Marilou Cramer, BS

Areas of expertise: Clinical Operations, Regulatory Affairs, Project Management

Marilou has over 30 years of experience in pharmaceutical/biotech product development with a strong background in clinical trials work across a broad range of therapeutic areas with emphasis in type 1 and type 2 diabetes, hormone replacement, women’s healthcare, and pain management.  Her contributions have moved projects from start-up to regulatory approvals, guiding programs from IND to NDA submission through development of clinical plans, trial design, protocol writing, CRO selection, study management or oversight, participation in FDA and ex-US regulatory authority meetings, and involvement in NDA preparation. Marilou has a B.S. in Medical Technology from Wilkes University in Pennsylvania.

During 28 years with ALZA Corporation, Marilou held positions of increasing responsibility in various areas of pharmaceutical product development. She led the development team through NDA approval of Estraderm®, the first transdermal product developed and approved by FDA for hormone replacement therapy and built an integrated clinical sciences department (monitoring, data management, biostatistics, and report writing) to conduct trials for ALZA and client sponsored programs. Marilou managed that team through NDA approvals of Duragesic®, Testoderm®, Actisite®, Effidac®, Procardia XL®, and Nicoderm®. Marilou also led a discovery team to identify and rigorously assess product candidates for development by Therapeutic Discovery Corporation and Crescendo Pharmaceuticals, companies established by ALZA to develop products for their own pipeline. She has participated in regulatory authority meetings in the US, UK, and EU and made presentations to FDA. Marilou has organized European clinical trials identifying resources to manage various clinical and regulatory tasks.  She has presented papers at US and international scientific meetings, developed relationships with key investigators and thought leaders and participated in preparation, negotiation, and oversight of government agency contracts.

Marilou was recognized for her scientific accomplishments by peer-review appointment to the rank of Senior Research Fellow at ALZA Corporation.

After moving on from ALZA Marilou has worked as an independent consultant, to small and mid-size pharmaceutical and biotech companies to help them with clinical development programs from Phase 1 through NDA submissions. Her strong interpersonal and leadership skills have contributed to building and leading successful teams through development of key internal and external relationships.

Marilou has a good understanding of the logistical requirements to get a study up and running and then managed through to a clinical study report. In working with early stage companies it’s important to have a creative approach to balance internal and external resources to achieve goals. Companies  that Marilou has worked with include ALZA, Depomed, AcelRx, PharmacoFore, Corium, One World Health, Achaogen, Revance Therapeutics, Illustris Pharmaceuticals, and Tolerion, Inc. Undertakings and contributions have been dependent on company needs and have included the following:

• Provide strategic input into clinical development programs from Phase 1 studies through NDA submission and input to regulatory submissions from pre-IND packages to NDAs
• Participate in FDA meetings
• Mentor and supervise in-house clinical staff and assist with set-up of infrastructure where needed
• Develop clinical operating plans and design clinical studies utilizing tools such as regulatory guidances and relevant literature
• Author protocols and investigator brochures
• Evaluate, select, and manage CROs and other vendors
• Provide oversight of clinical trials
• Organize and participate in investigator meetings
• Review trial data, review or author clinical study reports, assist in preparation of clinical summaries for NDA
• Participate in Business Development meetings to present clinical data to prospective partners
• Set-up and manage first-in-man studies conducted in Australia and in the US