Pharmaceutical Executive, Medical Affairs

JOSEPH B. LAUDANO, BS.PHARM, PHARMD

*** ****** ****** ******, ** 07044 973-***-**** ********@***.***

PHARMACEUTICAL EXECUTIVE, MEDICAL AFFAIRS

– Articulate, ambitious and results-driven senior executive leader with extensive experience in all facets of Medical

Affairs, including Medical Information Call Center operations, Publication Planning and medical/scientific review of

commercial communications in multiple therapeutic areas for industry leaders that includes Roche Pharmaceuticals

and Forest Labs.

– Skilled in leading multidisciplinary teams, project planning and the launch of start-up departments and programs,

including the Medical Affairs function at Alliqua Biomedical and the unprecedented RPS/Novartis Medical Affairs

Embedded Program.

– Strong background in departmental oversight and supervision of personnel with accountability to senior

management for budget planning and execution and operational compliance

– Extensive history of academic achievement, with a Doctor of Pharmacy and Bachelor of Science degree in Pharmacy

from St. John’s University. Author and contributor to numerous manuscripts and posters.

CORE COMPETENCIES

Department Leader in Medical Affairs Launching New Departments & Programs

Medical Information and Communication Leading Large 50+ Member Work Groups

Publication Development, Planning and Execution Establishing Standard Operating Procedures

Managing Multimillion Dollar Budgets Designing Marketing/Medical Education Programs

Leading Medical/Scientific Review Collaboration with Sales & Marketing Staff

P HISTORY

ROFESSIONAL

2012 to 2014: Alliqua Biomedical Inc., Langhorne, PA

– Vice President for Medical Affairs

Lead vision, strategy, and execution for all Medical Affairs activity on behalf of this newly launched advanced wound

care corporation. Responsibilities included: publication planning and execution, medical and scientific inquiries, medical

review of promotional materials, medical and scientific databases, scientific advisory boards, and post-marketing clinical

trials. Developed scientific assessments for potential in-licensing and line extension opportunities.

Key Achievements

Authored and implemented the 30/60/90 Day Plan for presentation to the CEO, outlining the strategic roadmap to

accompany the launch and growth of the Medical Affairs Department.

Envisioned, developed, and deployed a framework of procedures and policies to govern all Medical Affairs activity,

including the process infrastructure to guide publication planning and the creation of a product inquiry database.

Engaged in extensive data mining and assessment to identify relevant information for inclusion in the

commercialization of brands and clinical publications; efforts produced a direct impact on the effectiveness of sales

and marketing efforts.

Served as Project Manager for the development and launch of advanced wound care products that included

Silverseal, Hydress, Sorbion, and Biovance (in collaboration with Celgene Cellular Therapeutics); assumed a lead role

in creating the post-marketing clinical research plan for Silverseal.

Effectively managed all publications, while serving as author for two posters and one manuscript.

2011 to 2012: ReSearch Pharmaceutical Service Inc., Fort Washington, PA

– Executive Director, Embedded Clinical Programs, Novartis Pharmaceuticals

Fulfilled a critical leadership role for this global provider of innovative and effective outsourcing Clinical Development

Solutions, managing a team of 52 professionals engaged in the execution of a broad array of Medical Affairs services

including: medical information, clinical trials, budget tracking, publication planning, editorial review, materials approval,

and contracts.

JOSEPH B. LAUDANO, BS.PHARM, PHARMD

167 Sunset Avenue Verona, NJ 07044 973-***-**** ********@***.***

2011 to 2012: ReSearch Pharmaceutical Service Inc., Fort Washington, PA (Continued)

Key Achievements

Ensured the overall quality of the client experience for the Novartis Pharmaceuticals account, serving as the on -site

manager directing the launch and execution of the first-of-its-kind $7.5MM RPS-Novartis Medical Affairs Embedded

Program.

Assessed and re-engineered team contract processes to support an expansion of the services for the portfolio to

include investigator initiated trials, publications, speakers and sponsored post-marketing clinical trials.

Introduced a series of process improvements and cross-functional team training to enhance the cost-effectiveness of

the RPS-Novartis Medical Affairs Embedded Program and reduce client expenses.

