Case Studies

Managed API Issues; Client Achieved Licensing Deal

Situation:

• Pre-IND candidate, API did not meet specifications

The Rondaxe Team:

• Identified and executed process improvements
• Product is reworked
• New CRO is engaged and given technology transfer support

Results:

• Increased yield 2X in the API process
• Lengthened client’s cash burn rate
  • COG reduction thru increased yield
  • Shortened elapsed time to achieve key milestones
• IND filed; Product licensed to Big Pharma for $215 million

Resolved CMC Issues & Increased Licensing Value

Situation:

• Client had worldwide partnering discussions underway
• Due diligence uncovers CMC issues threatening to devalue licensing event

The Rondaxe Team:

• Eliminated COGs, Supply Chain and Regulatory issues
• Oversaw production through drug product
• Transferred process to two new vendors

Results:

• $10 Million licensee devaluation was overcome
• ~6x productivity enhancement in the API process
• Licensee with Rondaxe support has successful End of Phase II meeting

Maximizing CMC Value

Situation:

• Client needs to license out Phase II product to proceed to Phase III
• API & Drug Product have stability issues

The Rondaxe Team:

• Initiated development of comprehensive due diligence package
• Resolved API & Drug Product instability issues
• Designed & implemented improved supply chain / COG’s structure
• Solidified clients Intellectual Property position

Results:

• Product Licensed to Big Pharma for $508 million

CMC Due Diligence

Situation:

• Client requires CMC due diligence on two clinical candidates with both IV and soft-gel formulations (4 products)
• Client is resource constrained

The Rondaxe Team:

• Sends three content experts to Europe to execute due diligence and collect pertinent data
• Prepares complete due diligence report & strategic analysis for client

Results:

• Client receives comprehensive report including:
  • Detailed analysis of “show stoppers” & Gap analysis versus NDA timelines
  • Development and commercial COG?s forecast
  • 18 month projection of client development resource requirement
• Client narrows negotiation to a single product
• Client amends staffing plans

QA Audit and Commercial Strategy

Situation:

• Client, a US based emerging pharma company, licenses in Phase III product.
• Client desires strategic evaluation of supply chain

The Rondaxe Team:

• Rondaxe initiates a multi-phase program:
  • Performs QA audits of existing suppliers in India and Eastern Europe.
  • Extracts critical COG’s data from suppliers.
  • Assists client with negotiation of supply contracts
  • Works with client to establish commercial launch plan.

Results:

• “At risk” suppliers eliminated from launch plan.
• Robust, cost effective supply chain established.

QA Audit Remediation and PAI Prep

Situation:

• Client, an API supplier in India, fails a GMP inspection
• Client desires a remediatition program for the 38 audit observations

The Rondaxe Team:

• Rondaxe initiates a multi-phase program:
  • On-site meetings to develop and kick-off remediation action plan
  • Off-site monitoring and guidance of remediation team
  • Final on-site review and approval of remediation program
  • On-site Pre-Approval Inspection (PAI) training

Results:

• Successful remediation of all 38 observations.
• Facility and staff positioned to pass a PAI from the FDA.

Resolved CMC Issues & Increased Licensing Value

Situation:

• Client had worldwide partnering discussions underway
• EMEA has questions requiring responses prior to initiation of Phase III studies
• Supply Chain threatened by loss of Key Vendor

The Rondaxe Team:

• Provided response to EMEA within 14 days
• Establish new supply chain plan within 21 days
• Transferred process to new vendors

Results:

• License negotiations continue to a successful close
• Phase III clinical plan stays on track

Managing CMC & Development Activities to Improve Efficiency & Ensure CMC Approval

Situation:

• Rondaxe hired to manage Development and Regulatory activities
• Client receives unorganized historical information from Licensor
• Client needs to develop a CMC Regulatory strategy and present to FDA at End of Phase II meeting

The Rondaxe Team:

• Organized historical information into logical development histories
• Prepared IND and IMPD updates
• Prepared CMC End of Phase II briefing package

Results:

• FDA agreed to all proposals at End of Phase II meeting.
• CMC Data ready for go/no go to NDA

Pre-IND & IND Preparation

Situation:

• Client preparing for Pre-IND meeting with FDA
• API and DP Development work performed by Multiple CRO’s
• Client lacks internal capabilities to address CMC issues or prepare Pre/IND documents

The Rondaxe Team:

• Organized all process information from CRO’s, prepared Pre-IND briefing package and attended meeting with Client and FDA
• Prepared the CMC section of the IND

Results:

• FDA agreed to GMP starting materials as proposed
• No CMC related questions requiring a response to the FDA
• The IND was submitted and approved without any questions from FDA