The PDI principals traveled to Boston last week for a Growth Summit with the Danforth leadership team and sister companies, where we explored strategies to strengthen a robust support network for our collaborators. While in town, we also hosted an impromptu dinner bringing together Boston-based colleagues and team members who happened to be visiting. It’s always a pleasure to connect in person, especially as a primarily virtual organization.
PharmaDirections
Pharmaceutical Manufacturing
Cary, NC 2,363 followers
Leaders in Virtual Drug Development.
About us
Bringing a new therapy to market is complex. PharmaDirections simplifies the process, guiding biotech and pharma companies through drug development efficiently, strategically, and cost-effectively. As pioneers of the virtual biotech model, we have unique insights & visibility into the Biotech Ecosystem. We offer full-spectrum drug development expertise, from early discovery to regulatory approval, without the overhead of a full in-house team. Our partnership approach ensures senior-level expertise exactly when and where you need it, with hands-on program leadership that keeps projects on track. Proven Success ✔ $50M+ annual outsourced contract work managed ✔ 45+ patents/applications generated for our partners ✔ 150+ successful biotech collaborations How We Help ✅ PRECLINICAL & CLINICAL STRATEGY – Translating science into a clear, regulatory-ready path to approval ✅ CMC & FORMULATION – Ensuring scalable, regulatory-compliant drug development ✅ REGULATORY & IP STRATEGY – Guiding IND, NDA, and global filings while safeguarding innovation ✅ FULL PROGRAM MANAGEMENT – Seamlessly integrating with your team for hands-on execution Our expertise spans small molecules, biologics, gene therapies, and drug-device combinations across multiple therapeutic areas. 📩 Contact Cathi Clark: CClark@pharmadirections.com
- Website
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http://www.PharmaDirections.com
External link for PharmaDirections
- Industry
- Pharmaceutical Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Cary, NC
- Type
- Privately Held
- Specialties
- Virtual Drug Development & Program Leadership, Preclinical & Clinical Strategy, Chemistry, Manufacturing & Controls (CMC), Regulatory Affairs (IND, NDA, MAA, CTA) , Biopharmaceutics & Pharmacokinetics, Drug Formulation & Delivery Optimization, Toxicology & DMPK Modeling, Intellectual Property & Patent Strategy, Strategic Planning & Commercialization, Grant Writing, and Global Development Programs
Locations
Employees at PharmaDirections
Updates
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Congratulations to Seaport Therapeutics on its trading debut at Nasdaq (SPTX) on Friday! Tiffany, who has been an integral contributor on the regulatory team since 2021 while Seaport was still PureTech, was present to witness this significant milestone. We are thrilled to be a part of the journey that led to this momentous event! 💊 ⚓ 📈
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That is a wrap to #JPM2026! Thank you for making the time to (re-)connect with us! Please reach out to Cathi Clark Michelle Soltero Higgin, Ph.D Tilmann Brotz for follow-up discussions :)
Having a great time at #JPM. In addition to many invigorating meetings with our clients, I really enjoy connecting with my colleagues from PharmaDirections and the wider Danforth Health family. Feel free to reach out via DM if you’d like to schedule a last minute meeting. Michelle Soltero Higgin, Ph.D Dan Dehner Cathi Clark Maeve Conneighton Barb Carlin CPA, MBA
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Happy Holidays and Thank You from the entire PharmaDirections team! Photo taken at a team building event in Austin, Texas. Cheers to a memorable year and may the next year be full of adventures, yeehaw! 🤠 #EndOfYear #Hello2026
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The PharmaDirections team will be at JPM in January 2026! Learn how we can help you move your Development Assets forward, and how our sister companies at Danforth Health fit into the picture by sending Michelle Soltero Higgin, Ph.D , Tilmann Brotz, and Cathi Clark a DM to schedule a meeting. Looking forward to connecting in the new year!
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We are honored to be joining Danforth Advisors, a strong leader in the life science ecosystem! Danforth is the perfect complement to what we do best at PharmaDirections: advancing drugs from discovery to the clinic and beyond. Read the announcement here: https://lnkd.in/eRnADFFk For more than 20 years, our mission has been to partner strategically and operationally with outstanding biotech companies developing state of the art therapies. Joining Danforth allows us to expand that mission – bringing even more resources, capabilities, and opportunities to both our clients and our team. We look forward to this exciting adventure! #lifesciences #biopharma #drugdevelopment #biotech
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