Patricia Baum Key Career Highlights

Unique combination of private, public and academic sector experience:

Bachelor of Science Degree in Nursing

Saint John College - Cleveland, Ohio (Ursuline College)

Graduated Cum Laude.

Master of Liberal Arts Degree in Psychology

Harvard University - Cambridge, Massachusetts

Course work completed, Extension School

Certificate of Advanced Clinical Training in Behavioral Medicine

Harvard Medical School - Boston, Massachusetts

Certificate of Zenger Miller Training and Facilitation

Achieve Global

Clinical Director

Abiomed, Inc., Danvers, MA

Health Education Project Manager

Wellpoint Health Networks, Andover, MA

Director of Vascular Services

MetroWest Medical Center, formerly Leonard Morse Hospital until Merger

with Framingham Union Hospital

Manager of Quality for UNIFY contract with EOHHS and CMS for Network-

Health/TUFTS

. Legal experience as Medical/Nurse Consultant Lubin and Meyer PC

Boston.

. Zenger Miller certified Trainer from Achieve Global

. Harvard Medical School Behavioral Medicine Certificate

. Biogen Medical Information Specialist, pre-clinical work with

Interferon and Hirugen. All Phases drug research, Biogen's Alzheimer's

drug

. Peripheral Vascular Nurse Specialist for Brigham and Women's Hospital,

Cleveland Clinic Foundation, Medical College of Wisconsin and UMass

Med Center

Patricia Baum

621 Hale Street

Beverly Farms, Massachusetts 01915

617-***-****

Massachusetts RN Nurse Licensing #157962

EDUCATION

Bachelor of Science Degree in Nursing

Saint John College - Cleveland, Ohio (now Ursuline College)

Graduated Cum Laude.

Master of Liberal Arts Degree in Psychology

Harvard University - Cambridge, Massachusetts

Course work completed, Extension School

Certificate of Advanced Clinical Training in Behavioral Medicine

Harvard Medical School - Boston, Massachusetts

Certificate of Zenger Miller Training and Facilitation

Achieve Global

CAREER HIGHLIGHTS

. Clinical Trial Monitoring Private and Public sector

. Trial design, protocol design, consenting patients, recruitment methods,

design recruitment tools

. Trial management

. Data management, case report form design

. Quality Management at Tufts Health Plan for Government contract

. BSN from Saint John College Cleveland, Ohio, (Cum Laude) which merged

with Ursuline College,Ohio

. MA course work complete from Harvard Extension for MA Psychology

. Authored medical and nursing and lay-person clinical papers.

. Authored, designed and presented Medical and Nursing Research Posters

. Authored and presented many lectures to Nurses, Physicians and Lay-

persons.

. Television and radio work to educate population about Cardiovascular

Disease

ICU / Critical Care / Cath Lab Experience:

. ICU patient care at Cleveland Clinic in cardiac surgery and neurosurgery.

. ICU patient experience with Abiomed across country when ventricular

assist device inserted.

. ICU research studies such as the INTENSIVE study consenting patients in

ER,Cath Lab.

. Cared for PVD patients in ICU at Brigham and Women's Hospital as a

vascular nurse specialist.

. Patient education specialist and author of patient education materials

for over 30 years

Device Experience:

. Several cardiac stenting studies for Abbott, Medtronic, Boston

Scientific, Cordis

. Intracoronary imaging for Massachusetts General Hospital, Optical

Frequency Domain Imaging

. First in human for INFRAREDX intracoronary imaging

. Medtronic renal artery ablation catheter and point of care device for

Accumetrics

Monitoring Experience:

. Data Review / Query Resolution

. Biogen for clinical trials for AIDS, Multiple Sclerosis, Oncology,

Alzheimer's studies well as medical information specialist for all

trials.

. Was the query generator and did all review of all case report forms for

all studies.

. Post-market experience at Abiomed for the ventricular assist device.

. SAE Reconciliation

. At Biogen as data reviewer, at Abiomed as clinical director

responsibility for all SAE's and clinical reports and post market data

gathering for VAD.

. SAE data gathering and reporting for all studies while at Lahey Clinic

managing the safety reports from all sponsors...

