SPECIAL SPONSORED SECTION

An Executive
Summary
Todd Salsbury
Director of Global Product
Development Project Management
Catalent Pharma Solutions
Planning Successful Launches
of Complex Drug Products
How risk reduction in pharmaceutical research and
development and identification of other key
determinants lead to successful product launch.
Introduction
Developing and bringing a new drug to market is a long, expensive, and uncertain process.
Keys
Whether it isto Successful
a complex Pharmaceutical
New Chemical Entity (NCE) or Launch Management
simple immediate-release product,
there are always variables to resolve in the formulation, process, and analytics. The key to any
successful product launch is to minimize risk while managing time and cost.
Catalent utilizes a New Product Introduction Excellence (NPIx) process
Catalent uses aand
to assess Newmanage
Product the
Introduction Excellence
development and (NPIx)
launchprocess to assess and manage
of pharmaceutical
products. and launch of pharmaceutical products (Figure 1).
the development

Melissa Buchanan Figure 1: Keys to successful pharmaceutical launch management.

Senior Project Manager
Catalent Biologics

Katie Noah
Pharmaceutical Research and
Development Project Manager
Catalent Pharma Solutions

Stage gating is a process that starts with matter expert assigned to the project, and
©2018 Catalent Pharma Solutions. All rights reserved. 4
determining which project must be performed, how much of their time is taken. Last, project
continued with risk management and the go/no management determines what level of project
go decision making through development, reg- management is needed, how much project
Dave Boerschel istration, scale-up, and launch. Catalent utilizes oversite and escalation is necessary, and what
Program Manager the Quality by Design (QbD) approach through level of risk is tolerable.
Product Development
Catalent Pharma Solutions Design of Experiment (DOE). We use Total The following three case studies of the devel-
Project Risk management, which deals with opment and launch of complex pharmaceutical
quality risk management as well as resource, projects show how the Catalent teams identi-
external risk factors, supply chain, etc. Cross fied and applied NPIx, along with their project
functional teams are used for decision-making, specific keys to success.
risk management, determining the subject

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SPECIAL SPONSORED SECTION PLANNING SUCCESSFUL LAUNCHES OF COMPLEX DRUG PRODUCTS

Case 1: Cross-Functional Collaboration There was much internal discussion about how informa-
Facilitate Rapid Launch tion moved through the facility and among different func-
In the first case, cross-functional collaboration was key to tional groups. Catalent frequently met face to face with the
launching a biologic product within 24 hours of FDA approval. client to facilitate communication and keep them connected
Keys to success included: to their molecule. The project manager and project team
• Planning and risk management went on Gemba walks, visiting the manufacturing floor to
• Communication and operating mechanisms see what operators were doing. The team also went to the
• Governance and leadership. warehouse to see how materials were being managed. In
Figure 2 shows the timeline for activities leading up to the addition, the team collaborated with vendors to understand
launch date. their systems and processes to ensure that all the inputs
The Catalent team used several tools to meet the project’s were tied together.
compressed timeline. In this project, Risk Scenario Planning The project team provided leadership with concise, digestible,
identified several potential risks in terms of cost, timing, and routine reports. Frequency varied as the project progressed.
risk tolerance. These included possible resource diversion, Initial output consisted of monthly readouts. Closer to launch, it
circumstances that could interrupt the distribution chain, and became detailed, daily tactical summaries of timelines and how
situations when a key subject matter expert (SME) was unavail- issues were being addressed. Catalent worked to ensure that
able due to unforeseen circumstances. In addition, last-minute all stakeholders were well informed throughout the process.
changes to print material could prolong the timeline. The goal was to launch the product within 24 hours of
Thus, when a risk came to fruition during this project, the FDA approval, and it was accomplished in only six hours.
team used the tool kit to address it. When a key SME was Upfront planning and a stepwise process for incremental
unavailable, the Responsibility Matrix indicated a back-up SME improvements were critical to the significant success of
assigned to complete the work. The Swim Lane—combining this partnership.
Process Flows and Responsibility Matrix and identifying key
handoffs between functional areas—enabled the alternate SME Case 2: Partnered Risk-Management
to smoothly drop into the process midstream. Practice Deming Approach to Achieve First-to-File Timeline
Cycles gave the involved parties the opportunity to address In the next case, a partnered risk-management approach was
gaps and challenges in a lower-pressure situation. key to achieving first to file of a complex oral solid medication.
The project was a complex, multistep, highly regulated The client asked Catalent to perform technical transfer and
process that included intricate discussions. Many internal analytical methods transfer that entailed several strengths of
and external influencers and stakeholders contributed to the a modified-release capsule.
conversation, as well as individuals from the FDA. It involved The objective was the execution of batches to obtain
Cross Functional Collaboration Keys to Rapid Launch
frequent transfer of information—from the client to Catalent, stability data in time to win a first-to-file oppor tunity.
Planning
from Catalent to other vendors, and among agencies. Catalent was approached by the client approximately five

Figure 2: Cross-functional collaboration keys to rapid launch planning.

