Dr. Marilyn Carlson

Dr. Marilyn R. Carlson has 20 years of industry experience in the development and post-marketing support of drugs, biologics, and diagnostics.

• BA in Anthropology/Biology from Hunter College of the City University of New York
• D.M.D. from the Harvard School of Dental Medicine
• Dental Residency in Geriatrics & Special Patient Care - Long Island Jewish-Hillside Medical Center and The Jewish Institute for Geriatric Care
• M.D. from Case Western Reserve University, elected to Alpha Omega Alpha
• Internal Medicine Residency - The Cleveland Clinic Foundation
• Regulatory Affairs Certification - Regulatory Affairs Professionals Society
• Clinical Research, Medical Affairs, Technical Brand Management - Procter & Gamble Healthcare and P&G Pharmaceuticals
• Vice President Clinical & Medical Affairs – XOMA, Inc.
• Chief Medical Officer & Vice President of Clinical- Ista Pharmaceuticals, Inc.
• Chief Medical Officer & Vice President of Regulatory/Medical Affairs - Prometheus Laboratories, Inc.
• Appointed Member of the National Advisory Dental and Craniofacial Research Council of NIH
• Founder, entreMeDica, Inc. – California-based consulting company providing Chief Medical Officer services for entrepreneurs in biotechnology and the life-sciences
• U.S. Agent for non-U.S. companies seeking and maintaining FDA approval
• Vice-President Medical & Regulatory Affairs Synteract, Inc.
• Co-founder of The Consultants’ Forum
• U.S. Agent for non-US company with GI product granted FDA approval in 2006

Education

M.D. 1988

Case Western Reserve University School of Medicine

D.M.D. 1982

Harvard School of Dental Medicine

B.A. 1978

Hunter College of the City University of New York

Residency Training

Medicine

Internal Medicine
Cleveland Clinic Foundation
July 1988 - June 1991

Dentistry

General Practice Residency - Geriatric Track
Long Island Jewish - Hillside Medical Center/Jewish Institute for Geriatric Care
July 1982 - August 1983

Certification

• Diplomate in Internal Medicine: 1991 - 2001
• Regulatory Affairs Certification: 1998 - 2010

Work History and Experience

Synteract, Inc.

July 2004 to Present
Carlsbad, California
Vice President Medical & Regulatory Affairs

• Responsible for clinical and post-marketing safety surveillance, assisting clients with product development, medical oversight during all phases of clinical development (from protocol development to manuscript preparation), IND preparation and representation with regulatory authorities.

entreMeDica, Inc.

June 2004 to Present
Encinitas, California
President

• Founded consulting firm that provides Chief Medical Officer (CMO) services to entrepreneurs in the biotechnology and life sciences community in North America and Europe. Client companies range from start-ups seeking funding to established organizations with marketed, or soon-to-be marketed, products.
• Services include medical information & safety surveillance launch preparation, medical/regulatory review of sales and promotional materials, regulatory & clinical strategic planning in all phases of development, preparation for and representation at meetings with regulatory authorities, US agent for non-US companies, partnering, due diligence, training.

Prometheus Laboratories Inc.

May 2000 to June 2004
San Diego, California
Vice President Medical/Regulatory & Chief Medical Officer

• Created and built the infrastructure for drug development, regulatory approval and marketing support for an emerging specialty pharmaceutical company promoting individualized medicine through pharmacogenomics.
• Recruited and hired experienced staff for Medical, Regulatory & Clinical Affairs, Pharmaceutical Manufacturing & Development, Quality Systems and a team of field-based Clinical Science Liaisons.
• Filed 3 INDs, 5 sNDAs (all approved within 4 months), one ANDA (first generic to be approved since brand launched in 1953), as well as 17 Annual & Periodic Reports each year.
• Led clinical development for 4 studies; 3 completed in adults (Phase 2, Phase 4 and bioequivalence) and one initiated in children (Phase 2/3).
• Selected and implemented a post-marketing safety surveillance system to expedite the documentation, review and submission of safety data.
• Led teams conducting technical due diligence for development stage and marketed product acquisitions. Prepared technical due diligence reports to be used in decision-making.
• Served two years as Chair of the Norgine/Prometheus Joint Development Committee responsible for North American registration of two pharmaceutical products developed in Europe.

