Speakers

Speakers

The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields. We’ll post their bios as they’re confirmed!

Alonza Cruse
Director • Office of Pharmaceutical Quality Operations
FDA, Office of Regulatory Affairs (invited)

Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative.

From 2013 to 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments, pharmacy compounding, and the development of a new inspection protocols program.

Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA’s regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in medical technology from York College (City University of New York).

Brent Del Monte
Senior Vice President
BGR Government Affairs

Brent Del Monte currently serves as Senior Vice President at the BGR Group. In this role he represents clients, particularly life sciences companies, to help them achieve their objectives with the Federal government.

A native of Northern Virginia, after graduating from the College of William & Mary in Williamsburg, Virginia, Brent embarked on a career in public policy by joining the staff of Senator John Warner (R-VA). Brent later served on the staff of Representative Tom Bliley (R-VA), where he held various positions, all with responsibility over health care issues. While serving for Representative Bliley, Brent attended Georgetown University Law Center in the evening, graduating with high honors.

After graduating law school and clerking for United States District Judge Claude Hilton, Brent returned to the Hill where he served as a Counsel for the House Committee on Energy and Commerce, with primary responsibility over food and drug issues. In this position, he successfully saw enactment of the Medical Device User Fee Act, the Project BioShield Act, and the reauthorization of the Best Pharmaceuticals for Children Act and the Prescription Drug User Fee Act (PDUFA).

Brent then served as the Senior Vice President for Federal Government Relations at the Biotechnology Industry Organization (BIO), where he successfully worked for the successful enactment of priority legislation, such as: a pathway for the approval of biosimilars at the FDA; the Therapeutic Project Discovery Tax Credit; liability protections for bioterrorist and pandemic countermeasures; two reauthorizations of PDUFA, including important reforms to the Accelerated Approval pathway at FDA; patent reform; and the 21st Century Cures Initiative.

Commander Tara Gooen Bizjak
Senior Science Policy Advisor
Division of Regulations, Guidance, and Standards
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
FDA, CDER

Commander Tara Gooen Bizjak is an engineering officer in the United States Public Health Service and a Senior Science Policy Advisor at the FDA. She works in the Office of Policy for Pharmaceutical Quality in the area of developing new regulations, guidance, and standards. CDR Bizjak has been with the FDA for 15 years, starting as a field investigator in the New Jersey District, primarily focusing on drug manufacturing and current good manufacturing practice (CGMP) inspections. In 2007, she transferred to CDER to the area of a manufacturing and product quality and was a subject matter contact for several CGMP topics, including pre-approval inspections, continuous manufacturing, pharmaceutical quality systems, water quality, and scale-up issues. Prior to her current role, she served in multiple roles, including branch chief and senior advisor. CDR Bizjak received a B.S. in Chemical Engineering from Cornell University, a Masters in Biomedical Sciences from the University of Medicine and Dentistry of New Jersey, and is an ASQ (American Society for Quality) Certified Quality Engineer.

Kir Henrici
Chief Executive Officer
The Henrici Group

Kir Henrici is the CEO of The Henrici Group. Hg provides strategic quality and compliance solutions to regulated life science innovators around the world. Kir has special interest and expertise in Data Integrity & Enterprise Data Management and a passion for the emerging regulatory focus on Big Data, Data Science & AI.

She has extensive experience serving in Quality and Compliance executive and consulting roles for Nutraceutical, Pharmaceutical, Biotech, and Medical Device industries to include managing and supporting FDA inspections, communications and remediation for companies in receipt of 483’s, Warning Letters, Untitled Letters, and Import Alerts.

As a Principal Consultant, she has had the opportunity to gain diverse and continuous exposure, perspective and knowledge of quality and technical projects and solutions; building core expertise in Quality Assurance/Quality Management Systems, Data Integrity, Risk Management, Regulatory Support, Auditing, Technical Reviews, Validation, Training and Project Management.

Kir is a current member of the PDA Task Force for Data Integrity collaborating on the design and publication of reports addressing data integrity compliance in Quality Management Systems, Manufacturing and Laboratories. She is a committee member for the 2019 PDA Data Integrity Workshop and moderator for the session ‘Big Data Integrity’.

Kir is co-author/contributor for several industry guidance reports/publications including PDA/DHI Book: Assuring Data Integrity for Life Sciences, and has developed presentations and training modules for key industry forums to include PDA, PDA/FDA Joint Regulatory Conference, PCCIG, and IQPC.

