Leon Marcell Huddleston
Oak Forest
Summary
In summary, the role of Medical Affairs is multifaceted, focusing on scientific expertise, clinical research, regulatory compliance, external relationships, and patient-centered outcomes, all while ensuring that a company’s products and services meet the highest standards of safety, efficacy, and value in healthcare.
Overview
37
37
years of professional experience
Work History
Key Opinion Leader
INSPE Associates, Inc, Medical Consultants Network, LLC, Medical Evaluation Specialists
- KOL) Engagement: Medical Affairs teams work to build relationships with KOLs and scientific experts to foster collaboration and obtain feedback on medical products and research
- They often manage advisory boards and participate in scientific congresses
- Scientific Exchange: They facilitate the exchange of scientific data between internal teams, external researchers, clinicians, and stakeholders in various forums, including conferences, symposia, and webinars
- Market Access and Commercial Support
- Medical Strategy Alignment: Although Medical Affairs remains independent from sales and marketing, it collaborates with these departments to ensure that the promotion of products is scientifically accurate and aligned with the needs of patients and healthcare providers
- Real-world Evidence (RWE): Medical Affairs plays a key role in gathering real-world data (such as from patient registries or post-market surveillance) to support the efficacy, safety, and value of treatments once they are on the market
- Patient-Centered Approach
- Patient Advocacy: Medical Affairs helps advocate for patient needs by gathering insights from patients and caregivers
- It supports the development of patient-centered education programs, ensuring that the voice of the patient is heard in the development of new treatments
- Health Economics and Outcomes Research (HEOR): This includes assessing the cost-effectiveness of treatments and their broader impact on health systems, which is increasingly important for securing market access
- In summary, the role of Medical Affairs is multifaceted, focusing on scientific expertise, clinical research, regulatory compliance, external relationships, and patient-centered outcomes, all while ensuring that a company’s products and services meet the highest standards of safety, efficacy, and value in healthcare., Inc
- Veterans Evaluation Services
- Leidos/QTC
- EdiPhy Advisors
Communication Center Operator
United States Marine Corps Lance Corporal, Schwab Rehab Hospital
01.2009
- Course
- Combat Action Ribbon
- Letter of Appreciation
- National Defense Service Medal
- Completion of Field Wire Course
- Kuwait Liberation Medal
- Certificate of Good Conduct
- Southeast Asia Service Medal
- Certificate of Commendation
- LECTURES
- Hyperbaric Oxygen Therapy and its Indications 10/2023 – Northern Illinois Affiliate of the Wound, Ostomy, Continence Nurses Society Conference
- Pain Management in the Home Care Setting 3/2016 – Illinois Homecare and Hospice Council Annual Conference and Exposition
- Clinical Pathway to an Amputation 4/2013 – Hangar Clinic Symposium: Best Practices for Successful Rehab of the Amputee
- The Role of Electrodiagnostic Testing in Carpal Tunnel Syndrome and Radiculopathy 5/2009 – Diamond Mark Educational Meetings
- Cervical & Lumbar Radioculopathy 2, Resident Lecture Series
- Pain Management in the Elderly 1/2008
- Fall Prevention in the Elderly 12/2007
- Diagnosis & Non-Surgical Treatment of Common Neuropathies 11/2007
- Breast Cancer 10/2007
- Best Infection Control Practices 8/2007
- Diabetes Mellitus 7/2007
- Hereditary Motor Neuron Diseases 6/2006 – International African American Prosthetic & Orthotic Coalition Annual Meeting
General Counsel and VP
Grand Prairie Services Integrated Health
07.2019 - Current
- Corporate Risk and Compliance, Provide legal advice to senior leadership on a variety of matters, including corporate governance, mergers and acquisitions, healthcare regulations, litigation, compliance, and risk management
- Collaborate with other executives to drive strategic initiatives, ensuring all legal aspects are appropriately addressed
- Ensure compliance with applicable federal, state, and local healthcare laws (e.g., HIPAA, Stark Law, Anti-Kickback Statute, Affordable Care Act)
- Advise on risk management and compliance strategies, ensuring the organization adheres to healthcare industry regulations and accreditation standards
- Oversee and manage the drafting, negotiation, and review of contracts with healthcare providers, insurers, vendors, and other stakeholders
- Ensure that contracts align with company objectives while mitigating legal and financial risks
- Manage litigation and dispute resolution, including overseeing external counsel and developing strategies for legal matters
- Represent the organization in regulatory investigations or hearings as necessary
- Corporate Governance:
- Support the organization’s board of directors in governance matters, ensuring legal compliance in corporate structures, policies, and procedures
- Advise on corporate ethics, risk mitigation strategies, and legal governance best practices
- Leadership & Team Management:
- Lead and manage a team of legal professionals, ensuring efficient and effective legal support across the organization
- Foster collaboration between legal, compliance, and operational teams
- Education & Training:
- Develop and deliver training programs on relevant healthcare laws and compliance issues for staff and executives
- Stay up-to-date with evolving healthcare laws, policies, and regulations to proactively mitigate risks.
