Full CV is available upon request

EDUCATION                                                                

 ·        MBA: University of Washington School of Business – June 2001, Executive Master of Business Administration

·        Certificate of Advanced Management Program (CAM), Babson College, began classes Fall, 2005

·        Certificate Program, “Leadership and Strategy in Pharma and Biotech”, Harvard Business School, June, 2007

·        M.D.: UMDNJ-New Jersey Medical School, Newark, NJ - May 1980

·        B.A.: The Johns Hopkins University, Baltimore, MD – December 1975  Major, Natural Sciences

 POSTGRADUATE TRAINING

 ·        Neurology Residency: University of Washington School of Medicine, Seattle, WA - July 1981 thru July 1984.

·        Medical Internship: University of Washington School of Medicine, Seattle, WA - June 1980 thru June 1981.

PROFESSIONAL EXPERIENCE         

 Principal, NeuroDevMA Consulting, Inc.                                   December 2022 – Present

Clinical Neuroscience Consulting: Clinical Development and Medical Affairs

• Clinical neuroscientist with 21 years of CNS pharmaceutical/biotech industry experience.

• Has worked extensively in clinical development and medical affairs in small, medium, and large-sized companies.

• Board-Certified Neurologist, a Fellow of the American Academy of Neurology, and has more than 17 years of combined clinical practice/academic experience prior to embarking on a second career in pharmaceutical medicine.

• Works remotely from his homes in Arizona and Colorado but can assist your company irrespective of your location. Located close to commercial traffic airports (Phoenix Sky Harbor (PHX) and Montrose (MTJ)), Rob is able to easily travel to your destinations.

Executive Director, Clinical Development, Jazz Pharmaceuticals                    February 2021 – November 2022

• Clinical neuroscientist, Neuroscience Therapeutic Area Unit

• Business Development Neuroscience evaluation team, clinical development lead

• Global Development Lead (GDL) JZP150, endocannabinoid modulator (FAAH-I)

• Phase 2 Study Post-traumatic Stress Disorder (PTSD) – study design, regulatory interactions, study start-up activities

• Other areas of potential development interest: Autism Spectrum Disorder (ASD), Cannabis Use Disorder (CUD), Social Anxiety Disorder (SAD), Niemann Pick Disease (NPD) and other sphingolipidoses

• Interim GDL, JZP441, selective orexin-2 receptor agonist for the treatment of hypersomnias (narcolepsy and IH)

• New partnership of Jazz and Sumitomo

• Clinical development lead, Jazz diligence team; design of the initial CDP

• Jazz early asset phase 1 development team, medical lead

Senior Medical Director, CNS Clinical R&D, Takeda Pharmaceuticals                    October 2018 - January 2021

• Clinical neuroscientist, Neuroscience Therapeutic Area Unit

• Global Clinical Lead (GCL) for neurodegenerative synucleinopathies programs

  • TAK-341, anti-synuclein MAb for treatment of Parkinson’s disease (PD); collaboration with AZ; 3 phase 1 studies are in progress; IND and pre-IND meeting package submissions;

  • Use of digital sensor technologies – WATCH-PD Study collaboration with Biogen and University of Rochester will complete 12/2021

  • Critical Path for PD (CPP-3DT) precompetitive consortium to obtain regulatory feedback on the use of digital sensor technologies as endpoints in PD pivotal trials; Face-to-face meetings with FDA & EMA completed in 2019;

• Medical Lead for hypersomnia studies (TAK-925-2001 and TAK-925-2002) with selective orexin agonist compounds

• Global Project Team Co-Leader (GPL), for rare or familial neurodegenerative synucleinopathies

Senior Director, Clinical R&D, Impax (Amneal) Pharmaceuticals                    February 2011 – October 2018

• Sole R&D physician in the brand division and the only full-time neurologist ever employed by Impax Laboratories.

• Medical lead for all regulatory meetings and interactions

• IPX066 for the treatment of Parkinson’s disease; phase 3 program, NDA and EMA submissions - 1st draft author of the ISS; regulatory approvals (Rytary 2015) and Numient (2016);

• IPX203 for the treatment of advanced Parkinson’s disease; first draft author for phase 2 and 3 protocols; currently in 2 ongoing phase 3 studies (IPX203-B16-02 (has SPA Agreement with FDA) and B16-03);

• IPX229 (Zomig Nasal Spray) Migraine Phase 3 pediatric trials; primary author of new pivotal phase 3 Study IPX229-B16-01 which was required by FDA as part of a PREA (Pediatric Research Equity Act). This ongoing study is unique as the largest randomized, controlled phase 3 trial targeting the acute treatment of migraine attacks in young children ages 6 – 11.

• IPX159 (RLS): IND filing, design, execution, and completion of phase 1 and 2 studies;

• IPX233 (ADHD), IPX218 (epilepsy - ARS), IPX231 (Parkinson’s disease - acute abortive treatment of severe “OFF” episodes), IPX234 (migraine - acute abortive treatment), IPX237 (refractory MDD - abortive acute treatment); IND filings and phase 1 studies completed.