Daniele Iacovelli
Partner
McKinsey & Company

Daniele Iacovelli is a Partner and global leader of McKinsey’s Pharma & MedTech Operations practice. Daniele is based in Hamburg, Germany and he has served top Pharma, Biotech and MedTech companies on topics around Ind 4.0, Digital & Analytics transformations, Digital strategy & roadmap development, design of Digital Center of Excellence/ Digital Incubators as well as operational topics as network optimization, large scale operational excellence programs (SC, manufacturing, quality, procurement), etc.

In addition, Daniele is leading the initiative of the Ind 4.0 plant of the future lighthouse in collaboration with the World Economic Forum. Daniele is passionate about helping organizations applying design thinking and agile development methods and he frequently facilitates hackathons and other ideation formats to develop new innovative business growth opportunities.

Before McKinsey, Daniele worked as expert with a global automation/ robotics solution provider for electronics industry in Beijing, China. He holds a Master degree in Commercial Engineering with focus on International Management and a Master degree in Mechanical Engineering.

Paula Katz
Special Counsel
Covington & Burling

Paula Katz advises clients on pharmaceutical compliance and enforcement. She joined Covington & Burling after serving as Director of Guidance and Policy for the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). While at the FDA, Ms. Katz focused on current good manufacturing practice (CGMP) enforcement and drug quality policy issues. She advised CDER and FDA leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy.

Eric Langer
President, Managing Partner
BioPlan Associates

Eric Langer has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher. He has published, edited and authored numerous books, reports, and major studies on topics including: Advances in Biopharmaceutical Technology in China, Advances in Large-scale Biopharmaceutical Manufacturing, Biopharmaceuticals in the US Market, cell culture reports, media, sera, tissue engineering, stem cells, diagnostic products, blood products, genetics, DNA/PCR purification, blood components, and many others.

He lectures extensively on marketing, pricing and channel management topics, and teaches at Johns Hopkins University and American University: Biotechnology Marketing, Marketing Management, Services Marketing, Advertising Strategy, and Bioscience Communication. In 1989 he co-founded BioPlan Associates, Inc. He has launched and managed marketing programs for product lines ranging from $500k to $500 million.

Jim Miller, MBA
Founder and President
PharmSource Information Services, Inc. (ret’d.)

A preeminent expert in bio/pharmaceutical outsourcing, Jim Miller established and presided over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource Strategic Advantage. He was editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report, before his retirement last year.

Jim served as an Editorial Advisory Board member for Advanstar Communication’s Pharmaceutical Technology and BioPharm magazines, and wrote regular columns on outsourcing for Pharmaceutical Technology, Contract Services Europe and BioPharm magazines. He served on the board of directors of the American Type Culture Collection (ATCC) from 2007 until 2016. Jim chairs the advisory committee of the PBOA.

Jim formerly was Vice President of Sales and Marketing at Circa Pharmaceuticals, Inc., a solid dose manufacturer. Prior to that, he was President of St. Anthony Publishing, a provider of database information services for the health care industry. He also was a consultant in corporate strategy with the Boston Consulting Group. Jim holds an MBA degree from the Stanford University Graduate School of Business.

Robert Di Scipio
Chief Executive Officer and Chairman
Skyland Analytics

Bob Di Scipio has served as a senior executive in the life science and software sectors with experience that spans data analytics, biotechnology, corporate law, enterprise risk management, software, and supply chain management. Currently, Bob serves as CEO & Chairman of Skyland Analytics, which provides cloud-based SaaS data management and data analytics solutions for biopharma manufacturers. Bob has served in management and board roles in Life Science and software organizations, including as CEO of Aegis Analytical (acquired by Accelrys/Dassault Systèmes), which developed the first manufacturing informatics software designed specifically for pharmaceutical manufacturers. He also served as the VP Business Development & Associate General Counsel of Martek Biosciences (NASDAQ:MATK, acquired by DSM) and as the General Counsel & VP Corporate Development of OmegaTech (acquired by Martek). Bob speaks and writes regularly on life science manufacturing informatics, data analytics and data integrity, outsourcing, and FDA & SEC compliance issues.

