Inovio Pharmaceuticals Kicks Off Phase 1 Clinical Trial for Experimental COVID-19 Vaccine

The Motley Fool | April 06, 2020

Inovio Pharmaceuticals Kicks Off Phase 1 Clinical Trial for Experimental COVID-19 Vaccine
Inovio Pharmaceuticals (NASDAQ:INO) has been moving fast in the race to develop a vaccine for COVID-19. The company claimed it had created a potential vaccine for the rapidly spreading coronavirus on Jan. 10, just three hours after Chinese researchers publicly released the genetic sequence of SARS-CoV-2 the virus that causes the illness. Now, it's starting human clinical trials for that potential vaccine, INO-4800.  The trial will involve up to 40 healthy adult volunteers, each of whom will receive two doses of INO-4800 four weeks apart. The goals of the phase 1 trial are to test the vaccine's safety and its immunogenicity --i.e., its ability to trigger an immune response in the body. Inovio expects initial data from this trial by late summer, and plans to move on to phase 2 clinical trials -- which will test INO-4800's efficacy -- as soon as possible. Other companies are also making headway in their efforts to develop a vaccine for COVID-19. For instance, pharma giant Johnson & Johnson (NYSE:JNJ) recently announced that it would initiate human clinical trials for its investigational COVID-19 vaccine by September.

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CATO SMS Acquires Nuventra in order to Expand its Drug Development Offering Into Clinical Pharmacology

Nuventra, CATO SMS | May 27, 2021

CATO SMS, a global provider of regulatory and clinical research services, announced today the acquisition of Nuventra, Inc., to expand its offering into the critical area of clinical pharmacology. Nuventra, headquartered in Durham, North Carolina, is a leading company in clinical pharmacology science and services. The acquisition expands CATO SMS's portfolio of specialized solutions that help biopharmaceutical companies with drug development by providing a key set of skills targeted at significantly reducing development risk, costs, and timelines. CATO SMS now provides customers cutting-edge clinical pharmacology services such as strategic consulting, pharmacokinetics/pharmacodynamics (PK/PD), pharmacometrics (population PK), and biosimulation. Nuventra is well-known for its track record of transforming complex data into meaningful insights for over 650 biopharmaceutical companies across a wide range of therapeutic areas. Its team of scientific experts and senior consultants use the most advanced mathematical modeling tools in the industry to inform clinical design and predict trial outcomes. Nuventra's range of solutions include: • pharmacokinetics and pharmacodynamics (PK/PD), which describes the movement of drugs through the body from absorption to elimination (PK), as well as the body's biological response to drugs (PD) to determine optimal dosing paradigms, safety margins, and efficacy characteristics. • population pharmacokinetics (popPK and popPK/PD), which studies the variability in drug concentrations among individuals in a group of interest receiving clinically relevant doses of a drug. • clinical pharmacology strategic consulting, which includes overall and targeted clinical pharmacology strategy in support of marketing applications for drugs and biologics. • physiologically based pharmacokinetic (PBPK), which incorporates blood flow and tissue composition of organs to predict the absorption, distribution, metabolism, and excretion (ADME) of drugs. • quantitative systems pharmacology (QSP), which models the interplay of the drug (dose, dosing regimen, etc.) with target biology, using computational systems to characterize the interaction between drugs, biological systems, and disease processes. • model-informed drug development (MIDD), which uses modeling techniques to improve the decision-making process in drug development, thereby leading to clinical trial efficiencies and, in some cases, replacing trials altogether. About Nuventra Nuventra is the pharmaceutical industry's preferred provider of clinical pharmacology, pharmacokinetics, and pharmacometrics consulting services. Nuventra provides pharmaceutical companies and contracts research organizations (CROs) with unique access to a hands-on team of industry-leading consultants with extensive experience in complex studies and analyses. By taking complex pharmacokinetic and pharmacometrics concepts and making them understandable and usable for common sense drug development, we embrace the notion that simplicity and clarity lead to smart decisions. About CATO SMS CATO SMS is a provider of specialized clinical research solutions formed in 2019 by the merger of Cato Research and SMS-oncology. CATO SMS, with over 30 years of professional experience focusing on the needs of small and emerging biopharmaceutical companies, effectively designs and executes studies from strategy to approval in complex indications and modalities throughout a wide range of therapeutic areas, with a proven center of excellence in oncology. The regulatory, therapeutic, and operational expertise of CATO SMS enables the company to meet and exceed expectations.

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Lilly Launches Digital Health Open Innovation Challenge to Help Transform Atopic Dermatitis Care

Eli Lilly and Company | September 16, 2020

Eli Lilly and Company has launched an open innovation challenge for individuals and teams across the United States to submit inspiring digital health solutions that can help make life better for people living with atopic dermatitis. The challenge, "Transforming Atopic Dermatitis Care: Enhancing Quality of Life and Patient Care for People Living with Inflammatory Skin Diseases," focuses on leveraging digital technologies to enhance care and improve health and well-being for people with inflammatory skin diseases. The submission site, including additional details about the challenge's criteria, eligibility and requirements, is available at www.lilly.com/atopicdermchallenge.

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PHARMACY MARKET

Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

Evergreen Theragnostics, Inc. | July 17, 2021

Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility. Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227). Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing. The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment. About Evergreen Theragnostics, Inc. Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. About Tema Sinergie Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.

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Spotlight

This one-page infographic on global pharmaceutical distribution, gives a quick overview of the current landscape, explaining the key issues that senior supply chain and distribution professionals face today when optimizing an international supply chain.