Therapeutic Area (TA) Spotlights*


*Complimentary Short Courses—These are offered IN-PERSON ONLY. RSVP Required.

Tuesday, February 3, 2026  11:00 - 1:10 pm

TA SPOTLIGHT 1: CNS and Mental Health Trials

Detailed Agenda
CNS and mental health trials remain some of the most complex and challenging studies to execute. Unique patient populations, evolving diagnostic criteria, high placebo response rates, and burdensome assessments create hurdles that impact trial design, recruitment, and execution. This TA Spotlight session explores practical strategies for optimizing trial execution, from protocol design through site selection, recruitment and operations. Explore common challenges—including site selection and readiness, recruitment and retention of diverse patient populations, and the operationalization of innovative digital endpoints.
Rachna Saralkar, MD, MS, Principal Investigator, Flourish Research
Sean Lynch, Clinical Innovation Head, Innovative Trial Operations, Novartis Pharmaceuticals
Rachel McGovern, Clinical Development Operations Lead, TA CRM, Boehringer Ingelheim Pharma GmbH & Co. KG
Christine Oman, MS, Clinical Trial Manager, Definium Therapeutics
Kristen Dopf, MHS, PA-C Principal Investigator, Suburban Research Associates
Emma Rouse, Senior Patient Engagement Lead, Global Trial Optimization, Regeneron
Kristen Dopf, MHS, PA-C Principal Investigator, Suburban Research Associates
Sean Lynch, Clinical Innovation Head, Innovative Trial Operations, Novartis Pharmaceuticals
Rachel McGovern, Clinical Development Operations Lead, TA CRM, Boehringer Ingelheim Pharma GmbH & Co. KG
Christine Oman, MS, Clinical Trial Manager, Definium Therapeutics
Emma Rouse, Senior Patient Engagement Lead, Global Trial Optimization, Regeneron
11:00 am Chairperson's Remarks

Rachna Saralkar, MD, MS, Principal Investigator, Flourish Research

11:05 am

Innovation & Flexibility in Neuroscience Trials

As neuroscience trials grow in complexity, a tailored approach to decentralized clinical trial (DCT) elements is essential. This session explores how innovations such as remote assessments, home nursing, and digital recruitment are being selectively applied across diverse neurological conditions—including Alzheimer’s, MS, Parkinson’s, and rare diseases. Drawing on real-world examples, we’ll examine which tactics are delivering true value for patients and sites, and which remain unproven. Attendees will gain practical insights into balancing patient-centricity, scientific rigor, and operational feasibility—learning why “one size fits all” doesn’t work, and how early, systematic assessment drives success in a rapidly evolving landscape.

11:25 am

Walking in the Patient’s Shoes: A Mock Trial Walkthrough to Reduce Burden

This presentation explores the value of doing a “mock patient” protocol walkthrough as a tool for uncovering operational burdens that traditional feasibility reviews often miss. By stepping through visits, procedures, and logistics from the patient’s perspective, the team identified unexpected pain points and redesigned assessments to reduce friction. Attendees will gain practical guidance on conducting trial walkthroughs, interpreting findings, and using them to streamline visits to hopefully minimize burden on both patients and research sites.

11:45 am

Designing Trials around the Human Experience

This talk explores the unique challenges of psychedelic mental-health studies, where patient mindset, setting, and the support of the clinical study team play a critical role in both participant well-being and data quality. It highlights practical approaches to improving comfort and engagement—such as thoughtful environment design and extended visit support—while emphasizing that informed consent is an ongoing process rather than a one-time event. 

12:05 pm

The Site View: Building Trust and Retaining Participants

Offering a frontline view from psychiatric research sites, this session highlights the unique challenges of recruitment and retention in mental health clinical trials and approaches site can incorporate to overcome them.  From protocol development to trail execution, understand what a truly patient-centric trial looks like. Explore communication frameworks and trust-building practices. Learn where sites encounter constraints and what sponsors can do differently to improve trial continuity and participant satisfaction.

