Placebo and Nocebo Response Mitigation

Empirical Strategies to Mitigate Placebo and Nocebo Effects

CenExel sites are committed to enhancing understanding of the causes and implications of the placebo and nocebo effects within central nervous system and internal medicine clinical trials and developing solutions to mitigate them. Under the leadership of Elan Cohen, Ph.D., Principal Investigator at Hassman Research Institute (HRI) and a thought leader in clinical rater assessment services, CenExel researchers meet regularly to discuss and develop systemic strategies to help overcome the primary causes of the placebo and nocebo responses or Placebo Response Factors (PRFs), namely subjects’ naivety of the placebo, expectation bias, misconception of expected interactions with research site staff, and uncertainty of their role in the trial.

A significant development toward this purpose is the copyrighted Placebo-Control Reminder Script (PCRS; Drs Howard Hassman and Elan Cohen). The PCRS is a methodical instrument which carefully reviews the PRFs with trial participants while also reminding the primary efficacy endpoint site raters of such factors. The PCRS is diligently read to each study subject starting at the SCR Visit and at all study visits thereafter before any efficacy scales are administered.

The PCRS has been thoroughly empirically explored in regard to its ability to effectively manage placebo and nocebo responses among trial participants with major depressive disorder (MDD) and schizophrenia/schizoaffective disorder as well as among migraine sufferers. Research posters presented at professional clinical trial industry conferences illustrate the studies we have conducted for this robust endeavor, and an article on the PCRS was published in the prestigious scientific journal, Neuropsychopharmacology. Our current findings indicate that the PCRS significantly helps manage the placebo effect among subjects with MDD and schizophrenia/schizoaffective disorder (p<.01 and p=0.002, respectively) while also helping to significantly mitigate the nocebo effect. More recently, in an effort to further explore the PCRS’ content and face validity, raters have been surveyed about their administration of the tool and have reported significantly positive feedback in this area (see related conference posters).

The current PCRS results have prompted the FDA to review this tool and its associated research, commenting: “It’s amazing how a simple intervention like the PCRS can be so effective in reducing placebo response!” (J. Toure, FDA Sr. Policy Advisor of Division of Psychiatry Products, email communication dated March 27, 2019) and “We [FDA] found the approach interesting and that a simple intervention like education can be quite impactful.” (J. Toure, FDA Sr. Policy Advisor of Division of Psychiatry Products, email communication dated April 12, 2019).

Following the publishing of our empirical findings and the FDA’s appraisal of the PCRS, sponsors and CROs have expressed great interest in applying the script to their respective clinical trials, and as such, the PCRS is licensable for such purposes. The PCRS has been licensed by sponsors conducting clinical trials in both various psychiatric and general medicine indications, including pain and migraines. The license includes actual PCRS source specifically tailored for the respective clinical trial design and methodology to be read by the site staff member (typically the psychometric rater administering the primary efficacy scale in the study) as well as a PowerPoint slide deck training the site staff member on using the PCRS. The PCRS has also been incorporated into a computerized tablet system where the script interaction between the rater reading the script to the subject and the participant summarizing the primary concepts of the PCRS (to exhibit a meta-understanding of the script, a key efficacy aspect to this instrument) is recorded for quality checks and sponsor review at any time.

For more information on the research we have engaged in pertaining to this crucial area within our industry and licensing the PCRS, please email Dr. Elan Cohen at e.cohen@cenexel.com.

In conjunction with our PCRS and our concerted determination to stay current on recent literature regarding theories of what promulgates placebo and nocebo responses, the proprietary Placebo-Control Daily Reminder Campaign (PCDC) has been implemented for subjects participating in our Single- or Double-Blind Placebo-Control clinical trials. The PCDC involves providing such subjects with a small, convenient magnet participants take home after their Baseline Visit to place on their refrigerator (or any other convenient place where they will see the magnet daily and be reminded of its message). The campaign also involves reminding subjects of the intended message (see below) during their actual visits at our site, and as such, a banner was also created and hung in all our common areas (inpatient and outpatient facilities).

Speak Your TruthThe magnet and banner indicate: “Speak Your Truth. No Expectations.*” with the smaller font at the bottom: “*Ask your Coordinator or Rater.” Why these words? Research continues to strongly show that unchecked and any level of expectations from subjects about their own improvement in a study and what they perceive from study staff as wanting them to improve or not improve during their participation has the strong potential of generating a placebo effect. An expectation is also derived from subjects forgetting they may be on a placebo and thinking that they are receiving true medicine to help them with their respective indication. While there is arguably minimal empirical evidence that shows implementing actual interventions to control and educate subjects about such expectations subsequently reduces a placebo effect (apart from our multi-site study investigating the efficacy of the PCRS to reduce the placebo effect; see posters which present our findings), it makes rational sense to incorporate such continued education in our trial work.