Vice President, Medical Affairs, Arena Pharmaceuticals Inc. June 2010 – December 2010

• In preparation to launch first commercial product, lorcaserin, a 5HT-2C agonist that was being reviewed by FDA for the treatment of obesity and weight management. BELVIQ received FDA approval 6-27-2012.

• Plan, assemble, mentor, and develop a highly functional Medical Affairs team

• Assisted clinical development team to prepare for a FDA Advisory Committee Meeting, including Briefing Book and REMS Strategies

• First draft author of the pediatric investigation plan (PIP)

Vice President, Global Medical Affairs, Elan Pharmaceuticals Inc. January 2010 – June 2010

• Led a team of 10 medical affairs professionals,

  • Promotional materials review team oversight

  • US and European MSL teams

  • Publications and medical information groups

  • Full budgetary responsibility

• Primary product: TYSABRI for MS; also PRIALT;

Vice President, Medical Affairs, Myriad Pharmaceuticals Inc. November 2007 – January 2010

• Plan, assemble, mentor, and develop a highly functional Medical Affairs team

• Medical Affairs organizational plan of approximately 45 individuals

• Full budgetary responsibility

• Preparation to launch its first product, Flurizan, a gamma secretase modulator and selective amyloid Abeta 42 lowering agent (SALA) nearing the termination of Phase 3 clinical trials for the treatment of mild Alzheimer’s Disease.

Senior to Executive Medical Director, CNS, Medical Affairs, Sepracor, Inc. August 2003 – November 2007

• Oversight of LUNESTA-related medical affairs activities and work streams; final package label negotiations with FDA; all pre-launch, launch, and post-launch activities;

• Phase 3b/4 and IIT studies design and execution, publications (abstracts, posters, oral presentations), scientific meeting paper presentations; medical information SRLs, safety;

• Promotional and scientific materials review, sales training materials and training, advisory boards (medical and commercial);

• Answering unsolicited clinical data questions from national health care payers and pharmacy benefits managers;

• Education and collaboration with MSL team (N=12)

• Pharmaco-economics and health outcomes research; managed markets dossier

US Medical Director, CNS Medical, Pfizer, Inc. January 2002 – August 2003

• Oversight of RELPAX-related US medical affairs activities and work streams; final package label negotiations with FDA; all pre-launch, launch, and post-launch activities;

• Primary activities: publications, MI (SRLs), MSL training, phase 3b/4 studies, advisory boards (medical and commercial);

• Pharmaco-economics and health outcomes research;

Founder and CEO, Edmonds Neurology Clinic, PC. October 1984 - December 2001

University of Washington School of Medicine – Seattle, Washington                          1984 - 2001

• Clinical Associate Professor of Neurology, Department of Neurology

CERTIFICATES AND LICENSES

• Active Medical License, State of Washington. #252-09 0019246; issued June 26, 1981

• Active Medical License, State of Utah. #7201234-1205; issued February 18, 2009

• Active Medical License, State of Arizona #29767; Issued September, 2002.

• Diplomat, National Board of Medical Examiners, # 228590; July 1981

• Diplomat, American Board of Psychiatry and Neurology, #31677, June 1989 

PROFESSIONAL AFFILIATIONS 

• Parkinson’s Progression Marker Initiative (PPMI) Partner Scientific Advisory Board (PSAB)

  • Elected Chair, 2021 - 2022 term (never served because left Takeda)

• American Academy of Neurology, 1984 - present

• Movement Disorders Society (2011 – 2022)

• American Headache Society (2011 – 2018)

• American Association of Sleep Medicine (2003 – 2007, 2011 - 2012)

• American Academy of Pharmaceutical Physicians (2001-2007)

• Washington State Medical Association (1984 - 2001)

• Medical Advisor, Washington State Chapter of the National Multiple Sclerosis Society, 1998-99

• Board of Directors, Multiple Sclerosis Association of King County, 1999-2001

• American Headache Society (2002-03)

• International Association for the Study of Pain (2002-03)

AWARDS AND HONORS 

• Beta Gamma Sigma, National Honor Society of Business Schools, Univ of Washington, April 2001.

• North Pacific Society of Neurology and Psychiatry for the first prize-winning paper in Neurology, March 24, 1983, on CNS Aspergillosis, Salishan, OR.

• Graduation Award for the top Pediatrics Student, UMDNJ-New Jersey Medical School, 1980.

• Alpha Omega Alpha (AOA) National Medical Honor Society, New Jersey Medical School, 1980.

• Graduated Honors, The Johns Hopkins University, 1976.

• Phi Beta Kappa, The Johns Hopkins University, 1976.

• Paper presentation at the Joint Immunobiology Meetings at Skyline Drive, VA, and at Ocean City, MD, 1976, 1975.

• New Jersey Air National Guard Scholarship Award, 1972

• President, National Honors Society, Somerville, NJ, 1971 - 72.

• Top Ten Statewide New Jersey State Science Day Award, 1971.

• Community Award for the cardiopulmonary resuscitation of two elderly people, 1970.