Pillar5 Completes Successful FDA Audit

Pillar5 Pharma Successfully Passes FDA Inspection

Pillar5 Pharma Inc. recently received notice that they have successfully passed a cGMP  and pre-approval inspection (PAI) for a New Drug Application (NDA) by the U.S. Food and Drug Administration to manufacture a solid dose product on behalf of one of its clients.  The acceptable rating was received after full inspection by the FDA of the Quality, Facility and Equipment, Materials, Laboratory, Production, Packaging and Labeling Systems, and a PAI, with no 483 observations.

“I am very pleased that Pillar5’s high quality standards and expertise were reflected in the outcome of this inspection” notes John Carkner, President and CEO of Pillar5. “This is a significant milestone for our client partnership and brings this important product one step closer to market.”

Managing Talent at Pillar5

Talent planning is an important objective for any organization.  As a start-up CMO with a world class pharmaceutical legacy workforce, it is particularly important for Pillar5 Pharma to ensure a succession plan is in place.  Anne Graham, Director of Human Resources with P5 believes that talent drives performance and that teams with the best people perform at the highest level.  Accordingly, Anne ensures a yearly talent review is completed to develop and fine tune the organization’s succession plan.

Talent management starts with getting the right people inside the organization, then managing an ongoing process continuous development of individual potential.  The formal talent review process begins with employee evaluations covering 2 major areas:  employee performance and employee potential.  Combining the standard evaluation measurement of employee performance with an evaluation of an employee’s potential to develop skills and increase levels of responsibility creates the basis for identifying employees that align with the organization’s development and succession requirements.

When evaluating employees with high potential, P5 looks for behaviors that are in line with the performance competencies and readiness to take on a more senior role.  Talent management is based on a combination of organizational and job-focused competencies, all of which include knowledge, skills, values and behaviours.

In any organization, people are the difference and talent needs to be managed.  When an organization looks after their talent, it’s a sign of how well leadership is focusing on the future.  For the employees, it’s a key driver of employee retention.  From the organizations’ perspective, succession planning reinforces corporate priorities and shared values.  It links people to the company’s strategic business and develops leadership talent and bench strength.  From the individual’s perspective, it ensures they feel valued by the organization, particularly if they receive coaching and feedback on their personal development as well as career progression opportunities across the business.

Maximizing Value of Mature Products

A strategy for building strong contract manufacturing partnerships

Pillar5 Pharma Inc. has emerged as a new entry in the contract manufacturing arena. They are a relatively small Canadian based company, manufacturing for Canadian and global markets from a former Pfizer facility in Arnprior, Ontario.

In seeking new business they have developed a strategy to work with customers to maximize the value of mature brands. This strategy is supported by:

• Providing regulatory and product development support to standardize and optimize product formulations, to support a robust manufacturing process that can be registered for multiple markets
• Applying Lean manufacturing principles to the production process to maximize value for the customer
• The capability and flexibility of scale to provide large or small volumes of product
• A flexible pricing structure that enables customers to share in the cost benefits of volume consolidation while providing maximum flexibility as volume erosion of mature brands begins.

“We would like to supply innovative and growing products to our clients” says John Carkner, President of Pillar5 Pharma, “but we also see a niche opportunity in doing a great job in supplying mature products. With trends like corporate consolidation and increasing numbers of competitive products, there are many products that still serve a need in the market place, but no longer generate the volume of production that lends itself to high-volume facilities.”

For example, Pillar5 Pharma recently prepared a proposal that represented great value for a customer who had lost exclusivity on a patented product. By consolidating volume for multiple global markets and passing the volume benefit on to the customer through stratified pricing, Pillar5 was able to reduce cost-of-goods by over 40%. This was driven by:

• Process streamlining and standardizing to one presentation for multiple markets
• Application of NIR (near infra-red) analytical capability to reduce cycle time and analytical cost
• Applying the favourable cost structure attendant on Pillar5 Pharma having purchased the Arnprior facility at nominal cost
• Developing a flexible pricing structure that compared favourably to the customer’s internal costs, but provided the added benefit of allowing the customer to reduce fixed overhead by outsourcing
• An understanding of global regulatory expectations, and the ability to satisfy those requirements

“We like to think of ourselves as problem-solvers for our clients” Carkner went on to say. “By adapting the wide range of production scale available at our facility, we can help customers find additional value in brands that might otherwise be only marginally profitable, or even discontinued.”

Pillar5 Pharma prides itself on providing world-class quality at a competitive price. The facility has been in operation for over 50 years, and that experience, coupled with contemporary understanding of Lean and Six-σ process optimization, lends itself to reliable customer service.

There is a belief in some quarters that production can be cheaper in low-cost locations around the globe. While this may be true for large volume products purchased on a frequent basis, it raises logistics and service issues on the maturing brands that represent a large proportion of many customers’ product portfolios. Pillar5 Pharma believes that they can better serve the needs of these customers through frequent communication and rigorous attention to their needs.

“In my past experience, the bottom 20% of products by volume represented more than 80% of the product supply problems” said Carkner.  “By specializing in these products, we believe we can offer great value, and extend the life of products that still have the potential to contribute to our customers’ business.”