Advanced Corneal Systems (now ISTA Pharmaceuticals)

January 2000 to May 2000
Irvine, California
Vice President, Clinical and Medical Affairs Chief Medical Officer

• Participated in partnering discussions with several companies leading up to an agreement with Allergan.
• Led team for global clinical program for Vitrase® for the treatment of vitreous hemorrhage.
• Participated in technical aspects of preparation for Initial Public Offering (July 2000).

XOMA (US) LLC

June 1999 to April 2000
Berkeley, California
Vice-President Clinical and Medical Affairs

• Led all clinical development activities for the recombinant human defense protein, bactericidal permeability increasing protein (rBPI21), NEUPREX®. Managed the clinical team during Phase I and II of the psoriasis development project with Genentech (RAPTIVA®).
• Managed a Department of 25 consisting of Clinical Operations, Biostatistics & Data Management and Clinical Research.
• Led medical/clinical aspects of partnering discussions resulting in joint product development agreements with Allergan, Baxter and Procter & Gamble.

Medical Director
September 1997 to May 1999

• Team leader for pediatric meningococcemia and cystic fibrosis clinical development programs with the platform technology, rBPI21.
• Developed and successfully executed an aggressive timeline for completing the multicenter (U.S. and U.K.) Phase III study in pediatric patients with severe meningococcemia. Developed and delivered the sponsor presentation at the end of Phase III meeting with FDA.
• Presented meningococcemia program to regulatory authorities in potential rapporteur countries (Sweden, France, U.K. and The Netherlands) and to the EMEA.
• Provided medical information and clinical data to support regulatory submissions that included the BLA, MAA, Package Insert, and labeling.
• Successfully completed the Phase I/II clinical study in patients with cystic fibrosis (CF) and furthered collaborations with the Cystic Fibrosis Foundation and the CF research community.
• Developed new clinical indications for NEUPREX® leading to joint development agreements with companies with marketing capabilities.

Procter & Gamble Pharmaceuticals

March 1996 to September 1997
Cincinnati, Ohio
Worldwide Technical Brand Manager Product Development

• Project leader for premarket strategic and competitive worldwide positioning for a new generation oral bisphosphonate, Actonel®, for the prevention and treatment of bone disorders including Paget's disease and postmenopausal osteoporosis.
• Managed the technical aspects of the launch plan for this new entrant into a highly competitive market. Key aspects of the plan included scientific publications, innovative packaging, unique claims and support from international thought leaders.
• Led technical aspects of Actonel partnering discussions with multi-national pharmaceutical companies resulting in a co-development and co-marketing agreement with HMR (now Sanofi-Aventis).
• Managed the multi-million dollar premarket conditioning/commercialization budget.
• Developed the strategy and design of Phase 3B and 4 clinical studies to maximize competitive worldwide marketing claims and product differentiation.

Medical Director, Medical Affairs
July 1994 to February 1996
Bone and Arthritis

• Collected and analyzed safety data from worldwide clinical development programs in arthritis, Paget's disease and osteoporosis.
• Managed post-marketing safety surveillance for marketed products in North America.
• Delivered medical/technical presentations and submissions to provincial formularies and pricing review boards in Canada and to managed care organizations/pharmacy boards in the U.S.
• Developed medical and technical materials for new drug launches, including sales training manuals, advertising claims, sales promotional materials and medical communication responses.
• Designed and executed Phase 4 studies and provided ongoing medical/technical support for the advertising and promotion of marketed drugs.
• Led safety due diligence for health care licensing and acquisition opportunities across a broad range of therapeutic areas including; analgesics, endocrine, oral care and oncology.
• Developed Frequently Asked Questions and easily understood technical responses for use with the media.
• Single-point, technical spokesperson for press covering FDA Advisory Committee hearings and other external events involving P&G interests.