Boyd Spencer
Associate Partner
McKinsey & Company

Boyd Spencer is an Associate Partner and Leader in both McKinsey’s Pharmaceutical & Medical Products and Biologics Operations practices. He has over 20 years of experience in pharmaceutical operations with the bulk of that time spent in biologics. While at McKinsey he has served clients in multiple engagements globally, focusing on operations improvements and efficiencies (across manufacturing, procurement, quality, supply chain), due diligence for operations expansions and new modalities (e.g., cell and gene therapy), implementation leadership to realize value, and operations strategy.

Prior to McKinsey, he was a Managing Consultant with IBM’s Life Sciences Strategy and Transformation practice. Boyd also spent 12 years at Merck with roles in Operations, primarily in Technology Operations, Manufacturing, Network Strategy, Supply Chain and Procurement. He holds a Master of Business Administration, Finance and Operations from the University of North Carolina Chapel Hill and Bachelor of Science in Chemical Engineering from and University of Virginia.

Adam Sybrowsky
General Business Manager
MasterControl

Adam Sybrowsky has over 10 years’ of project management experience within the product and quality management spheres of the life sciences and other regulated sectors. As a general business manager at MasterControl, he has been instrumental in all phases of the creation of the company’s new manufacturing software solution, from planning and development to beta testing and launch. In his current role, Sybrowsky works closely with C-level stakeholders and quality engineers to demonstrate how digitized solutions can help manufacturers improve quality while also reducing production errors and delays while obtaining gaining greater operational efficiencies.

He is Project Management Professional (PMP) certified and has a wealth of experience leading business projects with multimillion-dollar portfolios. Sybrowsky has consistently assisted clients in increasing productivity and efficiency by helping them implement quality and project management principles and planning. He holds a bachelor’s degree in Russian with a minor in business management from the University of Utah.

Ian Tzeng
Managing Director and Partner
L.E.K. Consulting

Ian Tzeng, a Managing Director and Partner in L.E.K.’s Boston office, joined the company in 1998 with experience in growth strategy, regulated markets, innovation, pricing, and mergers and acquisitions. He focuses on healthcare and life sciences, including pharmaceuticals, vaccines and medical devices. He leads L.E.K.’s Pharmaceutical Contract Services practice, including CROs, CDMOs, supply chain and distribution, commercial, medical, and market access services. Other areas of deep experience include rare diseases, biodefense, biosimilars and generics, and consumer-directed healthcare. Additionally, Ian has extensive consulting and board experience with nonprofit organizations in education, arts, LGBT advocacy and public service. He received a Bachelor of Arts degree, magna cum laude, in chemistry from Harvard College and is a George F. Baker Scholar, Master of Business Administration with high distinction from Harvard Business School.

Chris Verbicky, Ph.D., MBA
Director of Scientific and Regulatory Affairs
PBOA

With nearly 20 years of experience in API and Finished Product R&D and Manufacturing operating in the CDMO industry, Dr. Verbicky has served technical and business roles, consulting on countless programs. Since 2017 Dr. Verbicky has consulted in the areas of CMC Project Management, Alliance Management, Injectable Product Development, API Process Development and Scale Up, and Licensing/Partnering.

Previously, Dr. Verbicky was Vice President of Business Development and Marketing for TCG Lifesciences, Vice President of Commercial for Piramal Pharma Solutions, Director of Business Development and Marketing for Coldstream Labs, and Manager of Project Management at AMRI. During his career he routinely consulted to develop project plans and regulatory strategies with pharmaceutical and biotech companies of all sizes.

Dr. Verbicky received his B.S. (Chemistry) from the University at Albany, a Ph.D. in Synthetic Organic Chemistry from the University of New Hampshire, and an MBA focused on Marketing from the University at Albany. Dr. Verbicky completed his post-doctoral research in the synthesis of phospholipids and sphingolipids at Queens College. He is an expert in synthetic chemistry, mechanistic investigation, process optimization, and project management. Dr. Verbicky has authored or contributed to more than 70 patents, publications, and presentations in the areas of project management, business, pharmaceutical development. He is a member of technical advisory boards for INTERPHEX, CPhI North America, and AAPS’s Contract Research Organization Focus Group.

David H. Windley, CFA, CPA
Managing Director – Healthcare Equity Research
Jefferies LLC – Nashville, TN office

Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 20-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, having served as an officer and board member of the CFA Society of Nashville, an Alumni Board Member of the Owen Graduate School of Management, and a member of Leadership Healthcare.