Market is currently valued at $770 million see more
Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).
Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.
“We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”
Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.
As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.
AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.
SC invention provides a solution for reducing accidental needle sticks see more
Medical University of South Carolina neurophysiologist Jessica Barley, Ph.D., and neurologist Jonathan C. Edwards, M.D., noticed a clinical problem and decided to do something about it. The needle electrodes used to monitor a patient’s nervous system function during surgery can also pose a safety risk. Stranded uncapped needles can find their way into health care workers or even patients. Working with the Zucker Institute for Applied Neurosciences (ZIAN), an MUSC technology accelerator, and Rhythmlink International LLC, a medical device manufacturer headquartered in Columbia, South Carolina, the team created a novel safety electrode that has the potential to reduce needle sticks.
The electrode, known as the Guardian Needle, was recently approved by the U.S. Food and Drug Administration for intraoperative monitoring (IOM). The technology has been licensed to Rhythmlink, which is ramping up production for a rollout to hospitals nationwide this autumn.
“We thought it was unacceptable and unfair that the team providing the care to the patient should be put in harm's way by equipment that was meant to do the opposite and ensure patient safety,” said Barley, who runs the intraoperative neurophysiology program at MUSC Health and is co-inventor of the Guardian Needle. “This is how we first came up with the design.”
During high-risk surgical cases, the neurophysiology team uses IOM to monitor a patient’s nervous system. The process involves inserting approximately 40 needles throughout the patient’s body and connecting them with long wires to the IOM machine.
“IOM serves as a vital early warning system,” explained Barley. “It preserves neurologic function in real time.”
However, the setup increases the risk of needle dislocation. Currently available needles can become uncapped when dislodged from the patient’s skin. This results in a danger of needles sticking the staff while in the operating room (OR).
“We don't have to accept that a certain number of our staff are going to get stuck by an IOM needle,” said Edwards, chief of the Integrated Centers of Clinical Excellence in Neuroscience at MUSC Health and co-inventor of the Guardian Needle. “That's a problem, and it's our responsibility as people in the field to solve it.”
The Guardian Needle should protect the surgical team from harm because it is never uncapped. It was designed to deploy the electrode safely only when inserted in the patient. If the needle is dislodged from the skin, it automatically resheathes into its protective casing.
“The key thing is that you don't have to cap and uncap the needle, and it automatically retracts when it's not in the patient,” said Paul Asper, vice president of commercialization at ZIAN.
The design also includes adhesive bandages around the needles. The adhesives enable the team to secure needles to the patient without manually taping them, thus decreasing OR time and cost. The bandage, like the needle electrode, is sterile, which reduces the risk of infection from nonsterile tape.
“We did timed trials,” said Barley. “Just trying the full setup the very first time using the new design, we were all faster,” she said, comparing the new needles with the needles they had used before.
Not only does the Guardian Needle protect the surgical team and decrease OR time, but it also enables better patient care by reducing the risk of needle sticks to patients and helping to maintain a sterile environment.
The adhesives on the needle also secure it in place despite shifts in patient positioning. The adhesives thus ensure signal integrity as the electrodes monitor nervous system function during surgery.
The clinician-innovators were able to come up with the clever design because they were personally familiar with the clinical problem they were trying to address.
“Clinicians have great ideas all the time,” said Edwards. “But 99% of those ideas die, mostly because we don’t have time.”
Enter ZIAN, with the expertise, knowledge and resources to turn an idea into a product. In the case of the Guardian Needle, the ZIAN team developed a business plan and patent strategy, raised funding for research and development, engineered the prototype and forged a licensing agreement with a world-class medical device company, saving valuable time for the busy clinicians.
“The expertise on the ZIAN team aligns perfectly with the clinical expertise of the inventors, enabling both parties to execute on their strengths,” explained Mark Semler, CEO of ZIAN. The core mission of ZIAN is to develop and bring to market technologies that solve unmet clinical needs.
“We have that clinical perspective to create a pipeline of ideas,” said Edwards. “ZIAN provides the practical implementation of those ideas, and neither of those two would be successful without the other.”
