About Smart Consulting Group
Our clients remind us daily of how important our customized, tailored solutions-based programs are to their companies, and the incredible value this brings them as we help them better streamline their operations and compliance programs for greater productivity and profits.
Although most consulting in the Life Sciences & Healthcare sectors still consists of awkward one-size-fits-all approaches, Smart Consulting Group, LLC is a progressive consultancy committed to going the extra mile to provide specific technical and regulatory compliance services to our clients. Your operation is unique, and the solutions that will bring you the greatest economies and results must be equally unique.
While the demands of our modern Pharmaceutical, Biotechnology, Vaccine, Biologics and Medical Devices industries are better served by this focused consulting approach, no single fixed team can have all the skillsets necessary to meet every client’s needs in today’s fast-changing economic and compliance landscape. That’s why we’ve taken extraordinary steps to supplement the extensive industry experience of our internal core team by investing over 20 years developing our extensive and proprietary network of dozens of key industry and compliance experts. Because of these deep relationships, we can bring in as many — or as few — precisely-selected consultants as needed on almost any project, for any sized company… based solely on the unique needs of your actual operation.
Smart Consulting Group’s core internal team is led by founders Nigel and Denise Smart, who alone have over forty-five years of combined industry-specific lab and manufacturing experience with such companies as SmithKline Beecham, DuPont Pharma, Sterling Winthrop, and Allelix BioPharmaceuticals. Combined with our other team members, who average 15-20 years of industry experience each, you have access to over 1000 years of experience to provide you with Smart Solutions that are timely, focused and immediately applicable for you.
About Nigel Smart
Nigel holds a BS in Chemistry from Leicester University (UK), a MS from the Victoria University of Manchester (UK) in Microbial/Fermentation Technology and a PhD in Biochemical Engineering, also at Manchester. He is also a Chartered Chemist, member of Institute of Biology, and a Chartered Scientist. Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE).
About Denise Smart
Denise holds a BS in Biology from Kutztown University, a MBA from Penn State, and a JD from Widener Law School. She has been admitted to the Delaware Bar and the Federal District Court, District of Delaware.
Both Principals are active in numerous industry associations including Pennsylvania Biotechnology Association, Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE).
About Tony Barcia
Tony Barcia is in his 31st year of a successful pharmaceutical career. He is currently a senior consultant for the Smart Consulting Group. Prior to joining SCG he was an Account Director for Johnson & Johnson Corporate Quality and Compliance Services. He was responsible for the oversight of the analytical/laboratories functions across the vast array of J&J companies. Read more.
This included the +200, Pharmaceutical, Consumer and Device companies located throughout the world. Integrating the corporate requirements while maintaining there independence and spirit of discovery was critical to the corporation’s success. Aligning corporate and regulatory functions across this diverse mix of companies was an ongoing challenge. Streamlining (Lean Laboratory) laboratory functions from development to final QC release within individual companies was especially important to maintain competiveness in the world markets. In addition to International GMP and laboratory training seminars, special HIV/AIDS Humanitarian projects in Sub Sahara, Africa were part of his many assignments. He is one of the contributing authors to the ISPE Technology Transfer Guide and was leading the development effort on the ISPE GMP Laboratory Guide.
Prior to J&J he had a successful career at The Consumer Division of Ciba-Geigy (now Novartis) where his last position was Director of Analytical Development. He was very successful in melding the external (contract laboratory) development group with the traditional internal group in such a way as to maintain optimum flexibility and exposure to new technology. He re-defined the advantages and importance of utilising cutting edge technology in routine and specialized testing.
After Graduating from City University of New York with a Bachelors degree in Chemistry he joined E.R.Squibb & Sons (now Bristol Meyers Squibb) where he rose from an analytical chemist in the QC labs to the supervisor of the HPLC/Robotics lab and then on to several assignments within the Quality Assurance organization.
About Jerry Long
Jerry Long has more than 30 years of experience in the pharmaceuticals, biotech, medical device and specialty chemicals industries, with leadership experience in Supply Chain Management, Engineering, Quality Management, and R&D. An acknowledged change leader with a passion for business process improvement, he is known for bringing order out of chaos through customer focus, team-building, and practical solutions. He is currently a senior consultant with Smart Consulting Group. Read more.
