How AI is helping pharma cope with supply chain disruption

EPM Magazine | June 25, 2020

As the Covid-19 crisis continues to unsettle global economies and business sectors worldwide, pharma companies are facing huge disruption to their supply chains and clinical research.

And while research into potential Covid-19 vaccines and treatments is speeding along, the pandemic has slowed or brought to a halt clinical trials for other diseases, with organisations like Eli Lilly and other big name pharma’s’ putting the brakes on non Covid-19 trial activity. In fact, 50% of respondents in a recent BSI survey said they will be making changes to their supply chain moving forward.

In this climate, with pharmaceutical supply chains under so much pressure, businesses are understandably focused on protecting supplier relationships as different parties are forced to cancel agreements, delay their contractual obligations or renegotiate key terms.

Spotlight

The rapidly expanding specialty pharmacy market has created unique challenges for pharmaceutical manufacturers looking to obtain dispensing, adherence, and switching data for specialty drugs. Access to timely, anonymized, longitudinal patient data forms the foundation of brand analytics within pharmaceutical manufacturers. While there are numerous syndicated sources for retail pharmacy data for traditional drugs, a comparable source for specialty drug data does not exist. Strong growth within the fragmented specialty pharmacy industry means that specialty drug data are now spread across a large number of pharmacies that include independent pharmacies, retailers/chains, hospitals, health plans, and pharmacy benefits managers (PBMs).

Spotlight

The rapidly expanding specialty pharmacy market has created unique challenges for pharmaceutical manufacturers looking to obtain dispensing, adherence, and switching data for specialty drugs. Access to timely, anonymized, longitudinal patient data forms the foundation of brand analytics within pharmaceutical manufacturers. While there are numerous syndicated sources for retail pharmacy data for traditional drugs, a comparable source for specialty drug data does not exist. Strong growth within the fragmented specialty pharmacy industry means that specialty drug data are now spread across a large number of pharmacies that include independent pharmacies, retailers/chains, hospitals, health plans, and pharmacy benefits managers (PBMs).

Related News

BUSINESS INSIGHTS

Virpax Pharmaceuticals Engages Torreya Capital to Advise on Global Partnering Efforts

Torreya Capital, Virpax Pharmaceuticals | April 23, 2021

Virpax® Pharmaceuticals, Inc. reported today that it has appointed Torreya Capital, LLC as the Company's sole financial adviser for its partnering and licensing activities in strategic global markets. Torreya is a leading investment bank that has supported more than $100 billion in life sciences transactions since its establishment in 2007. “We are thrilled to be collaborating with Torreya to extend our partnerships in key markets,” said Anthony Mack, Chairman, and CEO of Virpax Pharmaceuticals. "There is an increasing worldwide need for non-opioid, non-addictive pain treatments, and we agree that our product candidates, EpoladermTM, ProbudurTM, and EnveltaTM, will provide a competitive advantage in their target markets," Mr. Mack concluded. "We look forward to assisting Virpax Pharmaceuticals in identifying strong regional partners for their innovative acute and chronic pain product candidate pipeline,” said Torreya Partner Tom Bird. "Virpax's product candidates include proprietary technologies that can enable the product candidates to provide enhanced benefits while providing non-addictive pain relief.” About Torreya Torreya is a global investment banking boutique that works with life sciences industries. Since its inception in 2007, the company has closed over $100 billion in transactions spanning branded pharmaceutical, biotechnology, generic pharmaceutical, and life sciences firms in nearly 250 assignments. Their associates are senior bankers and executives with extensive industry expertise, insights, and networks. They are a preferred advisor for businesses seeking secure, conflict-free, and knowledgeable advice on M&A, capital markets, licensing, and asset sale transactions. The breadth of Torreya's global footprint separates it from any other life sciences advisory practices. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates by optimizing and enhancing drug delivery using its proprietary technologies. Virpax is seeking FDA approval for its three proprietary drug delivery systems. EpoladermTM is a metered-dose topical diclofenac spray film formulation being used to treat acute musculoskeletal pain and osteoarthritis. ProbudurTM is a liposomal bupivacaine formulation for a single injection that is being used to treat post-operative pain. EnveltaTM is an intranasal molecular-envelope enkephalin formulation that is being developed to treat acute and chronic pain, particularly cancer-related pain. Virpax is also developing its PES200 product candidate to treat post-traumatic stress disorder (PTSD) and its MMS019 product candidate to prevent viral replication caused by influenza or SARS-CoV-2 using its intranasal Molecular Envelope Technology (MET).

Read More

BUSINESS INSIGHTS

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.

Read More

RESEARCH

Thermo Fisher sketches out Carlsbad plasmid DNA plant as German cell and gene therapy facility preps for opening

Thermo Fisher | December 23, 2020

Thermo Fisher Scientific is shoring up production of cell and quality treatments on the two sides of the lake, a move it expectations will support the advancement of COVID-19 medications and antibodies—and guarantee supplies are set up should they get by with controllers. The New Jersey contract producer is spreading out another plasmid DNA fabricating office at its Carlsbad, California, grounds, intending to help its phone and quality treatment contributions against the setting of a worldwide plasmid market where request has immediately dominated supply, the organization said. That is on top of plans for another cryocenter in Germany. That webpage, one of two new German offices set to come online in the following not many weeks, will offer virus chain support for clinical preliminaries of cell and quality treatments, including COVID-19 immunization hopefuls, in Europe and past. The 67,000-square-foot Carlsbad office will add exactly 150 positions throughout the following a year, with development fixed to enclose by the principal half of 2021, Thermo Fisher said. The site will support clinical and business yield of plasmid DNA used to create and deliver cell and quality treatments for disease, just as mRNA immunizations. It will likewise be prepared to produce huge scope plasmid DNA as an essential medication substance for DNA treatments, the organization said. The office will be kitted out with single-utilize hardware equipped for taking care of undertakings up to 1,000 liters and will flaunt computerized network and information visibility to smooth activities and make preparing representatives simpler, Thermo Fisher said. Thermo Fisher is no more abnormal to the field, with a phone and quality treatment impression in Massachusetts and Florida, in addition to a recently stamped cell treatment producing plant in Princeton, New Jersey—however it calculates the extended business and supply chain administrations at its Carlsbad site will smooth the wrinkles in the current plasmid market. "The competition to grow new groundbreaking cell and quality treatments and antibodies is outperforming supply of business quality plasmid DNA that can be created at scale," Mike Shafer, SVP and leader of pharma administrations at Thermo Fisher, said in a delivery. "Our new cutting edge site won't just handle the supply bottleneck for our clients yet in addition particularly positions us to convey powerful, start to finish cell and quality treatment capacities."

Read More