Category Archives: Science: Biology

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Ambry Genetics’ Data Reveal that Expanding Genetic Testing Guidelines Could Identify More Patients with Increased Risks of Cancer


Ambry Genetics

This study identifies specific opportunities to expand the current testing guidelines to identify more individuals facing increased cancer risks, who would benefit from more intensive cancer surveillance and/or preventive surgeries.

Ambry Genetics (Ambry), a leading clinical genetics testing company, announced today new opportunities to improve genetic testing guidelines. In the largest cohort study of its kind, Ambry presents novel, detailed evidence on how to improve the guidelines to identify more at-risk patients.

Clinicians use guidelines to inform decisions about which patients should receive genetic testing for hereditary cancer and for those patients which genes should be tested. These guidelines also have implications for how insurance plans cover genetic testing, and for appropriate medical management of patients after testing is complete.

In their recent study published in Genetics in Medicine, researchers from Ambry and Mayo Clinic applied genetic testing criteria from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology to 165,000 patients who underwent multigene, hereditary cancer panel testing.

Ambry specifically looked at the testing guidelines for BRCA-Related Breast and/or Ovarian Cancer Syndrome (HBOC) and for Lynch Syndrome to better understand how the guidelines for these two common, inherited conditions might be improved to identify more at-risk patients.

The study found that updating the BRCA1 and BRCA2 and Lynch syndrome testing criteria to include more medically actionable, cancer-predisposition genes – and relaxing current criteria, such as age-at-diagnosis constraints – would identify more patients at risk for developing hereditary cancer.

The study found that:

  • 1 in 4 (409/1518) patients with pathogenic variants in Lynch syndrome genes would have been missed using current Lynch syndrome testing criteria;
  • 1 in 17 (302/5200) patients with pathogenic variants in BRCA1 and BRCA2 would have been missed using current BRCA1 and BRCA2 testing criteria; and
  • 3 in 5 (7647/12,847) patients with pathogenic variants in clinically actionable breast and/or ovarian cancer genes would have been missed if tested for BRCA1 and BRCA2 only.


“This study identifies specific opportunities to expand the current testing guidelines to identify more individuals facing increased cancer risks, who would benefit from more intensive cancer surveillance and/or preventive surgeries,” said Holly LaDuca, lead author on the study and senior manager of Clinical Affairs Research at Ambry Genetics.

In addition, this study revealed several new gene-cancer associations that have the potential to impact patient care. For example, pathogenic variants in BARD1 were associated with a 2-fold increased risk for breast cancer. However, there are no recommendations for increased breast cancer surveillance for these variants like there are for other genes associated with similar risk.

“Results from this study refined several gene-cancer associations for which there are no rec-ommendations for increased surveillance and/or preventive surgeries. More studies are need-ed from the genetics community to better understand how these new gene-cancer associations have the potential to impact patient care,” added Ms. LaDuca.

ABOUT AMBRY GENETICS ®

Ambry Genetics, as part of Konica Minolta Precision Medicine, excels at translating scientific research into clinically actionable test results based upon a deep understanding of the human genome and the biology behind genetic disease. Our unparalleled track record of discoveries over 20 years, and growing database that continues to expand in collaboration with academic, corporate and pharmaceutical partners, means we are first to market with innovative products and comprehensive analysis that enable clinicians to confidently inform patient health decisions. We care about what happens to real people, their families, and the people they love, and remain dedicated to providing them and their clinicians with deeper knowledge and fresh insights, so together they can make informed, potentially life-altering healthcare decisions. For more information, please visit ambrygen.com.

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DuPont Nutrition & Biosciences to Showcase Extensive Bakery Ingredients at IBIE19


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As part of its industry-leading portfolio of emulsifiers, DuPont will introduce DIMODAN® NG 100 at the expo.

