JOSEPH A. SLIMAN, MD, MPH

**** ********** ***** • Kensington, MD 20895

808-***-**** • ac7h0w@r.postjobfree.com

In providing senior leadership for clinical, public health, biotechnology and pharmaceutical development organizations, I have an extensive portfolio of successful programs and accomplishments, to include:

Over 16 years directing product development, clinical development and research in public health and in multiple medical therapeutic areas: respiratory, neurology, neuroendocrinology, nutrition, circadian rhythm disorders, dermatology, gastroenterology, infectious diseases and vaccines.

More than 8 years directing clinical and public health operations at clinics, acute care centers, field sites, and community health offices.

Leadership of multiple simultaneous clinical development projects and a separate, full pre-clinical and clinical development program.

Leadership and successful facilitation of multiple simultaneous clinical, research, field, and multidisciplinary teams, with administrative responsibility for professional excellence and growth of up to 23 individuals including up to 6 direct reports.

Leadership of the U. S. Pacific Fleet disease surveillance programs, including influenza surveillance, preparedness, and prevention as well as communicable disease and injury surveillance and prevention and health policy development.

Successful writing, reporting, and presentation of study findings, for academic, scientific, industry, and government leadership audiences.

PROFESSIONAL EXPERIENCE

SYNTHETIC BIOLOGICS INC, Rockville, MD • 2014 - present

Chief Medical Officer 2017 – present

As a member of the senior executive leadership of the company, I engage with the Chief Executive Officer and Board of Directors to define the company’s strategic direction and overall vision. In addition to leading and implementing the company’s overall clinical vision, I continue to perform the ongoing duties related to heading Clinical and Regulatory Affairs.

Providing key leadership and medical and clinical expertise for business development activities

Promote collaboration with Key Opinion Leaders across the company’s therapeutic areas (infectious diseases and gastrointestinal diseases).

Provide leadership of all regulatory activities including meetings with regulatory authorities

Significant accomplishments include:

oAchievement of End-of-Phase 2 meeting with FDA with agreed Phase 3 program and protocol requirements for a small molecule drug candidate for the treatment of irritable bowel syndrome

oAchievement of End-of-Phase 2 meeting with FDA with agreed Phase 3 protocol requirements for a biologic candidate for the prevention of C difficile infection

Senior Vice President, Clinical & Regulatory Affairs 2014 - present

Providing senior medical, regulatory, and clinical development leadership for multiple new drug candidates, for targeted pathogens that cause specific infectious diseases. Responsibilities include:

Strategic leadership for product development

Medical consultation and review of clinical study protocol design

Key clinical and regulatory document authorship and review

Data analysis and review

Liaison for clinical and medical consultants

Built a new Clinical and Regulatory Division, hiring 11 employees and spearheading the efforts to bring 2 new drug candidates from pre-clinical, IND-enabling studies to successful INDs and through end-of-Phase 2, all within a span of 36 months

oDesigned and led the initiation and completion of 2 Phase 1 studies and 5 Phase 2 studies for these 2 drug candidates

Led the design of proposed Phase 3 protocols for both programs

Leading the design of proposed initial Pediatric Study Plans for both programs

oLeading the design and implementation of IND-enabling studies for three additional drug candidates, including successful achievement of orphan drug designation for one monoclonal antibody candidate

VANDA PHARMACEUTICALS INC, Washington, DC • 2012 - 2014

Senior Medical Director 2012 - 2014

Providing senior medical and clinical development leadership for multiple new drug candidates, for indications including circadian rhythm disorders, mood disorders, schizophrenia, and alcohol dependence. Responsibilities include:

Strategic leadership for product development

Medical consultation and review of clinical study protocol design

Key document authorship and review (Clinical Study Reports, Integrated Summary of Safety, other regulatory documents)

Medical Monitoring of clinical studies including:

Non-24 Hour Disorder (Phase 3)

Major Depressive Disorder (Phase 2)

Pruritis (Phase 2a)

Data analysis and review

Liaison for clinical and medical consultants

Member of publications committee

Medical consultation for formulary support

Member of commercial team strategic planning and relations committee

Medical consultant for business development team

Providing senior pharmacovigilance oversight for candidate drugs in development and marketed products as Head of Patient Safety.