He has relevant experience in lean analysis/business process improvement, quality improvement, project management, biopharma commercialization preparation, manufacturing strategy, sourcing/contract manufacturing, inventory systems, sales & operations planning, demand management, cGMP materials management/warehousing, ERP selection/ implementation, clinical supply, cold chain, process development and scale-up, and facility design.
Mr. Long graduated from Lehigh University with a Bachelors in Chemical Engineering and added an MBA from the Katz Graduate School of Business at the University of Pittsburgh. He also holds CPIM and CSCP certifications with APICS, the Association for Operations Management. He is a member of ISPE, CSCMP, and APICS.
About Gregory Worosila
Gregory Worosila has over 25 years of experience in the pharmaceutical industry, primarily in the area of analytical chemistry and laboratory operations. His technical expertise was developed during a career working for Ciba-Geigy Pharmaceuticals (later Novartis), as well as within the Pharmaceutical Research & Development division of Johnson & Johnson. He has experience in the development of all types of drug substances and products, from small molecules to biologicals and all phases of development from Phase 1 through Phase 4 (post commercial support). Read more.
In addition, he has significant expertise in quality systems as they apply to laboratory operations, and designing quality into processes (Quality by Design). He has been successful in elaborating and implementing process redesign, organizational changes, and in streamlining laboratory operations and costs.
Dr. Worosila holds a Bachelor of Science degree in Chemistry from Seton Hall University and a Ph.D. in Chem
istry from Rutgers, the State University of New Jersey. He is currently a member of the American Chemical Society (ACS) and the American Association of Pharmaceutical Scientists (AAPS).
About James Robinson
James Robinson has over 32 years experience in the regulation of pharmaceutical, medical device and biologics products. For the first 28 years of these he was a government employee with the US Food & Drug Administration (FDA) as an investigator conducting various audits including GCP audits of clinical study sites connected with investigational products. Read more.
Now as a key member of SCG, he applies this experience to product companies to help them develop appropriate Quality Systems and to prepare them for regulatory audits by the FDA & foreign agencies.
A key piece of Jim’s experience is employed in instructing client firms to be proactive in their conduct of investigational clinical trials and in developing their compliance programs to meet FDA regulations, guidances and ICH documents.
With over 100 audits of pharmaceutical products completed, more than 40 in medical devices and another 45 audits of Institutional Review Boards (IRBs), client companies are provided with a very experienced knowledgeable opinion of their state of compliance readiness.
Aside from GCP experience, Jim rounds out his capabilities by bringing cGMP inspection experience for medical device firms, blood centers/plasma fractionation centers and pharmaceutical facilities.
His range of experience cover inspections in the US, Argentina, Australia, Austria, Belgium, Canada, China, Germany, Hong Kong, Hungary, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Russia, Singapore, South Africa and Thailand.
Mr. Robinson holds a BS in Biology from Livingston University, Livingston, Alabama. He is also a member of the Regulatory affairs professional Society (RAPS).
About Lisa Grim
Business Development for San Diego southern California region
Lisa Grim is a doctor of veterinary medicine. Dr. Grim has 20 years of direct and supervisory clinical veterinary medical experience. Her practice, which specializes in equine medicine, has included the extensive use of cutting edge pharmaceuticals. She knows the joys of victory when regimens work effectively as well as the agonies of defeat when the medications fail. She has contracted with a variety of consulting professionals in her own practice and knows what works and what doesn’t. Read more.
She has worked as an expert in pharmaceutical focus groups and has participated in several clinical trials for new drug products. As a business owner, CEO and corporate board member, she has the business acumen for successful, timely, and cost effective performance in a competitive scientific environment. With a special emphasis on bottom line accountability and the incorporation of best practices, her collaborative consulting style is direct and effective.
A member of UCSD Connect, a science based and academic consortium in La Jolla, Lisa also participates in the MIT science seminar colloquia.
She is a graduate of the prestigious UC Davis School of Veterinary Medicine.
About Michael Hemenway
Business Development for the Minneapolis Region
Michael Hemenway has over 9 years of experience in the pharmaceutical industry and over 4 years of product development experience in the medical device industry.
