Nicole and Gavin Pierson

Nicole and Gaving Pierson

Made
For

Compassion & Courage

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW ONE INCREDIBLY BRAVE KID INSPIRED A ONE OF A KIND CLINICAL TRIAL.

Gavin had late stage brain cancer and not a lot of time. Chemotherapy and surgeries were not working, and Nicole was desperate to find a way to save her son. She knew of a drug in clinical trial that was showing promising results in adults, so she contacted the manufacturer and made her case for Gavin. The manufacturer agreed to let Gavin take the drug, but as a child he couldn’t participate in the existing trial. They needed to create a special trial so he could participate. Fisher Clinical Services, by Thermo Fisher Scientific, and the drug company worked together to create a special clinical trial, just for him. For the next two and half years, Thermo Fisher delivered Gavin’s individual dose on time, every time. The result was astounding. Not only did the tumor stop growing, it actually shrunk. And Gavin? He’s able to be a kid again, attending school, playing with friends and taking karate class. He’s now a brown belt in karate, going for black.

Chris Tama

Made
For

TRIALS & TRIUMPHS

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW A CONTRACT MANUFACTURER NEVER LOSES SIGHT OF WHAT IT’S REALLY MAKING.

For most companies, time and money are always on the line. At Thermo Fisher Scientific, the stakes are much higher. You see, we know that our biopharma clients’ brilliant discoveries save lives. Millions of them. But only if we can help them meet clinical development milestones to get their drugs to patients. That’s why we combine sophisticated science and engineering strategies with industry-leading experience and, most importantly, our passion for making a difference. We call it the power of human ingenuity. The results? More than 1,000 new molecules developed for clinical trial, and 112 new drug approvals launched in the last decade – more than the next six manufacturers combined. But with millions more patients awaiting new treatments every day, we know our work is just getting started.

Adamou Seydou
Gelatin Associate,
Pharma Services,

High Point, NC

Adamou Seydou

Delivered
With

Ingenuity & Insight

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW WASTED MATERIAL INSPIRED SAVING TIME AND MONEY.

When it comes to manufacturing softgel dosage forms, nobody knows more about operating the equipment that makes them than Adamou. He’s relentless about finding new ways to make the manufacturing process more efficient. So, when he saw the amount of scrap material being produced during a specific manufacturing process, he was determined to find a way to decrease it. He enlisted the help of a team of experts who supported his cause and they worked after hours and weekends until they found a solution. The result is a new process that greatly reduces scrap, delivers savings to customers, and most importantly, helps to lower the cost of medicines for the patients who need them.

Tony Pidgeon
Director, Business Management
Pharma Services,

Swindon, UK

Tony Pidgeon

Solved
With

Protocols & Passion

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW HALF THE BATCHES ACHIEVED TWICE THE RESULTS.

Sometimes, the future of a client’s entire company is riding on the success of one trial. That was the case when a small client came to Tony looking for a formulation solution for a revolutionary treatment. The problem was, their clinical trial protocol, as originally written, required six blinded doses. But the client could only afford to produce three batches, not six. If they couldn’t complete this trial milestone, the company was at risk of going out of business. When the client presented Tony with the issue, he recommended an adjustment to the trial protocol that would ensure they could gather the clinical data they needed with just three batches. By changing the clinical protocol, the trial the client thought was beyond their reach, suddenly became possible. And now this small company could move forward to make a big impact.

Whitney Sandberg
Sr. Director, Quality,
Pharma Services,

St. Louis, MO

Whitney Sandberg

Made
With

Flexibility & Focus

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW SHORT-TERM FLEXIBILITY ENABLES LONG-TERM SUCCESS.

When a client tells us that our internal processes are getting in the way of meeting their needs, we take it to heart. That’s the position Whitney faced when her client felt that her facility, originally designed for GMP biologic drug substance commercial manufacturing, was too rigid for the fast-paced, rapidly-changing world of clinical manufacturing. So, she pulled together a cross-functional team that included Quality, Tech Transfer, and Biological Sciences, to take a new look at their commercial quality processes to determine how they could appropriately adapt them to meet the unique needs of their clients in development phases. And the change worked. Now her facility can deliver the robust and reliable commercial process it has always been known for, as well as the more flexible, faster-turn execution needed for clinical. Best of all, her clients can get to clinical trial faster and expedite delivering medicines to the patients who need them most.

Sanjay Konagurthu, Ph.D.
Sr. Director, PDS Global
Science & Technologies
Pharma Services,

Bend, OR

Sanjay Konagurthu

Solved
With

Chemistry & Conviction

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW TAKING THE EDGE OFF A CRYSTAL GAINED AN ADVANTAGE.

