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Certified Consultant Pharmacist Medical Expert Witness


Expert Witness No.894

New Jersey

Doctorate of Pharmacy
Masters of Business Administration
Pharmacy Bachelor of Science
N.J. Board Licensed Pharmacist
N.J. Board Certified Consultant Pharmacist

                                     
Summary: New Jersey board licensed clinical pharmacist experienced in managing therapeutic outcomes in collaboration with interdisciplinary teams consisting of physicians, nurses, and other healthcare providers. Additional education includes a Masters of Business Administration focused in strategic management and business policy coupled with nine years of experience as a National Medical Science Liaison Manager, Associate Director, Assistant Director, Field Operations Manager, and Medical Science Liaison within the pharmaceutical industry. Responsible for managing daily business activities, creating management infrastructure, and developing supportive materials that improved the execution and effectiveness of a field-based Medical Science Liaison (MSL) team. Additional experience includes hiring, training, and managing Medical Science Liaisons as well as ensuring product life cycle objectives align with corporate strategic planning.
Industry and academic therapeutic areas of focus: 
Psychiatry (Lexapro), Neurology (Namenda), Diabetes (Tresiba), Cardiovascular Disease (Bystolic), Oncology (Zofran), Nephrology (Mircera-erythropoiesis stimulating agent), Irritable Bowel Syndrome (Linzess), Infectious Disease (Teflaro), ADHD (Dyanavel XR)

Core Competencies:

  • Demonstrated individual contributor skills as well as field-based and internal team management experience.
  • Proven competency in customer engagement and development of credible scientific relationships with top experts.
  • Extensive experience in creating business/strategic models, management tools and educational materials.
  • Ability to understand and effectively communicate complex pharmacologic drug information to the medical community.
  • Interface effectively with management platform tools for the collection, review, and dissemination of field activity reports.
  • Proficient in scientific / medical literature research.
  • Solid understanding of managed markets, HEOR data, customer segments, market dynamics, and disease management.
  • Ability to respond appropriately to needs of key stakeholders and manage expectations with excellent project management skills and follow through.
  • Proven success as a leader, coach, and performance manager with excellent oral, written communication and interpersonal skills.
  • Advanced skills in using Microsoft Outlook, Word, and Power Point.

EXPERIENCE:
TRIS Pharma                                               
March 2016 – August 2016
Manager, Medical Science Liaisons
Create onboarding, training and management documents for a field-based team of Medical Science Liaisons.
Establish relationships with Investigators, Managed Care Organizations (MCOs), Medical Directors, State Medicaid and P&T Committee Members as well as professional association/society members.
Provide clinical presentations to key healthcare stakeholders and customers including MCOs focused in Attention Deficit Hyperactivity Disorder (ADHD).
Work in conjunction with regional account executives to develop strategic plans focused on the clinical needs of organized providers within the U.S.
Educate formulary decision makers about the clinical data and value of TRIS products.
Develop ADHD-related scientific documents and provide educational and technical product information to physicians in response to medical inquiries.
Provide scientifically balanced medical and drug information in accordance with regulatory guidelines for unsolicited physician requests.
Assist in supporting product launch and department initiatives as well as staff medical information booths at scientific meetings

Novo Nordisk, Inc.                                                         
March 2015 – February 2016
Associate Director Scientific Resources                            
Responsible for ensuring Medical Affairs (MA) has scientific resources and knowledge needed to help facilitate customer engagement focused in managed care markets.
Develop scientific content and execute utilization strategies for the MA team in close collaboration with the MA management team as well as Clinical Development, Medical Information, Marketing, Sales Operations, Market Shaping and Health Economics and Outcomes Research (HEOR).
Assist in the implementation of scientific initiatives focused on external customers such as Endocrinologists, Key Opinion Leaders, Payers and health plans (Cigna, Aetna, Anthem, Humana and United Healthcare).
Coordinate with Medical Strategy Director, Medical Directors and Competitive Intelligence teams for regular MA updates on ongoing and anticipated clinical trials that support Novo Nordisk brands and those related to competitive products.
Collaborate with Product Safety, Public Affairs, HEOR and other cross functional groups to provide relevant issues to the MA team in order to provide Medical Liaisons (MLs) with the most current medical and scientific information.
Lead development of resources used by field Medical Liaisons focused in specific customer segments such as Organized Providers, Integrated Health Systems, and Managed Markets. Anticipate field-based tools needed for critical business needs arising from the impact of the Affordable Care Act on Accountable Care Organizations and health care delivery.
Prepare and communicate scientific material and clinical updates to stakeholders in advance of new data, new product launches, speaker training programs, and the competitive landscape.
Submit all medical deliverables and scientific resources for appropriate medical and legal review in order to ensure compliance with Novo Nordisk standardized review processes and federal guidelines.   

