March 2021 Update

Serving the NC Life Sciences Industry

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Governor Roy Cooper announced that Machelle Sanders, current secretary of the NC Department of Administration, will now serve as secretary of the Department of Commerce. She is a former member of the NCBIO Board of Directors.

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The NC General Assembly's Life Sciences Legislative Caucus held its first meeting on Feb. 22. Senators Paul Newton (R-Cabarrus, Union) and Mike Woodard (D-Durham, Granville, Person) and Representatives Donna White (R-Johnston) and Robert Reives (D-Chatham, Durham) continue to serve as co-chairs.

BIO's Phyllis Arthur, vice president for infectious diseases and diagnostics policy, talked to legislators about how the COVID-19 vaccines were created so quickly and how maintaining elements of the streamlined and collaborative process could speed the development of future treatments.

PhRMA reps Thomas Hardaway, senior regional director, and Zach Poss, director of state policy, told lawmakers about the 250,000 NC jobs supported by the biopharma industry and its $75 billion in economic output in NC alone. BIO also shared the average cost of developing a new drug was $2.6 billion and climbing with about a 12% success rate while the cost of prescription drugs was growing slower than other health care expenses.

At the national level

• The COVID Relief Reconciliation Package is proceeding through the House Budget and Rules Committees with a final version possible by the end of the month. Reconciliation is a tool created in 1974 that allows expedited consideration of certain budget legislation. The package is expected to include coverage for therapeutics and sets the average manufacturers price cap, or AMP cap, at $16 billion with less than two years' ramp up to the implementation date.
• Drug pricing will continue to be a major issue. BIO is seeing new activity, such as the consideration of international pricing models, in states that have been less open to imposing regulation in the past, such as Virginia, Oklahoma and Montana. BIO is working to guide policy in responsible directions by sharing long-term Medicaid best practices guidelines and encouraging states to improve transparency, as well as access to new meds for their citizens.
• BIO is keeping an eye on an antitrust bill introduced by Sen. Amy Klobuchar (D-MN) that could put limits on mergers and acquisitions that could negatively affect the industry's pipeline for new products.
• Sen. Thom Tillis (R-NC) will serve as ranking member of the Senate IP Subcommittee for the 116th Congress. Sen. Patrick Leahy (D-VT) will chair the subcommittee.

The Biotechnology Innovation Organization released a blueprint highlighting goals to strengthen America’s innovation ecosystem, end the COVID-19 pandemic and get more Americans back to work over the first 100 days of the Biden administration.

The blueprint includes BIO’s priorities for the first 100 days working with Congress and the Biden administration and include  

• ensuring a speedy transition and an expedited Senate confirmation process for agency leadership critical to advancing public health, nutrition, and environmental goals;
• developing and approving more vaccines, therapeutics and diagnostics to prevent and treat COVID-19;
• promoting robust and equitable patient access to COVID-19 vaccines, therapeutics, and diagnostics;
• better preparing for future infectious disease outbreaks; and
• driving economic revival and resiliency through adoption of advanced biotechnology solutions.

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Gov. Roy Cooper announced the state will begin vaccination of Group 3 essential workers on Feb. 24 with PreK-12 educators and day-care workers. On March 10, vaccinations will be available for other essential workers. State officials will decide closer to that date whether all essential workers will be eligible or if certain groups will be given priority based on vaccine supplies.The state is now getting just over 150,000 vaccines from Pfizer and Moderna each week.

The Council for Entrepreneurial Development has announced the tech and life science companies that will present at Venture Connect 2021, to be held virtually March 23-25.

The 2021 selection of companies represents the future and scope of tech and life science industries with over 100 companies selected for the event. These companies will take the stage to present their big ideas in front of an audience of investors, sponsors and fellow entrepreneurs. Venture Connect provides these entrepreneurs with brand awareness and visibility to one of the fastest growing ecosystems in the country.

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The National Cancer Institute is eager to support and collaborate with innovative scientists and small companies and has two relatively new programs in place to support them, according to NCI representatives presenting during a Jan. 26 webinar hosted by BIO.

Director Michael Weingarten and Program Director Nancy Kamei of the NCI’s SBIR Development Center shared information about the NCI’s efforts to partner with small businesses through the Small Business Innovation Research and Small Business Technology Transfer programs in their presentation, “NCI SBIR: Funding and Commercialization Resources for Cancer Technologies.”

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On Wednesday, Feb. 24, NCBIO hosted a webinar on “New Dynamics in Talent Recruitment” as part of the NCBIO Life Sciences Forums. Panelists discussed the challenges and opportunities that have arisen in recruiting and retaining employees during the pandemic.

The panelists from Aerotek, Enzerna Biosciences, G1 Therapeutics and Mayne Pharma participated. Chubb and Research Solutions sponsored the webinar. Both companies are part of the BIO Business Solutions program available to NCBIO members.

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On Wednesday, Feb. 17, LaunchBio hosted a webinar discussing diversity in life science venture capitalism. This month’s webinar featured a panel discussing ways to increase diversity, equity and inclusion in the life-science investment community.