2010 to 2011: Forest Research Institute, Inc. Jersey City, NJ

– Senior Director, Publication Planning and review, Infectious Disease Portfolio, Medical Affairs (2011)

Met the challenge of managing the development of scientific and medical publications for three antimicrobial products

produced by this leading specialty pharmaceutical company, while leading scientific and medical review of all

promotional materials leading up to the launch of the antibiotic Teflaro.

Key Achievements

Maintained accountability for a publication budget of $2.3MM; collaborated extensively with stakeholders from sales

and marketing to ensure the completeness and accuracy of all claims and marketing communications.

As an integral member of the global antimicrobial development team with partner AstraZ eneca, provided strategic

guidance, gap analyses, and “pull-through” of pre-clinical and clinical data from study reports for inclusion in

publications.

Served as a primary and contributing author on multiple papers on Ceftaroline, published in the Journal of

Antimicrobial Chemotherapy in coordination with product launch.

2008 to 2010: Senior Director, Department Head, Publication Planning & Review, Medical Affairs

Directed strategy and tactics governing publications and scientific review of commercial materials within all therapeutic

disciplines covered by the Medical Affairs team, including internal medicine, cardiovascular, CNS, gastrointestinal and

infectious disease. Exercised supervisory authority over a team of 7 direct reports and administrative st aff engaged in

planning and review for publications supporting a portfolio of 15 compounds. Additionally, exercised authority over

budget administration and the conduct of services by external agencies.

Key Achievements

Transformed multiple disparate publication planning strategies into a single cohesive approach featuring shared best

practices, capturing significant gains in efficiency, productivity, and operational effectiveness.

Introduced consistency and reliability to the publications process through the creation of process maps and Standard

Operating Procedures to govern all authorship and publication development.

Effectively managed strategic alliances with partners that included AstraZeneca, Ironwood, Almirall, and others.

2007 to 2008: Director, Publications Planning & Review, Internal Medicine / Infectious Diseases, Medical Affairs

Effectively managed three direct reports and an administrative staff member engaged in the publication and scientific

review of commercial materials across all internal medicine and infectious disease products. Introduced departmental

guidelines to govern the development process and address authorship issues. Supervised the activities of external

publication agencies, overseeing the development of manuscripts, posters, presentations, and symposia.

Key Achievements

Authored the publication plan, abstracts and posters in support of the investigational antibacterial Ceftaroline.

Contributed additional expertise assessing the needs of the department with respect to publishing software,

developing proposals detailing specific requirements.

JOSEPH B. LAUDANO, BS.PHARM, PHARMD

167 Sunset Avenue Verona, NJ 07044 973-***-**** ********@***.***

1986 to 2006: Roche Laboratories Inc., Nutley, NJ

– Product Director, Diversified Portfolio, Primary Care Marketing (2005 to 2006)

Administered a $200MM portfolio of 16 non-POA brands produced by this industry leader in pharmaceutical products

and services, driving growth and overseeing strategic planning, business development, and marketing.

Key Achievements

Partnered with GSK Consumer health to co-promote Xenical, leveraging limited promotional resources to boost

awareness of this prescription-strength counterpart to Ally; demonstrated strong leadership and planning in the

transition of this medication from a prescription-basis to an OTC market launch with GSK.

Served as the resident subject matter expert on Accutane, led the Accutane Risk Management and Pharmacovigilence

Program iPLEDGE, a federally mandated initiative designed to maximize awareness of the risks of Accutane when

taken during pregnancy.

Managed institutional contracts, production forecasts, and patent expiry for all products including Rocephin during

post patent-expiry period. Expertly managed Rocephin inventory during post-patent erosion to maximize sales and

minimize in-house product expiration.

2000 to 2004: Product Director/Manager, Rocephin, Xenical, Boniva, Primary Care Marketing

Developed medical marketing and education programs in support of the ph armaceutical products Rocephin, Xenical and

Boniva, a portfolio collectively valued at over $1B in sales, designing educational programs, planning and executing

medical/scientific publications and educational electronic media.

Key Achievements

Served as part of the most successful product team for the company, building sales of Rocephin from $500MM to

nearly $1B over four years; engaged in promotional activity, sales aids, medical education, publications, journal

advertising, CME symposia and conventions for the company’s flagship product.

Produced medical education materials and programs for Xenical, including publications, web programs, CME,

symposia and the Weight Management Workshops.

