Summary
Overview
Work History
Education
Skills
Certification
Bibliography
Timeline
Generic

Kersten F. Reich, MPH

McKinney,TX

Summary

Performance-driven Vice President with 20 years of experience in outcomes research and strategy, aligning systems with business requirements, policies and regulatory requirements. Passionate about applying excellent organization and communication skills to manage and lead teams. Results-oriented individual well-versed in interfacing and consulting on business processes to drive results based on sound overall business judgment.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Vice President Scientific Services

JB Ashtin
01.2022 - Current
  • Therapeutic Areas: Epidemiology/Infection Prevention; Neurosciences: real-world evidence (RWE), health economics and outcomes research (HEOR); Immuno-dermatology; Immuno-rheumatology; Neurosciences; Ophthalmology; Rare Diseases (eg, progressive supranuclear palsy); Women’s Health; Vaccines (hepatitis B) and Population Health
  • Lead, manage, and hold accountability for the Scientific Services division; line management of a team of 20 scientific services team members
  • Partner with pharmaceutical partners to develop strategic and scalable scientific platforms and publication plans to support product launches and existing pipelines
  • Promote cross-functional communication and collaboration
  • Ensure scientific rigor, accuracy, and relevance of deliverables by therapeutic asset and pillar
  • Set department objectives, policies, and direction in alignment with corporate vision
  • Ensure efficiency and continuous qualitative improvement metrics meet corporate standards
  • Provide medical insight over all intellectual products produced by the Company
  • Review medical content, provide feedback and relevant medical information to Scientific Directors
  • Develop and maintain relationships with key thought leaders and other professionals
  • Support scientific services team on select accounts from a strategic and content perspective, as needed
  • Demonstrated proficient leadership skills to motivate employees and build competent teams.
  • Collaborated with senior management to develop strategic initiatives and long term goals.
  • Monitored industry trends, keeping current on latest changes and competition in industry.
  • Cultivated company-wide culture of innovation and collaboration.
  • Analyzed industry trends and tracked competitor activities to inform decision making.

Senior Scientific Director

JB Ashtin
01.2020 - 01.2022
  • Responsibilities included managing assigned scientific services group, ensuring appropriate staffing, effective performance management, workload efficiency and quality
  • Led and directed strategic planning initiatives for publications and medical affairs deliverables
  • Independently managed wide range of complex projects with a high level of expertise in multiple therapeutic areas
  • Conducted competitive intelligence rare diseases, genetics, and genomics and manages of team for congress coverage activities
  • Acted as primary source of product/therapy areas expertise within JB Ashtin and for clients
  • Maintained up-to-date knowledge of and adheres to GPP3, PhRMA, FDA (including FDAAA), and OIG guidelines
  • Managed diverse team of scientific directors (x2) and medical writers (x3)
  • Reviewed and approves all scientific content for assigned accounts andprovides feedback and relevant medical information to assigned writers
  • Sustained multi-channel communications strategies for multiple clients across medical publications, medical affairs, patient advocacy organizations, and other key stakeholders
  • Led strategic planning working collaboratives across multiple therapeutic areas and pillars of communication for outcomes dissemination through congresses, symposia, and publications
  • Coordinated key opinion leader engagement activities and measurement of efficacy metrics

Scientific Director

Envision Pharma Group
01.2019 - 01.2020
  • Gene therapy for rare disease movement disorders (eg, Duchenne’s muscular dystrophy, Limb-Girdle muscular dystrophy); complement therapeutics for rare diseases, such as atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria; immunotherapy (eg, CAR-T); oncology
  • Responsibilities included client-facing collaborations and interpreting and conveying raw data to support scientific and commercial objectives; strategic planning, project management, generation of evidence-based deliverables in population health and real world outcomes; and appreciation of the nuances of medical communications and implementation
  • Strategic planning and publication planning across multiple therapeutic areas
  • Development of scientific platforms
  • Team lead on rare disease registry publications
  • Development of plain language summaries
  • Scientific solutions director medical affairs deliverables, including MSL educational slide decks, symposium booth panels, advisory boards
  • Competitive intelligence efforts through symposium attendance and related deliverables