The panelists shared their journeys to becoming venture capitalists, the current state of the venture capital community and advice for increasing diversity in the industry. NCBIO is a sponsor of these LaunchBio webinars, and a recording of the discussion can be found at https://launchbio.org/webinars.

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AdvaMed is seeking session proposals for The MedTech Conference 2021 (Sept. 27-29) that are relevant, timely and practical to the medical device, diagnostic and digital health industries. Organizations from or affiliated with the medtech industry are welcome to submit session ideas dealing with the latest trends, advancements and critical issues in the field. The deadline for submissions is Friday, March 12, 2021.

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BIO, Informa Pharma Intelligence and QLS Advisors have released a new collaborative report, Clinical Development Success Rates and Contributing Factors 2011-2020. The report includes comparisons of success rates across indications and modalities, regulatory factors, and predictive factors driving successes and failures in drug development. This new data will help shape risk profiles and valuation metrics across investment and pharma R&D portfolios.

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The North Carolina Biotechnology Center awarded 17 grants and loans totaling more than $1.4 million to universities, biosciences companies and other entities in the second quarter of its fiscal year.

The awards, made in October, November and December 2020, will support life sciences research, technology commercialization and entrepreneurship throughout North Carolina. The funding will also help universities and companies attract follow-on funding from other sources.

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The Board of Directors of the NCBIO voted unanimously Thursday, Jan. 28, to accept three new members to NC Biosciences Organization. MORE >>

To be included in Member News, send information about your organization to David Etchison.

The FDA has approved a new intramuscular injection route of administration for Biogen's PLEGRIDY (peginterferon beta-1a) for the treatment of relapsing forms of MS. MORE >>

The FDA granted Biogen and Eisai a three-month review-period extension for the biologics license app for aducanumab, an investigational treatment for Alzheimer’s. MORE >>

Bioventus is the latest North Carolina life sciences firm joining the public markets, raising $104 million from its initial public offering. MORE >>

Cambrex has been recognized across six categories in the annual CMO Leadership Awards marking the seventh consecutive year the company has been honored. MORE >>

G1 Therapeutics CEO Jack Bailey participated in the Guggenheim Healthcare Talks: 2021 Oncology Day conference fireside chat on Feb. 11. MORE >>

The FDA has approved G1 Therapeutics' COSELA (trilaciclib) for injection to reduce chemotherapy-induced myelosuppression in small cell lung cancer patients. MORE >>

Locus Biosciences completed its Phase 1b clinical trial of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage targeting E. coli bacteria causing UTIs. MORE >>

PPD has been awarded Defense Health Agency funds to develop and execute an adaptive platform clinical research trial of drug interventions to treat PTSD. MORE >>

PPD has been recognized for the 10th consecutive year as one of the leading U.S. businesses for employee learning and development by Training magazine. MORE >>

Sarepta Therapeutics announced that Hampstead, NC, educator Kaitin Payne is a winner in the company's Rare Lessons lesson-planning competition. Payne was congratulated by Sen. Bill Rabon (R-Bladen, Brunswick, New Hanover, Pender). MORE >>

NCBIO members are eligible for BIO Business Solutions volume-based discounts and favorable contract terms on lab supplies, waste removal, microscopes, shipping, gases and more. This is a benefit of your NCBIO membership. Review the cost-savings offered here (PDF), and choose the programs you're interested in. Email Bob Dearth or call 781-716-7555 with your choices, and he will get you started. For all the latest news, promos and event information, follow BIO Business Solutions on LinkedIn.

Research Solutions / Reprints Desk simplifies how R&D organizations access scientific literature. More than 70% of the top pharmaceutical companies, universities and emerging life-science businesses rely on Article Galaxy, Research Solution’s cloud-based SaaS platform, for simplified and lowest cost access to the latest scientific content, including open-access content and subscription holdings.

• BIO Oncology Virtual Partnering (3/2/2021 to 3/5/2021)
• HBA RTP The Intersection of COVID-19: Moving in a New Direction (3/5/2021)
• Kymanox Lessons from Inspiring Women Life Science Leaders (3/8/2021)
• BIO Immunology Virtual Partnering (3/9/2021 to 3/12/2021)
• ISPE-CaSA Life Sciences Technology Conference (3/9/2021 to 3/10/2021)
• MDMA 2021 FDA Forum (3/10/2021 to 3/11/2021)
• LaunchBio Larger than Life Science: You Are What You Eat - The Microbiome is the Next Chapter in Drug Discovery (3/11/2021)
• National AgTech Forum: Farming What?s Next - Unlocking the Potential of the Soil (3/17/2021)
• CED Venture Connect (3/23/2021 to 3/25/2021)
• Prospanica NC Finding your Unique Latino Voice in Corporate America with GSK (4/7/2021)
• LaunchBio Larger than Life Science: Making Your Exit - Strategic Trends to Consider (4/8/2021)

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