. Interpreting safety reports for the principal investigators at hospital

and managing all follow-up reports.

. Meticulous with seeking out medical records for all the key data points

crucial in reporting SAE's.

. Serious Reportable Events management for Government contract at Network-

Health a Division of Tufts Health Plan

. Regulatory Binder Review

. Organized and managed a binder for all studies sometimes 12-14 at a

time for Lahey Clinic. These include:

. Protocol and Amendments

. Informed Consent Documents

. IRB Approvals and Correspondence

. Investigator Qualification Documentation

. Clinical Investigator's Brochure

. FDA Documents

. Signed Consent Documents

. Study Product Records (documentation of study product and

accountability forms/logs)

. Laboratory Certification

. Serious Adverse Events (SAE) Documents

. Protocol Deviation Form or Memo

. Clinical Site Monitoring Visits (Site visit log, Site visit reports,

Site visit correspondence)

. Sponsor Correspondence Data Safety and Monitoring Documents

. Audit Participation

. Has participated in several dry-run audits for the FDA. Familiar with

preparing documents for an FDA audit.

. Participation in preparation for GOV audit from CMS

. Enrollment Tracking And Patient Recruitment

. Has written recruitment documents to assist hospitals with recruitment

of patients.

. Considered an expert by coordinators and nurses needing help with

patient recruitment

. Was top enroller worldwide for Sanofi insulin study INTENSIVE. And

invited to participate in Global Operations Committee.

Career Positions

Manager of Quality for UNIFY (Three-way-Contract with EOHHS "ONE

CARE" and CMS)

Network-Health Division of Tufts Health Plan

02DEC2013 to present

. Complete management of all quality-related efforts for the contract

and the reporting protocols from the State and Federal demonstration.

. Government Liaison for both EOHHS and CMS with ONE CARE Program in

Massachusetts.

. Collect data, Chart audit, Manage, Author and Review submissions:

Quality Improvement Projects, Healthcare Effectiveness Data and

Information Set (HEDIS), Consumer Assessment of Healthcare Providers

and Systems (CAHPS) and Chronic Care Improvement Projects (CCIP).

Senior Clinical Research Coordinator (CTC)

07JAN2013 to 07JUN2013

InVentiv Health at Biogen Idec (contract)

Responsibilities include:

. Up to 20% Clinical Trial Manager activities e.g. reviewing

monitoring visit reports, providing for RDC studies,

creating recruitment materials etc., provided that it is a task

that may be delegated per the Biogen Idec RACI and that the CTC is

qualified to execute the task

. Preparing Medical / Operational Assessment Consulting/Non-

disclosure Agreements

. Coordinating CDA preparation, collection and execution

. Collecting FDA 1572s and CVs from Principal Investigators for IND

studies

. Coordinating study critical meetings e.g. Investigator, Advisory, DSMC

etc

. Distributing, collecting and reviewing Financial Disclosures

. Setting-up, updating and maintaining the clinical trial management

system e.g. IMPACT

. Creating, reviewing, approving, distributing and tracking Site

Reference Materials e.g. Study Manual, Pharmacy Manual, Regulatory

/ Investigator Binder

. Sourcing and distributing study supplies, as needed

. Preparing and maintaining Insurance certificates

. Distributing recruitment materials

. Tracking protocol deviations

. Populating, distributing, reviewing and tracking all essential

documents throughout the study

. Tracking investigational product and managing temperature excursions

. Tracking laboratory samples

. SUSAR coordination

. Creating and maintaining VCTR, Biogen Idec's CT.gov registry platform

. Supporting audit/inspection readiness

. Ensuring CCF completion and quality

. Coordinating the final transfer of the CCF from the CRO(s)

. Delegating administrative tasks to the Clinical Trial Assistants as

applicable

. Being a knowledge resource to other CTCs

. Mentoring Junior CTCs

. N.B. performed Clinical Trial Manager functions for three months due

to absence of assigned Clinical Trial Manager. Responsibilities were

broadened to include budget review, complete vendor and timeline

management, protocol deviation definitions, and medical review of data

for review by Medical Director.

