appropriate implementation strategies. Please refer to the separate handout
entitled “Planning Matrix: Integration of GBC Modules into Existing CCRI
Biotechnology Coyurse Curricula” for a tabular display of this plan.


3) Provide Professional Development Opportunities in
Biomanufacturing for Faculty



     Richard Cardin presented a Process Control workshop to fellow
      educators at the “Bioman 2006” Conference at the Northeast
      Biomanufacturing Center at NHCTC.
     Dana Hopkins, Josephine Pino, Richard Cardin, and Wayne Suits
      (Chem Tech faculty) attended “Bioman 2006” as participants.


     Rena Med Biologics has contributed to the building of an Equipment
      and Supplies Resource to support Biomanufacturing Education and
      Training in the Hub. Supplies are currently stored at CCRI and
      Davies High School.

     Faculty internships were not obtained in the Rhode Island hub,
      largely due to communication chllenges with biomanufacturing
      partners during year 1. The goal is to pursue better opportunities for


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         on-site professional development via tours, visits, or job shadowing
         during year 2, with the new industry partner, Alexion
         Pharmaceuticals in Smithfield, RI. The hub director has been able to
         participate in tours of Lonza and Centocor, during trips to the
         respective hub regions.

October 2006-February 2007 Professional Development Updates
Additional donations of plastics and gowning supplies were received from
RenaMed Biologics, shortly before there recent downsizing. Unfortunately,
RenaMed suffered a recent setback in their Phase3 clinical trials and has had to
reduce their workforce. Donated supplies are currently stored at CCRI and
Davies High School.



4) Collect and Disseminate Biomanufacturing Education and Training
and Workforce Information

The RI hub director collected biomanufacturing education and training and
workforce information for dissemination via the NBC2 website at
www.biomanufacturing.org and at local Hub, regional NBC2 and national
meetings. Year 1 data included:

  Initial baseline survey data on students, graduates and program
        characteristics.
  Annual end-of-year survey data on students.
  Hub activities and alliances.
  One web log.
  Hub company representation on the NBC2 Jobs and Internships Page
        on-line at www.biomanufacturing.org;
  Hubs provide regular updating of List of Hub Collaborators on line at
        www.biomanufacturing.org;
  Hub contribution to publications list at www.biomanufacturing.org.

October 2006-February 2007 Dissemination Updates
The RI Hub director participated in the 2006 ATE Conference in Washington,
D.C. and in the January ISPE-sponsored BioPharma Conference in Warwick, RI.
In addition, she has met with the RI Department of Labor director, Adelita Orefice
and higher level staff to discuss NBC2 and CCRI goals. She has also
disseminated this information via networking at meetings with members of the RI-
Tech Collective, the RI Economic Development Corporation, and RI-EPScoR.
J. Pino is currently conducting student surveys to obtain detailed information
about student goals and expectations.




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5) Build Biomanufacturing Infrastructure Capacity and Self-
Sufficiency

Developing the Biomanufacturing Education and Training infrastructure for
the Northeast should help to ensure self-sufficiency of the NBC2. The CCRI
Hub and the other NBC2 Hubs will document the following evidence of
infrastructure development in their locales:

  New biomanufacturing programs and courses at educational institutions
       (high school, community college, universities/4 year colleges, and
       middle schools);
  Best Practices for maintaining enrollment and job availability.
  Developing products and services will also help to ensure self-sufficiency
of the NBC2. The CCRI Hub and the other NBC2 Hubs will collaborate on
developing products and services.


CHALLENGES
 Facilities
All of the Biology courses in CCRI’s certificate program are taught in shared
laboratory classrooms. This has posed a challenge as new equipment arrived
and grant funded curriculum development activities began. Thus far, the college
has been able to provide a small dedicated “prep lab” (formerly the site of a
small aquaculture lab) for our grant activities and support of new biotechnology
curricular preparations. This space provides room to house the equipment and
store some materials. With some movement of equipment, it is possible for one
or at most two people to work in the lab. It is not adequate for use as a teaching
space. Recently, we were offered some hope in the form of an empty unfinished
space that used to house the college’s Integrated Manufacturing Laboratory.
This space would, unfortunately, require over $200,00.00 in renovations to
render it adequate for our needs. There is currently no obvious source of these
funds.

