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

Harry Benson
Global Director, Human Performance
CAI

Serving as the Global Director Human Performance Services at CAI, Harry Benson leads a team of experienced professionals in developing and executing structured programs, processes, and tools across industry sites to prepare, standardize, and improve the performance of their people. A former nuclear-trained submarine officer, he is an expert in organizational culture and structure, operational staff readiness, and continuous improvement. With over 25 years of experience in applying current methods for organizational effectiveness, his work has driven strong measurable improvements for a wide range of companies and sites. Harry has a B.S. from the U.S. Naval Academy and a Master’s in International Business from Wright State University. He and Karen live in Dayton, OH.

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

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.

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.

Anooj Desai
Senior Manager, Vault Quality Strategy
Veeva Systems

Having previously held roles in manufacturing, quality assurance, and validation in the CDMO industry, Anooj gained an appreciation for implementing more efficient and more effective quality systems to manage critical process data. Drawing on 6 years of experience as both an end user and administrator of quality systems at companies like Miltenyi Biotec, Anooj is a part of Veeva’s strategy team dedicated to developing solutions that drive stronger compliance and safer manufacturing for contract service organizations. Anooj received his Bachelor of Science degree in biotechnology from University of California, Davis.

Joe Hamel
Acting Deputy Director
Administration for Strategic Preparedness and Response • Industrial Base Management & Supply Chain Office (ASPR/IBMSC)

Joe Hamel is the Acting Deputy Director for the Industrial Base Management & Supply Chain Office (IBMSC) , which is housed in the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR). He received his BA in molecular biology from Colgate University and his MS in biotechnology from John Hopkins University. Prior to joining ASPR, Hamel worked as a biologist for the US Army, where he also served as a team leader and chief of planning and policy. Later, Hamel was a program director for the Department of Homeland Security, and a program manager at Johns Hopkins University’s applied physics laboratory. You can find him on Twitter at @JoeHamel9.

Elizabeth Millman Hardin
Partner
Boston Consulting Group (BCG)

Elizabeth Millman Hardin is a core member of Boston Consulting Group’s Operations and Social Impact practices. She is devoted to advancing sustainability and societal impact across the end-to-end value chain in partnership with clients spanning the private, public, and social sectors. Her experience cuts across industries, particularly with clients in the Health Care, Industrial Goods, and Consumer practices. She is an expert on sustainability in operations, especially sustainable supply chain and circular economy. She has also worked extensively in biopharma operations, including lean production systems, supply chain transformation, quality remediation, and manufacturing strategy.

Liz has a background in and lifelong passion for societal impact. At BCG, this has translated into supporting clients on topics ranging from sustainability to education and humanitarian response. She has also led social impact initiatives and is active with Women@BCG in the New Jersey office, and is enthusiastic about advancing creativity in business as a training and workshop facilitator teaching BCG’s approach to Thinking in New Boxes.

Before joining BCG, Liz worked as Managing Director for the education programs at the Joffrey Ballet, a Chicago-based NGO.

Evan Knisely
Founder
Tides Group, LLC

Evan Knisely is the Founder of Tides Group, LLC, a boutique corporate strategy and government relations consulting firm.  Prior to establishing Tides Group, Knisely served for nearly fifteen years as an executive with MacAndrews & Forbes Incorporated, a private diversified holding company with interests in a broad portfolio of publicly traded and privately held companies.  Most recently, Knisely served as Executive Vice President, Government Affairs managing all federal public policy, regulatory, and political matters for the holding company and its various operating subsidiaries. He also advised the firm’s Chairman and senior executives on matters related to corporate strategy, business development, due diligence and philanthropy. Preceding MacAndrews and Forbes, Knisely served for eight years as Vice President of Van Scoyoc Associates, Inc., one of Washington, D.C.’s premiere multi-client government relations firms.

Knisely is a member of the Ford’s Theatre Board of Trustees and is a past president of the Business-Government Relations Council; the only DC-based trade association comprised exclusively of the heads of corporate government affairs offices.  He also sits on the Limited Partner Advisory Committee of Cobro Ventures Opportunity Funds I and II

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.

Aaron Pritz
CEO
Reveal Risk

Aaron Pritz is the CEO, Co-Founder of Reveal Risk, a boutique cybersecurity consulting company focused on building and improving cybersecurity programs and processes. Reveal Risk has a specialized focus on pharmaceutical and life sciences companies, ranging from Fortune 500 to earlier stage and contract research/manufacturing suppliers.

Prior to co-founding Reveal Risk, he spent 17+ years in large pharmaceutical leadership roles across IT, Information Security, Audit, Privacy, and Risk Management. He founded the risk management working group for the H-ISAC (Healthcare Information Security and Analysis Center) which enabled information sharing and benchmarking across pharma, payers, and health care providers.

Aaron is a certified Six Sigma blackbelt with a career emphasis on building and improving internal processes and controls. He enjoys building and enhancing programs and processes to make them more effective and enabling for businesses that they serve. Aaron is the President of the Central Indiana-ISACA board of directors as well as a Board Advisor for TrustMAPP and Eleven Fifty Academy (a cybersecurity boot camp program).

