BUSINESS INSIGHTS

Corval™ Launches New Biopharma Commercialization Planning Platform

Corval | September 22, 2021

Corval LLC announced the launch of its cloud-based commercialization planning platform designed for early- to mid-stage biopharma companies. Created by industry veterans with deep experience in biopharma commercialization, the platform provides a technology-based approach that expedites the commercialization planning process and helps teams align on strategic decisions, timing, and future resourcing needs.

I have spent my entire career in this space and been exposed to the many challenges facing early- to mid-stage biopharma companies, particularly, how the lack of in-house expertise and constrained resources can threaten the ability to know what to do when.

- Sue Nemetz, founder and CEO of Corval and CEO of The NemetzGroup LLC, a strategic consultancy that has supported the progression of more than 100 companies with assets at every phase of development.

As a biotech CEO and investor, I have seen many companies get mired in the commercialization planning process. Corval, built upon the wealth of knowledge and experience from The NemetzGroup, will help ensure biotech executive teams don't miss any critical steps on their path to market.

- Abbie Celniker, Ph.D., a Partner at Third Rock Ventures.

Corval's platform is built upon decades of biopharma commercialization experience and more than 75,000 data points that drive recommendations throughout the entire development timeline and accommodate the unique circumstances of each asset's commercial strategy. Corval contains foundational tools for commercialization success, including:
  • Custom Commercialization Map: a detailed and adaptable roadmap of the objectives and activities necessary to commercialize an asset
  • Budget and Resource Plan: a customized schedule of the resources and investments required to support these activities and achieve organizational objectives
  • Commercialization Center: a single workspace to collaborate on the roadmap and access a trove of commercialization knowledge
About Corval
Corval develops technology solutions to empower biopharma leaders to navigate the commercialization process with confidence. Built on decades of commercialization expertise, its innovative cloud-based platform assesses each asset's unique situation and creates a customized, detailed map to illustrate every step on the journey from clinic to market. Corval reduces the commercialization planning process from three to six months to three to six days, dramatically streamlining efforts to set commercialization plans in motion.

Spotlight

ValGenesis e-Logbook eliminates traditional, error-prone, paper-based logbooks for any GMP log type. Say goodbye to illegible handwritten entries, sticky notes, lost logbooks, and cleanroom contamination concerns. Welcome fully compliant, next-generation efficiency.

Spotlight

ValGenesis e-Logbook eliminates traditional, error-prone, paper-based logbooks for any GMP log type. Say goodbye to illegible handwritten entries, sticky notes, lost logbooks, and cleanroom contamination concerns. Welcome fully compliant, next-generation efficiency.

Related News

BUSINESS INSIGHTS, PHARMACY MARKET

Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

prnewswire | April 20, 2023

Ajinomoto Bio-Pharma Services a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States Food and Drug Administration (FDA) has approved the company's high potency vial line to manufacture a commercial product. "Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of preparation, diligence and support from the Aji Bio-Pharma team across our whole organization. As a leading global CDMO, we are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide." said Bert Barbosa, President & COO, Ajinomoto Bio Pharma Services, US. Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line that offers a range of configurations, including prefilled syringes, cartridges and vials. The high-speed process is rated to move up to 22,000 syringes per hour through the line, with a batch capacity of over 200 thousand syringes. This multi-purpose fill line has been designed to meet FDA and EMEA commercial compliance. About Ajinomoto Bio-Pharma Services Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP API manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including high potency APIs (HPAPI), continuous flow manufacturing, oligonucleotide synthesis, biocatalysis, Corynex® protein expression technology, antibody drug conjugations (ADC) and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets

