PEOPLE INTERVIEWED

Michael Kopcha, Ph.D., R.Ph. is the Director of the FDA’s Office of Pharmaceutical Quality (OPQ). This office has over 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of Investigational New Drug Applications (INDs) and establishes quality standards for over-the-counter drug products and facilities.

Prior to joining the FDA, Dr. Kopcha amassed more than 25 years of experience in major and mid-sized innovator, generic, drug/device, and over-the counter (OTC) pharmaceutical and consumer health companies. He developed expertise in areas including formulation and process development, product scale-up, process validation, technology transfer, project management, change management, and off-shoring/outsourcing. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy from Rutgers University. He also served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.

Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe. Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative.

He is an ISO 9000 certified lead assessor and six sigma / lean manufacturing master black belt. Chatterjee is a member of the USP national advisory board, past chairman of the Golden Gate Chapter of the American Society of Quality (ASQ. Chatterjee is a regular editorial contributor to several industry journals, serves on the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, and is a founding member of the CPhl expert industry advisory board. Chatterjee is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry” (ISBN: 978-0-566-09204-6). He holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.

Mike Tobyn, Senior Scientific Director, Materials Science and Engineering, Bristol Myers Squibb Mike has worked for BMS for 18 years and is part of Materials Science and Engineering function within Drug Product Development (Product Development and Supply. His team is based in Moreton, England and New Brunswick, New Jersey.

Their function is to look at all small molecule assets, from Discovery through to Manufacturing, and assess the characteristics, and using data to predict and understand their performance in solid oral dosage forms. The work involves analytical science and big data analysis, and Mike has co-edited book on the use of Multivariate Data Analysis in the Pharmaceutical Industry. Mike has worked extensively in the area of excipients and is a member of the USP Committee on excipient test methods and is an advisor to the Handbook of Pharmaceutical Excipients. A Registered Pharmacist, Mike trained in Pharmacy at the University of Strathclyde, and took his PhD there in 1994. Mike taught Pharmaceutical Technology at the University of Bath and at the University spin-out company Vectura, where he was with the company from inception through to IPO.

In 2019 Mike was elected as the Eminent Fellow of the Academy of Pharmaceutical Sciences for his contribution to the field of Pharmaceutical Technology in the UK and across the world. Mike is married with four children, two are currently at High School and two at University.

Tom Sellig brings more than 30 years of global experience in the life sciences industry to Adare, including experience scaling organizations and driving growth in the CDMO and Pharma Services space.

From 2019 to 2021 Tom served as Chief Executive Officer of LabConnect, a clinical trial laboratory services organization. Under his leadership, the company more than doubled in revenue and underwent significant team expansion to meet the growing needs of the biopharma industry.

Prior to LabConnect, Tom was Chief Commercial Officer at ConnectiveRx, where he was responsible for all commercial and customer-facing activity at the patient support and patient access company. Earlier, Tom was Senior Vice President of Global Sales at Patheon, where he played an integral role in the company’s sale to and integration with Thermo Fisher. Previously, he served as the Global Vice President of Sales and Client Services at Covance.

Tom received his bachelor’s degree in Economics from Vanderbilt University and an MBA from New York University.

Michael Kallelis has spent his career in public and private life science companies where he has successfully implemented commercial and operational growth strategies. Prior to Mikart, he held several senior roles including president of Exiqon Inc., co-founder and chief operating officer of Boston Biosystems, vice president of business development at KMC Systems, and general manager of several GE Healthcare businesses.

His experience covers a range of technologies, including radiopharmaceuticals, gene expression analysis, medical devices, automated laboratory systems, oligonucleotides, specialty chemicals, biologics, and small molecules. Mike has been the CEO at Mikart since the fall of 2018.

Gus LaBella, director of formulation development at Mikart, has over 30 years of experience in oral dosage form development. He is responsible for the management of the formulation development team and the development, transfer, and scale-up of new products. Gus’ role also provides support in Mikart’s manufacturing area regarding troubleshooting and process improvements of currently manufactured products.

Prior to joining Mikart, Gus worked as a formulation technologies manager at Colorcon®, a pharmaceutical excipients manufacturer. Gus’ experience also includes various positions within the research and development group at McNeil Consumer Products, a Johnson & Johnson company. While at McNeil, Gus held positions in product development, investigational supplies, support to marketed products, and R&D technologies. His skills range from pre-formulation of novel dosage forms to post-launch support of marketed products. His areas of interest are wet granulation and design of experiments. Gus holds a B.S. in materials engineering from Drexel University in Philadelphia, Pennsylvania.