Engaged in product management and market intelligence activities in support of Boniva, an osteoporosis treatment

medication, including medical education, publications data entry in support of the NorthStar 2001 Strategic Plan,

regulatory strategies, and business case models.

Early Career

Director / Group Leader, Professional Product Information, Medical Affairs, Roche Laboratories, Inc. Nutley, NJ

External Scientific Liaison, Medical Affairs, Roche Laboratories, Inc. Nutley, NJ

Manager, Professional Services, Roche Dermatologics

Product Services Manager, Professional Services, Roche Laboratories

Staff Pharmacist, Cambridge Pharmacy - North Merrick / Medical Group Pharmacy, Hicksville, New York

Drug Information Specialist, Medical Department, Winthrop-Breon Laboratories, New York, New York

Staff Pharmacist/Nursing Home Consultant, Center Drug Co., Oceanside, New York

Assistant to the Executive Director, Pharmaceutical Society of the State of New York, White Plains, New York

Pharmacy Intern / Staff Pharmacist, Dale Drug Co., Valley Stream, New York

EDUCATION

Doctorate of Pharmacy Degree – St. John’s University, Jamaica, NY (Recipient of the Rho Chi Award)

Bachelor of Science Degree in Pharmacy – St. John’s University, Jamaica, NY

PROFESSIONAL LICENSES, CERTIFICATIONS & AFFILIATIONS

Licensed Pharmacist in New York State

Antimicrobial Stewardship, New York State

Member, American Society of Health-System Pharmacists

Member, American College of Clinical Pharmacy

Member, Pharmaceutical Society State of New York

Master Captain’s License & United States Coast Guard Auxiliary: Operations, Navigation Systems, Boat Crew

JOSEPH B. LAUDANO, BS.PHARM, PHARMD

167 Sunset Avenue Verona, NJ 07044 973-***-**** ********@***.***

MANUSCRIPTS & PRESENTATIONS

Caraccio T, Moffenson H, Laudano JB. Phenol Toxicity from Glucagon. Letter. JAMA 255:2025; 1986.

Laudano JB, Patton L. Travelers Diarrhea. Accredited C. E. Article No. 79, Pharmacy Times. July :96-107;1986.

Westra S, Laudano JB. Acne: Therapeutic Perspectives with an Emphasis on the Role of Isotretinoin. Dermatology

Nursing. December, 2:328-336;1990.

Westra S, Laudano JB. Perspectives on Acne Therapy with an Emphasis on Isotretinoin. A.C.P.E. accredited program.

Roche Laboratories. 1993

Laudano JB. Ceftaroline Fosamil: a new broad-spectrum cephalosporin. J Antimicrob Chemother. 66 Suppl:iii11-

iii8;2011.

Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III

randomized, double-blind studies evaluating Ceftaroline Fosamil for the treatment of patients with community-

acquired pneumonia. J Antimicrob Chemother. 66 Suppl 3:iii53-iii59;2011.

Friedland HD, O'Neal T, Biek D, Eckburg PB, Rank DR, Llorens L, Smith A, Witherell GW, Laudano JB, Thye D.

CANVAS 1 and 2: analysis of clinical response at day 3 in two phase 3 trials of Ceftaroline Fosamil vs. vancomycin

plus aztreonam in the treatment of acute bacterial skin and skin structure infections. Antimicrob Agents Chemother.

2012;56:2231-2236

Eckburg PB, Friedland HD, Llorens L, Smith A, Witherell G, Laudano, JB, Thye D. Day 4 Clinical Response of

Ceftaroline Fosamil Versus Ceftriaxone for Community-Acquired Bacterial Pneumonia. Infectious Diseases in Clinical

Practice. 20(4):254-260, July 2012

Singh BN, Dedhiya MG, DiNunzio J, Chan P, Kupiec TC, Trissel LA, Laudano JB. Compatibility of Ceftaroline Fosamil

for injection with selected drugs during simulated Y-site administration. Am J Health-Syst Pharm. 2011;68:2163-

2169.

Laudano JB, Fluder A, Krupa, S, Snyder S, Smiell J. Evaluation of Silver Ion Release and Antimicrobial Properties of

a New Silver Fiber Hydrogel Wound Dressing. Manuscript submitted to Journal of Wound Care.

SELECTED RECENT PRESENTATIONS

Symposium on Advanced Wound Care Spring 2013

Krupa S, Laudano J, Smiell J, et al. Bactericidal activity of a silver-coated nylon fiber hydrogel wound dressing.