Sometimes, even if your job focuses on data, you have to look beyond it. That’s why Sanjay and his team at Thermo Fisher Scientific don’t just apply data to solve formulation challenges. They look beyond the data for other potential roadblocks. In the early phase trials of a complex API molecule, his team recognized that dagger shaped crystals were inhibiting flow during production. While short-term workarounds for trials were at hand, they knew that in future scale ups, this would become a significant problem. So they collaborated with teams who modified the API process in advance. Smoothed the crystal. And solved the problem before it became one.

Angie West
Global Relationship Director,
Pharma Services,

Allentown, PA

Angie West

Delivered
With

Capacity & Compassion

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW A COMBINATION OF TEAMWORK, HEART, AND SCIENCE ENSURED THOUSANDS OF PATIENTS AROUND THE GLOBE DIDN’T GO WITHOUT MEDICINE.

Angie will never forget the day she got a call from a client with a packaging and logistics challenge of global proportions. They needed her help figuring out how to get an oncology drug labeled for 60,000 patients in 35 countries every month. And they needed that solution to fit in a four week cycle – half the time typically required to turn around a trial of that scale. So, Angie pulled together a team of experts across 10 departments to break down every step of the process. They worked long hours and explored every possible opportunity to increase efficiencies and take time out of the process. Then they set up an operator training lab to ensure everyone on the team could deliver the new solution as planned. The result was a 55% reduction in cycle times and thousands of patients around the world received the life-saving medication they needed.

Mike Cruskie
VP & GM API Operations
North America,
Pharma Services,

Florence, SC

Mike Cruskie

Solved
With

Science & Service

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW ON ANY GIVEN DAY, A SUIT JACKET CAN BECOME A LAB COAT.

When a client’s molecule experienced a problem during scale up at Mike’s API facility, he did exactly what any Thermo Fisher Scientific general manager would do: he put on his lab coat and got to work. As a process chemist who spent many years in the lab himself, Mike is uniquely qualified to lead a team of API chemists, analysts, and operators. And when the situation requires it, he’s ready and able to jump in to solve complex problems like this one. And that’s exactly what they did. The cross-functional team uncovered the issue, minimized the batch waste, and gave a small company a shot at making it big.

Mandy Bosse
VP & GM Cincinnati
Regional Operations
Pharma Services,

Cincinnati, OH

Mandy Bosse

Delivered
With

Capacity & Compassion

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW 800 EMPLOYEES WORKING 3 SHIFTS FOR 365 STRAIGHT DAYS KEEP A SINGULAR FOCUS.

Managing a 24/7 facility that simultaneously handles more than 90 molecules requires a leader who understands development, manufacturing technology, operations, logistics and customer needs. But, if you ask Thermo Fisher Scientific site GM Mandy Bosse, she’ll tell you that the most important aspect of her job is to inspire. Which is why she regularly invites patients to her facility to speak to her team about the drugs they make every day. One such patient is Tyler, who suffers from nephropathic cystinosis, and takes a drug made at the facility to treat his disease. Tyler, who is surpassing patient life expectancy norms, didn’t come alone. He brought his wife who is expecting their first child. That’s a healthy dose of inspiration for a team whose work may be predicated on precision, but is fueled by compassion.

Jeff Hou, Ph.D.
Manager, Cell Culture
Development, Pharma Services,

Princeton, NJ

Jeff Hou

Made
With

Process & Purpose

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW A SMALL STARTUP WAS ABLE TO SCALE UP, WITHOUT LOSING THEIR PRECIOUS MATERIAL.

Jeff faced a dilemma: how to complete a large biomanufacturing scale up with the very small amount of material his client gave him. And the stakes were high. His client had spent a lot of time and money developing this potentially revolutionary Alzheimer’s treatment. Any wasted material would put the execution of the clinical trial at risk, and possibly risk the future of the entire program. Jeff knew the process needed to be perfect. So, his team worked tirelessly to find ways to improve the cell culture performance. They examined key process parameters and even completed additional work in the process development laboratory to ensure success. The result was a flawless scale up and, most importantly, a potentially breakthrough drug was able to get into the clinic.

Michael Stanek, Ph.D.
VP Business Management,
API Pharma Services,

Linz, Austria

Michael Stanek

Solved
With

Optimization & Optimism

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW MONITORING THE BOTTOM LINE INSPIRED A LEADING-EDGE SOLUTION.