DuPont Nutrition & Biosciences will offer its baking innovation expertise and wide-ranging DuPont™ Danisco® ingredient solutions to attendees at the International Baking Industry Expo, September 8 to 11, in booth 5015. DuPont uses cutting-edge science to solve today’s baking challenges from optimizing production efficiency to cost and waste reduction and from maintaining freshness throughout shelf life to reformulating for cleaner labels. DuPont offers ingredient technology in applications across the baking industry, including yeast-raised sweet goods, cakes, tortillas, flatbreads, pan breads, buns, rolls, bagels and fillings, glazes and toppings.

As part of its industry-leading portfolio of emulsifiers, DuPont will introduce DIMODAN® NG 100 at the expo. DIMODAN® NG 100 is a non-GMO, next generation emulsifier solution to replace hydrated monoglycerides as a dough conditioner and crumb strengthener in a broad range of applications. Using this new monoglyceride powder instead of hydrated pastes, baking manufacturers achieve similar product yields with a smaller ingredient amount, leading to cost savings and big sustainability gains with this easy-to-use solution.    

Visitors can sample the breadth of DuPont innovations for the baking industry and beyond during the expo. Daypart menus will begin with a Brunch Bar featuring an assortment of on-trend toasts and toppings followed by an afternoon Taco Bar with tortillas and various fillings. Or stop by anytime for a sweet treat! All the food featured offers the perfect chance to discuss market trends, customer challenges, innovation opportunities, and how DuPont’s expertise makes the perfect partnership for success.

Knowledge sharing

On Tuesday, September 10, David ‘Guilley’ Guilfoyle, Group Manager with DuPont, will present an educational session called, Pushing the Boundaries of Freshness Through Hurdle Technology. Attendees will learn about a three-pronged hurdle approach for shelf life extension that uses antioxidants, antimicrobials, and anti-stalling technologies in synergy. Guilfoyle will discuss this in detail, plus a new development called “hyper-extended” shelf life that pushes freshness boundaries even further. The hour-long session begins at 9:45 a.m. CT in room N256.

For more information on all DuPont bakery ingredients and broader food and beverage solutions, go to http://www.food.dupont.com/

About DuPont Nutrition & Biosciences

DuPont Nutrition & Biosciences applies expert science to advance market-driven, healthy and sustainable solutions for the food, beverage, dietary supplement and pharmaceutical industries. We also use cutting-edge biotechnology across a range of markets to advance bio-based solutions to meet the needs of a growing population, while protecting our environment for future generations. We are innovative solvers who help our customers turn challenges into high-value business opportunities. For more information: http://www.dupontnutritionandbiosciences.com or http://www.biosciences.dupont.com.

About DuPont

DuPont (NYSE: DD) is a global innovation leader with technology-based materials, ingredients and solutions that help transform industries and everyday life. Our employees apply diverse science and expertise to help customers advance their best ideas and deliver essential innovations in key markets including electronics, transportation, construction, water, health and wellness, food, and worker safety. More information can be found at http://www.dupont.com/.

08/28/19

DuPont™, the DuPont Oval Logo, and all trademarks and service marks denoted with ™, SM or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted.

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LiveWall Living Wall Brings Natural Beauty and Calm to the TSA Checkpoint at Appleton International Airport (ATW)


The lush, vibrant green wall at Appleton International Airport.

The living wall softens and brightens the area following the airport’s TSA checkpoint.

Not only does it provide a calming effect, it quickly became an unexpected attraction.

The renovation and expansion of the Transportation Security Administration (TSA) checkpoint at Appleton International Airport (ATW), Appleton, Wisc., features a 276-square-foot green wall installed with the LiveWall ® Indoor Living Wall System. Completed in August 2018, the three-sided living wall is positioned at the end of the security lines, where it serves as green design element that has a natural, biophilic calming effect.

“We set out to make ATW’s TSA checkpoint the most visually appealing and pleasant in the U.S.,” said Patrick Tracey, marketing manager, Appleton International Airport (ATW). “The living wall is essential in realizing this goal.”

“The living wall serves to calm and de-stress the checkpoint,” said Mitchell Walker, designer, aviation architecture, Mead & Hunt.

