August 2022 Update

Serving the NC Life Sciences Industry

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The NC General Assembly finished its work in early July and adjourned. Here's a look at what was and wasn't accomplished in this short session.

The biosimilars sunset provision was repealed, which reinstated a communication requirement for pharmacists to inform physicians when they substitute an interchangeable biosimilar for a prescribed biologic. In 2015, the General Assembly approved the use of biosimilars as substitutes for biologic treatments, and pharmacists were required to notify prescribing physicians if a substitution was made. That notification requirement came with a sunset provision that eventually nullified the communication requirement. NCBIO worked with a coalition of biologics and biosimilars manufacturers to encourage legislators to repeal the sunset provision, which reinstated the notification mandate. Pharmacists, providers and health plans were brought into the discussion to find common language all could support.

The NC Biotechnology Center received an additional $500,000 recurring and $1 million nonrecurring funds.

 

The One NC Small Business Program, which provides matching dollars to companies who win SBIR and STTR grants, will have $2 million in recurring funds for the 22-23 fiscal year.  This short session budget did not include any additional funding. In 2021 the legislature and governor enacted a two-year budget that included $5 million in the first year for the One NC Small Business program, $2 million of which was recurring and $3 million was nonrecurring.

 

There was no movement on the NC Qualified Business Venture Tax Credit this session. From 1989 to 2013, North Carolina?s QBV program provided significant tax benefits for investments in certain types of businesses. Individual investors were entitled to a tax credit equal to 25% of the purchase price paid by the investor for the equity securities or subordinated debt of the Qualified Business. The maximum credit was $50,000. NCBIO is working with a growing network of angel investors to advocate for the reauthorization for the Qualified Business Venture Tax Credit or a similar mechanisms for encouraging innovation across the state.

NCBIO President Laura Gunter moderated a discussion July 27 on the role of science in policy making at the Sigma Xi Society's Science Policy Boot Camp. Life Science Caucus Co-chairs Sen. Paul Newton and Sen. Mike Woodard, along with Rep. Gale Adcock, comprised the panel.

The bat­tle over what to in­clude in this lat­est round of user fee leg­is­la­tion ? the in­dus­try money that pays for all bio­phar­ma drug and bi­o­log­ic re­views at the FDA and has to be reautho­rized every five years ? is com­ing to a head as Con­gress looks to meet an Au­gust re­cess dead­line be­fore the FDA has to send out thou­sands of warn­ings to much-need­ed review­ers that they?ll be soon laid off.

 

Not on­ly would the FDA be forced to send the pink slips, but all cur­rent PDUFA (and other UFAs, including medical devices and biologics) reviews would grind to a halt as the agency would no longer have the staff to meet its dead­lines.

 

Sen­ate health com­mit­tee rank­ing mem­ber Sen. Richard Burr in­tro­duced a blank ver­sion of the user fee leg­is­la­tion as an at­tempt to start over with­out any of the pol­i­cy rid­ers that made it out of the com­mit­tee, like the ac­cel­er­at­ed ap­proval path­way changes that would al­low the FDA to re­quire com­pa­nies to be­gin post­mar­ket­ing stud­ies be­fore grant­i­ng the sped-up approvals.

 

?Un­for­tu­nate­ly, the user fee pack­age re­port­ed out of com­mit­tee would, if en­act­ed, un­der­mine the very pur­pose of the user fee pro­gram,? Burr said in a state­ment. ?The poli­cies added to this bill en­dan­ger the de­vel­op­ment of drugs for rare dis­eases, im­per­il in­tel­lec­tu­al prop­er­ty rights, threat­en Amer­i­cans? ac­cess to break­through treat­ments and cures, and de­ter pri­vate sec­tor in­no­va­tion. In ef­fect, this pro­pos­al would com­pro­mise the FDA?s over­all abil­i­ty to keep pace with ad­vance­ments in the in­dus­try it reg­u­lates.?

