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Dr Paul Frohna

Paul Frohna M.D., Ph.D. is principal of Frohna Biotech Consulting. Learn more about Frohna Biotech Consulting's services and Frohna's speaking engagements.

http://www.paulfrohna.com/

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Dr Paul Frohna | paulfrohna.com Reviews

https://paulfrohna.com

Paul Frohna M.D., Ph.D. is principal of Frohna Biotech Consulting. Learn more about Frohna Biotech Consulting's services and Frohna's speaking engagements.

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1

Clinical and Regulatory Affairs Strategy - Paul Frohna M.D., Ph.D

http://www.paulfrohna.com/clinical-and-regulatory-strategy

Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Preparation of clinical and regulatory affairs strategy documents including study protocols, Investigators’ Brochure, FDA meeting packages (e.g., pre-IND, EOP2), INDs and IND updates, and European CTAs. Prepare for and participate in meetings with regulatory agencies (US and EU). Target product profile (TPP) preparation and updating. Generate product development plans (PDP).

2

Guarantee - Frohna BioTech

http://www.paulfrohna.com/guarantee

Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Translating Your Scientific Ideas into Clinical Reality. Clinical Pharmacology Expertise to De-risk Your Program. Clinical & Regulatory Strategy. Global Clinical and Regulatory Affairs Planning and Execution.

3

Paul Frohna Speaking Engagements

http://www.paulfrohna.com/speaking-engagements

Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Paul Frohna speaking engagements have included the following:. 2nd International Conference on Translational Medicine, Omics Group. Session Chair and Speaker: The challenge of genetic diversity in clinical trials: Is precision medicine up to the challenge? Chicago, Illinois, August 2013 http:/ www.omicsgroup.com/conferences/translational-medicine-2013/scientific-programme.php? PK-PD Modeling with the QTc: Previous Experie...

4

Translational Medicine Services - Paul Frohna M.D., Ph.D.

http://www.paulfrohna.com/translational-medicine

Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Develop translational medicine strategy that includes relevant preclinical disease and safety models, biomarker identification and selection, and precision medicine strategies that can form the basis for a pre-IND meeting with the FDA. Design and execute clinical first-in-human, proof-of-principle and proof-of-concept studies, including writing protocols, CRO selection and management, and medical safety monitoring.

5

About Paul Frohna M.D., Ph.D. - Frohna Biotech Consulting

http://www.paulfrohna.com/about

Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Welcome to the ‘About Paul Frohna’ page. Paul Frohna, M.D., Ph.D., is Principal of Frohna Biotech Consulting. He is also the current Chief Medical Officer at ProFibrix, Inc. and an Advisory Board Member at International Symposium on Hematology. VP, Clinical Development and Regulatory Affairs at Stem Cell start-up in San Diego. Interim Vice President, Clinical Development at FibroGen, Inc.

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Dr Paul Frohna

Clinical and Regulatory Affairs Strategy. Clinical and Regulatory Affairs Strategy. Paul Frohna, M.D., Ph.D. Translating Your Scientific Ideas into Clinical Reality. Clinical Pharmacology Expertise to De-risk Your Program. Clinical and Regulatory Strategy. Global Clinical and Regulatory Affairs Planning and Execution.

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