Careers in Pharmacology and Toxicology Kurt W. Carlson, Ph.D.

Career Areas Academia Professional Government Industry

Academia Basic Research (M.D. or Ph.D.) Grad Student/Post-Doc/PI Research Associate (Bachelor/Master) Clinical Research (M.D./Ph.D./Pharm.D.) Investigator Sponsored Clinical Trials Liaison with Industry/Government

Professional M.D. Pharm.D.

Government FDA NIH EPA DoD USPTO

FDA Regulates: Food Drugs Biologics Medical Devices

Drugs Center for Drug Evaluation and Research CDER ensures safe and effective drugs are available to improve patient and consumer health Small molecule oriented/pharmaceutical industry focus

CDER Employs: Biologists Chemists (Medicinal/Pharmaceutical) Physicians Pharmacologists Toxicologists

CDER Pharmacologists Non-Laboratory Responsibilities: Review/evaluate pharmacological and toxicological data in NDAs and INDs Submit recommendations for approval

CDER Pharmacologists Laboratory Research Includes: The absorption and metabolism of chemicals The disposition of xenobiotics in normal and diseased animals The effects of drugs and toxins from the molecular level to the total body response

Location/Salaries Employment only in Washington D.C. Starting Salaries (basic pay): $36,050 (Bachelor level) $43,621 (Master level) $86,417 (Doctorate level)

Biologics Center for Biologics Evaluation and Research CBER has the same mission as CDER but evaluates vaccines, gene therapy, recombinant protein, monoclonal antibody products Biologics oriented/biotechnology industry focus

CBER Similar employment areas as CDER but more focused on the biological sciences: MCB Microbiology Physiology Pharmacology Toxicology Interdisciplinary Scientist (salary range: $70,519 - $91,672)

NIH Non-regulatory – “the Steward of Medical and Behavioral Research for the Nation” More Basic Science and Clinical Research (27 research centers) Well funded For FY 04 received $23.5 billion Lots of jobs 18,000 employees in Bethesda, MD and around the world

EPA Leads the Nation's environmental science, research, education and assessment efforts Employs 18,000 Pharmacologists and Toxicologists General biologists and physiologists Environmental Health Scientists Manages 17 labs FY 04 budget of $7.6 billion

CDC Centers for Disease Control and Prevention Promotes health and quality of life by preventing and controlling disease, injury, and disability Employs 8,500 worldwide $6.5 billion FY04 budget Salaries are equivalent to FDA, NIH, EPA 170 public health disciplines represented Epidemiology, toxicology, microbiology, virology

DoD Military and civilian positions Civilian pay comparable to FDA, NIH, EPA Military pay is lower, but 40% is not taxed Employs all fields of life sciences Worldwide and well funded

DoD (cont.) World-class medical research facilities U.S. Army Medical Research Institute of Infectious Diseases National Naval Medical Center Uniformed Services University of the Health Sciences U.S. Army’s Walter Reed Medical Center Countering bioterrorism is a major focus but all disease areas are investigated

USPTO Patent Examiner Requires a Bachelor degree or higher Examines patents for patentability and grants them if meets statutory criteria Novelty Nonobviousness Utility

USPTO (cont.) Two-week intense course in patent law Starting Salary from $45,000 (Bachelor degree) to $75,000 (Ph.D.) Valuable experience for later private sector employment

Industry Pharmaceutical (Ten largest companies*) Employs 750,000 worldwide $183.5 billion in revenue Ten leading products generated $44.7 billion $34.4 billion in R&D spending Concentrated in the Northeast and Midwest * 2002 Figures

Industry Biotechnology (Ten largest companies*) Employs 38,200 $15.8 billion in revenue $3.7 billion in R&D spending Concentrated in SF, Boston, San Diego, D.C., RTP, (some in NY, Michigan, and Seattle) * 2002 Figures

Pharmaceutical/Biotech Careers Scientist Research Associate Regulatory Affairs Clinical Affairs Business Development Venture Capital Legal

Scientist All types of life scientists and chemists Generally requires a Ph.D. Exception: Programs where there is a research associate to scientist career track (e.g., Genentech) More jobs in the pharmaceutical industry than in biotech Starting Salary: $70,000. Biotech pays less/Bay Area pays more

Research Associate All types of life scientists and chemists Requires a Bachelor degree Master degree is helpful later in career More jobs in pharmaceutical than in biotech Starting Salary: $45,000 Biotech pays less/Bay Area pays more

Regulatory Affairs Generally Non-entry Level but Lateral Move from Scientist or Research Associate Focuses on submissions to FDA IND, Clinical Trials, NDA, BLA, AE reporting Works with Clinical Affairs and Manufacturing Staff High Demand and Salaries Reflect this: $55,000 to $275,000+ (VP level)

Clinical Affairs Clinical Research Associate A lateral move from Research Associate (unless have a BSN) Higher level jobs are filled by M.D.s Another High Demand Area with salaries starting at $55,000 and increasing to $300,000+ for VP position (M.D.)

Business Development Generally Lateral Move from Scientist VP positions Ph.D., some with MBA Directors and Managers can have Bachelor/Master degrees + MBA Not a high demand field but a critical one so well compensated Starting salary $80,000 to $100,000 VP level $275,000+

Venture Capital Work in Industry for a few years Get an MBA – Learn Finance! Biotech analyst Advise private capital firms on investment decisions Burrill & Co. (Life Sciences Merchant Bank in SF), many venture capital firms in SF, Peninsula Starting salary: $60,000 to $120,000+

Legal Patent Agent Take Patent Bar Exam All you need is your MCB or IB degree Home study sufficient to pass Registered Patent Agent Write biotech patent applications Argue patentability with Patent Examiner Work in licensing patent applications Starting salary $80,000

Legal (cont.) Patent Attorney Why Go to Law School? Essentially same work as patent agent but can also litigate in court Starting salary $125,000+ in law firms Less in industry ($115,000) Partners in law firms make $400,000+ VP of IP in industry makes $275,000+ (Ph.D./J.D.)

Summary and Conclusion Bay Area is World Capital of Biotech Largest concentration of biotech AND venture capital firms that fund biotech Jobs are most plentiful in science and Regulatory Affairs. Other in-demand jobs are Quality Control, Quality Assurance, and Manufacturing The business side, BD, VC, and Legal are very lucrative and rewarding career areas Networking is Vital