Rhythmlink, a South Carolina-based company specializing in medical devices that record or elicit neurophysiologic biopotentials, has licensed the technology and has begun to ramp up production of the Guardian Needle. Their unique position in the industry allowed them to recognize the importance of this invention. That, combined with their contribution to the intellectual property, design enhancements for manufacturing and expertise in regulatory guidelines, helped the product become a reality.
“This is a great example of South Carolina organizations collaborating in the health care space and an illustration of South Carolina’s prowess in innovation, entrepreneurship, life sciences and manufacturing,” said Shawn Regan, co-founder and chief executive officer of Rhythmlink. “Creating a safer work environment for health care professionals absolutely aligns with our mission to improve patient care. Working with ZIAN and MUSC to develop the Guardian Needle and bring this creation to life was a no-brainer from a collaboration standpoint.”
Successful commercialization of the product and the widespread distribution that Rhythmlink can provide are key to realizing a potentially industry-changing standard of care. As the novel electrode is rolled out in hospitals across the country, researchers will collect needle-stick data to determine whether it is safer than the current standard of care. If it is safer, as its inventors believe, it would likely become the new standard of care, given federal workplace safety rules.
“Being at the forefront of an innovative and potentially industry-changing movement is exciting and exactly where we strive to be,” said Regan.
To the inventors, the Guardian Needle provided a way to make a difference not only for their MUSC Health colleagues but also for surgical team members across the globe.
“In health care, we gladly and eagerly place ourselves at risk every day when we're caring for others. But it does have an element of stress and anxiety,” said Barley. “This invention is particularly special because we're not only caring for our patients in a safer, higher-quality way, we're also protecting our colleagues and teammates. It feels like a way of giving back to them and keeping them safe.”
Edwards explained that it is this type of innovation that has enabled him to help patients and health care providers he will never meet. This he considers a benefit of practicing academic medicine.
“We always think of clinical practice, teaching and research as the three pillars of medicine,” he explained. “There's a fourth pillar, and that fourth pillar is innovation.”
Innovation has led this MUSC team to create a solution for a once-tolerated problem. They encourage other clinicians to do the same.
“Take obstacles as an opportunity to find the solution yourself,” encouraged Barley.
Milliken leveraging textile expertise in COVID fight see more
Milliken & Company, a global diversified manufacturer with more than 150 years of textile expertise, has invested significant resources to increase domestic production of its Milliken PerimeterTM advanced medical fabrics. Since March, the company has distributed more than 10 million yards of reusable medical fabrics in response to the global shortage of personal protective equipment (PPE). This recent inventory increase signals Milliken’s continued commitment to ensuring a sustainable, U.S.-based PPE supply chain.
Reusable medical textiles are ideal when cost is a driving factor and when single-use PPE supply is limited or unreliable. Garments made with Perimeter fabric can be laundered for safe reuse at least 25 times. The current demand for protective medical garments and the potential for shortages in the fall and winter prompted Milliken to prioritize production of the advanced material.
“Scaling up U.S. manufacturing of reusable protective fabrics protects the country’s PPE pipeline, which in turn protects more medical professionals,” said Chad McAllister, president of Milliken’s Textile Division and EVP, Milliken & Co. “These brave people have continued to care for us tirelessly, and we are committed to doing all we can to help keep them safe.”
Milliken’s durable Perimeter fabric is not only engineered for manufacturing Level 1 and 2 gowns for critical medical environments such as trauma centers but also provides a smart solution for other industries such as dental, educational and hospitality environments where advanced PPE is now important. The material’s ability to be used multiple times while maintaining a demonstrated protective barrier makes it a cost-effective, made-in-USA alternative to single-use PPE.
“An increasing number of industries and service providers are looking for American-made PPE solutions to protect their employees and customers. This demand highlights the critical need we noted earlier this year, specifically for the U.S. to have a stable PPE supply chain,” McAllister said. “Our goal at Milliken is to be part of the solution, so we’re proactively taking steps to help avoid another shortage of critical PPE.”
Milliken is collaborating with industry partners to ensure protective garments made with Milliken Perimeter fabric are available immediately across the country.