Challenge: Ship product to the US Market <= 24 hours post approval

Context: First rapid biologics launch for CDMO & Partner
Result: Product shipped to US market 6 hours post approval

Nov-17 - Jan-18
Jan-16 - Mar-16 Wave 1 Launches
Scenario & Risk Planning Oct-16 - May-17
Jun-16 - Jul-16 Product 1 Launch Staging
RACI Development
Jan-16 May-17 Nov-17
Initial Client Request Product 1 US Approval Product 2 US Approval Feb-18 - May-18
Wave 2 Launches

Jan-16 May-18
Jul-16 - Oct-16 May-17 - Oct-17
Product 1 Mock Activities Product 2 Mock Activities
Apr-16 - May-16
Baseline Schedule Development Oct-17 - Nov-17
Product 2 Launch Staging
 PLANNING SUCCESSFUL LAUNCHES OF COMPLEX DRUG PRODUCTS SPECIAL SPONSORED SECTION

months before stability data were needed; thus, time was need, or item had a certain response time that dictated its
the highest priority. Three keys to success of this project prioritization. For example, batch records and deviations were
were identified: considered top-level issues and needed approvals quickly. As
• Strong partnership a result of the established communication policy, time was
• Mutual understanding of risk management not spent on locating items or asking people for follow ups.
• Clear and concise communication. One communication strategy that helped avoid delays were
Partnership enabled the teams to work as one cohesive unit twice-daily meetings. The first was with the entire project team
rallying around a common goal. Fostering trust and an open and the second included only the project management team.
dialogue helped in collaboration on project planning, technical Communication across the Catalent network was also
consultation, and recommendations sharing. The client’s team essential. The project management office had experience
was interested in a consultative, collaborative approach. Face- with first to file and provided solid advice such as establishing
to-face visits were important in building trust and fostering triggers for the next step. This helped create seamless hand
collaboration as well as helping with practical matters. For offs because a team with downstream activity understood
example, any needed signatures could be obtained in real time. what would trigger them to start their work. In addition, certain
Throughout the process, milestones were jointly celebrated activities that were “nice to haves” were reduced.
to build camaraderie and show that the team was working Finally, Catalent used standardized updates and templates
towards a common goal together. so that all team members understood what was being done.
Equally critical was establishing an environment in which Each meeting began with a countdown to filing, which allowed
risks and issues could be openly discussed. Discussions the team to focus on the goal—achieve the filing in a safe and
about risk are easier when both parties are involved with sug- compliant manner. A detailed timeline was shared and dis-
gesting solutions. The environment offered an open dialogue cussed at each meeting. Topics included the critical path, status
to address concerns and new ideas at any given time. of any items on the critical path, and risks/risk management.
Risk management encompasses risks that can be miti- Keys to success of this project are summarized in Figure 3.
gated, those that have a contingency plan, or those that can It was a win–win for Catalent and the client. The project’s suc-
be accepted. In this project, the material was a controlled cess would not have occured without the components that
substance for which risk mitigation was required. Catalent helped Catalent to overcome time constraints, develop a new
understood that early quota filing would be very important. operating framework, and work collaboratively as one unit.
Through upfront collaborative planning, quotas were obtained
before project kickoff. Case 3: Dedicated Team Approach to
Sample shipment can be complicated when testing is done Complex Pharmaceutical Development
by an outside laboratory. In this project, a Saturday delivery as The objective of the third project was to develop and launch
well as a same-day delivery were made to reduce risk in timely a complex ophthalmic product that was formulated and filled
delivery of material to the laboratory. into a single-unit–dose container. The main goal of Catalent’s
Parallel processing was performed to increase speed. client was timely execution of the development, scale up, and
Formal risk assessment before registration included contin- launch of its high-quality product, incorporating product-
gency planning and mitigation in the form of purchasing extra specific facility modifications. Keys to success included:
excipients should an extra batch be necessary. In the event that • Communication and coordination
Partnered Risk Management
an issue arose, a plan was in place to enact immediate action.
Approach to Achieve First
• SME contributions
In fact, a scenario did arise that required an extra batch. In • Project management expertise.
this instance, the preexisting plan
to File Timeline - Accomplishments
was consulted and executed. Figure 3: Partnered risk management approach to achieve first to file timeline.
Later in the process, an issue
arose with an agency response. KEYS TO SUCCESS: Partnership, risk management and communication
Catalent was able to resolve the were vital to meeting an aggressive timeline
issue in nine days. It was a great
win for the team, proving that
These components helped us to overcome time constraints, develop a
the risk-management approach
new operating framework, and work together as one unit
worked.
Clear and concise commu-
nication was critical to reacting
quickly to changes. A fast and
Results
fluid communication policy with Exceeded the original timeline by 14 days
a how-to, rule-based approach First to File Success
was established during a kickoff
meeting. Each type of question,
SPECIAL SPONSORED SECTION PLANNING SUCCESSFUL LAUNCHES OF COMPLEX DRUG PRODUCTS