Aaron lives in Indianapolis, Indiana, and is a proud father of 2, enjoys outdoor activities, and is a drummer that has played in over 15 bands (before kids). He enjoys swimming, outdoor activities, and grilling/smoking all sorts of food pool-side on his Big Green Egg.

Nandini Rakala, Ph.D.
Visiting Associate
FDA/CDER

Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master’s degree in Applied Mathematics and Computing and a bachelor’s degree in Mathematics Honors from India. During her past three and a half years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of Pharmaceutical Quality System effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on multiple occasions at various conference seminars and has been a recipient of several awards. In her free time, Nandini enjoys volunteering in community service activities, serving as a math judge, playing tennis, writing, and reading.

Mary Beth Spencer
U.S. Federal Government Relations
Thermo Fisher Scientific

Mary Beth Spencer joined the Thermo Fisher Scientific U.S. Federal Government Relations team in September 2022. Before joining the team at Thermo Fisher, Mary Beth worked at the Health Industry Distributors Association (HIDA) where she advocated on behalf of the healthcare supply chain. During her time at HIDA, Mary Beth led key engagement efforts on Capitol Hill throughout the COVID-19 pandemic working with policymakers to write and introduce the bipartisan, bicameral Medical Supplies for Pandemics Act. Mary Beth previously worked on Capitol Hill for former Energy and Commerce Chairman, Congressman Greg Walden (R-OR). Additionally, she spent time in political fundraising, having managed the national fundraising efforts for Governor Linda Lingle’s 2012 bid for the United States Senate in Hawaii. Mary Beth earned her B.A. in Political Science from Colgate University in Hamilton, NY and her Master’s degree in Legislative Affairs at the George Washington School of Political Management.

Aloka Srinivasan, Ph.D.
Principal and Managing Partner
Raaha LLC

Dr. Aloka Srinivasan brings more than two decades of experience in the pharmaceutical industry, including progressive experience with the U.S. FDA in the Office of Generic Drugs, Parexel International, Lupin Pharmaceuticals, and Lachman Consultants. She provides strategic guidance to the pharmaceutical industry on regulatory and chemistry, manufacturing and controls (CMC) for drug products and drug substances at all stages of development, and for all types of regulatory submissions, including NDAs, INDs, ANDAs, DMFs, and products. Dr. Srinivasan has worked on a broad range of dosage forms and products, including anti‐diabetics, anti‐epileptics, anti‐Alzheimer’s, oncologic, topical antibiotics, NSAIDs, cardiovascular drugs, PDE‐5 Inhibitors, narcotic analgesics, iron‐carbohydrate products, inhalation, and more. Dr. Srinivasan spearheaded the foundation of a division in FDA related to review of drug master files (DMF) under GDUFA and has been a representative of the International Generics and Biosimilar Medicines Association (IGBA) in the ICH Q11 Q&A Implementation Working Group (IWGI). Dr. Srinivasan did her Ph.D. on carcinogenic activation of nitrosamines, including NDMA, NDEA, NDELA in cosmetics, drugs, and tobacco. She also spent seven years as a scientist at the National Cancer Institute researching nitrosamines in potential drug candidates. Dr. Srinivasan champions the regulatory efforts of RAAHA’s clients based on her extensive experience and in‐depth knowledge of the U.S. FDA’s regulatory requirements.

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.

Aaron Weinstein
Senior Director, Validation Services • Principal
IPS-Integrated Project Services, LLC

Aaron Weinstein is Senior Director of Validation Services at IPS-Integrated Project Services, LLC. He has over 23 years of experience in commissioning, qualification, and validation in the pharmaceutical and biotech industries. Mr. Weinstein’s expertise includes: performing facility design reviews, planning and executing commissioning and qualification projects, preparing master plans, performing quality risk assessments, quality audits, and remediation. Mr. Weinstein has a broad range of experience in the facilities, utilities, equipment, and automation related to CAR-T manufacturing, bulk biotech manufacturing, bulk drug manufacturing, and specialized packaging.

WEBINAR SPEAKERS

Kelly DiBattista
Research Manager
Pharma Solutions

Kelly DiBattista, Esq. is the Research Manager at Pharma Solutions and leads the research efforts in assessing and determining state licensing and compliance requirements for Pharma Solutions clientele. She brings over 5 years of experience in conducting research for the pharmaceutical supply chain. Kelly is an attorney admitted to the New York State Bar.

Sue Winter, CQA
Quality & Regulatory Compliance Manager
Pharma Solutions

Sue leads the Quality and Regulatory Compliance initiatives for Pharma Solutions clientele. She brings over 12 years of experience in the drug supply chain industry. She has previously participated as an active member on two Washington D.C. based pharmaceutical and medical device coalitions where she acted as an SME on DSCSA regulatory licensing areas working with FDA and Capitol Hill. She is also an ASQ Certified Quality Auditor.