The Procter & Gamble Company

April 1992 - June 1994
Over-The-Counter Health Care Division
Medical Director, Worldwide Clinical Development for Oral Care and Worldwide Medical Affairs for Oral Care and Analgesics

• Managed scientists three distinct groups; the upstream technology clinical group, global project clinical group and the Medical Affairs postmarketing safety and medical communications group.
• Managed postmarketing and clinical safety surveillance, market support and claims development for analgesics, gastrointestinal, respiratory and oral care products.
• External, media-trained company spokesperson for OTC products. Appeared with Consumer Product Safety Commissioner Ann Brown at press conference and award ceremony for Safety Squease, the new consumer-friendly, child-resistant closure for Aleve and Baking Soda Scope.
• Represented company at the Non-prescription Drug Manufacturers Association meetings regarding product safety issues.
• Developed scientifically and clinically sound defense strategies for FDA Advisory Committees on diverse topics including the risk of oral cancer from mouthwashes and hepatotoxicity associated with OTC cough/cold preparations.
• P&G Corporate Medical Director on the joint Syntex-Procter Advertising Review (SPAR) Team responsible for the medical/technical accuracy of promotional materials for the successful naproxen sodium (Aleve) OTC-switch and launch.

Manager, Worldwide Clinical Development for Analgesics
August 1991 - March 1992
Gastrointestinal and Oral Care

• Project physician for Phase 3 gastrointestinal studies, Phase 1-2 upstream technology oral care studies and Phase 3B analgesic studies to support New Drug Applications.

 

Marilyn R. Carlson, D.M.D., M.D., RAC

Curriculum Vitae

• Experienced senior executive with 20 years pharmaceutical industry experience in the development and post-marketing support of drugs, biologics, and diagnostics.
• Proven ability to maximize opportunities to integrate scientific data and knowledge into effective and successful drug development and commercialization programs.
• Broad range of expertise including; gastroenterology, rheumatology, pulmonary, infectious disease, endocrinology, ophthalmology, women’s health, pediatrics, geriatrics, and oral care as well as pharmacogenomics and drug metabolite monitoring.
• Extensive experience in Medical Affairs including medical information, safety surveillance, creating and managing a field-based team of doctoral level clinical science liaisons.
• Excellent track record in Regulatory Affairs including preparing for and participating in meetings with regulatory authorities in the U.S., Canada and Europe, organizing and preparing successful submissions, working with sales and marketing to achieve creative scientifically and medically valid promotional and sales training materials. Utilized innovative approaches to update and enhance pharmaceutical product labeling resulting in product growth and increased revenue.
• In depth Clinical Development experience including the design, initiation, medical monitoring and successful conduct of studies from phase 1 through 4. In 2004, demonstrated bioequivalence in a single well-designed study leading to the first generic approval after competitors failed. Product launched 2 hours after ANDA approved generating sales in excess of $6 million the first week.
• Broad experience in product development, product launches and re-launches including, but not limited to, the OTC switch of naproxen sodium (Aleve®), Ultradol® in Canada (<6 weeks after marketing agreement signed with Wyeth), Didrocal® in Canada shortly after FDA failed to approve. World-wide Technical Brand Manager for planned launch of Actonel®.
• Demonstrated success in companies of varying size ranging from large (P&G >100,000 employees) to mid-size (XOMA and Prometheus at <500) to start-up (ISTA Pharmaceuticals at <50).
• For a specialty pharmaceutical company promoting individualized medicine through pharmacogenomics, created an operational organization to grow existing marketed products, integrate new products and provide drug development, clinical research, regulatory approval and post-marketing support capability. Three INDs filed, 5 sNDAs approved, 3 studies completed (Phase 2, Phase 4 and BE) and one study initiated (multicenter Phase 2/3).
• Founded successful consulting company offering chief medical officer services to entrepreneurs in biotechnology and the life-sciences
• Executive team member of rapidly growing full-service CRO in Carlsbad, California
• Co-founder of The Consultants’ Forum, a networking and professional development organization for independent consultants supporting the biotechnology and life science community in San Diego, the United States and abroad.