Scientific Director, Full-time Consultant

Stryker Medical Inc
01.2011 - 01.2020
  • Therapeutic Areas: Hospital-Acquired Infection Prevention, Wound Care
  • Responsibilities included client-facing, evidence-based strategic planning and conducting analyses of the clinical market, ensuring strategic plan alignment with past, on-going, and future international deliverables; line management of a team of 8 interprofessional collaborators
  • Developed global outcomes dissemination and strategic plan to educate clinical staff and reach key opinion leaders internationally
  • Held role of team lead on quality improvement initiative design from inception to completion
  • Collaboratively developed Center of Excellence for Stryker Performance Solutions metrics and strategic rollout
  • Competitive intelligence efforts through symposium attendance
  • Experience building strategic brand-supportive scientific outcome stories
  • Proactively analyze business needs working with internal and external stakeholders to identify opportunities to enhance market impact, while ensuring full ethical compliance in medical communications
  • Collaborate across multiple regions and stakeholders to identify, plan, and implement key deliverables (all media) across product lines, including accredited and non-accredited education
  • Strategic planning and development of key clinical messages from research
  • Provide guidance on evidence-based medical projects to ensure appropriate publication planning efforts are undertaken for timely outcomes dissemination
  • Strong understanding and broad fund of knowledge of medicine, epidemiology, and biostatistics and ability to analyze and interpret epidemiological reports to help identify knowledge gaps
  • Expertise in manuscript research and writing of ethically-adherent publications, systematic literature review methodology, manuscript submission and in-depth knowledge of peer-reviewed methodology – global publications

Senior Medical Writer, Consultant

Sage Products LLC
01.2005 - 01.2011
  • Responsibilities included medical device publication planning and management of Institutional Review Board approvals, including protocol development for Phase 1 and 2 clinical protocols and clinical study reports; research and writing of peer-reviewed medical publications, abstracts/posters, federal grants, and medical education materials; and adherence to best practices in publications management and clinical research (e.g., Good Publication Practice guidelines, International Committee of Medical Editors) and industry guidelines (e.g., AdvaMed)
  • Medical writer on numerous deliverables (manuscripts, abstracts, posters)
  • Authored multiple continuing education programs

Medical Writer and Editor

Constella Group, Inc
01.2004 - 01.2005
  • Responsibilities included federal grant writing and regulatory writing
  • Participated in development of 8 federal grant proposals and awarded approximately 1.8 million for telemedicine research
  • Responsibilities included preparation of Phase 1 and 2 clinical protocols and integrated clinical and statistical reports in compliance with ICH guidelines, applicable standard operating procedures and working practice documents, and guidelines specified by the FDA and other international regulatory agencies
  • Protocol preparation involved collaboration with internal and external experts in the development of the study design and facilitating the review of the document by the sponsor and internal project team members
  • Clinical study report preparation involved interacting with internal experts and sponsors to determine format, design, and presentation of results; interpreting and articulating study results using study-generated tables, listings, and figures; incorporating pharmacokinetic and statistical results; and interfacing with internal experts and sponsors to establish the overall study conclusions
  • Additional responsibilities included demonstrating compliance with internal and sponsor training requirements; reviewing statistical analysis plans to ensure clarity and accuracy; representing medical writing in project team meetings; providing input on medical writing timelines; facilitating and participating in internal and external review processes of all deliverables; and ensuring that all deliverables meet quality standards throughout the life of the project
  • Responsibilities also included supporting completion of appendices compilations and electronic publishing; representing medical writing in sponsor audits, bid defenses, and capabilities presentations; mentoring new medical writers; conducting detailed one-on-one training sessions; performing peer reviews of deliverables for other medical writers; and providing guidance on project management
  • Additional details on employment in healthcare before 2003 are available upon request.