Providing senior leadership for review and management of grant-in-aid requests for medical education activities and investigator-initiated studies.

MEDIMMUNE LLC, Gaithersburg, MD • 2008 - 2012

Director, Clinical Development 2011 - 2012

Provided leadership and direction for multiple vaccine candidate projects, and clinical development program leadership for pediatric herpesvirus vaccine development. This included responsibility for clinical development plan, protocol, and key documents authorship and review. Other responsibilities included clinical oversight and strategic direction for: preclinical project development, data analysis, key opinion leader communication and liaison, and assay development. Clinical Product Development Team lead for:

Epstein-Barr Virus vaccine (Pre-clinical)

oAlso clinical development subject matter expert for the Research Project Team

Respiratory Syncytial Virus vaccine (Phase 1)

Intranasal Vaccine Delivery Device (Phase 3)

Clinical Development team member:

oRespiratory Syncytial Virus / Parainfluenza Virus 3 vaccine (Phase 1)

oQuadrivalent Live Attenuated Intranasal Influenza Virus vaccine (Phase 3 through Registration)

Team member and contributor to the successful licensure application for Quadrivalent Live Attenuated Intranasal Influenza Virus vaccine:

BLA section authorship; BLA review and editing team member

VRBPAC preparation and review data expert and team member

Recipient of MedImmune “Excellence in Clinical Development” Award (2)

Clinical Development voting member of MedImmune Protocol Review Committee

Associate Director, Clinical Development 2008 - 2011

Provided medical monitoring, clinical oversight, and protocol and key document (final study reports, abstracts, and manuscripts) authorship and review. Provided strategic direction and team leadership for pediatric and adult respiratory vaccines development projects and studies, and oversaw communication with key opinion leaders and principal investigators. Clinical development projects include:

Respiratory Syncytial Virus vaccine (Phase 1)

Respiratory Syncytial Virus / Parainfluenza Virus 3 vaccine (Phase 1)

Quadrivalent Live Attenuated Intranasal Influenza Virus vaccine (Phase 3)

Intranasal Vaccine Delivery Device (Phase 3)

DYNPORT VACCINE COMPANY LLC, Frederick, MD • 2008

Associate Medical Director

Subject matter expert and clinical director for seasonal and pandemic influenza vaccine trials as well as Defense Vaccines development program (partnered with DoD Joint Vaccines Acquisition Program). Provided leadership of program and study teams including protocol and key documents authorship and review, enrollment screening monitoring, clinical medical monitoring duties (safety and adverse events monitoring), and data management oversight. Led the clinical development study team for:

Seasonal Influenza vaccine (Phase 3)

Pandemic Influenza vaccine (Phase 1)

Recombinant Botulinum toxin vaccine (Phase 2)

NAVY ENVIRONMENTAL AND PREVENTIVE MEDICINE UNIT SIX, Pearl Harbor, Hawaii • 2004-2008

Head of Office of Clinical Research

Created and directed a new office of clinical research to plan and carry out effectiveness studies for the US Pacific Fleet and US Pacific Command, providing subject matter expertise and study team leadership as well as financial management. Activities included:

Drafted Standard Operating Procedures (SOPs) for the establishment of a DoD Navy FWA Addendum.

Oversight of the Clinical Research Laboratory.

Partnership with other Federal and DoD research centers to ensure compliance with “The Common Rule” and all Federal and DoD-specific policies for the protection of Human Subjects

Drafted all grant requests and managed granted funds for conduct of clinical studies.

Designed and conducted a Fleet-wide study of antibiotic effectiveness against CA-MRSA skin infections among sailors assigned to Submarine Forces Pacific.