 

More @ Endpoints >>

Democratic lawmakers in the U.S. Senate advanced drug pricing legislation July 6 that would drastically alter the Medicare program. The drug pricing provisions would, among other things, empower the government to directly negotiate with pharmaceutical companies on the prices of select drugs.

 

?The misguided legislation, which is largely similar to a proposal floated last year, includes risky medical price control tactics that will ultimately harm the very patients and seniors that lawmakers claim to be helping," said Michelle McMurry-Heath, M.D., Ph.D., president and CEO of the Biotechnology Innovation Organization.

 

?As we?ve previously warned, ?negotiation? is simply a euphemism for a government takeover of a sector that, on its own, has been historically successful in saving millions of lives."

 

The Incubate Coalition, an organization of venture capital firms representing the patient, corporate and investment communities, sent a letter to all Senate offices urging them to pursue reforms that protect R&D and more meaningfully reduce patient out-of-pocket costs.

 

"As the voice for life science venture capital in the United States, Incubate appreciates the ongoing opportunity to work with you on health care policy. At a time when biopharmaceutical advancements are enabling us to cure disease, fight pandemics and even extend longevity, it is critical that policymakers enact legislation that not only supports the U.S.? robust ecosystem for research and development that makes life-changing medicines a reality but ensures that all Americans have equitable access to them.

 

That is why we are so disheartened to see the Senate considering a package that ignores those priorities and instead pursues political headlines at the cost of future therapies for patients."

 

Let Congress know that government price setting is a bad idea! Click to email your senators and representatives.

 

More @ BIO >>

Leaders from public and private universities, businesses, nonprofits, trade associations and state government have joined forces to bring the new Advanced Research Projects Agency for Health headquarters to North Carolina.

 

ARPA-H recently received $1 billion in inaugural funding from Congress to improve the U.S. government?s ability to speed biomedical and health research to prevent, detect and treat diseases like Alzheimer?s, diabetes and cancer.

 

The ARPA-H in NC Coalition, facilitated by the North Carolina Biotechnology Center, is some 30 partners strong and growing. The Coalition is coordinating efforts locally and in Washington to demonstrate that, with this partnership, ARPA-H can have a rapid, effective start and accomplish its mission in the Tar Heel state. Each partner adds to the case that North Carolina has the expertise, record of entrepreneurial disruption, cross-sector collaboration and scientific innovations. North Carolina translates ideas from initial technology to discovery to development through manufacturing to prevent, treat and potentially cure a range of diseases.

 

This statewide collaboration follows a recent bipartisan letter from members of North Carolina?s Congressional delegation led by Rep. David E. Price and both Sens. Richard Burr and Thom Tillis. The bipartisan members urge Xavier Becerra, secretary of the U.S. Department of Health and Human Services, to strongly consider North Carolina, with its unique assets, as the best location for launching ARPA-H?s success. 

 

More @ NCBIO >>

On July 12, the Equal Employment Opportunity Commission updated its guidance and FAQ around COVID-19 testing and the Americans with Disabilities Act, the Rehabilitation Act and other EEO laws.

 

While employers previously had broad latitude to screen workers for Covid-19, the new EEOC guidelines say employers must show testing procedures are both job related and consistent with business necessity. They'll also need to consider the trajectory of COVID-19 cases in their communities.

• Screening Employees: Before the update, an employer was legally permitted to require on-site COVID-19 viral screening testing. According to the new guidance, employers have to prove that testing employees is ?job related and consistent with business necessity.? Whether testing is a ?business necessity? can be based on several factors, including community transmission rates, employee vaccination status, and working conditions.
• Antibody Testing: Employers cannot require antibody tests before allowing employees to re-enter the workplace, as they do not reliably determine whether someone is currently infected or immune. 
• Applicants: Employers may test applicants for COVID-19, after making a conditional job offer, so long as they are doing so consistently. 
• Rescinding Job Offers: A job offer can only be rescinded if it is absolutely necessary that the employee start employment immediately and in-person. Current CDC guidelines should be evaluated prior to making this decision. 

