ISPE Member Spotlight: Erich Bozenhardt
Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. He is a Lead Process Engineer in Regenerative Medicine Operations at United Therapeutics Corporation. During his career, Erich has led the process activities for several biopharmaceutical projects, provided internal and external project leadership, is a published author of more than 30 technical papers, and a conference presenter on process technologies and operations.
Erich became a member of ISPE while attending the University of Delaware (UD), where he started the UD student chapter. He is an active member of several Communities of Practice and a contributor to guidance documents. He is the Chair of ISPE’s newly formed Advanced Therapy Medicinal Products Community of Practice.
Tell us about United Therapeutics.
United Therapeutics was founded with the mission to find a cure for pulmonary arterial hypertension and other life-threatening diseases. We have FDA approval for 5 medicines, are always conducting new clinical trials, and are working to create an unlimited supply of manufactured organs for transplant. One of the things I am working on is the need to be planning and designing new facilities in order to meet new needs. It is exciting to be at the forefront of cell and gene therapy discoveries and to meet the challenges of developing facilities where these new medicines and treatments can be made, and life-changing research can take place.
How did you become interested in cell and gene therapy?
I started working on cell therapy projects in 2014. In 2016 a client company I was working with was developing a CART-T therapy for relapsed myeloma. We were able to go lightning fast from project concept to completion in 11 months instead of the projected 16-18-month timeframe. About 4 months after the project was completed, I was speaking with the client, and they mentioned they had dosed several patients already. Then it dawned on me with a response rate of 98%– patients who had had a life expectancy of less than 6 months, now had a chance to survive and that by being able to complete the project in less time than we had anticipated, I was able to have an impact on patients’ lives, just by being an engineer. It really strengthened my passion. These are new life altering medicines that will forever change how we view disease.
What do you enjoy most about the advanced therapy medicinal products (ATMP) field?
It’s all new, it’s all innovative, there is no standard way, you have to sit down and think up new solutions, you have a chance to shake up and change the industry. Right now, there are very few commercialized ATMP therapies.
Because they are such innovative medicines that make such a difference in patients’ lives, the companies I’ve worked with have pushed through the clinical trials to get the medicines helping patients quickly, but from the manufacturing side we have a lot of work to bring these treatments to more people and to reduce the cost of goods. There are lots of opportunities to work on projects that will have a long-lasting positive impact. These are great therapies that have given patients years of lives and we are at the very beginning of a revolution.
What advancements are you most excited about?
Overall, it is exciting to see all the advancements in the industry. It is a big change to go from a paradigm of treating disease to curing it, with certain select cancers we are seeing durable remission. All the indications are that we’re able to cure patients with some of these innovative therapies. We’re changing medicine.
Why did you join ISPE?
I started an ISPE student chapter when I was attending the University of Delaware. I wanted to gain a better understanding of what was going on in the pharmaceutical industry and find the right niche for me. I started the Delaware student chapter because I knew there were other students interested in the industry, but like me, they didn’t know what opportunities were out there, didn’t know all the different areas that were integral to the industry.
What ISPE means to me has changed over the years. As I’ve grown in my career, it has giving me the chance to meet and work with other people, to share ideas. There are a lot of people facing the same challenges and asking the same questions as me and ISPE gives me the chance to collaborate, share what I know, and learn from others.
What led to the formation of the new CoP?
Lots of different factors lead to the formation of the CoP and I think ultimately the timing was just right. I’ve been interested in ATMP and the unique challenges presented for a number of years. Several years ago, people starting talking more and more about these therapies at conferences and the need for a focused group, and recently it came to fruition. The ISPE board saw this segment of the industry as unaddressed within ISPE and really got behind the formation of this CoP. ISPE is responding to what’s going on in the industry and what members’ needs are.
Right now, there is a lot of interest in ATMP, but not a lot of knowledge, not a lot of guidance. The Biotechnology, Aseptic, and Disposables (Single Use Technologies) CoPs are all involved in cell and gene therapies, but we are trying to bring it all together to see what we need to do to move this forward to get to the next level. The complexity of the processes and manufacturing are still not very automated. They are not where you would expect if you look at the rest of the biopharma industry.
What are your goals with the new CoP?
More and more companies are interested in ATMP, but not a lot of people have that background, we need to prepare them for the uniqueness and challenges of ATMP and provide training to help transition people into the field.
We also need to create cohesive standards to help us move forward. One of the major challenges for the industry is that every therapy is a little different. We need to create good general guidance that will help the industry.
What have you enjoyed about being a member of the team working on the ISPE Advanced Therapeutic Medicinal Products (ATMPs) Guide on Autologous Cell Therapy?
The best part of working with the team is being able to talk to other people and hear their challenges. Sometimes they are the same, sometimes they are slightly different. It is interesting to hear how other people are looking at problems, it helps me to think about what solutions will work best.
Why would you tell someone they should volunteer with ISPE?
In order to move the industry forward, we need everyone’s opinion and everyone’s input, we really need people from different perspectives to come together and look at and discuss what risks are out there, how we can mitigate those risks, and how can we best get these therapies to patients. There is so much new ground to cover in this space.