The transformation of the security area is part of a multi-million renovation and reconstruction of 50,000 square feet of ATW’s commercial passenger terminal designed by Mead & Hunt. The project included opening up and maximizing the space in the security area and establishing dedicated lanes for entering the security lines from the terminal and exiting to the terminal from the gates. Adding glazing, both at the exterior and for interior partitions, brightens up the area with borrowed light.

The living wall is situated at the end of the security lines in the “composure area” (where passengers can sit, put their shoes back on, and gather their belongings). Installed by SMA Construction Services (Green Bay, Wisc.), and maintained by Beauty By The Yard (Neenah, Wisc.), the green wall at ATW covers three sides of a structural wall. The section facing the TSA checkpoint is 10’-8” x 8’-3 3/8.” The wrapped corner section is 6’-8” x 10’-11 3/8.” The section facing toward the gates is 10’-8” x 10’-11 3/8”. In total, the wall includes 148 LiveWall modular planter boxes, which are high-impact, UV-resistant, architectural quality moldings. They contain re-usable inserts that hold the growing medium and contain a mix of five different indoor plants.

“The LiveWall green wall softens the feeling of the terminal, where many other materials for the flooring and walls are hard,” said Scott Volberding, C.M., ACE, operations and maintenance manager, Appleton International Airport (ATW). “Not only does it provide a calming effect, it quickly became an unexpected attraction.”

“Travelers are delighted with the wall,” said Tracey. “We see passengers taking selfies in front of the wall after they go through security. Their positive experience of the living wall makes for a memory they want to save and share on social media.”

Appleton International Airport (ATW)

Appleton International Airport, the third largest airport in Wisconsin, is one of the fastest growing airports in the U.S. ATW serves Northeast Wisconsin via four airlines (American Airlines, Delta Air Lines, United Airlines and Allegiant Air) with nonstop services to 10 destinations including five major hubs (Atlanta, Chicago, Denver, Detroit, Minneapolis/St. Paul) and five warm weather destinations (Fort Myers/Punta Gorda, Las Vegas, Orlando/Sanford, Phoenix/Mesa and Tampa/St. Pete). For more information, visit http://www.atwairport.com.

LiveWall

Designed with a healthy regard for plants, LiveWall®  is the patented living wall system that achieves simplicity and sustainability in harmony with nature. LiveWall is the result of four years of R&D by the professionals who created LiveRoof®, the superior green roof system. LiveWall green wall solutions are engineered with horticultural and structural features specific for indoor and outdoor environments. LiveWall supports plants as nature intended — roots growing down, stems and leaves growing up. With unsurpassed versatility to grow a diversity of plant types, LiveWall transforms ordinary walls into inspiring, thriving vertical landscapes that are simple to install and easy to maintain. Follow LiveWall on LinkedIn, like LiveWall on Facebook, and for more information call 877-554-4065.

Link to Project Photos:

LWall_ATW_Photos

Link to Project Video:

https://youtu.be/JuxAR0Z6Njc

Media Contacts:

LiveWall

Mike Haynes

LiveWall

616-935-1974

mikeh(at)livewall(dot)com

David Aquilina

Strategic Storyteller

612-716-5628

davida(at)strategicstoryteller(dot)com

Appleton International Airport

Patrick Tracey

Marketing Manager

Patrick.tracey(at)outagamie(dot)org

920-209-9031

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A Frost & Sullivan Executive MindXchange


https://www.prweb.com/

CSIRO US Logo

“I am delighted to share my expertise on open innovation,“ said Lucas-Conwell, “which is the lifeblood of future success. across industries ranging from Agtech to space commercialization.”

CSIRO US, Australia’s pre-eminent national science organization, today announced that Susan Lucas-Conwell, Executive Vice President CSIRO US, will be speaking at the Frost & Sullivan Growth, Innovation and Leadership Summit on September 17, 2019 at the Hyatt Regency Lost Pines Resort and Spa.

