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!

Daniel Cohen
Managing Director
RBC Capital Markets LLC

Mr. Cohen is a Managing Director at RBC Capital Markets, where he is responsible for the firm’s relationships with pharmaceutical and pharma and medical device outsourcing companies including CMOs and CROs. He is an accomplished M&A practitioner, having worked with and advised companies over the past 20 years on the execution of M&A transactions valued at over $75 billion. Recently he advised Cambrex on its acquisition of Halo Pharma, Medplast on the acquisition of Integer’s Advanced Surgical and Orthopedics business, SK Capital on its acquisition of Perrigo API and GTCR on its acquisition of AMRI.

Prior to joining RBC in 2015, he was a member of the Executive Leadership Team and head of Global Corporate Development at Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products which completed its IPO in July 2014. He joined Catalent in 2010 and, after developing Catalent’s inorganic growth strategy, completed 14 transactions valued at approximately $1 billion. Mr. Cohen’s transaction experience at Catalent included acquisitions, divestitures, structured transactions and emerging markets. He has extensive experience evaluating the acquisition and monetization of pharmaceutical products, having completed multiple transactions including the acquisition of US rights to propranolol ER from Forest Laboratories.

Prior to Catalent, Mr. Cohen spent 13 years on Wall Street where he focused on healthcare M&A, particularly within the drug delivery, specialty pharma and generic pharma industries, including at JP Morgan and Bear Stearns.

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.

Paula Katz
Director of Manufacturing Quality Guidance and Policy
FDA, CDER Office of Compliance

Paula R. Katz, J.D., is Director of Manufacturing Quality Guidance and Policy in CDER’s Office of Compliance. She leads an interdisciplinary staff of senior compliance officers and technical experts who focus on CGMP enforcement and drug quality policy issues. Ms. Katz frequently advises Center and Agency leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy. Ms. Katz has chaired Agency working groups and directed the development of guidance for industry, regulations, and legislation; managed responses to Congressional oversight and other stakeholder inquiries; and conducted domestic and international inspections, case evaluations, and enforcement actions. She is a frequent presenter at industry and agency meetings, conferences, and training events. Prior to joining FDA in 2009, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white-collar crime, and general commercial litigation. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.

Jo Pisani
Pharmaceutical and Life Science Consulting Leader
PwC United Kingdom [INVITED]

Jo Pisani is a Partner leading the UK Pharma and Lifesciences Consulting Practice. She has thirteen years of industry experience in the pharmaceuticals, energy, petrochemicals, and fast-moving consumer goods industries with BP and SmithKline Beecham where she held positions in the engineering, operations, IT, and commercial functions. Before joining PwC, she spent three years with Booz&Co, a strategic management consultancy where she focused on strategic issues in the pharmaceuticals and energy sectors.

Jo assists the pharma and lifesciences sector in developing strategy and supporting deals. Her clients include Big Pharma, biotech, generics, OTC, contract manufacturers, contract research organisations, ministries of health, private equity and banks. She is a key author on PwC’s Pharma2020 thought leadership series. She is an advisory board member of MedCity.

Jo has an MBA from Warwick Business School and is a Chartered Engineer

Robert G. Sussman, PhD, DABT
Managing Director
SafeBridge Consultants, Inc.

Dr. Sussman is currently Managing Director of SafeBridge Consultants, Inc., a Trinity Consultants company that provides environmental health and safety services to pharmaceutical, chemical, biotechnology and other industries. With more than 25 years of experience, he is a recognized expert in the evaluation of occupational hazards of potent pharmaceutical compounds and has delivered numerous papers and lectures on the subject. Dr. Sussman has extensive experience in: (1) performing risk assessments including evaluating toxicological and exposure information to determine potential health effects of chemicals, (2) presenting toxicological data to regulatory agencies and assessing the potential impact of environmental, health and safety regulations on chemical and pharmaceutical companies, (3) evaluating safe levels for product cross-contamination by drug substances or other chemicals, and (4) the testing of chemicals for their toxic effects and the interpretation of data from these tests. Dr. Sussman has provided clients with the practical aspects of applying toxicological data to worker and consumer exposure situations for potent and toxic compounds handled in the workplace. He has provided training and technical support to diverse audiences to meet regulatory requirements and to provide solutions to their environmental health and safety challenges.

He has worked in various capacities in corporate occupational toxicology groups culminating as a Director of Occupational Toxicology in Pfizer’s Corporate Environmental Health and Safety Department. His group was responsible for evaluating the toxicity of pharmaceutical products, their intermediates and other chemicals handled in research facilities and providing hazard communication information to all research facilities worldwide.

Bob has an Sc.B. in Bioenvironmental Engineering from Brown University and a Ph.D. in Environmental Health Science from New York University. He is a Diplomate of the American Board of Toxicology, a past member and chair of the AIHA’s WEEL Committee, and a founding member of the Occupational Toxicology Roundtable and serves on that organization’s steering committee. Bob is also a member of the Society of Toxicology, American Industrial Hygiene Association, and the International Society of Pharmaceutical Engineers. He has had an adjunct appointment at the NYU Medical Center where he gives several lectures each year on regulatory toxicology, risk assessment, and industrial hygiene aspects of the pharmaceutical industry.