2023 Summit Speaking Faculty
William Schmidt, Ph.D.President
William Schmidt, Ph.D., President, Northstar Consulting
Dr. Schmidt is head of NorthStar Consulting, LLC, which specializes in providing advice on preclinical and clinical studies of novel analgesic drugs. He is simultaneously President and CEO of Catalina Pharma (Tucson, AZ), part-time Senior VP of Global Clinical Development for Helixmith Inc. (formerly ViroMed, Inc.; Seoul, South Korea), part-time VP of Clinical Development for EicOsis, LLC (Davis, CA), and Chief Medical Officer for Ensysce Biosciences (San Diego, CA).
Dr. Schmidt currently sits on the Scientific or Medical Advisory Boards of 3 biotech companies and one internet medical publishing company. Dr. Schmidt is the Parliamentarian and a Past President of the Eastern Pain Association. He received the John J. Bonica award for the development of new analgesics and his sustained contributions to the educational efforts of the Eastern Pain Association in 2014.
US FDA/Hertz & Fields Consulting
NINDS/National Institutes of Health
Walter Koroshetz, MD., Director, NINDS, National Institutes of Health
Walter J. Koroshetz, M.D., was selected Director of NINDS on June 11, 2015. Dr. Koroshetz joined NINDS in 2007 as Deputy Director, and he served as Acting Director from October 2014 through June 2015. Previously, he served as Deputy Director of NINDS under Dr. Story Landis. Together, they directed program planning and budgeting, and oversaw the scientific and administrative functions of the Institute. He has held leadership roles in a number of NIH and NINDS programs including the NIH’s BRAIN Initiative, the Traumatic Brain Injury Center collaborative effort between the NIH intramural program and the Uniformed Health Services University, and the multi-year work to develop and establish the NIH Office of Emergency Care Research to coordinate NIH emergency care research and research training.
Suma Gopinathan, Ph.D., Executive Director, Clinical Development, Lexicon Pharmaceuticals
Suma Gopinathan, Ph.D., is Executive Director, Clinical Development at Lexicon Pharmaceuticals. Suma is an experienced R&D leader with expertise in early drug discovery to late-stage clinical development. In her current role, she is the head of clinical development and program strategy for the neuropathic pain program at Lexicon Pharmaceuticals.
Becky Baggett, BS, RAC, Associate Vice President, Project Delivery, Rho
A pain expert at Rho, Ms. Baggett has over 14 years of clinical trial experience. In the last 8 years alone, she has led 3 chronic pain studies and 7 acute pain studies across 5 programs. This success is partly due to her keen understanding of the unique challenges inherent to chronic and acute pain studies such as accurate pain reporting for efficacy endpoints, operational challenges resulting from swift enrollment on elective surgical models for acute pain, and subject retention challenges for single-injection chronic pain studies.
In 2017, Ms. Baggett earned her Regulatory Affairs Certification (RAC) which provides her with a deeper understanding of regulatory requirements and challenges facing her clients. That, paired with her strong understanding of clinical trial management and innate ability to create strong site-sponsor relationships almost instantly, Ms. Baggett regularly leads teams to meet or beat timeline deliverables for various multicenter trials. On a large Phase 3 OA knee pain trial for example, she worked very closely with study sites and together, completed enrollment six weeks early.
Ms. Baggett also has 6 years of experience as a data manager. This added perspective fosters a more clear understanding of the link between clinical and biometric activities and allows her to provide her clients with high-quality data. Regularly working with many of the industry-standard pain scales and quality-of-life questionnaires (in both paper and ePRO form), Ms. Baggett frequently helps her clients navigate the balance of quality data collection, patient burden, and cost with regards to these collection mediums. Ms. Baggett earned her bachelor of science degree in Exercise Science at East Carolina University.
National Institutes of Health
Mary Ann Pelleymounter, Ph.D., Program Director, NINDS, Division of Translational Research, National Institutes of Health
Dr. Pelleymounter has over 25 years of experience in scientific research and over 20 years of experience in drug discovery and develop- ment. Mary Ann’s scientific training is in the field of behavioral neuroscience with a focus on age-related cognitive dysfunction, neurodegeneration and neuropharmacology. She received her Ph.D. at the University of Colorado and conducted her post-doctoral research at the University of North Carolina (Chapel Hill) in the laboratory of Dr. Michela Gallagher. Following her post-doctoral work, Dr. Pelleymounter focused her research on drug discovery and development in the therapeutic areas of neurodegeneration and neuroropsychiatry until the mid-1990s when she shifted her research emphasis to obesity and metabolic disease therapeutics.
Lotus Clinical Research
Neil Singla, MD, Chief Scientific Officer, Lotus Clinical Research
Dr. Neil Singla, a board-certified anesthesiologist, is the founder and Chief Scientific Officer of Lotus Clinical Research. Since its inception in 2001, Dr. Singla has served in several roles within the organization including: Research Coordinator, Sub-Investigator, Principal Investigator, Coordinating Investigator, and Chief Scientific Officer.
In his capacity as CSO for Lotus Clinical Research, Dr. Singla has had the opportunity to interact frequently with the FDA’s Analgesics Division on behalf of clients and to play a significant role in guiding development strategies for dozens of putative analgesic agents. In the company’s 18-year history, Dr. Singla and Lotus Clinical Research have played a significant role in bringing several molecules to market.
Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at the International Association for the Study of Pain (IASP), chaired the Clinical Trials Shared Interest Group at the American Pain Society (APS) through 2019, chairs the annual Conference on Analgesic Clinical Trials, which aims to help experts advance best practices in analgesic drug development, as well as, serving on the Clinical Research Committee at Huntington Hospital.