Although the PCRS is read to all subjects at all our Placebo-Control study visits, this script is only provided once a week / per study visit. In contrast, the PCDC is a continual reminder to our Placebo-Control investigation subjects that we have no expectations, that they should have no expectations, and that they should simply come to the site per their study visits reporting “the truth” of their symptoms. If a subject asks any of our staff what the message means, they ardently refer to the verbiage from our PCRS, i.e., to tell the subject none of us at the site have expectations of how you should or should not be feeling because none of us here at the site know if you are randomly assigned to receive the active medication or the placebo (remind subject what a placebo is) and that their role in the study is to simply come to each visit and be truthful in describing how they are doing in regard to their symptoms.

The above are just a few examples of how the CenExel team of researchers are dedicated to exploring and implementing strategies aimed to manage the placebo and nocebo effects within its awarded trials, and moreover, sharing our gained knowledge with other interested entities to reduce these effects overall within our industry. We genuinely welcome ideas and partners to this venture. Please send inquiries to Dr. Elan Cohen at e.cohen@cenexel.com.

CenExel FCR Wins Tampa Bay Times Best of the Best in Clinical Research Award

Tampa, Florida, July 26, 2023 /GlobeNewswire/ — CenExel FCR has been named the 2023 Tampa Bay Times People’s Choice, Best of the Best in Clinical Research. This remarkable achievement showcases CenExel FCR’s unwavering dedication to advancing medical knowledge and improving patient care, driving innovative treatments and pioneering groundbreaking discoveries.

FCR Best of the Best Award

CenExel FCR has established itself as a trusted name in the industry, and this award serves as a testament to the impact they have made in the lives of countless individuals. Their dedication to excellence and their passion for improving human health have earned them the trust and support of the Tampa Bay community and beyond.

The team at CenExel FCR is immensely grateful for the overwhelming support and votes they received from the public. They are honored to have been recognized for their contributions to clinical research and patient care. This award is a reflection of their steadfast pledge to continue pushing boundaries, embracing challenges, and driving meaningful breakthroughs in the field.

As they celebrate this remarkable achievement, CenExel FCR CEO Seth Forman, MD, stated, “This award is evidence of our commitment, expertise, and the trust we have earned from both the medical community and the general public. We remain focused on our mission of advancing medical science and improving patient outcomes.”

 

Media Contact: media@CenExel.com

About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of Phase 1 – 4 clinical trials. Our network now includes 18 of the most proficient clinical research sites in the country, with special emphases on Neurology, Pain, Psychiatry, Vaccines/Immunology, Dermatology, Ethnic Bridging, Sleep studies, and Clinical Pharmacology. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for our Principal Investigators and research professionals in our dedicated, state-of-the-art facilities. We deliver the engagement, expertise, and results to ensure that our clients achieve their clinical research goals, reducing costs and development times for innovative therapies to advance patient care.

 

Stuart Goldblatt Joins CenExel as CEO

Salt Lake City, July 17, 2023 /GlobeNewswire/ — The CenExel Board of Directors is delighted to announce that Stuart Goldblatt has joined CenExel as our new CEO effective July 17, 2023. Tom Wardle will transition to the role of Executive Chairman, CenExel Board of Directors. Said Tom Wardle, “We are very excited to have a seasoned executive such as Stuart join our team to help us continue on our path as the premier therapeutically-focused and fully integrated clinical research site network in the United States.”

Stuart Goldblatt

Goldblatt brings to the position a wealth of knowledge and an array of experiences within pharmaceutical research, and he is an accomplished and proven senior executive in life sciences with more than 30 years of experience specifically within pharmaceutical research. Goldblatt will have leadership responsibilities for all aspects of CenExel including the development of strategies, goals, policies, and achievement of financial goals and growth.

Prior to joining CenExel, Goldblatt was President and CEO of Cliantha Research North America. Cliantha Research is a mid-sized, full-service contract research organization (CRO) that provides comprehensive and integrated research offerings in both early and late phase studies. Prior to Cliantha, Goldblatt served as Chief of Staff, Organizational Effectiveness, reporting to the CEO of LabCorp Drug Development (Covance), where he led sales management and operational delivery improvements to exceed customer and corporate expectations via comprehensive and cross-functional strategies.