12:25 pm

Supporting Patients and Caregivers through Engagement

This session explores how meaningful patient and caregiver engagement can reshape study design in neurology trials. It covers tools and approaches—such as simplified visit guides, scheduling aids, digital reminders, and caretaker-support resources—that reduce burden and strengthen adherence. Drawing on lessons from ALS studies, it demonstrates how early input and structured engagement can improve feasibility, reduce attrition, and support the realities of daily life for participants and caregivers.

12:45 pm

CLOSING Q&A: Optimizing CNS & Mental Health Trials: Practical Strategies for Success

This final session provides an open forum for audience questions and shared discussion, allowing participants to reflect on the topics covered throughout the workshop. Speakers and attendees will explore common themes, lessons learned, and remaining challenges, helping to reinforce key takeaways and highlight considerations for future study design and execution.

INSTRUCTOR BIOGRAPHIES:

Kristen Dopf, MHS, PA-C is a board-certified Physician Assistant and Principal Investigator at Suburban Research Associates, part of the Atlas Clinical Network. With over 10 years of clinical experience and a strong background in both medical and psychiatric care, she leads medical and mental health-focused clinical trials aimed at advancing evidence-based treatment options. Kristen has conducted more than 10 clinical trials as a Principal Investigator in the past year alone and has contributed to over 40 psychiatric trials as either a Primary or Sub-Investigator throughout her career. She is passionate about bridging the gap between research and real-world practice and is dedicated to improving outcomes and quality of life through compassionate and science-driven care.

Sean Lynch has been working in clinical research for over 17 years with a heavy emphasis on the role of technology and vendors in the very changing landscape of clinical innovation. He started as a data managed at Quintiles before progressing into project management roles at software companies. CROs and start-ups. He has even dabbled in consulting and business development and has lots of tales to tell. Today he is the Innovation Capability Head for Innovative Trial Operations at Novartis.

With over 30 years of experience in pharmaceutical research and development, Rachel is a distinguished leader in clinical program operations. Currently serving as Clinical Development Operations Lead (CDOL) for Mental Health/Cardio-Renal-Metabolic at Boehringer Ingelheim. Rachel oversees the delivery of key clinical development programs across various assets and indications, provides strategic operational insight into Evidence and Execution Plans for early- and late-phase clinical trials. Her expertise lies in navigating complex organizational and regulatory environments to ensure the successful execution of clinical trials. Rachel’s previous role supported CNS programs at Purdue Pharma. Prior to that Rachel worked at Bristol-Myers Squibb and held various operations positions, including site manager, protocol manager, hybrid line manager for site and protocol managers. Rachel's comprehensive background and leadership in pharmaceutical R&D empower her to guide teams with vision, rigor, and a deep commitment to driving results that align with company goals and patient needs.

Christine Oman is a Clinical Trial Manager at Definium Therapeutics (formerly MindMed), a clinical-stage biopharmaceutical company pioneering novel psychiatric therapies and digital therapeutics to address some of the most common and widely recognized mental health disorders. Since joining Definium Therapeutics in June 2024, Christine has been managing clinical trials that combine traditional approaches with digital tools to better understand patients and improve study outcomes. She holds a Master of Science in Biotechnology Innovation and Regulatory Science from Purdue University and brings over ten years of experience in the clinical research industry. Her background spans hands-on site-level work as a study coordinator and operational roles within CROs as well as biotech companies. This range of experience helps Christine run clinical trials with a strategic mindset, strong organizational skills, and a focus on the patient's experience and safety. Beyond her professional work, Christine is actively involved with Linking Pharma Women, a community dedicated to empowering and connecting women across the pharmaceutical and life sciences industries.

Emma Rouse is Senior Patient Engagement Lead in Global Partnerships and Trial Optimization at Regeneron, overseeing patient engagement across the Oncology and Genetic Medicines portfolio. With 20+ years in biopharma, she has extensive operational expertise and a proven track record of integrating patient perspectives to improve trial design, recruitment, and retention. Passionate about advancing patient-focused research, Emma takes a strategic and collaborative approach to strengthen the connection between patients and clinical trials, helping ensure that research is both meaningful and accessible.