Cardiology Research Coordinator

August 2005 to June2012

Lahey Clinic Medical Center, Burlington, MA

Complete Trial management from writing protocols, designing case

report forms,

enrolling patients and in-depth interaction with Internal Review

Board. Research includes cardiac catheterization stent devices, novel

imaging devices, cardiology pharmaceutical research and EP data base.

Clinical skills in the Cardiac Catheterization and EP Lab and people/

business skills include negotiating budgets with sponsors, risk

management skills through diligence providing safety for patient,

sponsor and research site. Familiarity with PMA, 510K, IDE processes.

Clinical Director

September 2001 to 2003

Abiomed, Inc., Danvers, MA

Managed 12 clinical consultants across the US to educate surgeons

about the BVS 5000 ventricular support system. This includes teaching

implantation, didactic presentation and ongoing teaching at the

bedside when patients are implanted. Successfully turned around a team

of consultants experiencing lack of leadership. Created a new data

capture process currently in place, developed a new outcomes

assessment tool to track variables starting with patient selection,

medical management and political issues at each site to increase

utilization. Worked on design and content of ABIOCOR educational

tools for professional healthcare providers and laypersons. ABIOCOR

is the total replacement heart. Familiar with CE Mark process

internationally.

Health Education Project Manager

October 1999 to April 2001

Wellpoint Health Networks, Andover, MA

Project leader for Chronic Disease Management Program and Wellness

Education. Managed 5 nurses.

Vascular Nurse Specialist

December 1992 to May 1999

The Vascular Center, Brigham and Women's Hospital, Boston, MA

Case management and total patient care supervision of vascular medical

and vascular surgical patients, as well as coordination of several

research projects and patient education.

Director of Vascular Services

September 1990 to December 1992

MetroWest Medical Center, formerly Leonard Morse Hospital until Merger

with Framingham Union Hospital

. Newly created role similar to medical science liaison.

Primary goals included:

. Expansion and revitalization of existing under-utilized services.

. Address new needs of vascular patients with private consultation for

patient and family emphasizing risk factor modification and stress

reduction utilizing Dr. H. Benson's Relaxation Response Model.

. Enhance the awareness and understanding of vascular disease and

patient needs for nurses and physicians.

. Bring the services and capabilities of the MetroWest Medical Center to

the surrounding community.

Areas of management included:

. Non-invasive laboratory.

. Patient Flow. For complete patient care for the vascular patient from

the initial consult through the non-invasive testing, radiology,

surgery, and rehabilitation.

Medical Information Specialist

January 1985 to September 1990

Biogen, Inc., Cambridge, MA

Responsibilities focus on clinical trial design, coordination and

evaluation. Emphasis is placed on writing investigator's brochures,

protocols and clinical summaries. Significant interaction with

Biostatistics and Data Management Departments required for case report

form evaluation and compilation. Actively involved in management of

drug development via interaction with the Scientific Staff, Medical

Board and Marketing Department. Proficiency in all aspects of clinical

trial monitoring and management. Clinical educator for Biogen staff

about Cardiovascular pathophysiology, medicine and interventional

techniques with Hirugen project start-up for anticoagulation therapy.

Hirugen now marketed as Angiomax.

Research and Clinical Consultant

January 1982 to January 1985

Peripheral Vascular Surgery Department, UMMC, Worcester, MA

Collaborative work environment under the supervision of the Chief of

Surgery,

Dr. H. Brownell Wheeler and Senior Vascular Surgeon, Dr. Bruce S.

Cutler.

Similar to medical science liaison:

. Daily rounds with physicians and floor nurses.

. Plan, coordinate and monitor patient care with physicians,

nurses, physical therapists, physician's assistant and social

workers on both an in-patient and out-patient basis.

. Create Patient Education Programs (pamphlets and audio/visual

material) such as the Anticoagulation Information Resource intended

for patients taking Coumadin.

. Present Medical Education lectures to the nursing and medical staff,

as well as, community resources such as the Visiting Nurses

Association.

. Coordinate prospective and retrospective research projects.

Vascular Nurse Specialist

August 1981 to November 1982

Milwaukee County Medical Complex, Milwaukee, WI

Collaborative work environment Director of Nursing and Dr. Jonathon B.