Education

Doctorate of Public Health - Public Health Practice

Medical College of Wisconsin
Milwaukee, WI
05.2025

Master of Public Health - Public Health Practice

University of Massachusetts, Amherst School of Public Health
Amherst, MA
02.2019

Bachelor of Science - Healthcare Administration

Charter Oak State College
New Britain, CT
05.2015

Skills

  • Outcomes Research Interpretation
  • Grants Research and Management
  • Business Growth and Marketing Strategies
  • Market Trend Analysis
  • Project Oversight
  • Process Improvement
  • Critical Thinking
  • Trend Identification and Forecasting
  • Competitor Trends
  • Cash Flow and Financial Analysis
  • Budgeting and Forecasting

Certification

Certified Medical Publications Professional - CMPP, ISMPP

Bibliography

 Continuing Education Programs

1. Reich KF (2016). Faculty: Bakris GL. WebMD/Medscape. Benefits and risks of RASS inhibitor therapy: A clinical practice assessment. Available at: https://www.medscape.org/viewarticle/869596  2. Reich KF (2015). Faculty: Li, E. WebMD/Medscape. Biosimilars: An Assessment of Current Clinical Knowledge and Attitudes. Available at: http://www.medscape.org/viewarticle/849699

3. Reich KF (2015) Faculty: Kindsvater S. WebMD/Medscape. Stroke of Unknown Cause. Available at: http://www.medscape.org/viewarticle/840594_2 

4. Reich KF (2014) Faculty: Culpepper L. WebMD/Medscape. Major Depressive Disorder. New Perspectives on Diagnosis and Management. Available at: http://www.medscape.org/viewarticle/820386_6 

5. Reich KF (2014). Faculty: Bhatt DL. WebMD/Medscape. Differential Diagnosis: A Patient With Chest Discomfort. Available at: http://www.medscape.org/viewarticle/827743

6. Reich KF (2014). Faculty: Scirica B. WebMD/Medscape. Women with Angina. Evaluating Next Steps. Available at: http://www.medscape.org/viewarticle/828375

7. Reich KF (2014). Faculty: Robinson JG. WebMD/Medscape. Guideline-Based Lipid Management in Practice. Available at: http://www.medscape.org/viewarticle/828932 8. Reich KF (2014). Faculty: McLendon, KS. WebMD/Medscape. Weight Management Options: Guidance for Pharmacists. Available at: http://www.medscape.org/viewarticle/830150  9. Reich KF (2014). Faculty: Apovian CM. WebMD/Medscape. FAQs in Obesity Management. Available at: http://www.medscape.org/viewarticle/830851 


Acknowledgments

I am acknowledged as a publication professional within the following publications and adhered to all ethics of the International Society of Medical Publication Professionals.

1. Snabes M, Ng J, Li H, Ali I, Shebley M, Schlaff W. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. Fertil Steril Rep. 2023;in press.

2. Burmester GR, Cohen SB, Winthrop KL, et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735.doi:10.1136/rmdopen-2022-002735

3. Thaler A, Barer Y, Gross R, et al. Long-term persistence and monotherapy with device-aided therapies: a retrospective analysis of an Israeli cohort of patients with advanced Parkinson’s disease. Adv Ther. 2022;10.1007/s12325-022-02072-x. doi: 10.1007/s12325-022-02072-x

4. Kovacs N, Bergmann L, Anca-Herschkovitsch M, et al. Outcomes impacting quality of life in advanced Parkinson’s disease patients treated with levodopa-carbidopa intestinal gel. J Parkinson Dis. 2022;12(3):917-926. Doi: 10.3233/JPD-212979

5. Leyland N, Leonardi M, Murji A, Singh SS, Al-Hendy A, Bradley L. A call-to-action for clinicians to implement evidence-based best practices when caring for women with uterine fibroids. Reprod Sci. 2022;29(4):1188-1196. Doi:10.1007/s43032-022-00877-3

6. As-Sanie S, Laufer MR, Missmer SA, et al. Development of a visual, patient-reported tool for assessing the multi-dimensional burden of endometriosis. Curr Med Res Opin. 2021;37(8):1443-1449. doi:10.1080/03007995.2021.1929896

7. Abrao MS, Surrey E, Gordon K, et al. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021;21(1):246. Published 2021 Jun 16. doi:10.1186/s12905-021-01385-3

8. Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone mineral density changes associagted with pregnancy, lactation, and medical treatments in premenopausal women and effects later in life. J Womens Health. 2021;ePub ahead of print PMID: 34435897. Doi: 10.1089.jwh.2020.8989.