SCBIO webinar generates stance from SC Senator Lindsey Graham on repatriation see more
South Carolina's senior Sen. Lindsey Graham introduced legislation last week that he cited as important during a recent SCBIO webinar, saying it will make sure that essential medical personal protective equipment is made in America.
With support from other senators, Sen. Graham introduced the U.S. Made Act of 2020 to “decrease U.S. dependence on countries like China for personal protective equipment for our health care providers."
“With the spread of coronavirus, the inability of the United States to be self-sufficient with our supply of PPE has shown itself to be a national security issue,” he stated. “Just as the United States does not rely on China to supply military uniforms or equipment, we must not rely on them to supply PPE.”
Items declared national priorities include testing swabs, surgical and respirator masks, face shields, surgical and isolation gowns, sanitizing and disinfecting wipes, gauzes and bandages, and privacy curtains, beds and bedding.
The bill also outlines personal protective equipment acquisition requirements for the Strategic National Stockpile, and establishes an investment credit for qualifying personal protective equipment manufacturing projects.
“Coronavirus has been a painful wake-up call that we are too reliant on nations like China for critical medical supplies,” Sen. Graham noted. “Without changes, China remains set to dominate the PPE market for years to come. We have seen firsthand the problems not having a reliable source of PPE places on our health care system. The Chinese grip on this critical supply chain must come to an end, and this legislation accomplishes that goal.”
U.S. News & World Report releases annual national rankings see more
MUSC Health University Medical Center in Charleston was named by U.S. News & World Report for the sixth year in a row as the No. 1 hospital in South Carolina, with three of the MUSC Health, Charleston Division, specialty areas ranking among the best in the entire country: ear, nose and throat; gynecology; and cancer. Six other MUSC Health programs based in Charleston are considered “high performing” in the 2020-2021 U.S. News & World Report rankings: gastroenterology and GI surgery; nephrology; neurology and neurosurgery; orthopedics; rheumatology and urology. In addition, MUSC Health Florence Medical Center is designated “high performing” in chronic obstructive pulmonary disease (COPD) and heart failure, and MUSC Health Lancaster Medical Center is designated “high performing” in COPD and heart failure.
“These six consecutive years of recognition demonstrate that our teams remain committed to keeping the needs of patients as the focal points of what we deliver every day,” said Patrick J. Cawley, M.D., MUSC Health CEO and vice president for Health Affairs, University. “With all the pressures bearing on the health care industry right now, especially during this pandemic, yet again earning this level of recognition as the leading health care organization in the Charleston area, the Lowcountry and the state engenders a tremendous sense of accomplishment and pride in our teams’ abilities to change what’s possible for those we serve.”
The Best Hospitals 2020-2021 https://health.usnews.com/best-hospitals report is designed to help patients with life-threatening or rare conditions identify hospitals that excel in treating the most difficult cases. The annual report includes consumer-friendly data and information on 4,500 medical centers nationwide in 16 specialties, 10 procedures and conditions. In the 16 specialty areas, 134 hospitals were ranked in at least one specialty. In rankings by state and metro area, U.S. News & World Report recognizes hospitals as high performing across multiple areas of care.
“It is particularly gratifying to see two of the newest hospitals within the MUSC Health system, in our Florence and Lancaster Divisions, recognized in this year’s report,” Cawley said. “Our teams statewide are engaged in delivering health care that is built on quality, safety and innovation at every level.” The Florence and Lancaster hospitals joined the MUSC Health system in March 2019 when MUSC Health acquired four community hospitals.
The U.S. News & World Report Best Hospitals methodologies, in most areas of care, are based largely or entirely on objective measures such as risk-adjusted survival and readmission rates, volume, patient experience, patient safety and quality of nursing, among other care-related indicators.
“For more than 30 years, U.S. News & World Report has been helping patients, along with the help of their physicians, identify the Best Hospitals in an array of specialties, procedures and conditions,” said Ben Harder, managing editor and chief of health analysis at U.S. News. “The hospitals that rise to the top of our rankings and ratings have deep medical expertise, and each has built a track record of delivering good outcomes for patients.”