Before LabCorp/Covance, Goldblatt spent two decades at Quintiles (IQVIA) as Vice President in a variety of senior leadership roles, including Chief of Staff, Global Operations and Implementation Management, Global Integration, Head of Global Resourcing Center of Excellence, Global Strategy and Initiative Management, Head of Global Proposal Management, Head of Global Records and Information Management, and Customer Account Management. Prior to Quintiles, he helped develop and grow a large national Site Management Organization (SMO) serving clinical research.

“I am absolutely thrilled to join CenExel and collaborate with such an established national team of industry thought leaders and high-quality research facilities,” said Stuart Goldblatt. “CenExel’s existing Centers of Excellence will continue to partner and forge even deeper relationships with biopharmaceutical, biotech, and CROs, thereby reducing drug development timelines and costs. I remain keen to continue the deliberate growth trajectory CenExel has been maintaining.”

 

Media Contact: media@CenExel.com

About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of Phase 1 – 4 clinical trials. Our network now includes 18 of the most proficient clinical research sites in the country, with special emphases on Neurology, Pain, Psychiatry, Vaccines/Immunology, Dermatology, Ethnic Bridging, Sleep studies, and Clinical Pharmacology. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for our Principal Investigators and research professionals in our dedicated, state-of-the-art facilities. We deliver the engagement, expertise, and results to ensure that our clients achieve their clinical research goals, reducing costs and development times for innovative therapies to advance patient care.

 

Michele Baptista Joins CenExel

Salt Lake City, May 18, 2023 /GlobeNewswire/ — CenExel announces the addition of Michele Baptista as the new Senior Director of Business Development. In this new capacity, Michele will be responsible for developing, selling, and supporting CenExel’s 18-site network for early phase clinical trials, while also identifying new business opportunities and expanding CenExel’s customer base.

Michele Baptista

Michele joins CenExel from WCG IRB, where she was a Business Development Director developing and selling ethical review services for all Phase 1, biotech, medical device, diagnostics, biologics, and social and behavioral research.

Prior to her position with WCG, Michele was co-founder and president of Aspire IRB, building strong relationships with clients by understanding their institutional review board needs and delivering solutions that exceeded expectations. Michele has also held other business development and administration positions in the clinical trial space working for Biomed IRB. Throughout her career, she has always distinguished herself with a reputation for professionalism and integrity. Michele attended Mesa Community College and National University for Business Administration with a focus on sales and marketing.

“We are thrilled to have Michele join our team as our new Senior Director of Business Development,” said CenExel Chief Commercial Officer, Casey Orvin. “Michele has been an active part of the industry for over 30 years, and we look forward to her joining our CenExel commercial team. With Michele’s extensive background and experience, we know she will play a crucial role in driving growth and exceeding partner Sponsor and CRO expectations, particularly in the early phase space.”

Michele added, “I am excited to join CenExel’s dynamic, therapeutically-aligned network to work alongside such a talented team. CenExel has a strong reputation in the industry for its high-quality clinical trial management services, and I look forward to helping the company expand its capabilities and develop concierge relationships with our Sponsor and CRO partners to streamline studies.”

While Michele will be reaching out to Sponsors and CROs soon, she can be contacted before then at m.baptista@cenexel.com.

CenExel was formed in 2018. The network now includes 18 of the most proficient clinical research sites in the country, with special emphases on Neurology, Pain, Psychiatry, Vaccines/Immunology, Dermatology, Ethnic Bridging, Sleep studies, and Clinical Pharmacology. The CenExel research units have outstanding records of assisting pharmaceutical Sponsors with protocol development, study design, and conducting Phase I-IV trials to develop new therapeutics for improved patient care. The mission of CenExel is to work with trial Sponsors and CROs to reduce costs and development times for innovative therapies while advancing patient care.

Media Contact: media@CenexelResearch.com

 

About CenExel Clinical Research
CenExel provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.

 

Administrating and Training on the Placebo-Control Reminder Script: A Deeper Dive Into the Tool’s Psychometric Properties

CenExel is proud to highlight the poster we’re presenting at the Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP), May 2023, Miami, FL.