Head of Threat Assessment Department and Epidemiology Division

Directed a multidisciplinary team of 14 allied health professionals to address multiple public health threats and track developing health trends in the US Pacific Fleet, providing overall leadership and professional and financial management.

Provided clinical occupational medicine consultation, including pre- and post-deployment physicals and health screenings and health surveillance physicals as well as tropical medicine and travelers’ health consultation for Navy Region Hawaii.

Led the Pacific Fleet Disease and Non-Battle Injury Surveillance program and implemented the training protocol and standard operating procedures for data collection and analysis; standardized the application of risk assessment, mitigation, and communication efforts to reduce the operational and financial impact of disease and injury clusters within the Fleet.

Directed and led outbreak investigations as primary investigator for Pacific Fleet; investigated 11 disease outbreaks, wrote the report for each investigation and presented the findings to senior leaders as well as peers at professional meetings.

Trained the junior officers and preventive medicine technicians in epidemiology and outbreak investigation through weekly seminars and case studies; assembled and led an eight-person team for a combined respiratory disease-industrial hygiene investigation aboard ship.

Conducted cost-benefit analyses on clinical and preventive health services to provide recommendations on maximizing return on investment and improve measurable health indicators within various government and international populations.

Maintained field epidemiology and biostatistics research programs as adjunct professor of Medicine for both the John Burns School of Medicine of the University of Hawai’i at Manoa, and the F. Edward Hebert School of Medicine of the Uniformed Services University.

Provided leadership and subject matter expertise for the influenza vaccine program implementation for Navy region Hawai’i.

Certified by the World Health Organization in the Training of Trainers for Pandemic Influenza Civil-Military Preparedness; conducted several training seminars for U.S. and international groups on pandemic flu and disaster preparedness and disease outbreak investigation.

Health Policy Analyst, Environmental Protection Agency, Washington, DC (2002-2003)

Served as the medical officer and senior health policy adviser to the Division of Pollution Prevention, Pesticides, and Toxic Substances and the Office of Science Policy and Coordination. Activities included:

oLiaison to the USEPA Office of Science Coordination and Policy for medical epidemiology and public health.

oDevelopment of revised continuing education materials on environmental health and toxicology.

oDevelopment of an investigational plan on the health effects of methylmercury and fish consumption.

oDevelopment of an investigational plan on the health benefits of omega-3 fatty acid consumption (natural vs supplemental); included a retrospective analysis via NHANES and a series of prospective clinical studies.

Community Health Officer, Anne Arundel County Department of Health, Annapolis, MD (2003)

Served as the Communicable Disease Prevention and Disaster Preparedness Officer. Conducted a county-wide review of the Health Department’s emergency preparedness before, during, and after Hurricane Isabel, and developed the county’s preparedness plans.

Community Health Officer, Division of Health Promotion & Disease Prevention, Baltimore City Health Department, Baltimore, MD (2003)

Performed a cost-benefit analysis of the HIV/AIDS mobile outreach program in Baltimore City; produced a cost-reduction plan for the through elimination of redundant operations and contracting, with a marketing plan to improve efficiencies and return on investment.

Flight Surgeon, 26th Marine Expeditionary Unit (2001-2002)

Conducted investigation and wrote aeromedical analysis for 11 aircraft mishap investigations (8 as primary aeromedical investigator).

Provided aeromedical evacuation coordination, planning and training support for Operation Enduring Freedom.

Provided infectious diseases consultation to the coalition forces and for detainees in Kandahar, Afghanistan.

Operations Officer, Branch Medical Clinic, Marine Corps Air Station, New River, NC (2000-2001)

Developed and instituted the standard operating procedures for the medical staff for the Air Station; improved coordination with state and local health departments for disaster planning and preparedness as Air Station Disaster Preparedness Medical Officer. Improved local response capabilities through development and exercise of civil-military training plans.

