Blue Train Design Consulting, LLC  

Boutique consulting firm specializing in content design for digital therapeutics that converges software and content to optimize engagement & outcomes and product market fit. Results-oriented with deep expertise in evidence-based treatments and AI-driven personalized medicine. 

Achieving durable behavior change guides the design of all products, whether for mental health (depression, anxiety, substance use), medical conditions (obesity/weight loss, stress-related conditions), and wellness / personal growth. 

RESULTS ORIENTED: The firm’s founder, Edmund Neuhaus, longstanding Harvard Medical School psychologist, leads the clinical content design initiatives. Priority is changing individuals’ behavior to improve functioning and quality of life. Successes: 

+ Pfizer Digital Health & Medicines: designed the protocol and content for the migraine digital app that is Pfizer’s first commercial app product delivering behavioral treatment for a medical condition. Prototype tested on 500 patients leading to 2.0 version for commercial distribution. 

+ atai Life Sciences: led the design of protocol and content (CBT, Behavioral Activation, Mindfulness) for digital app to deliver therapeutic content to enhance treatment w/ ketamine and other psychedelic compounds. Successful prototype testing: 50 users had high degrees of engagement and reported usefulness to change behavior. 

+ deliq / Afterglow, where he leads the design of DTx app protocol and content (Mindfulness and Acceptance-Commitment Therapy) to enhance the effects of ketamine and plant-based medicine for mental health and wellness. Tested with 300+ users. 

+ Atheneum Learning, Neuhaus' start-up 2010's was forerunner of comprehensive eLearning training 1000 therapists in Neuhaus' Transdiagnostic, Flexible CBT approach. 

 ➕ Expertise in Evidence-based treatments (EBP): CBT, Behavioral Activation, Mindfulness-Based Cognitive Therapy--MBCT, ACT, DBT, and the common factors of psychotherapy that predict good outcomes.

Founder & Principal

College Parents of America

Strategic leadership role to develop content for parents guiding them to support the mental health and well-being of their children who are students in college.

Senior Clinical Advisor

Pfizer

Lead content designer for DTx app products delivering behavioral treatments to enhance care for medical conditions. Designed products for personalized medicine converging clinical content and software features. My evidence-based clinical approach integrates core CBT principles, behavioral activation, and mindfulness-based interventions.
✅  Signature achievement: Designed and wrote clinical content for prototype app product. Worked with dev and product teams to optimize product market fit. Tested with 500 patients yielding positive results on effectiveness, usefulness, and satisfaction with the product.
✅  Designed /upgraded to version 2.0 for commercial use. First commercial app product for the company.

Digital Health & Medicines, Lead Consultant in DTx Content Design

Harvard Medical School

McLean Hospital: Clinical Leader; Principal Investigator, CBT Outcome research on effectiveness of CBT in partial hospital/ Intensive Outpatient Treatment; and, Co-Director of Psychology Training. Served as teacher, mentor, and clinical supervisor for psychology interns and post-doctoral fellows. 

I began as an Instructor in Psychology in 1991, and in 2003 I was promoted to Assistant Professor based on achievements at McLean Hospital in innovative clinical care, administrative leadership, and achievements in upgrading the Psychology Training Internship program. At that time I was full-time at McLean serving in multiple roles: Director of the Behavioral Health Partial Hospital Program, 
Co-Director of Psychology Training, and Principal Investigator of the CBT Treatment Outcome Program. When I left my full-time position at McLean in 2009, my title changed to Assistant Clinical Professor which reflects part-time, unpaid status.

A major achievement of my academic career was integrating the Harvard/ McLean Psychology Internship training program into the clinical service delivery of the Behavioral Health Partial Hospital Program. In 2006, the internship earned national recognition from the American Psychological Association as Best Psychology Internship among 900 programs in the US.At

Assistant Clinical Professor

atai Life Sciences

I co-led cross-functional initiatives in R&D to design and develop DTx app products for clinical trials with psychedelics. We utilized a human-centered design and behavioral economics/ behavior design to maximize engagement and changes in positive changes in behaviors and habits to overcome long-standing dysfunctional patterns due to chronic mental health conditions. 

