Due to summer break, there currently are no programs planned on our event’s schedule. Check back soon, however, as we will be listing new opportunities in August.
Spotlighting the Local CR Scene
Due to summer break, there currently are no programs planned on our event’s schedule. Check back soon, however, as we will be listing new opportunities in August.
Insights that Steer CR Growth
Due to summer break, there currently are no programs planned on our event’s schedule. Check back soon, however, as we will be listing new opportunities in August.
Broad Clinical Connections Await
Due to summer break, there currently are no programs planned on our event’s schedule. Check back soon, however, as we will be listing new opportunities in August.
Fish 2.0 Workshop Draws Seafood Industry Startups
Oysters, crab, shrimp, lobster and scallops were on the menu at this week’s Fish 2.0 South Atlantic & Gulf Coast Shellfish Workshop, hosted by University of North Carolina Wilmington at the university’s MARBIONC facility.
Fish 2.0, founded by executive director Monica Jain, uses a competition platform to connect seafood innovators, investors and industry experts so that promising ventures could find funding and knowledge resources.
It’s the first time the organization has extended its competition track into the Southeast U.S. and the first time it has conducted a workshop for the region to help entrepreneurs in the shellfish industry prepare to pitch their businesses to potential investors. Entrepreneurs with the strongest proposals, drawn from all regions, pitch to investors from around the world at a global competition next fall, according to Diane Durance, executive director of UNCW’s Center for Innovation and Entrepreneurship.
Durance is a veteran of Fish 2.0’s competition platform, having pitched her own project in Michigan in 2013. When she became head of the CIE in June, she realized there was no Fish 2.0 regional competition track in this part of the country, and set about to change that.
“I’ve had Fish 2.0 on my mind since 2013,” she said at the workshop opening Wednesday morning. “I knew we had a lot of strength in marine technology here. Attending the workshop increases participants’ ability to compete at the global event, which takes place at Stanford University in November.”
The inaugural workshop in Wilmington drew 21 participants from five states. The businesses seeking investor funding ranged from startup oyster farms to shellfish-centric software firms to researchers streamlining the process of diagnosing disease in shellfish populations.
Niels Lindquist of Morehead City is co-founder and CEO of Sandbar Oyster Co. Inc., which has invented a material that can be formed into various shapes and submerged to form an artificial substrate to which oysters can attach.
After trying out his pitch on the workshop audience Friday morning, Lindquist said the workshop had been helpful in understanding how to develop his appeal to investors.
“It gave me a better understanding of the investor side of the equation: what motivates them, what turns them off, and their limitations,” he said. “I also understand how to tailor a pitch to different investors.”
Deborah Keller, owner of Oyster Mom LLC in Oyster Bay, Florida, said the workshop helped her focus on what she wants to accomplish as she expands her business.
“I realize what I need to move forward. I need more tool sharpening,” she said.
Keller is more than an oyster farmer. She takes on apprentices who have disabilities and teaches them the business. Thus far she has trained a blind man and a disabled teenager the routines of growing and harvesting the in-demand bivalves.
“I want to be an oyster fisherman that trains new oyster fishermen,” she said. “There are so many people out there that need that kind of work, and that have the passion for that kind of work.”
Workshop participants spoke of the high demand for shellfish and the ways in which technology and automation can raise the productivity and sustainability of existing aquaculture operations, and make it easier for new ones to get started.
Jain, who moderated the wrap-up pitch session, said she expects more participants in the regional workshop next year. The first year’s competition in a region typically draws what she calls “early adopters,” while other entrepreneurs watch and see how things go.
“The first year in Seattle we had about 20 participants,” she said. “The second year, we had 70 applications in five days.”
Entrepreneurs with shellfish-related ventures located in the 12-state Southeastern U.S. region are encouraged to participate in Fish 2.0, Durance said. The deadline to apply is April 29. Click here for more information.
By Jenny Callison, posted March 17, 2017 on WilmingtonBiz.com
Copyright © 2017 SAJ Media, LLC dba Greater Wilmington Business Journal
Clinical Drug Development in Oncology – the Science and the Art
Tuesday, March 28, 2017 @ 6 p.m.
NC Coast Clinical Research Initiative and UNCW Student Association of Clinical Research Present “Clinical Drug Development in Oncology – the Science and the Art” with speaker Dr. Sandra L. Silberman, Attending Physician, Durham VA Medical Center.