ABSTRACT

Introduction: Placebo and nocebo responses continue to hinder potential treatment effects (Haflioadottiret al., 2021). The Placebo-Control Reminder Script (PCRS; Cohen et al., 2020) is the only empirically-validated tool found to significantly mitigate these phenomenon by reviewing factors causing placebo responses (Evans et al., 2021). The PCRS is read by the site rater to each participant throughout the study and assesses participants’ comprehension. The PCRS has been sponsor licensed in over 25 clinical trials. Assessing this tool’s face and content validity is essential for further substantiating its instrument properties (American Educational Research Association, 2014). PCRS raters were surveyed about their training and the effectiveness of the PCRS’s content, structure, phrasing, length, and administration process to mitigate placebo and nocebo responses. This gold standard method for obtaining these validities (Beck & Robert, 2001; Parrott, 1991) also addresses sponsors’ questions regarding the tool’s operational integration into trials. Methods: The PCRS User Survey assessed face and content validity, with four placebo/nocebo content experts confirming this goal. The survey contained four demographic questions, ten 5-point Likert items regarding raters’ views about training and face/content validity principles, and three open ended questions. Sponsors who licensed the PCRS since 2017 agreed to (a) send us the email addresses of the PCRS raters to be emailed a link to the SurveyMonkey questionnaire, or (b) send the survey link by the sponsor. Raters were informed of why they were receiving the survey, how their email addresses were obtained, the voluntariness and anonymity of survey completion, and the 5-minute duration of completion Results: The survey was completed by 169 raters (39% male and 61% female), with a majority (68%) working in the industry for at least 6 years and thus having ample experience to comment on the PCRS. A majority (56%) administered the tool for at least 2 years, and most used the PCRS in depression (78%) and schizophrenia (45%) trials. Rater response rate could not be specifically calculated because three sponsors sent the survey directly to raters without providing us their email addresses, but we estimate the total survey response to be 70%. Using a chi-square test, significantly more raters reported the PCRS has appropriate wording, phrasing, content, and length aimed to reduce the placebo effect, successfully assesses participants’ PCRS understanding, is a better strategy than others used in the industry to reduce the placebo and nocebo effect, and would not revise anything in the PCRS (all factors yielded p<.001). A Pearson coefficient indicated a significant positive relationship between years administering the PCRS and its ease of use (r=.27; p=.001), phrasing/wording (r=.17; p=.03), and length (r=.20; p=.008) which all complemented the tool’s intent. Significantly more raters confirmed the PCRS training was sufficient to administer the tool and that the PCRS integrated well into study procedures (all were p<.001). Discussion: A survey of experienced trial raters provided significant evidence for the PCRS’s face and content validity, noting that the instrument’s language is suitable to address its aim and the content effectively represents what it purports to mitigate. Raters who administered the PCRS longer had greater understanding of the tool’s principles than those with less years using it. Sponsors can be assured the scale does not hinder study processes.

BACKGROUND

  • The placebo response across various psychological and physiological clinical trial indications continue to permeate within our industry, leading to significant decreases in potential signal detection and thus increasing trial costs (Haflioadottir et al., 2021; Mallinckrodt et al., 2011).
    • A meta-analysis of 96 Major Depressive Disorder studies conducted between 1980 – 2005 representing 9,566 depressed participants found a significant positive correlation between placebo response and publication year (p<.001) (Rief et al., 2009). Jones et al. (2021) also found this significant correlation in 50 treatment-resistant depression trials (of 3228 participants).
    • Schizophrenia trials also experienced significant placebo response increases (Gopalakrishnan et al., 2020; Rutherford et al., 2014).
    • Among 23 antihypertensive clinical trial programs, placebo response increased significantly over time (1990-2016) without a clear explanation as to why after analyzing several physiological and non-physiological potential confounding variables (Khan et al., 2018a). Khan et al. (2018b) found similar results in 19 oral antihyperglycemic agents (23,438 participants and 50 trials).
  • Therefore, strategies to reduce placebo and nocebo effects cannot be overemphasized.
  • The Placebo-Control Reminder Script (PCRS) has been scientifically verified as a tool which significantly reduces these phenomenon in depression and psychosis indication studies (Cohen et al., 2020).
    • The PCRS is a paragraph respective of the study visit which is read by a site staff member (typically the rater) immediately before administering the primary efficacy scale and which thoroughly reviews factors established in the industry as causing placebo and nocebo responses, including expectation bias (Evans et al., 2021; Haflioadottir et al., 2021).
    • At the end of its reading, the rater assesses the participant’s comprehension of the PCRS content.
    • The PCRS has been licensed since its inception in 2017 in over 25 clinical trials across psychiatric and physiological indications (see Table 1).
  • The primary objective of the current study was to advance data on the PCRS’s psychometric property via surveying PCRS raters’ perceptions on training and administration to explore its face and content validity. Evaluating raters’ views to evaluate such validity data is a gold standard method for any ongoing full-scope instrument validation (American Educational Research Association, 2014; Parrott, 1991; Tsang et al., 2017)
  • Sponsors licensing the PCRS frequently ask about the scale’s implementation considering other study procedures. Therefore, the secondary goal of the current study was to query site raters about the operational aspects using PCRS in trials.