The main focus of Dr. Singla’s academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint analgesic clinical trials can be minimized. As a result, he has developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect size.
Kaitlin Roberson, Co-founder & CEO, Cacti Therapeutics
Kaitlin is co-founder and CEO of Cacti Therapeutics, a biotech company developing non-hallucinogenic psychedelic-related therapeutics for neuropathic and nociplastic pain. She moved in this direction after working in the humanitarian field with populations disproportionately affected by trauma and pain, who lacked equitable access to quality care.
Kaitlin received her Master’s degree in Human Development and Psychology from Harvard University and has professional experience in trauma care and business finance. Her passion is helping people experience growth and transformation as they overcome physical, sexual, and attachment traumas, and the chronic pain that so often follows these adversities. In her spare time (when is that?), Kait trains for triathlons, boxes, chases 4 kids and 4 pets around, and volunteers with various NGOs.
University of Miami, Miller School of Medicine
Jeff Gudin, MD, Faculty, Department of Anesthesiology & Pain Management, University of Miami, Miller School of Medicine
Jeff Gudin, MD, is on the faculty of anesthesiology and pain management at the University of Miami Miller School of Medicine. He previously served as attending physician in the Department of Anesthesiology at Englewood Hospital and Medical Center in New Jersey, and served as an associate clinical professor of anesthesiology at Rutgers-NJ School of Medicine. He is board-certified in pain medicine, anesthesiology, addiction medicine, and hospice/palliative medicine, and is a medical acupuncturist. Dr. Gudin’s clinical and research focus includes: novel non-opioid analgesics, post-operative pain management, opioid abuse and potential solutions, and increasing clinician awareness of pain assessment and risk management.
Dr. Gudin received his medical degree from Albany Medical College. He completed a residency in anesthesiology at Yale University School of Medicine and a post-doctoral fellowship in pain medicine at the Yale Center for Pain Management. He previously held the role of director of pain and palliative care at Englewood Hospital and Medical Center, NJ.
Imperial College London
Praveen Anand, MD, Professor of Clinical Neurology, Imperial College London
Praveen Anand is Professor of Clinical Neurology and Head, Centre for Clinical Translation, based at Hammersmith Hospital campus. His medical education was at the Universities of Oxford and Cambridge, and post-graduate training at the Hammersmith Hospital and the National Hospital for Neurology and Neurosurgery, Queen Square, London.
His research focuses on pathophysiological and molecular mechanisms in human sensory neuropathies and chronic pain syndromes. Collaborations with colleagues and pharmaceutical companies are directed to projects which bridge the gap between pre-clinical developments and their successful clinical applications. The translational approach has guided the recent success of 4 novel drugs from the laboratory to Phase II trials for chronic neuropathic pain and itch. He has over 200 peer-reviewed publications in journals including Nature, Nature Medicine, Nature Genetics, Science and The Lancet.
Ryan Lanier, Ph.D., Director, Clinical Development & Abuse Liability, Pinney Associates
Ryan began his career in the pharmaceutical industry as a clinical research scientist at Javelin Pharmaceuticals, where he assisted in the development of reformulated analgesic drug products intended to treat acute pain syndromes, including novel intranasal formulations of ketamine and morphine.
He then joined Rock Creek Pharmaceuticals, Inc., where he oversaw the development of CNS-active dietary supplements and modified risk non-combustible tobacco products. Ryan went on to lead the consulting team at Analgesic Solutions, Inc., providing strategic scientific and regulatory counsel to companies developing new analgesic therapies. He was the scientific lead for the validation and implementation of MADDERS®, a novel standardized system for prospectively identifying and assessing potentially abuse-related adverse events in clinical trials of CNS-active drugs to better estimate a drug’s true abuse potential.
Just prior to joining PinneyAssociates, Ryan worked on the early clinical development (phase 1 through 2a) of cannabinoid-based medicines and novel cannabinoid formulations for treating pain and other indications. He also led the assessment of market opportunities and created development plans for new products which could address unmet medical needs, including orphan indications. He counseled AusCann and worked as Associate Director, Pain and Abuse Liability for Spectrum Therapeutics (a Canopy Growth Corporation Company).
US Pain Foundation
Cindy Steinberg, National Director of Policy & Advocacy, US Pain Foundation
Cindy Steinberg is the National Director of Policy and Advocacy for the U.S. Pain Foundation and Policy Council Chair for the Massachusetts Pain Initiative. She is a nationally prominent and articulate spokesperson for the needs of people living with pain. She has been interviewed in print and on radio, television and internet websites including NPR’s All Things Considered and Marketplace, The New York Times, The Boston Globe, WCVB’s News Center 5, WHDH’s Channel 7 Urban Update, Boston’s NBC affiliate, WBZ News Radio, WBUR Boston, the Boston local CBS affiliate and ABCNews.com. She has authored Op-Ed’s that have appeared in the Huffington Post, the Boston Sunday Globe and WBUR’s CommonHealth Blog. Her dedication to pain advocacy was sparked when she sustained a severe crush injury, more than 20 years ago, that left her with daily back pain.