This 15th Anniversary Growth, Innovation and Leadership: A Frost & Sullivan Executive MindXchange will focus on how innovation will drive growth and revolutionize the workforce, customer engagement and strategies in the digital future. Drawing on her deep expertise in Global 1000 corporate innovation and venturing, Lucas-Conwell will lead a discussion on “Where Ventures are Venturing” with ATX Ventures, Baird Capital, Dreamit Ventures, gener8tor, Saudi Aramco Energy Ventures LLC, and S3 Ventures.

“We are seeing that cross-industry innovation is the primary source for digital disruption and the enabling technology behind it. Entire markets are being redefined and reshaped from one day to the next,” said Lori Salazar Strubhart, Senior Vice President, Business Financial Services, Frost & Sullivan. “Alternative strategies around diverse VC investing models, gut versus data investing to IPO versus mega-investing, and the number of capital sources and opportunities for funding are on the rise. Now entrepreneurs have more options to go direct. Corporate and private equity firms are listening, too. This session will be extremely insightful from the VC perspective.”

Lucas-Conwell opened CSIRO’s North American innovation center in Silicon Valley in 2017. She is a member of Frost & Sullivan’s Growth Innovation Leadership Council, an independent Board Director and NACD Fellow recognized for her successful track record of driving innovation and accelerating revenue growth.

“I am delighted to share my expertise on open innovation,“ said Lucas-Conwell, “which is the lifeblood of future success across industries ranging from Agtech to space commercialization. At CSIRO US we work with global leaders to solve the world’s greatest challenges through innovative science and technology.”

About CSIRO US

Based in Silicon Valley, CSIRO US is the North American innovation center for CSIRO, Australia’s pre-eminent national science organization, accelerating innovation through global science with more than 2,000 patents and 150 spinouts to date. CSIRO US facilitates relationships with Global 1,000 customers, USA government agencies, universities, and research institutions to turn big ideas into disruptive products. Learn more at http://www.csiro.us/ and follow us on LinkedIn.

Media Contact:

Christine Crandell, New Business Strategies

Christine.crandell@newbizs.com

415 309 7017

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World Molecular Imaging Society Concludes 2019 Annual Global Congress Featuring Gold Medal Award Winner and Molecular Imaging Pioneer


This year’s congress featured many ground-breaking research presentations in the world of molecular imaging.

The World Molecular Imaging Society (WMIS) recently concluded its annual Congress in Montreal, highlighting new discoveries focused on the integration of molecular imaging into science and healthcare to develop innovative complementary approaches to understand biology and improve patient care. WMIS also announced the key award winners for outstanding molecular research.

Providing the closing ceremony presentation was molecular imaging pioneer Kathy Ferrara, Ph.D., professor of Radiology at Stanford University and this year’s Gold Medal Award winner. Her Gold Medal Award Lecture was entitled Incorporating Ultrasound in Molecular Imaging and Therapy.

Dr. Ferrara’s contributions span the field of ultrasound imaging and therapy, including nearly 300 technical papers that have been cited nearly 18,000 times. She pioneered the development and incorporation of ultrasound contrast agents, publishing numerous seminal papers on the physics of the interaction of these agents with ultrasound waves. Her work has had a clinical impact in techniques that are very widely used worldwide in the diagnosis of cancer. Dr. Ferrara also has been a pioneer in the area of image-guided drug delivery, synthesizing new particles and integrating these technologies with imaging methods. Currently, she is a member of the WMIS Board of Trustees.

“I am honored to receive the WMIS Gold Medal Award supporting this important field of medical research,” said Dr. Ferrara. “Molecular imaging has already greatly contributed to patient care and will continue to do so in the years to come. It is essential that we encourage the next generation of researchers and clinicians to carry on this important mission.