U.S. News & World Report produces its Best Hospitals rankings with RTI International, a leading research organization based in Research Triangle Park, N.C.
Enjoy this week's Monday Moment from SC Life Sciences see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from Will Williams, President & CEO of the Economic Development Partnership... plus lots of uplifting news... get details here
AI efforts to fall under Artificial Intelligence Research Institute for Science and Engineering see more
Clemson University is consolidating its ongoing and future artificial intelligence research and education initiatives under one umbrella: the Clemson Artificial Intelligence Research Institute for Science and Engineering.
Eighty faculty members, including some researchers who have used and researched AI for years, will work under the umbrella organization, which also will spearhead STEM workforce development projects at the school to strengthen skills in science, technology, engineering and math, according to a news release. The move follows a presidential executive order last year that called for intensified AI training across the country, which led Google, Facebook, Microsoft and Amazon to establish AI labs.
“AI is pervasive now, and we have to prepare our students for a different world,” professor Mitch Shue, executive director of AIRISE, said in the news release. “Combining all of Clemson’s resources in one institute will help us recruit top students and faculty and better compete for federal grants that fund cutting-edge research.”
Feng Luo, AIRISE’s director and founder, hopes the institute will help open new opportunities for Clemson students to meet mounting demand in the field.
“The requirement for AI from industry has dramatically increased. When a company has data, it wants to make sense of the data, and AI is one of the ways to help them,” Luo said in the release. He is also a computer science professor.
One of Luo’s earlier AI projects included an initiative to help quell citrus-greening disease with a $4.3 million federal grant, according to the release. Other studies undertaken by Clemson researchers include deploying a cyber attack defense system for autonomous vehicles, inspecting vehicles on an assembly line for defects and earlier diagnosis of Alzheimer’s disease.
“With AIRISE, Clemson will be well-positioned to play a key role in conducting cutting-edge research and creating the STEM workforce of the future,” Amy Apon, director of Clemson’s School of Computing, said in the release. “We have a real opportunity to help enhance economic development and U.S. competitiveness.”
Yes, Virginia, there is good news, and SCBIO serves it up right here... see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from Jeff Stover, shareholder with Haynsworth Sinkler Boyd... plus lots of uplifting news... get details here ...
Nephron Pharmaceuticals Corporation expanding operations again, adding 380 jobs, $215.8 million investment$215.8 million investment will create 380 new jobs in Lexington County, SC see more
Nephron Pharmaceuticals Corporation (Nephron), a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing, today announced plans to expand operations in Lexington County. The company's $215.8 million investment will create 380 new jobs.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19.
The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
Headquartered at 4500 12th Street in West Columbia, Nephron’s expansion will add new offices, a new warehouse and production space at its campus in Saxe-Gotha Industrial Park.
The expansion is expected to be completed by Q1 of 2021. Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
The Coordinating Council for Economic Development has approved job development credits related to this project.
“The Nephron family is extraordinarily grateful for the opportunity to grow in South Carolina. Thanks to our partnerships with state and local officials, and the trust they have placed in us, we have been able to provide life-saving medications to patients around the world and establish ourselves as the global leader in what we do. We are proud of these achievements and more, and we know our best days are ahead of us. That is what makes this latest announcement so special.” -Nephron Owner & CEO Lou Kennedy
“We are proud to have Nephron Pharmaceuticals in South Carolina. Since coming here they have become an integral part of the community, and recently have been vital in the fight against COVID-19. This new investment of more than $215 million creating 380 new jobs in Lexington County is a great win for Team South Carolina.” -Gov. Henry McMaster
“Nephron is a longtime steward of South Carolina’s business community, and we congratulate them on their continued growth within our state. Today’s announcement is yet another big win for South Carolina, our people and our burgeoning life sciences sector.” -Secretary of Commerce Bobby Hitt
“We are excited to continue to partner with such an innovative and forward-thinking company like Nephron Pharmaceuticals. We know that Lexington County is a great place to establish and grow a business, and Nephron’s continued success is a testament to good government-business relations.” -Lexington County Council Chairman Scott Whetstone
FIVE FAST FACTS
• Nephron Pharmaceuticals Corporation (Nephron) is expanding operations in Lexington County.