Rachna Saralkar, MD, MS, Principal Investigator, Flourish Research

Rachna Saralkar, MD, is a double board-certified Investigator at Flourish Research, specializing in psychiatry and clinical informatics.

Prior to joining Flourish Research, Dr. Saralkar served as Medical Product Director at Deliberate AI, where she worked on the development of AI-enabled tools for mental healthcare. She also served as an advisor and fractional chief medical officer to early stage startups working on incorporating AI into their care delivery platforms. Her experience spans traditional psychiatric care delivery – including outpatient, emergency, and virtual settings.

Dr. Saralkar completed her psychiatry residency at Johns Hopkins University and holds a Master’s in Clinical Informatics Management from Stanford University School of Medicine. As a practicing psychiatrist licensed in California and Pennsylvania, she is passionate about bridging the gap between innovative healthcare technologies and clinical research, working to advance treatments that can meaningfully improve patients’ lives.

Tuesday, February 3, 2026  3:00 - 5:35 pm

TA SPOTLIGHT 2: Obesity and Metabolic Trials

Detailed Agenda
With a record number of obesity and metabolic trials currently underway, the demand for innovative strategies to advance clinical development has never been greater. This spotlight session explores approaches to strengthen collaborations, improve trial efficiency, and address the complexities of recruitment and retention in obesity and metabolic disease studies. Presentations will highlight emerging partnership models, novel tools such as point-of-care pre-screening to reduce costly screen failures, and best practices for aligning operational execution with scientific goals. The session concludes with an interactive panel discussion where experts from sites, sponsors, and research organizations will share practical insights on overcoming barriers and driving progress in obesity and metabolic trials.
Laura Whitmore, Senior Director, Business Operations and Clinical Outsourcing, Kailera Therapeutics
Jennifer Jackman, PhD, MBA, Associate Director, Industry Partnerships and Strategic Programs, Duke Clinical Research Institute
Sheetal Telang, Vice President, Americas Head of Therapeutic Strategy, IQVIA
Calvin Bidner, Key Account Executive, Clinical Trials, Abbott Point of Care
Rebecca Clark, MBChB MRCGP DFSRH, Principal Investigator, Layton Medical Centre
Eli Alford, COO, Pinnacle Clinical Research
Michelle Hartmann, MS, CCRP, Director, South Broward Research
Jennifer Jackman, PhD, MBA, Associate Director, Industry Partnerships and Strategic Programs, Duke Clinical Research Institute
Kaushal Mehta, Portfolio Director, Novo Nordisk
Sheetal Telang, Vice President, Americas Head of Therapeutic Strategy, IQVIA
Laura Whitmore, Senior Director, Business Operations and Clinical Outsourcing, Kailera Therapeutics
3:00 pm

Chairperson's Remarks

Laura Whitmore, Senior Director, Business Operations and Clinical Outsourcing, Kailera Therapeutics

3:05 pm

Partnering for Success in the Obesity Therapeutics Landscape

Organizations with complementary capabilities can, when aligned in the right context, create synergies that advance clinical research. Achieving this, however, requires thoughtful planning, intentional collaboration, humility, and a shared commitment to the mission. DCRI and IQVIA have initiated a prospective collaboration to accelerate the advancement of obesity-related clinical research that emphasizes synthesis of scientific, operational, and data-informed decision making, unique site-relationships, and impactful dissemination of insights.

3:30 pm

Point-of-Care Testing in Obesity and Metabolic Trials

Point-of-Care Testing (POCT) is rapidly gaining traction in clinical trials due to its speed, portability, convenience, and ease of use. Nowhere is this more evident than in obesity and metabolic programs, which leverage POCT to improve patient experience, reduce screen failures, and expedite operations. This talk will cover the history of POCT as well as specific examples of its use case in MASH/MASLD trials, which have seen significant activity over the past few years.