Clinical and Medical Affairs
Healogics, Inc
07.2019 - Current
- Responsible for Resource calls for clinical/ administrative purposes
- Regional educational symposium participation and planning
- CME presentations
- Physician hotline
- E-mail correspondence
- Wound Center visits
- Calls with Development re: pipeline, updates, key MD contact information
- Development presentation (including travel)
- Interviews and selection process for LMD/ panel
- Coordinate physician selection with hospital partner/ implementations/ regional team Payer education presentations
- Implementation training for LMD/panel Scientific Expertise and Support
- Medical Information: Medical Affairs provides accurate and up-to-date scientific information to healthcare professionals (HCPs), patients, and internal stakeholders
- This includes answering complex medical questions, presenting data on clinical trials, and disseminating new research findings
- Medical Education: It offers educational materials and training to healthcare providers, ensuring they are informed about new products, therapies, or clinical guidelines
- This helps them make evidence-based decisions for patient care
- Clinical Expertise: Medical Affairs professionals often have deep expertise in specific therapeutic areas, such as oncology, cardiology, or immunology, and help guide the company in understanding the evolving landscape of medical science
- Clinical Development Support
- Clinical Trial Design: Medical Affairs teams collaborate with clinical development to design and execute clinical trials, ensuring they are scientifically sound and aligned with the needs of patients and the medical community
- Medical Insights: They gather insights from key opinion leaders (KOLs), healthcare professionals, and scientific communities to ensure clinical trials are relevant and that new treatments meet the unmet medical needs
- Trial Results Interpretation: Medical Affairs is responsible for interpreting the results of clinical trials and translating these findings into actionable insights for healthcare providers
- Regulatory and Compliance Support
- Regulatory Affairs Collaboration: They ensure that all communication, data, and materials related to the company's products comply with regulatory guidelines set by authorities like the FDA, EMA, or other health agencies
- Ethical Oversight: Medical Affairs ensures that the scientific and medical integrity of all activities is maintained and adheres to ethical standards, which is crucial for maintaining trust and credibility
- Strategic Communication and External Engagement
Principal
Gritstone Professional Services, LLC, SBA Certified
06.2018 - Current
- Veteran-owned professional services firm that provides legal, consulting, regulatory compliance, and arbitration services
- The primary area of practice is in the healthcare sector.
Medical Director
Amita St. Joseph Center for Wound Care and Hyperbaric Medicine
10.2010 - Current
- Responsible for implementing the full spectrum of care in the management of chronic and acute wounds in the hospital’s wound care and hyperbaric medicine center
- Work with attending physicians and staff to ensure best wound care outcomes while informally supervising 10-11 staff members
Practice Manager
Huddleston Medical Services, S.C
03.2007 - 07.2023
- Full accountability for all daily operations of a private medical practice for the rehabilitation as well as medical and interventional management of patients with acute and chronic pain syndromes
- Performs credible and unbiased independent medical examinations, medical record, utilization, disability, and workers compensation reviews along with expert testimony for local and national companies including:
- Claims Eval, Inc
- ExamWorks, Inc.
Volunteer Physician Advisor
Texas Medical Center Innovation Institute
02.2018 - 01.2020
- As a physician advisor provided strategic and tactical guidance to the innovation community that includes digital health and medical device startup companies, Biodesign fellows, and strategic partners.
Attending Physician
Advocate South Suburban Hospital
08.2009 - 01.2020
- Responsible for implementing a full spectrum of care in the management of chronic and acute wounds in the hospital’s wound and hyperbaric medicine center.
Consultant
Medline Industries, Inc
06.2014 - 06.2015
- Contracted to assist Medline in the preparation of clinical posters reflecting clinical data accumulated by the use of Medline’s products in wound management and to perform data collection to support the same; present the clinical poster during selected wound care conferences.
Assistant Attending Physician
Rehab Associates of Chicago, Rush University Medical Center, Rush Oak Park Hospital
06.2006 - 01.2012
- Provided rehabilitation and medical management similar to the position described above (Schwab)
- Instructed resident-physicians in the principles and practice of physical medicine and rehabilitation
- Responsible for providing wound care services at Rush Oak Park Hospital.