• The $215.8 million investment is projected to create 380 new jobs.
• Nephron is a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing.
• Headquartered at 4500 12th Street in West Columbia, S.C.
• Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
ZEUS Names New President and CEO see more
Frank P. Tourville, Sr., Founder and Chairman of the Board of Zeus Industrial Products, Inc. announced on Wednesday, July 1, 2020 that Steve Peterson, President of Zeus, assumed the role of Chief Executive Officer. This organizational change comes with the recent retirement of former CEO, John Winarchick, who dedicated over 30 years of service to the company.
Peterson, who joined Zeus in 2017, previously held the position of Senior Vice President of Global Sales and Marketing. Before joining Zeus, Peterson held global leadership positions with TE Connectivity, Samsung Electronics, and General Electric. During that time, he assumed roles of increasing responsibility in sales, marketing, product management, supply chain management, and executive management.
As President and CEO of Zeus, Peterson will continue to play an instrumental role in leading the company forward by focusing on developing powerful growth strategies and providing ongoing value to customers, team members, and the surrounding communities. His invaluable contributions have already helped to shape the company Zeus is today.
“Steve Peterson has shown the true measure of a leader in unprecedented times of difficulty. His charisma, resilience, dedication, and vast industry knowledge are huge assets to Zeus,” said Frank P. Tourville, Sr., Founder and Chairman of the Board, Zeus Industrial Products, Inc.
SC life sciences news of note fro your reading pleasure is now live! see more
This edition of SCBIO's semi-monthly newsletter is chock full of great information, including next week's eagerly anticipated webinar featuring top elected officials on SC's path forward from COVID, the "Slow the Spread" PSA campaign from BCBSSC and SCHA, highlights on companies stepping up in tough times, late-breaking news and more. Read the entire thing by clicking here!
Effort to focus on life sciences, other knowledge-based industries see more
In preparation for an anticipated economic rebound once the effects of the COVID-19 health crisis subside, the Richland County Economic Development Office (RCEDO) has teamed with a group of regional partners to develop an economic development action plan for promoting the growth of knowledge-based industries within the region.
RCEDO is also collaborating on the plan’s marketing components with those partners, which include Lexington County, the City of Columbia, the University of South Carolina, Midlands Technical College, the S.C. Research Authority (SCRA) and the Central SC Alliance.
The initiative focuses on five knowledge-based industry segments: information technology/data analytics, financial services, aerospace, medical devices and the biosciences. It is designed to build on existing assets in the region and capitalize on the growing base of research, innovation and industry partnerships at the University of South Carolina.
“I am exceptionally proud that the entire economic development community in our region has united to ensure that we can more effectively compete to expand the number of knowledge-based jobs,” said Paul Livingston, chair of Richland County Council. “This initiative will have a substantial economic impact on the whole region.”
The plan also contains a robust marketing component, and RCEDO will collaborate with its regional alliances to implement key strategies. The development office will coordinate with partners to position and promote the Columbia region as a technology and innovation hub.
“South Carolina is among the most successful states in the nation in building its manufacturing base, but the state has not been as successful in generating jobs in knowledge-based industries,” said Garry Powers, who is overseeing the project for the County as a member of the Economic Development staff.
“The Columbia metro area has the highest concentration of software-related employment in the state, and bioscience-related companies are expanding rapidly in the region,” said Jeff Ruble, RCEDO director. “Therefore, once we adapt our economic development and workforce programs so that we have an improved capacity to support companies in these targeted industries, the Midlands region is well positioned to substantially increase employment, both within our existing firms and within the new firms that we will attract to the region.”
As part of this initiative, Deloitte Consulting has analyzed the region’s capacity to grow employment in the targeted industry segments. Using this information, the company developed a detailed action plan that mitigates competitive weaknesses and builds on the region’s strengths.