Towne, Director of Vascular

Surgery Service.

Specific responsibilities similar to medical science liaison:

. Plan and coordinate treatment and care for Peripheral vascular disease

patients with physicians, nurses and residents.

. Perform non-invasive diagnostic vascular tests: Arterial, Carotid and

Venous Doppler, as well as, impedance plethysmography studies.

. Active participation in weekly vascular conference to discuss recent

clinical data and incorporate new clinical management techniques into

hospital procedures.

. Design and present teaching programs to the medical and nursing staff

to facilitate daily management of patients with peripheral vascular

disease.

. Create education programs for patients in the amputee clinic.

. Manage venous stasis ulcer clinic.

Vascular Nurse Specialist

October 1979 to August 1981

Medical College of Wisconsin, Milwaukee, WI, Dr. Victor Bernhard,

Director

Responsibilities similar to those listed above.

Registered Nurse

June 1977 to June 1979

Cleveland Clinic Foundation, Cleveland, Ohio

Provided medical/surgical care in a 21-bed Surgical Care Unit whose

function is to manage critical vascular patients during their recovery

from anesthesia. Specific responsibilities included charge nurse,

total patient care, medication administration, staff orientation, and

training in intensive care techniques (Swan Ganz monitoring and

Electronic Transducer monitoring of arterial mean and central venous

pressures).

Registered Nurse

June 1976 to June 1977

Cleveland Clinic Foundation, Cleveland, Ohio

Provided medical care in a 9-bed Neurosurgical Intensive Care Unit

dedicated to the observation and management of unstable neurological

patients, including peri-operative care of the craniotomy patient and

medical management of patients with subarachnoid hemorrhage.

Specific duties included charge nurse, team leader, administering

medication, providing total patient care, familiarity with advanced

I.C.U. equipment such as the Intra-cranial pressure monitoring

devices; and communicating with patients to determine individual

patient care requirements.

Registered Nurse

June 1975 to June 1976

Cleveland Clinic Foundation, Cleveland, Ohio

Provided medical care in a 40-bed Cardiac Step Down designed for the

maintenance of third to tenth day post-operative care of open heart

surgical patients. Specific duties included charge nurse, team leader,

administering medication, orienting staff, proficiency in interpreting

EKG patterns.

TEACHING/LECTURES

Milwaukee County Medical Complex, Milwaukee, WI

Marquette University, Milwaukee, WI

Saint Anselm's College, NH

University of Massachusetts Medical Center, Worcester, MA

Brigham & Women's Hospital, Boston, MA

Massachusetts General Hospital, Boston, MA

University of Tennessee College of Pharmacy, Memphis, TN

MAJOR PRESENTATIONS

Existential Needs of the Person Undergoing Cardiac Catheterization

Poster at Cleveland Clinic Heart-Brain Summit 2010, Las Vegas

Recognizing Educational Needs of Persons with Cardiovascular Disease

Poster at Cardiovascular Nurse Conference 2010, Orlando

Educating the Patient in the Cardiac Cath Lab

Poster at Massachusetts Nurse Association 2008, Cape Cod

The Future of Vascular Nursing: thriving on Enlightened Humanism

University of Toronto, March, 1998.

Sensitivity and Sophistication in Vascular Nursing: The Next

Millennium keynote address Massachusetts General Hospital, February,

1997.

The Art and Science of Caring for Women with Vascular Disease

Tulane University, 1995.

Peripheral Vascular Nursing in America

Presented at the first annual symposium of the Austrian Vascular Nurse

Society, Vienna, Austria, October, 1996.

Nursing in the 90's: Evolution or Extinction.

Designed and coordinated symposium held at the University of

Massachusetts Medical Center May, 1988.

Educating the PVD Patient in the Vascular Laboratory.

Poster presented at the National Symposium of the Society of Non-

invasive Vascular Technology, Atlanta, GA, June, 1984.

The Peripheral Vascular Patient: Could You Recognize Him?

Presented at the first annual symposium of the Society for Peripheral

Vascular Nursing, San Francisco, CA, June 1983; and the Albert

Einstein College of Medicine Nursing Update, November, 1984.

