End-to-End CMC and

Manufacturing Solutions

Guiding you on the pathway to CMC, manufacturing, and outsourcing excellence.

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About

Pathways Pharma Consulting LLC delivers end-to-end CMC and manufacturing solutions to help biopharma innovators and CDMOs bring therapies from preclinical development to commercial launch. Our mission is to simplify the complexity of outsourcing drug development and manufacturing, enabling our clients to focus on science, patients, and growth.

About

Pathways Pharma Consulting LLC delivers end-to-end CMC and manufacturing solutions to help biopharma innovators and CDMOs bring therapies from preclinical development to commercial launch. Our mission is to simplify the complexity of outsourcing drug development and manufacturing, enabling our clients to focus on science, patients, and growth.

Our Expertise

Strategic CMC & Manufacturing Leadership

We provide strategic guidance across all stages of development, from early process design through global commercial readiness. Our perspective spans small molecules, biologics, oligonucleotides, and advanced modalities including mRNA and AAV.

Phase-Appropriate, Value-Driven Manufacturing Strategies

Pathways Pharma Consulting develops and implements fit-for-purpose CMC and manufacturing strategies tailored to each stage of the drug development lifecycle. We align technical rigor, cost efficiency, and risk management to maximize program value from preclinical through commercial supply.

Outsourcing & CDMO Partnerships

We support clients in identifying, evaluating, and partnering with the right CDMOs. Pathways Pharma Consulting manages the full outsourcing process — from landscaping and site selection to contracting, negotiation, and execution — ensuring technical and business alignment, supply resilience, and long-term partnership value.

Contracting & Legal Integration

Our integrated business–legal approach enables efficient structuring, drafting, and negotiation of development and manufacturing agreements that protect your interests and accelerate timelines. We bring clarity and confidence to complex deal structures across development and commercial supply, with in-house legal expertise that eliminates the need for additional external support.

M&A and Due Diligence Support

We advise CDMOs and biopharma clients in M&A and investment contexts, performing CMC and operational diligence to assess manufacturing capabilities, network synergies, and risk exposure. Our insights help clients make informed, value-driven decisions.

Who We Support

Biopharma innovators seeking experienced CMC, manufacturing, and outsourcing guidance

CDMOs evaluating growth, acquisition, or partnership opportunities

Investors and business development teams requiring due diligence or strategic landscape assessments

Why Us

End-to-end CMC and outsourcing experience — from preclinical to commercial stages

Phase-appropriate, value-driven strategies that align cost, quality, and speed

Proven success advising leading biopharma and CDMO organizations globally

Cross-functional expertise spanning development, manufacturing, supply chain, business operations, and legal

Independent, objective perspective to guide critical manufacturing and partnership decisions

Our Team

Joseph Graskemper brings over 15 years of leadership experience in pharmaceutical and biotechnology companies, guiding programs across modalities from preclinical development to commercial launch. With strong technical and business acumen, he serves as an industry advisor, speaker, and published thought leader, helping clients optimize CMC strategy, manufacturing, and outsourcing decisions.

Joseph Graskemper

Founder & Principal

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Alexandra Graskemper brings over a decade of legal expertise spanning contracting, dispute resolution, and regulatory strategy. With strong analytical and negotiation skills, she helps clients navigate complex manufacturing and outsourcing agreements with precision, efficiency, and confidence.

Alexandra Graskemper

Lead Counsel

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Contact

Let’s discuss how Pathways Pharma Consulting can support your drug development and manufacturing strategy.

Visit Us

Boston, MA, USA

Message Us

info@pathwayspharma.com

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Pathways Pharma Consulting, LLC