To assess the Midlands’ competitive position, Deloitte measured the region’s capacity to support industry expansion compared with more than two dozen other metro areas that are hotbeds of knowledge industry growth.
Further, the initiative identifies opportunities to improve the region’s competitive position in a variety of areas, including:
- Enhancing education/training programs based on an analysis of industry needs
- Expanding programs that build the talent pipeline
- Ensuring there is sufficient infrastructure (e.g., wet labs, broadband, real estate) to support the targeted industries
- Restructuring state/local education and training incentives and other state/local incentives to ensure they are competitive nationally
The SCRA is an active partner in the project because of its mandate to promote the growth of the state’s innovation economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry. Deloitte’s action plan includes provisions for growing existing small firms and attracting new, innovative small firms within the targeted industry segments. The plan will especially focus on firms capable of building university partnerships.
The project is expected to provide substantial economic development benefits statewide, and the region has established strong, project-related working relationships with several entities. These include the S.C. Department of Commerce, the State Board for Technical and Comprehensive Education, the S.C. Council on Competitiveness and SCBIO, a statewide, not-for-profit, public–private economic development organization that actively promotes, builds, supports, expands and convenes the state’s life sciences industry.
Company opens new manufacturing, quality control facilities see more
AmbioPharm Inc. a leading supplier of peptide active pharmaceutical ingredients has recently opened its new manufacturing and quality control facilities at its headquarters in South Carolina.
“The new buildings were completed in April and qualified by May 15, 2020 expanding our peptide manufacturing capacity,” stated Dr. Chris J. Bai, CEO. “The new buildings add nearly 56,000 sq. ft of production space to our current footprint in South Carolina. In the near future, our subsidiary site in Shanghai will also complete a new campus of 350,000 sq. ft. later this year.”
“As the world battles the Covid-19 pandemic, it has become increasingly apparent that no single solution will suffice for patients who are fighting the disease. Peptide approaches have been recently advanced for potential vaccine development, diagnostic testing and as therapeutic agents to help ameliorate the cytokine storm,” stated Dr. Michael W. Pennington, CSO. “Furthermore, we believe that science will prove to be the Achilles’ heel of the virus, and the world will recover more quickly as better therapies become available,” added Dr. Pennington.
AmbioPharm Inc. is uniquely positioned to help companies that are developing peptide-based approaches targeting the virus. As the company with the world’s largest cGMP peptide manufacturing capacity, AmbioPharm Inc. has a very unique business model which helps us to produce peptides of both high quality and purity with very economical cost. AmbioPharm Inc. can be contacted through our website if you have a project which requires our services.
Okra Medical Receives a U.S. Patent for SafeMedWaste; Product destroys addictive substances like opioidsOKRA Medical product completely destroys highly addictive substances like opioids see more
Okra Medical is pleased to announce The US Patent and Trademark Office issued a Patent for Okra’s SafeMedWaste product suite which provides a safe, environmentally friendly, and cost-effective solution to ending the lifecycle of highly-addictive controlled substances, including opioids.
“With our patent in hand, we are beyond excited to get SafeMedWaste out onto the market and offer this exciting new alternative to destroying dangerous drugs such as opioids,” said Justin Stas, Chief Technology Officer, Okra Medical.
Currently many large manufacturers of prescription drugs incinerate their waste which is a costly solution to meet the regulatory requirement for destruction. Citizens, who have leftover prescription drugs often have to wait months for special “take-back” programs to safely discard the controlled substances. Now, Okra Medical’s SafeMedWaste provides a disposal product with verified results from a DEA-licensed laboratory proving its effectiveness for regulatory destruction of more than 30 controlled substances.
SafeMedWaste is the only drug disposal product verified to completely denature a wide variety of controlled substances using high performance liquid chromatography, mass spectroscopy(HPLC-MS). HPLC-MS is the only data that the DEA considers reliable and resolute enough to meet their definition of non retrievable based on what we know currently.
“Receiving this patent has taken more than a year of hard work, but it’s worth every minute knowing SafeMedWaste will help people destroy highly addictive drugs and potentially keep them out of the hands of people who might misuse them,” said Okra Medical’s CEO Marshall Hartmann.