Ms. Steinberg has won numerous awards for her pain policy and advocacy accomplishments. She was awarded the 2023 American Academy of Pain Medicine Patient Advocacy Award for her commitment, contribution and leadership in the field of Pain Medicine, the 2021 American Massage Therapy Association President’s Award for her advocacy for access to therapeutic massage and other integrative modalities for individuals with chronic pain, the American Academy of Pain Medicine’s 2017 Presidential Commendation Award for leadership on behalf of individuals living with pain, the Grunenthal Unsung Hero Award for significant contributions to advance public policy in pain management as well as the social awareness of pain and suffering, the American Pain Foundation's Presidential Medal for outstanding contributions to the field of pain management and the State Pain Initiative Champion Award from the Alliance of State Pain Initiatives for her pain policy accomplishments. Ms. Steinberg was selected as one of six leaders in the field of pain management to receive the Mayday Pain & Society Fellowship for 2013-2014.
In 2015, she was appointed by Massachusetts Governor Charlie Baker to serve on his Opioid Working Group and subsequently Governor Baker appointed her to be a Commissioner on the Massachusetts Drug Formulary Commission. At the federal level, she has served on the Interagency Pain Research Coordinating Committee (IPRCC), a high-ranking pain policy oversight committee chaired by the NIH. In 2018, Ms. Steinberg was appointed by the US Secretary of Health and Human Services, Alex Azar, to serve on the Pain Management Best Practices Inter-Agency Task Force created by Congress and was the only patient and pain advocate appointed to the panel. In February of 2019, Ms. Steinberg was invited to testify before the US Senate Health, Education, Labor and Pensions (HELP) Committee at a hearing on “Managing Pain During the Opioid Crisis”.
In 2000, she founded the Boston-area/Arlington, Massachusetts Chronic Pain Support Group which she has led monthly, continuously all year around for 23 years. The group has introduced more than 500 chronic pain sufferers to positive ways to manage their lives despite their pain. Ms. Steinberg is a Phi Beta Kappa, Summa Cum Laude graduate of the University of Pennsylvania with a B.A. in psychology and a B.S. in education.
South Rampart Pharma
Hernan Bazan, MD, DFSVS, FACS, CEO & Co-Founder, South Rampart Pharma
Dr. Hernan Bazan completed his undergraduate work at Vanderbilt University and his medical school training at Georgetown University. During his medical school training, he was a Howard Hughes Medical Institutes Research Scholar at the National Institutes of Health (HHMI-NIH Research Scholars Program) in Bethesda, MD. He conducted his General Surgery training at The Mount Sinai Hospital in New York and his Vascular Surgery fellowship at Yale University/Yale-New Haven Hospital. During his training, he was elected member of the medical honor society Alpha Omega Alpha (AOA), The Arnold P. Gold Foundation, and numerous vascular surgery societies. He was awarded the HHMI Continuing Medical Studies Award for the work he conducted during his time at the NIH.
Dr. Bazan is the CEO and Co-founder of South Rampart Pharma and The John Ochsner Endowed Professor in Cardiovascular Innovation of the John Ochsner Heart & Vascular Institute. As a Board-certified academic vascular surgeon, his work aims to develop a safer non-opioid treatment for chronic and acute pain in order to avoid narcotic dependency and liver and kidney toxicity present in current analgesics. He is a co-inventor in the Composition of matter IP that protect the lead asset, SRP-001 and co-PI of an NIH/NINDS STTR fast-track commercialization grant. He has coordinated the various CROs work for the opened IND and, along with a CMC and FDA Regulatory experts team members, overseeing the current Ph 1 trial.
Hope in Pain
Shoshana Lipson, Executive Director, Hope in Pain
Shoshana Lipson is the President of Hope in Pain, Inc. and the founder of Hope for Migraine™ and Migraine Meanderings™. She is a patient advocate, speaker, and writer with a passion to encourage, support, educate and inspire people with migraine and other chronic pain conditions to find purpose and value in the midst of chronic illness. Shoshana was diagnosed in early childhood with migraine that rapidly chronified, as well as widespread joint pain. In 2018, she started exploring how to use her background in non-profit management, social media, and public speaking to help with patient advocacy.
Since 2018, Shoshana has built a community of over 20,000 active members across multiple social media platforms, and in 2021 launched a new initiative called, Empowering Patient Voices. She collaborates with various advocacy organizations and leaders who advocate for people with migraine and chronic pain, writes regularly for Migraine.com, and is the Partnership Director for MWS and WHEF. Shoshana has been a migraine advocate spokesperson for several organizations including the Association of Migraine Disorders, Healthy Women, the American Journal of Managed Care, and CHAMP, and she consults with various pharmaceutical and medical device companies.
Social Media & Contact Information
NINDS/National Institutes of Health
DP Mohapatra, Ph.D., Program Director for Pain, NINDS/National Institutes of Health
Dr. D.P. Mohapatra, is a Program Director at the National Institute of Neurological Disorders and Stroke (NINDS), and the NIH HEAL Initiative. He oversees research programs and portfolios in basic, preclinical, translational and clinical pain research & management, neurobiology of itch, peripheral and spinal mechanisms of somatosensation, glia/microglia biology, and communication between sensory and non-sensory systems in pain, itch and somatosensation. He leads several NIH HEAL Initiative programs such as, PRECISION Human Pain Network, Integrated Basic and Clinical Team-based Research in Pain, and Advanced Postdoctoral-to-Independent Career Transition Awards etc. He also serves in advisory role and as a subject matter expert for multiple HEAL Initiative programs on pain therapeutics discovery, development, screening, and optimization, as well as for NIH Blueprint Neurotherapeutics and NIH BRAIN Initiative programs.