WMIS also welcomed Julie Sutcliffe, Ph.D., professor of Biomedical Engineering and Medicine at University of California Davis, as incoming WMIS president for 2019-2020. She will preside over the annual congress in 2020. Dr. Sutcliffe leads a multidisciplinary translational research team that is recognized nationally for its contributions to the field of Molecular Imaging. Her laboratories’ primary research focus is the design, synthesis, in vitro evaluation and in vivo screening of targeted molecular imaging agents with the ultimate goal of rapid deployment to the clinic.

“This year’s congress featured many ground-breaking research presentations in the world of molecular imaging,” said Dr. Sutcliffe. “We anticipate many cutting-edge research advances throughout the coming year and look forward to hearing the results at next year’s 2020 Congress in Prague.”

ABOUT WORLD MOLECULAR IMAGING SOCIETY

The WMIS is dedicated to developing and promoting translational research through multimodality molecular imaging. The education and abstract-driven WMIC is the annual meeting of the WMIS and provides a unique setting for scientists and clinicians with very diverse backgrounds to interact, present, and follow cutting-edge advances in the rapidly expanding field of molecular imaging that impacts nearly every biomedical discipline. Industry exhibits at the congress included corporations who have created the latest advances in preclinical and clinical imaging approaches and equipment, providing a complete molecular imaging educational technology showcase. For more information: http://www.wmis.org

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Catalent Announces the Appointment of David Schaffer to Biologics Advisory Board


We welcome David to the advisory board and look forward to his insights and guidance at this exciting time in the company’s evolution as we embrace the new technology of gene therapy into the services we offer.

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that professor David Schaffer has been appointed to the advisory board of the company’s biologics business. Dr. Schaffer has played an integral advisory role on the gene therapy industry, as Catalent has moved into gene therapy services through the company’s May 2019 $1.2 billion acquisition of Paragon Bioservices, Inc., a leading viral vector development and manufacturing partner for gene therapies.

“We welcome David to the advisory board and look forward to his insights and guidance at this exciting time in the company’s evolution as we embrace the new technology of gene therapy into the services we offer,” commented Mike Riley, Vice President and General Manager of Catalent Biologics. “David’s depth of knowledge and expertise in this area will complement our team, especially advising on the new viral vector development and manufacturing technologies we have gained through our acquisition of Paragon Bioservices, Inc.”

The biologics advisory board was originally founded in 2015 to bring together scientific thought leaders and biotechnology industry veterans to strengthen and support Catalent’s growth in the rapidly evolving field. Professor Schaffer joins the current board’s members, Carolyn Bertozzi, Ph.D., Barry Buckland, Ph.D., Michael Buckley, Ph.D., Daniel R. Marshak, Ph.D., Edward R. Robinson, and Matthew Stober.

Professor Schaffer serves as Director of the Berkeley Stem Cell Center, in addition to holding a position as a professor of chemical and biomolecular engineering, bioengineering, and neuroscience at University of California, Berkeley. He completed his bachelor’s at Stanford University, before undertaking his doctorate at the Massachusetts Institute of Technology, and postdoctoral training at the Salk Institute. His research at Berkeley applies engineering principles to enhance gene therapy and stem cell approaches to treat human disease.

He is the co-founder of three companies: 4D Molecular Therapeutics, Inc., which uses a novel technology platform to engineer optimized, proprietary adeno-associated viral (AAV) vectors for gene therapy; Ignite Immunotherapies, Inc., which is developing novel oncolytic virus technologies as cancer therapies in partnership with Pfizer; and Valitor, Inc., which is developing a novel protein-polymer conjugation technology to develop greatly enhanced protein biologics for a range of disease targets.

Catalent Biologics provides advanced technologies and integrated solutions for biologic and biosimilar development and manufacturing, from DNA to fill/finish and commercial supply, through its extensive Biologics network including: Bloomington, Indiana, where the company recently announced a twenty-first commercial launch of a fill/finish product, and; Madison, Wisconsin, home of Catalent Biologics’ proprietary GPEx® technology for stable, high-yielding mammalian cell lines with twelve approved molecules. For more information on Catalent Biologics, visit biologics.catalent.com.