Dedicated Team Approach to Complex Pharmaceutical

Development – Project Management Expertise reached a joint agreement with
Figure 4: Dedicated team approach to complex pharmaceutical development.
the client on new set points that
were required to achieve a six
Project Management Expertise Skilled in the art and
knowledgeable about site, product and process sigma–capable process.
•  Critical path and
problem solving During construction of
mindset Catalent’s formulation suite, it
Task coordination, oversight and critical path throughout came to light that the cleaning
obstacles identified
•  Sequencing of actions correctly to facilitate efficient and addressed and sanitation process required
execution and compliance with procedures major changes to ensure accept-
•  Continuous follow up and challenging of individuals to •  Maturity and able microbial counts. Cleaning
willingness to
deliver to the timeline ex p e r ts a c ro s s C at a l e nt ’s
openly speak of
issues and realize internal network, as well as
top leadership help outside vendors, were engaged
Stakeholder engagement
•  Demonstrated to accomplish this. To date, the
•  Ensured ongoing awareness and alignment ownership of the effort has been successful. The
•  Facilitated collaboration with stakeholders regarding goal and the process has been adopted
challenges and prioritization timeline
in other areas of Catalent’s
•  Leveraged resources as needed from throughout network facility, demonstrating a positive
to address issues outcome from an effort that was
performed for purposes of the
Communication and coordination throughout the project ophthalmic project.
©2018 Catalent Pharma Solutions. All rights reserved. 25
lifecycle greatly assisted with overcoming technically difficult Challenges with the product-specific facility design required
challenges, time zone differences, and normal development experts in fabrication and installation. An extensive and com-
obstacles. Regular weekly meetings were held, both internally plex formulation process had to fit into a very tight space. The
and with the client. In addition, Top to Top steering committee allotted space was not ideal, but experienced pipefitters and
meetings were held to share and resolve obstacles. welders were able to achieve adequate accommodation for
Meeting agendas and minutes were published from every the process.
meeting. These were shared with all stakeholders to help Finally, the project manager successfully coordinated all
coordinate and reinforce their actions and decisions. A rolling tasks for this project, due to their expert internal knowledge of
action item list was maintained in real time and was consistently site procedures. The excellent sequencing of actions facilitated
used as the main focus during meetings. It served as a key efficient execution of the project while maintaining full compli-
reference for due dates and the latest activity required in the ance with all procedures. The project manager continuously
project. It helped to avoid many mistakes in communication followed up and challenged individuals to deliver according to
and delays in the completion of tasks. the timeline.
Cross-functional SME contributions were key throughout Collaboration was facilitated with the client and other stake-
the project’s lifecycle. They allowed concerns to be addressed holders regarding the critical path , including challenges and
quickly. As the project’s scope evolved, it was critical to incor- prioritization. The project manager properly leveraged both
porate and engage many different SMEs. Catalent and external resources, demonstrated ownership of
For batch record document quality, Catalent conducted a the goal and timeline, maturity, and a willingness to openly
thorough cross-functional expert review and utilized technical share issues with Catalent’s top leaders and the client, all of
writer expertise to create a top-notch batch record. A high level which were essential to successful delivery.
of emphasis was placed on critical control points within the Figure 4 summarizes keys to success. Catalent’s dedicated
record. Manufacturing floor-level personnel (e.g., formulators, team approach overcame multiple difficult challenges associ-
technicians, and packaging leaders) were key to development. ated with the project.
Cross-functional engagement ultimately led to strong owner-
ship of solutions. Summary
Technical challenges in formulation, delivered dose, and The article describes three scenarios in which the Catalent
sterile environment monitoring were addressed. SMEs were key team applied NPIx principles to support challenging develop-
to overcoming these issues. Catalent and its client engaged ment projects leading to commercialization. Factors contrib-
numerous formulation experts to resolve a critical processing uting to project success were revealed. Rigorous upfront
parameter needed for critical quality attribute capability assur- planning, developing a stepwise process with built-in con-
ance. Operational excellence personnel, engineers, and the tingencies, collaboration, risk management, communication,
client worked to overcome an unfamiliar product characteristic and leveraging the expertise of SMEs and project managers
discovered during the scale-up process. Catalent ultimately are all critical attributes.