The Associate Read Online Free PDF Page B

his energy into law instead of serial murder.
    To Briggs’s left was Brock Newbauer, a junior partner with a sunny smile and whitish-blond hair. Brock would never have made the cut at Reed, Briggs if his father’s construction company had not been one of the firm’s biggest clients.
    Daniel took the chair next to Susan Webster. Arthur Briggs shot him an annoyed glance, but said nothing. Susan scribbled,
You’re late,
on her notepad and moved it slightly in Daniel’s direction.
    “Good morning, Dr. Schroeder,” Aaron Flynn said with a welcoming smile. Daniel placed a legal pad on the table and started taking notes.
    “Good morning,” Schroeder answered without returning the smile.
    “Why don’t we start by having you tell everyone your occupation.”
    Schroeder cleared his throat. “I’m a board-certified pediatrician by training and am currently a senior vice-president and chief medical adviser to Geller Pharmaceuticals.”
    “Could you tell us a little bit about your educational background?”
    “I graduated from Lehigh University with a chemistry major and biology minor. My medical degree is from Oregon Health Sciences University.”
    “What did you do after medical school?”
    “I had an internship in pediatrics at the State University of New York, Kings County Hospital Center, in Brooklyn. Then I was assistant chief resident at the Children’s Hospital of Philadelphia as a pediatric resident.”
    “What did you do after your residency?”
    “I spent several years in private practice in Oregon before joining Geller Pharmaceuticals.”
    “When you joined Geller did it have any particular focus on pediatric drugs?”
    “Yes, it did.”
    “Could you describe for us your job history after joining Geller?”
    “I began in the clinical research and development division and rose through the ranks in various different positions of responsibility until I was appointed vice-president for medical affairs and later was promoted to senior vice-president. For the past eight years I’ve had responsibility for the development of, and gaining approval for, products we’ve discovered.”
    “And that would include Insufort?”
    “Yes.”
    “Thank you. Now, Dr. Schroeder, I’d like to discuss with you the normal process for drug development and marketing and just sort of walk through the steps so that I’ll have an understanding of what’s involved in bringing a drug onto the market. And am I correct that the first step is identifying something that might have some pharmacological value?”
    “Yes.”
    “And then you conduct preclinical studies, studies that are not done with humans.”
    “Yes.”
    “And the preclinical studies involve animals.”
    “Not necessarily. Prior to animal studies, you might conduct studies in tissues or cells. Maybe you would do a computer simulation.”
    “Okay, but at some point you get to the stage where you do what are called preclinical studies to assess both safety and effectiveness?”
    “Yes.”
    “And when you do preclinical studies, the results of those studies are submitted to the Federal Drug Administration, or FDA, for review in what’s called an investigational new drug application or IND, is that correct?”
    “Yes.”
    “What is an IND?”
    “It’s a request for an exemption from the regulations which preclude physicians or companies from giving a substance which has not been approved by the FDA to humans in a clinical situation. If the FDA approves the IND, you are permitted to conduct clinical studies of the drug with humans.”
    “Can I assume that you, as chief medical adviser to Geller Pharmaceuticals, were familiar with the results of the preclinical and clinical studies conducted to determine if Insufort was a safe and effective product?”
    “Well, I certainly reviewed the studies.”
    Flynn smiled at Schroeder. “Can I take it that is a yes?”
    “Objection,” Briggs said, asserting himself for the first time. “Dr. Schroeder did not say