This session will explore:
- New Therapies, New Challenges: The Need for Innovation in Trial Design
- Looking Toward the Future
Come prepared to ask your questions and engage in active discussion with a leading industry professional.
Event will include heavy appetizers and beverages.
Speaker
Dr. Silberman is a Hematologist/Oncologist who earned her B.A. and Ph.D. from Johns Hopkins University, her M.D. from Cornell University Medical College and a clinical fellowship in Hematology/Oncology at the Harvard Medical Institutions.
She led the clinical development and managed the regulatory approval of several novel first in class cancer drugs, and now serves the biopharmaceutical industry as a senior advisor with her own consulting company. Throughout her career, she has continued part time in active clinical practice, and is currently an attending physician in the Duke fellowship program at the Veteran’s Administration Medical Center Hematology/Oncology clinic in Durham, NC.
**REGISTER EARLY: Space is limited.
FAQs
Where will the event be held?
The event will be held at the UNCW McNeill Hall, Rm. 1051, located on UNCW main campus, in Wilmington.
What are my parking options?
PPlease park in the parking deck on the opposite side of Cahill Dr. from McNeill Hall and beside the Dunkin Donuts. There is a charge for parking.
Who can I contact regarding any questions or concerns?
Please contact Randall Johnson at Randall_Johnson@ncbiotech.org at the North Carolina Biotechnology Center Southeastern Office with any questions or concerns.
This event is hosted by the North Carolina Coast Clinical Research Initiative, sponsored by the North Carolina Biotechnology Center Southeastern Office, and the UNCW Student Association of Clinical Research. The event will enhance the region’s knowledge about topics specific to the clinical research cluster in southeastern North Carolina.
Addressing Global Health Challenges: Vaccine Development Initiatives Against Emerging Disease
Wednesday, Feb. 15, 2017 @ 6 p.m.
Explore the field of drug discovery, including vaccine research and development for infectious diseases, such as the Zika virus and Ebola virus.
This session will:
- Explore the process and business of drug discovery, including vaccine development
- Describe the necessary skills and occupational opportunities for drug discovery
- Look at a typical “Day in the Life” of drug discovery professionals
- Answer your questions with regards to life and work as a drug discovery professional
- Come prepared to ask your questions and engage in meaningful, active discussion with a leading industry professional.
Event will include heavy appetizers and beverages.
Speaker
Kevin Gilligan, Sr. Director of Medical Affairs, Clinical Research Management, Inc. (ClinicalRM)
30+ yrs. experience in health care, biotech, and pharmaceutical development at Bayer Corp., US Dept of Health and Human Services BioMedical Advanced Research and Development Authority, Innovative Genetics, and CommonWealth Biotechnologies.
Background in discovery science, vaccine discovery, development and testing, clinical study sample testing, diagnostic development and validation, immunology, virology, bacteriology, biologics process development and manufacturing and pathogen safety.
Extensive experience in management of $100M+ advanced development programs, procurement contracts for antivirals, management of contracts, management of proprietary products in emergency scenarios, emerging threat product development, conceiving and creating bio-threat countermeasures.
Lead inter-agency, interdisciplinary, private/public partnerships, to address outstanding public health crises.
**REGISTER EARLY: Space is limited.
FAQs
Where will the event be held?
The event will be held at the UNCW Center for Innovation and Entrepreneurship (UNCW CIE), located at 803 S. College Rd., Wilmington, NC 28403.
What are my parking options?
Please park in either the lot in front of or behind the UNCW CIE.
Who can I contact regarding any questions or concerns?
Please contact Randall Johnson at Randall_Johnson@ncbiotech.org at the North Carolina Biotechnology Center Southeastern Office with any questions or concerns.
This event is hosted by the North Carolina Coast Clinical Research Initiative, sponsored by the North Carolina Biotechnology Center Southeastern Office, and the UNCW Student Association of Clinical Research. The event will enhance the region’s knowledge about topics specific to the clinical research cluster in southeastern North Carolina.
UNCW Partners with Medidata to Bring Clinical Cloud Technology to the Classroom
Medidata, the leading global provider of cloudbased
solutions for clinical research in life sciences, and the University of North Carolina Wilmington have announced a new partnership to educate the next generation of clinical researchers.
