Trends in Biomanufacturing
Single use systems, continuous manufacturing, use of data, and modular construction units were among the topics discussed at the Biomanufacturers Forum meeting. Thanks to Rich Motruk (Kymanox), Stephen Perry (Kymanox), Keith Fritsky (Gore PharmBio Products, and Raj Vora (DPR Construction) for making the presentations to the group.
Changing Landscapes for Clinical Trials
Analytics, virtual clinical trials, more diversity in participants, adaptive designs and other topics were discussed during the NCBIO Luncheon and Forum on “Clinical Trials: Changing Landscapes and Potential Pitfalls. Panelist Matt Becker of SAS talked about the use of “real world data” and simulations to optimize patient selection and recruitment.
Christina Cocciardo of PPD defined some of the challenges with adaptive designs and novel approaches to clinical trials, noting there is a reluctance to depart from traditional designs. “Optimizing Diversity in Clinical Trials” was the focus of the presentation by Allison Kalloo of Clinical Ambassador Health. Karen Makhuli of G1Therapeutics served as moderator for the panel discussion. For more information about the event, contact Amber Niebauer.
NCBIO Celebrates Its 25th Anniversary as Part of the Annual Meeting
Tributes from partnering organizations, staff cutting a cake, and a slide show highlighting NCBIO work were all part of the 25th anniversary celebration.
Innovation, Access, Microbiome, Market Trends and More at NCBIO Annual Meeting.
Dr. Martin Murphy, Founding Chief Executive Officer, CEO Roundtable on Cancer and Project Data Sphere was the opening keynote for the NCBIO Annual Meeting. Dr. Murphy discussed innovations in personalized medicine and the impact on cancer treatment. The meeting also featured panels on Access and Availability and Ag and Human Microbiome along with presentations on Capital Formation and Market Trends by Peter Meath and Lauren Ruane, the Co-Heads of Healthcare Banking at JP Morgan.
Thank you to our sponsors:
Platinum: BIO, Bioventus, Cook Medical, and VWR
Gold: BDO, FUJIFILM Diosynth Biotechnologies, Grifols, LaSalleGroup/Mentor Technical Group, and Novo Nordisk
Silver: AdvaMed, Charter Medical, Office Depot, The Conafay Group, UCB
Bronze: Business Wire, G1Therapeutics, GSK, IQVIA Biotech, Liquidia, Mispro Biotech Services, Nikon, Novozymes, ThermoFisher, and UniFirst/UniClean
NCBIO Annual Meeting Dinner
Partnering 101: Tales from the Trenches was the topic for NCBIO's Annual Meeting Dinner. Neil Jones of Lindy Biosciences was the moderator. Panel Participants were Derek Norman of Bayer and Tom Adams or Pairwise discussing their company collaboration, and Lauren Drowley of UCB and Charles Gersbach of Element Genomics talking about UCB's purchase of Element Genomics. Thanks to BIO, Frankel Staffing Partners and VWR, part of avantor, for sponsoring the event.
Next Steps for Window on Workplace Study
NCBIO has been working with the NCBiotech Center on a study of workforce needs for the bio/pharma manufacturing industry. NCBIO President Sam Taylor and NCBiotech Sr. VP of Economic Development Bill Bullock updated Biotech Manufacturers Forum members at the September meeting. Taylor outlined plans for working with companies and academic partners on updating and expanding training and education programs. Bullock discussed efforts to raise awareness about jobs in the industry and ways to recruit more talent.
Growing Pains in Lab Space Market
Lab space for start-up companies moving to the next stage of development is limited in a maturing market according to panelists at the July 16 NCBIO Luncheon and Forum. Bill Bullock, Sr. VP, Economic Development & Statewide Operations, North Carolina Biotechnology Center (NCBiotech), moderated the lively discussion with the four panelists who shared a range of views about the lab space market. Panelists were:
Thanks to Davis Moore, Longfellow Real Estate Partners, and VWR for sponsoring the event.
Lawmakers Hear about North Carolina’s Role in Genomic Medicine
NCBIO and BIO hosted a one-hour session at the General Assembly this month to brief lawmakers on Genomic Medicine, including North Carolina’s leadership position in bringing new genomic medicines to market. The program included information regarding:
Speakers were Sara Imhof (NCBiotech), Dr. Jude Samulski (AskBIO), Jay Griffin (Parent), Rep. David Lewis (Legislative Host), and Sam Taylor (NCBIO). More
Plant and Animal Production Topics for Caucus Meetings
The General Assembly’s Life Science Caucus met jointly in June with Assembly’s Agriculture and Rural Caucus. The two groups used the opportunity to learn of new life science technologies promising to bring better crops and improved livestock management to farmers. Guest presenters included representatives of NCBIO members Pairwise and Premex.
Tom Adams, CEO of Pairwise, told lawmakers his company decided to locate in North Carolina because of the diversity of agriculture in the State and the researchers at the universities. He discussed the company’s efforts to change where berries and fruits can be grown and research on how to extend shelf life an create other improvements in fruits and vegetables.