HealthSTAR Clinical Education Solutions                                                                           
August 2014 - February 2015                                                                                                             
National MSL Manager (Short-term contract position)
Responsible for recruiting, on-boarding, training and management of a national field-based team of professionals including PharmDs, MDs, PhDs, and nurses with advanced degrees.
Manage and coordinate the activities of MSLs including field performance related to individual / team goals and objectives.
Develop and monitor personal performance plans based on the needs and feedback provided by Medical Directors and attending physicians within U.S. clinics.
Conduct routine field coaching visits to analyze MSL performance metrics related to dialysis clinic initiatives and ESA therapy.
Responsible for working with the program Director to develop strategic product plans that support project initiatives and assist in training MSLs to execute pre-determined plans of action.
Provide feedback to internal stakeholders regarding challenges / gaps within the ESA marketplace and work collaboratively with cross-functional teams to develop solutions.
Develop and maintain expertise in Nephrology, ESA treatment and anemia caused by chronic kidney disease
Leverage clinical data that differentiates features / benefits of short and long acting ESAs.
Identify and coordinate resource and budget needs to assist with team / individual development. Effectively manage team budget and review / approve weekly expense reports.
Ensure team complies with OIG Guidelines, PhRMA Code, FDA Guidance for responding to unsolicited requests for off-label information, driver safety as well as corporate policies and procedures.  

 Full-time Doctorate of Pharmacy (PharmD.) Graduate Student                
August 2011 - October 2013
Graduate training that focused on the principles of pharmacotherapeutics and functional consequences of major diseases, therapeutic problem-solving and the evaluation of treatment strategies commonly used in clinical practice. A major component of the program included formulation of appropriate treatment plans based on monitoring parameters, assessment of adverse drug reactions and adverse events, drug interactions, drug-induced diseases, and determination of therapeutic endpoints and goals for patients based on current evidence-based medicine. Enhanced practice of pharmacy skills through the development of individualized patient therapy utilizing pharmacokinetic, pharmacodynamic, and pharmacoeconomic principles that incorporated medication safety and efficacy. Therapeutic areas of clinical training included Diabetes, Oncology, Cardiovascular Disease, Infectious Disease and CNS disorders. 


Forest Laboratories, Inc.                                       
February 2003 - July 2011
Associate Director External Scientific Affairs    (December 2008 – July 2011)
Worked in conjunction with PricewaterhouseCoopers and the Forest Compliance group to review policies for the ESA team. Evaluated processes and made recommendations for new department SOP based on industry standards, better practices, and regulatory requirements.
Served as point-person in SOP workshops to design and implement new procedures needed for the proper execution of MSL business activities based on OIG Guidelines, the PhRMA Code, and corporate policies.
Managed a $9MM Investigator Initiated Trial (IIT) Phase 4 program for a national field-based MSL team. Oversaw the uniform implementation regarding submission, review, and disposition of all IITs. Ensured approved protocols were compliant with the PhRMA Principles on Conduct of Clinical Trials. 
Managed business activities of four direct reports; Assistant Director, Investigator Initiated Trial (IIT) Manager, IIT Coordinator and ESA Administrator. Responsible for tracking all money spent on IITs in order to stay compliant with new transparency regulations related to the Sunshine Act Bill.
Increased the awareness of Forest products through the publication of IIT clinical manuscripts in select medical journals as well as through IIT poster presentations at targeted medical meetings. Monitored the specific segments of the medical community exposed to, and impacted by, the outcomes data of completed IIT trials.
Co-authored the guideline manual for the Publication Planning group within Medical Affairs. Manual explained specific roles and responsibilities of publication planning team members regarding the management of manuscript/abstract development and authorship criteria.
Worked in conjunction with Training and Process Development to create new on-line learning library which contained all SOPs for External Scientific Affairs, Medical Information & Communication, and Publication Planning. Managed on-line learning library used by new hires to electronically complete necessary training for specific job functions.