Prior to joining NINDS, Dr. Mohapatra was a tenured Associate Professor of Anesthesiology in Washington University School of Medicine in St. Louis, and prior to that he was a tenured Associate Professor of Pharmacology at The University of Iowa Carver College of Medicine. During his academic career, he established multiple NIH- and DoD-funded research programs on peripheral mechanisms and models of inflammatory, cancer and neuropathic pain, as well as on translational pain research. His research utilized multidisciplinary approach, and simultaneous assessment of transcriptomic, molecular, biophysical, cellular and histological characterization of rodent and human sensory neurons and skin/tissue biopsies under physiological and painful conditions. He also established novel mouse models of neuropathic and cancer pain pathologies, and new/modified voluntary pain-associated behavioral outcome measures in mice, with pharmacological validations.
Dr. Mohapatra mentored several undergraduate & graduate students, and postdoctoral fellows, many of whom currently hold faculty positions at reputed academic institutions. During his academic career as a faculty, he extensively taught different neuroscience and pharmacology-related topics to undergraduate, graduate and medical students. Dr. Mohapatra earned his Doctorate in Human Biology from the University of Erlangen-Nuremberg, Faculty of Medicine (Germany), where his studies led to better understanding of how modifications in TRPV1 and Nav channel functions contribute to inflammatory pain signal transduction.
Jeff Reich, MD, Co-Founder, CEO, Sparian Biosciences
Jeff is a co-founder and CEO of Sparian Biosciences with over 30 years of experience in science, medicine, finance, and drug development. He co-founded and has served as CEO of Sparian Biosciences for the past four years since inception. Sparian is a bio-pharmaceutical company focused on discovering and developing new therapies to target CNS and substance use disorders. Prior to Sparian, Jeff was a founding board member of Neurologix – CNS focused gene therapy company and Scolr Pharma- a specialty pharmaceutical company. As CEO of Sparian, he has raised ~$20M in non-dilutive financing from NIH and led the successful advancement of the company’s pipeline. Specifically, he has led the advancement of SBS-1000, a novel non-opioid analgesic, through preclinical development, IND submission and a Phase 1 trial. Jeff has also advanced SBS-226, a program for opioid use disorder, through lead optimization and selection. He has also led Sparian’s efforts to build out the pipeline with innovative programs in related therapeutic area of focus. Multiple academic labs have entrusted Sparian to develop their innovative, discovery-stage compounds. Through in-licensing compounds from these labs/universities Sparian currently have 5 pipeline programs focused on non-opioid analgesia and substance use disorders.
He is a neurologist by training and those early years helped him build a strong foundation of knowledge in the neurobiology of pain, opioids, OUD, and other substance use disorders. As an Attending Neurologist and Assistant Professor of Neurology at Cornell, he established and built the Cornell Headache Center. After participating as a primary investigator on several clinical trials for pharma, he became more interested in the business of drug development than the practice. In 2001, he left clinical medicine for finance. For over 20 years he worked for two asset management funds focusing on both early and commercial stage companies. He managed an investment portfolio worth between $1B – $1.5B devoted to investing in innovative therapeutics. As an analyst and portfolio manager at Merlin Bio Med, he took active positions in early-stage companies. In 2005 he became a founding board member of Neurologix – a gene therapy company focusing on disorders of the nervous system – and took on many CEO responsibilities. There, he secured an IND that led to a successful Phase 2A trial of AAV2/GAD in Parkinson’s Disease (LeWitt PA et al., Lancet Neurol. 2011 Apr;10(4):309-19). In addition, he led the board’s effort in seeking a strategic partnership culminating in a term sheet from a major multinational pharmaceutical company and successfully negotiated a series C and series D financing.
National Institute of Neurological Disorders & Stroke, National Institutes of Health
Ram Arudchandran, Ph.D., Program Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health
In Ram's 20 years with the pharmaceutical industry and the government, including the Department of Defense (DOD) and the National Institutes of Health (NIH), he has managed multifaceted biomedical research projects involving basic, clinical, applied, and product-oriented research. Throughout his career, Ram has led interdisciplinary research teams engaged in biomarker development and drug discovery and development.
At the Department of Defense, he led the effort to create a working group on biomarkers as part of the Prostate Cancer Clinical Trial Consortium (PCCTC), which collaborated with industry, academia, non-profits, and government agencies to devise recommendations for precision medicine in prostate cancer treatment. Currently, Ram is the Program Director of the HEAL (Helping to End Addiction Long-Term) Biomarker Program at NINDS (The National Institute of Neurological Disorders and Stroke), overseeing the NINDS and HEAL pain biomarker research portfolios.
Aakanksha Jain, Ph.D., Senior Postdoctoral Fellow, Harvard University
Dr. Aakanksha Jain earned her PhD in Immunology from the University of Texas Southwestern Medical Center in 2019. Her thesis work in the laboratory of Dr. Chandrashekhar Pasare described how inflammation is triggered by autoreactive T cells uncovering novel therapeutic avenues for autoimmunity.
She is currently a Jane Coffin Childs postdoctoral fellow in the laboratory of Dr. Clifford J. Woolf at Boston Children’s Hospital, where her research is focused on delineating the neuroimmune mechanisms of inflammatory pain and hypersensitivity. She is also a researcher in the Precision Pain project, where she aims to characterize the non-neuronal cell types, cell states, and the immune microenvironment that influence pain signaling in chronic pain patients.
James Hackworth, Ph.D., President, Tris Pharma
James Hackworth, Ph.D., has over 15 years of multi-therapeutic area experience domestically and internationally with an extensive track record in licensing, M&A and partnership transactions, particularly those with a high degree of complexity; pharmaceutical commercialization; and drug development. Currently, he is President of Tris Pharma’s Brand Division, overseeing the commercialization of the company’s ADHD drugs and leading the development of products for pain, psychiatry and neurology. Prior to that he founded and was President of Park Therapeutics until it was acquired by Tris in April 2021.