Anne Ballou, Lead Scientist at Premex’s North Carolina research center, reviewed the company’s research on animal health, especially the need to understand the microbiomes of livestock digestive tracts. Among other things, Premex hopes to exploit microbiomes’ capacity to stimulate the immune system and improve animal health.
Workplace Safety and Human Performance Focus of Safety Summit
Todd Conklin challenged participants at the NCBIO Biotech Manufacturers Safety Summit to change some of their traditional views about safety in the workplace. Conklin, author of Simple Revolutionary Acts: Ideas to Revitalize Yourself and Your Workplace, said that the traditional viewpoint is that “Workers are the problem to be fixed.” He countered that “Workers are not the problem. They are the problem solvers.” He talked about the importance of encouraging workers understand their environments noting that “Safety is not the absence of accidents rather safety is the presence of defenses.” Conklin reinforced the importance of “shifting thinking from who failed to what failed.”
Peter Self, Associate Director, Environmental, Health, Safety and Sustainability, at Biogen opened the day’s activities noting the importance of integrating human performance principles into Biogen’s operations, which helps drive continuous improvement. Biogen was a sponsor of the event and also served as the host site for the Summit.
Tom Wilson, the sole survivor of a plane crash in Canada that killed seven other people, talked about the importance of courage. Wilson is author of a book about his experience, Moments of Impact. He talked about the importance of individuals taking a risk and having the courage to speak upwhen they recognize a safety issue. He noted that if he or others had spoken up about the weather problems the day of the plane flight, the crash could have been avoided. He outlined 10 areas for hazard and safety identification.
Jennifer Bailey with Alabama Power Company & Southern Company outlined steps her organization has taken to help change behavior, encouraging reporting of incidents and using positive reinforcement to break down barriers to safety, which in-turn have significantly reduced significant injury and fatality rates.
Roger Paules and Ray Best of Duke Energy discussed steps the organization takes to help companies with emergency and disaster situations.
Drug Development and Innovation Discussed at Legislative Life Science Caucus Meeting
“More than 7000 new medicine are in development around the world,” Sharon Brigner, PhRMA Deputy Vice President, State Policy, told the Legislative Life Science Caucus May 22. “Medicines are transforming the treatment of devastating diseases. On average 70% of the drugs are potential first-in-class therapies, meaning they use a completely new approach to fighting a disease.” More
Diagnostics in the Age of Precision Medicine
Patent protection, coverage and reimbursement, use of diagnostics for new cell and gene therapies - just a few of the topics covered at the May NCBIO Life Sciences Lunch and Forum. NCBIO President Sam Taylor served as moderator. Thanks to Rick West of baebies, Geraldine McDowell of LabCorp and Nick Lazaridis of AccuGenomics for a great panel discussion.
2019 NCBIO Legislative Reception
NCBIO members talked with legislators about the growth in the industry and its economic impact on the State at the annual event. The new Legislative Life Science Caucus Co-Chairs attended the session. Co-Chair Sen. Paul Newton (R-Cabarrus & Union) talked with NCBIO members from his district. Co-Chairs Rep. Donna McDowell White (R-Johnston), Sen. Mike Woodard (D-Durham, Granville & Person) and Rep. Robert Reives (Chatham & Durham) gathered for a group photo.
Biotech Manufacturers Forum Focuses on Workforce Needs
The growth in North Carolina's biomanufacturing sector and the need for more employees and training was the topic for the March BMF meeting. John Balchunas of the National Institute for Innovation in Manufacturing of Biopharmaceuticals (NIIMBL) talked about assessments under way by the organization. Bill Bullock and Laura Rowley with the North Carolina Biotechnology Center discussed growth by the industry and the Window on the Workplace Survey being conducted by the Center and NCBIO.
Emerging Therapies: Reshaping How We Treat Disease - Winter NCBIO Luncheon and Life Science Forum
The opportunities, the challenges and the financing of gene therapies and other innovative cell technologies were topics at the recent NCBIO Life Science Forum. Four panelists outlined plans by their companies in developing treatments for patients.
Michael Dombeck (Precision Biosciences), Tom Jede (bluebirdbio), Susan Nichols (Falcon Therapeutics), Al Pritchard (Kaio Therapy) and Cartier Esham (BIO)
Michael Dombeck, Vice President of Business Development, Precision BioSciences, outlined qualities of the ARCUS therapeutic-grade gene editing platform developed by his company. bluebirdbio selected North Carolina over other locations for its manufacturing site primarily because of the talent here stated Tom Jede, Site Head and Senior Director, Vector Manufacturing. Susan Nichols, Chief Executive Officer, Falcon Therapeutics, discussed the Trilogy cells, a new class of cells, that can seek out tumor cells and destroy them. Kaio Therapyis developing an Immune Activating Hyperthermia Treatment that CEO Al Pritchard says “awakens your body’s immune system to fight your specific cancer.”
Brian Johnston (BIO), Faye Woolf (Aperio Clinical Outcomes), Chris Capel (Smith Anderson) and Tom Fagley (Hughes Pittman & Gupton, LLP)