About Catalent Biologics

For more than two decades, Catalent Biologics has built capabilities and experience in development, manufacturing, and analytical services for new biological entities, gene therapies, biosimilars, and antibody-drug conjugates. Catalent Biologics has worked with 600+ mAbs and 80+ proteins, and 12 biopharmaceutical drugs produced using GPEx® technology have been approved and marketed, with more than 120 ongoing clinical trials utilizing therapeutic candidates developed using the GPEx platform. A further 25 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Catalent Biologics’ latest addition, Paragon Gene Therapy’s AAV development through commercial-scale manufacturing facilities in Baltimore, Maryland, have produced over 100 clinical GMP batches across 40 programs. Using advanced technology and tailored solutions for clinical through commercial supply, Catalent Biologics brings better biologic treatments to patients, faster. For more information, visit biologics.catalent.com

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including over 2,400 scientists, at more than 35 facilities across five continents, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com

More products. Better treatments. Reliably supplied.™

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DuPont Animal Nutrition Launches Axtra® PHY, the Latest Generation of Phytase Enzyme in Japan


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We are proud to be the first company to launch a new generation phytase enzyme in the Japanese market.

DuPont Animal Nutrition, a business unit of DuPont Nutrition & Biosciences (DuPont), today announced the launch of Axtra® PHY in Japan. DuPont™ Axtra® PHY is the fast-acting phytase enzyme designed to improve animal performance and reduce phosphorus waste.

Axtra® PHY is the fastest route to top animal performance in poultry and swine, while improving profitability for producers and reducing phosphorus waste. The phytase enzyme works quickly in the digestive tract to break down phytate, the main storage form of phosphorus contained in plants and a key anti-nutrient. By lowering the impact of phytate, Axtra® PHY increases the availability of phosphorus, energy and amino acids naturally present in the feed, meaning the producer needs to add fewer costly ingredients. Reducing phosphorus waste also reduces the amount of phosphorus runoff that may pollute nearby surface and groundwater systems. This helps producers operate more sustainably by reducing their overall environmental footprint.

“DuPont offers innovative enzymes that are not only the fastest-acting in market, but also enhance the interaction of nutrition, the microbiome and gut and immune function, improving the nutribiotic state of the gut,” said Aart Mateboer, Business Unit Director, DuPont Animal Nutrition. “We are proud to be the first company to launch a new generation phytase enzyme in the Japanese market.”

Reduction of the anti-nutrient phytate factors leads to improved gut health for swine and poultry. Axtra® PHY also leads to improved weight gain and feed efficiency, helping producers save on feed costs and improving their profitability. DuPont provides optimized dosing that is specific to species, diet and life stage, leading to maximized return for customers.

The launch of DuPont™ Axtra® PHY in Japan follows the 2017 launch of phytase enzyme Phyzyme® XP.

DuPont is investing in science and innovation to help producers improve performance, increase livability and support welfare in the face of increasing pressure to reduce or remove antibiotics from production systems. To learn more, visit http://animalnutrition.dupont.com/AxtraPHY.

About DuPont Nutrition & Biosciences

DuPont Nutrition & Biosciences applies expert science to advance market-driven, healthy and sustainable solutions for the food, beverage, dietary supplement and pharmaceutical industries. We also use cutting-edge biotechnology across a range of markets to advance bio-based solutions to meet the needs of a growing population, while protecting our environment for future generations. We are innovative solvers who help our customers turn challenges into high-value business opportunities. For more information: http://www.dupontnutritionandhealth.com or http://www.biosciences.dupont.com.

About DuPont

DuPont (NYSE: DD) is a global innovation leader with technology-based materials, ingredients and solutions that help transform industries and everyday life. Our employees apply diverse science and expertise to help customers advance their best ideas and deliver essential innovations in key markets including electronics, transportation, construction, water, health and wellness, food, and worker safety. More information can be found at http://www.dupont.com/.

DuPont™, the DuPont Oval Logo, and all trademarks and service marks denoted with ™, ℠ or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted.