“From the advent of new technologies and continuous data streams to increasingly complex trial design, this is a
time of tremendous opportunity for those of us at the intersection of medicine, science and technology,” said
Medidata’s president Glen de Vries. “We’re proud to partner with UNCW and help train the next generation of
clinical researchers as they prepare to join the life sciences industry and transform patients’ lives.”
As part of the three-year agreement, Medidata will provide UNCW with access to the Medidata Clinical Cloud® pro bono, equipping future leaders with the cutting edge technology and practical experience needed to excel in the field of clinical research and make a lasting impact on patient health. Beginning in the Fall 2016 semester, approximately 80 students enrolled in UNCW’s College of Health and Human Services’ Clinical Research program will be trained on Medidata’s platform annually.
UNCW students will use Medidata’s industry leading solution for electronic data capture, management and
reporting (Medidata Rave®) and Medidata’s eLearning platform, Medidata Academy. Using a mock study with fabricated patient data, students will learn to organize, collect, review, monitor and track data.
Similar to professional Clinical Research Associates (CRAs) at more than 700 life sciences companies who use
Medidata’s technology, the UNCW students will also leverage iMedidata®, a secure portal which provides unified access to all studies, eLearning courses and centralized user administration.
“This partnership will train UNCW clinical research students on some of the most advanced software available,
enabling them to experience how what they learn in their coursework applies to situations involving actual patients
and lab analysis,” said Kathy Browder, senior associate dean of the College of Health and Human Services. “The
practical experience they receive will help them as they seek employment in this rapidly growing field.”
The partnership expands UNCW’s commitment to advancing clinical research and economic development in North
Carolina. Last fall, the University received a grant from the Duke Energy Foundation to establish UNCW’s Clinical Research Workforce Development program, which includes curriculum enhancement, student fellowships and continuing education programs.
About UNCW
The University of North Carolina Wilmington, the state’s coastal university, is dedicated to learning through the
integration of teaching and mentoring with research and service. Guided by our strategic plan
(http://uncw.edu/strategicplan/index.html), the university is committed to nurturing a campus culture that reflects its values of diversity and globalization, ethics and integrity, and excellence and innovation. A public institution with more than 15,000 students, the university is focused on supporting and enhancing the student centered learning experience that has been a hallmark since its founding in 1947. UNCW offers an array of programs at the baccalaureate and master’s levels, and doctoral programs in marine biology, educational leadership, psychology and nursing practice.
About Medidata
Medidata (https://www.mdsol.com/en) is reinventing global drug development by creating the industry’s leading cloudbased solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including more than 700 global pharmaceutical companies, innovative biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our
customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide
deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution
powering clinical trials for 17 of the world’s top 25 global pharmaceutical companies, from study design and
planning through execution, management and reporting.
Initiative to prepare workforce, support growth in local CRO industry ahead of schedule
An effort to strengthen and expand Wilmington’s clinical research industry is making progress and is ahead of schedule, officials said Tuesday.
Under the umbrella of the N.C. Coast Clinical Research Initiative, a number of players are working to create a more cohesive CRO community and forge relationships among those businesses, University of North Carolina Wilmington and community partners. A central piece of the initiative is the expansion of an area workforce that can support growth in the CRO sector, according to Randall Johnson, executive director of the southeastern North Carolina office of the N.C. Biotechnology Center, one of the community partners.
Last September, UNCW received a $390,000 grant from the Duke Energy Foundation to develop such a workforce development program, with a significant investment from UNCW itself.
The grant required a cost share from the university, Kathy Browder, senior associate dean of UNCW’s College of Health and Human Services (CHHS) said Tuesday.
The program will focus on providing enhancement opportunities to existing employees in the CRO sector as well as attracting, educating and preparing the next generation of talent to the industry. Upgrades to the university’s Center for Innovation and Entrepreneurship will make that space a convenient and productive place for industry, academic and community partners to meet and collaborate, Johnson said.
Ahead of an initiative leadership meeting later this month, Johnson discussed progress thus far on designing and implementing the workforce development program, which he said was ahead of the schedule UNCW originally submitted to the Duke Energy Foundation.
“We’ve been very aggressive in setting up the advisory council and [the council’s] action teams,” he said.