EDUCATION & POSTGRADUATE TRAINING

Residency in Preventive Medicine, Johns Hopkins Bloomberg School of Public Health, 2002-04

oDavid Paton Award (given to Preventive Medicine Resident of the Year at Johns Hopkins SPH), 2003

M.P.H., Johns Hopkins Bloomberg School of Public Health, 2003

Internship in Transitional Medicine, National Naval Medical Center, 1998-99

M.D., Uniformed Services University of the Health Sciences, 1998

B.S., Molecular and Cell Biology, with Honors in Biology, Pennsylvania State University, 1994

PROFESSIONAL CERTIFICATIONS

Licensed to practice medicine and surgery in Maryland, unrestricted, 1999 (current through 2019)

Board certified in Public Health and General Preventive Medicine, American College of Preventive Medicine, 2005

Certified in Clinical Tropical Medicine and Travelers’ Health, American Society of Tropical Medicine and Hygiene, 2005

Certified in Travelers’ Health, International Society of Travel Medicine, 2005

Designated Naval Flight Surgeon 5148 by the Naval Aerospace and Operational Medical Institute, 2000

SELECTED SPEAKING ENGAGEMENTS

Chairman, 3rd Annual European Microbiome Congress, 2017 November 27-29, London, UK.

5th Annual Cdiff Awareness Conference, “Primary Prevention of CDI and Antibiotic Resistance”, 2017 November 10, Las Vegas, NV.

National Cancer Institute Center for Global Health Burkitt Lymphoma Meeting, “EBV Vaccine development”, 2012 July 30, Philadelphia, PA

47th Navy Occupational Health and Preventive Medicine Conference (Keynote), “An Outbreak of Respiratory Illness Aboard USS Boxer (LHD 4)”, 2008 March 19, Hampton, VA

University of Hawai’i School of Medicine Tropical Medicine Seminar Series, “An Outbreak of Leptospirosis in U.S. Marines in the Northern Training Area of Okinawa”, 2007 November 28, Honolulu, HI.

WHO/CDC Rapid Response for Avian and Pandemic Influenza Workshop for U.S. Pacific Command Rapid Responders, “Case Investigation of Avian Influenza: Epidemiology”, 2007 April 3, Pearl Harbor, HI

International Conference on Emerging Infectious Diseases 2006, “Community-Acquired Methicillin-Resistant Staphylococcus aureus (CA-MRSA) Carriage Among Pacific Submarine Personnel”, 2006 March 21, Atlanta, GA

Internal Medicine, Family Practice, and Pediatrics Combined Grand Rounds, Tripler Army Medical Center, “Operation Unified Assistance: NEPMU-6 Humanitarian Assistance & Disaster Relief Efforts in Indonesia”, 2005 May 18, Tripler Army Medical Center, HI

Internal Medicine Grand Rounds, National Naval Medical Center, “26th MEU ACE Medical: Operation Enduring Freedom”, 2002 October 17, Bethesda, MD

SELECTED PUBLICATIONS

Kokai-Kun JF, Roberts T, Coughlin O, Sicard E, Rufiange M, Fedorak R, Carter C, Adams MH, Longstreth J, Whalen H, Sliman J. The Oral β-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies. Antimicrob Agents Chemother. 2017 Feb 23;61(3).

Muskal SM, Sliman J, Kokai-Kun J, Pimentel M, Wacher V, Gottlieb K. Lovastatin lactone may improve irritable bowel syndrome with constipation (IBS-C) by inhibiting enzymes in the archaeal methanogenesis pathway. Version 3. F1000Res. 2016 Apr 8 [revised 2016 Jan 1];5:606.

Roberts T, Kokai-Kun JF, Coughlin O, Lopez BV, Whalen H, Bristol JA, Hubert S, Longstreth J, Lasseter K, Sliman J. Tolerability and Pharmacokinetics of SYN-004, an Orally Administered β-Lactamase for the Prevention of Clostridium difficile-Associated Disease and Antibiotic-Associated Diarrhea, in Two Phase 1 Studies. Clin Drug Investig. 2016 Sep;36(9):725-734.