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Improved Pharma to teach at upcoming Sustainable Medicines in Africa Program


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I encourage pharmaceutical scientists to become involved in global activities. Because of the pharmaceutical scientists’ skillset, they can provide a way to address medical disparity, improve quality of life in the developing world, and increase longevity

Prof. Stephen R. Byrn travels to Africa several times a year to teach in the Sustainable Medicines in Africa program, which includes a master’s degree in biotechnology innovation and regulatory science. The next course will take place in Arusha, Tanzania September 2nd through 13th, 2019. Topics to be addressed include Manufacturing, Quality, Regulation, Devices, Harmonization, Innovation, Drug Development, Legal, Control, Lab, Statistics, Audits, Inspections, and INDs.

About 12 years ago, shortly after selling SSCI, Byrn was contacted by Sister Zita Ekeocha of the Medical Missionaries of Mary in Africa. She was teaching industrial pharmacy at the Kilimanjaro School of Pharmacy (KSP) in Moshi, Tanzania, and she was looking for a way to expand the program for her students. Byrn and his wife Sally decided to take some of the funds from the sale of SSCI and used it to help establish the program, working with Purdue University and the KSP. The goal of the program is to enable the manufacture of quality medicines in Africa by Africans. Since its inception, the program has graduated over 100 students and has now expanded to the MS-TCDC, ActionAid Denmark in Arusha, Tanzania, with the support of a grant from the Bill and Melinda Gates Foundation. Some of the profits from Improved Pharma are also used to help support the program in Africa.

For more information on our work in Africa, please visit this link.

Stephen R. Byrn, Ph.D., FAAPS, is the Charles B. Jordan Professor of Medicinal Chemistry for the Department of Industrial and Physical Pharmacy and co-director of the Biotechnology Innovation and Regulatory Science Center at Purdue University. He is also the founder of two pharmaceutical research and information companies, SSCI West Lafayette and Improved Pharma LLC. He currently serves as the Chief Scientific Officer for Improved Pharma, a research and information company dedicated to improving pharmaceutical methods, formulations, and processes. Current research is focused on using synchrotron X-ray powder diffraction to understand the structure of amorphous materials.    

About Improved Pharma

For more information about the techniques discussed in this article or about Improved Pharma’s services, please contact us at 1-765-463-9951 or info@improvedpharma.com.

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Catalent to Present Case Studies in Expediting Biologic Development at BioProcess International (BPI) East Conference


Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that Steve Hager, Ph.D., Senior Director, Technical Support will present at the BioProcess International (BPI) East Conference, to be held at the Boston Convention and Exhibition Center, Boston, on Sept. 9 – 12, 2019.

Dr. Hager’s presentation, on Tuesday, Sept. 10 at 2:30 p.m., titled “Beating the Clock: Case Studies in Expediting Biologic Development” during the “Speed from Gene to Market” session will highlight case studies in which project timelines were shortened, and risk was mitigated during biologic development and manufacturing. Catalent Biologics has extensive experience in biopharmaceutical development, undertaking projects resulting in more than 600 monoclonal antibodies and over 80 proteins; and Dr. Hager will discuss how strategic partnerships and effective communication can reduce scheduling delays during drug substance development and expedite drug product filling and clinical trial supply timelines.

Dr. Hager joined Catalent in 2001, and in his current role, provides technical support for the business development and marketing functions. He has more than 25 years’ experience in the biopharmaceutical industry, a bachelor’s degree in biology from St. Olaf College, Northfield, Minnesota, and a doctorate in physiology and biochemistry from the University of Wisconsin-Madison. Dr. Hager also performed his postdoctoral work at the University of Illinois Medical Center.