His experience in the pharmaceutical industry includes analytical QC chemist and analytical development chemist with The Upjohn Company (now Pfizer), senior research scientist in organic synthesis and biocatalysis (applied biotechnology) at pharmaceutical outsourcing firm Albany Molecular Research, Inc. (now AMRI), and analytical development manager for P3 Scientific (now Pace Analytical Life Sciences), a major pharma and medical device contract lab in the Minneapolis area. Read more.
This collective experience has given Michael solid expertise in quality control, specifications development, analytical method development and validation including both spectroscopy and chromatography, problem-solving technical skills in a research environment, and business development in a contract laboratory environment.
Michael’s medical device industry experience involves previous work as a Product Development Manager for Medtronic CRDM Therapy Delivery Systems in a pharmaceutical support, change management and project management role. Michael is well-experienced in medical device product development, especially in the area of implantable cardiac pacing and defibrillation leads and knows well the challenges and opportunities in combination drug/device product pre-clinical development, including quality system, materials science, analytical method development and validation, biocompatibility, drug coatings and controlled-release drug components, long-term pre-clinical pharma stability (shelf life) evaluations and interfacing with the FDA specifically on CMC topics in both pre-IDE and pre-PMA phases of development. He also has good insights into point-of-care conditions for implantable medical devices through numerous hospital on-site preceptorships and operating room experiences.
Dr. Hemenway holds a Bachelor of Arts degree in Chemistry from Saint Olaf College and a Ph.D. in Pharmacy (medicinal chemistry) from The University of Iowa. He has been a member of the American Chemical Society for nearly 20 years and the American Association of Pharmaceutical Scientists (AAPS).
About Christopher Smith
Christopher Smith is a Senior Consultant with Smart Consulting Group, LLC and has more than 30 years of experience in the pharmaceutical industry having held senior positions at the FDA, large and small pharmaceutical companies and clinical and CMC focused contract research organizations.
Prior to joining the Smart Consulting Group team, Mr. Smith was Vice President, Regulatory Affairs and Quality Assurance at AAIPharma Services Corp., a provider of contract research and development services to the pharmaceutical, biotech and medical device industries including regulatory and quality consulting services. Mr. Smith returned to AAIPharma following the successful establishment and sale of Endeavor Pharmaceuticals, a start up “virtual” company focused on the development of therapies for women’s health at which he was Vice President, Regulatory Affairs and Quality Assurance and a member of the Executive Committee. Mr. Smith joined Endeavor after nine years at AAIPharma where he served on the Executive Committee and held the position of Global Vice President, Regulatory Affairs and Quality Assurance. Read more.
He joined the original AAIPharma in 1992 following five years as Associate Director of Regulatory Affairs in Abbott Laboratories’ Pharmaceutical Products Division. Mr. Smith began his regulatory career as an Investigator in the Detroit District of the U.S. Food and Drug Administration and spent 12 years with FDA in positions of increasing responsibility including Assistant Director of Congressional Operations, Associate Director of Program Management and Deputy Associate Commissioner for Public Affairs in Rockville, MD. He was one of the key authors of FDA’s last major rewrite of the IND and NDA regulations in the 1980s and managed several other key FDA regulatory initiatives such as the tamper-resistant packaging regulations following the cyanide poisonings with Tylenol in 1982.
Mr. Smith has a Bachelor’s degree from Michigan State / Oakland University, Rochester, MI, and a Master’s degree in Microbiology from Wayne State University, Detroit, MI. He is a member of the Drug Information Association, the Regulatory Affairs Professional Society (certified RAC), the Parenteral Drug Association and the American Society for Quality (certified CQE). He has several publications including “Laboratory Operations: A Vital Link,” GMP Compliance, Productivity, and Quality (Interpharm Press, 1998), “Speed Dating: the Rapid Way to Phase I Clinical Studies,” PMPS Journal (Winter 2006) and “A Fish Story: The One That Got Bigger,” Communicating in a Healthcare Crisis, (FDANews, 2007). He is a sought-after speaker and panel participant on regulatory and quality issues affecting the pharmaceutical industry and has presented on topics including drug development, 505(b)(2) NDAs, GxPs, compliance, outsourcing, stability, PAIs, interactions with regulatory agencies and controlled substances.