The Who, What, When, and Where of Inpatient Direct Oral Penicillin Challenge-Implications for Health Services Implementation.

Inpatient direct oral challenge programs are increasingly deployed as part of antimicrobial stewardship initiatives to reduce the burden and impacts of penicillin allergy labels on antibiotic prescribing. Using data from a prospective, multicenter cohort inpatient penicillin allergy program, we identify the key targets for delabeling to aid health service implementation.

Developing gene therapies for rare diseases: an interview with Geoff MacKay.

Geoff MacKay is a pioneer in cell and gene therapy with a track record of successful leadership at innovative biotechs. He is currently the president and CEO of AVROBIO, a clinical-stage lentiviral gene therapy company that treats lysosomal disorders, and a board member of Talaris Therapeutics and Satellos Bioscience. He is also the founding CEO of eGenesis, a biotech that applies CRISPR-Cas9 gene editing to xenotransplantation and the former president and CEO of Organogenesis, a world-leading cell therapy company. Earlier in his career, MacKay spent 11 years at Novartis in senior leadership positions within the global transplantation and immunology franchise.

Bioactive wound healing, bioaesthetics and biosurgery: three pillars of product development. Interview with Geoff MacKay.

Tissue regeneration specialist company Organogenesis Inc. was one of the first biotech companies formed. Incorporated in 1985, the company was originally a spin-off from a research program at MIT. For the first 10-15 years, Organogenesis was heavily research based, but then gradually moved into development. The company's flagship product is Apligraf--a living, bilayered skin construct with two FDA-approved indications: diabetic foot ulcers and venous leg ulcers. As Apligraf neared the market, it was necessary to 'graft' a manufacturing capability onto the company. As a consequence the company moved south from Massachusetts's cradle of biotechnology to Canton, MA, USA. Having experienced many of the highs and lows that characterize the biotech industry, the company is now consolidating its position as a center of expertise in commercializing living, cell-based products. The company has now built a sales, marketing and reimbursement team with the unique skill set to integrate novel technology into the US healthcare system. President & Chief Executive Officer Geoff MacKay takes great pride in the leading role that Organogenesis is playing in ushering in the field of tissue regeneration. Here, he discusses with Regenerative Medicine's Elisa Manzotti the 'three pillars' of the Organogenesis pipeline: bioactive wound healing, bioaesthetics and biosurgery. He focuses both on the rewards, and the trials and tribulations, of the commercialization of living cell-based technology.