Wound Management Audio Cassette and Workbook.

Designed and created at a seminar funded by E.R. Squibb and Sons.

Local Cable Television and Radio spot in Worcester about Heart Disease

and Women

PROFESSIONAL ACHIEVEMENTS

. President, Society for Vascular Nursing, 1997-1998.

. American Heart Association Committee Member on Task Force for Women &

Heart Disease, 1991.

. Volunteer PVD Clinic, Costa Rica, 1997.

. Honorary Member in Austrian Vascular Nurse Society.

. Co-founder and former Vice President of the Society for Peripheral

Vascular Nursing.

. First Editor for Journal of the Society of Peripheral Vascular

Nursing.

. Former member of Society of Non-Invasive Vascular Technology.

. Clinical Consultant to Springhouse Corporation Book Division resulting

in 2 books: Vascular Problems and Cardiovascular Care Handbook.

. Global Operations Committee, Sanofi-Aventis, Research in Patients with

Myocardial Infarction and Hyperglycemia, 2008 - 2009.

PUBLICATIONS

. Vollrath K., Salles-Cunha S.X., Baum P.L., Bernhard V.M., Towne J.B.

Profundaplasty follow-up in the vascular laboratory, BRUIT, 5:17,

1981.

. Towne J.B., Bernhard V.M., Rollins D.L., Baum P.L. Profundaplasty

limitations in the long-term management of limb ischemia, Surgery, 90

(6), 1037-1046, 1981.

. Rollins D.L. Bernhard V.M. Rollins D.L., Baum P.L., Fasciotomy: An

appraisal of controversial issues, Archives of Surgery, 116: 1474-

1481, 1981.

. Towne J.B., Bernhard V.M., Rollins D.L., Baum P.L. Profundaplasty in

perspective: limitations in the long-term management of limb ischemia,

Surgery, 90: 1037-1046, 1981.

. Baum P.L., Abdominal aortic aneurysm, Nursing 82, Springhouse Corp.,

December, 1982.

. Baum P.L., Carotid endarterectomy - one strike against stroke, Nursing

83, Springhouse Corp., March, 1983.

. Arous E.J., Baum P.L., Cutler B.C., The ischemic exercise test in the

Peripheral vascular patient: Implications for management, Archives of

Surgery, Presented by Dr. Arous at New England Society for Vascular

Surgery, September, 1983.

. Baum P.L., et al., Teaching plan for vena caval interruption, American

Operating Room Nurse (AORN), January, 1984.

. Baum P.L., et al., Vena caval interruption: An historic perspective,

American Operating Room Nurse (AORN), January, 1984.

. Rollins D.L., Towne J.B., Bernhard V.M., Baum P.L., Endarterectomized

Superficial femoral artery as an arterial patch, Archives of Surgery,

120:360-369, 1985.

. Baum P.L., Heed the early warning signs of PVD, ANA and AACN approved

for credit, Nursing 85, March, 1985.

. Rollins D.L., Towne J.B., Bernhard V.M., Baum P.L., Isolated

Profundaplasty for limb salvage, Journal of Vascular Surgery, 2:585-

589, 1985.

. Baum P.L., Taking the PVD patient's history, Nursing 86, Springhouse

Corp., May, 1986.

. Gerhard, M., Baum P.L., Raby, K., Peripheral Arterial-Vascular Disease

In Women: Prevalence Prognosis and Treatment, Cardiology 1995, 86:349-

35.

BOOK CHAPTERS

Baum P.L, Peripheral Vascular Structure, Function and Assessment,

Medical Surgical

Nursing: A Psychophysiological Approach, 3rd Edition, W.B. Saunders,

1987.

Baum P.L., Nursing People with Arterial Disorders, Medical Surgical

Nursing: A

Psychophysiological Approach, 3rd Edition, W.B. Saunders, 1987.

Baum P.L., Peripheral Arterial Disorders: Chronic Occlusion and Other

Disorders,

Vascular Problems, Springhouse Corporation, 1988.

BOOKLET

Baum P.L., Lundstrum R., Love Your Feet, E.R. Squibb and Sons, 1984.

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