While observing the API manufacturing process for a client, Michael wasn’t happy with what he saw. The purification process was inefficient, unnecessarily driving up costs. So, he got to work analyzing the entire process and his ideas were tested in the lab. The improvements discovered were so impressive that the client agreed to test the process at a larger scale. After another successful outcome, they decided to implement the refinements across the entire manufacturing process. The result not only reduced impurities and cut costs, it enabled capacity improvements which allowed greater control to manage larger volumes.

Shawn Regits
Manager, Process Engineering,
Pharma Services,

Allentown, PA

Shawn Regits

Made
With

Accuracy and Action

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW A SIMPLE PROCESS BUILT PERFECT PERFORMANCE.

When a client required the 100% error-free assembly of syringes that included a backstop, Shawn knew his operations team would require a new process. The current process required multiple steps, each with the potential to risk deviation. A deviation could quarantine the job and risk medicine not being delivered on time. The solution was a smart and simple error-proofing tool Shawn designed and built, which replaced several steps in the process. The tool allowed only syringes with a backstop to continue through the line. Several months after implementation, there are zero deviations and shipments are out the door faster than anticipated.

Angela Colarusso
Sr. Director, Program &
Proposals Management
Pharma Services,

Princeton, NJ

Angela Colarusso

Made
With

PROCESS & PURPOSE

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW A FRAGILE BIOLOGIC TESTED A GLOBAL TEAM’S STRENGTH.

In the field of biologic drug development, there is a mantra: "the process is the product." These complex, fragile, and precious proteins require an extreme focus to keep process development well controlled and on track. So when a clinical trial was moved forward – far forward – the last thing Angela wanted to do was disrupt the process. She knew, however, that the new timeline pushed the current biologics production facility past capacity. Something had to change. So Angela pulled together a team of experts, including scientists and biochemists from across Thermo Fisher Scientific’s global biologics network to find a solution. Together they developed a plan to leverage additional Thermo Fisher facilities to help meet demand, all while maintaining the integrity of the biologics process and, of course, meeting the client’s clinical trial deadline.

Eric Jayjock, Ph.D.
Director of Continuous Manufacturing
Pharma Services,

Greenville, NC

Eric Jayjock

Solved
With

Vision & Precision

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW CONTINUOUS EFFORT BROUGHT CONTINUOUS MANUFACTURING TO THE NEXT LEVEL.

Eric had a vision that could change the face of drug manufacturing – if he could make it a reality. As a post doctorate, he had already perfected the process of continuous manufacturing for one drug. When he joined Thermo Fisher Scientific, he took on a much bigger challenge: creating a continuous manufacturing platform that could operate using interchangeable components, creating a solution that delivered the efficiency of a continuous process, with the flexibility to adapt to multiple types of drugs for multiple clients. So, he and his team relentlessly designed, tested and built individual components of the interchangeable platform to bring to create a first-of-its-kind modular solution that worked flawlessly. Now any Thermo Fisher client can take advantage of this custom technology.

Isabelle Lafosse
Director, Global Technology Transfer
Pharma Services,

Cincinnati, OH

Isabelle Lafosse

Delivered
With

Power & Partnership

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW A GLOBAL NETWORK PROVIDES A GENUINE ADVANTAGE.

When a client gets an opportunity to expand rapidly, it takes a global partner to pull it off without a hitch. That’s what happened when Isabelle’s client received approval for a second indication for a drug that Thermo Fisher Scientific’s Patheon business was making. She knew manufacturing volume would go up. Fast. Her fear was that the two sites currently making the product couldn’t handle the increased volume. So, she tapped into the power of her global team, and in partnership with the client, conducted multiple trials simultaneously across Thermo Fisher’s global manufacturing network. As a result, they found a third site that met the client’s regulatory filling specifications, and most importantly, met the growing patient demand.

Emily Anderson
Ph.D., Analytical R&D,
Pharma Services,

Florence, SC

Jessica Floyd
QC Lab Supervisor
Pharma Services,

Florence, SC

Emily Anderson & Jessica Floyd

Solved
With

Chemistry & Collaboration

  • API
  • BIOLOGICS
  • EARLY DEVELOPMENT
  • CLINICAL TRIAL SOLUTIONS
  • COMMERCIAL MANUFACTURING

HOW, IN A CULTURE OF KNOWLEDGE SHARING, A MENTOR PAVED THE WAY TO SUCCESS FOR THEIR MENTEE.

At Thermo Fisher Scientific, we believe that knowledge belongs to everyone. So, years ago, when Emily worked with her intern, Jessica, in the analytical department, she taught her all she could, as freely as possible. Today, Jessica leads her own team in quality control. Because of her past experience, she is uniquely qualified to identify issues that might have otherwise been missed and everyone benefits. This unique culture of knowledge sharing is a big part of how we get medicine into the hands of patients faster.