Barriers to A.S. Program State Approval and Implementation
These barriers are due to a combination of financial and administrative factors.
During the past two years, CCRI has undergone major leadership changes such
that at the present time there is a new president, interim VP of Academic Affairs,
and vacancies in Student Services and Business. As a result of these rapid
changes and vacancies, as well as a recent large deficit problem, development of
innovative, new programs has been slow to happen. In addition, questions about
local and close regional job availability, potential for student recruitment, facilities
issues, and wage capability in the field have resulted in a conservative approach


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to proposals of a new program such as this. The existence of the University of
Rhode Island’s “1+3” biomanufacturing program in this small state has also
contributed to this cautious approach. Articulation strategies have been worked
out through discussion with URI representatives, but implementation and logistics
of training a possible sharing of facilities remain a big issue. In short, there have
been large strides in the conceptual plan to create a statewide cooperative
training plan for biomanfuacturing, but the logistics still pose a challenge. Of
these, financial limitations loom largest, as described below under “supplies and
equipment”.

Supplies and Equipment
Development and implementation of new technical curricular materials is a costly
endeavor. Ongoing budget problems have had severe impacts on the purchase
of new supplies and equipment for laboratory courses. Although the grant
provided seed funds, the amount was limited to those items needed for curricular
development, not full sustainable implementation in our training program. As a
result, it has been difficult to test-run some curricular materials with actual
students. Also, the iterative nature of this type of work has at times required
changes to original plans, especially with regard to the core production system
itself. In a more flexible budgetary environment, these problems would be trivial,
but in the absence of a robust college/departmental operating budget, even slight
changes pose a large problem. Compounding this problem are the delays we’ve
had to endure due to slow administrative handling of budgets, billing and
accounts.

Partner Challenges
Education Partners
Relatively speaking, Rhode Island is a newcomer to the biotechnology education
movement. The high schools, have, until now, focused mostly on forensic or
agricultural biotechnology. CCRI initiated its Biotechnology program in 2004, and
the University began a unique “1 + 3” strategy of biomanufacturing education
only a year before. The University’s 1 + 3 strategy poses a unique challenge, for
which no known articulation models exist. This, combined with the tiny size of
the state has led to some degree of competitiveness between the programs.
Although the seeds of cooperation have been planted, progress remains a
challenge. Do the institutions share facilities? Do we share supplies?
Personnel? How would articulation work? A 2+2 model works very well between
CCRI’s proposed A.S. program and the URI Microbiology program, but what
happens to URI’s 1+ 3 biomanufacturing program in this case? In short, many
questions remain to be answered.
With regard to the high school program, Rhode Island is in the process of making
some important decisions. Some disagreements exist among the high school
biotechnology steering committee members over some issues such as what
applications should be taught? What is the goal of the high school training; is it
workforce development, or college preparation? Fundamental to many of these
disagreements are common misconceptions about the nature of the



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biomanufacturing process itself and of the careers and jobs to be found in that
area.
Industry Partners
Perhaps because of lingering misconceptions about the links between education
level and biomanfuacturing employment, the community college-industry
partnerships in some cases have been challenging. Amgen has a large
manufacturing plant in Rhode Island, just a few miles from CCRI. Despite this,
communication with the company has been inconsistent and difficult at times.
Current efforts to make our training activities more visible are centering around
gaining the support of state and industry agencies such as the Economic
Development Corporation, RI-EPSCoR, and the RI Tech-Collective. The
participation of CCRI in the NBC2 is proving to be a major factor in the survival
and growth of biomanufacturing training opportunities in RI.




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