Globenewswire | March 30, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced it has expanded its exclusive license and supply agreement with Atnahs Pharma UK Limited (“Pharmanovia”), a global pharmaceutical company that revitalizes, extends and expands the lifecycle of established medicines, for Libervant™ Buccal Film to cover the rest of the world, excluding the United States, Canada, and China. The original licensing agreement with Pharmanovia announced in September 2022 covered the European Union, United Kingdom, Sweden, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA). “We are pleased to announce the expansion of our collaboration with Pharmanovia,” said Daniel Barber, Chief Executive Officer of Aquestive. “We believe Pharmanovia’s experience and geographic footprint align well with our goal of providing patients throughout the world with access to Libervant. This announcement also aligns with our mission to put the patient at the center of everything we do. We will continue to advocate for patient access, patient choice, and patient empowerment on a global basis.” Pharmanovia CEO, James Burt, commented, “Following a strong start to our collaboration with Aquestive Therapeutics, we’ve expanded our agreement to include many more territories. Our experience with diazepam marketed under an established brand in Valium®, combined with Aquestive Therapeutics’ unique PharmFilm® technology, provides a potentially significant delivery option to caregivers and patients in times of critical need and enables us to optimize an existing medicine to better meet the needs of patients, healthcare professionals and payors.” Pursuant to the expanded agreement, Aquestive Therapeutics will serve as the exclusive sole manufacturer and supplier for the product and Pharmanovia will be responsible for all regulatory and commercialization activities. Aquestive will receive an undisclosed upfront payment and, if approved for market access, milestone payments, and double-digit royalties on net sales of the diazepam buccal film in the licensed territories. About Aquestive Therapeutics Aquestive Therapeutics, Inc. is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

Read More

PHARMACY MARKET

Athenex, Inc. Reaches Agreement With Lenders to Pursue Expedited Sales Process

Globenewswire | May 16, 2023

Athenex, Inc. a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that, following an ongoing strategic review, it has reached agreement with its lenders to move forward with an expedited sales process of the Company’s assets across its primary businesses: Athenex Pharmaceutical Division (“APD”), Orascovery, and Cell Therapy. To best facilitate this process, Athenex and certain of its subsidiaries filed voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas. This will enable the Company to divest its assets and wind down the Athenex platform in an orderly fashion, while seeking to maximize value for its stakeholders. The Company anticipates concluding the expedited sales process by July 1, 2023, with the Chapter 11 cases continuing thereafter to resolve claims. Athenex has also reached an agreement with its secured lenders, subject to court approval, for the consensual use of cash collateral, which will enable the Company to, among other things, satisfy certain obligations to its vendors for authorized goods received and services rendered after the filing. Athenex Pharma Solutions (“APS”), which includes the Company’s manufacturing facility in Clarence, New York, is expected to continue its operations for at least the next 90 days, to provide commercial supply of tirbanibulin ointment. In addition, APD is continuing to operate in the ordinary course and fill customer orders with the ample inventory it has on hand. Dr. Johnson Lau, Chief Executive Officer of Athenex, on behalf of the management team and the Athenex Board of Directors, said, “Throughout our history, we have sought to become a leader in bringing innovative cancer treatments to the market and improving patient health outcomes. Our team was successful in bringing tirbanibulin, through regulatory approvals, to the U.S. market and a number of EU countries, as well as Taiwan. Unfortunately, our oral paclitaxel product candidate received a complete response letter from the U.S. Food and Drug Administration, and this significant regulatory setback, coupled with challenging biotech markets and the difficult economic environment, put tremendous pressure on our ability to continue to fund our businesses. “Over the past two years, we made considerable progress in refocusing our business around our promising NKT cell therapy platform, monetizing non-core assets to improve our balance sheet and extending our cash runway, paying down $108 million of debt, and undertaking a comprehensive review of strategic alternatives to create value for our stakeholders. While we explored every viable avenue to avoid this outcome, an orderly sales process represents the best path forward at this time. “Our goal remains to identify purchasers who will continue development of the important drug candidates for which we have established a good foundation, and to bring them to market on behalf of medical practitioners and, most importantly, for patients. We are incredibly thankful to our team for their dedication to Athenex and will look to support our colleagues through this transition period.” Pachulski Stang Ziehl & Jones LLP is acting as Athenex's legal counsel. MERU is serving as its financial advisor and Cassel Salpeter & Co., LLC as its investment banker. About Athenex, Inc. Founded in 2003, Athenex, Inc. is a clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next-generation cell therapy products for the treatment of cancer. The Company’s mission is to become a leader in bringing innovative cancer treatments to the market and to improve patient health outcomes. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company is focused on its innovative Cell Therapy platform, based on natural killer T (“NKT”) cells.

Read More