Assistant Director Operations, External Scientific Affairs (July 2005 – December 2008)
Continued to manage a team of field-based Managed Care Medical Science Liaisons. Responsibilities included clinical training, account and territory alignment, as well as monitoring and evaluation of performance outcomes.
Acted as ESA point-person with medical education companies to create new therapeutic training manuals for emerging products. Developed weekly training agendas, selected appropriate reference text books, and coordinated with other Forest departments to ensure new hires received all necessary materials / equipment prior to start date.
Collaborated with Forest sales training personnel to identify training needs within specific therapeutic areas. Enhanced disease state knowledge of National Sales Trainers by leveraging the clinical and scientific expertise of the Medical Science Liaison team.
Reviewed letters-of-agreement from institutions requesting grant funds and determined if monetary allocation aligned with Forest policies and federal guidelines. Checked for content accuracy and ensured sponsors adhered to ACCME guidelines for commercial support. 
Created on-line grant submission process in conjunction with Marketing Services. Responsible for reviewing grant requests for CME, unrestricted education and training programs. Ensured CME programs were sponsored by accredited ACCME providers and line-item budgets were within fair-market-values. 
Determined yearly budgets for Forest Medical Affairs Department, monitored budgets quarterly and provided rationale for variances within each category. 
Served as ESA point-person on steering committees for corporate initiatives. Responsibilities included providing insight and expertise to other Forest groups regarding the business activities and functions of the ESA team as they related to current and future business models. Researched specific topics and prepared internal reports for dissemination to other committee members for informational purposes.  

Field Operations Manager, External Scientific Affairs (June 2004 – July 2005)
Managed a team of field-based Managed Care Medical Science Liaisons. Responsibilities included clinical product training, account and territory alignment, as well as monitoring and evaluation of performance outcomes.
Responsible for identifying and mapping Thought Leaders for the MSL team.
Authored the ESA Guideline Manual which provided a detailed explanation of the roles and responsibilities of MSLs, Managed Care MSLs, and Managers within the ESA team. The manual thoroughly explained business-related processes that were routinely performed by field personnel and contained samples of documents necessary to conduct daily work activities. Examples included compliance issues surrounding clinical presentations and scientific exchange with Thought Leaders.
Authored the ESA Compliance Binder which provided the ESA team with specific healthcare guidelines and legal requirements that governed Forest interactions with healthcare professionals. The document discussed the manner in which complete, accurate, and balanced information must be disseminated to medical professionals that was consistent with the PhRMA Code, OIG Guidelines as well as Forest corporate ethical and moral standards. 
Created the MSL Development Plan for field managers which identified specific competencies, skills, and behaviors essential for optimal field performance. Document was used by field managers to identify specific areas of strength as well as areas requiring attention and improvement.
Developed Forest process using legal and ethical means for effectively identifying, gathering and delivering timely, relevant Competitive Intelligence (CI) about the external environment. Created CI template to better assist team with information gathering. CI reports were used by internal personnel to monitor competition, improve market knowledge and enhance cross-function interaction within the organization. 

Medical Science Liaison (February 2003 – June 2004)
Developed and cultivated relationships with academic Thought Leaders (TLs) specializing in Psychiatry and Neurology. Functioned as a clinical resource within specific therapeutic areas and provided clinical data to TLs upon request. Identified and supported appropriate educational opportunities through unrestricted educational and CME grants. Academic institutions included: Cornell University-Weill Medical College, Mt. Sinai School of Medicine, Columbia University and New York University School of Medicine.
Participated in new product launches and collaborated with other departments to create awareness about Forest products in the medical community.                                                                                                                                                                                                                                                                                                                                 Developed business objectives through interaction and alignment with internal departments and increased market penetration of Forest products by leveraging medical and scientific interchange with key external customers across product life cycles.
Developed Investigator Initiated Trial (IIT) protocol designs with TLs for presentation to the Research Steering Committee and facilitated the process of protocol approval and sign-off. Reviewed final data for abstracts / posters / manuscripts with internal Forest personnel and Principal Investigator for publication opportunities. 
Presented credible, balanced scientific data while observing promotional boundaries at Managed Care Organizations and Speaker Training meetings to support appropriate use of Forest products. Demonstrated the value of Forest products to healthcare managers through clinical and pharmacoeconomic data. 
Represented Forest by participating in advisory boards, medical congresses and professional association meetings. 

Pfizer Inc. - Worldwide Safety Group                                   
June 2001 - February 2003
Safety Trainer                                               
Responsible for training external vendors, call centers, and field sales representatives regarding standard operating procedures for determining potential untoward effects of marketed Pfizer drugs. The process included the proper collection, analysis, and reporting of all adverse events required to meet legal, ethical, and regulatory obligations. Discussed the definition of serious and non-serious adverse events, the distinction between solicited and spontaneous reports, timeframes for reporting events as well as important medical experiences considered to be adverse events.  Explained strategies for detecting differences between medical inquiries and product complaints. Worked in conjunction with Project Managers to coordinate and deliver safety training for specific Pfizer campaign launches. Assisted training team by updating power point presentations with current safety and regulatory changes. Managed scheduling of all domestic external training sessions as well as shipping of training materials needed. Also, coordinated tele / video conferences with internal audio-visual technicians for long distance training programs.