Attending Physician
Schwab Rehabilitation Hospital
07.2005 - 10.2010
- Responsible for the rehabilitation and medical management of patients with loss of function due to stroke, brain and spinal cord injuries, and various traumas
- Instructed resident physicians in the core principles of physical medicine and rehabilitation.
Medical Director
Divine Providence Home Health Services
06.2007 - 04.2010
- Oversaw and directed all medical programs for a Medicare certified home health agency recognized as a leader in quality of care
- Developed and implemented policies and procedures, coordinated care planning and participated in marketing, quality assurance, and patient relations
- Collaborated with physicians to achieve short and long-range goals for staff development and programs to enhance patient quality of life.
Medical Director
Health Benefits Pain Management
07.2005 - 02.2007
- Provided leadership and direction for all medical programs at the practice for nonsurgical spine care, EMGs, peripheral joint injections (including arthrography) and medical pain management
- Defined performance standards and measurements to improve care plan development, implementation and service delivery
- Directly managed care for patients with acute and chronic pain secondary to a variety of musculoskeletal and nerve injuries.
Schwab Rehabilitation Hospital
07.2002 - 06.2005
- Residency: Physical Medicine & Rehabilitation
- Directed and coordinated inpatient care and outpatient management while guiding patients through the system of care to ensure safe discharge
- Gained experience with patients of multiple socio-economic backgrounds in various aspects of neurorehabilitation, musculoskeletal medicine and amputee care
- Specialized in the diagnosis, treatment and medical management of patients with various pain syndromes at the University of Chicago Pain
- Clinic and Health Benefits Pain Management Clinic
- Worked with a high number of patients with minor, acute trauma along with treatment of emergent medical issues
- Participated in 200-plus EMGs at Schwab Rehab Hospital, Northwestern Hospital, Midwest Orthopedic Consultants and, Chicago Institute of Neurosurgery & Neurosciences.
MILITARY SERVICE
09.1988 - 07.1992
Education
Juris Doctor -
DePaul University College of Law
05.2012
Certificate in Mediation - undefined
Northwestern University School of Continuing Studies
02.2014
Residency - Physical Medicine & Rehabilitation
Schwab Rehabilitation Hospital/University of Chicago
06.2005
General Surgery Internship - undefined
Loyola University Medical Center
06.2002
Doctor of Medicine - undefined
University of Illinois at Chicago College of Medicine
05.2001
B.S. - Molecular Biology emphasis
Chicago State University
06.1997
Affiliations
- Diplomate of the American Board of Physical Medicine & Rehabilitation
- American Health Lawyers Association – Leadership Development Program, Health Information - Technology Practice Group (2015-2016)
- American Bar Association
- Chicago Bar Association
- Chicago Medical Society
- Cook County Bar Association
- Fellow – Illinois Bar Foundation - (until 2015)
- Illinois State Bar Association – Military Affairs Committee, Health Care Section Council (2015-2017)
- Illinois State Medical Society – Medical Legal Council (2015-present)
- Illinois Association of Healthcare Attorneys – past member
Research
- Research Assistant in Molecular Genetics, Chicago State University, 1994-1997, Worked with Dr. Mark Erhart on the t-complex located on mouse Chromosome 17, which is related to the Human Major Histocompatibility Complex II, to understand how the t-complex is inherited in mice which would help to determine how the MHC II is transmitted in humans.