Placebo-Response-Mitigation-Article

METHODS

  • The PCRS User Survey was developed specifically for the purposes of this study with four demographic questions (e.g., gender and years working in clinical trials), ten 5-point Likert items assessing users’ views on various training and administration standards (e.g., “Agree/Disagree” regarding whether PCRS phrasing was clear and easy to understood given its intention), and three open-ended questions
  • Four placebo/nocebo response experts reviewed the PCRS User Survey to ensure questions were straightforward, unbiasedly phrased, and able to complete the objective of this investigation to assess content and face validity of the tool, as well as address sponsor questions regarding the scale’s implementation respective of other study procedures
  • To send the survey, all sponsors who have licensed the PCRS were contacted to obtain addresses of the respective study’s PCRS certified (trained) administrators/raters
  • Sponsors agreed to either send us the email addresses of the PCRS rater directly to complete the questionnaire via an outside survey company (SurveyMonkey), or directly send the survey link to the raters. Given that three sponsors chose the latter and did not share the raters’ email address with these authors, the survey response rate could not specifically be calculated but we estimate it at 70% given the number of survey responders and number of PCRS study licenses.
  • Regardless of distribution method, all PCRS raters were informed of why they were receiving the survey, how their email addresses were obtained, the voluntariness and anonymity of survey completion, to complete the survey only once (thus, duplicate surveys are unlikely), and the 5 minutes expected duration of completion
  • Three separate reminders requesting completion were sent to all PCRS raters, including when sponsors directly sent the survey and content validity.

RESULTS

Table1-Demographic-Variables

PCRS-Results

PCRS-Results-2

CORRELATIONAL RESULTS

A Pearson correlation coefficient indicated a significant positive relationship between years administering the PCRS and its ease of use (r=.27; p=.001), phrasing/wording (r=.17; p=.03), and length (r=.2; p=.008) which all complemented the tool’s intent.

CONCLUSION

  • Confidence in using the PCRS has been further established in this investigation, as a significant majority of this tool’s raters reported:
    • The PCRS was easy to administer, is user-friendly, accurately used verbiage (i.e., had appropriate content) to help reduce the placebo response in the respective clinical trial, and was appropriate in length given its crucial intent.
      • The more the rater has used the PCRS, the more likely they were to report the above. It thus seems raters who have more PCRS administration sees its value in reducing the placebo and nocebo responses.
    • The questions posed to the participants at the end of reading each script per study visit does help determine if the participant truly understands the PCRS’s content and purpose (i.e., what a placebo is, to have no expectations of improvement, to be honest when reporting symptoms, and that the site will be treating them neutrally rather than therapeutically).
    • No changes are needed in the PCRS (although of course we will continue to evaluate its validity and operational impact to ensure proper streamlined implementation in clinical trials).
    • The tool is better than other strategies which have been implemented in the industry to control the placebo response.
    • The PCRS does not interfere in the conduct of the trial.

Elan A. Cohen,1 Howard A. Hassman,1 David P. Walling,2 Vera M. Grindell,2 Katarzyna Wyka,3 Brett A. English,1,2 Cassie L. Blanchard,1 Jaclyn M. Lobb,1 Djouher Hough,1 Stephanie M. Iglesias,1 and Larry Ereshefsky1,2,4

1CenExel Hassman Research Institute 2CenExel Collaborative Neuroscience Network 3The City University of New York, Graduate School of Public Health and Health Policy 4Retired Professor, The University of Texas

References provided on reverse side of poster handout at conference or upon request to e.cohen@cenexel.com.

View full poster PDF

CenExel CNS Opens Center in Los Alamitos, California

Los Alamitos, November 29, 2022 /GlobeNewswire/ — CenExel CNS announces the grand opening of the newest clinical research facility in Los Alamitos, California. CenExel CNS has been operating clinical research centers in the area since 2000, and this site will be the largest, with 20,000+ square feet, more than 80 beds, and state-of-the-art equipment throughout. The event will be celebrated during an open house from 4:00 pm to 7:00 pm (Pacific Time) on November 30, 2022.

