3 Business Challenges from the CDMO's Perspective

By Erin Harris, editor-in-chief

Partnering with a CDMO that marries innovation with technical, regulatory, and manufacturing experience can be cell therapy and gene therapy companies’ best opportunity for scalability and yet their biggest hurdle. From process development through commercial supply and all the steps in between, cell and gene therapy companies expect CDMOs to meet an understandably high bar.
I recently had the opportunity to take a quick trip down 76 East to WuXi AppTec located in Philadelphia’s Navy Yard. I toured WuXi’s Manufacturing suits, which is where they company does its Viral GMP production. I also toured their Testing suits, which includes the WuXi’s Testing and GMP production building. The tours were informative and helped me shape my questions for the second half of my visit, which was a sit down with WuXi’s SVP and Global Head of Wuxi Advanced Therapies, Felix Hsu.

Hsu and I had a great conversation around the CDMOs perspective on manufacturing, and I feel the outcomes of our conversation can benefit our readers. Here’s why.
He and I talked about the top challenges WuXi’s clients bring to the table. As you research and visit CDMOs that can potentially execute your vision, consider how you and your team can address these three challenges. Does any of this sound familiar?

1. Time.
Hsu assured me that WuXi’s clients often have more money than time. Or, clients have developed a platform and sometimes expect to accelerate this platform without a well-characterized process — or very little process in place. Accelerated timelines to meet an IND date won’t always work for the CDMO in these circumstances, and the timelines are often aggressive or unrealistic.

2. Stop tinkering.
Hsu stressed that how things work in an academic setting is different from how they work for GMP manufacturing. And, so, scientists sometimes have a difficult time accepting that they cannot continue to work on process and must stop making changes to move forward with GMP manufacturing.

3. No last-minute changes.
He explains that sometimes clients struggle to determine exactly what they want or need in terms of the assay development in the timeframe needed. As always, time is a major factor and manufacturing is one of the biggest decisions your organization will make. Academic labs vary greatly from manufacturing environments and have greater flexibility; CMDOs often cannot allow last-minute changes to the process and/or raw materials if they are to meet tight deadlines.
What has your experience been with partnering with CMDOs and how has your organization learned?

Some of the Best Running Trails in Philadelphia

With a bachelor of science in biology from Philadelphia University and an executive MBA from the New York University Stern School of Business, Raymond J. (RJ) Fitch works for WuXiAppTec Advanced Therapies in Philadelphia as the Vice President of Operations & General Manger. As often as possible, RJ Fitch enjoys taking time out for his health, which includes running.

A few of the best running trails in Philadelphia are:

1. The pedestrian walkway on the Benjamin Franklin Bridge. Allowing runners to take a three-mile trip from Philadelphia to Camden, New Jersey, and back, the walkway gives runners a panoramic view of the Delaware River and both cities.

2. The Schuylkill River Trail. The most popular trail for Philadelphia runners stretches approximately 26 miles from South Street to Phoenixville. The trail takes runners past the old Pennsylvania railroad and Valley Forge National Historical Park.

3. Cobbs Creek Park. Located in West Philadelphia, the park provides a four-mile run from 63rd and Market Street to 73rd and Chester. Unpaved parts of the trail wind through the woods and down to the creek.

The Parenteral Drug Association Offers Industry Training Programs

Business executive Raymond J. Fitch has over 20 years of experience in the global health care industry. Currently, RJ Fitch serves as the Vice President Operations & General Manager for the WuXiAppTec Advanced Therapies Philadelphia site. To stay abreast of developments in pharmaceuticals, RJ Fitch supports the Parenteral Drug Association, a leading provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community.

The Parenteral Drug Association offers educational and training programs for those in pharmaceutical sciences, with courses covering topics related to aseptic processing, biotechnology, microbiology, training, and quality and regulatory affairs. Updated regularly and enhanced to reflect emerging technologies and data, classes are offered at the organization’s Training and Research Institute in Bethesda, Maryland.

Located at the association’s global headquarters, the Training and Research Institute incorporates labs and classrooms for lectures and hands-on learning. The aseptic processing suite includes a fill room, gowning rooms, a component prep lab, and a clean staging area. The institute also has microbiology and biotechnology labs and a clean-in-place lab set aside for instruction.

Characteristics of a Successful Organizational Leader

Raymond J. (RJ) Fitch is the vice president of operations & General manager at WuXiAppTec Advanced Therapies in Philadelphia. The executive MBA program at the New York University Stern School of Business helped RJ Fitch become an effective organizational leader. 

Here are several important characteristics of a good leader:

1. Leaders must have a thorough understanding of their own strengths, weaknesses, habits, and assumptions. They must simultaneously do what is best for employees and the company. 

2. Leaders must have good communication with personnel at all levels of an organization. Leaders need to clearly inform employees what is expected of them while building a rapport with them and being attentive to their concerns. 

3. Leaders must emphasize that they expect accountability for results and determine when to follow up with individuals for accountability. 

4. Leaders must address failure directly and in a constructive way to create an environment that promotes success in future endeavors.

5. Leaders must evaluate themselves to ensure their performance meets the organization's standards and values. An ethical leader can boost morale and encourage others to abide by set values.