Academic and Clinical Experience

Case Western Reserve University

1988 – 1991
Cleveland, Ohio
Project Co-Director, Faculty Training
Project in Geriatric Medicine and Dentistry

• Wrote and integrated dental component into the successful geriatric medical/dental fellowship training grant application; one of 12 Federal training programs funded in first cycle.
• Developed the University's first geriatric oral health fellowship curriculum, recruited first dental fellows and supervised oral health training program for dental and medical fellows at inpatient, outpatient and long-term care clinical sites.

Western Reserve Geriatric Education Center

1985 – 1988
Cleveland, Ohio
Dental Faculty Coordinator

• Wrote dental component of successful Geriatric Education Center (GEC) Federal grant application; one of 24 GECs funded in highly competitive first cycle.
• Created the University's first dental curriculum for the training of faculty and community-based clinicians in geriatrics and geriatric oral health care and taught geriatric oral health in multi-disciplinary GEC-sponsored education programs in Northern Ohio.

Department of Dentistry

1983 – 1986
MetroHealth Medical Center
Cleveland, Ohio
Chief, Dental Home Care Division

• As a non-commissioned officer of the National Health Service Corps (NHSC), successfully expanded the unique, part-time dental home care pilot program to a full-time alternative oral health care delivery system for the chronically-ill residents of Cuyahoga County.
• Received the 1985 NHSC Regional Health Administrator Exceptional Achievement Award in recognition of the success of the Dental Home Care Program.
• Provided a full range of oral health services at bedside for several hundred patients with severe handicapping conditions ranging in age from 6 to 100 years.
• Used the opportunity provided by the MetroHealth Medical Center Speakers Bureau to increase community awareness of the unmet oral health needs of the chronically-ill, elderly, institutionalized and homebound residents of the county.
• Founder and editor of newsletter, On the Home Front, for homebound patients, their families and caregivers.

Academic Appointment

Case Western Reserve University

School of Dentistry
Department of Community Dentistry
Adjunct Assistant Professor - 1988 - Present
Clinical Instructor - 1983 - 1987

Medical Licensure

Ohio and California

Honors and Awards

The Cleveland Clinic Foundation

Distinguished Senior Medical Resident - 1991

Case Western Reserve School of Medicine

Alpha Omega Alpha - 1988

Professional Organizations

• American Association of Pharmaceutical Physicians
• American College of Gastroenterology
• American College of Physicians
• American Society for Geriatric Dentistry (Fellow, 1992)
• Regulatory Affairs Professionals Society

Memberships

National Institute of Dental and Craniofacial Research

Member, National Advisory Dental Research Council - 1998 - 2001

Society for the Advancement of Women's Health Care Research

Chair and Vice-Chair Corporate Advisory Council - 1995 - 1996

Case Western Reserve University, School of Dentistry

Member, Visiting Committee - 1988 - 1994

American Society for Geriatric Dentistry

Member, Board of Directors- 1985 - 1990

Harvard School of Dental Medicine

Student Member, Admissions Committee- 1981 - 1982

Recent Publications

• Tremaine, WJ, Carlson MR, Isaacs, KI et al. Ethical Issues, Safety, and Data Integrity in Clinical Trials
  Inflamm Bowel Dis. 2005; 11:S17-S21.
• Carlson, MR. HIPAA and the Privacy Rule: What Clinical Investigators Need to Know. Prac Gastroenterol. 2005; 29: 66-73.