Presented at the Symposium on Advanced Wound Care/Wound Healing Society. May 1-5, 2013. Denver

Colorado.

Fluder A, Laudano J, Smiell J, et al. Silver Ion Release From a Silver Fiber Hydrogel Wound Dressing. Presented

at the Symposium on Advanced Wound Care/Wound Healing Society. May 1-5, 2013. . Denver Colorado.

European Congress of Clinical Microbiology and Infectious Diseases, 2011

Rank DR, Baculik T, Eckburg P, Smith A, Laudano J, Friedland HD. Integrated safety analysis of CANVAS and

FOCUS studies: randomized, double-blinded, phase 3 studies of Ceftaroline (CPT) Fosamil versus comparators

in complicated skin and skin structure infection (cSSSI) and community-acquired bacterial pneumonia (CABP).

Presented at the 21st Annual Meeting of the European Congress of Clinical Microbiology and Infectious

Diseases; May 7-10, 2011; Milan, Italy.

JOSEPH B. LAUDANO, BS.PHARM, PHARMD

167 Sunset Avenue Verona, NJ 07044 973-***-**** ********@***.***

American Society of Health-System Pharmacists 2010

Laudano JB, DiNunzio J, Singh B, Chan P, Kupiec TC, Trissel LA. Compatibility of Ceftaroline Fosamil for injection

with selected drugs during simulated Y-site coadministration. Presented at the 2010 American Society of

Health-System Pharmacists Summer Meeting; June 6-9, 2010; Tampa, FL. Poster #33-M.

The American College of Clinical Pharmacy 2010

Eckburg P, Friedland HD, Lee J, Llorens L, Critchley IA, Laudano JB, Merrill C, Thye D. FOCUS 1 and 2:

randomized, double-blinded, multicenter phase 3 trials of the efficacy and safety of Ceftaroline Fosamil vs

ceftriaxone in community-acquired pneumonia. Presented at the Annual Meeting of the American College of

Clinical Pharmacy; October 17-20, 2010; Austin, TX. Poster #141E.

American Society of Health-System Pharmacists Midyear Clinical Meeting 2010

Lodise T, LaPensee K, Berger A, Laudano J, Drusano G. Comparison of hospital length of stay between

Ceftaroline (CPT) Fosamil and ceftriaxone (CRO) among hospitalized patients with community-acquired

pneumonia (CAP): analysis of 2 phase III randomized controlled trials. Presented at the 45th Midyear Clinical

Meeting and Exhibition of the American Society of Health-System Pharmacists; December 5-9, 2010; Anaheim,

CA. Poster #5-073.

The American College of Clinical Pharmacy 2009

Corey R, Wilcox M, Baculik T, Thye D, Laudano JB. CANVAS-1: randomized, double-blinded, phase 3 study

(P903-06) of the efficacy and safety of Ceftaroline vs. vancomycin plus aztreonam in complicated skin and skin

structure infections. Presented at the Annual Meeting of the American College of Clinical Pharmacy; October

18-21, 2009; Anaheim, CA. Poster #116E.

Sader HS, Williams G, Critchley I, Laudano JB, Jones RN. Bactericidal activity of Ceftaroline combined with

NXL104 critical targeted organisms possessing various resistance mechanisms. Presented at the Annual Meeting

of the American College of Clinical Pharmacy; October 18-21, 2009; Anaheim, CA. Poster #119E.

Riccobene T, Laudano JB, Fang E, Thye D. An open-label pharmacokinetic, safety, and tolerability study of

single intravenous doses of Ceftaroline in subjects with normal renal function or severe renal impairment.

Presented at the Annual Meeting of the American College of Clinical Pharmacy; October 18-21, 2009;

Anaheim, CA. Poster #191E.

American Society of Health-System Pharmacists Midyear Clinical Meeting 2009

Laudano J, Wilcox M, Corey R, Baculik T, Thye D. CANVAS-2: randomized, double-blinded, phase 3 study

(P903-07) of the efficacy and safety of Ceftaroline vs vancomycin plus aztreonam in complicated skin and skin

structure infections. Presented at the 44th Annual Midyear Clinical Meeting of the American Society of Health-

System Pharmacists; December 6-10, 2009; Las Vegas, NV. Poster #6-080.

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