9. Fasano A, Gurevich T, Jech R, et al. Concomitant medication usage with Levodopa-Carbidopa Intestinal Gel: Results from the COSMOS Study. Mov Disord. 2021 Apr 28. Doi: 10.1002/mds.28596. Epub ahead of print. PMID: 33908647

10. Höglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021;20(3):182-192

11. Missmer SA, Tu FF, Agarwal SK, Chapron C, Soliman AM, Chiuve S, Eichner S, Flores-Caldera I, Horne AW, Kimball AB, Laufer MR, Leyland N, Singh SS, Taylor HS, As-Sanie S. Impact of Endometriosis on Life-Course Potential: A Narrative Review. Int J Gen Med. 2021 Jan 7;14:9-25. doi: 10.2147/IJGM.S261139. PMID: 33442286; PMCID: PMC7800443.

12. Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021;14:263-271. https://doi.org/10.2147/JPR.S284703

13. Warren RB, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br J Dermatol. 2020 Jun. doi: 10.1111/bjd.19341.Epub ahead of print.

14. Rondeau et al. Eculizumab Safety: 5-Year Experience From the Global Atypical Hemolytic Uremic Syndrome Registry. Kidney International Reports [ahead of print]; 2019. Available at: http://kireports.org/article/S2468-0249(19)31437-8/fulltext

15. Socié G, Caby-Tosi MP, Marantz JL, Cole A, Bedrosian CL, Gasteyger C, Mujeebuddin A, Hillmen P, Vande Walle J, Haller H. Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10-year pharmacovigilance analysis. [Post Hoc Plain Language Summary] Br J Haematol. 2019;185(2):297-310. Available at: https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1111%2Fbjh.15790&file=bjh15790-sup-0001-FigS1.pdf

16. Meyers T. Prevention of Heel Pressure Injuries and Plantar Flexion Contractures With Use of a Heel Protector in High-Risk Neurotrauma, Medical, and Surgical Intensive Care Units: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2017;44(5):429-433.

17. Edger M. Effect of a Patient-Repositioning Device in an Intensive Care Unit On Hospital-Acquired Pressure Injury Occurences and Cost: A Before-After Study. J Wound Ostomy Continence Nurs. 2017;44(3):236-240.

18. Way H. Safe patient handling initiative in level I trauma center results in reduction of hospital-acquired pressure injury and fewer patient-handling injuries. Am J SPHM. 2016: 6(4): 160-165

19. Gray M. External collection devices as an alternative to the indwelling urinary catheter: evidence-based systematic review and expert clinical panel deliberations. Gray M, Skinner C, Kaler W. External Collection Devices as an Alternative to the Indwelling Urinary Catheter: Evidence-Based Review and Expert Clinical Panel Deliberations. J Wound Ostomy Continence Nurs. 2016;43(3):301-7.

20. Hanna-Bull D. Preventing Heel Pressure Ulcers: Sustained Quality Improvement Initiative in a Canadian Acute Care Facility. J Wound Ostomy Continence Nurs. 2016;43(2):129-32.

21. Edwards M, Purpura J, Kochvar G. Quality improvement intervention reduces episodes of long-term acute care hospital central line-associated infections. Am J Infect Control. 2014;42(7):735-8

22. Thompson P, Houston S. Decreasing methicillin-resistant Staphylococcus aureus surgical site infections with chlorhexidine and mupirocin. Am J Infect Control. 2013;41(7):629-33.

23. DeJuilio PA, Rivera SJ, Humi JP. A successful VAP prevention program. J Resp Care Pract. 2012;25(6):26-32

24. Heck K. Decreasing ventilator-associated pneumonia in the intensive care unit: a sustainable comprehensive quality improvement program. Am J Infect Control. 2012;40(9):877-9

25. Ryan J. Leveraging the skills of APRNs to prevent HAIs. Nurs Manage. 2012;43(9):22-5

26. Lopez AC. A quality improvement program combining maximal barrier precaution compliance monitoring and daily chlorhexidine gluconate baths resulting in decreased central line bloodstream infections. Dimens Crit Care Nurs. 2011;30(5):293-8

27. Dixon JM, Carver RL. Daily chlorohexidine gluconate bathing with impregnated cloths results in statistically significant reduction in central line-associated bloodstream infections. Am J Infect Control. 2010 Dec;38(10):817-21

28. Eiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate cloth reduces rates of surgical site infection in orthopaedic surgical patients. Orthop Nurs. 2009;28(3):141-5

29. Lipke VL, Hyott AS. Reducing surgical site infections by bundling multiple risk reduction strategies and active surveillance. AORN J. 2010;92(3):288-96.

