Robert J. Michalik, Esq., RAC

Principal Consultant

Professional Experience:

I have over 20 years experience working in the biopharmaceutical and medical device industries.    In 1982, with an undergraduate degree in biochemistry, I began my career as a research associate at Harvard Medical School/B&W Hospital in Boston, MA specializing in protein chemistry and cell biology research.  After two years of basic research, I moved into the burgeoning biotechnology industry as a protein chemist with the Repligen Corp. where the emphasis was on rapid and accurate applied research and focused product development ("r&D"). 

In 1987, I took a position at Serono Laboratories, Inc., Randolph, MA where I coordinated several recombinant DNA-derived biopharmaceutical projects.   At first, my efforts were focused on protein purification process development, technology transfer and process validation relating to Serono's first r-DNA derived product, Saizen^® (r-human growth hormone, r-hgh).  As lead scientist on the r-hgh project, I worked closely with members of the Regulatory Affairs Department in preparing CMC-related submissions to agencies around the world.  Later, after completing the process development and technology transfer phases, I stayed with the Saizen^® project and assumed managerial responsibilities for establishing Serono’s new biopharmaceutical manufacturing department.  Within two years of operation, my department was manufacturing approximately $40 million of cGMP compliant product. 

In 1991, I left Serono to pursue a law degree in the evening program at Suffolk University Law School.  While attending law school I continued to work full-time as a consultant for several biotech clients in the Boston area. I provided a variety of technical, quality and regulatory services, including cGMP-compliant quality system design and implementation, Chemistry, manufacturing & control (CMC) drafting, validation protocol design and execution, and manufacturing process development and production in support of Phase I/II clinical trials.   Clients included Biogen, Genzyme, The Center for Blood Research Labs, and Epix Medical.  

In 1997 I accepted a full-time regulatory affairs position at Diatide, Inc., a small radiopharmaceutical company based in southern New Hampshire.   Diatide's core technology (a proprietary linker peptide capable of chelating gamma and beta emitting radioisotopes) was used in an array of investigational new drug products.   No fewer than six investigational new drugs were in clinical trials at any given time.  All INDs submitted to the FDA were under the CDER's regulatory review.  Indications under investigation included cancer, unstable arthrosclerotic plaque, pain management, infection, and inflammation.  During my three years at Diatide, the four member Regulatory Affairs team succeeded in submitting and gaining marketing approval for two new drug applications (NDAs) (AcuTect^®, Technetium Tc 99m Apcitide Injection; and NeoTect^tm, Technetium Tc 99m Depreotide Injection)

In 2000, Diatide was acquired by Berlex/Schering AG and thereafter all Regulatory Affairs operations were transferred to Berlex's corporate headquarter in New Jersey.   I then joined the Boston Scientific Corp/Microvasive division as a Senior Regulatory Affairs Specialist.   During my 1½ year tenure at BSC, I contributed significantly to the success of over a dozen products in BSC's extensive new product pipeline.   I compiled Design History files ("Letters to file"), Premarket Notifications (510k) to FDA CDRH, preliminary activities for an Investigational Device Exemption (IDE), and various written opinions, reports and memoranda relating to foreign regulatory applications.  

As Director of Regulatory Affairs & Quality Assurance for Bioheart, Inc., a small, CBER-regulated cell therapy and medical device company, I compiled and successfully submitted two IND applications in the U.S. and comparable applications in various European countries.   Clinical trials are now underway in the U.S., Germany, Italy, and The Netherlands to investigate the safety and efficacy of the company's primary investigational product, an autologous cell therapy treatment for the repair of damaged heart muscle tissue subsequent to myocardial infarction.  Bioheart decided to consolidate its  Massachusetts and California R&D operations (including regulatory affairs and quality assurance) into its corporate center located in Florida and consequently closed its Massachusetts labs in 2002.

I established RegulatoryPro in 2002 with a mission to offer accurate and timely regulatory and quality system consulting services to client companies in the biotechnology, pharmaceutical and medical device industries.