?[The new guidance] makes clear that, going forward, employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify viral screening testing of employees to prevent workplace transmission of Covid-19,? the EEOC said in the new guidelines.

Strategies for meeting the booming demand for lab space in the Triangle and across North Carolina were shared and discussed by panelists from Azzur Group, Lee & Associates, Longfellow Real Estate Partners and Lincoln Harris at the NCBIO Lab Space Forum and Luncheon held Thursday, July 14, at the NC Biotechnology Center. 

 

The event was sponsored by Alexandria Real Estate Equities, American Laboratory Trading, Azzur Group, Lee & Associates and Longfellow Real Estate Partners. 

 

Marlene Spritzer, vice president of Lee & Associates, moderated a panel comprising 

• Greg Capps, managing director, North Carolina, Longfellow Real Estate Partners; 
• Joel Gates, senior director of operations, Azzur Group; and  
• Amy Watkins, vice president, brokerage, Lincoln Harris. 

More >>

At the July 28 meeting of the NCBIO Board of Directors, the following companies were unanimously approved as new members of the organization:

• Alacrity Medical Innovations has helped medical innovators advance their vision on over 53 Class II and Class III devices since 2006.
  
• Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients.
  
• Cell Culture Company delivers whole cell pellets, cell lysates, custom monoclonal antibody and recombinant protein manufacturing services from development to commercialization.
• Dovetail Consulting Group is a boutique consulting firm providing compliance advisory services to pharmaceutical and biotech companies. 
• Frontier Scientific Solutions is a new, more efficient, effective, and innovative supply chain solution for the life sciences and pharmaceuticals industry based in Wilmington.
  
• NoviSystems provides a bundled hardware/software solution for data fusion, self-service dashboards, NLP, and machine learning.
• McDonald York Building Company is one of the oldest and largest local, family-owned commercial general contracting companies in the Triangle and provides general contracting, construction management and design-build services.
• Pathalys Pharma is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of late stage chronic kidney disease.
  
• RS&H offers award-winning architectural design services, engineering and consulting across a spectrum of industries.
• Veloxis Pharmaceuticals is a fully integrated specialty pharmaceutical company committed to improving the lives of transplant patients and focused on the global development and commercialization of medications used by transplant patients and by patients with serious related diseases.
  

To be included in member news, send information about your organization to David Etchison.

 

BioAgilytix has secured the ISO 27001:2013 certification for its Information Security Management System, a seal of approval for the safety of its IT systems and processes. More >>

 

Biogen announced that the FDA has accepted a New Drug Application and granted priority review for tofersen, an investigational drug for superoxide dismutase 1 amyotrophic lateral sclerosis. More >>

 

Chiesi signed the U.S. Department of Health and Human Services Health Care Sector Climate Pledge, committing to reduce greenhouse gas emissions 50% by  2030. More >>

 

Eisai and Biogen announced today that the FDA has accepted the Biologics License Application under the accelerated approval pathway for lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer?s disease with confirmed presence of amyloid pathology in the brain. More >>

 

G1 Therapeutics has appointed Norman E. ?Ned? Sharpless, M.D., to its Board of Directors. Sharpless is an accomplished oncologist who has led academic institutions and government agencies, including most recently serving as Director of the National Cancer Institute. More >>

 

G1 Therapeutics announced that the China National Medical Products Administration has conditionally approved COSELA (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1 Therapeutics. More >>

 

IQVIA was named a Leader in the IDC MarketScape: Worldwide Life Science Sales and Marketing IT Outsourcing Services 2022 Vendor Assessment. More >>

 

Kymanox named Izi Bruker, Ph.D., has been named as the first Fellow of Kymanox, an honor reserved for professionals who are at the very pinnacle in their field and who are regarded as one of the most advanced subject matter experts amongst peers. More >>