Atai Life Sciences is a global biotech start-up company with the mission to develop new and innovative treatments for alleviating the recovery of severe mental health conditions primarily using psychedelic compounds. I was hired to co-develop the new DTx product line to deliver psychotherapy via DTx app in combination with psychedelics. I started as the sole clinical content designer, working with the lead software designer and a small team of digital software engineers. We built the DTx prototype and began testing within just 6 months. 

Over my tenure, the psychotherapeutic team grew to four and we refined our behavioral design / human-centered design approach to converge clinical content with software features to maximize user engagement. We designed and built several new DTx products for clinical trials testing, and completed iterative testing of DTx products with 40+ participants showing positive results for engagement with Ketamine-combination interventions. 

I co-developed Behavioral Psychedelics model (published in Frontiers in Psychiatry)that informed the clinical treatment design for the DTx products to achieve durable behavior change and relapse prevention.

Senior Director, Psychology and Psychotherapeutic Development

Community Intervention Services, Inc.

I led initiatives to establish clinical standards of care with CBT evidence-based protocols, instituted outcomes measurement systems and EHR Clinical Decision Support, implemented quality/compliance, and designed eLearning training for 2000 clinicians serving 30,000 patients annually. This was largely a home-based care model of therapists going to patients' home.

Community Intervention Services--CIS was a PE-backed parent company of a national network of community-based, behavioral healthcare companies providing care for 30,000 clients annually with 2000 clinicians in seven states along the east coast with an exit in 2021. 

As Chief Clinical Officer, I was responsible for clinical strategic planning and execution of initiatives to improve standards of care across five subsidiaries offering multiple services lines: child and adult outpatient services both in-clinic and at clients' homes, psychiatric evaluation and management, intensive outpatient services, Autism services, and Early Intervention for birth to age 5. 

Major accomplishments: Co-led initiative to establish a standardized screening and Clinical Decision Support system for Suicide Risk Assessment fully integrated into clinician workflow with EHR dashboards to monitor quality and compliance; designed and implemented an outcomes measurement system that was incorporated into the standard EHR clinical workflow yielding data for descriptive, predictive, and prescriptive analytics to improve quality of care; co-led team to establish a company culture for data-informed clinical care by optimizing the use of EHR technology across the enterprise; instituting comprehensive Quality Assurance and Performance Improvement (QAPI) processes to meet industry standards for Quality and Compliance, and Corporate Compliance.

Chief Clinical Officer

Atheneum Learning

In 2008, I founded Atheneum Learning to train mental health providers in Cognitive Behavior Therapy-CBT using scalable eLearning technology and human/technology hybrid approaches. My vision was to expand the use of CBT worldwide by providing gold-standard clinical training content developed and researched at Harvard Medical School/ McLean Hospital through an innovative approach. In 2009, this was one of the few comprehensive, online training programs in competency-based CBT practices. The "Flexible CBT Approach" was based on a pragmatic, transdiagnostic, patient-driven approach that is effective for treating depression, anxiety disorders, personality disorders, and combinations thereof. I decided to enter the start-up world with the aim of providing scalable training that would otherwise not be available to thousands of mental health professionals needing training in CBT evidence-based approaches. 
 
Atheneum Learning was funded through a combination of bootstrapping, Angel Investments totaling $250K, and $450K revenue from contracts and partnerships. I negotiated a sole source contract with US Navy Medicine to train their therapists worldwide, with additional channel-partner contracts with CIGNA and Aetna insurance companies and their provider panels in over 40 states in the US.

Founder & CEO

Private Practice

Board Certified Clinical Psychologist with a wide range of specialties, treating depression, anxiety, personality disorders, bipolar disorders, schizophrenia, and the spectrum of psychotic disorders.

