The average pharmaceutical company will take 2 drugs a year through regulatory proceedings. We’ll take 8 to 10. And with a success rate of 80% we bring our clients a unique advantage from day one.
It’s an advantage built on 3 pillars:
Science and strategy
Communications and training
Planning and process
ProEd helps you win on all 3.
ProEd is a member of the Healthcare Consultancy Group (HCG), a global company in the Omnicom Group.- Our team can help you create and deliver messages that cut across medical and scientific disciplines, transcend preconceived notions, and withstand regulatory scrutiny.
- Our regulatory and development consultants provide the guidance and resources you need at all the critical junctures of a product’s life cycle.
- We combine strategic acumen with rigorous scientific discipline and compelling storytelling to give your drug, device, or biologic product the greatest chance for success.
Antiepileptic drug for 2 distinct indications
Combined meeting of the Peripheral and Central Nervous System Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee, with representation from the Risk Communication Advisory Committee.
Primary Challenges:
- Two distinct indications and populations, each with its own unique benefit/risk profile presented over 2 consecutive days
- A potential clinically meaningful visual defect that is difficult to detect
- Committee meeting postponed due to FDA difficulties in empanelling experts
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- Two distinct indications and populations, each with its own unique benefit/risk profile presented over 2 consecutive days
- A potential clinically meaningful visual defect that is difficult to detect
- Committee meeting postponed due to FDA difficulties in empanelling experts
Learn More
Antiviral drug for an indication with broad public health implications
Antiviral Drugs Advisory Committee
Primary Challenges
- First NDA for the organization. Very few individuals had previously been involved in an NDA or participated in an advisory committee meeting.
Primary Challenges
- First NDA for the organization. Very few individuals had previously been involved in an NDA or participated in an advisory committee meeting.
- Large amounts of complex virology and clinical data from bench to multiple large phase 3 trials
- Dosing strategy not typical in the field with concomitant administration of standard of care
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- Dosing strategy not typical in the field with concomitant administration of standard of care
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Antimetabolite for an orphan oncology indication
Oncology Drugs Advisory Committee
Primary Challenges:
- No standard of care
- Patient population consisted of a heterogeneous mixture of histologic subgroups that did not all appear to benefit
Primary Challenges:
- No standard of care
- Patient population consisted of a heterogeneous mixture of histologic subgroups that did not all appear to benefit
- Small, single-arm trial with primary end point of objective response rate
- Assessment of response duration confounded by extensive censoring
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- Assessment of response duration confounded by extensive censoring
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