Experienced and accomplished Pharmaceutical Program Management Professional with a strong track record of 20 years in progressively challenging roles.

Sam joined Thermo Fisher Scientific’s site in Toronto, Ontario in 2018, where he held leadership roles in Business Management and Project Management.

In his current role at Thermo Fisher, Sam is responsible for OSD Portfolio optimization and growth partnering with the network of OSD sites and sales, as well as multi-site network business relationships for non-strategic accounts. Sam serves as a member of the North America Leadership Team, providing Commercial leadership and Voice of Customer. He leads the mid and long-term demand planning process’ for the global OSD network and partners with sales to support complex deals and drive pricing strategy for key opportunities, bridging business and customer points of view.

Sam earned his Bachelor and Masters of Applied Science at the University of Toronto both in Materials Engineering.

Expert in drug product development with 20 years of leadership experience in both small companies and large CDMOs. Professional project manager, helping diverse teams to develop oral and parenteral formulations for "difficult to deliver” APIs, including peptides and complex oral small molecules.

James joined Thermo Fisher Scientific's site in Bend, Oregon in 2014, where he held leadership roles in early formulation development and project management. In his current role at Thermo Fisher’s Cincinnati site, James leads scientific and technical teams responsible for new product introduction, supporting customers from pre-clinical development through validation, scale-up and commercial life cycle management. Before joining Patheon, James managed a portfolio of early-stage drug companies as Director of R&D for Arrowhead Pharmaceuticals, including RNA-based drugs for hepatitis B and oncology indications, as well as successfully completing early fund-raising rounds for two biotech start-ups: Nanotope Inc. (2006) and Ablaris Therapeutics Inc. (2010).

James earned his BS degree at Cornell University (Ithaca, NY) and PhD at Northwestern University (Evanston, IL), both in Materials Science & Engineering, and holds eight U.S. patents, as well co-authoring 16 peer-reviewed journal articles with 5000+ total citations.

Dr. Kane has more than 30 years of experience in the science and business of taking molecules through the entire drug development process. His extensive knowledge spans early stage development to scale-up and commercial manufacturing of drug products and includes technical transfers between global sites and drug life cycle management.

Dr. Kane received his Bachelors, Masters and Ph.D. degrees from the Bombay College of Pharmacy, University of Bombay, India, and served as a post-doctoral fellow at the School of Pharmacy, University of Cincinnati, Ohio. He has also earned an executive MBA from Richard Ivey School of Business, University of Western Ontario, Canada. Dr. Kane is a member of various international pharmaceutical professional organizations and is a speaker at many industry events. He has also published many articles in International journals and delivered many talks at meetings and conferences cross the globe.

Krizia M. Karry, Head of Global Technical Marketing at BASF Pharma Solutions, leverages 15+ years of expertise in pharmaceutical formulation and process engineering to drive innovation and accelerate drug product development. Her experience with continuous manufacturing platforms, PAT tools, and drug delivery, currently support BASF's customers in accelerating time to market and developing safer medicines.

Known for presentations at global conferences and publications on novel formulations, accelerated drug product design, control systems and PAT implementation, Krizia’s work extends to innovative companies such as Pfizer, Bristol-Myers Squibb, AstraZeneca and Eli-Lilly.

Dale Natoli, a visionary leader in the pharmaceutical machinery industry, is the esteemed President of Natoli Engineering. Under his leadership, Natoli has experienced remarkable growth and expansion, consistently pushing the boundaries of tablet and capsule manufacturing technology.

Dale’s passion for excellence extends beyond the realm of machinery. His commitment to research and development and emphasis on customer satisfaction and support ensures Natoli Engineering’s clients receive the highest quality products, services, and support. Dale’s leadership has solidified Natoli Engineering’s position as an industry pioneer and his tireless dedication to innovation continues to drive the company’s success as a world leader in an ever-evolving pharmaceutical and nutraceutical landscape.

Robert Sedlock is the Director of Natoli Scientific and brings over 25 years of industry experience. Roberts earlier career spans strain gage technology and data acquisition systems. When joining Natoli Engineering Company in 2015, Robert worked with the industrial pharmacy graduate students at Natoli Institute / Long Island University, AMS school of Pharmacy in Brooklyn, NY.

This initiative brought in industry contract laboratory projects and developed the solid dosage manufacturing process training program. In 2018 Robert opened the Natoli Scientific, Telford, PA facility which is now a 14,000 square foot facility that offers solid dosage training programs, contract research and development projects from pre-formulation to formulation development and start-up manufacturing GMP services. Robert is an invited speaker at many universities worldwide and has published many technical articles and peer-reviewed research papers.