Innovation PharmASSIST
PHARMACY

Innovation to move to new campus in New York’s southern tier

BY Sandra Levy

Innovation, makers of PharmASSIST pharmacy automation solutions, is moving to a 91,000-sq.-ft. campus located at the newly renamed 701-720 Innovation Way, formerly Azon Road, in Johnson City, N.Y. The company said the larger campus will accommodate its expanding operations and recent staff growth.

The new site virtually doubles Innovation’s current space, which is spread across three separate sites in Johnson City.

“In the past several months, we’ve had the good fortune to secure multiple large contracts with both government and commercial customers, and in response to that business we’ve hired 68 new employees and are still hiring,” Innovation CEO Mary Reno said. “Due to this rapid growth and the need to build and test these large high-volume pharmacy systems, we needed to expand our space, and our goal was to have all employees at one centralized campus.”

Innovation has begun detailed planning of the necessary renovations the company will require and has developed the transition plan related to moving to the new site, all of which will take place over the ensuing 3-to-6 months, according to the company.

“Our founder and my father, Harry Boyer, was always committed to keeping Innovation in Johnson City. Therefore, I’m very happy to say we’ve lived up to Harry’s pledge, and we’re confident that our new campus on Innovation Way will enable all of us to work together more efficiently and be better equipped to respond to market demands,” Reno said.

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FDA commissioner addresses actions to deter ‘gaming’ of generic drug approval process

BY Sandra Levy

Noting that citizen petitions that are subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act have rarely delayed specific generic drug approvals, FDA commissioner Scott Gottlieb issued a statement today saying, “There’s no doubt that the process requirements associated with 505(q) petitions can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making. This increased burden on the FDA can take resources away from the daily work of application review. A key to improving the speed and predictability of the generic drug review process — and reducing the multiple cycles of review many applications undergo — is to improve our own review process efficiency.”

Gottlieb said, “This revised draft guidance, which will be finalized after an opportunity for public comment, describes some of the factors the FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a generic drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response. The agency’s determination will be part of the petition response, a public document available through the citizen petition docket. We believe this will provide an additional deterrent to pursuing these tactics.”

“To further dissuade companies from improperly using these petitions, the FDA also intends to highlight in our annual report to Congress our determinations of petitions that are judged by the agency to have been submitted with the primary purpose of delaying an approval. Importantly, the guidance also outlines our intention to refer these matters to the Federal Trade Commission. This is the agency that oversees anticompetitive business practices. We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients. We’re taking the abuse of this system seriously. And we hope that this increased transparency will reduce gratuitous hurdles to generic drug development and approval,” Gottlieb said.

Gottlieb continued, “The revised draft guidance also seeks to lessen the impact that our review of petitions may have on any pending approval actions. Our new approach would help the FDA focus our resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs. Once an application is submitted, the FDA has a goal date of making an approval decision on that application within 10 months, or, for some priority applications, within eight months. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the draft guidance states that the FDA would expect to respond to that petition within 150 days.

This policy aligns the FDA’s 150-day timeline to review and respond to these petitions described in federal law with the timeline for review of the applications themselves. We will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval. Sometimes citizens’ petitions can raise relevant concerns. This new approach will help reduce approval decision delays in certain scenarios simply because a citizen petition has been submitted.”

By addressing challenges associated with the 505(q) citizen petition process, we aim to provide greater regulatory certainty, improve the efficiency and predictability of the generic drug review process, and help to drive down costs of generic drug development and create incentives for new market entrants, Gottlieb said.

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Cardinal Health sponsors Women Pharmacist Day

BY Sandra Levy

“The statistical increase of female pharmacists is inspiring; women are particularly well positioned to serve as trusted healthcare resources, especially for fellow women,” director of the Women in Pharmacy initiative at Cardinal Health and Women Pharmacist Day sponsor Eden Sulzer said in a statement. “Women make an average of 80% of the healthcare purchasing decisions for their families — and often serve as caregiver for their children and aging parents.”

Women Pharmacist Day was founded by Suzanne Soliman, a pharmacist, who also is founder of PharmacistMomsGroup.com, a not-for-profit organization that offers support, resources and a professional network for pharmacist moms. The group has grown in one year to over 16,000 pharmacist moms.

Soliman chose Oct. 12 to honor the legendary first female pharmacist in the United States, Elizabeth Gooking Greenleaf, who had 12 children and is an inspiring role model for women who want to become pharmacists.

“Whether you’re a pharmacy student, practicing pharmacist, pharmacy educator, pharmacy association, female pharmacy owner or an advocate for the advancement of women within health care, we invite you to get involved in Women Pharmacist Day,” Soliman said in a statement.

Soliman said that multiple colleges of pharmacy across the United States are hosting #WomenPharmacistDay themed events, bringing alumnae and students together to encourage career mentoring within the pharmacy profession, discuss career paths within pharmacy and explore ways to increase female representation in pharmacy leadership roles.

“Cardinal Health is proud to sponsor the inaugural Women Pharmacist Day,” Cardinal Health CEO Mike Kaufmann said in a statement. “Our commitment to female leadership within health care is long-standing, and we sincerely thank the fellow companies, pharmacy schools, pharmacy associations, pharmacy educators, practicing pharmacists and pharmacy students joining us in support of Women Pharmacist Day.”

“Practicing and student female pharmacists, let us know why you’re pursuing a career in pharmacy. Recognize the role models and mentors who have paved the way for your career. Thank a pharmacist or pharmacy educator who has positively impacted your life. And make sure to use the hashtag #WomenPharmacistDay, so we can amplify each other’s voices,” Soliman said.

Soliman encourages all #WomenPharmacistDay posts to tag Cardinal Health on Facebook, Twitter and LinkedIn, and tag Pharmacist Moms Group on LinkedIn, Instagram or Twitter.

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