Prior to founding Park, James held the position of Sr. Vice President, Corporate Development and Commercialization Strategy at Shionogi where he launched Symproic and Mulpleta and prepared the launches of Fetroja and Xofluza, the latter in partnership with Roche. James began his career as a consultant at McKinsey and Company and holds a Ph.D. in Physics from Columbia University and a B.S. in Physics from The Ohio State University.
Judy Ashworth, MD, Senior Vice President, Pinney Associates
Judy Ashworth draws on nearly two decades of experience in pharmaceutical drug development to provide clients with strategic input on target product profile development, clinical development plans, regulatory pathways (US and EU) and unmet medical need analyses with attention to potential market access challenges. Given her vast experience in the development of analgesics, including abuse deterrent formulations, Judy is particularly adept in advising clients on the development of CNS-active drugs with an emphasis on strategies for assessing abuse liability of novel compounds as well as new formulations of marketed compounds.
Trained in internal medicine, Judy began her pharmaceutical career in 2001 as a clinical pharmacologist at Gruenenthal GmbH, a German pharmaceutical company primarily focused on the development of innovative pain medications. In 2003, Judy took on the project leadership of Gruenenthal’s development of abuse deterrent formulations (ADFs) and an internal working group tasked with developing Gruenenthal’s expertise in abuse liability assessment as well as monitoring the rapidly evolving regulatory landscape surrounding the development of these new products.
From 2006-2008, Judy served as a visiting lecturer in Columbia University’s Department of Substance Abuse Research where she and Professors Sandra Comer and Herbert Kleber worked to develop new clinical trial designs for assessing the relative abuse potential of ADFs. During this time, she participated in the Tufts Health Care Institute’s Program on Opioid Risk Management – a series of summits which brought together major stakeholders including FDA, DEA, academia, and industry to work on potential solutions to the rising abuse of prescription opioids.
Judy established the Center of Excellence for Abuse Liability at Gruenenthal USA, Inc, a unit which supported the company’s commitment to help develop safer alternatives for the management of pain. In addition, Judy was the clinical lead for tapentadol during its registration process in the US and EU, set up a partnering intelligence department to support business development, helped establish the Innovative Medicines Unit at Gruenenthal’s headquarters and opened its first hub, and performed the search for and evaluation of novel analgesics to help enrich the company’s internal pipeline with external innovation from academia and biotech.
Judy graduated as a Dean’s Scholar from UCLA School of Medicine in 1993 and then completed the Internal Medicine residency program at Santa Barbara Cottage Hospital in 1996, serving as chief resident in her final year of training.
Dr. Todd Bertoch, M.D. is a diplomate of the American Board of Anesthesiology. He graduated Summa Cum Laude with a Bachelor of Science Degree in Biochemistry from California State University at Fullerton and received a Doctor of Medicine degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland. After an internship in Internal Medicine, he completed his Anesthesiology residency at Wilford Hall Medical Center in San Antonio, Texas, where he was Chief Resident and received the Arthur B. Tarrow Outstanding Resident Award. He is a member of the esteemed Alpha Omega Alpha Honor Medical Society.
Dr. Bertoch served as an anesthesiologist in the United States Air Force until 2006. Following the terrorist attacks of September 11, 2001, Dr. Bertoch participated in combat deployments to Mindanao in the southern Philippines and later to Balad Air Base in Iraq in support of Operation Enduring Freedom. He is a recipient of the Air Force Achievement Medal, the Air Force Commendation Medal, and the Meritorious Service Medal.
After completing his military service, Dr. Bertoch served for 11 years as the managing partner of Prescott Anesthesia in Prescott, Arizona where his practice included a focus on cardiovascular surgery, chronic pain management and addiction medicine. Since joining JBR Clinical research in 2017, he has served as Principal Investigator for over 80 clinical trials, defended development programs for sponsors before the FDA, been invited to present study results on behalf of clients at professional meetings, designed and authored numerous clinical trial protocols, and has helped author several industry-related articles and white papers.
David Roberson, Ph.D., Co-founder & CEO, Blackbox Bio
David Roberson is a pain neuroscientist and CEO of Blackbox Bio, a company he founded in 2021 with Clifford Woolf to address the need for automated, high-throughput measures of preclinical rodent behavior. He leads an active research program at Blackbox characterizing rodent behavioral phenotypes and their human correlates. His other research interest is exploring the application of psychedelics for treatment of chronic pain and central sensitization. David received his PhD from Harvard University and completed his postdoctoral training at Boston Children’s Hospital under Dr. Woolf.
Shariff Bayoumy, Co-founder & Managing Partner, Mebias Discovery
Shariff Bayoumy is a co-founder and Managing Partner of Mebias Discovery Inc, a clinical stage company focused on developing pathway selective drugs for G-protein coupled receptor targets founded in January 2016. At Mebias, Shariff directs protein biochemistry, cell biology, and in vivo efficacy studies.
Prior to co-founding Mebias Discovery, Shariff held various positions within Janssen Pharmaceuticals, 3 Dimesnional Pharmaceuticals, Memorial Sloan-Kettering Cancer Center, and at the University of Rochester. At Janssen North America, Shariff was Team Leader of the protein group which supported protein production for all small-molecule drug discovery across Janssen R&D sites in North America. He collaborated and consulted for cell biology and protein expression/purification at Janssen’ R&D site in Belgium. As a member and eventual team lead for all membrane protein production within Janssen, Shariff was responsible for managing a team to deliver membrane proteins, including G-protein coupled receptors for a wide range of discovery purposes including crystallography, biophysical screening, enzymology, NMR, large molecule discovery, and target validation.
