We get results! Check out a few project case studies.

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Master Batch Records were needed for multiple new facilities. Conventional MBR generation was increasingly costly, critical path, inefficient.  We were brought on to implement new MBRs and take documentation off critical path.

SOPs were being drafted by engineering vendor without concern or visibility to the MBRs. Legacy MBRs were being adapted from other facilities, and as a result, were carrying-forward systemic documentation problems.  Additionally, the new MBRs were not aligning with new facilities.

• The team dreaded batch records and were resistant to change.
• The client was not aware of “unit operation” concept (huge, jumbled MBRs).
• The MBRs were not integrated with the SOPs, logs/data forms, and automation.
• Stakeholder departments and partner functions were centered on the legacy MBR development approach.

• Proposed new MBR template and parameter solution with paired recipes and SOPs
• Implemented generic MBRs; reduced number of documents needed per campaign
• Reduced doc lead time by 6 weeks (50%) and man hours 63%
• MBRs for any product any time!

The client expanded the MBR solution to multiple DS and DP plants.

And for the next pipeline product they filed their IND early!

Client requested instructional design and training curriculum development for new Success Factors electronic learning management system (LMS). Fundamental and technical cGMP trainings needed.

As the client prepared for their first pre-approval inspection, the client was challenged with training large departments for their cGMP curriculum requirements and to build a quality culture.   Additionally, the client was implementing a new learning management system for compliant training management and had retained new leadership to oversee the training function.

• There was so much work to do!
• The cGMP training programs and curriculum were immature.
• The training staff lacked instructional design experience and basic cGMP knowledge.

• Implemented a large volume of e-learning and instructor-led trainings for manufacturing, quality, and regulatory programs
• Mentored internal training staff on how to rapidly develop e-learning modules and concepts for appropriately detailed content and optimal skills mastery.

“You did an amazing job! I think every one want to use this [Quality Agreement e-learning] platform for their training!”

The client's Managed Care and Customer Operations organization is responsible for managing the consolidation of the portfolio of bio-oncology product distribution channels and minimizing market reaction by proactively managing communications around the changes.  There were thousands of impacted outlets within the US ranging from hospital pharmacies, major pharmacies, specialty pharmacies, and local pharmacies.

Client financial objectives and patient compliance drivers illustrated the benefit of consolidating the distribution channel.  However, a previous attempt at  restructuring the distribution channel was unsuccessful and halted.  Now, after waiting over two years to try again, prescriber, pharmacy, and patient tolerance for changes in how they access their cancer medication was highly uncertain.

• Risk of prescriber emotional response and potential threat of diverting sales.  Earlier attempts to consolidate the distribution channel resulted in prescribers directly calling top-ranking company leaders and threatening to change to another company's therapy.
• Project had very high visibility internally with mixed levels of confidence for successful execution.  
• Absolute necessity for confidentiality in the planning phases to prevent undue and premature market reaction.

Organized and implemented communications ‘control tower’

On first day after announcement of consolidated distribution channel, the team triaged 700+ calls, categorized and trained the sales team on each call type overnight, so that the sales team was prepared with messaging (and mitigation strategies to protect the market) the next business day.

The market reaction was averted!  The client retained market share and the project set the gold standard for additional channel distribution projects for products in other therapeutic areas.

Biosimilars developer required a team of CMC and medical writers to develop regulatory filings. Technical documentation needed to support CMC content.

The client was dissatisfied with the quality of regulatory writing they were receiving from their CRO.  The content was accurate but it did not sufficiently tell “the product story” or reflect the maturity and depth the client sought for their biosimilar.  The client wanted subject matter expertise, writing excellence, data analysis, and partnership from their writers to distinguish their submissions through scientific excellence.

• Extreme pace and highly competitive biosimilars landscape
• Relatively young company with immature systems 
• Our writers were required to operate fairly autonomously with little/no oversight or guidance due to the aggressive timeline and lean staffing model

• We proposed and defended product control specifications and shelf-life expiration dating.
• Provided team leadership, medical writing, and coordination of work for team of medical writers.
• Contributed to the successful submission of BLA and MAA for first pipeline product and IND for fourth pipeline product.

The client's first product received EU approval in Sep2018 and US approval in Nov2018.  They are now a commercial biosimilars company!

The client's CMC development teams provided high level project oversight. However, the process validation/process characterization subteam activities were neither visible nor valued by development leadership, resulting in PV/PC deliverables becoming a growing risk to BLA timelines for products in development.

Senior leadership changes created a knowledge gap and limited visibility to PV/PC milestones. This cascaded to blind spots within the CMC development teams and caused a breakdown in collaboration across the PV/PC subteams. Additionally, the PV/PC management departed, leaving the PV/PC without leadership or sponsorship for a period of time.

• Stakeholder involvement waned during the department leadership changes
• The CMC teams had varying expectations for the PV/PC subteams, causing confusion and disastisfaction
• There was no consistent PV/PC reporting or structure, so CMC teams did not know what to expect or how information would be provided.

• Conducted voice of customer interviews to confirm value of centralized PV/PC management
• Implemented real-time PV/PC interactive dashboards for portfolio 

There was a PV/PC headcount reduction of 1 FTE.  The PV/PC subteam meeting hours were reduced by ~2 hrs/week/project/team member.  None of these changes resulted in PV/PC subteam output or quality of work.

The EMA reviewed the client's phase II data and, based on that, agreed to allow the company to bypass the phase III clinical trial to pave the way for earlier product approval.

Our task was to review their body of GCP policies and processes to prioritize and remediate for EMA pre-approval inspection. 

Our timeline was three months to complete review and provide a compliance plan.

• This was their first pipeline product, so their processes were phase I/II-appropriate. 
• The client's systems were paper-based and in some cases, without written procedures.
• Departments relied on tribal knowledge.
• The company was experiencing a phase of turnover and simultaneously rebuilding their internal teams and bringing in new leadership.
• The company was transitioning from development to a commercial pharmaceutical company, however there was resistance to change and lack of experience bringing a product to market.

• Prioritized doc roadmap for PAI
• Provided critical processes in a short period of time, including:  Data Mgmt, Blinding Plan, CTM, Trial Master File ,Drug Accountability, Protocol deviations

Client successfully hosted EMA inspection and shortly thereafter received FDA breakthrough designation.  They now have two commercial products and one more pending approval.