Ventiv Health U.S. Sales March                                                       
March 2000 - April 2001
Sales Trainer                                        
Responsibilities included facilitating the training of pharmaceutical sales representatives for new drug product launches. Experienced in delivering medical overviews explaining the pathophysiology of various disease states and current drug treatment options. Worked in conjunction with client Product Managers to formulate key marketing messages delivered at regional Plan-of-Action meetings. Instrumental in outsourcing academic institutions and independent clinical consulting firms to work with in-house training teams.
Organized clinical content of medical overviews with physicians and pharmaceutical consultants needed for specific product launches. Developed training workshop material/information utilized in Facilitator Leaders Guides and Rep Training Manuals explaining; marketing messages of Visual-Aids, Package Insert content, and the advantages / results of clinical studies. Evaluated the competency levels of training class participants and formulated a representative development plan for District Managers. Provided detailed evaluations and feedback mainly through video-taped role play, assessment tests, and field ride-withs. 
Extensive disease state knowledge acquired in CNS Disorders, Diabetes, Hypertension, Heart Failure, Gastroesophageal Reflux Disease, and Pain Management. Conducted clinical product training for Bristol Myers Squibb, Novo Nordisk, Forest Laboratories, Endo Labs, and Reliant Pharmaceuticals.

American Pharmaceutical Services Inc. – Consultant Pharmacist                           
1998 - 2000
Pharma-Care Inc. – Consultant Pharmacist                                                                                                    
Monitored therapeutic efficacy of patients’ drug regimens in various clinical settings. Interacted with medical directors, directors of nursing, and various other healthcare team personnel to achieve positive therapeutic outcomes. Developed quality assurance system to streamline and expedite delivery time of pharmaceutical services to outside clients. Responsible for managing data-entry team to ensure error free processing of medical orders.
Monitored all facets of drug therapy for patients with multiple disease states in numerous clinical settings with emphasis on Pain Management, Depression, Epilepsy, Alzheimer’s Disease, Parkinson’s Disease, Schizophrenia, and Diabetes. Reviewed patients’ charts for abnormal laboratory values and drug concentrations resulting from medication treatment. Instrumental in initiating educational in-service programs for internal medical staff personnel by working in conjunction with outside pharmaceutical sales reps. Provided drug safety information to attending physicians, nurses-in-charge, and administrators through monthly drug utilization reviews. Responsible for investigating, collecting, and reviewing all adverse drug event information with all internal and external health care providers for fifteen Long Term Care facilities. 

K-Mart Pharmacy                                                                                                                                                    1994 - 1998
Staff Pharmacist and Pharmacy Manager                                
Filled drug prescriptions, checked for potential drug interactions, and monitored medication usage. Discussed possible side effects through patient consultations. Advised local physicians about new medications, uses and available strengths. Responsible for a 69% increase in total prescriptions filled in 1995 compared to 1994. Increased gross sales by 96% in 1995 from previous year. Departmental sales exceeded 1995 corporate goal by 57%. Managed yearly prescription drug inventories within a 2.5% variance of planned corporate budgets.

EDUCATION
Doctorate of Pharmacy: September 2013
Massachusetts College of Pharmacy and Health Sciences University – Boston, Massachusetts
Clinical Rotation: St. Barnabas Behavioral Health Center – Toms River, N.J. – clinical training focused on depression, bipolar disorder, schizophrenia, Parkinson’s Disease, Alzheimer’s Disease, Multiple Sclerosis and alcohol/drug addiction 

Masters of Business Administration: December 2010 
Georgian Court University – Woodbridge, New Jersey
Emphasis in strategic management and business policy

Pharmacy Bachelor of Science: May 1985 
University Rhode Island College of Pharmacy – Kingston, Rhode Island
Internship: St Joseph’s Hospital - Providence, Rhode Island
Externship: Butler Neuropsychiatric Hospital - East Providence, Rhode Island


LICENSE: 
R.Ph. - New Jersey Board of Pharmacy: June 1985
New Jersey board licensed (registered) pharmacist
Status: Active and in good standing.

CERTIFICATION: 
CCP - Joint Board for Certification of Consultant Pharmacists: August 1999
New Jersey board certified consultant pharmacist – geriatric medicine specialist for long term care and sub-acute facilities. Therapeutic experience in CNS disorders and cardiovascular disease.

 

 

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