oncology expertise at all levels - syneos health · 2020-02-21 · marketing capabilities. syneos...

8
Oncology Expertise at All Levels © 2020 Syneos Health ® . All rights reserved. Whether motivated by the personal journey of a cancer patient or the challenge and rigor of cancer clinical research, at Syneos Health we are passionate about collaborating for a cure. At Syneos Health, we believe that every clinical trial is an opportunity to shorten the distance from lab to life. We are living in a “golden age” for cancer research and discovery. Our knowledge and ability to have direct impact on tumor cells are increasing at a rapid pace, and patients are living longer thanks to advances in genetics, immunotherapy and precision medicine. Our experts dedicated to oncology and hematology—all 4,400 of us— are collaborating with our customers to change the history of cancer treatments by embracing our customers’ boldest visions and bringing experience, innovation and passion to every oncology program we run.

Upload: others

Post on 07-Jul-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

Oncology Expertise at All Levels

© 2020 Syneos Health®. All rights reserved.

Whether motivated by the personal journey of a cancer patient or the challenge and rigor of cancer clinical research, at Syneos Health we are passionate about collaborating for a cure.

At Syneos Health, we believe that every clinical trial is an opportunity to shorten the distance from lab to life.

We are living in a “golden age” for cancer research and discovery. Our knowledge and ability to have direct impact on tumor cells are increasing at a rapid pace, and patients are living longer thanks to advances in genetics, immunotherapy and precision medicine.

Our experts dedicated to oncology and hematology—all 4,400 of us— are collaborating with our customers to change the history of cancer treatments by embracing our customers’ boldest visions and bringing experience, innovation and passion to every oncology program we run.

Page 2: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

2 | © 2020 Syneos Health®. All rights reserved.

The Challenges of Modern Oncology Clinical Development

Specificity

Every cancer is unique, and within each tumor type we now know there

can be many molecularly defined subsets of disease, which can now be

targeted specifically. Successful oncology trials require specific expertise in the

therapeutic modality and target tumor type under investigation.

Innovation

What we know about oncology changes every day. Emerging science is shifting the research paradigm, so sponsors need a CRO partner that is

prepared to manage novel study designs and execute with excellence

to develop the next generation of oncology treatments.

Recruitment

Investigators, sites and sponsors need a CRO partner that is knowledgeable about the specific recruitment needs of a trial, aligning them to the patient

treatment journey and developing collaborative strategies with

stakeholders to ensure that the right trials get to the right patients.

Consistency

Management and on-time, on-target delivery of complex oncology trials involving thousands of patients and sites worldwide require established

metrics-driven processes and proven therapeutic depth.

Page 3: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

© 2020 Syneos Health®. All rights reserved. | 3

All We Do Is Oncology. It’s Our Passion.

Each and every one of us is devoted exclusively to the work of accelerating innovative oncology treatments that could one day help patients in their fight against cancer. We are a team with an exceptional breadth and depth of clinical development experience and scientific expertise that we bring to our work advancing research in oncology and hematology.

We have diverse and measurable experience across the full range of cancer therapies, from Immuno-oncology and Targeted Therapies to Novel and Emerging Therapies, including cell and gene therapies. We also have dedicated Early Phase Oncology experts who provide necessary expertise in first-in-human, dose escalation and expansion trials, from drug development and licensing and acquisition strategy to product registration and commercialization.

Our therapeutic expertise in oncology and hematology runs deep but it also runs wide. Our unique lab-to-life service offering extends from preclinical and translational science to clinical development and regulatory, through to full commercialization and marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New Oncology Drugs approved by the Food

and Drug Administration (FDA), and 94 percent (59 of 63) of oncology products granted marketing authorization by the European Medicine Agency (EMA) in a recent five-year period. Our success is directly attributable to our therapeutic alignment and the depth and breadth of our oncology expertise across product development disciplines.

We also offer an integrated suite of translational science capabilities for efficient preclinical and early clinical assessment and prioritization of oncology drug candidates, as well as the clinical experience to help you build optimal designs for conclusive clinical proof-of-concept and efficacy studies. When it comes to oncology clinical development, we understand the importance of speed, quality and creative statistical approaches. Our Oncology Team has the right experience to support you in expediting your clinical development program to result in faster agency approval.

Outcome Our oncology teams hit the ground running; our recent experience from more than 519 oncology and hematology studies can support efficient conduct of trials that safeguard patients and generate meaningful data based on the latest scientific thinking.

We have diverse and measurable experience across the full range of cancer therapies, from Immuno-oncology, Targeted Therapies and Novel and Emerging Therapies including cell and gene therapies.

1

Page 4: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

4 | © 2020 Syneos Health®. All rights reserved.

Our Site Relationships Help You Find the Right Patients.

We recognize that site relationships are critical to successful patient recruitment. Our site relationships are second to none.

Our therapeutic alignment means that we are able to engage with focus, passion and peer-to-peer scientific expertise to develop deep relationships with key opinion leaders, investigators and sites. We are the only CRO to field dedicated medical site liaisons (MSLs) for this purpose.