3:55 pm

New Blueprint for Delivery of Large-Scale, Late Phase Clinical Trials of Drugs Targeting Metabolism and Obesity

Learnings from the UK’s first clinical trial delivery accelerator—the UK Vaccine Innovation Pathway—are being translated to accelerate obesity trials in the UK. This trailblazing programme has created a new blueprint for delivery of large-scale, community-based trials. This session explores how clinical expertise, operational leadership, enhanced inclusivity, and optimized research delivery facilities, services, and settings emerged as the key components for delivering efficient obesity trials.

4:20 pm PANEL DISCUSSION:

Operational Realities of Obesity Clinical Trials: What Sites & Sponsors Need to Know

INSTRUCTOR BIOGRAPHIES:

Eli Alford is Chief Operating Officer (COO) of Pinnacle Clinical Research. Eli served 26 years as a combat arms leader and in research and analysis roles in the U.S. Army, retiring as a colonel. His second chapter has been in operational leadership roles in the clinical research industry, starting with INC Research (now Syneos Health). Prior to Pinnacle, Eli served for eight years as a COO, first with Schulman Associates IRB (now Advarra) and then Elligo Health Research, a clinical research site network integrated with healthcare. He received a BA from the Virginia Military Institute, MS from the University of Southern California, and was a National Security Fellow at the Harvard Kennedy School.

Calvin is a Key Account Executive at Abbott Point of Care Diagnostics and serves as subject matter expert in the clinical research utilization of POC blood testing in trials. Holding a degree in Biochemistry and having worked for various biotech companies previously, his experience spans biotechnology, AI, and clinical research. He currently resides in San Francisco, CA.

Dr. Rebecca Clark is a Partner at Fylde Coast Clinical Research at Layton Medical Centre, a dedicated commercial trials centre in Blackpool. She is a highly experienced trialist with over 70 Phase II/III clinical trials conducted over the last 13 years, with multiple studies as Chief Investigator in the therapy areas of vaccines, obesity medicine, cardiovascular medicine, asthma and diabetes. She holds a number of senior leadership roles including co-clinical lead for the UK Vaccine Innovation Pathway, a UK clinical trials accelerator. Fylde Coast Clinical Research at Layton Medical Centre recruits amongst the highest number of commercial participants across the NHS in England and was in the top 1% of NHS recruiting sites when compared with all 637 sites across both primary and secondary care in 22/23. Study participant retention rates exceeded 99%. Her site regularly achieves UK FPV and she is renowned for accelerated set up and recruitment timelines, experience she is now bringing to her role in the UK VIP. Fylde Coast Clinical Research currently holds contracts with Eli Lilly, Moderna, Astra Zeneca, Roche, Amgen, Merck, Novo Nordisk and GSK, with whom they are members of the PEER preferred site network. Dr. Clark continues to be recognised nationally for her excellence in clinical trial delivery, being a former recipient of the Gold Award for Clinical Site of the Year at the Pharmatimes International Clinical Researcher of the Year awards.

Michelle Hartmann, CCRP, is the Director/Owner of South Broward Research which is located in SE Florida. She started with South Broward Research in 2006. South Broward Research is a community based, independent site. She is dedicated to the pursuit of advancing healthcare by ensuring integrity and quality in the work performed at South Broward Research. She feels fortunate to be a part of an incredible team. She attended The Florida State University where she received both her Bachelor of Science and Master of Science. She continues her education in the field of research by attending research seminars and conferences, participating in panels with sponsors and industry organizations, and becoming a Certified Clinical Research Professional. She enjoys spending time with her family, traveling, and can often be found reading a good book.

Jennifer Jackman, PhD, MBA, is the Associate Director of Strategic Programs at the DCRI. Dr. Jackman has over 15 years of research experience, including managing an oncology research team at the site level and leading the DCRI Medical Communications team. In her Strategic Programs role, she oversees various programs that relate to clinical research policy, education, and efficient/innovative study design. Dr. Jackman has a passion for optimizing clinical trial design to align with regulatory and evidence-generation needs in a broad range of therapeutic areas. She strives to understand and align the pursuits of stakeholders across the clinical research ecosystem to advance clinical research and healthcare to improve the lives of patients and their families.