Psychotherapist and Consultant

Shanghai Mental Health Center

I led an intensive workshop training program in transdiagnostic, Flexible CBT Approach (from Atheneum Learning) from 2009 to 2012 at the Shanghai Mental Health Center, China's largest psychiatric institution.  After giving a Keynote address and workshop in Flexible at the First Chinese CBT Conference in Nanjing, China, I was recruited to teach 100 clinical leaders from 14 Provinces in China to proliferate CBT in the Chinese Mental Health System. This three-year program was designed for two workshops per year (1 week each) for didactic training, case consultation, the applied practice of CBT skills, and watching live interviews I conducted to demonstrate approach and technique. I still maintain close connections with my Chinese colleagues there and am pleased that CBT has really taken hold.

Master Teacher/ Master Clinician in Cognitive Behavior Therapy

McLean Hospital

I led this CBT partial hospital ("day hospital) program with specialty tracks: Mood andAnxiety, Bipolar/Psychotic Disorders, and Borderline Personality Disorder, all told serving 10,000 patients during my tenure. The program earned a national reputation as one of the premier intensive CBT treatment programs drawing patients nationally from the US and internationally. 

The BHP was the basis of the "Fixed Values and Flexible Treatment" program model I published as a peer-reviewed position paper featured in the Harvard Review of Psychiatry. The basic assumption of the model is that both clinical and organizational aspects of a psychiatry program must be inherently adaptable to maintain consistent effectiveness for all stakeholders: patients, staff, hospital, and payers.

Director, Behavioral Health Partial Hospital Program (BHP)

I led the day-to-day operations of the nationally recognized Harvard Medical School/ McLean Hospital Psychology internship program starting in 1996 with the title of Associate Director of Training and then to Co-Director.  In 1996, I completely revamped the organizational structure and training curriculum and made it financially viable by integrating it into the clinical service of the partial hospital program. In 2006, the program earned the American Psychological Association award for excellence as the #1 internship program in the US among 900 training programs.

Co-Director, Psychology Training

I bootstrapped this research program with trainee and staff volunteers which evolved into a nationally recognized CBT research program in partial hospital treatment with five peer-reviewed publications on data collected from 1200 patients.

The research tested and showed effectiveness of the transdiagnostic Flexible CBT approach for depression and related mood and anxiety disorders. We developed, validated, and published the CBT Skills Questionnaire demonstrating that acquisition and use of Behavioral Activation and Cognitive Restructuring skills predict depression recovery.

Principal Investigator, CBT Research Program, Behavioral Health Partial Hospital 

I approach every day with a start-up mindset. My focus? What can I contribute to improve the lives of 10 million people? Behavior change is my North Star. I get results by designing innovative digital products that maximize engagement and change behavior, at scale. There is no effective clinical treatment, no personal growth, no weight loss, no fitness, and no enduring healthy relationships without behavior change. Let’s get to it!

Edmund Neuhaus, PhD, ABPP

- Regulatory Lead: clinical-stage drug and DTx development programs at Atai and portfolio companies (Viridia, Emphath Bio, Revixia, Innaris Bio, IntroSpect)

Senior Director, Regulatory Affairs

Northeastern University

Courses taught:
- RGA6211 "Combination Products"
- RGA6202 "Medical Device Development: A QA/RA Regulatory Overview"
- RGA6220 "Global Registration of Biotechnology Products"
- RGA6203 "Food, Drug, and Medical Device Law: Topics and Cases"
- RGA6218 "Regulatory Affairs in an Entrepreneurial Environment". Designed course and developed curriculum.

Graduate Instructor-Regulatory Affairs

Glympse Bio

Director and Head of Regulatory Affairs

Sanofi

Associate Director, Global Regulatory Affairs (CMC &Devices)

- Combination Products
- Connected drug delivery and software apps
- Regulatory Lead for the Sanofi - Google Life Sciences collaboration (http://www.wsj.com/articles/google-sanofi-join-forces-on-diabetes-monitoring-treatment-1441026001)

Senior Manager, Global Regulatory Affairs

Philips

Regulatory & Quality Engineering

AlvaMed

Representative projects:  

•       Regulatory Strategy: For a Fortune 50 Medical Products company, evaluated Postmarket Surveillance Systems of five operating companies. Assessments focused on signal (adverse event) detection and escalation, and alignment with FDA Sentinel Initiative. 