This enables us to engage with the right sites targeting the right patients from day one, helping customers meet their recruitment targets faster, no matter how complex the trial.

Our site relationships helped earn Syneos Health the title of “Top CRO to Work With” among top 10 global CROs in the 2017

CenterWatch Global Investigative Site Relationship Survey, and in 2019, for the third consecutive year, we were honored to receive the Society for Clinical Research Sites (SCRS) prestigious Eagle Award for exceptional site relationships—an award voted on by sites themselves and a testament to the professionalism and integrity with which we approach our site relationships.

Outcome From day one we’re positively engaged with the right sites targeting the right patients, helping you meet your recruitment targets no matter how complex your trial. Our strong site relationships generate time, cost and operations benefits for both customers and sites.

Our therapeutic alignment means that we are able to engage with focus, passion and peer-to-peer scientific expertise to develop deep relationships with key opinion leaders, investigators and sites.

2

Page 5: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

© 2020 Syneos Health®. All rights reserved. | 5

We Are Ahead of the Game.

We are conducting trials at the forefront of newer immunotherapy discoveries, embracing the changing face of immunotherapy and precision medicine, including studies of novel immunomodulators and combination treatments.

We constantly look toward the future as we implement novel approaches to oncology drug development and innovative trial designs, including cellular and gene therapy clinical trials and investigator-led and cooperative group trials.

For example, we are proud to be providing full-service clinical development support to the Leukemia and Lymphoma Society’s “BeatAML” Master Trial, a ground-breaking targeted therapy umbrella trial designed to expedite development innovative therapies for acute myeloid leukemia patients.

Our clinical, medical and biometrics innovation leaders enable us to offer customized approaches to oncology study designs using design technologies, helping to set our customers on the most streamlined path to the required study endpoint and regulatory approval—often in accelerated fashion.

Our specialists in hematology and oncology have worked on some of the

most promising novel and emerging therapies in development, in indications ranging from non-Hodgkin’s lymphoma and chronic lymphocytic leukemia to acute myeloid leukemia and multiple myeloma, transitioning them from early phase to marketing authorization.

Our clinical professionals are currently supporting new approaches to precision medicine in solid tumors, working with cutting-edge therapies including combination immunotherapies and complex study designs (e.g., basket studies, platform trials, umbrella trials, etc.) across all phases of clinical development.

In fact, we were early pioneers in immunotherapy clinical trials. We conducted the studies that led to the approval of the very first checkpoint inhibitor, seeing it all the way through from Phase I through to marketing authorization and commercialization.

Outcome True therapeutic alignment enables us to leverage experience, insights and capabilities across our global team and offer thoughtful, integrated solutions to the challenges inherent to oncology drug development and commercialization.

We constantly look toward the future as we implement novel approaches to oncology drug development and innovative trial designs.

3

Page 6: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

6 | © 2020 Syneos Health®. All rights reserved.

We Lay Strong Foundations That Give You Confidence in Your Data.

At Syneos Health, we know that the one certainty during the course of an oncology clinical trial is change—be it in terms of evolving standards of care, regulations or research strategy. These kinds of changes can quickly derail a pivotal study. That’s why we developed The Trusted Process®, a strong operational foundation that sets the tone for discipline, accountability and metrics tracking. That means that no matter how far-reaching your trial or

complex your protocol, we are providing consistent delivery and generating actionable data.

OutcomeOur teams are experts in proactive quality and risk management—ensuring that they consistently deliver studies with excellence, committing to getting it right the first time, every single time.

We know that the one certainty during the course of an oncology clinical trial is change.

4

Page 7: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

© 2020 Syneos Health®. All rights reserved. | 7© 2020 Syneos Health®. All rights reserved. | 7

Whether motivated by the personal journey of a cancer patient or the challenge and rigor of cancer clinical research, at Syneos Health we are passionate about collaborating for a cure.

Novel and Emerging Therapies

Immuno-OncologyTargeted Therapies

Patients Are Our Passion and the Reason We Do What We Do.

We are deeply grateful to the cancer patients who, by participating in clinical trials, make it possible for all of us, working together, to collaborate for a cure.

At Syneos Health we collect and analyze insights from patients, their families and advocacy communities to inform everything from protocol design, study

endpoint identification and patient recruitment to market access and commercialization strategies. We recognize how important it is to help patients feel more comfortable with the clinical trial process, manage their expectations and communicate results —in other words, to engage them more fully as partners in our work.

We are deeply grateful to the cancer patients who, by participating in clinical trials, make it possible for all of us, working together, to collaborate for a cure.

5

Page 8: Oncology Expertise at All Levels - Syneos Health · 2020-02-21 · marketing capabilities. Syneos Health has helped to develop or commercialize 95 percent (62 of 65) of Novel New

About Syneos HealthSyneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.

© 2020 Syneos Health®. All rights reserved.

Contact us: +1 919 876 9300syneoshealth.com