- Platform Speaker, Board of Governors 7th Annual Student Research Conference, 07/01/96, Possible Transcription of Presumptive Anonymous DNA Sequence in the Mouse
- Platform Speaker, 7th Annual Argonne Symposium, 07/01/96, A Proposed Mechanism of the Splicing of the Mouse Alpha – A Crystalline Gene
- Presenter, National Conference of Undergraduate Research, 1995, The Effects of Rat Muscle Hypertrophy on Cellular RNA Levels
Posters
- Innovative Use of Total Contact Casting in Atypical Lower Extremity Ulcers, Huddleston, L, Wrona, C, Diabetic Foot Conference, DFCon, 2017
- The Use of a Hyaluronic Acid Based Skin Substitute in the Management of Extremely Recalcitrant Wounds, Huddleston, L, Montoya, L, Symposium on Advanced Wound Care, Fall 2014
- Unexpected Diagnosis of Charcot-Marie-Tooth Disease in a 14-year-old with a Traumatic Heel Fracture, Huddleston, L, Mercurio, K, Cohen, R, American Academy of Physical Medicine and Rehabilitation Annual Assembly, 11/01/10
Lectures
- Hyperbaric Oxygen Therapy and its Indications, 10/01/23, Northern Illinois Affiliate of the Wound, Ostomy, Continence Nurses Society Conference
- Pain Management in the Home Care Setting, 03/01/16, Illinois Homecare and Hospice Council Annual Conference and Exposition
- Clinical Pathway to an Amputation, 04/01/13, Hangar Clinic Symposium: Best Practices for Successful Rehab of the Amputee
- The Role of Electrodiagnostic Testing in Carpal Tunnel Syndrome and Radiculopathy, 05/01/09, Diamond Mark Educational Meetings
- Cervical & Lumbar Radioculopathy, 02/01/09, Schwab Rehab Hospital Resident Lecture Series
- Pain Management in the Elderly, 01/01/08
- Fall Prevention in the Elderly, 12/01/07
- Diagnosis & Non-Surgical Treatment of Common Neuropathies, 11/01/07
- Breast Cancer, 10/01/07
- Best Infection Control Practices, 08/01/07
- Diabetes Mellitus, 07/01/07
- Hereditary Motor Neuron Diseases, 06/01/06, International African American Prosthetic & Orthotic Coalition Annual Meeting
Hospitals
- Advocate South Suburban Hospital, 2009-2020
- Ascension Joliet Medical Center, 2010-present, Bylaws Committee
- Rush University Medical Center, 2006-2012
Boards
Grand Prairie Services Integrated Health, Board Member, 09/01/16 – present
Awards
- Fellow – Future Leaders in Minority Health Fellowship Program
- Charles Gavin Memorial Scholar
- Most Outstanding Graduate Student – August Myrolie Student Research Award
- Cancer Federation Scholarship
- Robert Jarrett Memorial Scholar
- DePaul University College of Law Merit Scholarship
Publications
- The Medicare Recovery Audit Program: Top strategies to overcome a backdoor attempt to save the Medicare Trust Fund, Chicago Medicine, 12/01/12, 12-15
- Updated Law of Medical Practice in Illinois, Chapter 34: Criminal Liability and Specific Crimes, 2022 Edition
Military Service
United States Marine Corps, Lance Corporal, 09/01/88 to 07/01/92, Honorable, Completion of Communication Center Operator Course, Combat Action Ribbon, Letter of Appreciation, National Defense Service Medal, Completion of Field Wire Course, Kuwait Liberation Medal, Certificate of Good Conduct, Southeast Asia Service Medal, Certificate of Commendation
Timeline
General Counsel and VP
Grand Prairie Services Integrated Health
07.2019 - Current
Clinical and Medical Affairs
Healogics, Inc
07.2019 - Current
Principal
Gritstone Professional Services, LLC, SBA Certified
06.2018 - Current
Volunteer Physician Advisor
Texas Medical Center Innovation Institute
02.2018 - 01.2020
Consultant
Medline Industries, Inc
06.2014 - 06.2015
Medical Director
Amita St. Joseph Center for Wound Care and Hyperbaric Medicine
10.2010 - Current
Attending Physician
Advocate South Suburban Hospital
08.2009 - 01.2020
Communication Center Operator
United States Marine Corps Lance Corporal, Schwab Rehab Hospital
01.2009
Medical Director
Divine Providence Home Health Services
06.2007 - 04.2010
Practice Manager
Huddleston Medical Services, S.C
03.2007 - 07.2023
Assistant Attending Physician
Rehab Associates of Chicago, Rush University Medical Center, Rush Oak Park Hospital
06.2006 - 01.2012
Attending Physician
Schwab Rehabilitation Hospital
07.2005 - 10.2010
Medical Director
Health Benefits Pain Management
07.2005 - 02.2007
Schwab Rehabilitation Hospital
07.2002 - 06.2005
MILITARY SERVICE
09.1988 - 07.1992
Key Opinion Leader
INSPE Associates, Inc, Medical Consultants Network, LLC, Medical Evaluation Specialists
Certificate in Mediation - undefined
Northwestern University School of Continuing Studies
Residency - Physical Medicine & Rehabilitation
Schwab Rehabilitation Hospital/University of Chicago
General Surgery Internship - undefined
Loyola University Medical Center
Doctor of Medicine - undefined
University of Illinois at Chicago College of Medicine
B.S. - Molecular Biology emphasis
Chicago State University
Juris Doctor -
DePaul University College of Law
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