Kaleko M, Bristol JA, Hubert S, Parsley T, Widmer G, Tzipori S, Subramanian P, Hasan N, Koski P, Kokai-Kun J, Sliman J, Jones A, Connelly S. Development of SYN-004, an oral beta-lactamase treatment to protect the gut microbiome from antibiotic-mediated damage and prevent Clostridium difficile infection. Anaerobe. 2016 Oct;41:58-67.

Gottlieb K, Wacher V, Sliman J, Pimentel M. Review article: inhibition of methanogenic archaea by statins as a targeted management strategy for constipation and related disorders. Aliment Pharmacol Ther. 2016 Jan;43(2):197-212.

Malkin EM, Yogev R, Abughali A, Sliman JA, Wang CK, Zuo F, Eickhoff M, Esser MT, Tang RS and Dubovsky F. Safety and Immunogenicity of a Live Attenuated RSV Vaccine in Healthy RSV-seronegative Children 5-24 months of age. PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104.

Balfour HH, Sifakis F, Sliman JA, Knight JA, Schmeling DO, and Thomas W. Age-specific Prevalence of Epstein-Barr Virus (EBV) Infection among Children in the United States and Factors Affecting its Acquisition. J Infect Dis. 2013 July 18. doi: 10.1093/infdis/jit321.

Sheldon EA, Jeanfreau R, Sliman JA, Charenkavanich S, Rousculp MD, Dubovsky F, and Mallory RM. Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study. Influenza Other Respi Viruses. 2012 Oct 14. doi: 10.1111/irv.12027.

Sliman JA, Metzgar D, Asseff DC, Coon RG, Faix DJ, and Lizewski S. An Outbreak of Acute Respiratory Disease Caused by Mycoplasma pneumoniae onboard a Deployed US Navy Ship. J Clin Microbiol. 2009 Dec;47(12):4121-3.

Sliman JA, Eberly, BJ, Tamashiro DA, Calimlim PS, and Whelen AC. Community-Acquired Methicillin-Resistant Staphylococcus aureus (CA-MRSA): Investigation on a United States Navy Ship. Haw J Public Health. 2008;1:62-67.

Sliman, JA, Young, JL and Brostrom, R. Tuberculosis in the CNMI: A Perspective Over a Decade. International Conference on Emerging Infectious Diseases 2008. Poster, 2008 March 19, Atlanta, GA.

Sliman JA, Althoff J, Thornton SA, Kasowski EJ, Smith WJ and Smith V. Staphylococcus aureus Carriage in Pacific Fleet Submarine Crewmembers. 45th Navy Occupational Health & Preventive Medicine Conference. Poster, 2006 March 20, Hampton, VA.

Sliman JA, Joseph CB, and Mahaffey KR. Fish Consumption and Dietary Counseling. 6th International Conference on Mercury as a Global Pollutant. Poster, 2004 June 27, Ljubljana, Slovenia.

Shuping EE, Sliman JA, Gaydos JC, & Gaydos CA. Chlamydia trachomatis screening in Defense Department recruits. International Conference on Emerging Infectious Diseases 2004. Poster, 2004 March 01, Atlanta, GA.

Sliman JA & Cyr RJ. “Cytoplasmic calcium levels alter the sensitivity to anti-microtubule drugs in carrot protoplasts”. Molecular Biology of the Cell. Vol. 3supp, Sept., 1992, p. 168a.

COMMUNITY ACTIVITIES

Rotary Club of Southern Fredrick County (Frederick, MD)

oPresident, 2013-14

oHistorian, 2011-13

oMember, 2009 - 2016

Board of Directors, Mental Health Association of Frederick County

oMember 2013-16

Board of Trustees, Trinity School of Frederick (Frederick, MD)

oMember, 2009 - 2012

Tivoli Society of the Weinberg Center for the Arts (Frederick, MD)

oMember, 2010 - present

Alumni Association, The Pennsylvania State University (University Park, PA)

oGolden Lion Society Member, 2010 - present

oPresident’s Club Member, 2008 – present

oLifetime Member, 1994 - present

Contact this candidate