The focus of this Center will be a variety of therapeutic areas in clinical research, including Psychiatry, Neurology, Ethnic Bridging (primarily for local Japanese and Chinese populations), Sleep Disorders, Vaccines, Substance Abuse, Analgesia, and Dermatology. The scientific contributions of the researchers’ daily efforts are incalculable, ensuring the safety of investigational medicines and helping new therapies advance patient care. Beyond this essential work, the community enjoys the positive impact from the possibility of access to innovative medicines, the collaborative participation in moving research forward, and the financial benefits of compensation for time and travel.

The CenExel CNS Los Alamitos site will be led by Chief Clinical Officer David Walling, PhD, and Chief Operating Officer Dalia Botros, MD. Los Alamitos Mayor Pro Tem Tanya Doby will also attend the grand opening event, supporting local businesses and community services.

“We’re thrilled to be expanding CenExel CNS,” said Dr. Walling. “Our Centers in Garden Grove and Torrance will maintain their growth and community outreach as we offer clinical research participants another location to meet their needs.”

CenExel was formed in 2018, and since its formation has strategically invested to support organic growth in its Centers of Excellence while also pursuing acquisitions of state-of-the-art research centers across the U.S. The mission of CenExel is to work with trial Sponsors and CROs to drive efficiencies in clinical research while reducing the costs and development timelines for innovative therapies to advance patient care.

Media Contact: media@CenExel.com

About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.

CenExel Creates Clinical Sciences Business Unit

Salt Lake City, November 15, 2022 /GlobeNewswire/ — CenExel announces a new Clinical Sciences business unit, composed of early phase and translational medicine scientists, plus the broader network of CenExel therapeutic experts and key opinion leaders (KOLs), providing support to all the CenExel Centers of Excellence as well as standalone consulting services. Clinical Sciences by CenExel (Clinical Sciences) offers a unique opportunity for collaboration with pharmaceutical sponsors, CROs, and vendors, to support study development and conduct within the Sponsor’s clinical development program across the development lifecycle. These activities include Clinical Sciences support from pre-Investigational-New-Drug (pre-IND), Phase I, and translational medicine studies through to Phase III pivotal studies, peri-approval, and Phase IV studies. Clinical Sciences can provide scientific consulting for clinical development planning, study design, recruitment solutions, dose selection criteria to support more confident go/no-go decisions through the application of fit-for-purpose biomarkers, measures, and endpoints. CenExel’s leadership in the design and conduct of ethnic sensitivity and bridging studies enables global product development. All told, these elements combine in Clinical Sciences to create a unique, first-of-its-kind, holistic approach in the clinical research industry.

The Clinical Sciences team is led by Doctors Larry Ereshefsky, Robert Litman, and Brett English. Larry Ereshefsky, PharmD, BCPP, will serve as Chief Scientific Officer – Early Phase, while Robert Litman, MD, will serve as Chief Scientific Officer – Psychiatry. Brett English, PharmD, PhD, will serve as Vice President in the division.

Clinical Sciences by CenExel offers unprecedented expertise and experience in study design strategies including complex biomarker studies that can inform key go/no-go decisions. CenExel has already leveraged the National Institute of Mental Health’s (NIMH’s) Research Domain Criteria (RDoC) approach with many novel molecules, working directly with Sponsors and various academic KOLs in adapting novel paradigms utilizing both electrophysiology and neuroimaging. Doctors Ereshefsky and English are innovators in the application of translational drug development tools, adept at integrating state-of-the-art technologies within a single study for corroborative and correlative analyses.

For later Phase II and III studies, Clinical Sciences by CenExel provides real-world experience and consultation for sponsors to design protocols with feasibility characteristics that maximize recruitment and retention of high-quality research subjects while meeting sponsor’s scientific objectives. This is accomplished by leveraging the experience and know-how of CenExel’s formidable group of PIs, clinical managers, and therapeutic area thought leaders overseen by Dr. Robert E. Litman, an NIH-trained, experienced clinical trialist and researcher. Dr. Litman joins Doctors Ereshefsky and English in supporting the scale up and integration of lessons learned from early-phase studies, extending biomarker/translational endpoints into the design and execution of later phase clinical trials which can be conducted at CenExel’s centers of excellence.

In addition to in-house scientists, Clinical Sciences also includes a CenExel Scientific Advisory Board, whose primary function is to provide independent clinical and scientific guidance in areas requiring specific therapeutic expertise such as neuroimaging, cognitive and behavioral measures, psychedelics, and new technologies.