Chris Benko, CEO & Co-founder, Koneksa Health
Chris Benko is the CEO and co-founder of Koneksa Health, the leading patient-centric digital biomarker company for the pharmaceutical and biotechnology industries that develops end-to-end solutions for remotely collected clinical data. Koneksa supports agile decision-making in drug development and market strategy. By delivering integrated solutions for efficient trial designs that produce more meaningful data, Koneksa aims to revolutionize effect detection in clinical research. Learn more at koneksahealth.com.
Prior to founding Koneksa, Chris was a vice president in Merck’s corporate strategy office, working with its Global Health Innovation venture capital fund. He began his career at Merck in 1995 and progressed through roles in information technology as well as talent and organizational development, working in R&D, commercial, and at the corporate level as vice president for global talent management.
Translational Scientist working >30 years’ within R&D, spanning both research & clinical development to senior executive level.
Broad experience developing new pain medicines and associated with >30 compounds progressing into clinical development. Led the research at Parke-Davis and Pfizer that identified Gabapentin (Neurontin®) and Pregabalin (Lyrica®) as analgesics and identified their MoA. Lyrica now treats millions of patients with pain disorders – generating peak revenues of over $5 Billion.
Inventor of the Personalized Analgesics® research approach including development of the Pain Diseasome® and Pain Landscape®.
Mark's research is documented in over 100 full-length manuscripts, abstracts and patents with ~5000 citations and h-index of 33. See Google Scholar.
Mark is a Fellow of the Royal Society of Biology and the Institute of Science & Technology and has a Visiting Lecturer appointment at King's College London.
Cleveland Clinic, Case Western Reserve Univ.
Carl Saab, Ph.D., Director, Pain Science, Technology and Research (STAR) Lab, Professor, Department of Biomedical Engineering & Neurological Institute, Cleveland Clinic, Case Western Reserve University
Carl Saab PhD, MA, MS. Professor, department of Biomedical Engineering, Cleveland Clinic and Case Western Reserve University, and adjunct Professor, department of Engineering, Brown University. Founder and Director of the Cleveland Clinic Consortium for Pain. Neuroscientist with expertise in basic and clinical pain research with a focus on biomarker development for pre-clinical and clinical use cases. Research in the Saab lab is mapping neural circuits of somatic and ocular pain in animal models using optogenetics, high density electrophysiology and automated behavioral paradigms, and in humans using EEG / ML.
South Rampart Pharma
Josh Blacher, MBA, Chief Financial Officer, South Rampart Pharma
Mr. Blacher has served in senior financial leadership roles for 25+ years and is currently Managing Partner of Columbus Circle Capital, a strategic finance and corporate development advisory firm focused on the life sciences industry, as well as Chief Financial Officer for South Rampart Pharma. Previously, he helped build and manage Teva Innovative Ventures, Teva Pharmaceuticals’ early-stage in-licensing and investment unit. Following his tenure at Teva, he served as CFO/CBO to three NASDAQ-traded biotechnology companies, the most recent of which was Inmed Pharmaceuticals. At Inmed, he championed and helped execute the company’s IPO, and managed its finance and accounting, business development and investor relations departments. Earlier in his career, he held senior positions in portfolio management at Deutsche Asset Management and equity research at Morgan Stanley, as well as in mergers & acquisitions at Lehman Brothers. He earned an MBA in Finance from Columbia Business School and BA in Economics from Yeshiva University.
Marc Lesnick, Ph.D., Chief Development Officer, Tris Pharma
Marc Lesnick, Ph.D., has over 20 years of experience in drug discovery and drug development, operating in regulatory affairs, quality and clinical roles. He has worked in multiple therapeutic areas, specializing in pain, anti-infectives and oncology. He is currently the Chief Development Officer at Tris Pharma, coordinating R&D, Clinical and Regulatory activities to accelerate the various development programs to market. Dr. Lesnick was a co-founder of Park Therapeutics, founded to develop novel solutions for pain, which was acquired by Tris in April 2021.
Prior to his current role, Dr. Lesnick held Sr. Vice President positions at Spruce Biosciences and QED Therapeutics, as well as at Cascadian Therapeutics and Shionogi. He held key roles in the development and approval of Fetroja, Symproic, Tukysa, and Dificid. He received his Ph.D. in Biology from the University of Oregon and a B.A. in Biochemistry and Molecular Biology from the University of California, Santa Cruz. His postdoctoral work in bacterial pathogenesis was performed at the University of California, San Diego, School of Medicine.
Ian Orozco, Ph.D., Senior Scientist, Anabios
Ian Orozco joined AnaBios in 2022 as a Senior Scientist in Neuroscience. There, he works with clients in both academia and bio/pharma industry to investigate pain mechanisms and test therapeutics in isolated human sensory cells. Ian acquired his Bachelor at UCLA, Ph.D. at Columbia University and post-doctoral training at the Leibnitz Institute for Molecular Pharmacology in Germany, where he acquired expertise in electrophysiological methods and published original research about the physiological and biophysical properties of various ion channels/proteins important for neural activity, endocrinology, channelopathies and small molecule therapy.
University of California Irvine
Kalpna Gupta, Ph.D., Professor, Department of Medicine, UC Irvine
Dr Kalpna Gupta has led pioneering work in understanding the mechanisms of adverse effects of opioids on cancer pain leading to cancer progression, and laid down the foundation of understanding the mechanisms of pain in sickle cell disease (SCD). These insights will help us treat both pain and the underlying disease process causing pain in the first place. Her laboratory has identified several new targets at the intersection of the sickle disease process and pain, including cannabinoid receptors, mast cells, and the nociceptin receptor, in addition to integrative approaches including environment’s modification, acupuncture and perception modulation to relieve pain.