30. Wolfman, Ann. Preventing Incontinence-associated Dermatitis and Early-stage Pressure Injury [online]. WCET. 2010;30(1):19-24

31. Meyers TR. Preventing heel pressure ulcers and plantar flexion contractures in high-risk sedated patients. J Wound Ostomy Continence Nurs. 2010;37(4):372-8

32. Rauk PN. Educational intervention, revised instrument sterilization methods, and comprehensive preoperative skin preparation protocol reduce cesarean section surgical site infections. Am J Infect Control. 2010;38(4):319-23

33. Schmitz T. Location, Location Location: Incontinence supplies at the bedside. Manuscript and CE article. Published online at Lippincott Nursing Center. Available at: http://www.nursingcenter.com/lnc/pdf?AID=1095503&an=00006247-201012000-00013&Journal_ID=54013&Issue_ID=1095378

34. Johnson D, Lineweaver L, Maze LM. Patients' bath basins as potential sources of infection: a multicenter sampling study. Am J Crit Care. 2009;18(1):31-8, 41; discussion 39-40

35. Garcia R, Jendresky L, Colbert L, Bailey A, Zaman M, Majumder M. Reducing ventilator-associated pneumonia through advanced oral-dental care: a 48-month study. Am J Crit Care. 2009;18(6):523-32

36. Hutchins K, Karras G, Erwin J, Sullivan KL. Ventilator-associated pneumonia and oral care: a successful quality improvement project. Am J Infect Control. 2009;37(7):590-7

37. Cuddigan JE, Ayello EA, Black J. Saving heels in critically ill patients. WCET Journal April/June 2008, 28(2):16-24

38. Fowler E, Scott-Williams S, McGuire JB. Practice recommendations for preventing heel pressure ulcers. Ostomy Wound Manage. 2008 Oct;54(10):42-8, 50-2, 54-7

39. Howe L. Education and empowerment of the nursing assistant: validating their important role in skin care and pressure ulcer prevention, and demonstrating productivity enhancement and cost savings. Adv Skin Wound Care. 2008;21(6):275-81

40. Junkin J, Selekof JL. Beyond "diaper rash": Incontinence-associated dermatitis: does it have you seeing red? Nursing. 2008 Nov;38(11 Suppl):56hn1-10; quiz 56hn10-1

41. Junkin J, Selekof JL. Prevalence of incontinence and associated skin injury in the acute care inpatient. J Wound Ostomy Continence Nurs. 2007;34(3):260-9

42. Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, et al. Rhinosinusitis Initiative. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006;118(5 Suppl):S17-61

43. O'Brien TP. Emerging guidelines for use of NSAID therapy to optimize cataract surgery patient care. Curr Med Res Opin. 2005;21(7):1131-7 

Gayton JL. A clinical comparison of two different prednisolone acetate formulations in patients unde 

Timeline

Vice President Scientific Services

JB Ashtin
01.2022 - Current

Senior Scientific Director

JB Ashtin
01.2020 - 01.2022

Scientific Director

Envision Pharma Group
01.2019 - 01.2020

Scientific Director, Full-time Consultant

Stryker Medical Inc
01.2011 - 01.2020

Senior Medical Writer, Consultant

Sage Products LLC
01.2005 - 01.2011

Medical Writer and Editor

Constella Group, Inc
01.2004 - 01.2005

Doctorate of Public Health - Public Health Practice

Medical College of Wisconsin

Master of Public Health - Public Health Practice

University of Massachusetts, Amherst School of Public Health

Bachelor of Science - Healthcare Administration

Charter Oak State College

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Kersten F. Reich, MPH