For further information on this event, visit https://biologics.catalent.com/events/bpi-conference-east-2019. To arrange a meeting with Dr. Hager, contact Richard Kerns at NEPR – richard@nepr.agency

About Catalent Biologics

For more than two decades, Catalent Biologics has built capabilities and experience in development, manufacturing, and analytical services for new biological entities, gene therapies, biosimilars, and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and more than 115 clinical trials and 11 marketed products have used GPEx® cell line engineering technology. A further 20 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Catalent’s latest addition, Paragon Gene Therapy’s AAV development through commercial-scale manufacturing facilities in Baltimore, Maryland, has produced over 100 clinical GMP batches across 40 programs. Using advanced protein improvement technology and tailored solutions from DNA through to clinical and commercial supply, Catalent Biologics brings better biologic treatments to patients, faster. For more information, visit biologics.catalent.com

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists, at more than 35 facilities across five continents, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com

More products. Better treatments. Reliably supplied.™

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BioPlus Specialty Pharmacy in Semi-Exclusive Relationship to Dispense Vyleesi™ (Bremelanotide Injection)


BioPlus Specialty Pharmacy (BioPlus), one of the nation’s leading innovative specialty pharmacies, announces that it will be one of only two specialty pharmacies to dispense the newly approved medication Vyleesi™ (bremelanotide injection). Vyleesi, from AMAG Pharmaceuticals, Inc., earned approval from the U.S. Food and Drug Administration (FDA) on June 21, 2019 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Vyleesi is the first as-needed treatment option for this patient population that can be self-administered in anticipation of sexual activity. HSDD is characterized by low sexual desire that causes distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or other drug substance. HSDD affects approximately 1 in 10 premenopausal women. Vyleesi is self-administered with an autoinjector at least 45 minutes before anticipated sexual activity. Patients should not administer more than one dose within 24 hours or 8 doses per month.

“BioPlus is ready to dispense Vyleesi to eligible to patients,” shares David DuRoss, Senior Vice President of Trade for BioPlus. “With our extensive history and expertise with specialty pharmaceuticals, we’re proud that BioPlus was selected as a specialty pharmacy for this new medication. Our pharmacists are available 24/7, putting us in a unique position to guide patients through starting treatment,” he adds.

The FDA approval of this medication was based on two identical pivotal trials of approximately 1,200 women demonstrating that Vyleesi improved desire and reduced distress related to HSDD as measured by validated patient-reported outcome instruments. At the end of the core six-month studies, women were given the option to continue in an open-label extension study for an additional year. Approximately 80% of the women who completed the six-month studies chose to volunteer for the open label extension in which all the women received Vyleesi. In the pivotal trials, the most common adverse events were nausea, flushing, injection site reactions, headache, and vomiting. The majority of these events were reported to be transient and mild-to-moderate in intensity. Vyleesi also caused small, transient increases in blood pressure and decreases in heart rate, as well as darkening of the skin in some women. Women who are pregnant, or have uncontrolled hypertension, known heart disease or are taking oral naltrexone-containing products intended to treat opioid or alcohol addiction should not use this medication. Women who can become pregnant should use effective birth control during treatment with Vyleesi.

About Vyleesi™ (bremelanotide injection)

Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector is self-administered into a woman’s abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day. Vyleesi is thought to possess a novel mechanism of action. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system.

For Full Prescribing Information please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9146ae05-918b-483e-b86d-933485ce36eb&audience=consumer

About BioPlus Specialty Pharmacy

BioPlus Specialty Pharmacy is a leading independent, national specialty pharmacy and the first and only specialty pharmacy to offer a two-hour turnaround from referral to patient acceptance. Our company celebrates 30 years of innovative excellence in specialty pharmacy, working closely with payers and the pharmaceutical industry, as well as with prescribers to get prompt treatment for patients, and directly supporting our patients nationwide to achieve optimal health outcomes. We provide a complete range of specialty services, including for cancer, rheumatology, dermatology, hepatitis C, and other complex, chronic conditions. BioPlus, a privately-held, pharmacist-owned company based in Altamonte Springs, Florida, is accredited by URAC, VIPPS, and ACHC with a Distinction in Oncology.

For information: http://www.bioplusrx.com or

Contact: info(at)bioplusrx(dot)com

Phone: 1-888-292-0744

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