•	Cordis Division of Johnson and Johnson: prepared Clinical Evaluation Reports (EU, Tier 1 countries) for Catheters, Drug Eluting Stents and Delivery Systems. Tasks included Risk and Complaint Data Analysis, and monitoring of MDR, MDV, Clinical Trials.gov, ICH GCP (E-2A, E-3 and E-6) Guidelines, and FDA MAUDE database.

•	For CE Marking of a medical device containing antimicrobial agents, developed efficacy and biocompatibility tests, and prepared technical file; according to requirements of the Personal Protective Equipment Directive (Category III device); and the revised (effective 3/2010) EU Medical Device Directives.

•	Global Regulatory Project Manager, Shire Human Genetic Therapies, Lexington MA. Responsibilities included:
o	Worked with cross functional groups to proactively identify issues that may delay submissions, helped teams to provide solutions to identified issues, and spearheaded the completion of action items. 
o	Generated weekly status reports to senior management.  For delayed submissions, a Gap Analysis was done and included in the reports.

•	To obtain approval of a Annex II List B in vitro diagnostic for the EU, prepared documentation for Annex IV Conformity Assessment Route.

•	For ISO 13485:2003 Certification and FDA registration of a medical device manufacturer, prepared Quality Agreements and components of the Quality Manual (Design and Document Control, and CAPA).

Regulatory Affairs

RenaMed Biologics, Inc

Director, Product Development

Argose Inc.

Group Leader, Process Development

Scient Inc.

eBusiness Systems Integrator. Scient was purchased by Razorfish in 2002, and in 2007 Razorfish was bought by Microsoft and became part of Microsoft's Advertiser and Publisher Solutions (APS) Group.

Senior Associate

Molecular Geodesics Inc.

•	Initiated and managed collaboration with the U.S. Army Medical Research Institute of Infectious Diseases at Ft. Detrick, MD to test the efficacy of hydrogel-coated scaffolds to filter and neutralize aerosolized biological threat agents, such as anthrax and ricin.
•	The projects’ success was critical for obtaining a $6.2M contract from the Defense Advanced Research Projects Agency’s “Unconventional Pathogen Countermeasures” Program, and venture capital funding.

Principal Scientist

Accomplished Regulatory & Quality professional with expertise in drug and medical device regulatory submissions and post-market compliance. Proven ability to use scientific knowledge for insightful quantitative analysis, and to deliver innovative solutions in deadline-driven business environment. Qualifications highlights:

• Working knowledge of FDA regulations, EU Directives and compliance with International Standards is advantageous for preparing successful submissions and maintaining regulatory compliance throughout the product lifecycle.

• Responsible for compliance with International Standards (IEC 60601 3rd Ed, IEC 62304, IEC 62366, ISO 10993), and International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice.

• Mobile Medical Devices - including FDA and FCC regulatory requirements for wireless and cellular connectivity, and validation of cloud storage of patient data.
                                       
• Risk Management - ISO 14971 and Corporate Risk Assessment Initiatives (Product Security Risk Assessment and Privacy Impact Assessment).

• Responsible for audits of contract manufacturers and vendors to ensure compliance with FDA Quality System Regulations, ISO 13485 and Corporate Quality Agreements. 
                     
• Project Management and Leadership skills to align regulatory requirements with business objectives, and leverage relationship with regulatory, clinical and quality to effectively work together and meet aggressive time lines.

• Outstanding biomedical research and publication record at Harvard Medical School, MIT and UC Berkeley.

taplio

The Battle

Edmund Neuhaus, PhD, ABPP

Robert Ezzell Jr.

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