 

Mycovia announced U.S. availability of VIVJOA (oteseconazole) capsules, an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis in females with a history of RVVC who are not of reproductive potential. More >>

 

NALA Membranes successfully closed a $1.5 million investment round to support commercialization of a new generation of chlorine resistant membranes for reverse osmosis applications. More >>

 

Womble Bond Dickinson is opening an office in San Francisco through a combination with Cooper, White & Cooper LLP, a multipractice firm with more than a century of experience providing comprehensive representation to clients in the Bay Area and across the country. More >>

BIO released its third annual report that examines diversity, equity, and inclusion in the biotechnology industry. The report, ?Measuring Diversity in the Biotech Industry: Tracking Progress in Small and Large Companies,? investigates the state of DEI in the biotechnology industry and includes representation data, current DEI approaches and initiatives, and data comparisons to previous reports.

 

At the responding companies, women now make up 49% of employees, compared to 47% in 2020 and 45% in 2019, but 34% of executive teams and 20% of CEOs. Employees of color make up 38% of all employees compared to 24% of executive teams and 28% of CEOs. The survey found meaningful growth in some companies ? more than 4 in 10 increased representation of executives of color by more than 5%.

 

Other key findings:

• Most organizations (nearly 80%) indicate that attracting, recruiting, and promoting diverse talent are priorities of their DEI programs.
• Small and large organizations differ significantly in the establishment of their HR and DEI functions. While large organization respondents all have established HR functions (100%) and the vast majority also have DEI programming (86%), half of small organizations have HR staff (50%), and only a few have DEI programming (18%).
• Small organizations have opportunities to increase their commitment to DEI. Four out of 10 small companies have a stated goal to create an inclusive environment and 37% have a public commitment to diversity.
• Large companies set DEI commitments, but could improve accountability. Only 15% of large organizations consider workforce diversity in leadership evaluations, and DEI metrics impact performance evaluations and/or compensation for leaders in only 23% of large organizations.
• Large companies should focus on sustaining and growing existing DEI efforts. For example, only 32% of large employers require diverse pools of candidates for senior positions and only 28% have sponsorship programs.
• Small organizations should focus on prioritized DEI initiatives and setting up Employee Resource Groups. Fewer than one out of 10 small organizations have ERGs compared to almost 80% large organizations.

Get the BIO report and many other DEI resources at ncbioscience.net/dei.

Hear from the NC Legislative Life Sciences Caucus co-chairs in a session moderated by NCBIO President Laura Gunter and NCBIO Consultant Joe Lanier of Milestone Strategies. This is an outstanding opportunity to visit with Caucus leadership and discuss the state of our industry.

• Sen. Paul Newton
• Sen. Mike Woodard
• Rep. Donna White
• Rep. Robert Reives

The Caucus co-chairs will provide a wrap up of recent legislative activity with a focus on ongoing economic development initiatives. Additional topics may include discussion of regulatory issues, the One NC Small Business Fund, workforce development, science and technology education and more.
 
This is your time to help educate and create champions for the life sciences industry. Please bring your questions to the forum and be prepared to interact with Caucus leadership.

Thank you to Ultragenyx for sponsoring this forum. If you are interesed in sponsorship, please contact Membership Director Natacha Janvier for more information.

 

At this time, registration is limited to active members. Courtesy members may register

but will be notified of their status and added to a wait list.

Join us in person for our Annual Meeting on Wednesday, Oct. 12, at the NC Biotechnology Center in Research Triangle Park. The Annual Meeting program features multiple networking opportunities, a keynote address and three panels.

• Success Stories: Talent Recruitment and Retention highlights Aperio Clinical Outcomes, Novozymes and StrideBio
• Financial Trends and Outlook with GSK, Incubate Coalition, JPMorgan, Pappas Capital and Solas Bioventures
• Health Equity and Disparity features Biogen, BIO, ECU's Center for Health Disparities, the Global Liver Institute and mdgroup

You will not want to miss this year?s programming and networking opportunities. Thank you to our current sponsors.