According to statistics from a National Survey on Drug Use and Health, 11.4 million Americans misused illegal prescription opioids in 2017. SafeMedWaste provides a critical solution through its breakthrough formula that completely destroys highly addictive controlled substances often used in hospitals, hospice, pharmacies and veterinary care clinics. Destroying unused and unwanted prescription drugs helps eliminate the threat of diversion and misuse.
Patents are only granted for new, useful and non-obvious inventions. Okra Medical also filed a Patent Cooperation Treaty (PCT) application to protect SafeMedWaste intellectual property internationally.
About Okra Medical Inc.
Okra Medical, Inc., headquartered in Johns Island, South Carolina, specializes in product development, manufacturing and strategic sourcing of controlled pharmaceutical substance disposal solutions. Founded in 2018, the Company’s mission is to improve public health. Its best-in-class suite of SafeMedWaste products use single formulas that are fully compliant with DEA regulations requiring non-retrievable destruction of controlled substances. Okra Medical is a strategic sourcing partner to hospitals, hospice facilities, law enforcement agencies, pharmaceutical manufacturers, and veterinary care clinics. Visit www.okramedical.com
Lindsay Cobbs named to head KPIC at USC see more
The Kennedy Pharmacy Innovation Center (KPIC) announced that James Lindsay Cobbs has been named chair for the center.
In his role, Cobbs will focus on creating a regulatory affairs program for students in the College of Pharmacy, including classroom, cocurricular, experiential, and post-graduate opportunities, as well as supporting Nephron Pharmaceuticals in regulatory affairs.
“My priorities will hone in on developing experiential training opportunities that will enable our students to build skills for both traditional and nontraditional pharmacy roles, developing key partnerships that can support training for our students and to identify ways that will make the College of Pharmacy stand light years apart from other colleges across the country,” says Cobbs.
Cobbs brings a wide array of career experiences to KPIC, ranging from clinical pharmacy to global policy development in the pharmaceutical industry. After graduating from the UofSC College of Pharmacy in 1992, he launched his career as a staff pharmacist at Johns Hopkins Medical Center. After four years, he entered public service as a regulatory affairs professional at the U.S. Food and Drug Administration (FDA) where he served as regulatory project manager, special assistant and lead project manager in the Office of Compliance and later as associate director for regulatory affairs (ADRA) in the Office of Translational Sciences.
Cobbs then transitioned to the corporate sector at Janssen Pharmaceuticals, a division of Johnson & Johnson as a policy lead in the Americas, Global Regulatory and Policy Intelligence Department. Cobbs later became the head of US Policy, Global Regulatory Policy and Intelligence for UCB (Union Chimique Belge translated as Union Chemical of Belgium), a multinational biopharmaceutical company headquartered in Brussels, Belgium.
Cobbs says his various roles have led him to this next challenge. “My experience as a pharmacist at a major teaching institution, working as a public health servant, co-leading drug review teams for novel drug products, and regulatory policy and intelligence in the pharmaceutical industry have prepared me for this unique role,” he says.
Patti Fabel, Pharm.D. and executive director of KPIC is looking forward to joining efforts with Cobbs. “Our faculty, staff, and students can learn a great deal from him due to his background, experience and skill set,” Fabel says. “He will broaden the scope of what KPIC can offer our students and alumni by developing a regulatory affairs program. I’m excited to see the impact he has on the center and college.”
Dean Stephen J. Cutler says Cobbs is an exceedingly accomplished expert in pharmaceutical regulatory affairs. “His addition to our faculty will bring added depth and breadth to our educational program as we launch our college’s latest initiative, the Regulatory Affairs Academic Program,” Cutler adds. “This academic program will offer regulatory education to our pharmacy students, provide postgraduate education for residents and fellows, and give another educational track to our graduate program. Our partnership with Nephron Pharmaceuticals will afford us a working laboratory for the development of future pharmacists and scientists serving in regulatory affairs. We are thrilled that Lindsay Cobbs will shepherd this initiative for the College of Pharmacy.”
Cobbs will begin his role on July 1, 2020.