Dr Gupta is also a recipient of the Excellence in Hemoglobinopathies Research Award from NHLBI to examine the potential of cannabinoids to treat pain and develop methods to quantify pain objectively. She has served as an advisor to the SCD program at NHLBI/NIH and received the “Pioneer Award” from the Sickle Cell Disease Association od America.
Kenneth Mackie, MD, Distinguished Professor, Psychological and Brain Sciences , Indiana University
Ken Mackie’s research program focuses on cannabinoid receptors, the cell surface receptors responsible for most of the psychoactive and therapeutic actions of cannabis. His group uses a variety of techniques, including electrophysiological, molecular, immunological, and imaging, to better understand how cannabinoid receptors signal and how their signaling interacts with other cellular processes.
Much of the current work in his lab centers on endogenous cannabinoids (endocannabinoids), compounds produced by the body that interact with cannabinoid receptors. These molecules have been implicated in processes as diverse as memory, analgesia, anxiety, schizophrenia, and obesity. One recent result from his group suggests that cannabis produces some of its effects by blocking the normal actions of endocannabinoids. This contrasts with the mode of action of opiates, which appear to produce their psychoactivity by mimicking the effects of endogenous opiates (endorphins). Another recent result found that cannabidiol counters some of the deleterious effects of delta-9-tetrahydrocannabinol.
Kathryn DeFea, Ph.D., Co-founder & CEO, Parmedics
Dr. DeFea received her BA in Physiology from UC Berkeley, her PhD in Biomedical Sciences from UCSF, and did postdoctoral fellowships at Stanford University and UCSF. Dr. DeFea’s general research interest has been in signal transduction, specifically protease-activated-receptor (PAR2) and the role of beta-arrestins in spatial regulation of downstream signaling moieties.
She was a Professor of Biomedical Sciences at UC Riverside for 17 years, during which time her laboratory elucidated the molecular mechanisms of PAR2 signaling in cell migration and general inflammatory responses. She also collaborated with several researchers examining the role of PAR2 and beta-arrestins in asthma, neuronal plasticity, and pain. In 2017, Dr. DeFea retired from academia to pursue work in the private sector, serving on biotech scientific advisory boards and as a consultant on opioid and cannabinoid signaling.
In 2020, Dr. DeFea co-founded PARMedics with researchers from U. Arizona and U. Texas at Dallas. The formation of PARMedics was driven by longstanding collaborations between the cofounders and the development of several peptide mimetic and small molecule ligands for PAR2. PARMedics currently has 2 NIH-STTR/SBIR-funded drug programs examining the efficacy of beta-arrestin-biased PAR2 antagonists as oral migraine and inhaled asthma therapeutics. Additional discovery phase programs examining PAR2 antagonists as therapeutics for osteoarthritis and cancer pain are underway.
Smriti Iyengar, Ph.D.,Program Director, Preclinical Screening Platform for Pain Program (PSPP), Division of Translational Research, NINDS, National Institutes of Health
Smriti Iyengar, Ph.D., is Program Director for the newly formed Preclinical Screening Platform for Pain (PSPP) program, in the Division of Translational Research, NINDS. She is a neuroscientist with extensive research and drug development experience focused on neuro-disorders including pain and headache. Prior to joining NINDS, she was an adjunct Senior Research Professor in the Department of Anesthesia, Indiana University School of Medicine, where her research interests included pain and headache mechanisms and neuroimmune interactions following traumatic brain injury as well as mechanisms leading to neuropathic pain.
She was formerly at Eli Lilly and Company, and prior to that at G.D. Searle and Company, Schering-Plough Inc. and Ciba Geigy. Her drug discovery expertise includes target, lead and clinical candidate identification and characterization as well as translational and clinical development, regulatory strategy, launch and commercialization. She played a key role in the development of duloxetine for pain and depression and has made significant contributions to >20 clinical candidates across a range of neuroscience targets, including CGRP and 5HT1F. Her postdoctoral training was at Rutgers University as a Charles and Johanna Busch Fellow in the Dept. of Physiology and Neuroscience, with her research focused on central regulation of opioid function and central regulation of neuroendocrine function including the HPA axis and stress.
She received her Ph.D. from M.S. University of Baroda, India, where she worked on the neurochemical basis of behavior in the developing brain. She has served as a member of several permanent and ad-hoc national and international committees established to evaluate research issues and to accelerate translational medicine in the area of pain, including ACTTION, IMMPACT, IMI Europain, TI Pharma translational pharmacology pain consortium and the Imaging consortium for drug development, as well as a member of several grant committees and cross functional strategy committees in neuroscience and pain. She is a Fellow of the American College of Neuropsychopharmacology.
University of California San Diego
Tony Yaksh, Ph.D., Professor, Anesthesiology and Pharmacology, University of California San Diego
Tony L. Yaksh obtained his Ph.D. degree from Purdue University (1971). He served in the U.S. Army (Captain / Cmlc) in the Biomedical Laboratory at Edgewood Arsenal, MD (1971-73), was a research scientist in the School of Pharmacy, University of Wisconsin (1973-76), and an Associate Research Scientist in Anatomy at University College London with Pat Wall (1976-77). He worked at the Mayo Clinic with Dr. Frederick Kerr in Rochester, MN in Pharmacology and Neurosurgery (1977-1988), where he rose to the rank of Consultant and Professor. Dr. Yaksh joined the University of California San Diego in 1988 as Professor and Vice Chairman for Research in the Department of Anesthesiology, and Professor in the Department of Pharmacology.