“We enjoy a long history of collaboration with vendors and external key opinion leaders who support our turnkey strategies for neuroimaging data acquisition and analysis, as well as EEG-/ERP-related endpoint selection, collection, and analysis,” said Dr. Larry Ereshefsky, “We also continuously refine processes to ensure safe and efficient first-in-human trials.”

“We look forward to continuing to work directly with clinical teams at the CenExel Centers of Excellence, providing guidance and training,” said Dr. Brett English, “We’re committed to harmonizing the scientific, technological, and clinical processes across the whole site network.”

“Our extensive experience spans a wide variety of study objectives and designs,” said Dr. Robert Litman, “We know the intricacies of working on every phase of a trial, including ensuring quality ratings data, facilitating recruitment, and selecting the right patient for trial inclusion.”

CenExel was formed in 2018, and since its formation has strategically invested to support organic growth in its Centers of Excellence while also pursuing acquisitions of state-of-the-art research centers across the U.S. The mission of CenExel is to work with trial Sponsors and CROs to drive efficiencies in clinical research while reducing the costs and development timelines for innovative therapies to advance patient care.

Media Contact: media@CenExel.com

About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.

Brandy Isaacks Joins CenExel as Vice President of Project Management & Scientific Affairs

Salt Lake City, October 20, 2022 /GlobeNewswire/ — CenExel announced that Brandy Isaacks has joined their team as Vice President of Project Management and Scientific Affairs. Brandy’s responsibilities will include providing project management coordination and support across CenExel Centers of Excellence. She will also manage CenExel’s Scientific Affairs division which encompasses early phase and translational medicine scientists, plus the broader network of CenExel therapeutic experts, supporting and consulting on the design and execution of clinical trials.

Brandy has a lengthy and admirable career history of more than 20 years in clinical research project management and operations. Most recently, she was serving as the lead for all Psychiatry in the Neuroscience Division at Syneos Health. Her background also highlights working with small to mid-size pharma and biotech clients, providing strategic guidance for clinical development planning, holistic team management, and ongoing client and program support.

Brandy’s training and career began with conducting structured clinical interviews, clinical ratings, and electrophysiological (ERP) assessments at clinical research sites. Her work developing and sustaining client relationships has led her project teams to positive completion of numerous Phase I – IV clinical trials, resulting in approved products for psychiatry and neurology indications.

By focusing on early engagement, clinical team support, data quality, and project delivery, Brandy has found success in her CRO and client collaborations. She was recognized by the Healthcare Businesswomen’s Association (HBA) as a Luminary for being a role model for women in the healthcare industry and for mentoring and building industry leaders.

“I’m excited to be a part of the CenExel team,” said Brandy Isaacks. “I’m eager to work with the scientists, key opinion leaders, and principal investigators in the CenExel site network, drawing from their professional experience to provide additional value for our clients.”

“We’re thrilled to have Brandy leading these efforts,” said Tom Zoda, COO of CenExel. “Having a single point of client contact for multi-site trials, as well as our customers with multiple studies with CenExel, will accelerate study start-up and overall timelines, ensure consistency, drive quality, and offer more efficient progress reporting. Our Scientific Affairs engagement will equally benefit from her harmonization of existing resources.”

CenExel was formed in 2018, and since its formation has strategically invested to support organic growth in its Centers of Excellence while also pursuing acquisitions of state-of-the-art research centers across the U.S. The mission of CenExel is to work with trial Sponsors and Contract Research Organizations to drive efficiencies in clinical research while reducing the costs and development timelines for innovative therapies to advance patient care.

About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.

CenExel Acquires Apex Innovative Sciences

Salt Lake City, June 16, 2022 /GlobeNewswire/ — CenExel announces the acquisition of Apex Innovative Sciences, parent company of Collaborative Neuroscience Research (CNS) and Hassman Research Institute (HRI), which will be renamed as “CenExel CNS” and “CenExel HRI”, respectively, going forward. CenExel CNS and CenExel HRI consist of five prominent clinical research sites across California and New Jersey with significant expertise in early phase complex clinical trials and particular emphasis on central nervous system (CNS) indications. CenExel CNS will continue to be led by Dr. David Walling, while CenExel HRI will continue under the direction of Dr. Howard Hassman. Both leaders have decades of experience conducting Phase I-IV studies across a variety of CNS medical specialties. The primary therapeutic areas served by these five Centers include Complex Early Phase normal healthy volunteer (NHV) and patient studies, Psychiatry, Addiction (including human abuse liability/human abuse potential), Neurology, Pain, Ethnic Bridging, and General Medicine (particularly vaccine, endocrine, and infectious diseases).