The advisory council is composed of CRO-related business leaders, Johnson, and representatives of CHHS and the mathematics and statistics department. Each of the council’s action teams is responsible for one aspect of the program, which involves:
- developing continuing education opportunities for current workers in biostatistics, statistical programming and clinical operations
- ensuring continuous improvement of current degree programs for undergraduates, with coursework and field work more directly related to job skills, as industry needs evolve
- providing advanced applied learning through a new fellowship program available to top students. An internship program related to the CRO industry already exists at UNCW.
- creating a collaborative workspace at the CIE to build connections between the industry and academia.
“[UNCW] chancellor [Jose] Sartarelli has been very supportive, and [CHHS dean] Charlie Hardy is extremely supportive as well. We have UNCW support at all levels,” Johnson said. “A portion of the initiative is focused on clinical, but it’s also focused on the more math-specific part of the industry that’s so important. We need the clinical side as well as statistical side. The math department has been key to our work.”
Browder said that some of the continuing education offerings, and possibly a pilot of the industry fellowship, should be up and running by the start of fall semester.
UNCW is eager to do anything it can, as an institution of higher education, to better position its students for success in the workforce, she added. This public-private partnership was such an opportunity.
“A public-private partnerships is not a new concept but it’s something we have not done as much as we might,” she said. “And this [CRO] industry really serves the region. It will become a niche area for us, to serve students better, position them better, and to serve the workforce [needs].”
Another component of the N.C. Coast Clinical Research Initiative is to update the Southeastern N.C. Clinical Research Industry Report, which contains an inventory of CRO firms operating in the area, along with the businesses that provide support services for them.
Although that update is not yet complete, Johnson said that there are currently 30 CROs that have a Wilmington area presence and about 40 support companies. Such companies range from medical writing and patient recruiting firms to CRO-specific software, data management and even human resources companies, he explained.
“There are more companies starting here or coming here,” Johnson said, adding that these businesses are looking to UNCW and the community in general to find the talent they need to grow.
By Jenny Callison, posted May 10, 2016 on WilmingtonBiz.com
Copyright © 2016 SAJ Media, LLC dba Greater Wilmington Business Journal
A Day in the Life: Clinical Study Startup
Wednesday, April 6, 2016 @ 6 p.m.
Explore the training requirements, responsibilities, daily activities, advancement potential, and other characteristics of several careers related to the broad clinical research field.
EVENT DESCRIPTION: “Clinical Study Startup – Insights from the Real World”
“The study start up phase of clinical trials is a very crucial and timeconsuming component of the clinical study process. A key challenge in conducting the clinical trials is that it spans so many different parties, including study sponsors, contract research organizations (CROs), site management organizations (SMOs), patient recruiters, investigators and patients. It is critical that sponsors, CROs and SMOs bring the right resources, tools and techniques to the clinical trial start up process to meet study start up timelines. It is important to streamline the start up from the beginning because it sets the pace for the study. Study start up activities includes assessment of site feasibility, negotiation of contract and budgets, planning for patient recruitment, legal reviews and approvals by Institutional Review Board (IRB) and/or ethics committee.” Source: U. North Texas Health Sciences Center
This session will:
- Explore the necessary skills for Clinical Study Startup
- Discuss occupational opportunities for Clinical Study Startup
- Describe potential team members and roles for Clinical Study Startup
- Look at a sample “Day in the Life” during Clinical Study Startup
- Answer your questions with regards to life during Clinical Study Startup
- Come prepared to ask your questions and engage in meaningful, active discussion with a leading industry professional.
Event will include heavy appetizers and beverages.
**REGISTER EARLY: Space is limited.
FAQs
Where will the event be held?
The event will be held at the UNCW McNeill Hall, Rm. 1051, located on UNCW main campus, in Wilmington.
What are my parking options?
Please park in the parking deck on the opposite side of Cahill Dr. from McNeill Hall and beside the Dunkin Donuts. There is a charge for parking.
Who can I contact regarding any questions or concerns?
Please contact Randall Johnson at Randall_Johnson@ncbiotech.org at the North Carolina Biotechnology Center Southeastern Office with any questions or concerns.
This event is hosted by the North Carolina Coast Clinical Research Initiative, sponsored by the North Carolina Biotechnology Center Southeastern Office, and the UNCW Student Association of Clinical Research. The event will enhance the region’s knowledge about topics specific to the clinical research cluster in southeastern North Carolina.