His research has been on the biology of pain processing. This work has provided a basis for understanding the pharmacology of the spinal and dorsal root ganglion gating of pain information. He is an expert in spinal drug kinetics and evaluation of spinal drug safety and has published more than 850 papers and edited 6 texts. His work has garnered over 53,000 citations in over 31,000 papers. He has been a mentor to more than 150 postdoctoral fellows and trainees. He has been funded consistently by NIH since 1977 and has twice been a Javitz Award recipient from NIH.
Dr. Yaksh has received several honors, including the Kerr Award from the American Pain Society, the Seldon Memorial Lecturer award from the International Anesthesia Research Society, the American Society of Anesthesiologists award for Excellence in Research and the FAER-Helrich lectureship, the Torsten Gordh lecturer award from the Swedish Society of Medicine, the Bonica Award from the International Association for the Study of Pain, and lifetime achievement/service awards from the North American Neuromodulation Society and from European Society of Regional Anesthesia.
Empirical Pharmaceutical Services
Brian Thomas, Ph.D., Principal Scientist, Empirical Pharmaceutical Services
I earned a doctoral degree in 1992 from Medical College of Virginia/Virginia Commonwealth University (MCV/VCU), where I became the first recipient of the Lauren A. Woods Award for outstanding graduate research in the Department of Pharmacology and Toxicology. My dissertation research was focused on characterization of cannabinoid physicochemical properties, structure-activity relationships, and receptor binding affinity and efficacy in the laboratory of Dr. Billy R. Martin.
In 1992, I joined Research Triangle Institute (RTI) and assumed the role of Principal Investigator on National Institute on Drug Abuse (NIDA) research contracts titled “Purity Specifications, Storage and Distribution for Medications Development” and “Preparation and Distribution of Research Drug Products”. I also began working with the University of Mississippi and Dr. Mahmoud ElSohly on the NIDA contract titled “Production, Analysis and Distribution of Cannabis, Marijuana Cigarettes and Related Materials” at this time. Serving in these roles continuously since 1992, I coordinated the preparation and analysis of research drugs and substance abuse treatment medications at RTI for more than 28 years, including a variety of novel cannabinoid drug substances and formulations, and over 35 million tobacco cigarettes of varying nicotine content for the United States Food and Drug Administration (FDA) to support clinical trials of reduced nicotine exposure tobacco products. These efforts also involved preparation and submission of Drug Master Files, Tobacco Product Master Files, and Chemistry, Manufacturing, and Control documentation to support their use in clinical trials. In addition to contract research service awards, NIDA R01 grant-funded research awards I received as Principal Investigator while at RTI involved the characterization of cannabinoid ligand-receptor interactions and their relationship to in vivo pharmacological effects (R01 DA011638), the development of novel cannabinoid receptor antagonists (R01 DA019217), and the characterization of synthetic cannabinoid inhalation exposures and pharmacological consequences (R01 DA040460), which received a perfect impact score of 10 (1 percentile) in 2016. During my tenure at RTI, I also received funding and directed pharmacological and analytical chemistry research studies to support a diverse group of organizations and health institutions, including the FDA, National Institute of Environmental Health Sciences (NIEHS), National Cancer Institute (NCI), National Institute of Mental Health (NIMH), National Institute of Neurological Diseases and Stroke (NINDS), National Institute of Justice (NIJ), U.S. Drug Enforcement Administration (DEA), and numerous universities and commercial clients.
In 2019, I joined Canopy Growth Corporation as Senior Director, Analytical Chemistry, Discovery Sciences, and Pharmaceutics, where I had management oversight of drug substance and product testing to support preclinical and clinical studies in accordance with regulatory guidance. I also directed the integration of medicinal chemistry and in vitro pharmacological screening approaches to support development of consumer products and drive clinical drug discovery and therapeutic product development and commercialization efforts. I was subsequently recruited by The Cronos Group to serve as the Director of Analytical Sciences, with management oversight of scientists at production and research and development facilities in the United States, Canada, and Israel. I am currently providing pharmaceutical consulting services as Principal Scientist at Empirical Pharmaceutical Services, LLC, where I leverage my knowledge and expertise in analytical chemistry, pharmacology, and toxicology to support drug discovery research and development in accordance with regulatory guidance and industry best practice. I was recently elected a Fellow of the College on Problems of Drug Dependence, and have authored or co-authored over 120 peer-reviewed manuscripts and numerous book chapters, and have co-authored a book on the analytical chemistry and pharmacology of cannabis.
Ben Vaughn, MS, RAC, Chief Strategist, Biostatistics & Protocol Design , Rho
A proven leader in the industry for more than 20 years, Mr. Ben Vaughn serves as Rho’s Chief Strategist for Biostatistics and Protocol Design. In this role, he utilizes his extensive expertise to guide sponsors through marketing applications, regulatory interactions, and the design and analysis of analgesia trials.
Mr. Vaughn has supported over 75 pain trials, over 30 marketing applications, and 6 FDA advisory committee meetings (both back room and bullpen) over the course of his career and has had speaking roles in dozens of FDA Type A, B, and C meetings. His experience spans many therapeutic areas with emphasis on abuse liability trials, substance use disorders, as well as other psychiatric disorders and rare disease (orphan) products. Mr. Vaughn earned both his bachelor’s and master’s degrees in Biostatistics from UNC-Chapel Hill.