SERVICES
Delivering for the patients
Manufacturing & Testing Strategy
Let's take company goals and make them into a reality together. Solid manufacturing and testing strategies are key to delivering life-changing therapies and medicines to patients.
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Make vs. Buy
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Outsourced testing vs. in-house
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Dual-sourcing
Strategic Sourcing
Partner with the right Contract Manufacturing Organization (CMO / CDMO) or Contract Testing Organization (CTO) at the right time, with as much or as little support as needed.
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Requests for Information (RFI)
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Requests for Proposals (RFP)
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Analyses & assessments
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Contract negotiation and bid defense
Partnership Management
Every biotechnology or pharmaceutical organization should have productive and beneficial relationships with outsourced partners. Let Apex Biopharma set up your supplier relationships for success.
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Governance creation & implementation
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Cultivation of new partnerships
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Scorecards
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Improvement of existing relationships
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Transition of relationships from R&D to clinical manufacturing to commercial
Why Choose Apex Biopharma Consulting?
No two companies are the same. We offer tailored solutions to fit your business.
Diverse modality experience:
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cell & gene therapy
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mAbs
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small molecules
Companies are their people. We know trust and empathy build successful partnerships.
ABOUT
Hi! I'm Ashley Bisognani - founder and principal of Apex Biopharma Consulting, LLC. I started Apex Biopharma as a way to use my expertise in and passion for GxP relationship cultivation, contract negotiation, and strategy creation in order to make a wider impact across multiple modalities and therapeutic areas at once, to help as many patients as possible.
Some quick facts about me:
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10+ years in the life sciences industry, large and small, most recently at bluebird bio in supplier strategy and operations
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Extensive experience in partnership building and strategic sourcing in cell and gene therapy, monoclonal antibodies, and small molecules (oral and sterile), including Entyvio, Ninlaro, Alunbrig, Zynteglo, and Skysona.
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10 years of small business management before jumping into biopharma
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Loves human connection, communication, and mentoring
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Bachelor of Science in Business Management from Lesley University in Cambridge, MA
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Masters of Business Administration from the Isenberg School of Management at the University of Massachusetts in Amherst, MA
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Originally from New England but now lives in the Research Triangle area in North Carolina
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Book nerd - fiction and non-fiction, I am not picky
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Aerialist - when I'm not consulting, I'm often found upside down or doing flips in the air