The acquisition of CenExel CNS and CenExel HRI elevates CenExel to be the most prolific wholly-owned neuroscience research site network in the world. These locations expand CenExel’s reach in California and New Jersey. CenExel CNS brings facilities in Garden Grove, CA; Long Beach, CA; and Torrance, CA, adding to CenExel’s five existing California clinical research centers. CenExel HRI has facilities in Berlin, NJ and Marlton, NJ, complimenting CenExel AMRI in Toms River, NJ. Each organization has moved beyond traditional psychiatry to further strengthen CenExel’s overall therapeutic experience, and this acquisition continues their Phase I expansion into other areas of medicine.

CenExel CNS operates in 54,000 square feet of clinical research space, including 60 beds in the Long Beach facility, with an upcoming planned move for this site to a new, nearby, state-of-the-art, 80-bed facility in Los Alamitos, CA. This will include space dedicated for psychedelic research and ethnic bridging studies. CenExel HRI operates in 42,000 square feet of state-of-the-art facilities totaling 90 beds, with 18 beds established for human abuse liability/ human abuse potential studies, and with additional beds in the Berlin facility dedicated to the efficient conduct of normal healthy volunteer studies.

CenExel CNS and CenExel HRI are led by Doctors David Walling and Howard Hassman, with Dr. Tom Zoda serving as the Chief Operating Officer. Doctors Walling and Hassman both have over 30 years of experience in clinical research having served as Principal Investigators for hundreds of clinical trials. Dr. Zoda has over 28 years of experience in senior roles in the pharmaceutical and clinical trials industry. Dr. Zoda will become the Chief Operating Officer of CenExel.

CenExel now comprises 19 of the most proficient, therapeutically-focused, wholly-owned clinical research sites in the country, with special emphases on Psychiatry, Neurology, Pain, Human Abuse Liability, Vaccines/Immunology, Dermatology, Ethnic Bridging, Sleep, and Clinical Pharmacology/Phase I. On a combined basis, CenExel’s clinical research units have more than 500 inpatient beds with the ability to perform both simple and highly complex early phase trials. Each of the CenExel Centers of Excellence units has an outstanding track record of assisting pharmaceutical sponsors with protocol development, study design, and conduct in Phase I-IV trials to develop new therapeutics for improved patient care. Through the acquisition of Apex Innovative Sciences, Dr. Larry Ereshefsky also joins CenExel and brings tremendous scientific affairs consulting expertise.

CenExel CNS and CenExel HRI will benefit from the CenExel site network’s fully integrated and collaborative processes, which include centralized budgeting, business development, contracting, standard operating procedures, rater training, and quality management, among other functions.

“The addition of CenExel CNS and CenExel HRI establishes the foremost therapeutically-focused clinical research site network in the neurosciences,” said Tom Wardle, CenExel CEO. “These teams have always delivered scientific expertise and operational excellence. We’re excited to work with such exceptional leaders in the CNS research community.”

We are very pleased to be joining the CenExel site network,” said Dr. Howard Hassman. “CenExel’s depth of experience and market-leading scale provides a tremendous platform for growth. We look forward to combining our extensive resources to provide unparalleled efficiency and clinical expertise as we build the industry’s highest quality and most dependable partner for complex early-stage clinical research services.”

“CenExel CNS and CenExel HRI, in combination with the rest of CenExel’s sites, now offer the foremost scientific proficiency, clinical content expertise, and operational capability in the industry,” said Dr. David Walling. “We recognize the value of coordinating with our customers to assist in the development and execution of protocols by deploying best practices in clinical research, especially pertaining to clinical quality, compliance, and patient engagement.”

CenExel was formed in 2018, and since its formation has strategically invested to support organic growth in its Centers of Excellence while also pursuing acquisitions of state-of-the-art research centers across the U.S. The mission of CenExel is to work with trial Sponsors and Contract Research Organizations to drive efficiencies in clinical research while reducing the costs and development timelines for innovative therapies to advance patient care.

FocalPoint Partners acted as the exclusive sell-side financial advisor to Apex Innovative Sciences in the transaction.

About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.

About FocalPoint Partners

FocalPoint is an independent investment bank specializing in mergers and acquisitions, private placements, financial restructurings, and special situation transactions. With offices in Los Angeles, Chicago, New York, and Shanghai, the firm serves middle-market clients throughout the U.S. and has a dedicated healthcare practice. Its patient-centric healthcare investment banking practice collaborates with healthcare service providers demonstrating value-based characteristics designed to reduce the cost of care while enhancing outcomes.
www.focalpointllc.com