• Platinum: Avantor delivered by VWR; Bioventus, Cook Medical, Kymanox
• Gold: American Laboratory Trading, Azzur Group, FUJIFILM Diosynth Biotechnologies, Grifols, Novo Nordisk, PSC Biotech
• Silver: AdvaMed, Alexandria Real Estate Equities, The Conafay Group, Frontier Scientific Solutions, Marsh McLennan Agency, Mispro Biotech Services, Smith Anderson
• Bronze: Nikon, Novozymes, PHC Corporation

By participating in BIO Impact?s Start-up Stadium at the Ag & Environment Conference Sept. 19-21 in Omaha, you?ll share your work with investors and get discounted registration fees and complimentary access to BIO One-on-One Partnering. Be sure and register before August 11 to take advantage of BIO's early bird rates!  

 

Who can participate? Companies that have:

• Raised less than $10 million since inception
• Previous business pitch or competition experience
• Fewer than 20 full-time employees
• Not previously been named a BIO Start-Up Stadium winner

Participation in Startup Stadium offers countless benefits: 

• Connect with capital: Engage with key members of the investment community, venture philanthropy groups, strategic partners and nondilutive capital at the world?s largest biotechnology event.
• Network strategically: Meet with state and regional affiliates, as well as early-stage companies at the beginning of their life cycle.
• Gain expert feedback: During BIO Impact, investor judges will attend start-up presentations and do live Q&As with start-up finalists.

The Azzur Training Center offers training that spans GxP concepts but specializes in the aseptic manufacturing space that will allow you to start, scale and sustain your GxP organization. Upcoming courses offered in August at Azzur's Cary location are

• Aug. 16, cGMP Boot Camp
• Aug. 17, Aseptic cGMP Boot Camp
• Aug. 18, Investigation Boot Camp

• Fermentation Engineering hosted by BTEC (8/2/2022 to 8/4/2022)
• Biopharmaceutical Lyophilization and Spray Drying hosted by BTEC (8/2/2022 to 8/5/2022)
• Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy hosted by BTEC (8/8/2022 to 8/11/2022)
• Leadership Summit hosted by NC TECH (8/10/2022 to 8/11/2022)
• Summer Bash at Boxyard hosted by WIB-RTP (8/24/2022)
• How Data Science is Revolutionizing the Agriculture Industry hosted by LaunchBio (8/25/2022)
• NCBIO Legislative Luncheon and Forum (8/31/2022)

UPS Healthcare brings reliability, scalability and security to life science companies every day. Its portfolio of end-to-end services is well-suited to meet today's complex logistics demands for the pharmaceutical, medical device, and laboratory diagnostic industries. Learn exactly how from UPS Healthcare.

 

Through NCBIO?s partnership with UPS Healthcare, you get access to exclusive rates on a full suite of UPS services. And after recent renegotiations, the savings have gotten even better. While the same popular shipping services, like UPS Next Day Air, and UPS Worldwide Express, remain at reduced rates, the price band range to qualify for discounts is narrower. For example, a company that spends $1,500 to $4,999.99 weekly for UPS Next Day Air shipping now receives a 60% discount rather than a 50-55% discount under the previous arrangement.

 

As an NCBIO member, be confident that your critical healthcare shipments will be delivered timely and with care by a quality-focused and patient-driven organization.

 

NCBIO members save up to

• 74% on UPS Next Day Air,
• 59% on UPS 2nd Day Air and UPS 3 Day Select Services,
• 51% on UPS Ground Commercial Services, and
• 68% on UPS Worldwide International Services.

BASF is auctioning off lab equipment and consumables from its RTP site. The online bidding will run from Aug. 26 to 30. You can view the items available and register to bid here.

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